Drugs

Drug Preemption Defense Demanding, Attainable: Attorneys

Writing in a Washington Legal Foundation Legal Opinion Letter, attorneys Philip Goldberg and Christopher Gramling (Shook, Hardy & Bacon) discuss court cases that demonstrate, they say, that while the preemption defense in state failure-to-warn cases is demanding, it is attainable. “District judges have issued thoughtful and thorough analyses of what the manufacturers and FDA knew, when they knew it, what they did with that knowledge, and, ultimately, what FDA decided was the proper public health care decision about the drug’s labeling,” the attorneys write. “There is no doubt that preemption remains a demanding defense, but, as these cases show, it is attainable.”

In Wyeth v. Levine in 2009, the Supreme Court rejected preemption, but said it could be found in situations in which there was “clear evidence” that FDA would not have approved the labeling change the plaintiff claimed was needed to prevent his or her injury.

Ten years later, the attorneys write, the court talked further about what constituted “clear evidence” in its decision in Merck Sharp & Dohme Corp. v. Albrecht. The ruling said clear evidence exists when either (1) the plaintiff presents no new evidence of a causal association between the drug and injury alleged warranting a labeling change or (2) FDA was “fully informed” of the justification for the labeling change and communicated it would not have approved the change.

The attorneys say they reviewed cases for an article published in the Rutgers Journal of Law and Public Policy and found that, although preemption is a demanding defense, it is certainly attainable. “Further,” they write, “ courts did not establish bright-line rules for when preemption exists. Each drug’s story is different, and the trial judge dove into the substance of the cases to determine whether preemption was appropriate based on the facts, medical science, and circumstances of the specific drug at issue.”

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