Access Denied? The Fight for Corporate Accountability

A New Corporate License to 'Hit and Run'?

If an unsafe medical device, car seat, toy, or other consumer product causes you serious harm, will the manufacturer continue to be legally liable? Will you be provided compensation for harms you suffer? Will corporations have a strong incentive to make safe products in the first place, knowing they will face legal consequences if they don’t?

These are questions that must be decided by Congress, the Obama administration, and the federal courts.

In an attempt to evade accountability when their products cause harm, major medical supply manufacturers are working to overturn product safety rights that every American has had for more than 100 years.

To accomplish this goal, they are relying on a legal theory called preemption. They claim that if a product has been approved for marketing by the Food and Drug Administration (FDA) or another federal agency, consumers can no longer rely on state unsafe product laws to ensure that corporations are held accountable for faulty products. This ignores FDA’s own safety experts, who point out that permission to market is based only on the limited evidence available at the time – much of it provided by the manufacturers themselves. Many drugs and medical devices that were marketed with federal permission later caused serious health damage, including Vioxx, Zoloft, Fen-Phen, Avandia, and Celebrex. 

Saying that manufacturers who have approval to put a medical device or other product on the market are not accountable if someone is harmed by that product is like saying that someone who runs into you on the highway is not responsible because the state gave them a driver's license. 

The Supreme Court sided with the corporations' attempt to evade responsibility last year in the Riegel v. Medtronic that turned decades of established law on its head.

The Riegel v. Medtronic decision prevents Americans harmed by medical devices such as defibrillators, heart pumps, and artificial heart valves, hips, and knees from suing the manufacturers if the FDA approved the medical device. 

The only sure way to protect us all is for Congress to pass legislation making it even more clear that federal permission to market a product does not preempt the right of Americans to hold manufacturers accountable for health and safety damage they may cause.

The Medical Device Safety Act

The Medical Device Safety Act would restore the rights of thousands of Americans who have suffered or even died because of defective medical devices to seek justice through the civil justice system.

Alliance for Justice joined with medical and consumer advocacy organizations in the Coalition to Stop Corporate Immunity to urge Congress to pass the Medical Device Safety Act.

The bill had a hearing in the House of Representatives in May of 2009, and has co-sponsors supporting its passage in both the House and the Senate.  The Senate held its hearing in August.  The next step will be for Congress to vote on the bill this fall and for President Obama to sign it into law.