Drugs

Court Rejects ‘Innovator Liability’ in Generic Drug Case

An Idaho district court has rejected the theory of “innovator liability” under which a branded drug manufacturer can be held liable for injuries caused by a generic version of its drug. A Washington Legal Foundation (WLF) Legal Pulse reports that the court ruled that plaintiffs could not sue Novartis for injuries caused by a generic form of its premature labor drug Brethine.

The plaintiffs said that the generic form of Brethine (terbutaline sulfate) caused harm to the mother and her child, and brought six causes of action against Novartis, including negligent failure to warn and negligence per se.

Novartis moved to dismiss the suit for lack of personal jurisdiction and for failure to state a claim. The plaintiffs alleged that the generic equivalent caused the injury, although the complaint does not state who manufactured the generic in question. The theory of innovator liability is based on the notion that the generic manufacturer has no control over the labeling contents.

Before analyzing each of the six counts raised by the plaintiffs, the court “made clear that one ‘crucial fact’ prevailed throughout the complaint: ‘Novartis did not manufacture the drug that caused the injuries,’” WLF says.

“In order for a brand-name manufacturer to be liable for a plaintiff’s harms,” the article says, “the manufacturer must owe a duty of care to the plaintiff. Foreseeability of harm determines the scope of a duty; it does not determine whether one actually exists.”

WLF says decisions such as this one should remind courts to leave the expansion of drug-labeling requirements to Congress and federal regulators.

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