Drugs

Massachusetts Court Clouds ‘Innovator Lability’: Attorney

Attorney Victor Schwartz (Shook, Hardy & Bacon) says the Supreme Judicial Court of Massachusetts has clouded the question of innovator drug company liability in cases alleging injury caused by a generic drug company’s version of their product. Writing in a Washington Legal Foundation Legal Opinion Letter, Schwartz says the court fully understood that “black-letter liability law limits a manufacturer’s responsibility for harms caused by a product it made or authorized. Nevertheless, the court permitted an end-run around that standard by allowing a claim based on recklessness.”

He says that in Rafferty v. Merck, the plaintiffs argued that without tort law exposure, branded companies would have little incentive to improve their warnings. “That argument does not hold water,” Schwartz declares. “Existing law provides significant fines and penalties for the failure of branded companies to inform FDA about a pharmaceutical product’s serious adverse side effects, particularly when it acts recklessly. In fact, post-patent, generic companies, not branded companies, are in the best position to protect consumer safety because they control 90% of the market. They are subject to the same fines and penalties. The court did attempt to cabin future litigation against branded drug companies to only the most extreme reckless behavior.”

According to Schwartz, once a reader gets past the court’s sympathetic statements about the risks of developing prescription drugs and its sincere efforts to limit its holding, the case is still another instance of “deep pocket jurisprudence.” The court believed that the plaintiff had been wronged, the attorney writes, and since the generic drug company had an absolute preemption defense, someone had to pay, and that someone was Merck and its deep pockets.

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

Read more

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