Merck Gets Big Preemption Win

Merck Gets Big Preemption Win

July 9th, 2013 // 12:19 pm @

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This is a decision that will hearten many in the pharmaceutical industry. This week, a federal court ruled that drugmakers can defend themselves against a lawsuit of product liability by using the concept of preemption – which is the idea that FDA approval of a medical product shall supercede any claims at the state level that challenge the safety, efficacy or labeling of a product.

Preemption was at the center of a 2009 Supreme Court ruling that determined that a woman in Vermont was allowed to sue Wyeth because that company had failed to put enough safety warnings on one of its drugs.

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Why is this? There was not any evidence that indicated FDA would have turned down a stronger warning if the company had tried to do so. It was not completely impossible for Wyeth to have tried to update the label. But the court also stated something that invited a defense of preemption. If a pharma company can give clear evidence to FDA that the agency would not have approved a labeling change with an updated warning, the drugmaker may argue that this shows it was not possible to comply with FDA requirements and a law at the state level that demands a stronger warning.

Merck has won such a ruling. The federal court decided that Merck had tried to improve the warning about a link between Fosamax for osteoporosis and fractures of the femur. FDA did not approve an addition to the warning sections of the label. This effort happened in 2008, when one patient had a fracture in New York. Her argument was that Merck knew Fosamax could increase risks of fractures, and knew this years before the drug was available but did not put this on the warning label.

But the judge on the case – Joel Pisano, disagreed and stated that preemption is allowed in this case. There is clear evidence, he said, that FDA would not have approved such a change to the label before the person’s fracture.

The judge stated that FDA had sent emails to Merck in 2009, where it said that FDA had rejected the new labeling in the same month that the plaintiff suffered the fracture. FDA also warned Merck that the drug could be misbranded if they made the labeling change without FDA consent.

In 2010, the American Society of Bone and Mineral Research gave a report prompted FDA to require Merck and other companies to put stronger wording on product labels regarding femur fracture.

So will we see a large number of briefs filed by drug companies, citing this preemption defense? There are some cases where companies might be able to establish strong evidence that FDA would not have approved a change to the label.

But it is hard to know how many such cases are out there. Some experts say that the Supreme Court must have thought that the preemption defense could only be used in limited cases, or it would not have issued the ruling.

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