Author Archives: Jill C. Owens

Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger. Background As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device…

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First Circuit Affirms Preemption of State-Law Claim for Consumer Fraud

labelIn a key preemption ruling late last month, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative class action. The First Circuit affirmed dismissal where the plaintiffs alleged consumer fraud, holding that state-law claims for false or misleading labeling are preempted by federal law. Read the full decision here. The First Circuit’s ruling built upon recent United States Supreme Court decisions holding that state-law claims aimed at generic drug labeling are preempted by applying this important defense to…

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Zoloft MDL Excludes on Daubert Grounds Plaintiffs’ Experts’ Opinions on General Causation

Last month the Pennsylvania federal judge presiding over the multi-district litigation in which the plaintiffs allege that the prescription anti-depressant Zoloft, taken during pregnancy, causes birth defects, issued another in an series of Daubert rulings on the plaintiffs’ proposed experts as to general causation. Although the defendant conceded the qualifications of the three research scientists whose expert evidence was being tested, the reliability of their general causation opinions was hotly contested and received a full evidentiary hearing. The Zoloft court’s rulings represent an important addition…

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Does a Medical Device Manufacturer Have a State Law Duty to Advise the FDA of Post-Market Problems? The U.S. Supreme Court May Tell Us

This week, the U.S. Supreme Court has asked the Solicitor General to comment about whether a state law personal injury claim against a medical device manufacturer for a post-market failure to warn the FDA of a subsequently-discovered potential problem is preempted by federal law.  While any pre-market duty to warn claim for an FDA-approved medical device is pre-empted, there is an open question as to whether a state law claim can be pursued against a medical device manufacturer for failure to inform the FDA of…

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Beware: Claims of Efficacy of “Off-Label” Uses of Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT), which involves exposure of the body in a chamber to 100% oxygen under pressure, is widely know as a treatment for “the bends,” the common name for decompression illness in divers. The FDA long ago approved this use of HBOT.  The benefit obtained from HBOT for that and other approved uses derives from injured tissue being exposed to up to three times greater oxygen than is dissolved in the blood through breathing ordinary oxygen at normal air pressure. Hyperbaric chambers are…

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Banana Boat High SPF Sunscreen Class Action Survives Challenge

A California plaintiff survived a challenge to her consumer fraud complaint against Playtex Products and other makers of Banana Boat sunscreens with SPF [sun protection factor] of 85 to 110.  The critical allegation is the claim that that scientific studies show that sunscreen with SPF over 50 provides no clinically-significant benefit over the use of SPF 50 products.  Plaintiff claims the marketing of the Banana Boat products is misleading because the advertising campaign combined extreme SPF values with unproven claims of greater sun protection than…

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