Court: Doctors, not drugmakers, must warn patients of risks

The Supreme Court of Texas has ruled that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drugmakers advertise their products directly to consumers.

The 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.

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 state Supreme Court on June 8 reversed that ruling. 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.

As part of the decision, the court also ruled that a physician treating a patient but not actually ordering the drugs has no duty to warn of risks.

The decision overturned the jury’s verdict against Centocor. At this article’s deadline, attorneys for Centocor and the Hamiltons had not returned messages seeking comment.

Most jurisdictions share same view

The majority of states follow similar doctrines as Texas when failure-to-warn claims arise, said Paul Schmidt, outside counsel for the Pharmaceutical Research and Manufacturers of America. PhRMA wrote a court brief in support of Centocor.

Only West Virginia and New Jersey have deviated from traditional learned intermediary doctrines, Schmidt said. For example, in 1999, the Supreme Court of New Jersey adopted a direct-to-consumer advertising exception to its doctrine. The court held that when drug companies choose to market directly to patients, the learned intermediary doctrine no longer provides them complete liability protection. However, aside from courts in West Virginia, most judges have declined to follow New Jersey’s lead on the matter, the Texas justices wrote in the Centocor opinion.

The Texas decision brings the state back in line with the majority of other jurisdictions, Schmidt said. “The whole system is set up with companies providing warnings to doctors,” he said. Drug companies “would have lost a very substantial defense had the [appeals] decision stood.”

But Hull and others said the learned intermediary doctrine needs updating as technology grows and more manufacturers target consumers directly for their business. When the doctrine was created, most patients learned of new drugs only from their doctors. Consumers now are inundated with marketing messages from drugmakers on television, through radio programs and online, Hull said.

In its court brief, TAPA and the Texas Medical Assn. stressed that in today’s world, the responsibility to inform patients should be a shared duty among doctors and drug companies.

“Physicians recognize and accept that theirs is a critical role in providing informed consent to the patient,” the brief said. “Nonetheless, pharmaceutical manufacturers who market prescription drugs have a duty to exercise ordinary care to assure that citizens who purchase and use their drugs are reasonably informed about the risks of those products.”

Not the final word on doctrine

Had the appeals court decision stood, drug companies likely would have seen an explosion of litigation involving failure-to-warn accusations, said Richard Samp, an attorney with the Washington Legal Foundation, a civil liberties law firm that wrote a brief in support of Centocor.

“The offshoot is that pharmaceutical companies can now devote more of their revenues to research and developing new life-saving medicine,” he said. “Doctors are by far in the best position to provide warnings to patients.”

Samp noted that drugmakers are not completely without liability if a patient is injured by a drug. If incorrect information is passed to physicians, a manufacturer still can be held liable, he said. But drug companies cannot be sued for failing to provide drug warning information directly to a patient.

Despite knocking down the direct advertising exception in Centocor, the court left open the possibility that the exception could be revisited in other cases, said Rocky Wilcox, vice president and general counsel for the Texas Medical Assn.

“It’s not black and white,” he said of the decision. “It’s a good ruling in the sense that they’re not denying there needs to be a reexamination of the doctrine, and that it may not apply in every case.”