Actos MDL Judge Approves a 25:1 Punitive Damage Ratio against the Manufacturers

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Judge Doherty, sitting in the Western District of Louisiana, and presiding over the Actos multi-district litigation, approved a ratio of 25:1 in punitive damages to compensatory damages, resulting in an award of punitive damages against Takeda in the amount of $27,656,250.00 and against Lilly in the amount of $9,218,750.00, where: – The Defendants knew or should have known that their product increased …

U.S. Fifth Circuit Refuses to Revive Claims Against Brand Manufacturer for Injuries from Generic Version of Drug (Reglan).

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Plaintiff argued that the US Supreme Court’s decision in PLIVA v. Mensing, 131 S.Ct. 2567 (2011) should render the brand manufacturer liable for the warning label and other properties utilized by generic manufacturers.  According to the plaintiff, Mensing undermined the logic of the U.S. Fourth Circuit’s decision in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) (relied …

U.S. Supreme Court Holds State Law Claims Preempted by the Locomotive Inspection Act.

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Plaintiff was employed as a welder and machinist who worked in locomotive repair and maintenance facilities. In 2005, he was diagnosed with mesothelioma, and filed suit in Pennsylvania State Court against 59 defendants, including respondents RFPC and Viad, who distributed locomotive brakeshoes locomotive engine valves containing asbestos. The Locomotive Inspection Act (LIA) provides that: A railroad carrier may use or …

U.S. Fifth Circuit Sustains Claim for Breach of Implied Warranty Against Hip Manufacturer to the Extent that Defendant Did Not Comply with Requirements of FDA.

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Patient who underwent hip replacement surgery sued company that designed, manufactured, and marketed hip prosthesis that malfunctioned under number of theories including products liability, negligence, and breach of warranty, as well as the Texas Deceptive Trade Practices Act. “In summary, Bass pleaded: (1) he received a Shell implant; (2) the FDA had previously warned Stryker of bioburden in excess of …

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 …