A prescription for drug disaster

- Georgetown Voice

04/11/2008 - If an Ohio District Court rules in favor of Johnson & Johnson in an upcoming case, it will set the precedent that drug companies are no longer responsible for their medicines’ unadvertised side effects. This legal shield would let drug companies literally get away with murder.

The lawsuit alleges that the label on Johnson & Johnson’s Ortho Evra birth control patch understated the amount of estrogen the patch contained, putting users at risk for blood clots. A ruling for Johnson & Johnson would be based on the doctrine of pre-emption, which holds that federal regulations override all state laws, including personal injury laws. Because the FDA approved the drug, pre-emption would protect the company from state prosecution.

If the justices side with Johnson & Johnson, they will be trampling on the rights of patients who have been injured due to inadequate or misleading labels or unforeseen side effects. They will no longer be able to seek redress from the drug company in court.

“You don’t get any compensation [and] the drug company bears no responsibility,” David Vladeck, co-director of Georgetown Law’s Institute for Public Representation, said.

Personal injury cases provide justice for patients and keep pharmaceutical companies accountable for the medications they produce, thus regulating the market and bringing attention to side effects that would otherwise remain unknown.

Under pre-emption, the only source of regulation would be the FDA, an agency whose spotty performance raises questions about whether they are capable of such a task. The agency’s problems were demonstrated when Vioxx, a popular, FDA-approved drug, had to be recalled because it increased a user’s risk of heart attack and stroke. A more effective solution is holding companies responsible for problems with their drugs, motivating them to test their products rigorously.

“The FDA cannot possibly fully monitor the safety profile of every drug,” Vladeck said.

With the cost of research for new drugs so high, it’s tempting to cut down on the risks faced by pharmaceutical companies, in hopes of encouraging innovation. Companies need incentives to keep researching life-saving medications, but this can be done in other ways that won’t compromise consumer safety. For example, Medicare could promise to cover a drug, ensuring profits for drug companies that take risks.

Allowing them to shirk responsibility for the injuries caused by their medications, however, trades patient safety for drug company profits.