Category Archives: Warnings/Instructions

Keep Your Hands Inside the Hayride: E. Coli Outbreak in Utah linked to Fall Festivities

Utah public health officials are investigating a marked increase in E. coli infections this fall that seem to correspond with visits to petting zoos, corn mazes, and hayrides. Although the exact source has not been identified, several of the 20 cases of E. coli infections were reported following visits to these popular autumnal attractions. Since October 1st, twenty cases of Siga toxin-producing E. coli have been reported in the Central and Southwestern regions of Utah. The infected individuals range in age from 10 months 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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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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Warning: Liability For Deficient Labels May Extend Beyond Your Own Products

Generally, the duty of care of a manufacturer for product liability is limited to consumers who use the manufacturer’s product.  This duty is based on the theory of strict liability in torts, which requires a plaintiff to prove that the defendant actually manufactured the injurious product.  However, in the pharmaceutical industry, courts are beginning to apply negligence principles to extend liability to persons who did not use the manufacturer’s product. In the 2009 case of Conte v. Wyeth, Inc., the California Court of Appeals…

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Warnings That Work: Pharmaceutical Manufacturer Secures Defendant’s Verdict

On Wednesday, May 30, 2011, a Connecticut federal jury held Pfizer not liable for damages resulting from a wrongful death, allegedly stemming from the decedent’s use of the product, Prempro. Prempro was approved by the FDA in 1994 and used to treat symptoms of menopause as well as prevent osteoporosis. In 2002 several studies raised concerns over the use of Prempro which was linked to unusually high instances of breast cancer. In this action, plaintiff alleged that the decedent’s six year use of the drug…

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Not So OraSure: First Over-the-Counter HIV Test Requires Enhanced Labeling

OraSure Technologies Inc. took a step forward in its bid to bring to market its OraQuick In-Home HIV Test.  If approved, OraQuick would be the first over-the-counter HIV test that lets people get results without using a doctor or laboratory.  The FDA Blood Products Advisory Committee unanimously determined that the benefits of the saliva test outweigh the risks.  The primary risk being false negative results.  Final-phase trials of the OraQuick home test are reported to have found 5,384 of 5,385 negative users resulting in one…

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