A Pennsylvania appeals court has upheld the $3 million verdict against Janssen Pharmaceuticals Inc., a Johnson & Johnson unit. Once again the court rejected arguments that claims over birth defects allegedly caused by the anti-epilepsy drug Topamax were preempted by federal law. A three-judge Superior Court panel said that prior decisions upholding verdicts against Janssen over Topamax-related birth defects had already dispensed with the company’s arguments that federal law did not allow the company to make unilateral changes to the medication’s warning label in order to avoid potential liability under state law. The opinion states:
Janssen’s argument that impossibility preemption precludes the failure-to-warn claim has already been rejected by this court. We conclude that Janssen’s preemption arguments … do not merit relief.
Kelly Anderson and her family had filed suit in December 2011 alleging her daughter Payton was born with a cleft lip after doctors continued to prescribe Topamax to her mother to treat chronic migraines during the pregnancy. They argued that Janssen should have pushed to have Topamax listed as a so-called Pregnancy Category D drug, which warns consumers there is evidence of fetal risk based on studies in humans.
The family was awarded $3 million in damages by a Philadelphia County jury in March 2014 after jurors agreed that the company failed to adequately warn the mother’s physicians about the risks associated with the drug. On appeal, Janssen said it had no authority to unilaterally change the drug’s pregnancy category without the blessing of the U.S. Food and Drug Administration (FDA).
The appellate court panel found that what was actually at issue was the company’s efforts across the board to warn doctors about what risks it may have known about. The opinion stated further:
Prior to trial, the court issued an order declaring that Janssen did not have the ability to unilaterally change the pregnancy category from C to D, and the jury was instructed as such multiple times during trial. Thus, the jury’s determination that Janssen is liable for its failure to warn was not predicated upon Janssen failing to change Topamax’s pregnancy category.
The appeals court rejected arguments by Johnson & Johnson that the failure-to-warn claim was precluded based on testimony from Anderson’s prescribing doctor that she could not have totally ruled out the possibility of Topamax causing birth defects at the time she prescribed the drug. The opinion stated:
Janssen’s argument fails to differentiate between the nonspecific, potential risk that Topamax’s Category C label implied and a known risk in which the drug has been scientifically established to cause particular birth defects. The evidence presented at trial indicated that Janssen knew of a causal relationship between Topamax and specific birth defects, including cleft palate, but failed to disseminate the information so that [Anderson’s] physicians would be adequately warned.
Only one of the two prior Topamax cases to be decided by the Superior Court was presented to the state’s Supreme Court for a potential appeal, but court records show that the application was withdrawn before the justices decided whether or not to hear arguments.
The Andersons are represented by the Law Offices of Howard J. Bashman, David deBruin of Bifferato Gentilotti LLC, David Matthews of Matthews & Associates, and Rosemary Pinto of Feldman & Pinto PC. The case is in the Superior Court of the State of Pennsylvania.
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