Medical Device Preemption Gets a Second Look

Last year, the US Supreme Court ruled that consumers who’ve been injured by faulty or defective medical devices are barred from suing the manufacturers if the device was marketed in a fashion that received premarket approval from the FDA. The FDA stamp of approval barred consumer justice lawsuits regarding medical devices and prevented a time honored system of checks and balances for the medical device industry. Prior to the Supreme Court decision in Riegel, medical device manufacturers claimed consumer and product safety in their best financial interest. The specter of lawsuits kept the medical device industry honesty and at least striving to provide quality, effective, and safe products for the consumer. Riegel tore at the very fabric of that system of checks and balances.
Of course, Congress can preempt state laws in areas of national concern by expressly providing in the language of a bill that state regulations are preempted or superseded by the federal law. That is called express preemption. Until the Bush administration the FDA had always taken the position that state consumer tort suits were a consumer protection that complemented the federal FDA regulation.
Congress recognized the basic inequity in the Riegel decision and began immediately crafting legislation to make the court decision moot. The Medical Device Safety Act of 2008, H.R. 6381-S.3398-is a proposed amendment to the Medical Device Amendment to the Food Drug and Cosmetic Act.
The proposed bill reads as such,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘Medical Device Safety Act of 2008’.
SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES.
(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act
(21
U.S.C. 360k) is amended by adding at the end the following:
‘(c) No Effect on Liability Under State Law- Nothing in this section
shall
be construed to modify or otherwise affect any action for damages or the
liability of any person under the law of any State.’.
(b) Effective Date; Applicability- The amendment made by subsection (a)
shall–
(1) take effect as if included in the enactment of the Medical Device
Amendments of 1976 (Public Law 94-295); and
(2) apply to any civil action pending or filed on or after the date of
enactment of this Act.
Significantly, there are some Congressional heavyweights who’ve either sponsored the legislation or have already voiced their support. The legislation will be reviewed in the House Energy and Commerce Committee chaired by John Dingell, a supporter. The primary sponsor in the Senate is the healthcare giant, Senator Ted Kennedy and the bill will be considered in the Senate Health, Education, Labor and Pensions Committee. Interestingly, one of the Senate sponsors is none other than former US Senator and current President-elect Barack Obama.
Prospects for bill passage look good either some time later this year or early next year.