No surprise, but The New York Times editorialists were shocked, appalled and outraged at the U.S. Supreme Court’s ruling in Riegel v. Medtronic, Inc.
Consumers are already at the mercy of the all-too-fallible Food and Drug Administration. So it is especially disturbing that the Supreme Court ruled this week that patients injured by defective medical devices cannot sue for damages in state courts if the device was approved for marketing by the F.D.A. and made to the agency’s specifications.
That means that any consumer harmed by a faulty device — whether it be an implanted defibrillator, a heart pump or an artificial knee — will have no chance of fair compensation and the manufacturers will have a dangerous sense of impunity.
Here are the facts of the case, as recounted in the majority opinion by Justice Scalia:
Charles Riegel underwent coronary angioplasty in 1996,shortly after suffering a myocardial infarction. App. to Pet. for Cert. 56a. His right coronary artery was diffusely diseased and heavily calcified. Riegel’s doctor inserted the Evergreen Balloon Catheter into his patient’s coronary artery in an attempt to dilate the artery, although the device’s labeling stated that use was contraindicated forpatients with diffuse or calcified stenoses. The label also warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Riegel’s doctor inflated the catheter five times, to a pressure of 10 atmospheres; on its fifth inflation, the catheter ruptured. Complaint 3. Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.
According to the Times’ logic, the manufacturer should bear the legal and economic consequences for the doctor’s error, or at least Riegel should have the right to sue based on the alleged inadequate warning labels.
It’s that federal pre-emption on labels, i.e., FDA pre-market approval, that’s really at issue here, not the supposed arrogance or impunity of manufacturers. At some point, some authority has to sign off on a medical device’s design and labeling and safety; Congress has determined, logically enough, that that authority should be a federal one, the FDA. And here’s what the court said:
The FDA requires that a device that has received premarket approval be marketed without significant deviations from the specifications in the device’s approval application, for the reason that the FDA has determined that those specifications provide a reasonable assurance of safety and effectiveness.
Again, to the Times, that approval should be subject to the state laws of 50 states, not a single federal standard, because the ability of an injured party to sue must always come first. The reasonable assurance of safety and effectiveness be damned.
The Times view reflects a cloistered and completely impractical view of the business and regulatory world. Put into place, it would only discourage the manufacture of life-saving devices.
P.S. Newsday’s editorial is equally unrealistic.
Latest posts by NAM (see all)
- Manufacturers Win Several Website Design Awards - June 15, 2011
- China Makes Commitments on Trade, Intellectual Property - December 16, 2010
- ITC Details Widespread Theft of Intellectual Property in China - December 14, 2010