HERE'S WHAT I THINK

What if you were hurt by a drug and couldn't sue?

On February 20, 2008, in the Riegel v. Medtronic case, our Supreme Court granted legal immunity to manufacturers of medical devices which had been approved by the FDA. This ruling means that in the future, in most instances, the medical device manufacturers will have no financial accountability for their mistakes when their products harm a patient. To reach this decision, the Supreme Court used the legal doctrine of "federal preemption". Ironically, this doctrine comes from the U.S. Constitution, but in recent years it has been used by the current Bush Administration to abolish a person's right to sue when injured by a company's product.

In October 2008 the Supreme Court will hear oral arguments in the Wyeth v. Levine case. The primary issue in that case is whether people who suffer a drug injury should be able to get legal compensation. At this hearing, the drug company's lawyers will be joined by the Bush Administration's Solicitor General in making the argument that there should not be any such legal right.

We start by considering the "FDA-approval" part of this Riegel decision. In the past year, the Institute of Medicine, the Government Accountability Office, and the FDA's own science board have all issued reports that essentially reach the same conclusion: The FDA is largely incapable of protecting the public from unsafe medical devices and drugs.

Moreover, the FDA does not do its own testing; rather, the FDA is almost totally dependent on the companies that it is suppose to oversee to provide the agency with data concerning the safety and effectiveness of new prescription drugs and medical devices.

Further, the vast majority of FDA approvals occur without any representation of patients' interests, and safety decisions after the drug or device is approved rarely include input from patient advocacy groups.

Meanwhile, the medical device manufacturers and the pharmaceutical companies clearly have an inherent conflict of interest when addressing safety issues concerning their products, which are intended to make them a profit. In addition, the corporations have stronger legal obligations to their stockholders than to patients who use their products.

Let's get back to the question about patients having access to the court system to sue for injuries.

The Bush Administration will be arguing in this Levine case that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's actual text does not include any preemption clause.

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA labeling requirements and, accordingly, the drug company should face no liability under state law. The trial court judge disagreed, and the jury in that case awarded $6.8 million in legal compensation to Levine for her injury. The Vermont Supreme Court ultimately upheld the trial court ruling and the jury verdict, but U.S. Supreme Court later accepted this case for review upon the request of the drug company and the Bush administration.

Oral arguments in the Levine case are scheduled for October 2008. Sometime thereafter the Supreme Court will decide whether FDA approval of a prescription drug prohibits the filing of personal injury and wrongful death lawsuits against drug companies.

According to some critics, federal preemption of drug injury cases may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%. But that has not been the situation in the past, nor is it the case today.

It is my opinion that Congress should move quickly to pass legislation that would correct the Riegel decision by the Supreme Court, and prevent such a ruling against patients' rights in the Levine case. This legislation is needed to restore, and assure, that there is a significant incentive for the medical device manufacturers and the pharmaceutical companies to ensure that their products are safe for use by American patients, i.e., the possibility of product liability litigation.