U.S. Supreme Court holds that Manufacturers of Generic Drugs have No Duty to Warn.

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Federal drug regulations, as interpreted by the FDA, prevent the manufacturer of a generic drug from independently changing the safety label. In general, a manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate. Although the same rules originally applied to all drugs, the …

U.S. Supreme Court Holds that All Design Defect Claims Against Vaccine Manufacturers are Preempted.

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Congress enacted the NCVIA in 1986. The Act establishes a no-fault compensation program, whereby a person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. A special master then makes an informal adjudication of the petition …

U.S. Supreme Court Holds that State Law No-Shoulder-Belt Claims Against Auto Manufacturers Are Not Preempted.

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Federal Motor Vehicle Safety Standard 208 (1989 version) requires, among other things, that auto manufacturers install seatbelts on the rear seats of passenger vehicles. They must install lap-and-shoulder belts on seats next to a vehicle’s doors or frames. But they have a choice about what to install on rear inner seats (say, middle seats or those next to a minivan’s …

U.S. Supreme Court Rejects Preemption in Drug Case.

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Rejecting Pfizer’s argument that it would have been impossible for the drug manufacturer to comply with a State Law “duty” to modify the drug Phenergan’s labeling without violating Federal Law, the Court noted that when a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about …

Presidential Memo Curtails Efforts to Effectuate Preemption thru Regulatory Agencies.

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The White House released a Presidential Memo “to ensure that executive departments and agencies include statements of preemption in regulations only when such statements have a sufficient legal basis.” (1) Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are …

Fifth Circuit Affirms Summary Judgment Dismissing Chronic Beryllium Disease Claims on Daubert Grounds; Court Further Finds that Beryllium Sensitization is Not a Compensable “Injury”.

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Applying Daubert at the summary judgment stage, a district court in Mississippi dismissed a worker’s claim for Chronic Beryllium Disease (CBD) on the basis that the diagnosis of granulomas by plaintiff’s expert was premised on a false assumption, and therefore unreliable. The court further determined that Beryllium Sensitization (BeS), which “precedes the formation of granulomas and clinical illness” is not …

New England Journal of Medicine Speaks Out Against Preemption.

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“Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has …

Louisiana First Circuit Rejects Cause of Action by User of Generic Drug Against Brand Name Drug Manufacturer.

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Plaintiff was prescribed Cordarone, a drug manufactured by Wyeth, for a non-life-threatening heart condition. The pharmacist filled the prescription with the generic version of amiodarone, made by Sandoz. The plaintiff took the medication as prescribed, developed severe liver complications, allegedly a side-effect from the drug, underwent two liver transplants, and ultimately died. The plaintiff’s family filed suit against Wyeth alleging …

Judge Wilson Delivers Pithy Admonition Against Federal Preemption as an Assault on Trial by Jury.

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In a Supplement to the Court’s April 10, 2008 Order, Judge Wilson took pause to consider the broad implications of preemption: “The thought underlying expansive preemption (‘backdoor federalization’) is that bureaucratic experts are better at determining what is reasonable, what is too dangerous, etc., than are juries. Over the past several years I believe that all three branches of government …

U.S. District Court in Indiana Holds that Destruction of Vehicle Does Not Compel Dismissal of Design Defect Case.

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“The Explorer itself is not necessary in order for Ford to conduct its defense. The allegedly defective design of the Explorer was not destroyed with Green’s Explorer. Ford and Green have access to other evidence regarding the design of the Explorer, such as schematics, expert testimony, and testing. Furthermore, video and photographs demonstrating the position of the Explorer after the …