Drug Companies Would Be Held Accountable for Concealing Dangers Under Bill Awaiting California Assembly Floor Vote

Heavy Lobbying by Big Pharma

By Michael Russo
Health Care Advocate and Staff Attorney
California Public Interest Research Group (CalPIRG)

Drug companies don’t always come clean with consumers about the risks their products pose. Vioxx is probably the example most people have heard of: the pharmaceutical manufacturer Merck knew that its drug posed a cardiac health risk to those taking it, since the clinical trials it sponsored showed that Vioxx almost doubled the rate of heart disease, but it refused to disclose that information for years. In fact, it covered up the results of those clinical trials, and trained its sales reps on how to dodge questions about Vioxx’s safety.

The families of patients injured or even killed by the drug have brought lawsuits, seeking compensation for the harm caused by Merck’s campaign of concealment. But in some of these cases, Merck has been able to hide behind a legal defense called the “learned intermediary doctrine,” which says that it’s up to the doctor, not the drug company, to warn the patient about the potential harms of a drug. The doctrine – which California’s courts have adopted – means that in some cases drug manufacturers can’t be held liable for not being up front about their products’ side effects.

The courts that developed the doctrine early in the 20th Century did so based on a simple premise: the sellers of pharmaceuticals had no relationship to the patient, but rather sold to the doctor, who acted as a sort of professional middle-man. Because the manufacturer had no avenue to communicate with the patient, it would have made little sense to hold them liable for a failure to warn.

While defensible enough in its day, this rationale for the learned intermediary exception has been overtaken by time. Since the FDA opened up the airwaves to drug companies in 1997, television has been flooded with advertisements hawking different prescription drugs, directly entreating the consumer to use their products. With drug manufacturers able to reap the rewards of direct advertising, and with patients convincing their doctors to write prescriptions on the basis of the ads, it makes little sense to say that the drug companies have no opportunity to deliver a proper warning about the possible risks.

That’s why AB 2690 (Krekorian) is such an important bill. This modest law will close this anachronistic loophole, and properly allow drug companies to be held accountable. If a Californian is harmed because a drug company didn’t tell the truth, the company should be liable – that’s the general rule of our legal system, and there’s no longer any principled reason to allow the learned intermediary exception to the rule to stand in the way of compensating injured patients for the harms they’ve suffered.

Comments

Get Email Updates

Want the California Progress Report by email? Once a week, we'll send you the latest and greatest headlines.