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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Complete Warnings Are A Pharmaceutical Necessity

In 2010 the anticoagulant drug Pradaxa, otherwise known as dabigatran etexilate mesylate, was approved by the FDA and introduced to the US market, offering consumers a replacement to existing versions of blood thinning drugs such as Coumadin. Since Pradaxa’s release several dozen consumers from Tennessee, Louisiana, Kentucky, and Connecticut have filed lawsuits alleging injury from the use of the drug, claiming the manufacturer failed to adequately warn consumers of the possibility of the irreversibility of the drugs anticoagulation effects. As of December 2011, the FDA…
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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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