An implantable defibrillator.

Americans who are injured by prescription drugs won an important protection last week: the right to sue for damages in state courts.
By a 6-to-3 vote, the U.S. Supreme Court upheld damages awarded to Diana Levine, a Vermont woman who lost part of her left arm after receiving an injection of an anti-nausea medication made by Wyeth Laboratories. She argued that the company should have included stronger warnings on the label.
Wyeth had argued that since the federal Food and Drug Administration had approved its drug and its warning label, the company should be immune from lawsuits in state courts, where most medical damage litigation is filed. The court rightly rejected that argument, placing the burden for manufacturing safe drugs and labeling them correctly where it belongs: on manufacturers.
Indeed, Justice John Paul Stevens, writing for five of the six-member majority (Justice Clarence Thomas wrote a separate concurring opinion), said lawsuits filed in state courts can “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly” and “serve a distinct compensatory function that may motivate injured persons to come forward with information.”
Tragically, last year the Supreme Court failed to extend the same protection to patients injured by defective medical devices such as replacement hip and knee joints. The FDA regulates drugs and medical devices alike, but there’s ample evidence that under increasing pressure from budget cuts and anti-regulatory zealots on Capitol Hill, the FDA has failed to adequately protect consumers.

At issue in the Vermont case decided this week, and in a similar case involving medical devices decided last year, is a legal doctrine called pre-emption. Business groups have increasingly sought to use it in product-liability cases.
The general idea is, because federal regulators have to approve a product before it can be sold, patients harmed by approved products shouldn’t be able to file suit in state courts. In this view, federal approval to market a drug or medical device would effectively immunize a company from liability for problems that later become apparent, when the product was in widespread use.
That’s the tact taken by lawyers for Wyeth. They argued that the FDA has authority over prescription drug labeling. Since it didn’t order stronger warnings, the company said it could not be sued over its failure to issue them.
The FDA traditionally has taken a different approach. In 1997, an attorney for the agency wrote that “even the most thorough regulation of a product such as a critical medical device may fail to identify problems.”
That’s all too true, as we’ve seen with the arthritis drug Vioxx and a number of other medications recalled in recent years.

Unfortunately, it’s also true with medical devices.
In 2007, Medtronic Corporation recalled electrical cables that had been implanted in 235,000 patients. The cables, which connect patients’ hearts with a device that shocks them back into the proper rhythm, were fracturing.
Another company, the Guidant Corporation, knew about problems with its version of that device for three years before warning doctors about them in 2005.
But the Supreme Court ruled last year that patients who were injured or killed as a result of those failures cannot sue. That’s because of language in a 1976 law that gives the FDA authority to regulate medical devices.
That may soon change. A bill that would allow such suits is expected to be introduced in Congress soon. A similar measure was introduced last year.
It’s not realistic to expect the FDA, with a few hundred employees monitoring more than 11,000 drugs and medical devices, to be able to spot every safety problem before a product gets to market.
Congress should give people harmed by defective devices the same protections the Court has now given those harmed by dangerous drugs.