The Supreme Court and the FDA

In an 8-1 decision in Riegel v. Medtronic, the Supreme Court has ruled that medical-device manufacturers whose products secured pre-market FDA approval are immune from liability for personal injuries. So, if youâre injured by a medical device (like a drug-coated stent or prosthetic hip) thatâs received this approval, you wonât be able to sue the manufacturer.

This might not be such a problem if we could have faith in FDAâs approval process. But, as reports from the Institute of Medicine and the FDAâs own Science Board have made clear, the agency lacks the resources and scientific infrastructure to do its job properly. Under such circumstances, itâs important the people be able to turn to the courts, as David Michaels explained in a post about a Texas Vioxx case:

[L]aw suits are an important part of our de facto system to protect public health. If the tide has turned against the entire tobacco industryâand I believe it hasâit is not due to actions by FDA or EPA, although the pioneering work of both these agencies raised public consciousness and helped reveal the workings of the tobacco industry. Rather, it is because the cigarette manufacturers have lost legal battles waged by the widows and widowers of deceased smokers, and by the states attempting to recoup the taxpayer money spent providing medical care for smoking-related diseases. As strong as it was and is, the strength of the science didnât convince Philip Morris to admit that tobacco causes lung cancer. Only after being pummeled by so much detrimental and expensive litigation has the cigarette-maker come up with a new strategy that involves telling at least partially the truth.

Likewise, the asbestos industry was tamed not by OSHA and EPA, not by a frank acknowledgment of the science, but by lawsuits brought by victims of mesothelioma, lung cancer, and asbestosis brought against Johns Manville and other producers.

Years after the first cases of flavoring-related lung disease appeared in food workers, OSHA still hasnât issued a standard protecting workers from diacetyl. But $100 million in court awards and settlements have convinced flavor manufacturers they have to address the problem.

The Drug and Device Law blog (via Pharmalot) gives the defense lawyersâ perspective on the Riegel v. Medtronic decision:

We defense lawyers retort that product liability litigation is horribly ineffective (given the influence of so many non-merits issues), inefficient (plaintiffsâ lawyers take 33% or more of most recoveries, and thatâs not even counting defense costs), and downright counterproductive (deterring innovation, and punishing manufacturers for doing the right thing when they discover problems) compared to governmental regulation as a means of ensuring product safety.

Well, now weâre going to find out whoâs really right.

In other words, the PMA medical device field is going to determine in practice whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public as we think it is â or if itâs as lousy a way of ensuring safe medical devices as the other side claims.

So, to the medical device industry â to the regulators at the FDA â and to our colleagues who practice FDCA regulatory lawâ¦. Donât let us down, please.

So, it looks like we can all agree that this decision means that weâll be relying on FDA more than ever before.

The question on a lot of peopleâs minds now is whether, following this medical device decision, the Supreme Court will decide that FDA approval can also shield drug manufacturers from liability claims. Gardiner Harris explains about a case the Court will hear in October, dealing with the listing of risks on a drug label.

As for the medical devices decision, it dealt with the Medical Device Amendments of 1976, and the intention of Congress in passing the amendments. Some of the lawmakers involved in that legislation donât agree with the majority opinion about it, reports the NYT's Linda Greenhouse:

âIn enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,â [Senator Edward M.] Kennedy said in a statement. He added: âCongress obviously needs to correct the courtâs decision.â

Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.

âThe Supreme Courtâs decision strips consumers of the rights theyâve had for decades,â Mr. Waxman said. âThis isnât what Congress intended, and weâll pass legislation as quickly as possible to fix this nonsensical situation.â

Congress may act to remove the immunity that the Court has now given to medical device makers, but in the meantime weâll have to redouble efforts to strengthen the FDA.