Are Medical Devices Next?
The Supreme Court decision this week for Diana Levine, concludes that consumers do have a right to sue if they are injured by an FDA approved drug or by the makers’ failure-to-warn label.
But this decision flies in the face of last year's high court decision over medical devices.
In Riegel v. Medtronics, the justices ruled 8-1 that patients cannot sue medical device makers when they are injured by a product approved by the FDA. The court looked to a preemption clause in a 1976 medical device federal law.
The next step may be in the hands of Congress.
Medical Device Safety Act of 2009
The Levine outcome has energized the efforts to address medical devices that harm consumers. Thursday legislation was submitted on the Medical Device Safety Act by Sen. Edward M. Kennedy (D-Mass.) and in the House by Rep. Frank Pallone (D-NJ) and Henry Waxman (D-CA).
The Medical Device Safety Act “puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year,” Pallone said, according to Reuters. Pallone chairs the House Energy and Commerce subcommittee on health.
Supporters say it is needed.
Even with FDA approval, many dangerous medical devices have been approved.
The precedent-setting Riegel case was brought by the widow of Charles Riegel. He was injured when a Medtronic balloon catheter burst while being inserted in his chest during an artery-clearing procedure.
The ruling in Riegel gave immunity to manufacturers making Class III devices such as heart defibrillators and breast implants, because they allegedly undergo a stricter scrutiny.
But a GAO report issued in January said many of the older medical devices were grandfathered in under federal regulations and have not been closely reviewed for safety under the premarket approval process.
In a statement, Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said the bill does not improve patient safety.
"It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans."
The implications of Riegel may be even more far reaching.
Suzanne McClain of Maben, Mississippi, says because of Riegel, she’s had difficulty finding representation in her surgical mesh case against Ethicon (Johnson and Johnson).
Surgical mesh is used to treat incontinence and it is a Class II device. Class I and II medical devices do not have to be approved for safety. Instead manufacturers must claim they are “substantially equivalent” to a device already on the market before being cleared for sale.
In McClain’s case, her doctor told her last year that the mesh has eroded through her vaginal wall. Surgery has been unable to extract any more than one-third of the petroleum-based mesh.
Her concern today is that it might migrate.
For McClain, it doesn't seem to matter that Class I and Class II devices were not included in the Riegel decision.
"I can’t find an attorney because no one will take it on because of that Supreme Court ruling,” she told IB News.
The Medical Device Safety Act, if approved, would nullify the Riegel v. Medtronic decision providing consumers with the same rights to hold a manufacturer accountable over defective heart stents as they now have when they claim injury from dangerous drugs or an inadequate warning label.
"Congress must make clear that big corporations do not have a right to 'hit and run' by causing serious health damage and then walking away from legal responsibility," says Nan Aron, President of Alliance for Justice, a coalition of consumer and advocacy organizations in a statement.
"Passage of the Medical Device Safety Act will protect the victims of unsafe products and ensure that manufacturers have a strong incentive to make safe products in the first place." #