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Stopping corporate immunity from lawsuits is one of the sweeping reforms Congress is undertaking this year. The pushback against corporate lawsuit immunity is occurring in multiple sectors of our economy and our society including the financial sector, pharmaceutical / drug industry, medical device and implant industry. Regulatory controls over these sectors is crucial to promoting consumer safety as well as restoring consumer confidence. The US Supreme Court provided a major victory for those fighting corporate immunity in the drug industry with its recent decision in Levine v. Wyeth, upholding a consumers right to justice and allowing her to proceed with a drug lawsuit when injured by a drug. After the Court’s decision in Riegel v. Medtronic, Inc., many industry analysts thought the Court would decide against the consumer justice injury attorney and in favor of corporate lawsuit immunity. However, they decided in favor of consumers by allowing the case to proceed as requested by the plaintiff lawyer.

This brings us to the Wyeth decision. Congress has assumed the consumer protection mantle and introduced legislation designed to protect consumers from defective medical devices and uphold the right of consumers to seek legal counsel and seek damages as a means of justice.

The Medical Device Safety Act of 2009 has been introduced by U.S. Representatives Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee. The bill has 71 co-sponsors.

The proposed legislation seeks to protect consumers from defective medical devices and implants that cause personal injury or death to unsuspecting recipients. It is a direct response to the 2008 U.S. Supreme Court’s Riegel v. Medtronic, Inc. decision in which medical device companies were given immunity from lawsuits seeking justice for their defective medical devices. In its decision, the Supreme Court found that claims against medical device companies were barred by a preemption clause in the Medical Device Amendments of 1976. The Court’s decision didn’t factor into its decision the intent of Congress or the 30 year history of the checks and balances system effectively played by the FDA and the tort liability process. According to leading congressional authorities, including Congressman Henry Waxman, the regulatory authority of the FDA was never intended to supercede or replace the proper function that the tort system enjoys in protecting consumers from defective medical devices.

This new Medical Device Safety Act of 2009 seeks to remedy that. In introducing the legislation, Rep. Pallone made reference to the more recent Supreme Court decision in its Levine v. Wyeth, decision. Chairman Pallone noted, “Today, we introduce legislation that gives patients that same right when injured by a medical device. This legislation puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year. We introduce this legislation today with strong bipartisan support, and I look forward to moving it through my subcommittee quickly."

In his separate remarks, Rep. Waxman made mention of the critical role the FDA and tort law play in protecting the public. "As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety," said Chairman Waxman. "The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products."

Both congressmen spoke about the recent FDA difficulty in ensuring consumer safety in both the pharmaceutical industry as well as the medical device market. Recent examples of drugs and medical devices causing injury and even death to consumers include: Medtronic’s Sprint Fidelis heart defibrillator leads, Zimmer Durom Cup hip replacement device, Vioxx, Bextra, Zyprexa, etc. The FDA is only one leg of a checks and balances system designed to protect consumers. The Supreme Court’s Riegel decision leaves this system woefully out of balance and leaves ordinary consumers, who have a legal right to consumer safety, with no recourse when they are injured. This legislation is crucial to bolster both consumer confidence and safety. Our society is based upon a delicate but necessary balance of trust between consumers and product/drug manufacturers. If the system breaks down, the consequences to our society are seriously impaired.

A companion bill to the Waxman-Pallone legislation has also been introduced in the United States Senate by Senators Edward M. Kennedy, (D-MA) and Patrick Leahy, (D-VT).

The legislation has received letter of support from AARP, the Center for Justice and Democracy, Consumer Federation of America, the Consumers Union, National Association of Consumer Advocates, among others. It is endorsed by National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL - The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families.

Lawsuit Practice Areas

As trial attorneys, we represent only injured people.  We don't represent insurance companies or large corporations.  As you can see from the Practice Areas listed to your left, we have represented numerous individuals in cases involving harmful products, dangerous pharmaceutical drugs such as Baycol and Vioxx and the diet drugs such as Fen-Phen, Redux, and Pondimin.

Most recently, we've represented victims of physical and sexual abuse against various churches and the Florida Department of Children and Families.  

We take our responsibility to our clients very seriously.  In each practice area, we are committed to providing them with the best representation possible.   

If you or a loved one have suffered a serious injury or death as a result of someone else's negligence,