Vested Interest - July 2008 Issue

The President's Thoughts

Preemption — The Silent Tort Reform

A family comes to see you following the death of a father and husband. The family includes his widow and children, all of whom are devastated and lost as a result of his death following a routine angioplasty with a defective medical device. The case seems solid, your experts and treating physicians all support your theory, and there is a history of the device being defective. You file your lawsuit with complete confidence that you’ll at least be able to do something, however minimal in the big picture, for this grieving family,

But wait — one of the very first motions filed on behalf of the defendant manufacturer of the medical device asks for dismissal based on the argument that the device was approved by the Food & Drug Administration. The manufacturer argues that the FDA’s review process was “uniformly thorough, science-based, and immune from commercial pressures.” Worse yet, the manufacturer also claims in its motion that the 1976 law on FDA oversight of such medical devices actually called for immunity from liability for the manufacturer. After a little research, you find that the manufacturer’s motion is well-taken and you have to tell the family that the U.S. Supreme Court — the highest court in the land — has essentially ordered that the manufacturer is immune from liability, regardless of the consequences of a poorly designed and manufactured medical device.

A casual observer of the legal landscape might opine that this could never happen in America, where laws are supposed to be made by the people’s representatives in the U.S. House and Senate. But that’s exactly what happened to the widow in Riegel v Medtronic following the death of her husband. The U.S. Supreme Court’s decision in that case basically validates the argument that federal regulatory agencies through their rule-making authority can and do preempt tort lawsuits in state courts, regardless of the injuries and relative defectiveness of the products.

Prior to the currently administration’s fixation with this “silent tort reform”, the FDA had long believed that state tort lawsuits actually enhanced public safety by compelling a financial incentive for companies to comply with federal regulations. Prior to 2001, the FDA had a longstanding policy against preemption because, according to Margaret Porter, a career (read: non-partisan) FDA official, “even the most thorough regulation of a product such as a critical medical devise may fail to identify potential problems presented by the product. Preemption of all such (tort liability) claims would result in the loss of a significant layer of consumer protection.”

And the current administrative agencies buried within the federal bureaucracy haven’t limited their regulatory zeal of protecting corporations to manufacturers of medical devices. Just a little bit of research turns up a multifaceted collection of manufacturers who’ve enjoyed unusual effectiveness at getting protective language added to federal regulations covering their industries. A few examples:

• Railway Safety (2006). The Federal Railroad Administration issued a rule that effectively grants immunity from state lawsuits to railroad companies in the event of a commuter train derailment — just four days after Congress approved a measure that preserved the right of victims to sue railroad companies in such instances.


• Chemical Plants (2006). The Department of Homeland Security issued new rules on chemical-facility safety that gives state and local communities the responsibility for emergency response and clean-up, but preempts states from adopting and enforcing their own stricter laws to avoid accidents in the first place.


• Prescription Drugs (2006). The FDA preempts state tort laws in coming out with new rules that require drug manufacturers to warn patients when they become aware of new drug risks. This action resulted in a drastic change in policy undertaken without the benefit of any public comment.


• Auto Safety (2005). The National Highway Traffic Safety Administration delivers its rules on seat belts, roof-crush resistance and rear-object detection systems — and specifically preempts state tort laws in the preambles to those rules.


• Mattress Safety (2006). And in what is arguably the worst example of this systemic abuse of the rules, the Consumer Product Safety Commission announced new flammability standards for mattresses that its own number crunchers predicted could save 270 lives a year. The original CPSC rule was largely silent on preemption of state tort suits. However, following the complaints by the mattress manufacturers’ political lobbyists, preemption of state tort lawsuits was included in the final version. It turns out that the last minute language was buried in the tabs of the briefing package of the CPSC’s websites and resulted in little to no public exposure. The decision by the CPSC to impose language that preempted state tort law was the first such move in the commission’s 33-year history.

It’s not surprising that this administration is attempting to control state tort law through the regulatory processes that it maintains. As the Peter Hart Research Associates polling from April, 2008 shows, Americans strongly disagree with the policy of federal preemption by a 2-1 margin. And an important correlation to this opposition to federal preemption is the concern by a majority of Americans that they or someone they know personally will eventually be harmed by an unsafe product.

The same poll also concluded that a strong majority of citizens believe that product manufacturers often put the bottom line ahead of consumer safety. Add to this that the same polling evidences a similar strong majority of Americans believing that “access to the civil justice system is an important safeguard for victims and a crucial mechanism for holding companies accountable” and you can see why the Bush administration and its allies want to circumvent the civil justice system. Contrary to popular mythology, the American public does not disapprove of product liability lawsuits.

In the upcoming months leading up to the election in November, we will all hear the old and tired voices of Big Business complain about the inadequacies of the civil justice system and what they argue it costs average Americans. But we are leaders, and we are committed to the public health and safety of our fellow citizens. Please remember what it’s been like over the last 7½ years when you march into the voting booth this coming November.

Philip H. Corboy, Jr., President 2008-2009
Illinois Trial Lawyers Association