After months of anticipation, the US Supreme Court today will hear a case that will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. At issue is whether federal law preempts - or supercedes - such claims from proceeding in state courts and if drugmakers can be held liable if they decline to withdraw their medicines.
However, the same notion might also be applied to brand-name drugmakers and, for this reason, has set the entire pharmaceutical industry on edge. For this reason, the Obama administration filed a brief in support of drugmakers over concerns that the FDA regulatory review process could be undermined if medicines deemed safe and effective by the agency could later be considered "unreasonably dangerous" (here is the US brief).
Here is the background: The court agreed to review an appeal by Mutual Pharmaceutical to overturn a $21 million jury award to Karen Bartlett, a New Hampshire woman who in December 2004 had taken its generic non-steroidal anti-inflammatory, or NSAID, called sulindac for shoulder pain. But a few months later, she developed Stevens-Johnson Syndrome and toxic epidermal necrolysis.
As a result, she is nearly permanently blind and suffered burn-like lesions on 65 percent of her body due to a hypersensitivity reaction. She spent 70 days at Massachusetts General Hospital, including 50 days in its burn unit; suffered two septic shock episodes and 12 major eye surgeries;, she is unable to read, drive or work, and must use a feeding tube, according to court documents.
Barlett and her husband subsequently sued Mutual for alleged design defects under New Hampshire state law, and last May, a federal appeals court upheld the award (read here). Mutual, however, continues to argue that federal law preempts this type of claim because the FDA had already approved sulindac and federal law requires a generic drug to have the same design as the brand-name medication.
As we have noted previously, Mutual points to a Supreme Court ruling in June 2011 that found generic drugmakers are not required to strengthen product labeling if alerted to side effects, when the same change has not been made to the labeling for the branded medicine (back story). The case was known as Pliva vs. Mensing.
Bartlett, however, argues that the FDA should never have approved the drug and claimed the medicine was inherently dangerous based on the number of incident reports of the skin reaction that were filed with the FDA. On that basis, Bartlett and her attorneys have maintained that the design of the drug was "unreasonably dangerous" and defective.
In a brief supporting Mutual, however, the Generic Pharmaceutical Association argued that the appeals court ruling “reopens avenues of liability” that the Supreme Court closed with its decision in Pliva vs. Mensing.
"Judgments of safety and efficacy of prescription drugs should rest with the scientific experts at the FDA," says GPHA president Ralph Neas in a statement. "This case, if decided incorrectly, threatens to undermine the authority of the FDA, which is the only body that has the scientific knowledge, regulatory experience, and complete data to make these decisions."
However, such concerns may later be rendered moot, because the FDA is considering a change in its regulations that may require generic drugmakers to update labeling to reflect what brand-name drugmakers disclose in their labeling (see this). And for more on what may happen, please read this op-ed by Kate Greenwood, a research fellow and Lecturer in Law at Seton Hall Law School Center for Health & Pharmaceutical Law & Policy, who previously worked at the Covington & Burling law firm where she represented drugmakers.
supreme court pic thx to robcrawley on flickr