In In re Neurontin Marketing and Sales Practices and Products Liability Litigation, 2010 WL 3169485 (D. Mass. Aug. 10, 2010), plaintiff was prescribed an anti-epileptic drug off-label, along with approximately 15 other drugs, to treat seizurelike symptoms she experienced after a stroke. Thereafter, plaintiff continued to experience seizure-like symptoms and also suffered “black-outs,” depression and constant lethargy. After consulting a neurologist who told her she had been overmedicated and took her off several drugs, including the antiepileptic, plaintiff stopped experiencing most of her symptoms. She then sued the anti-epileptic drug’s manufacturer in the United States District Court for the District of Massachusetts alleging the manufacturer had failed to adequately warn of potential adverse effects.
Defendant moved for summary judgment on three grounds: (1) plaintiff had no expert to testify that the drug caused her injuries; (2) plaintiff conceded the side effects she suffered were disclosed on the drug’s labels; and (3) there was no evidence that plaintiff or her prescribing physicians would have acted differently had there been additional warnings. With respect to causation, the court first observed that under Massachusetts law, a plaintiff must show that defendant’s conduct was a substantial contributing factor to the injury. Although plaintiff had designated her neurologist as a causation expert, in his deposition he refused to testify that the anti-epileptic drug was a substantial contributing cause to her injuries. Thus, the court held plaintiff could not establish causation.
The court also found summary judgment appropriate on the second and third grounds of defendant’s motion. Because plaintiff’s claims were based on an alleged failure to warn of risks associated with the drug, the claims were governed by the learned intermediary rule, which provides that a prescription drug manufacturer’s duty to warn runs only to the physician and it is the physician’s duty to warn the consumer. Here, plaintiff conceded that many of her symptoms were in fact listed on the label. Further, plaintiff offered no evidence that her physician’s decision to prescribe the drug was a result of any failure to warn or misrepresentation by the manufacturer.