The Supreme Court recently ruled that manufacturers of medical devices cannot be sued for injuries or deaths they cause if the Food and Drug Administration has approved them. A 2001 ruling bars suits even when a company has defrauded the F.D.A. Now, the Court is poised to rule on whether Americans can sue drug companies when their products have maimed or killed people. For the general public's right to 'standing', the future looks very bleak.
The Government claims the F.D.A. is competent enough to oversee the drug and device markets, and courts should not be "second-guessing" the agency. A majority of Justices seems to agree. Both the Government and the Court are dangerously mistaken. The Government Accountability Office and the F.D.A.'s own science board have released reports saying the agency is "incapable" of protecting America from unsafe medical devices, drugs, and even food.
To deny standing to those hurt by medical products just because there happens to be an agency that oversees the industry would be the same as denying standing to residents of communities poisoned by toxic waste released into their water supply because the company responsible for the pollution is overseen by the Environmental Protection Agency. It's the same as denying standing to people killed by defective electrical systems in vehicles because the industry is overseen by the Department of Transportation, or those killed in plane crashes because we have an F.A.A.
Should parents be prevented from suing a daycare center for child abuse because it passed inspection by the Department of Human Services? Are injured patients to be barred from filing malpractice suits merely because their doctor was considered competent enough to obtain a medical license? If hundreds of people are injured by a specific make of firearm because of a structural flaw, should their cases be summarilly dismissed because the overall design was approved by the Federal Firearms Administration?
Many products and services of every kind have been approved by one regulatory agency or another, only to be found defective or unsafe long after they were deemed harmless. The F.D.A. at one time appoved silicon breast implants, DDT, and cigarettes. Just in the past ten tears, at least 12 drugs initially approved by the F.D.A. have been pulled off the market after being found unsafe - and only after scores of people were harmed by them. Other products such as lead paint, asbestos, and mercury have been initially labeled as "safe" by our omnipotent bureacracies, and many men, women, and children have paid for that kind of "oversight" with their lives and health.
Congress should undo these ridiculous Supreme Court rulings with legislation that returns to the public the standing it has always had to seek justice in the courts against careless or unprincipled manufacturers of products that harm them. But if the Government wants to say that regulatory agencies are so competent that they, alone, can decide what is or isn't dangerous, then the agencies themselves should be ready and willing to accept full responsibility for the decisions they make. All lawsuits for every product or service they approve should be brought directly against the approving agency, and standing should be granted to anyone who has suffered from their dangerous arrogance.
Somehow, I don't think that's what the nine folks sitting on the High Court have in mind.
By JC Garrett
