As we have reported in previous issues, the Medical Device Safety Act of 2009 is awaiting passage in Congress. I predict that this legislation will pass because of its importance from a public health perspective. The American people have been alerted to a massive problem relating to medical devices and to the efforts to protect wrongdoers. Several legal groups, including the American Bar Association, support passage of this Act. The legislation was introduced on March 5th after the U.S. Supreme Court’s decision in the Wyeth v. Levine case.
In another case, Riegel v. Medtronic, the Supreme Court found last year that products liability claims against medical device manufacturer Medtronic were preempted by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act. But on March 4th, the Supreme Court ruled in the Levine case that federal law governing warnings on prescription drug labels does not preempt state claims asserting that pharmaceutical companies failed to warn of risks associated with the medication.
A number of consumer groups, including Public Citizen and legal organizations such as the American Association for Justice and the Alliance for Justice, have been pushing hard for passage of the Medical Device Safety Act. It’s most significant that the American Bar Association has joined with the consumer group. This legislation was introduced in both houses by Senator Ted Kennedy, the chairman of the Senate Committee on Health, Education, Labor and Pensions, and New Jersey Representative Frank Pallone Jr., the chairman of the House Committee on Energy and Commerce’s Subcommittee on Health. The legislation has broad support in both the House and Senate. The American people are clearly in favor of prompt passage.
In March, more than 20 consumer, health, women’s advocacy and legal groups sent letters to Senator Kennedy, Rep. Pallone and Rep. Henry Waxman, the chairman of the House Energy and Commerce Committee, urging passage of the Medical Device Safety Act. In the letters, it was stated:
Immunity should not be given to device manufacturers that fail to adequately warn about or prevent device risks; especially when the manufacturer knows, or should know, that the device could cause serious injuries or death.
One of the legal groups, the Center for Justice & Democracy, which is a consumer organization focused on the courts, released a report recently on defective heart devices and implants. Joanne Doroshow, executive director of the Center, which is based in New York, made this observation concerning the need for legislative action:
These are the very type of patients whose rights have been wiped out as a result of the Supreme Court’s decision last year, which is what Congress now needs to fix.
Meanwhile, the American Bar Association has formed a task force to review its policy regarding federal preemption of state products liability tort laws. On December 29th, ABA President H. Thomas Wells Jr., a Birmingham, Alabama lawyer, sent letters to Rep. Pallone and Senator Kennedy supporting a bill that would overturn the decision in the Medtronic case. President Wells, who is a very good civil defense lawyer, stated:
State product liability law holds manufacturers accountable for injuries caused by their products when they are negligent or irresponsible. These laws permit an injured consumer to be compensated by a manufacturer found to be negligent. Legislation such as the Medical Device Safety Act is consistent with ABA policy supporting the continued right of the states and territories to regulate product liability law with discrete exceptions.
While I believe this legislation will pass, corporate lobbyists are hard at work trying to derail the effort. Hopefully, the overwhelming support in favor of the legislation will enable the bill to pass, and to pass soon. It’s badly needed and would send the right message to the American people.
Source: National Law Journal
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