Michigan May Allow Suits Over FDA-Approved Drugs

A bill pending in the Michigan Senate would allow residents to sue drug companies for side effects, injury, or death despite the medication’s approval by the U.S. Food and Drug Administration.

House Bill 4317 also would allow residents formerly prevented from suing to take retroactive legal action.

‘Redundant’ Move

“Passing House Bill 4317 would be redundant after the Supreme Court ruled similarly in March, declaring state juries can award damages in cases where patients were harmed or killed even though the drug manufacturers had garnered federal approval,” said Peter Pitts, president of the New York-based Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.

“The issue has already been addressed by the U.S. Supreme Court,” Pitts said. “Right now in Michigan, there is no point at all.”

Pitts said because federal law preempts state law, the FDA should have the final word about what a drug should be used for. However, he notes, the Supreme Court ruling says federal preemption does not apply in cases regarding FDA labels, so consumers can sue.

Made State Drug-Firm Friendly

Erin Knott, assistant director of the Kalamazoo-based consumer organization Michigan Citizen Action, said HB 4317 would “grant justice to consumers harmed by the drugs.”

HB 4317 would “allow Michigan residents their fair shake to have a trial, go before a jury, present the evidence, and have, just like anybody else in the United States, an opportunity for justice,” said Knott.

“The Michigan legislature originally barred residents from suing in 1996 because state legislators wanted to reform tort laws and create jobs by drawing drug manufacturers to the state,” Knott explained. “Now there are thousands of potential plaintiffs in Michigan.”

‘Bad for Public Safety’

But Pitts said the legislation will only buy Michigan legislators a few inches of good publicity and will eventually hurt patients.

“It’s more for political grandstanding than for the public health, which is unfortunate,” Pitts said.

“Although it’s difficult to predict the consequences of allowing consumers to sue over side-effects or injuries caused by FDA-approved drugs, the decision will likely increase the price of health care, keep drug companies from investing in high-risk drugs, and incite doctors to give patients less-aggressive drug treatments, even when it could have helped them,” Pitts continued.

“This legislation is bad for the public health, bad for the public safety,” said Pitts. “The only thing it’s going to increase is the amount of money in lawyers’ pockets. Looking to punish drug companies does not make a single [person] safer.”

At press time, HB 4317 was awaiting floor action in the Michigan Senate.

Jillian Melchior (jilliankaym@gmail.com) writes from Michigan.

For more information ...

Michigan House Bill 4317: http://is.gd/DpoS