Drugs

Texas Federal Court Rejects Effort to Ditch Presumption

A Texas federal judge has rejected an effort to use Buckman preemption to eliminate an entire Texas tort reform statute that created a presumption in drug cases that a drug’s warning is adequate if FDA approved it. Attorney John Sullivan (Cozen O’Conner) writes in an online blog post that the state law gives plaintiffs five ways to rebut the presumption of an adequate warning, including showing that the defendant company withheld information from or misrepresented information to FDA. But it held that the means of rebuttal was held to be preempted by the Fifth Circuit Court of Appeals under Buckman because it requires a plaintiff to prove fraud on FDA.

In a case involving GlaxoSmithKline that was decided in 2015, Sullivan writes, the plaintiff argued that if the Buckman preemption applies at all, it must invalidate all of the applicable state law provisions and not just its fraud-on-FDA rebuttal. “In short, even though the statute created a presumption of adequacy and five ways to rebut it,” Sullivan writes, “the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.”

He points out that the rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing as little as necessary. Preempting only the fraud-on-FDA rebuttal provision accomplishes that, he says. Plaintiffs still have the potential option of four other means of rebuttal and, in fact, might even be able to use the fraud-on-FDA rebuttal if FDA itself made such a finding.

Sullivan says the court not only applied the basic rules of statutory construction but also applied a Texas code that favors severing only an invalid portion of a statute to invalidating the entire scheme.

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