So who do you think should be responsible to inform a patient of the dangers or side effects of a drug? Would you think it is your doctor’s job to tell you? Is it the drug manufacturer’s job to make sure you know? This question was recently answered by the Texas Supreme Court.
The court ruled that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drugmakers advertise their products directly to consumers.
The June 8 ruling overturns an appellate court decision that said drug companies have a duty to warn patients when marketing products to them. Health professionals said the decision creates greater liability for doctors and removes necessary responsibility from drugmakers after medication mishaps.
“Drug manufacturers can continue to market directly to patients without any accountability for what they say,” said Mike Hull, general counsel for the Texas Alliance for Patient Access. The group, along with the Texas Medical Assn., joined a court brief urging the state Supreme Court to uphold the lower court’s decision. Drug companies “have no legal duty, while everyone else in the world has a duty to warn about their product, whether it’s a lawnmower or car.” Hull said.
The case centers on a lawsuit filed by Texas residents Patricia and Thomas Hamilton against Centocor Inc. The couple claimed Centocor provided inadequate warnings and instructions for the use of Remicade (infliximab). The Hamiltons also sued several Corpus Christi, Texas-based physicians who treated Patricia Hamilton or oversaw her care. The suit centered on an informational video doctors showed Hamilton shortly before she started Remicade infusions to treat her Crohn’s disease. The video overemphasized the drug’s benefits while intentionally omitting warnings about its possible side effects, the plaintiffs said. Hamilton later developed a lupus-like syndrome that allegedly resulted from the medication.
At trial, the couple accused Centocor of fraud, negligent misbranding and negligent marketing, among other claims. A jury awarded the couple more than $16 million, which was reduced by a trial judge to $4.7 million. One physician defendant was dismissed from the case, while two other doctors settled with the couple, according to court documents.
The Learned Intermediary
Centocor appealed, saying it provided sufficient warnings to Hamilton’s physicians about Remicade and that it had no duty to warn Hamilton directly about the drug’s risks. In reviewing the case, the appeals court examined the state’s decades-old policy known as “learned intermediary doctrine.” The doctrine says a drug manufacturer satisfies its duty to warn the end-user of its product by providing an adequate warning to a learned intermediary. The intermediary, generally a physician, assumes the duty to pass on the necessary warnings.
The appeals court cited an exception to the doctrine that said drugmakers may be held liable when they directly advertise to consumers in a “fraudulent manner.” Centocor could not rely on its warnings to doctors when it “directly misrepresented its product’s dangerous propensities” to the plaintiff, the appeals court said.
The court acknowledged that some cases may warrant exceptions to the learned intermediary doctrine, but in Centocor, no such condition applies.
“We find no reason to adopt an exception where the physician-patient relationship existed, the pharmaceutical company provided a warning to the patient’s prescribing doctors that included the side effect of which the patient complains, and the patient had visited with her prescribing physician and decided to take the drug before she saw the informational video at issue,” the opinion said.
So whose job do you believe it to be? Should your doctor be responsible for sharing the information; or in our technology driven society, where there are numerous infomercials for various drugs, is it the drugmaker’s responsibility?