Articles Posted in Preemption

The Pennsylvania Supreme Court shot down generic Reglan manufacturers and the maker of Reglan’s request to flip the trial court’s decision to deny their preemption summary judgment motion.

Reglan is used to treat short-term heartburn caused by gastroesophageal reflux disease (GERD). It is also used to speed up gastric emptying in diabetes patients. Because the drug is a dopamine antagonist, it increases lower esophageal sphincter pressure.

The problem with Reglan – plaintiffs allege – is that it causes tardive dyskinesia, an often irreversible and just plain awful neurological disorder with symptoms that include involuntary grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for this disorder.

Sometimes, personal responsibility is hard to come by. The same can be true of corporate responsibility, which is another version of personal responsibility (under the law, corporations are entities capable of suing and being sued, and doing many of the same things that people do).

Guidant, a former medical device manufacturer, faced charges from both the FDA and DOJ over its handling of medical devices.

In 2005, Guidant faced a series of recalls related to its implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recalls were related to a defect in the devices’ wiring that could cause the devices to malfunction or fail to deliver a life-saving shock to the heart.

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

Facts of Wyeth v. Levine

Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.

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).

The Medical Device Safety Act (MDSA) was a bill introduced in the U.S. Congress in 2009 that sought to overturn the Supreme Court’s decision in Riegel v. Medtronic, which had limited the ability of patients to sue medical device manufacturers for injuries caused by their products.

Specifically, the MDSA would amend the Federal Food, Drug, and Cosmetic Act to allow state tort claims against medical device manufacturers, even if the device had been approved by the FDA. The bill would have essentially eliminated the preemption defense that medical device manufacturers have used to shield themselves from liability in lawsuits. The MDSA was introduced in response to growing concerns about the safety of medical devices and the ability of patients to seek compensation for injuries caused by these devices.

Many in Congress Support the Bill

The bill was introduced in Congress and has several sponsors and co-sponsors, mostly Democrats. Representative Frank Pallone Jr. of New Jersey, who is the Chairman of the Energy and Commerce Committee introduced the bill in the House of Representatives. It is co-sponsored by several other Representatives, including Henry Waxman of California, Rosa DeLauro of Connecticut, and Bart Stupak of Michigan.

In the Senate, the MDSA is introduced by Senator Edward Kennedy of Massachusetts, who is a strong advocate for patient safety and healthcare reform. The bill is co-sponsored by several other Senators, including Patrick Leahy of Vermont, Sheldon Whitehouse of Rhode Island, and Sherrod Brown of Ohio.

The MDSA also has support from several patient advocacy groups, including Public Citizen and the National Research Center for Women and Families, who argue that the bill is necessary to ensure that patients have the ability to hold medical device manufacturers accountable for injuries caused by their products.

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 that cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Doctors Support the Bill

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

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.