Drugs

Generic Drugs Not Covered by West Virginia Tort Law

The Supreme Court of Appeals of West Virginia says there is no cause of action in the state for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug taken by a plaintiff was produced by a generic drug company. The court issued its 5/11 ruling in response to a question posed to it by the federal Fourth Circuit Court of Appeals.

The case involved a generic form of Janssen’s Levaquin (levofloxacin) produced by Dr. Reddy’s, and a plaintiff’s claim that the drug caused acute respiratory distress (ARDS).

The plaintiffs argued that generic manufacturers used the labeling information from the branded version and claimed that Janssen was aware that ARDS had been linked to the use of levofloxacin but negligently failed to include a warning, knowing that the omission would appear in the labeling for both branded and generic versions.

According to the plaintiffs, although a generic version of the drug was taken, Janssen had exclusive control of the content of the Warnings that were published to the public and to healthcare providers for both the branded and generic forms of the drug.

Janssen sought and was granted summary judgment in a federal district court, with the court saying that every appeals court that had considered the issue had rejected the notion that a brand-name manufacturer’s statements about its drug could be the basis for liability for injuries caused by another manufacturer’s product. The plaintiffs appealed the case to the 4^th Circuit, which asked the state court to answer the question about applicability of state law in West Virginia.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome