Subject: Failure to Warn Standards

Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

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The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

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Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.

Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.

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California [Again] Confronts the High Cost of Litigation Uncertainty

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The first appellate shoe has dropped in the litigation involving the herbicide Roundup, Johnson v. Monsanto Co., decided July 20, 2020, by California’s 1st District Court of Appeal, Division One. We discussed the verdict and the trial court’s post-trial rulings here, and we now follow through with an update.

Initially, the price tag for allowing questionable science into the courtroom, as measured by this verdict, has been reduced. The court of appeal lowered the compensatory damages award from $39 million to about $10.25 million, concluding the jury had improperly awarded noneconomic damages that plaintiff would likely never suffer. Because plaintiff’s counsel had argued to the jury that plaintiff’s Non-Hodgkins Lymphoma had reduced his future life expectancy to two years, the jury could not award pain and suffering damages beyond that two-year span. And, agreeing with the trial court that constitutional limits required a 1:1 ratio between compensatory and punitive damages, the court slashed the $78 million punitive award to about $10.5 million.

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Deceptive Labeling Claims Based on Trace Amounts Sent to the Dog House

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In dismissing a plaintiff’s claims regarding dog food ingredients, the U.S. District Court for the Eastern District of Wisconsin confirmed the common-sense principle that manufacturers need not list anything and everything that could have possibly made it into a product as an “ingredient.”

In Weaver v. Champion Petfoods USA Inc., et al., case no. 18-cv-1996-JPS, a Wisconsin resident claimed that Champion Petfoods USA Inc. and Champion Petfoods LP deceptively marketed their dog food products. The plaintiff took issue with multiple characteristics of defendants’ products, including that the product packaging stated the dog foods adhered to a “biologically appropriate nutritional philosophy,” were made with “fresh” and “regional” ingredients, and were “never outsourced.” The plaintiff asserted claims for fraud by omission, negligence and violation of the Wisconsin Deceptive Trade Practices Act. The defendants moved for summary judgment.

“Biologically Appropriate”

The plaintiff contended that defendants deceptively marketed their products by stating their dog foods were made with a “biologically appropriate nutritional philosophy.” According to the plaintiff, this phrase indicated to consumers that the products did not contain Bisphenol-A (BPA), which the plaintiff argued was in the products.

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Lack of Admissible Expert Evidence Combusts PAM Can Claims in EDNY

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In a decision reinforcing the importance of expert testimony in design defect and failure to warn cases, the Eastern District of New York recently dismissed claims against the makers of PAM cooking spray.

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Whether Asbestos-Containing Components Were Manufactured by Third Parties No Longer Matters in New Jersey

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Aligning with neighboring New York, and clearing up conflict within the Appellate Division, the New Jersey Supreme Court ruled equipment manufacturers can be held strictly liable on the basis of failure to warn for asbestos-containing component parts made or supplied by third parties. Whelan v. Armstrong Int’l, Inc., (N.J. 6/3/20).

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