A Supreme Court decision to shield device makers from state lawsuits may be overturned by Democrats in Congress. The legislative effort is toward equalizing manufacturers' liability for devices and drugs, now treated differently after separate high court rulings.

The court has rejected Wyeth's claim that it could not be sued in state courts for its drug phenergan, because it had already been approved by the federal Food and Drug Administration. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the company's nausea medication.

Using that decision, Democrats have reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices.

In a statement, Rep. Frank Pallone, a New Jersey Democrat said that the legislation holds up a patient's right to legal recourse after sustaining an injury from a pharmaceutical product. He said the legislation will give patients that same right when injured by a medical device."

The idea that corporations are shielded from state liability claims by federal rules is relatively new and was pushed aggressively under the Bush administration.

Last year, the Supreme Court agreed with the pre-emption policy in a case involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices. There's no similar provision for drugs.

Since then thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts, citing the Supreme Court's decision.

But Pallone and other Democrats said that decision ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. The bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman, who chairs the Energy and Commerce Committee. He is expected to hold hearings on the issue in coming weeks.

Industry Opposition

The device industry's chief lobbying group criticized the effort, saying it will "produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans."

The Advanced Medical Technology Association, or AdvaMed, said the legislation would allow state courts to second-guess medical experts at the FDA and create a "patchwork of inconsistent and confusing guidance."

Despite opposition from industry, the Medical Device Safety Act enjoys support from a broad range of interest groups, including consumer advocates, trial lawyers and AARP. With companion legislation introduced by U.S. Sen. Ted Kennedy, D-Mass., many analysts have already predicted the measure will become law.

AdvaMed announced its first-ever advertising guidelines for companies like Medtronic Inc., Johnson & Johnson and Boston Scientific Corp. The guidelines urge companies to state the risks of their implants clearly and concisely when advertising them to consumers.

The device industry is attracting new scrutiny from lawmakers as companies increasingly promote their implants to consumers via TV and magazine advertisements.

Read DOTmed's extensive coverage of decisions leading up to this, including:
-Supreme Court Rules in Favor of Patient in Wyeth Case, DM 8369;
-AdvaMed Statement on Wyeth v. Levine Supreme Court Ruling, DM 8367;
-New Legislation Introduced to Override Landmark Supreme Court Decision on Medical Devices, DM 6440
Enter the DM number into any search box on DOTmed.com

Track the legislation on the Library of Congress THOMAS web site:
http://thomas.loc.gov/
H.R.1346
Title: To amend the Federal Food, Drug, and Cosmetic Act with respect to
liability under State and local requirements respecting devices.
Sponsor: Rep Pallone, Frank, Jr. [NJ-6] (introduced 3/5/2009)
Cosponsors (65)