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Article by Marisa  Trasatti

LID and Off-Label Use


Hot Cases for the week of July 11th

Hotcase Wolicki - Gables v, Arrow Intl.

Hotcase AtraZeneca (Settled 3-10-11)

Hotcaese Hughes

Hotcase Daniel

Hotcase Donovan


Legal Updates:


Reed Smith attorney Kevin Lohman addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor.  Although the unique roles and responsibilities of entities involved with clinical trials are clearly defined, plaintiffs oftentimes attempt to assign legal duties to the wrong entity — sometimes suing the clinical trial sponsor as if it were directly providing medical services to the participant — or attempt to create novel legal duties. Case law that has addressed this issue has consistently held that this is not appropriate. When faced with this scenario, it is important to clearly identify the role that the manufacturer/sponsor played in the clinical trial to determine whether they owed any legal duty to the plaintiff.

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The United States Supreme Court decided that FDA regulations applicable to generic drug manufacturers preempt state law "failure to warn" claims in PLIVA, Inc. v. Mensing, Nos. 09–993, 09–1039, and 09–1501, 564 U.S. ___ (2011).  Justice Clarence Thomas authored the Supreme Court's majority opinion inPLIVA. The court concluded that federal law preempts state law "failure to warn" claims asserted against generic drug manufacturers, because those manufacturers are required by federal law to use warnings that are identical to those used by brand name manufacturers. The case, which consolidated actions from Minnesota and Louisiana, involved plaintiffs who developed a condition called tardive diskinesia after taking metoclopramide--a generic of the brand name Reglan--for several years. Slip. op. at 3.

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The California Supreme Court soon will render its long-awaited decision in Howell v. Hamilton Meats & Provisions, Inc., No. S179115 (review granted March 10, 2010)and declare whether personal injury plaintiffs can recover the full amount of their medical bills versus the lesser amount actually paid by insurers. TheHowelldecision has garnered national attention as has the potential to dramatically affect personal injury litigants, the insurance industry, large corporations, and consumers.

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One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA's regulations governing the content of labels for prescription drugs. Essentially, defense lawyers argue that the labeling's warnings cannot be altered in a manner sought by the plaintiff when the manufacturer is faced with conflicting directives from the FDA regarding that very content.


In ruling on this very issue,Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) ("Levine"), the Supreme Court held that a "clear evidence" standard of proof was required to support a manufacturer's claim of conflict preemption defense. The Supreme Court held that unless the manufacturer presents "clear evidence that the FDA would not have approved a change" to the drug's label, which would make compliance with both the federal standard and the state standard espoused by the plaintiff "impossible," conflict preemption could not apply.


Post-Levine cases have grappled with this standard, with defendant manufacturers commonly failing to meet this "clear evidence" standard in asserting the defense of conflict preemption. Except recently. The latest decision from the Western District Court of Oklahoma demonstrates how the "clear evidence" of conflict standard provided (but not defined) inLevinecould be met.Dobbs v. Wyeth Pharmaceuticals, No. 5:04-cv-01762 (W.D. Okla. June 13, 2011). In doing so, the District Court distinguished or rejected as unpersuasive five other decisions where courts applied theLevineevidentiary standard in failure to warn claims involving the same class of anti-depressant prescription p.21.

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As every product liability lawyer knows, a client’s voluntary recall of a product will result in lawsuits. Plaintiffs’ lawyers for pharmaceutical product liability cases love using thefactof a recall as an easy stand-in for proving that the product in a specific case was in fact defective at the time of manufacture. So while equating a voluntary recall with the existence of a defect is a seductively persuasive assumption, defense lawyers should strenuously argue against it because it's an argument they can win.  In a very recent decision issued by the Southern District of Mississippi,Cothren v. Baxter Healthcare Corporation, No. 3:10-CV-347, 2011 WL 2174026 (May 31, 2011), the District Court resisted the temptation to make that very assumption.

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FDA Pharmacology Helpful Links

Administrative Materials:
Centers for Medicare & Medicaid Services
Code of Federal Regulations
Federal Health Law - Health and Human Services Office of the Inspector General
FDA Enforcement Report
Federal Register
Health & Human Services Decisions
Provider Reimbursement Review Board


Daily Reports & Current Developments:
American Political Network - American Health Line
Health Law


Analytical Resources:
Medicare and Medicaid Fraud and Abuse


Legal Periodicals:
Health Matrix: Journal of Law-Medicine
Medicine and Law


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3/24/2019 » 3/28/2019
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