Court: Drugmakers Do Not Have To Warn Patients About Drug Risks

Jane Akre
July 17, 2012

Finger pointing, WikiCommons, Debivort

July 17, 2012 ~ In a bizarre twist that puts one more advantage in the corporate side, the Supreme Court of Texas has ruled that manufacturers of pharmaceuticals do not have a responsibility to warn patients about the risks associated with using their products, even as they advertise directly to the public.

A lower court had ruled drug companies do have a duty to warn patients when they market to the public, reports the American Medical Association News (here).

This of course puts more liability on the shoulders of doctors while it lifts the burden of liability from the backs of the corporations who make drugs.

There are as many as 100,000 preventable deaths in the U.S. each year due to medical errors often medication errors, according to a report by the Institute of Medicine, To Err is Human (here).

The case results from a lawsuit filed by a Texas couple who claimed the drug company, Centocor did not adequately warn about the dangers of Remicade. When an informational video was shown to Patricia Hamilton about the treatment for her Crohn’s disease, it overemphasized the drug’s benefits and intentionally omitted warnings about the side effects, their lawsuit claimed. Hamilton later developed a lupus-like syndrome, allegedly from the medication.

While Patricia and her husband won a failure-to-warn case before a jury and were awarded $16 million, a judge reduced that to $4.7 million and the company appealed.

The argument on the part of the drug company was that it had provided adequate warnings to her doctor who is the end user, not the patient. The appeals court did says a drug company should be held liable when they advertise directly to the consumer in a "fraudulent manner."

But the case then was appealed to the Supreme Court of Texas which reversed that ruling June 8.

This is akin to a U.S. Supreme Court decision that relieves medical device makers of any legal responsibility if their product has been approved by the U.S. Food and Drug Administration. Riegel v. Medtronic ruling states a products liability lawsuit cannot be brought against a manufacturer in state court because the FDA approved their product.

Learned Intermediary

We’ve seen the learned intermediary argument in surgical mesh cases. American Medical Systems (AMS), Inc. out of Minnetonka, Minnesota, on April 6, filed its Position Statement in the federal court where hundreds of mesh cases are consolidated, which basically lays out how it plans to defend itself against product liability lawsuits filed by women injured by the AMS synthetic surgical mesh.

MDND background story is here.

AMS says it does not have to warn the end- user, the patient, because to the company, the warning goes to the physician in the form of the package insert or Instructions for Use. To AMS, this is the end user and that is where their liability stops, they argue.

Under legal theory this is the “learned intermediary” doctrine, and it means that AMS only had a duty to warn the physician using the product not the patient. It is up to the physician to pass that warning onto the patient.

Other States Do the Same

The AMA says most jurisdictions share the 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.”

Doctors Push Back

In a push back from doctors the Texas Medical Association said that informing patients should be a shared duty between doctors and drug companies, especially when the drug company advertises directly to the patient.

Industry says it’s good the appeals court decision didn’t stand otherwise you would have seen an explosion of failure-to warn litigation.

Richard Samp, an attorney with the Washington Legal Foundation, wrote a brief supporting 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.”#

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