Federal Judge Denies Merck Preemption Bid

This is another defeat for Merck - and big pharma. The federal judge who oversees thousands of Vioxx lawsuits earlier today tossed aside the drugmaker’s argument that an FDA rule pre-empts the right to file a product liability lawsuit. Just last week, the New Jersey state court judge who oversees thousands more Vioxx lawsuits made the same decision.

Merck had argued that two lawsuits in the multi-district litigation in Lousiana should be dismissed, based on preemption. But in his 21-page ruling, US District Court Judge Eldon Fallon wrote that FDA approval of warnings on a drug label doesn't clear Merck of claims that warnings are inadequate: "The Food, Drug & Cosmetic Act does not contain an express statement that Congress intended to displace state-law claims in the prescription drug context....Congress has never spoken on preemption with respect to prescription drugs...," he wrote.

"...Because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied preemption in these cases would abolish state-law remedies and, in effect, render legally impotent those who sustain injuries from defective prescription drugs."

Preemption is a hot topic in pharma these days. Essentially, preemption gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe. An exception would occur when, say, a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug. Drugmakers have been pushing preemption nationally, arguing that juries shouldn't be allowed to overrule the FDA, and many lawyers expect the US Supreme Court to eventually take up the issue.

In a statement, Merck's outside counsel, Ted Mayer, said: "We believed that these two cases should have been dismissed because the FDA approved the product label that was included with the medicine, and that label reflected the cardiovascular risks known at the time these plaintiffs started taking Vioxx...

"...In fact, the two cases specifically involved patients who began using Vioxx after the FDA approved label was revised to include the cardiovascular data from the VIGOR study.

As we argued to the court, the FDA has explicitly determined that its labeling regulations preempt or supersede state law claims which, as in these two cases, challenge the adequacy of FDA-approved labels. The FDA has noted that this preemption principle is critical to its mission.

In addition, there is compelling precedent in support of our position that the claims at issue here are preempted by the FDA, which among other reasons is why we are considering potential avenues for appellate review. In fact, we have always believed that this would be an issue to be resolved by the appellate courts and ultimately the Supreme Court.

The evidence has shown that Merck acted responsibly by promptly providing the FDA with the data it had and requesting expedited consideration of proposed language for a new label to reflect what was known at the time from the new data. The label provided physicians with the relevant information available to help them determine whether to prescribe the medicine to a given patient.

If every state were able to impose its own warning requirements on prescription drugs, there would be mass confusion about the potential risks of drugs."