In the 1990s, Michigan lawmakers passed a product liability shield (an "FDA defense law") for FDA-approved medicines in order to deter innovation-killing litigation. Today, a coalition of tort lawyers and consumer advocates is trying to rescind the law. Hantler, a long-time advocate of tort reform, weighs in defending Michigan's law and arguing that it should be seen as a national model:
Ten years ago, the Michigan legislature passed a historic legal reform, one that recognized the unique role of the FDA. That law provides that the careful studies and deliberations of the FDA cannot be overturned in Michigan courts unless a manufacturer procured the FDA's approval by fraud.
The law has worked for the past decade, striking a careful balance between providing a path for those who have been injured to seek compensation, while discouraging unwarranted lawsuits. But now state politicians—funded and backed by the Michigan Trial Lawyers Association—are trying to undo the Michigan law, and repeal the reforms retroactively to 1996.
And to get at this industry, the trial bar is deliberately confusing the public about the relative nature of safety, and the final responsibility of the FDA. If unchecked, the trial lawyers could easily wreck America's unique pharmaceutical system of risk investment and discovery. This campaign in Michigan should be a warning sign of things yet to come.
The biopharmaceutical industry is easily the most heavily regulated industry in the world. Companies that comply with the FDA's safety and efficacy requirements in good faith deserve liability protection, and Michigan's example should be a national model. One state, however, won't solve the industry's litigation woes when plaintiffs' lawyers can cherry pick forums in 49 other states.
Federal lawmakers should step in and codify the "FDA rule", and create an administrative compensation program modeled after the Vaccine Injury Compensation Program.