Members of Congress are considering legislation that would overturn a 2008 Supreme Court decision and make it easier for consumers to sue manufacturers over certain faulty medical devices.
A new device directive in the works?
Congress mulls act that would make it easier for consumers to sue manufacturers
The fate of the bill may rest on the question of whether justices misinterpreted the intent of a 1976 law giving the Food and Drug Administration sole authority over approving the sales and marketing of high-risk medical devices.
In 1976, we concluded that it was necessary to include a pre-emption clause (in the Medical Device Amendment Act) that made clear the federal governments power over states in the approval of medical devices, said Rep. John Dingell (D-Mich.), who was a Member of Congress at the time the law was passed. We did not, however, intend for a judicial decision to pre-empt consumers rights to relief if they are harmed by a medical device.
Dingell made his argument during last weeks Energy and Commerce Health Subcommittee hearing on the proposed Medical Device Safety Act of 2009. Sponsored by Rep. Frank Pallone Jr. (D-N.J.), the bill, if passed, would negate the Supreme Courts ruling in last years Riegel v. Medtronic case, which involved a Medtronic-manufactured balloon catheter that ruptured inside a patient during coronary artery surgery.
Basing their decision on the 1976 pre-emption rule, the Supreme Court justices said that the FDA, not state courts, have the final say on whether high-risk devices approved under the agencys premarket approval, or PMA, process meet safety and efficacy standards. The ruling also said state courts and juries should not be allowed to second-guess that decision by allowing injured patients to subsequently sue product manufacturers.
Rep. Michael Burgess (R-Texas), an obstetrician, agreed with the Supreme Courts ruling. During the hearing, Burgess argued that the Medical Device Safety bill threatens to usurp the FDAs authority and create a patchwork of state tort laws that elevate lay jurors to the status of professional experts in deciding on the fate of a devicemaker.
Medtronic, whose medical devices have been the focus of high-profile consumer lawsuits against companies with products approved through the FDAs PMA process, has lobbied heavily against the proposed bill. We think it would have a very negative effect on innovation, said company spokesman Rob Clark.
To bring a PMA product to market by having to meet not only FDA requirements, but also the unknown requirements of jurors and states across the countrythat was a concern back in 1976, Clark said. I think if you look at the record, it seems to suggest that what they (lawmakers) were trying to balance was how do we create a framework to ensure efficacy and safety without impacting innovation.
But Melissa Markey, a health law lawyer at Hall, Render, Killian, Heath & Lyman, said the contention that Supreme Court justices misinterpreted the 1976 pre-emption rule may have merit. There is no parallel pre-emptive act for drugs, and both approval processes look at whether a proposed intervention is safe and effective, Markey said. So, it doesnt make sense logically that state tort liability would be pre-empted for one and not for another, she added. I think what the FDA was trying to avoid was states setting up their own labeling and approval of devices. At that time, there had been a string of bad medical devices, and they werent really regulated.
Markey acknowledged, however, that the pre-emptive language in the 1976 law isnt specific, and that fact might give supporters of the proposed Medical Device Safety Act less room to question the legitimacy of the Supreme Courts decision.
Still, other arguments are also being made in support of voiding the courts decision. In her testimony before the House subcommittee, 35-year-old patient Bridget Robb of Gwynedd, Pa., noted that her insurance company, not the manufacturer, has been footing the bill for her ongoing health problems resulting from the removal of a defective Medtronic Sprint Fidelis defibrillator lead last year.
The defibrillator lead was FDA-approved as a PMA supplement to an existing Medtronic product. I think its unfair that cost of medical care should be shifted to consumers, private payers and in some cases public payers like Medicare, Robb said.
Robert Zirkelbach, spokesman for the health insurer lobby group Americas Health Insurance Plans, said his organization has no official stance on the bill. But Pallone said he believes healthcare payers are likely to see more cases similar to Robbs if the Medical Device Safety Act doesnt become law. He noted during the hearing that a Minnesota judge recently threw out 1,400 cases against Medtronic for its Sprint Fidelis lead based on the Supreme Court ruling.
This bill protects patients from the flawed interpretation of the courts reading of the Medical Device Amendment Act of 1976, Pallone said.
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