Congress Seeks to Side Step Supreme Court and Restore Right to Sue Medical Device Makers for Damages
It didn’t take Congressional Democrats long to propose legislation that would effectively overturn a recent U.S. Supreme Court decision giving companies that make defibrillators, heart stints, and other FDA-approved medical devices immunity from state personal injury liability lawsuits. The controversial ruling from the nation’s highest court means patients who are injured by approved medical devices can’t sue the manufacturers for damages.
The Medical Device Safety Act of 2008 (H.R. 6381) would reverse “an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product,” one the bill’s sponsors, Rep. Frank Pallone, D-N.J., said in introducing the bill on June 26.
The proposed law comes in direct response to the February 2008 Supreme Court ruling in which the court held that 1976 amendments to the Federal Food, Drug, and Cosmetic Act shield medical device manufacturers from state damages claims by injured patients. The court said once a medical device has received FDA approval, injured parties have no legal path to seek damages from the manufacturer, since personal injury claims rely on state laws, which are preempted – or voided – by federal laws in the area.
The Supreme Court could use another case now making its way through the federal courts to expand the immunity privilege to pharmaceutical manufacturers. That case, Wyeth v. Levine, is expected to receive Supreme Court review in the Fall of 2008.
Riegel v. Medtronic, Inc.
The Supreme Court ruling came in the case of Charles Riegel, a New York resident who underwent angioplasty in 1996 to clear a clogged heart artery. Riegel’s surgeon used a Medtronic, Inc. Evergreen balloon catheter, which burst during the procedure, leaving Riegel on life support with severe and permanent disabilities. He died in 2004 and his widow, Donna, is continuing the legal fight.
The Riegels sued Medtronic in a New York state court, alleging the catheter was negligently designed, manufactured and labeled. Medtronic argued the company was protected from state personal injury suits because of a preemption clause included in medical device amendments to the Food, Drug, and Cosmetic Act.
A district court agreed with Medtronic and later appeals to higher courts filed by the Riegels were rejected. The case eventually reached the nation’s high court, which refused to reverse the lower courts’ rulings in favor of Medtronic.
Preemption: Federal vs. State Law
Preemption is a legal principle, found in the Supremacy Clause of the Constitution, which states a federal law can supersede or supplant any inconsistent state law or regulation. Simply put, the founding fathers wanted the Federal government, not the individual states, to decide matters that affect the entire nation. In many cases, if federal law preempts a state law, the party seeking to file a state suit is left without a legal right to sue for damages. This is the case for people seeking to sue medical device manufacturers for state liability claims.
The Medical Device Amendments of 1976 created federal oversight of medical devices while at the same time limiting the states’ rights to oversee the products. The statute expressly says that states shall not establish rules regarding medical devices that are different from, or in addition to, any federal requirement on the same topic.
In Riegel, the case hinged on the question of whether state liability laws amounted to state “requirements” which differed from FDA rules and would be expressly forbidden by the Medical Device Amendments. Once the Supreme Court held that state liability claims did amount to requirements and that they differed from the FDA rules, the high court’s ruling went in Medtronic’s favor.
Medical Device Safety Act of 2008
The Medical Device Safety Act of 2008 would reinstate patients’ rights to file state liability claims seeking damages from manufacturers of defectively designed, manufactured or labeled medical devices that have been approved by the FDA. The new law would expressly state that existing federal laws governing medical device approvals do not “modify or otherwise affect” lawsuits brought in state courts. As proposed, the bill would apply to any civil action pending or filed on or after the date of enactment.
Sens. Edward Kennedy, D-Mass., and Patrick Leahy, D-Vt., reportedly plan to introduce companion legislation in the Senate.
The medical device industry was quick to criticize the proposed legislation, calling it a “patchwork approach” to medical device approvals that would allow state courts to review and regulate devices rather than leaving that duty to the Food and Drug Administration.
“Congress provided express preemption authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association. “The FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology.”
Is Embattled FDA the Best Watchdog?
Medical device manufacturers insist that the Food and Drug Administration should be the sole authority on whether their products are safe for consumers. Allowing individual states to impose their own regulations on medical devices would create a tangled mess of conflicting state laws and standards, industry officials say. In the Riegel case, the Supreme Court agreed with the manufacturers and ruled that FDA approvals exempt them from state personal injury lawsuits.
However, recent developments have illustrated the FDA’s shocking inability to ensure the safety of consumer products. Numerous incidents involving contaminated food, prescription drugs, and other dangerous products have lead to countless serious injuries and deaths and prompted members of Congress and various consumer watchdog groups to question the FDA’s ability to do its job.
Scandals involving salmonella-tainted tomatoes, counterfeit pharmaceuticals such as Heparin, and children’s toys coated in toxic lead paint have rocked the FDA in recent months, leaving many to wonder if the struggling federal agency is best suited to ensure the safety of medical devices and other products.
Related posts:
- Minn. Medical Device Maker Agrees to Shut Down Medical device manufacturer Sybaritic Inc. has agreed to stop making...
- U.S. Medical Device Maker Agrees to $5 Million Penalty A Colorado-based medical device maker has agreed to pay $5...
- Illinois Supreme Court Delays Ruling on Med Mal Cap The Illinois Supreme Court has delayed issuing a much-anticipated ruling...
- FDA Investigating Problems with Defective Medical Device Power Cords The Food and Drug Administration is looking into more than...
- Quaids Want Illinois Supreme Court to Hear Heparin Case Hollywood actor Dennis Quaid and his wife have asked the...
