Category Archives: Duty to Warn

Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the…

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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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Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…

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FDA Rule Proposal Could Lead to Liability for Generic Drug Manufacturers

The U.S. Food and Drug Administration (FDA) is proposing new rule changes that would permit generic drug manufacturers to amend drug warning labels when they receive new information related to drug safety; irrespective of whether the revised labeling differs from the brand name manufacturer. The proposed rules further provide that the generic manufacturer would be required to submit the labeling changes along with the data supporting the change to the FDA, which would review the request and post the data in a public web page.…

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First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…

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Natural Product Claims Lead to Liability

On Tuesday, May 7, 2013, a proposed class action lawsuit was filed in the United States District Court for the Southern District of New York on behalf of plaintiff, Michael Goldenberg, and other similarly situated consumers, against Johnson & Johnson Consumer Companies, Inc. (“J&J”), alleging the consumer manufacturer mislead consumers about the nature of the ingredients in its personal care products sold under the Aveeno brand name (see, Goldenberg v. Johnson & Johnson, 7:13-cv-03073).  According to the Complaint, these products were marketed with…

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DMAA Under Continuous Attack: Wrongful Death Suit Filed Against Manufacturer of Popular Dietary Supplement

On February 13, 2013, the parents of deceased soldier, Michael Sparling, filed a wrongful death lawsuit in San Diego Superior Court targeting  the controversial ingredient DMAA and naming manufacturer USPLabs  and distributor GNC Corp. as defendants. According to the Complaint, the plaintiffs are alleging that the DMAA-containing dietary supplement Jack3d is deceptively marketed as a safe and effective supplement and fails to warn consumers about potential health risks. The plaintiffs are seeking unspecified damages. Over the past several years DMAA, or Dimethylhexaneamine, has become a…

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Legislators Take Aim at Popular Dietary Supplement

On January 22, 2013, Senator Jeffrey Klein of New York set forth proposed legislation which would ban the sale and use of products containing the popular dietary compound Dimethylhexaneamine (DMAA) in the state of New York. Over the past several years, the use of DMAA  has become a hot topic for legislators and plaintiffs’ lawyers following criticism that the compound is not a “natural compound,” as marketed, and that it has led to several serious consumer health issues. The criticism helped spark a string of…

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Labeling Inequality: FDA May Attempt To Overrule Mensing on Its Own

The Food and Drug Administration has indicated that it may allow generic drug manufacturers to alter their labeling.  The motivation for this change appears to be to address perceived inequalities stemming from the United States Supreme Court’s decision in Pilva v. Mensing, 131 S. Ct. 2567 (2011). In the Mensing decision, the Supreme Court held that patients who claim injury from generic drugs cannot sue the manufacturer for failure to warn because its labeling must match the labeling of the brand-name version of the…

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