The American Association for Justice (AAJ), formerly the Association of Trial Lawyers of America, was named in an article published by The Hill in Washington, D.C., for including its own provisions in the draft of an FDA bill. The AAJ wants included in the bill the provision that drug and device companies cannot use FDA approvals as a shield to block state lawsuits. The AAJ opposes the notion that the drug companies are protected under the legal standard of federal preemption against claims in state courts. When these companies market “unsafe or mislabeled products” they should be held accountable for the harm that it causes those who take FDA-approved drugs. The AAJ is not looking to reverse the standard of federal preemption; more appropriately it wants drug and device companies to recognize that an FDA-approval will no longer be sufficient to protect it from claims brought in state court.

Trial lawyers’ win on suit provision threatens FDA bill

Mark and Jan:

I want to thank you for your insightful discussion on the potentially devastating impacts of federal preemption and how it is being misapplied to undermine the basic civil and personal injury rights of people harmed by defective products and drugs.

The example of Vioxx is startling.   It is incomprehensible that people injured not only by a defective drug, but one whose studied history of causing harm was apparently kept from the FDA, could be prevented by the same agency from pursuing the drug manufacturer for those injuries.

This is clearly an area of law that merits national attention and focus as I am aware that similar efforts are under way in the motor vehicle industry to protect manufacturers from similar liability from injuries caused by roll overs.  The theory there is that if the controlling regulatory body, I believe the National Highway and Safety Commission, gives its seal of approval to a particular vehicle design, people would be prevented from pursuing recourse if the same vehicle was deemed to be defective by independent means.  Why would anybody want to remove this independent “check” and the scrutiny of independent professionals when the ultimate effect is to evolve more robust design?  There has never been a requirement of perfection, but a duty for manufacturers to constantly evaluate product design to insure what? Good old safety for the intended use of the consumer.   What could be more equitable than that ‘bright line”?  As long as you use the best available technology and concepts and make reasonable efforts to insure the safe design of your product for its intended use, your liability is limited or eliminated…but testable in a check and balance system that allows independent forces to question both the manufacturer’s and governing body’s methodology.   It is, of course, plaintiffs counsel and trial lawyers, who get a sense of something “being wrong in Denmark” that usually take the initiative, spending time, energy, effort and funds to uncover any flies in the ointment.  Preemption would presumably relieve even State’s Attorney General’s from pursuing these claims…a gutting of the civil justice system that no democratic society should be forced to tolerate.

And by the way, if you develop a drug for a particular use, like Vioxx, please make sure to share the scientific studies that showed it caused heart attacks and strokes with the regulatory body governing the decision to allow its entry into the stream of commerce.  I think most end users and physician’s prescribing the product would like to have that information available to make an informed choice….