Author: James Sabatini

U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, recently introduced legislation in the House that will reverse a U.S. Supreme Court decision earlier this year involving medical devices. A companion bill will soon be introduced in the Senate by U.S. Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, and Patrick Leahy (D-VT), Chairman of the Senate Judiciary Committee.

In February, the U.S. Supreme Court immunized medical device companies from state lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc. the Court found that the product liability claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision was wrong.  It ignored both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks.

Because of the Court’s decision, seriously injured people are without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removes one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.

The Medical Device Safety Act of 2008 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.  People should contact thier elected Congressmen and Senator to voice support of this legislation to ensure that injured people have a right to compensation for injuries caused by dangerous and defective medical devices.

A Dallas County jury recently awarded a man who was partially paralyzed in a moving-truck accident with $87 million.  Talmadge Waldrip rented a U-Haul truck in September 2006 to help his daughter move. The 6-ton truck rolled over him, crushing his bladder and pelvis.  “When I stopped the truck and got out of it, the truck started rolling backwards, and it knocked me down,” Waldrip said.  The gravely injured man has gone through 14 surgeries and can still not properly walk.  He requires around the clock medical care. 

U-Haul’s response to the jury’s verdict: “While the plaintiff’s injuries are extremely regrettable, the final verdict is another example of abuse of the legal system against corporate citizens in America.”  No, U-Haul, the jury’s verdict is not an example of the abuse of the legal system.  The jury’s verdict is a message to your company that allowing your trucks to be rented by consumers with faulty emergency brakes will not be tolerated by the community.  And when your gross negligence causes serious injury, you will compensate the injured.