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June 2019

Bill Childs


In Albrecht, the Supreme Court Holds That Judges, Not Juries, Decide Whether the
"Clear Evidence" Preemption Standard is Met

In Wyeth v. Levine, the U.S. Supreme Court rejected broad preemption of state law products liability warnings claims against the makers of FDA-approved branded prescription medicines. That case only left a path when “clear evidence” indicated that the warning purportedly required by state law would not have been allowed by FDA. In the decade that has passed since then, trial and appellate courts have navigated that path, attempting to give meaning to the “clear evidence” phrase and to determine who should evaluate its presence or absence.

In Merck v. Albrecht, issued today, the Court provides some guidance on both questions. The case involves Merck’s Fosamax osteoporosis medication; plaintiffs alleged that Merck failed to warn adequately about atypical femoral fractures—unusual thigh fractures. In 2008, Merck had proposed adding those fractures to the drug’s labeling, and FDA staff told Merck that it would not approve that label change. The FDA eventually required an atypical fracture label change in 2011. When sued for failing to warn, Merck argued that, prior to 2011, it was impossible to comply with both federal law and give the warnings that plaintiffs contended were required by state law. The trial court agreed, ruling that as a matter of law that plaintiffs’ claims were preempted. The Third Circuit reversed, making two conclusions addressed by the Supreme Court. First, the Court of Appeals held that the question of preemption should be addressed by the jury rather than the court; second, it held that “clear evidence” was a standard of proof, requiring that jury finding to be by clear and convincing evidence.

The Court granted certiorari and found the Third Circuit was wrong on both questions. Six justices joined in Justice Breyer’s opinion of the Court; Justice Thomas filed a concurring opinion; and Justice Alito, joined by Justices Roberts and Kavanaugh, concurred in the judgment only.

All the justices agreed that judges—not juries—should evaluate whether a state law claim is preempted. The legal and regulatory questions involved are complex, and, as the Court states, “The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute” and “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.” Slip op. at 15-16.

The Court also concluded that, based on the fact that the determination is one for the court, the Third Circuit’s imposition of “clear and convincing evidence” as the standard was unnecessary, as was any additional attempt to define “clear evidence” as an evidentiary standard. Instead, “the judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.” Slip op. at 14 (quotation and citation omitted).

In dicta, the Court left open whether the evidence in the case of Fosamax would support a finding of preemption. This question, specifically addressing the nature of the agency actions that should be considered, has important implications for pharmaceutical companies. There was, as noted by Justice Alito in his concurrence, a lengthy and detailed regulatory history relating to atypical fractures. This history shows that the FDA was thoroughly and deeply involved in the issue, but the Court’s opinion (slip op. at 15) signals the justices’ doubts about whether the communications rejecting the label change proposal were sufficiently “official.” The Court does not rule on this question but notes that “the only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’s congressionally delegated authority.” Id. Indeed, Justice Thomas (writing only for himself) says that he would outright reject Merck’s argument based on the nature of the rejection. He emphasizes that he does not believe the record supports a conclusion that there existed federal “Law” that would preempt liability under state law, because there were no final conclusions from the FDA.

The Court’s discussion, albeit in dicta, suggests that companies should consider how best to communicate with the FDA about labeling changes on the assumption that informal communications may not suffice under the clear evidence standard.

In sum, Albrecht provides clarity on who answers the “clear evidence” question, firmly rejecting the Third Circuit’s anomalous view that juries should be asked to assess what the FDA intended.The opinion of the Court and the concurrence by Judge Thomas, however, suggest that, faced with the question, a majority of the Court may find that only formal action by the FDA provides the necessary clear evidence.



March 2019




Performing trials to evaluate the safety and efficacy of medicines and devices for a particular indication and patient population requires the navigation of complex medical, scientific, regulatory, and ethical principles—and such trials, of course, often continue after approval as well, supporting additional indications and evaluating ongoing safety questions.

And so it is no surprise that issues relating to clinical trials feature prominently in many products liability lawsuits, as plaintiffs’ attorneys try to show that corners were cut and something was missed—or intentionally avoided—in the study process, and as defense attorneys demonstrate the extensive work performed to learn about the medicine or device. The clinical trials themselves can become the direct subject of litigation as well, if a subject in a study believes an injury resulted from the trial.

2018 brought us litigation of both sorts, in addition to new proposed guidance from the FDA about how clinical trials ought to be performed—guidance that will, if adopted, be an important part of the regulatory story in litigation in the future.

Litigation About Clinical Trials

            In 2018, courts considering product liability and professional malpractice claims looked at several issues relating to clinical trials:  What is the scope of a trial sponsor’s duty?  What level of evidence is required to prove that participation in a clinical study caused a subject’s injuries?  What are the boundaries of a “lack-of-informed-consent” claim—does such a claim even exist or is it subsumed within another cause of action?  Is an actual injury required to successfully assert that the patient did not give “informed” consent? 

            The Eleventh Circuit considered some of these issues in Looney v. Moore,[i] a case involving a national clinical research trial to study the effects of oxygen saturation levels in infants with extremely low birth weights.  Parents of infants who participated in the study (and alleged consequent neurological issues and retinopathy) sued the doctor who designed and ran the study, the Institutional Research Board (“IRB”) physicians who approved the study, and the company that manufactured the medical equipment used.  The plaintiffs (three children in the study) brought claims ranging from breach of fiduciary duty and products liability to the amorphous “lack of informed consent” claim. 

The courts’ analyses are illuminating.  The trial court granted summary judgment in favor of the defendants.[ii]  On appeal, the Eleventh Circuit affirmed, determining that plaintiffs had failed to prove, as required under Alabama law, that their injuries were “probably” caused by participation in the study as opposed to a consequence of their premature birth.  As a practical matter, this—reflecting the typical preponderance of evidence required in negligence cases—may be a high hurdle for clinical trial patients, given the challenge of distinguishing injuries from the clinical trial from those that would ensue from the underlying condition.

            The Looney court also looked at plaintiffs’ purported “informed consent” claim.  The court refused to identify an “informed consent” claim on its own merits without attaching it to some other cause of action, such as medical malpractice or straight negligence.  Ultimately, the court tied this claim to Alabama’s medical malpractice statute and common law negligence law to determine that, as in all tort claims, an “actual injury” is required to make a claim based on the patient’s lack of informed consent. So even if plaintiffs’ “consent was not intelligently given, as a result of the incomplete information offered to them,” if they cannot show an “actual injury” caused by the study, then, under the Eleventh Circuit’s interpretation of Alabama law, they do not have a claim.  Put another way, a breach of duty “in the air” does not by itself result in liability. That breach must cause harm.  Because the absence of a causal link to any injury was lacking, the court had no reason to evaluate the question of whether a product manufacturer or an IRB can be liable for lack of informed consent.

            The California Court of Appeals addressed the issues of duty and causation in the context of a product liability action against a clinical trial sponsor.  In the unpublished decision Liu v. Janssen,[iii] the court looked at issues of causation and duty of a clinical trial sponsor.  In this case, the court overturned a $5.6 million jury verdict in favor of a parent whose child died after taking one dose of an antipsychotic drug being studied.  Like the court in Looney, the Liu court determined there was insufficient evidence, even under the looser “substantial factor” test, to demonstrate that the trial treatment had a causal role in the patient’s death.  According to the court, “a force which plays only an ‘infinitesimal’ or ‘theoretical’ part in bringing about injury, damage, or loss is not a substantial factor.”[iv]

            More interesting, however, was the court’s assessment of the study sponsor’s duty to trial participants.  The factual scenario was somewhat unusual, in that plaintiffs apparently argued both that the study drug caused the child’s death and, alternatively, that even if it did not, the defendant should have intervened to refer the child to a specialist to address his preexisting heart disease.  The court determined that while a manufacturer/sponsor of a clinical trial undertakes a general duty not to harm study participants as part of the clinical trial protocols, it does not undertake a duty to diagnose or treat a patient’s preexisting, life-threatening disease or to intervene in the medical care and decisions precipitated by a patient’s abnormal test results.  That duty rests with the study physicians who bear the ultimate responsibility for the safety and health of participants in the trial. 

            Finally, a non-profit and individuals involved in clinical trials sued the FDA in Center for Responsible Science (“CRS”) v. FDA[v] seeking to increase disclosures to subjects in studies.  This case began in 2014 with a citizens’ petition.  FDA responded that “extensive review” of the petition was required.  Three years later, FDA responded with a six-page denial of the petition, which the CRS viewed as inadequate.  The petitioners filed a lawsuit against FDA challenging the denial in April 2017.  In April 2018, the United States District Court for the District of Columbia granted the FDA’s motion to dismiss, finding that the CRS lacked standing to bring the suit.[vi]  In May 2018, the CRS filed an amended complaint and, once again, the FDA in August 2018 moved to dismiss on the same grounds.   Yet again, and in a final blow to the CRS, on October 22, 2018, the court determined that CRS fell short of establishing standing for the lawsuit to continue.[vii]  The CRS argued it had standing because it had diverted its resources “to picking up the slack left from the FDA’s desertion of its duties.”[viii]  Without getting into the machinations the CRS underwent to demonstrate some sort of organizational harm, the court was not convinced.  Additional efforts to force greater oversight of clinical trials may well be in the offing—and, as discussed below, the FDA itself does seem to be trying to increase transparency in clinical trials.[ix] 

            FDA Activity

            In May 2018, the FDA and the DHHS issued a Guidance for IRBs with a “written procedures checklist” for IRBs.[x]  The purpose of the guidance is to assist IRB staff responsible for preparing and maintaining written procedures.  Among other things, the 55-item checklist includes items such as considering additional elements for informed consent, reviewing qualifications of investigators and staff, and considering whether the study involves subjects who are likely to be vulnerable to coercion or undue influence and what additional safeguards are in place to protect them.

            In January 2018, FDA Director Scott Gottlieb announced a pilot program to make more data available to the public for new drug trials.  Currently, when a drug is approved, the FDA releases, via the Drugs@FDA website, certain information the agency used when reviewing the new drug application (NDA). This includes summaries written by medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other important, relevant data supporting safe and effective use.  The pilot program will include up to nine recently submitted NDAs.  For these applications, if approved, the Center for Drug Evaluation and Research (CDER) will release portions of the clinical study reports (CSRs) from the sponsor’s NDA along with the action package following approval.  The FDA will gather feedback about how useful posting portions of CSRs in this format might be for the drug research and development community, medical researchers, and the public.[xi] 

            Finally, in November, the FDA launched the MyStudies app to gather data for clinical trials and other research directly from patients. Patients can use the app to directly submit data to researchers, potentially enhancing the collection of “real world” data and evidence.

            Contract Research Organizations

            Litigation in 2019 will continue to mount, particularly relating to the use in clinical trials of contract research organizations (“CROs”).  CROs have of course been used for years by companies big and small, but there is some indication that the scope of their work may be continuing to expand to include tasks previously done by the sponsors, including decisions about interim analyses and study decisions.

Companies need to be vigilant in drafting clinical trial agreements to ensure appropriate oversight and collaboration, as it is easy to picture plaintiffs’ attorneys criticizing the delegation of go/no-go decisions to outside companies—companies that may have a financial interest in continuing to pursue studies. While CROs can be tremendously useful, their use—as with everything else in the development process—should be considered with an eye not just to a thorough and careful analysis of the benefits and risks of medicines and devices, but also to how their use could be (mis-)interpreted in future litigation.


            Everyone in the drug and device development process is already cognizant of the complex and important issues clinical trials face—the pressing need for treatments of countless conditions and the just as pressing need to properly measure the efficacy and risks of those treatments, both before and after approval. As they do so, in addition to the primary goals, they must be aware of the litigation implications, whether directly about the clinical trials or in products liability litigation where the adequacy of those trials is challenged.



[i]       Looney v. Moore, 886 F.3d (11th Cir. 2018)

[ii]      Looney v. Moore, No. 2:13-cv-00733 KOB, 2015 WL 4773747 (N.D. Ala. [date]].

[iii]     Liu v. Janssen Research & Development, LLC, Nos. B269318, B270332 (Cal. Ct. App. 2d Dist., filed Jan. 3, 2018).

[iv]     Id. (citing Bockrath v. Aldrich Chem. Co., Inc., 21 Cal. 4th 71, 79 (1999).

[v]      Center for Responsible Science v. Gottlieb, 311 F. Supp. 3d 5 (D.D.C. 2018).

[vi]     Center for Responsible Science v. Gottlieb, 311 F. Supp. 3d 5 (D.D.C. 2018).

[vii]    Center for Responsible Science v. Gottlieb, No. 17-2198 JEB (D.D.C. Oct. 22, 2018).

[viii]   Id.








Peering Behind The Curtain

Taking a closer look at peer review and predatory journals

Bill Childs[1]

The Daubert court, in interpreting Rule 702 of the Federal Rules of Evidence, laid out various non-exclusive criteria for consideration in evaluating proposed scientific evidence, one of them peer review. As the Court put it: “The fact of publication (or lack thereof) in a peer reviewed journal…will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.”[2]

Compared to other Daubert factors (or those described in the subsequent comments to Rule 702), the presence or absence of peer review may seem more binary than other factors—i.e., easier for a court to evaluate—it’s either there or it’s not, it seems. Not so, either in the traditional sense of peer review or the changing world of things that now get called peer review. Given this perceived simplicity, though, it frequently gets less attention than it deserves. Litigants should think about peer review as being more complex than it appears, and in some specific contexts, additional exploration—whether through discovery into your adversaries’ experts, or early investigation of your own potential experts—may make sense.

Daubert vs. Predator

One fascinating consequence of this consideration of peer review in the Daubert context is the potential for experts publishing litigation-related work in what are called “predatory journals.”

Predatory journals, like the eponymous Predator in the 1987 film and its 2018 reboot, camouflage themselves. They make themselves look not like the Central American jungle background, but like legitimate medical or scientific journals. Their publishers’ websites generally look like legitimate publishers’ websites (if sloppy at times), their PDFs look like “real articles,” and their submission process might even look normal. They’ll even claim to have peer review and editorial boards and all the rest of what you expect from journals. Like the Predator, they even try to manipulate their editorial voices to sound like real journals.

These journals are, however, just aping the façades of real journals. They typically do not have legitimate peer review processes—or possibly any review processes at all. Frequently, if an author pays the exorbitant fees, the submitted article will get published.

Myriad examples exist revealing such journals as frauds. My favorite is probably the publication of a case report of an entirely fictional condition—first referenced in Seinfeld as a condition from which Jerry claims to suffer after being arrested for public urination—by the purported journal Urology & Nephrology Open Access Journal.[3] After that article’s exposure as an obvious fake, and something that even the most casual of reviewers should have rejected, the article was removed, but the “journal” is still up and publishing on the MedCrave site, described, a bit awkwardly, as “an internationally peer-reviewed open access journal with a strong motto to promote information regarding the improvements and advances in the fields of urology, nephrology and research.”[4]

Such journals are largely set up to entrap new (and naïve) scholars who are under tremendous pressure to publish for promotion and tenure purposes—but they also can provide an opportunity for expert witnesses to get something published they can cite as “peer reviewed,” especially as courts more and more often note the presence or absence of peer review. It isn’t news to many litigation experts that having peer review for some of their more outlandish assertions can increase the odds of their testimony being admitted. If an expert in fact has published in such a journal (and it can be shown that the expert knew or should have known about that fact), that fact should count against the admissibility of the testimony.

Given the camouflage, it is fortunate that there are resources and strategies that can help identify such publications. Retraction Watch (, published by the Center for Scientific Integrity and headed by science writer Adam Marcus and physician and writer Ivan Oransky[5], while not focused solely (or even largely) on predatory journals, is an accessible look at the world of retractions “as a window into the scientific process.” They keep an eye out for interesting developments in the world of predatory journals and scientific publications more generally, and their coverage is what made me suspicious when, in one of my cases, an adversary’s expert’s article was published by a MedCrave journal (home to the Seinfeld article). Retraction Watch’s coverage of that article led to what I assume will be the only time in my career I had the chance to ask a Ph.D./M.D. if he was familiar with Seinfeld and if the show is, in fact, fiction, based on him publishing—and in fact being listed as an editor of—another MedCrave journal.

There is also a list of suspected predatory journals archived at The appearance of a journal on that list is not conclusive evidence that it is predatory[6], but it is enough to raise questions. The “Journal Evaluation Tool” available at can also provide a useful rubric, accessible to non-scientifically-trained lawyers, for evaluating whether a journal is likely legitimate or not. And your own experts can likely provide feedback to you about journals.

Most experts will not have published in predatory journals. But it is still worth the time to explore the question, especially about pivotal articles on which the experts are relying—whether the expert is your adversary’s or your own. Even if the publication offer was innocently accepted (i.e., even if the author did not realize she was publishing in a predatory journal), the lack of rigor in evaluating the article by the publisher should at a minimum eliminate any weight given to the peer review factor. And if an author has intentionally published in such a journal, that should be the equivalent of an intentionally false statement in a C.V.

Not All Peer Review Is The Same

Of course, these relatively new faux journals are not the only way experts get published.  Consider the most traditional form of peer review, where editors of a journal have outside reviewers, usually with their identities screened from the authors, evaluate the quality and originality of the work, confirming that the methodologies presented appear legitimate and that the conclusions reached are reasonable based on what’s described. Given the fact that those goals line up nicely with the goals of a Daubert analysis, it is sensible indeed for a court to look at that as a potential indicator of reliability—indeed, that’s why peer review is a factor in the first place.

But even if a proffered expert represents that she has followed a methodology that matches something in her peer-reviewed publication, it is often worth at least a few deposition questions about the review process and a line in your subpoena duces tecum requesting copies of any materials the author has received relating to the review, or to attempt some third party discovery on the journals in question—though some courts may limit or refuse that discovery.[7] If you get those notes, it’s possible you’ll find that a reviewer recommended the removal of a conclusion that the expert is now presenting, or that the reviewer warned against a particular inference from what is in the article. Making it even easier, some journals, traditional and, more often, “open access,” are now posting their reviewers’ comments online. Even if you do not find anything relevant, most experts will readily concede that peer review reflects at most an “approval” of the overall approach and is not a guarantee of correctness as to conclusions. And sometimes you’ll be able to establish that the study in question was based on flawed data or that the work done for litigation did not, in fact, use the same methodology as that in the publication.[8]

Sometimes, even in a more traditional context, the peer review that was performed was not what was likely pictured by the Daubert court, particularly when the work at issue is outside the so-called “hard sciences.” In a publicized example, the review of a history-oriented book about the lead and vinyl chloride industries, authored by frequent plaintiffs’ experts and published by the University of California, involved reviewers known to—and in some cases recommended by—at least one of the authors.[9] Whether or not that review was adequate for the academic purpose, it was materially different from, say, the reviewers of a double-blind clinical trial, and the facts surrounding it seem plainly relevant to how much weight a court should give it under Rule 702 and Daubert. Without that discovery, the court may well not have learned about what “peer review” meant in that context.

Consider also the scenario where an expert says that their methodology has gone through peer review but the article has not yet been published. Again, it may be worth pursuing more details, especially if the expert seems likely to cite to that review in defending their position. If it has not yet been accepted for publication, consider requesting a copy of the comments the expert received from the reviewers. If those comments are provided, they may be helpful; if their production is refused, the fact of that review should be rejected as a basis for admissibility.

What To Watch Out For

Fundamentally, the important thing is to look through your and your adversaries’ experts’ C.V.s with care, especially as to articles that are directly on point with the issue you’re addressing. It is not enough to think about what the articles say, and it also is not enough to think to yourself, “Well, that sounds like a legitimate journal.” Look at the publishers’ site; look for hints in the article itself; and do some searches. Ask a few questions of the expert about what the peer review entailed and throw in a document request to see if there is something worth exploring further. And if you are dealing with a situation with what you think is a predatory journal, be ready to teach a judge about what that means; as of this writing, no court has referenced “predatory journals” in a reported Daubert decision.


[1]      Partner, Bowman and Brooke LLP, Austin, Texas. Special thanks to Elizabeth Haley for research assistance. The positions in this article reflect my own views and do not necessarily reflect those of Bowman and Brooke or its clients.

[2]      Daubert v. Merrell Dow Pharms., 509 U.S. 579, 594 (1993). Peer review, or the absence thereof, was mentioned repeatedly by the New Jersey Supreme Court in endorsing Daubert in the recent decision in In re: Accutane Litigation (A-25-17) (079958). Among other things, the Court noted that the plaintiffs’ expert had not submitted “his ideas…for peer review or publication,” considering that failure to be a strike against his methodology.

[3]      The author of the intentionally nonsensical article—not a urologist, nor a medical doctor at all—wrote about his experience at

[4] A few years earlier, a computer scientist published an article consisting solely of the phrase “Get me off your [obscenity] mailing list,” with related graphs, repeated for eight pages. See That journal remains up as well.

[5]      Full disclosure: Ivan and I are friends, based in large part on our shared love for power pop like Fountains of Wayne and western Massachusetts bands like Gentle Hen. He should not be blamed for my Predator references.

[6]      For details, see Science magazine’s “sting” at

[7]      See, e.g., In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. Civ.A. 08-mc-10008-MLW, 2008 WL 859207 (D. Mass. March 31, 2008) (granting protective order for non-party medical journal publisher, expressing concerns about a chilling effect). The propriety of allowing such discovery is beyond the scope of this article, but I addressed it in more detail in The Overlapping Magisteria of Law and Science: When Litigation and Science Collide, 85 Neb. L. Rev. 643 (2007), also available at

[8]      See, e.g., In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 936, 945 (D. Minn. 2009) (reversing an initial denial of defendants’ Daubert motion after learning of flaws in underlying data and processing, noting that “Peer review and publication mean little if a study is not based on accurate underlying data.”); Palazzolo v. Hoffman La Roche, Inc., No. A-3789-07T3, 2010 WL 363834, at *5 (N.J. Super. Ct. App. Div. Feb. 3, 2010) (finding no abuse of discretion in excluding an expert’s conclusion based on conclusion that the expert did not in fact use the methodology claimed to have used in the underlying peer-reviewed study).

[9]      The website for the authors of the book,, has been taken down. It is described (and quoted) in an article I wrote when I was a law professor; it is available in the Nebraska Law Review cited supra note 2.


April 2018

Submitted by: Francisco Ramos, Jr.



Our interview with our Member William Fiasco


Please tell us a little about yourself and your practice.


I work at a mid-size firm in Tulsa. The firm's roots are in insurance defense but, probably like most insurance defense firms, we are looking to expand opportunities. The majority of my time is spent defending healthcare providers in medical negligence suits. I enjoy dealing with medical issues, as that provides the "special sauce," making many of my cases unique. I've also defended cases dealing with medical devices, drug cases, and I even do some bad faith defense.


Trial has a lot of moving parts.  When do you start preparing for trial?


If it's a less complex case and I have the only defendant, I will generally start "pure" trial preparation 2 to 3 weeks before trial.


Can you describe for us generally what checklists you go through to prepare for trial?


I might begin by reviewing what I anticipate will be the jury instructions. I would have met with my client even a few weeks before pure trial preparation begins in order to make sure we were on the same page in regard to our defense themes. I obviously want to come to firm decisions about what witnesses I need and what exhibits I'll use. If subpoenas are necessary for witnesses, those hopefully go out several weeks before trial. I actually try to read my entire file, pleadings and correspondence, from inception to trial. I prepare my client with a mock cross-examination, but usually only cover general areas of direct examination so as to keep that fresh. I will prepare broad outlines for direct examination of defense witnesses, but I prepare much more specific cross-examination outlines of the plaintiff and the plaintiff's expert(s). I'm still handwriting these things. Don't make fun. I cross reference medical records and other exhibits to utilize during these examinations. Preparation of any outstanding pretrial motion hearings, along with voir dire and opening statement outlines come last.


Do you rely on technology at trial?  If so, what?


Our paralegals have been trained on Trial Director, and I've used this for the last several years. However, I've grown unhappy with it. It also happens that we recently bought iPads with TrialPad. I've committed myself to learning how to use TrialPad for less complex or document-intensive cases. For the more complex cases, and for cases with multiple defendants, I would likely use an outside vendor. I'm also interested in using PowerPoint for either openings or closings, but still haven't done it. Despite all this, I'm still prone to putting critical documents on foam board. There's practically nothing better than having your doctor get out of the witness box and stand in front of the jury with a nice big Netter’s blowup which has a clear film over it for erasable marker. Lastly, I will get professional medical animations when the facts warrant.


How you work with the client to put her best foot forward at trial?


This obviously starts with the client's deposition. If we messed that up we are working to put our best foot forward at mediation, not trial.


I will want to meet with my client a couple months before our trial date in order to make sure we both understand our defense themes. Then, in the more intense meetings during the two weeks before trial, one thing I always do is ask my client, "If there were only three things the judge would allow you to tell the jury in your defense, what would those be?" It's a rare case where I would even tweak the three things, and it is more rare if we don't use those three things practically verbatim at trial. Also, if we have time in the run up to trial, I like to take my client over to the courthouse to visit the trial judge's courtroom. This is a good place to discuss the mechanics of a jury trial. I've sometimes had my client take the witness stand. As a part of all this the client can't help but see the preparation and production value you’re investing in the case. This hopefully lends some semblance of confidence to what is understandably a foreign and anxiety-producing undertaking.


How do you use your experts at trial to emphasize your themes?


As with the client's deposition, the ability to use my experts to emphasize themes had better have been worked out prior to their depositions. In many of my cases my client is called in the plaintiff's case in chief. If my client has done well I will severely curtail the workload of my experts. In any event, as with my client, I put together a direct examination outline of my experts which gets them up in front of the jury with models and/or diagrams.


What advice do you have when cross examining the Plaintiff’s expert?


The cross-examination outline of the plaintiffs expert is almost always the single biggest time sink in my trial preparation. It is the subject of my most meticulous preparation. I think that this fact causes me to often violate a good piece of advice, which is to stay out of the weeds. This is probably more important with experts who are not intellectually honest. They will view every question as a chance to harpoon and bootstrap, so the more questions you ask, particularly about more arcane topics/issues, it increases the risk of taking a hit. The defense lawyer rarely gets the chance to be aggressive, theatrical, emotional, etc. in front of a jury. However, I do think the jury expects the defense lawyer to set off at least a few fireworks during the plaintiff's expert’s cross exam. I would guess that it's true of most of us (it definitely is for me) that effective moments of cross-examination of an expert witness uncork the dopamine better than any other part of trial.


What goals do you have for closing argument?


One trick to a good closing argument is effectively weaving back together all of your defense themes without frustrating/angering jurors who have now heard all of those themes repeatedly. I do make an effort to think about whether I really need to repeat particular facts. Given this, I guess it sounds contradictory that one of the most important things I want to accomplish in closing is to make sure the jury understands that everything I told them was going to happen in my opening statement actually did happen. If I had a checklist for closing, it would probably include reading portions of the most important and helpful jury instructions, once again personalizing my client (usually by literally looking at him/her and pointing out the truly awesome responsibilities he/she accepts by making so many important life-affecting decisions, sometimes quickly), reviewing the most important documents (in a more cursory fashion), and circling back to the more significant promises the jury made in voir dire, particularly regarding sympathy.




Our interview with our Member Heidi Goebel


Please tell us a little about yourself and your practice. 


I am a former Hoosier who has practiced law in four states.   I married a ski instructor and we decided to make the Mountain West our home.   I primarily handle product liability and commercial litigation cases, including insurance bad faith litigation.  I have also developed a niche practice of defending entities in sexual abuse cases. 


Trial has a lot of moving parts.  When do you start preparing for trial? 


It really depends on the case.   Generally, I start envisioning the trial and what I will need to prove our case at the outset and check in on that list periodically throughout the case.  However, when it comes down to the wire, I usually block out the two weeks prior to the trial for preparation (if it is a shorter trial, then maybe a week out) and about two months in advance I start slotting in witnesses for their prep during that window.


Can you describe for us generally what checklists you go through to prepare for trial? 


I start a couple of months out with reviewing the proposed jury instructions which remind me of all the elements I will need to prove.  I use those as my chart to guide my preparation.   I get my assistants to issue the necessary subpoenas and I contact my experts to ensure I have the witnesses I need available.  The Utah Bar is pretty cordial and frequently attorneys will agree to take experts out of order if needed to accommodate travel schedules, but, as with most things, the more time you give them to adjust to your needs, the more likely they are to accommodate a request.  At that same time I’m finalizing our exhibits and making sure they are organized.  I have an outline for each witness identifying the exhibits I need them to address.  I then prepare my opening and the outline of what I anticipate my closing will be.  


Do you rely on technology at trial?  If so, what?


This is a timely question.   I am attending the FDCC Tech U to try to improve my skills here.  I’m embarrassed that I am a bit behind in my tech skills.  Up until now, I have frequently use a PowerPoint for closing argument, anatomy apps with experts to explain injuries and the functioning of various organs and I have had witnesses appear by Skype but that’s about.  As of next week, however, opponents need to watch out, as I expect to be proficient with Trial Pad, Timeline 3d and a host of other applications. 


How you work with the client to put her best foot forward at trial? 


Communication, communication, communication.   This is crucial throughout the entire case.   Making sure you understand your client’s goals and that they are adequately apprised of the developments in the case is key.  Surprises can deteriorate a relationship like wildfire and you need to have your client’s trust.   Letting them know about adverse developments as quickly as possible gives them the time to process that information and react as calmly and rationally as possible in front of a jury.   I also try to make sure they are prepared for any testimony that may come up. Sometimes that means doing my own investigations on line to find skeletons that the other side may have unearthed.  My goal is to have my preparation sessions cover harder topics and be more challenging than the actual trial testimony.


How do you use your experts at trial to emphasize your themes? 


Depending on the case, they can either bolster the testimony of others or they may be the main act.   I go over my themes with them so they understand where I am headed.   I do this early in the case, because sometimes I need to change my theme because it doesn’t mesh with the science.  I find that if they understand the whole picture the verbiage they use to explain their area of expertise can sometimes be a little more precise to the case at hand.


What advice do you have when cross examining the Plaintiff’s expert?


Rely heavily on your own expert. They are your best resource for challenging the Plaintiff, and to do so in a way that is effective.   And, know when to quit. If you’ve had the chance to depose them, you should have a pretty good idea of which points they will give on and which they will not. The old adage, don’t ask a question to which you do not know the answer, is especially important here.


What goals do you have for closing argument? 


I want the jury to be engaged in my story – and I believe that in today’s world, that mean using multiple media forms and basically making closing argument somewhat entertaining.   If they aren’t listening to me, they can’t buy in to my message.   I take the themes that I laid out in opening and connect the evidence for them.




Our interview with our Member Daniel Herling


Please tell us a little about yourself and your practice.


I am  a member(partner) at Mintz Levin, resident in its San Francisco office.  My practiced as evolved over the years but has had a concentration in product liability.  Many of the cases I work on today relate to consumer products that are involved in class actions regarding claims of deceptive or unfair trade practices, false advertising and violations of various regulations, both State and Federal.

Trial has a lot of moving parts. When do you start preparing for trial?


I actually start preparing for trial upon my initial reading of the complaint.  Even with cases that I have a feeling will settle, seeing how a trial will enfold starts from the beginning.

Can you describe for us generally what checklists you go through to prepare for trial?


When I started my career as a prosecutor in the US Navy JAG Corps., I would literally write down the elements of each offense alleged in the charge sheet (Military complaint) on one side of legal pad (pre-computer days) and what evidence I had or needed to prove that element (documentary or testimony and which witness would be needed to accomplish the admitting of that evidence) on the other.  Today, I still use a Proof chart to evaluate what the plaintiff needs to prove, how they may do that and what I need to counter or to establish affirmative defenses.  That chart starts the process and evolves as the case progresses.  I also use a checklist relating to what tasks that need to be done 120 days before trial, who is to perform that task; and several other checklists relating to witnesses, experts, logistics, evidence, motions in liminie, jury instructions, etc.  I use checklists to ensure that nothing is missed. 

Do you rely on technology at trial? If so, what?


Over the years, I have used many different types and scope of technology.  A recent trial judge required everyone to use the same technology and there was no paper in the courtroom. Videos of testimony and of the products at issue being manufactured and operated were used extensively.  I rely on technicians to ensure that the technology works and we practice before going live.  The type of trial, budget, and location also dictate technology usage.  In my most recent jury trial, blowups of photos were the only “technology” used and it was effective.

How you work with the client to put her best foot forward at trial?


I attempt to get the client to help develop the narrative so she is comfortable with it and we prepare and practice both direct and cross examination with the balance of trying not to make it appear staged.  For example, if the client has a background in sales, I let her tell her story in a comfortable manner and let her natural ability as a sales person come through.  Positive reinforcement is important.


How do you use your experts at trial to emphasize your themes?


In many product cases, the expert opinions drive the themes and I work off of that and ensure that in their testimony those opinions are asserted and ready to be defended.  Where the opinions are more in a support role, I attempt to use the opinions accordingly.

What advice do you have when cross examining the Plaintiff's expert?


Know beforehand what points you want to score with the particular witness.  Then like a good boxer, get in, score the points, get out and SIT Down.  To continue the metaphor, you can win a decision on points, you do not need a KO.  Don’t be greedy.

What goals do you have for closing argument?


1. Ensure that the jury knows what your narrative or themes are.  You told them in opening statement what they were, now the evidence establishes them.


2. That they believe that I am the most credible person in the room and what I say is credible.


3. That the result that I am asking for “makes sense”



March 2018

Submitted by: Michael A. Walsh


The following excerpt was presented by Michael Walsh of the Drug, Device, and Biotechnology Section at the FDCC 2018 Winter Meeting, Amelia Island, FL.


(Click here to download the complete presentation.)



The Opioid Crisis: Pain and Punishment

Industry-Wide Liability




The opioid crisis in America has given birth to a litigation poised to dwarf in scope and scale every previous mass tort litigation. While this article will focus on the litigation that has spawned from the expanded use of opioids in beginning in the 1990s, the civil litigation is dwarfed in scale and scope by the human tragedy that has unfolded over the past twenty years, ever since “pain” was recognized by the medical community as the fifth vital sign.  Drug over dose deaths are clearly a modern scourge and disgrace but there is far more to the solving the underlying problem than scapegoating industry will provide.


While opioid litigation shares some common attributes to prior mass torts, such as tobacco, opioids differ in that they are important prescription medicines that provide unique and significant benefits when used in the dose, duration and indication in the Food and Drug Administration (FDA) approved labeling.  What is unique in the opioid addiction context is that there is culpability, not necessarily civil or criminal liability, at every level of the vertical information and distribution chain.


The civil litigation is poised to reallocate resources from manufacturers, distributors, dispensers and others, to “compensate” state, municipalities, hospitals and others for past, present and future expenses to address a massive population of substance addicted Americans.  There is no dispute that addressing the cost of treatment is critical and urgent, but the faucet of illicit narcotics pouring in to American cities and towns continues unabated.  According to a March 6, 2018 report from the Centers for Disease Control and Prevention (CDC) the human carnage is rapidly increasing.


The opioid lawsuits threaten to settle in to either the familiar and protracted period of procedural maneuverings and discovery, as well as court mandated settlement discussions. There is little doubt that lawsuits change behavior, but expecting lawsuits to provide a remedy to this crisis is akin to driving a car using your rear view mirror and expecting to arrive at your destination. Moreover, expecting monetary relief to remedy or slow the opioid crisis is akin to a house with an overflowing bathtub where the homeowner scrambles to replace the living room furniture all the while the water continues to run and overflow. For a problem unparalleled in American history, what is needed is an equally unparalleled remedy.


No medication is to be trifled with, least of them are opioids. While we will always have drug addicts and drug deaths, opioid medications are good and efficacious for the approved indications, in the approved doses and for the durations in the approved labeling.  Nonetheless, as the labeling suggests, even when used in the dose, duration and indication in the approved labeling, some patients will develop dependence. The literature suggests that one out of every fifteen new prescriptions will produce a habitual uses and of those fifteen, close to half will become addicts. And of the addicts many will die.  


The President declared a National opioid emergency on October 26, 2017 and directing the Department of Health and Human Services to declare the opioid epidemic a public health emergency.  This designation puts the response under the jurisdiction of the DHHS as opposed to the appearance of a more sweeping national emergency under the Stafford Act, which would fall under the control of FEMA. The National emergency has been extended by the president and the White House has even called for increasing the penalties for drug traffickers to include the death penalty for certain offenses.


The Opioid Crisis has exploded without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, and has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our programs focus on where we are today, how we got here and what steps should be taken towards risk mitigation for employers and others in the chain of distribution.


“Unquestionably, our greatest immediate challenge is the problem of opioid abuse.  This is a public health crisis of staggering human and economic proportion … we have an important role to play in reducing the rate of new abuse and in giving healthcare providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction.”


Scott Gottlieb, FDA Commissioner, Address to FDA staff, May 15, 2017. If the current pace of opioid case filings is maintained, every political subdivision in the U.S. is on track to file an industry–wide liability suit against some or all of the participants in the vertical chain of supply and distribution for opioid medications.  As the discussion below, it is no coincidence that these are largely parens patriae cases, state, municipalities and tribes may get preferential rulings on issues of proof.


As the litigation landscape explodes with new cases and theories, and alignment of defendants, there is increasing uncertainty over whom, if anyone, is really to blame? Irrespective of whether and who may be liable, the components for a large mass torts are present; large-scale exposure, susceptible population, serious injury or death, and evidence (whether real or contrived) of profit over safety.


The Judicial Panel on Multidistrict Litigation transferred the flood of federal court case filings to Judge Dan Polster in the Northern District of Ohio. Judge Polster has declared a moratorium on filings and proceedings as he attempts to streamline the process and forge a global resolution.  On March 7, 2018, the MDL court entered a conference order requiring a Case Management Order establishing  “the appropriate scope and timing of a litigation track.” The parties had been ordered to engage in settlement discussions appointing  a panel of twelve negotiators, six for the plaintiffs and six for the defendants were appointed. In addition, despite having no jurisdiction over the States Attorneys General, the court “requested” a committee of Attorneys General. Adding to the complexity, on March 1, 2018 the United State Department of Justice filed a Statement of Interest on behalf of the United States of America to consider joining in the multiple actions pending in the MDL. 


From the plaintiffs’ lawyer perspective, the strategy is simple; repeat what you have done in prior large scale litigation and anticipate the same large payout.  The plaintiffs bar approach is familiar, time tested and calculated to produce financial rewards. For the defense, the approach is not as simple.  The controversy is being litigated, and lost, in the court of public opinion where the presumption of liability looms.  Tellingly, in its 140 page and 60,000+ word final report, the White House Commission on Combating Drug Addiction and the Opioid Crisis only mentions purported drug manufacturer over-promotion of opioids one time.  Yet the notion that manufacturers are responsible litters the media and litigation landscape. Opioid deaths are often compared to automobile deaths, yet we do not see the media clamor against car companies or states suing the industry on a market basis for automobile injuries. There are as many reasons not to hold drug manufacturers and distributors liable as there are for the automobile industry .  Perhaps the advent of autonomous vehicles will change that and we will get a similar retrospective look and sue approach.





February 2018

Submitted by: Francisco Ramos, Jr. 



Amelia Island Meeting

The Opioid Dilemma - Pain and Punishment


Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.


Preparing the Corporate Representative for Deposition

Interview with Jaret Fuente


Tell us a little about yourself and your practice

I am the proud father of a beautiful seven year old daughter.  She is smart, kind, curious and creative, and she lights up every room she enters with her boundless energy and personality. 


I have been practicing law with the Carlton Fields law firm, in our Tampa, FL office, since 2001.  I am an active member of our firm’s National Trial, Construction, Class Actions, and Products Liability practice groups. 


I represent product manufacturers in multiple industries, including the automotive, aviation, building and construction, chemical, medical device, pharmaceutical, and sporting goods industries.  I also represent builders and contractors in all manner of business disputes and construction defect claims. 


I regularly contribute to our firm’s class action blog, CLASSIFIED:  The Class Action Blog, which you can read at  And I serve on the firm’s E-Discovery team. 



What’s your approach to defending a corporate representative deposition in drug & medical device case?

Selection of the right witness(es) and preparation are the keys to successfully defending any corporate representative deposition. 


Selecting the right witness(es) is arguably the most important part of defending a corporate representative because no matter how much you prepare, if you don’t have the right witness, the deposition can be disastrous.  It is never too early to start thinking about this.  Don’t wait to receive a notice, though the matters for examination in the notice should factor into your eventual selection.


Selecting the right witness is not as simple as selecting someone knowledgeable or most knowledgeable of the matters for examination.  Nor is that required.  That is a consideration, but so is whether the witness is likeable, articulate, confident, patient, easily agitated or frustrated, detailed-oriented, persuasive, experienced as a sworn witness, and capable of expressing the corporation’s position in the manner necessary for the case.


Evaluate the notice for compliance with the rules.  Determine whether it is detailed enough to allow you to effectively prepare.  If it is not, seek a clarification or compromise with counsel who served it and, if necessary file a timely objection that will allow time for a hearing before the deposition. 


Once you’ve selected the witness, and settled on a notice and list of matters for examination, you must thoroughly prepare yourself and the witness as described below. 


How do you prepare the witness?

Meet with the witness, in person, and as many times and for as long as necessary to properly prepare the witness.  Explain the process.  Go over the rules.  Impress upon the witness the importance and significant impact of his or her testimony.  Review the history of the case and its issues.  Review pleadings, other depositions and exhibits, and other documents.  Interview and meet with others currently or formerly with the entity involved, and with outsiders, as appropriate.  Conduct a mock deposition of the witness.  Make the witness feel invested.  Build confidence.  


What documents do you show her?

Documents that are necessary to educate the witness about the corporation’s knowledge of the matters for examination and its position in the case.  This can include documents of the corporation or others, photographs, pleadings, deposition transcripts and exhibits, and correspondence. 


How much time do you spend with her?

As much time as necessary. 


Describe your deposition prep session.

Deposition preparation should not be limited to a single session.  Preparation should usually span multiple sessions.  Preparation should be focused, but also broad in scope.  Preparation should be focused in that there should be no interruptions and distractions.  It should be broad in that it should cover the landscape—from the rules to the specific details of the case.  Preparation should involve both educating and challenging the witness while building his or her confidence.  


What are your goals in deposition prep?

To impress upon the witness the importance and the effect of his or her testimony, to anticipate issues and questions so as to avoid surprises, and to build confidence in the witness. 


Any final tips.

If you fail to prepare, then prepare to fail.  Preparation is key.  Don’t put your client, the witness, or yourself in an avoidable position by failing to properly prepare. 


Know the rules and the case law, the players, the personalities, the issues, the documents—know everything.  Then put yourself in your opponent’s position and create an actual outline of how you would conduct the deposition.  What would you ask?  Why would you ask it?  When would you ask it?  How would you ask it?  How would you follow up?  What documents would you use and why? 


Conduct a mock deposition with the witness.  Consider videotaping it.  Assess how your witness handles the pressure.  Anticipate and prepare for everything.  And once you think you’re ready, go over it again, and then again.





January 2018

Submitted by: Francisco Ramos, Jr.

Amelia Island Meeting

The Opioid Dilemma - Pain and Punishment


Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.

Planning for 2018

Interview with our member Amanda M. Cialkowski

Tell us a little about yourself and your practice?

I'm a trial lawyer practicing in the areas of product liability, toxic exposures, drug and medical devices and mass torts.  Increasingly, I'm enjoying the role of last minute, drop-in trial counsel, working with other attorneys around the country.  My background in teaching lends itself well to explaining complex concepts in ways jurors can understand.  When I'm not working, I enjoy spending time with my husband and daughters and learning about midcentury modern architecture and furnishings.


At the beginning of a year, what plans do you make generally to advance your clients’ interests in their matters?

I inform my clients of any changes in the law that may impact their business.  This may include preventive advice to change internal policies or practices that help fend off future litigation.  I also start with a close look at the trial calendar for the upcoming year to ensure that clients are aware of upcoming deadlines and anticipated expenses, so they can budget and set reserves.

How do you apply how you plan and prepare for your cases to how you plan your professional career?

In terms of my style as a trial lawyer, I like to prepare by doing a deep dive into the documents, science and facts supporting my case.  That is balanced, however, by the challenge of unexpected drop-in trials.  So I'm learning to take risks and accept some of the uncertainties inherent in that role.  I've been doing the same with my marketing and promotion, accepting invitations to attend and speak at conferences where I am less familiar with the subject matter.  It's a great opportunity to learn and grow.


What advice do you have for our members on how they plan for 2018 regarding their cases? Business Development? Their careers?

One goal of mine for 2018 is to focus on clear, frank communication with my clients and colleagues.  I have seen clients' frustrations when they receive evolving stories or evaluations of cases from their counsel.  I think it is important to explain to a client quickly why my view of a case changed and to explain what happened to change that view (i.e., a witness crumbled in a deposition, I discovered a damaging document, etc.).  Those are not usually the most fun conversations, but it is critical to maintaining the client's confidence and helping them understand how to value the risks of litigation.

I also want to focus on providing candid, constructive feedback to my younger colleagues to help them grow as attorneys.  Since trials can be so few and far between, it's important to search for opportunities for roles for younger attorneys so they can develop trial skills.

How do you plan for the new year?  For example, do you create a formal plan? Can you share your ideas with our members?

I do create a written plan each year.  I include conferences I plan to attend, articles I plan to write, any speaking engagements, as well as the names of clients with whom I want to connect in the coming year.  Since many clients create their budgets in January, I make sure to let them know about future conferences that might be of interest to them, so they can include plans to attend in their budgets.  I also think about where my travel will take me and who I can visit while I'm there, including FDCC friends and clients.

How do you stick to your plans? 

Following through is definitely difficult.  Luckily, I have the benefit of a wonderful marketing team who checks in with me periodically throughout the year to see if I'm doing the things I committed to do.  Absent that, setting a reminder on your calendar to review your plan once a quarter or once a month (whatever works for you) is a good way to prompt yourself to take action.

How do you reward yourself when you check off an item for the year’s to do list?


Any last thoughts about long term planning for one’s career, business development or case load?

Without exception, the most fulfilling part of my career has been the relationships I've developed with colleagues and clients.  It's a difficult job, the hours can be long, but being yourself and developing friendships makes the work so much more enjoyable.

Planning for 2018

Interview with our member Marie E. Chafe


Tell us a little about yourself and your practice?

My practice is focused on product liability litigation, covering a variety of industries such as medical devices, pharmaceuticals, automotive and trucking, marine products, and toxic chemicals.  I have over 20 years of broad litigation experience throughout the state and federal courts of New England.


I am an active member of DRI, serving in the leadership of the Product Liability Committee and the Women in the Law Committee, and also am active in the Women’s Bar Association of Massachusetts, currently serving as the organization’s Vice-President of Operations, and the Massachusetts Defense Lawyers Association, as a member of the board of directors.  In addition to those activities, I enjoy writing and speaking about the legal issues and law firm practice.


I am lucky to have two terrific daughters (age 13 and 20) and a fabulous husband who give me personal joy and fulfillment, as well as law firm colleagues who are supportive of my organizational involvement.


At the beginning of a year, what plans do you make generally to advance your clients’ interests in their matters?

As a new year begins, I try to step back and get a global view of my cases and my clients.  When was the case filed, how long as it been going on, where are we in the discovery process, what additional work needs to be done?  Particularly when I am working on multiple cases for a single client – what overall schedule is coming in the next several months?  How can I prepare a client for what lies ahead?


Sometimes I, and perhaps others, get into the “weeds” of litigation that grow from smaller debates and discovery wrangling.  With a fresh perspective, it’s helpful to ask if those individual disputes are helping the ultimate objective for a client.


What does your client really want from this litigation?  I’ve had plenty of cases that resolve prior to trial, but I’ve had other clients that stand on principle and fully defend their products and their company reputation.  For each case that I am working on, it helps to ask that question – what does the client want.  If I don’t know, I need to ask and listen to the client’s needs.


How do you apply how you plan and prepare for your cases to how you plan your professional career?

In many ways, the approach is the same – take a step back and evaluate big picture.  I have greatly enjoyed my organizational work, but those demands can add up at times.  The New Year is a great time to stop and think.  Am I getting what I want out of this organization and work?  After some thought, I have stepped back from commitments that were no longer a priority (including a recent tough decision about a local organization that I care about).  I try not to lose sight of the fact that there are other, talented folks to take over and bring new life to a role that has worn me out.  It’s time to give them the chance, take a break for myself, and allow myself to focus on something new.


What advice do you have for our members on how they plan for 2018 regarding their cases? Business Development? Their careers?

Planning for anything takes time and energy.  Think of the effort you put into developing your last vacation, a recent golf/spa/movie/dinner outing with friends, even organizing family gatherings or personal errands.


Have we put that much time and energy into planning the “business” of our careers recently?  It’s tough – we’re busy with a lot of other stuff!  Plus, lawyers don’t get a lot of business training in law school.  Where do you even start; how do you keep it going?


I have gained a lot of insight and support from being a part of law practice committees and signing-up for law practice blogs.  A local bar organization’s law firm management committee is a great connection point.  One blog that I particularly enjoy is Attorney at Work although there are others.  One e-mail a day that gives me new ideas about business development, digital marketing, case management, and a whole host of law firm management topics.  Or pick-up a good book on legal careers, business development, and management.  The FDCC website is full of great content too!  Some time every week on these issues pays off.


How do you plan for the new year?  For example, do you create a formal plan? Can you share your ideas with our members?

I confess that I don’t always come up with a formal plan (and I say this as the former chair of the Business Development Committee of my local bar association).  I have lists and task outlines that help me keep an eye on different aspects of my practice.  On my computer screen desktop, I’ve had the same document that I’ve just called “Important Stuff” for many, many years.  It’s saved to a spot right in the center of the screen.  With my addition of a second screen a few years ago, I often keep the Important Stuff document open on the side screen.  It’s a reminder of long-term issues that need to be tackled – often in small doses and over time.  It’s not a weekend project.


There is no magic pill for business development plans.  There’s a lot said about building relationships, but it’s really true.  What does that mean?  Don’t stay at your desk everyday – get involved in organizations and groups that interest you.  Stay in touch with people you meet and ask them about business and career issues.  They are just as interested in it as you are.


How do you stick to your plans? 

Well, I try hard!  There are always work commitments, family activities, and person responsibilities that get in the way.  On the substantive work issues, I definitely take the time to stop and evaluate progress along the way.  That’s particularly true at the start of a New Year.  I also set aside a little time on a monthly basis to re-think about how a case is progressing.


As for the personal/career issues, I set-up a pretty general annual goal and focus on creating tasks that can be accomplished on a weekly or monthly basis.  For me, it’s about developing manageable goals that keep me going.


How do you reward yourself when you check off an item for the year’s to do list?

Chocolate!  Just kidding….mostly.  I have not developed a reward system for the checks on my to-do list.  But, this question is giving me some great, new ideas.




December 2017

Submitted by: Francisco Ramos, Jr.



The Opioid Dilemma - Pain and Punishment

Michael Walsh, Strasburger & Price LLP,


Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.



An interview with one of our section membersMarisa Trasatti


The following is an interview with an FDCC member, Marisa Trasatti, who shares her experience of moving from one firm to another as outside general counsel to a medical device company, and issues to consider when doing so


What are some of the unintended issues that tag along with being outside general counsel for a company, when considering joining a large national practice law firm?  You started at one firm on June 9, 2017, and began at the next one on August 31, 2017 due to a conflict with a client for which you serve as General Counsel (“GC”).  What lessons did you learn from this? 


There are at least two (2) takeaways from this experience:



I am outside General Counsel to a dermatological laser company, Sciton, Inc., in Palo Alto, CA.  This made me an appealing lateral hire,  however, it is also brought a heightened need to vet conflicts even heavier than if I had been simply outside defense counsel.  No piece of general  counsel’s workload is transferable and therefore, no conflict is waivable.  Therefore,  on the front end, any firm considering a lateral hire who has one foot in the general counsel role and one foot in private practice, must consider actual conflicts, as well as future conflicts with:  competitors, outsider investors and other interested individuals in the company such as Key Opinion Leaders, physician users, etc., secondary market or used device sellers, and most importantly, how the current work of the GC fits within the overall existing practice areas of the firm such that cross-claims and third-party issues do not rear their ugly heads.   Keeping in mind that general counsel may oversee outside local counsel depending upon the company’s insurance scenario (SIR versus deductible), this adds yet another layer of vetting. 


The best way to avoid a dilemma like the one that I experienced? Ask the lateral to present a “kill” list of company names, general types of companies that are adverse to the GC’s company, and perhaps individual names which must be flagged for actual or potential conflict purposes going forward.  The GC’s company may have exiting contracts to do business with these entities  or may just be aggressively positioned against these entities in the industry such that having proprietary information on a joint server (or even with a  Chinese wall in place) poses a conflict.  Additionally, the list should include “friends” of the company to which the law firm can never be adverse.  As far as the law firm is concerned, a broader “ask” to the law firm’s lawyers must be attempted to assure there are no existing clients in the same or similar industry as the GC’s client.  If there are such clients, then it is imperative that both sides know such relationship(s).



Second, and probably most importantly, this experience demonstrated first-hand how strong of a bond that Federation members enjoy.  It is THAT BOND which made my relatively speedy transition possible, and also cordial.  Federation lawyers rallied to re-home me provided their genuine support, professionalism, and collegiality.  While our spiral wound roster provided a critical initial source of guidance for steering the ship, the personal touches from our members were unparalleled.  FDCC is the best organization-BAR NONE—and  in my opinion, no other professional organization can offer stronger friendship bonds amongst its members.  Admissions Committee, you are hitting it out of the ball park as far as selecting members…please keep it up.  FDCC leadership, thank you for teaching us fellowship and civility.


Did you reach out to FDCC members for help?  Absolutely and they also reached out to me daily throughout the months of July and August.   Rather than call those FDCC members out by name, the real learning here is that we stick together.  Countless lawyers around the country, including the one interviewing me, went out of their way to call, text, and email to assure the transition was progressing and progressing hastily.  That is the Federation way.  An unwaivable conflict gave way to an unwavering bond that all FDCC lawyers share.    


What assistance did they provide?  They offered overwhelming support including phoning friends in Maryland;  taking lead on joint FDCC projects;  offering their staff to assist on projects and case assignments as a stop gap; setting  up conference calls with their office managers to run through the practicalities of hanging out my own shingle.  I have no  doubt that the Federation is THE SINGLE BIGGEST REASON that this worked out the way it did, with long standing friendships preserved and new bonds forged.



Tips for Young Lawyers – How to Find the Right Expert


            As a young lawyer, you may be asked to track down prospective experts.  There are many places to look. Before embarking on your search, ask yourself what type of expert you are looking for:


Should the expert have a national reputation?


Should he or she be published?


Should he or she be a professor or instructor?


Should he or she have led a relevant professional association?


How many years of experience should he or she have?


What educational background are you looking for?


Do you need a professional expert?

Do you prefer someone with little testifying experience?

How much experience should he or she have in handling depositions?


How experienced should he or she be at testifying at trial?


How aggressive do you expect opposing counsel will be cross-examining him or her?


What skeletons in his or her closet are you willing to work with?


How much is your client willing to pay?


What technical issues will the expert need to tackle?


How broad a range of expertise are you looking for?


When looking for an expert, consider the following sources to mine for one:


1.    Google search. Go online and search for the topic that you will need the expert to testify upon.


2.    Google Scholar. Look up experts who have written on your topics.


3.    Local Universities. Look up the faculty lists for local universities.


4.    The Ivies. Look up the faculty lists for the premier universities.


5.    Expert Referral Services. Study the lists of experts available on expert referral services.


6.    Bar Association lists. Plaintiff and Defense Bar associations often provide lists of experts used and approved by their members.


7.    Colleagues. Send an e-mail to colleagues requesting recommendations. Create a circle of other attorneys who ask one another for expert referrals. Make sure to make recommendations when you can, just as you will be asking for recommendations.


8.    Professional Associations. Look for the professional associations that cater to the type of expert you are looking for. See who is heading or has previously led those organizations. The ones who have held leadership positions generally are more active in their field.


9.    Verdicts. Do a search of jury verdicts to see which experts’ names come up, particularly experts who appear repeatedly. What are the verdicts associated with their testimony? In the cases they testified, were the results generally favorable for their clients?


When searching for an expert, remember that your goal is to find one that will resonate with the jury (even though most cases settle long before trial). Since your jurors are local, consider a local expert. Search through the faculty list at the local university, and search for someone who is published (demonstrates he's an expert), who teaches (shows that he is comfortable in front of others, teaching them about his expertise, as he will need to do with a jury) and has real world experience relevant to the issue central to your case. Being from Miami, an expert from the University of Miami or Florida International University may have a greater influence on a jury than someone from the Ivy Leagues. Often the expert you are looking for is in your own backyard.


When you have crafted your list of potential experts, take the time to pick up the phone and call them. Yes, you call them. Not a paralegal or a legal secretary. You. Who you hire as an expert can make or break your case, so take the time to become acquainted and comfortable with your choice. Before speaking with him, though, ask his office for a copy of his curriculum vitae. Review his C.V. closely, looking for the following:


1.             Is he published? Are any of his texts or articles relevant to the issues in your case? If so, you need to review them. You can't have your expert taking a position in your case contrary to his prior writings. If his publications undermine your case theme, consider another expert.


2.             If you're retaining a doctor, did he have to leave the country for medical school?


3.             Has he ever held any leadership positions where he was elevated by his peers?


4.             Has he received any honors or awards?


5.             Does he hold any teaching positions? Is he still active in academia? Professors are accustomed to teaching and your expert will have to teach the jury about your case.


6.             When's the last activity on his C.V.? If it's been years since he's written or spoken on a panel, he may not be up on the latest trends.


7.             Does anything in the C.V. not feel right? Intuition is powerful. Ask the expert about your concerns. More and more, we read about heads of companies, coaches, and experts fibbing on their resumes, assuming no one will ever find out. Assume your opposing counsel will find out. Even if no one ever has, assume your opposing counsel will be the first. If anything causes you to raise an eyebrow – a degree from a certain university, a speaking engagement, an award – take the time to independently verify it.


In addition to reviewing his curriculum vitae, find everything you can about the expert online. Do a search of the following:

·      Google

·      Google Scholar

·      Westlaw

·      Expert’s website

·      Expert’s blog

·      Linkedin

·      Facebook

·      Online articles

·      Online comments on blogs or message boards

·      Prior appellate opinions

·      Prior affidavits filed by expert

·      Online versions of his CV (compare to his current CV)

·      Licensing boards

·      Professional Associations

·      Pacer

·      Prior Depositions


Conduct the same investigation you would conduct on the other side’s expert. Be assured, that once you disclose your expert, opposing counsel will do everything within his power to find the dirt on your expert. Find it first. Investigate any chinks in the expert’s armor. You want to learn about them now, before you retain him, rather than hearing it for the first time at his deposition, or worse, at trial.


After you have reviewed the C.V. and done your online research, you are ready to interview the expert. There are two types of questions - the ones about his expertise and the ones about the skeletons in his closet. The ones about his expertise include:


1.    How long have you practiced in ___ field?


 2.    What are your general opinions about topic ____?


3.    So far, our case is based on _____themes? What do you think about those themes?


4.    We anticipate the other side will rely on ______ themes? What do you think about those themes?


5.    The facts of the case are ____. Based on those facts, what was our client’s responsibilities? What were the opposing party’s responsibilities?


6.    What are the applicable standards?


7.    How familiar are you with the issues involved in our case?


8.    How much do you charge?


9.    How much do you anticipate charging in this case?


These questions are directed to gain an appreciation about the expert’s expertise - how broad and deep it is and how applicable it is to your case – and to gain an appreciation regarding what his role will be in your case.


If you’re comfortable with his expertise, then ask him the tough questions. You owe yourself and your client the duty to ask your prospective expert these questions. Be upfront with him. Let him know that you ask all your prospective experts some tough questions. You do not mean to offend him and he should not be offended. Let him know that you, someone you know or someone you read about had a bad experience with a seemingly qualified expert and because of that experience, you go through a thorough list of questions just to avoid any surprises. Your questions will help you find out the following that the expert neglected to tell you:


“I am a convicted felon.” Yes, your expert may have a criminal past. He may have been guilty of crimes that undermine his credibility. Ask him if he’s ever been convicted, arraigned or arrested. And then do your online background search to confirm his answers.


“I am a person of interest in a federal investigation.” It is easy enough to find out if an expert is a convicted felon. But what if he is a yet-to-be-convicted-felon? Just ask him. And by the way, do Google searches for your experts, and check the websites for the local papers where they reside to see if they have received any negative press.


“I had a substance abuse issue.” Experts are human like the rest of us. They too can succumb to the temptations of alcohol and drugs. If it has affected their professional life, such concerns may have been flagged by their licensing board.


“I lied on my curriculum vitae.” Yes, sometimes experts fudge their resumes. And yes, they are naïve, or arrogant or just plain dumb enough to think no one will find out. If your expert lied on his resume, his credibility is shot. Who is going to believe what he says about whether a given product is defective, when he lied about what degrees he earned or what course work he took? If there is anything that raises any red flags on his CV, ask him about it. And ask him the ultimate question, “Are there any issues on your CV I should be concerned about?”


“My professional license was suspended.” “So Mr. X, has your license ever been suspended, revoked, curtailed or been the subject of an investigation?” Just ask. Also, he may belong to a board, organization or association that keeps track of such suspensions and makes them available to the public. Take the time to look and confront the expert with what you find.


“I collapse like a deck of cards at trial.” There are experts, and then there are experts. There are those experts who look great on paper, but when they take the stand they wilt like a dandelion. You need to ask them how often they have testified at trial and the verdicts in those cases. Then ask for the attorneys who retained them in those cases and ask them how the expert performed on the stand.


“I have a bit of a temper.” Some experts are prima donnas. Some have short fuses. Some are temperamental. Some are impossible to get a hold of. You need to spend some time with your expert and gauge his personality. Is he going to be easy to work with or does he have an ego, personality or character flaw with which you will have to contend. Ask for references of other lawyers who have retained him and ask them how easy (or difficult) this expert was to work with.


“My opinions have changed.” Your expert may have already addressed the very issue central to your case in a prior case. In fact, he may have once held an opinion that is just the opposite of his opinion in your case. You need to ask him whether his opinions have changed or evolved and ask for the names of the cases where he tackled the same issue and get his report or deposition from that matter. Odds are opposing counsel is going to get his hands on that report or deposition.


“My opinions have been disqualified.” Find out if he has ever been the subject of a Daubert challenge, and if so, whether the challenge proved successful. Has a court ever limited or struck his opinions? Has a court ever stated he was unqualified? Has his opinions ever been the subject of a written opinion? Make sure to do a Westlaw search to see if any appellate decisions have criticized the expert.


“I don’t think you’re going to like that article I wrote.” You hire experts because they are leaders in their fields. As experts, they often have been published and have taken positions in the articles they have written. You need to ensure those positions are not contrary to yours. Ask him what articles he has written on your topic, review them and make sure they support, not undermine, your case.


“I cost a fortune.” On the front end, find out what the expert is going to cost. In fact, ask what he generally charges for cases such as yours. Be up front regarding what records you want him to review, what testing you want him to perform, whether you need a report and when you need it. After you’re honest with him about what you want, press him to be honest with you about what his final bill will be. Clients hate big expert bills, and juries are suspicious of them.


This is not an exhaustive list of tough topics. Some other tough questions to ask include:

1.    Have you filed for foreclosure?

2.    Have you filed for bankruptcy?

3.    Have you ever been sued by a client?

4.    Have you ever sued a client?

5.    Have you ever been accused of sexual harassment? Discrimination?

6.    Have you ever been fired?


Your expert is there to help your case, not undermine it, and nothing undermines your case more than an expert with a secret that affects his credentials or credibility. Take the time to ask the hard questions. You will be surprised how often you will come across an expert who is not what he seems to be and who can hurt your case with who he really is. A little legwork can help you avoid retaining such an expert and retain the right one for you, your client and your case.


After you speak with the expert and are prepared to take the next step, ask for two to four references, other attorneys (both plaintiff and defense) who have retained his services. Call them, and ask them:

1.             Is he easy to work with?

2.             Is he arrogant?

3.             Does he have any pet peeves?

4.             How responsive is he? How responsive is his office?

5.             How good of a witness is he at deposition? At trial?

6.             How much was his total charge to you in your case?

7.             Does he have any skeletons in his closet?

8.             Where is he subject to impeachment?

9.             Any issues with any of his licenses or certifications?

10.          What did you like about him? What didn't you like about him?

11.          Would you use him again?

12.          Anything else you remember about him?

Track down prior depositions the expert has given, as well as prior trial testimony, and review it. How does he come across? What skeletons came out? What flaws were exposed? How did his opinions hold up under cross-examination? If your expert is hesitant to direct you to prior testimony, that may be a red flag.


The right expert can make your case.  The wrong can break it.  There is no such thing as too much due diligence when deciding upon an expert.




November 2017

Submitted by: Francisco Ramos, Jr.


Amelia Island Meeting


The Opioid Dilemma - Pain and Punishment


Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.




By: *Michael Bonasso, Lindsey M. Saad, and Elizabeth L. Taylor


 Drug and medical device cases are much like other serious product litigation, with certain nuisances depending on the product in issue. With drug and medical device cases, you will find yourself working with skilled and knowledgeable in-house counsel. These individuals will help guide the course of the litigation and are invaluable resources on the product and the company. We include the below ten tips and areas to think about when defending a drug and medical device case.


1.    What to do when a new D&MD CASE lands on your desk


First, determine the client’s goal for ultimate resolution of the case. Does the client want to settle the small damages cases or show plaintiffs’ counsel that the cases do not have merit through a strong defense? Is it possible that the case will open the flood gates of related litigation? The client will play a large role in the early development of the plan for the litigation, but will rely heavily on a litigator’s experience to read the “tea leaves” and anticipate the future of the case and litigation on that drug or device.


2.    Crucial items to do at the onset of the case


Once you have an understanding of the client’s goal for resolution, identifying and retaining quality experts will help flesh out the nuanced defense themes and alert you to any weaknesses. The expert may also help you identify key documents to obtain from the client and regulatory agencies and research to gather on specific topics.


3.    Documents to collect


If there has been other litigation for related products, obtaining documents already disclosed is an easy first step. This will help you see the strategies that Plaintiffs are attempting to develop in your case. Other categories of documents to consider include: correspondence with the Federal Drug Administration (“FDA”), internal memoranda about the drug or device, emails regarding the development and approval, clinical trial or testing history, and sales representatives’ custodial files.


4.    Witnesses to interview or depose


Aside from the typical cast of characters in any product liability case, you may consider interviewing or deposing individuals involved with product development (R&D), program directors, and sales representatives (depending on the type of product). It is also important to get an idea of internal defense witnesses that may be deposed. Meet with them if possible and begin an initial prep earlier rather than later.


5.    Discovery Plan


As part of the discovery plan, evaluating jurisdiction and venue should be at the top of the list. Is personal and subject matter jurisdiction proper? Is this a case where preemption will apply? Can you invoke federal question jurisdiction to remove to federal court if diversity does not exist? Next, it is very helpful to build a history of the product or drug and learn about predecessor products/drug development, design, testing, trials, warnings, marketing and selling of the drug or product at issue. This will dovetail into discovering the approval records, sales history, and complication rates that will help drive the defense of the case.


6.    How to keep the case moving forward toward a favorable resolution


The more you know about the good and bad of the drug or product you are defending and how the course of discovery is likely to proceed, the better the odds of moving the case in the direction that you want. It is often difficult to anticipate that a key corporate witness may blunder through a deposition, so in those instances, keeping the client timely apprised of new developments will weigh in your favor. Similarly, if you anticipate that certain depositions may go poorly, the timing of settlement negotiations can be critical.


7.    What makes a D&MD CASE a candidate for early settlement


Obviously, this is a client choice primarily. However, outside counsel might recommend early settlement when there are other similar cases that will make defending the current case difficult. Also, there are times when a case is filed too early in a product or drug’s lifespan to make it easy to defend because more time is needed to develop the overarching themes and defenses. The client may opt to settle an early case, so as to more fully defend a similar case later. Of course, the usual suspects are those cases with limited damages or cases that may be “one off” cases that may never be replicated.


8.    Getting ahead in Multi-District Litigation and Class Actions


Drug and medical device litigation can present the unique challenge of Multi-District Litigation (“MDL”) or mass tort claims. MDL or other mass cases require finding ways to simplify thousands of claims into common themes for defenses and damages. Early, case-specific strategies also will help guide MDL litigation and assist with evaluating what criteria will result in the ideal “bellwether plaintiff.” In class actions, one way to aggressively handle these cases on the front end for your client is to defeat class certification.  Pre-certification discovery and investigation combined are effective tools to utilize when opposing class cases.


9.    Regulatory Activity


As with many products, drugs and medical devices are heavily regulated.  The FDA and certain regulatory activity may play a key role in your case themes and defense.  For instance, depending on the claim, certain regulatory activity may be required.  There could be the need to report to the FDA or to get the company regulatory and compliance attorneys involved. Because of the important role the FDA plays not only in the development of these drugs and devices, but also with the approval of the products and whether they can be on the market (which, in return, directly impacts the client’s financial health and future), it is important to evaluate on the front end of the litigation whether any specific regulatory activity is required or ongoing.  


10. Items outside counsel can help the client address


Outside counsel’s role is not just limited to one case or even litigation in general.  Rather, outside counsel can provide a valuable function to the client in a myriad of other areas outside the specific litigation involved, such as assisting with any public relations issues, dealing with any consultants, and offering guidance regarding communications with company shareholders and board of directors. Outside counsel also can play an important role in helping the client recognize (and thus plan) long term by looking at the big picture – for both the product and the company in general.  We have all heard some variation of the joke that no one ever thinks of the phrases “outside counsel” and “cost savings” in the same sentence, but by helping the client appreciate the potential outcomes, outside counsel can do just that. This can result in the client taking proactive measures to minimize risk and exposure and thus, avoid future lawsuits, saving the client valuable time and money in the long run.


Michael Bonasso is managing member of Flaherty Sensabaugh Bonasso PLLC in Charleston, WV. He has extensive experience defending complex litigation cases. In products liability, he represents manufacturers of medical devices, vehicles, industrial and agricultural equipment, recreational equipment, and consumer/commercial tools. He can be reached at or (304) 347-4259.


Lindsey M. Saad is a member practicing in Flaherty’s Morgantown, WV office. Lindsey has a broad practice that includes defending cases involving drugs and medical devices, long term care, medical malpractice, product liability and complex personal injury and wrongful death claims. She can be reached at or (304) 225-3052.


Elizabeth L. Taylor is a member practicing in Flaherty’s Charleston, WV office. Elizabeth concentrates her practice in civil litigation, particularly in the defense of drug and medical device manufacturers as well as automotive and industrial equipment manufacturers in serious personal injury and wrongful death cases. She can be reached at or (304) 347-4217.



An Interview with William Vita about Defending Drug & Medical Device Matters


1.    Tell us about yourself and your practice.


I have been a trial attorney for 34 years.  I am a partner in a mid-sized law firm in New York.  We regularly practice in all of the jurisdictions in southern New York.  To the extent that I have a specialty, it is complex litigation.  I have been fortunate enough to work on many different types of matters, including:  commercial disputes; asbestos and other mass torts; employment; product liability, including medical devices; multi-district litigation and class actions.  The diversity of cases has made my work much more interesting than it would have been had I only worked on one type of litigation.


2.    Drug and Medical Devices cases have a lot of moving parts.  How do you keep everything moving forward toward a favorable resolution?


I try to discuss an overall strategy with my clients at an early juncture in each matter.  We try to decide what type of resolution we want to shoot for.  For example, is it a case that is susceptible to summary judgment?  Should the case go to trial?  Is it a case in which my client is a small player among several defendants and therefore we want to take a lower profile?  Can I show plaintiff’s counsel that my client’s device could not have caused the plaintiff’s injuries?  The ultimate desired outcome will determine the path we take to arrive at that goal.


3.    What do you do when a new D&MD lands on your desk?


I try to work with the client to understand the medical device in question.  Usually that means talking with technical representatives and sometimes engineers about the device, as well as reviewing the client’s manuals and brochures.  Medical devices can be highly technical and often incorporate cutting edge technology.  A defense attorney needs to understand the engineering in order to explain the workings of the device to the court and adversaries and also to properly question witnesses. 


4.    What are crucial to do items at the onset of the case?


If the case is originally filed in state court, the most important thing is to determine if the case can be removed to federal court.  If the case can be removed, then we ask if the case should be removed to federal court.  In our state court system, litigants do not have the right to depose expert witnesses.  This is usually a crucial factor in determining whether or not to remove the case.  If the case cannot be removed, then it is crucial to check if venue is proper and to check the statutes of limitations, including UCC § 2-725.


5.    What documents are you trying to track down?


The plaintiff’s medical records are key to understanding how the device interacted with organs or systems within the plaintiff’s body.  It takes time to assemble all of the plaintiff’s medical records and therefore this is a crucial early first step.  Conversations with the client about how the device was approved and how it works, usually determine what type of internal documents we need from the client.  It is helpful to talk with plaintiff’s counsel at a very early stage to determine what the plaintiff’s theory of liability is.  This will help determine which of the client’s documents are relevant to the defense of the matter.


6.    Which witnesses do you want to interview or depose?


I like to speak with internal witnesses who can explain the device and who will not be rattled by appearing at a deposition.  These conversations can also shape our thinking on whether or not we will want to retain outside expert witnesses to complement our in-house witnesses.  With regard to plaintiff’s witnesses, it is important to review the plaintiff’s disclosures to determine the witnesses that they identify.  The plaintiff should then be questioned about those witnesses during the plaintiff’s deposition.  If it appears that the witnesses may offer helpful testimony, they should be interviewed and/or deposed.  Indeed, even if a witness is likely to offer unhelpful testimony, they should usually be deposed so that the defendant knows exactly what they will say at trial.  This allows the defendant to build its defense accordingly.


7.    What makes a D&MD a good candidate for early settlement?


I try to talk to plaintiff’s counsel early in the litigation, in a non-adversarial manner, to explain the workings of the device and to candidly discuss the strengths and weakness of the plaintiff’s case.  At that point, we can usually determine whether the plaintiff really wants to pursue an early settlement for a rational and reasonable number.  If that is the case then early settlement will work.  It is also important to accurately assess plaintiff’s damages as early as possible.  If the case is of relatively modest value it may make the most sense, from a business perspective, to resolve the case as soon as possible and thereby save on defense costs. 


8.    What does your discovery plan look like?


 Our discovery plan is pretty simple.  We serve paper discovery, review the responses and then take the plaintiff’s deposition.  The results of those two things usually dictate the remaining discovery.


9.    What’s the role of counsel in helping the client appreciate the potential outcomes?


My corporate clients are very experienced and savvy about litigation in general and potential outcomes.  I think outside counsel perform a valuable role in explaining the quirks of the jurisdiction and how that will affect potential outcomes.  In particular, it is important to explain the expected jury pool and how potential jurors are likely to view large corporations.  It is also important to explain the leanings of the judge or judges who will hear the case.


William E. Vita is a Partner in the New York law firm of Westerman Ball Ederer Miller Zucker & Sharfstein, LLP  He has also held leadership roles in national bar associations, including the Federation of Defense and Corporate Counsel and the Defense Research Institute.  He is a Fellow of the Litigation Counsel of America, The Trial Lawyer Honorary Society.



 An interview with Brooks Magratten about Jury Selection


Tell us a little about yourself and your practice?


 I am a partner in the Providence and Boston offices of Pierce Atwood, LLP.  My practice concentrates on litigation of ERISA, Life, health & disability insurance and annuity claims.


What was your first experience picking a jury?  What lessons did you take from it?


 I conducted voir dire as an associate in a casualty case. An allegedly defective window casing caused a glass pane to fall on a bar patron’s head, embedding glass shards in his scalp.  I learned to be sincere and straightforward with the venire.  Plaintiff’s counsel oversold his case from the start.  The jury punished the plaintiff in the end.


What do you do to prepare for jury selection?


 I focus on major themes of the case and design questions to elicit juror reactions to those themes.  Most of my work is in federal court where most judges vet voir dire questions and ask the questions themselves.


Do you go into jury selection with a “juror profile” you want to select?


 In my experience most assumptions about juror age, gender and occupation turn out to be incorrect.  My principal criteria are 1) education and 2) interest in serving on the jury.  I want jurors who are intellectually curious and who want to serve.


Do you rely on jury questionnaires? 


 Most judges in my jurisdictions will permit jury questionnaires in more complex cases.  The biggest challenge is crafting questions that will elicit truthful and meaningful responses.  Many jurors do not want to reveal personal information in a written questionnaire where 1) they do not know who will read responses and 2) when or if responses will be destroyed.


What rules of the road would you share with our readers about jury selection?


 Remember theories of primacy and recency.  Voir dire may be your first impression with the jury.  Be yourself.   Be honest.  Let the jury know you (and your client) are grateful for their involvement.  Do not talk down to the jury or be overly formal.  Speak like you would address a next door neighbor.


What pitfalls should you avoid?


 See comments above


What are your thoughts on jury consultants?


 Can be helpful in the large case.  Again, however, in my experience many assumptions about juror age, gender and occupation end up being incorrect.


Any last thoughts on jury selection?


 See comments above.


Brooks Magratten is a partner at Pierce Atwood, LLP, where he is the partner in charge of the firm’s Providence, Rhode Island office.  He concentrates in insurance and financial services litigation.  Brooks is a former Northeast Regional Director on the DRI Board and is a current member of the ADTA Executive Committee.  He is a frequent author and lecturer on ERISA law.





October 2017

The Opioid Dilemma - Pain and Punishment

Michael Walsh

Strasburger & Price LLP


Without regard to race, ethnicity, gender, age, geography, socio-economic or other demographic, the opioid crisis has grown to be the most inclusive health crisis in American history.  And opioids now sit at the top of the agenda for state and federal regulators, legislators, prosecutors and civil litigants.  As the media points blame at every stage of the vertical distribution chain; from manufacturers to distributors, dispensers, hospitals, healthcare providers, employers, and possibly even extending to payors, schools and municipalities, our panel will discuss where we are, how we got here and what steps should be taken towards a solution.  We will peel back the veneer to expose the themes that comprise the claims to ensure that lawyers defending these claims are prepared to construct a cogent and compelling defense.



FDCC Members Leads NAWL

Angela Brandt

Larson King LLP


Can you tell us a little about yourself and your practice?


I grew up in South Dakota thinking I wanted to be a doctor.  At some point during college physics, I realized practicing law may be more aligned with my skillset.  I am now a trial lawyer/litigator at Larson King in St. Paul, Minnesota.  I focus on products liability, employment, and commercial litigation.  Because of my background and the fact my brothers and I recently bought my parents’ farm, I am particularly interested in the agriculture industry.  I’m licensed in Minnesota, North Dakota, South Dakota, and Wisconsin.


For our members who don’t know much about NAWL, can you tell us what are the most important items it is tackling this year?


NAWL was established in 1899 – before women could vote!  The important items then are the same as now:  advancing women lawyers in the law and protecting women’s rights under the law.  In 2016, NAWL issued the One-Third by 2020 Challenge.  This challenge to the legal profession seeks to increase the representation of women across five areas of the law.  The areas include: Fortune 1000 General Counsels; law firm equity partners; law firm lateral hires, law school deans, and diverse female attorneys (including women of color and LBTQI attorneys).  Our meetings and programming are designed to help women in each of those areas advance in their careers and give tools to the organizations that employ them.  Progress has been slow (see the results of NAWL’s recent survey here:  ) and we are hoping to accelerate some movement.


What’s your vision this year as President of the organization?


My vision for the year is for NAWL to be a place where attorneys with different backgrounds and ideas can come together and find some commonality.  It is when we find the commonality that we connect with one another and figure out how to work together.  I am particularly focused on the NAWL Challenge Club.  An initiative developed a couple years ago with another FDCC member, Alan Bryan of Walmart.  The Challenge Club provides opportunities for high potential female non-equity partners or senior associates to make connections with corporate legal departments seeking to hire more female outside counsel.  The overall goal is to increase the number of female equity partners in law firms.


What are your goals?


Overall, my goal is to leave NAWL just a little better than where I found it.  I hope to do this first by engaging in strategy work this year to establish ways to attract and strengthen relationships with sponsors and clearly defining NAWL’s ROI to its members.  Furthering the commonality theme, I also hope to find ways to involve more men and diverse lawyers in NAWL.  I believe there are ways for us to craft conversations that allow us to better hear and respect one another when discussing development and advancement of women lawyers.   


How can FDCC work with NAWL to help each other accomplish their respective purposes?


Perfect question.  I think there is an opportunity for each of the organizations to increase membership by helping the other with visibility.  NAWL can assist FDCC with its goal of increasing diversity in its membership.  There are countless phenomenal lawyers who are members of NAWL.  Likewise, NAWL is always open to more members – of any gender or background.  I have re-joined FDCC’s Diversity Committee and hope to collaborate throughout this year and beyond.


How can FDCC members get involved with NAWL?


I would be happy to speak with any FDCC member looking to engage with NAWL.  We have a number of events throughout the year.  We have  a number of active committees including our programs, membership, sponsorship, mentorship, and diversity and inclusion.  We also have a number of Affinity Groups that are specific to practice areas.  More information on all of this can be found at



Working with Local Counsel

Beth A. Bauer

HeplerBroom LLC

Can you tell us a little about yourself and your practice?


I have been in private practice at HeplerBroom for 16 years, after a year working as a law clerk for a judge on the Missouri Court of Appeals, Eastern District.  I provide creative solutions to clients’ complex legal problems in some of the most difficult jurisdictions for defendants in the U.S. – St. Louis City and Madison, St. Clair, and Cook Counties in Illinois.  I typically work on “bet the company” litigation in the form of class actions and mass torts, alleging consumer fraud, injury from products (typically pharmaceuticals and medical devices), and damage from environmental impacts.  For the past two to three years, I have worked primarily on mass actions alleging that a major personal care products manufacturer’s talcum powder products cause ovarian cancer.  My husband Brock Bauer is a pharmacist by training and now works as a healthcare consultant, and we have three daughters, Ainsley (14), Ava (10), and Camille (6).  I am an American Heritage Girls troop leader, serve in my church and community through various missions projects and outreach, and spend other “free” time hiking, going on Jeep rides, and cheering for the Blues hockey team.      


And you handle matters for clients as local counsel?


Although I have been the lead lawyer on complex litigation, I also often partner with other lawyers serving as national counsel for a client facing the same type of lawsuit filed in multiple jurisdictions.  Often, because the jurisdictions where I practice are considered beneficial for plaintiffs, the cases I am involved in are at the forefront of the national litigation.   Thus, I work with national counsel to develop strategies for handling the litigation that will benefit our client throughout the country and not just in my local jurisdictions. 


What responsibilities do you have as local counsel?


The responsibilities vary by client, national counsel, and type of case, but I try to bring as much value to the team as possible so that my role grows.  As local counsel, I aim to be the most knowledgeable about the judge, jurisdiction, local politics, and law, which is what you would expect a good local counsel to do.   But, I also have much experience working on risky complex cases.  So, my goal in every engagement is to add value to the overall strategy and preparation of a case beyond a typical local counsel.  Once you demonstrate a grasp of the bigger picture and make valuable suggestions that benefit national counsel and the client, often you gain a larger role in the litigation.  Although I often act as local counsel, I have handled everything from acting as someone to file documents prepared by others to presenting key witnesses at trial. 


How do you manage to ensure everyone across the country is rowing in the same direction?


I try to help national counsel accomplish this by developing regular and thorough communication with them.  I don’t wait for national counsel to ask me for information, but strive to be pro-active to keep them informed and ask questions about what is occurring in other jurisdictions.  I don’t want to be responsible for an action in my jurisdiction that later hurts the client in another jurisdiction, so I need to stay informed of events nationwide.


You work with national counsel throughout the country?


Yes, I am honored to have worked with some of the brightest and most accomplished lawyers in our country.  Many of them have been FDCC members.  (The others, I have started proposing for membership.)


What are your expectations of national counsel?


I expect national counsel to treat my team and I as an extension of their team, thoughtfully consider our advice and input, and give us opportunities to do more than review documents to conform to local practice and file them.  When national counsel views us this way, we all achieve more for the client.     


How can I help national counsel? 


The greatest help I provide is set out above in my philosophy to elevate the value I bring to any engagement.  Additionally, my firm is equipped to handle large litigation and to try big cases.  We have top talent at every level of lawyer and staff, so I can provide national counsel more than just my expertise.  I have a very creative and accomplished team of lawyers and paralegals that have tried big cases.  We understand the client and national counsel’s concerns and often anticipate their questions and needs. 


How can national counsel, without meaning to, hurt you?


National counsel can hurt local counsel when they do not give local counsel any credit with clients or fail to keep local counsel informed of developments elsewhere in national litigation.



Preparing Your Client for Deposition

Tiffany M. Alexander

Tanenbaum Keale LLP


Tell us a little about yourself and your practice?


My trial practice is devoted to the defense of corporations, product manufacturers, suppliers and insurers in complex litigation and personal injury matters. 



What types of clients do you defend in depositions?


I typically defend product designers, engineers and managers as designees or fact witnesses in product liability and negligence matters.


What are biggest challenges in preparing a client for her deposition?


The testimony of the corporate witness or designee is arguably the most critical aspect of the defense, and offers the best opportunity to educate the jury about the process by which decisions are made in business, not simply litigation. The case may not be won during the deposition, but it certainly can be lost if the witness is unprepared or ill-equipped to handle the examination by opposing counsel.   In cases involving experts and causation-based defenses, it can be very helpful to lay the groundwork for your expert opinions through the testimony of your design engineer.  For example, with the right experience, your witness may discuss (and possibly distinguish) a proposed alternative design in the context of the product development which will help your experts down the line.  


What are the pitfalls you try to avoid?


Putting up the wrong witness as a designee can have significant consequences for your client and may open the door to additional depositions.  I recommend working with your client early to identify the proper witness(es) based on your defense themes and the product at issue. An ideal designee will be knowledgeable, credible and cooperative.  Once the witness is identified, review and collect prior testimony of ensure you know what is already on the record and maintain a consistent message.   


How do you deal with a poor witness or bad facts?


Having been faced with both, I’ve found the best way to deal with it is directly.  It is critical that your witness is prepared to deal with or distinguish bad facts from your case, and can do it in a way that is credible and authentic.   Consider key words that the witness should avoid and offer alternatives.  Even a poor witness can be trained given the right amount of time and preparation.  A mock deposition tailored to the issue needing improvement, such as nerves, an inexperienced or “green” witness, and the overly confident witness who thinks they don’t need any help at all, is very useful.  This is sort of a good cop, bad cop approach, but it is effective and helps the witness experience the worst-case scenario before they are on the record. 


How much time do you spend with a client?


You cannot over-prepare for a deposition of a company witness, so the short answer is:  as long as it takes.  This will depend on the level of experience the witness may have testifying about the product or design allegation at issue, but at a minimum, I recommend 2 preparation sessions before the deposition plus ongoing contact as you both continue to prepare.  I do not recommend meeting your witness for the first time the day before the deposition.  Without the early lead time, you have no opportunity to gather and produce additional documents if need be, and your witness may not have enough time to prepare.


What is your process with the client?


I always meet with the witness for a preliminary session well in advance of the deposition.    In that first meeting, I get a sense if the witness is comfortable with the topics and defense themes and we discuss and identify any additional documents or information that is needed to support those themes.  If need be, we’ll gather the documents and produce them well in advance of the deposition so as not to open the witness up to a second “bite at the apple” based on surprise.   I then schedule additional preparation sessions as needed leading up to the day of the deposition. 

What do you tell your associates how to prepare clients for depositions?


Anyone preparing a company witness should be fluent with the facts, key documents and defense themes in the case before the first meeting.  If experts are involved, it may be useful to schedule a call or webex to discuss their preliminary opinions to help frame the defense themes.  It is also helpful to prepare a detailed prep outline before the first meeting to organize key documents and topics for discussion.  


What documents do you show your clients?


If the witness is a designee, he or she should review all of the documents produced by the company in the case.  Knowing their time is limited outside of our prep sessions, I collect key documents to discuss in detail during the prep session.  I never show my witness privileged materials or expert work product, and I only give them the most basic facts about the underlying accident to avoid the possibility of expert opinion testimony. 


Who gets involved with the prep session?


It depends on the witness, but I like to keep attendance at prep sessions limited to enable the witness to focus and minimize distractions.  Ideally, in-house counsel will attend all or part of the prep session, and at the very least, is aware of the intended areas of testimony and defense themes.  Collaboration with other lawyers or company witnesses on common issues or products can be very helpful, but be sure that you discuss the response if that question arises during the deposition.


Any other advice?


The goal for the extensive preparation is to ensure there are no surprises on deposition day, but that is never a sure thing. Whatever happens, defend your witness without being obstructive and take a break if he or she needs to re-group. You may also want to be armed with a direct examination to rehabilitate your witness if needed, and to ensure that your defense themes are conveyed in the most effective way. 





The board has spoken and the 2017-18 DD&B Chair is Michael Walsh and the Vice Chairs are Joseph P.H. Babington, Michael J. Hurvitz, John W. Sinnott, Andrew B. Johnson and Christopher P. DePhillips. We anticipate an aggressive agenda for 2017-18 and look forward to being an important resource for our section members.


A word about Montreux: DD&B partnered with Transportation and Class Actions and had a great panel on a unique topic entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement. The panel addressed domestic and international aspects of the new regulations under the Food Safety Modernization Act.  The speakers put a lot of effort into the program and did a great job presenting a complicated subject in a short period of time.


The Drug Device and Biotechnology section will be putting on a panel entitled: Opioids – The Fifth Vital Sign - Summary of Underlying Issues. According to the federal Department of Health and Human Services “[t]he United States is in the midst of a prescription opioid overdose epidemic. In 2014, more than 28,000 people died from opioid overdose, and at least half of those deaths involved a prescription opioid. The epidemic has significant civil and criminal liability implications for manufacturers, distributors, dispensers/formularies, payors, employers, physicians, hospitals and surgery centers. 

Because opioids do not discriminate based on geography or any social demographic and threaten death, the current “epidemic” is unlike anything we have seen before. Unlike other agents or products that have stirred up controversy, here the media and the public attribute moral “culpability” at every level, including academic medical, legislative, manufacturing, distribution, formulary/dispensing, hospital/medical facility, prescribing physician, payor, employer, patient and even family members.  In addition, beyond any medico-ethical or societal justification in looking for a solution, there are significant enforcement and litigation risks associated with these products that are reflected in the steady uptick in state and federal enforcement and private litigation against manufacturers, distributors, dispensers and prescribers of opioid products, including increasing creative theories of liability.  These actions include civil and criminal cases at the state, federal and even in tribal sovereign courts.  This is a trend with no end in sight.

SEPTEMBER WEBINAR The DD&B section will host its first Webinar for 2017 in September 7, 2017.  Click here and register today for the program entitled: Drug Device and Biotech: Shifting Political Winds –what does it mean for FDA regulated industry?

The speakers are

Jessica Davis, Roetzel, Columbus, Ohio
Michael D. Shalhoub, Goldberg Segalla
John W. Sinnott, Irwin Fritchie Urquhart & Moore LLC[1]
Michael Walsh, Strasburger & Price, LLP, Dallas

[1] John I’m happy to discuss regulatory trends. Here is a possible short blurb for that portion:

Regulatory trends—Possible changes in the FDA under President Trump and what they mean for drug, device, and biotechnology companies.



JULY 2017


Montreux Summer 2017:  Reminder that on Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Action program entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  This will be a dynamic panel addressing compliance requirements, risk reduction strategies and current enforcement and litigation trends under the new rules.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

Please arrive early for the joint program (if that is possible) to discuss any ideas you have for initiatives for the DD&B Section for the next year.

DD&B Webcast: We have made a change to the topic for our webcast scheduled for early September 2017. The topic is: Drug Device and Biotech: Shifting Political Winds –what does it mean for FDA regulated industry? Regulatory trends: what was left undone under the Obama Administration and where is FDA heading?


Amelia Island Winter 2018:  The DD&B Section is sponsoring a program topic for the Winter 2018 program on opioids.  Not a day passes that there is not a news headline, new medical journal or other data disseminated concerning opioids.  In fact, the federal Department of Health and Human Services puts it this way: “[t]he United States is in the midst of a prescription opioid overdose epidemic.” Our speakers are leading advocates on these issues and the panel will focus on where we are today, how we got here and where this is headed.



JUNE 2017

Welcome Jessica Davis! Jessica recently joined the FDCC ranks and is the newest member of the Drug Device and Biotechnology section.  Even before she joined our section she has been engaged in some issues we are working on and we look forward to her insight and active participation. Jessica’s practice includes defense of medical malpractice, professional negligence, products liability, breach of fiduciary duty, fraud, and premises liability. Her bio is here.  We asked Jessica if she would share additional information and, as you might expect from a fellow FDCC lawyer she said “I would also share with the group that we live in Westerville, Ohio and I am married to my wonderful husband, Scott, and we have 3 beautiful children ages 11, 9 and 7.”

Montreux Summer 2017:  On Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Action program entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  This will be a dynamic panel addressing compliance requirements, risk reduction strategies and current enforcement and litigation trends under the new rules.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

A First for the FDA: On June 8, 2017 the FDA requested removal of a prescription opioid. According to the FDA, “[t]his is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” DD&B Opioid Webcast We expect to have our webcast scheduled for early September 2017.  Liability issues surrounding this class of products continue to evolve involving claims by states, cities, municipalities and Tribal Nations against multiple industry sectors.  Our panel will outline where we are today, how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks throughout the vertical supply chain.

Winter 2018 The DD&B Section is working on a program topic for the Winter 2018 program.  We don’t want to steal any thunder from the Winter program planning folks by announcing anything prematurely but, if you are interested in working on a topic that is certain to change at least a few lives, please let one of the section leadership know and we will get you involved.




MAY 2017

Montreux Summer 2017:  On Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Actions entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  We will have a dynamic panel to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are closer to having a date for the webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This liability issues surrounding this product continue to evolve and our panel will have representatives of industry and FDCC lawyers to outline where we are today, how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

On May 9, 2017 the Senate confirmed President Trump’s appointment of Scott Gottlieb, M.D. by a vote of 57 to 42. There are a number of initiatives FDA has underway that might, at long last, see some positive progress.  Not the least of which is FDA’s docket on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” aka off-label promotion.





APRIL 2017

Charleston Winter 2017
: For those unable to attend the Charleston meeting, the Drug Device and Biotech Section had an outstanding panel on off-label promotion that Michael Hurvitz moderated and included FDCC member and former DD&B Chair, Marisa Trasatti, and Jonathan Kahan of Hogan Lovells. The topic and speakers brought us up to date on the more challenging aspects of compliance, enforcement and private litigation related to new uses for medical products. This is a hot topic in our practice area and will remain on the front burner for the foreseeable future.  Among the things to follow include, the effective date for the FDA final rule on Intended Use is extended until March 2018 and April 19, 2017 is the deadline to submit written comments to the FDA on the docket for Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”

Montreux Summer 2017:  DD&B is running a joint program with Transportation and Class Actions entitled: FSMA - What is it and what does it mean for foreign suppliers? An Update on Implementation, Compliance, Litigation and Enforcement.  We have a dynamic panel of speakers and industry representatives to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17. With a new administration at the helm, it is unclear how the agencies will enforce the new requirements. What is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are in the final planning stages for a webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This program will have representatives of industry and FDCC lawyers and will outline where we are today,  how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

The AMA and the Plaintiff’s Bar:
  In response to the recent DD&B request for members to submit important issues for the DD&B section members to consider, Tim Pratt forwarded letters to the ABA from the House Committee on the Judiciary and the ABA’s response  Both are attached here.

As you can see from the letter we attach to this newsletter, the Judiciary Committee expressed the concern raised in the recent American Medical Association resolution supporting a legislative or regulatory remedy to “[t]he onslaught of attorney ads” that has resulted in “some patients …stopping prescribed medications without speaking to a physician.” The ABA’s response reads like a plaintiffs brief. First, the ABA claims that drugs injure and kill many people each year. Second, the ABA takes the position that it is barred by the First Amendment from imposing rules regulating lawyer advertisements. Third, the ABA already regulates “false and misleading ads” and the attorney advertising is not false or misleading. If the one-sided and fallacious analysis of the First Amendment didn’t convince you of the ABA’s plaintiff oriented agenda, this third issue certainly should.

This is an important issue for the DD&B industry as these ads are directly focusing on our clients. As leaders in the defense bar, we might give serious consideration to lending our voice in response. Please respond to the Section Chair and Vice Chairs with any thoughts, suggestions or recommendations.

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