Philadelphia Court Rejects Off-label Claims

A Philadelphia Court of Common Pleas judge has dismissed a suit against Cephalon claiming that it promoted an opioid medication off-label. Attorney Michelle Yeary (Dechert) says the plaintiff claimed that he became addicted to the opioid cancer pain drug that he was given to treat his migraines. Yeary says the drug was prescribed to the plaintiff for seven years, during which time he was in and out of drug treatment programs due to opioid and other drug addictions. He ultimately died from his drug addiction.

The suit made claims for negligence, fraud, misrepresentation, and violation of the state unfair trade practices and consumer protection law. According to Yeary, the basis for each claim was an allegation that Cephalon illegally promoted the drug for off-label uses.

She says the court first held that generally off-label sales, promotions, and prescriptions are proper. It also noted that the plaintiff failed to allege that any off-label promotion was false. Because there is no state law duty to avoid off-label promotion, plaintiff’s claims “could not exist in the absence of federal law and regulations,” the court said.

Although the case was dismissed as preempted, the court also dealt with the company’s claim that it was barred by the learned intermediary doctrine. The plaintiff had argued that the doctrine should not apply because the plaintiff’s doctor was not learned in that he was given “misinformation” by the drug company. The court found that not only did the doctor have access to the risk and precaution information provided by Cephalon and his own medical training and judgment, he also had “actual knowledge” that his patient had become addicted and continued to prescribe the drug for many years. The court noted that a treater has a duty to know what other medications a patient is taking, Yeary wrote.