Articles Posted in Preemption

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Preemption is typically a bad thing (big business and their lawyers typically disagree with me on this). In a nutshell, preemption is the ability to one set of laws to override another set. Typically, the context is that the federal law says ‘A,’ a state’s laws say ‘B,’ and so ‘A’ wins. Of course, the way our country was set up, we encouraged states to experiment with their own laws.

Applied to the medical arena, many medical device manufacturers believe they should be immune from lawsuits for defective devices (devices may be defective for any number of reasons—they may have been designed incorrectly, the manufacturing process may have had errors, or they may come with improper warnings). Sadly, the Supreme Court agreed that the law allowed that conclusion in Riegel v. Medtronic, Inc.

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Last week, the President issued a memo for the executive department on preemption. In a nutshell, preemption refers to the supremacy of a federal law where it conflicts with or is inconsistent with state law. In the context of drug and device cases, this has been something of a hot topic lately, with the legislature and courts wrestling with the question of whether particular federal laws preempt the ability of the states to permit certain product liability suits.

The memorandum shows that the executive branch is taking a traditional approach— “preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption.” The directive to executive agencies and departments is clear—they should not make statements about preemption, even in regulatory preambles, unless the underlying regulation addresses preemption. Furthermore, they are asked to review the past 10 years of regulations to determine whether existing statements about preemption are accurate.

This is a phenomenal memo. Preemption has lately been the scourge of victims and injured consumers (see Riegel), but we are making good ground to provide avenues of relief for people who have been hurt by others (see also Wyeth v. Levine).

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Lobbying efforts, particularly by injured victims and their counsel (as well as manufacturers of medical devices), are continuing for the Medical Device Safety Act of 2009. It’s no surprise that each side takes the position it takes—the victims hoping to pass the legislation to prevent more blanket immunity for manufacturers of devices that hurt or kill patients, and manufacturers hoping to reap the benefits of zero liability for some of their devices which cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Physicians are coming out to support the Medical Device Safety Act. Typically, they support tort reform and anything to prevent or limit lawsuits against healthcare providers. However, in a New England Journal of Medicine Editorial of April 9, 2009, three physicians took a stand behind the proposed legislation. Continue Reading

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Yesterday, the Health Subcommittee of the U.S. House Committee on Energy and Commerce held a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). This new law that would restore important the rights of defective medical devices that were eradicated by the U.S. Supreme Court decision in Riegel v. Medtronic. The Medical Device Safety Act would restore the right of victims injured by a defective medical device to seek tort remedies for injuries and deaths.

Rep. Bruce Braley (D-Iowa) said at the hearing that the Supreme Court’s decision was flawed because preventing injured patients from suing device makers over FDA-approved products results in shifting the cost of caring for injured patients away from medical device companies who cause the injuries onto the already burdened American taxpayer.

Point of Law has a full list of those who testified before the subcommittee. One of those speakers is Michael Kinsley, a liberal columnist who wrote a silly editorial on Medtronic v. Riegel that showed off his complete lack of understanding of the facts of the case. I’m not saying an argument can’t be made – Justice Scalia did just that.