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 …

U.S. Supreme Court Rejects Preemption in “Light” Cigarette Case.

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Reaffirming the presumption against preemption, the Court rejected the tobacco companies’ argument that federal law both expressly and impliedly preempts claims that they violated Maine laws that prohibit fraudulent misrepresentation by promoting and advertising Marlboro and Cambridge Lights as “light” and having “low tar” nicotine. In regard to express preemption, the Court held that the Act does not immunize tobacco …

Sixth Circuit Holds that Trial Court Erred in Excluding Similar Incidents Evidence to Prove Design Defect Claim.

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“We hold it was error for the district court to make a blanket exclusion of all ‘other incidents’ evidence by plaintiff to prove a negligence claim involving a design defect. Prior accidents must be ‘substantially similar’ to the one at issue before they will be admitted into evidence. Substantial similarity means that the accidents must have occurred under similar circumstances …

Divided Supreme Court Allows the Kent Decision to Stand.

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In Desiano v. Warner-Lambert, the U.S. Second Circuit Court of Appeals refused to apply Federal Preemption under Buckman with respect to product liability claims under Michigan Law, which provides that a pharmaceutical manufacturer can escape liability where the drug is approved by the FDA, unless the defendant withheld or misrepresented material information that would have prevented approval. In a one-sentence per …

U.S. Supreme Court Holds that Claims for Defective Medical Devices Are Preempted Where Device Undergoes Pre-Market Approval Process.

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The plaintiff filed suit under New York law against the manufacturer of Class III device (balloon catheter) which received pre-market approval from the FDA in 1994. As contrasted with the “substantially equivalent” device at issue in Lohr, pre-market approval imposes “requirements” under the MDA. “Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no …

U.S. House of Representatives Unanimously Rejects Preemption under Consumer Product Safety Act.

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By a vote of 407 to 0, the House reauthorized the Consumer Product Safety Commission and included statutory language specifically prohibiting the CPSC from issuing any rule or regulation that expands the scope of preemption. The Committee Report language disapproves the Commission’s effort to preempt state law in preambles to proposed or final rules. The Report identifies the importance of …