Generic Drug Preemption – Good For Consumers?

Attorneys involved in pharmaceutical product liability litigation such as Testosterone Lawsuits  have been living with a United States Supreme Court decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). In this case, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers.

For consumers, often times, the first time they hear of preemption is when their attorney informs them they have no case because the product they used was a generic drug and not a branded drug. So what is preemption? Most pharmaceutical product liability are based on a failure to warn. This means the drug label failed to warn the user of the true risk or risks associated with the drug. Because Congress wanted to promote the generic drug industry they created a different path for approval of generic drugs and branded drugs. A company seeking approval of a generic drug must only show that the drug is a bioequivalent of the branded drug. On the other hand, the branded drug must show the drug is safe and effective as labeled. The branded drug creates the label and the generic manufacturer of the drug adopts the branded drugs label. The generic manufacturer has no control over the label.

This confusing issue reared its head in In Re Testosterone Therapy Products Liability Litigation, MDL 2545, where some of the defendants filed a motion to dismiss plaintiff’s state law claims arising out of use of certain prescription generic testosterone therapy drugs. They argued that federal law preempts state law claims. Plaintiff’s opposed the motion. Judge Matthew Kennelly granted defendants’ motion dismissing all claims against Pfizer, Inc. and Pharmacia & Upjohn Company, LLC and Auxillium Pharmaceuticals, Inc.

Plaintiffs then filed a motion for reconsideration and clarification of the order dismissing all of plaintiff’s claims, including those based on fraud. The issue whether fraud claims against manufacturers of generic drugs based on “off-label” promotion are preempted under Mensing. Judge Kennelly’s opinion focused on whether off-label promotion falls within the area of drug labeling. He concluded that “Defendants’ obligations under state fraud law to refrain from falsely promoting their drugs for unapproved use does not conflict with their obligations under federal law to maintain their warning labels.” Thus the fraud based claims are not preempted.

Questions About Testosterone Lawsuits?

For plaintiffs who used depo-testosterone, manufactured by Pfizer, Pharmacia & Upjohn, or Testopel®, manufactured by Auxillium, the court’s decision carves out a small avenue for hope that they may obtain compensation for injuries sustained by these products. However, without failure to warn, these cases are vulnerable.

If you have questions about bringing a testosterone lawsuit contact us.  We would like to help. We are representing select clients that used prescription testosterone and suffered life altering injuries.