Articles Posted in Preemption

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Myland has announced the recall of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg.

It is possible that several tablets from the affected lots may exceed the weight requirement, essentially causing higher dosages of acetaminophen, resulting in consumers possibly taking more than the intended acetaminophen dose.

This includes product with the following NDC numbers and lot numbers beginning with the letter “C” – The lot number can be found on the side of the manufacturer’s bottle.

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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.

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Guidant%20in%20Jail-04-21-10%29.JPGThe New York Times published an article yesterday, “When Heart Devices Fail, Who Should Be Blamed?” The article puts a nice gloss on how and whether a company and people in charge of a company can properly make amends and taking personal/corporate responsibility.

The backstory is, of course, that a federal judge is considering whether to accept a $296 million fine, and a guilty plea to two criminal misdemeanors by Guidant (now Boston Scientific). Two cardiologists are urging the judge to reject the deal, and instead, want prosecution of the company “and the individuals responsible.” The cardiologists, who cared for a 21-year-old patient who died because his Guidant device did not properly function, further stated that:

Manufacturers control the quality of their products. Manufacturers are the first to know when a medical device is dangerous or underperforming. Thus, it is in the best interest of patients, and society in general, for manufacturers to be liable for the safety and effectiveness of their products. To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.

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Guidant-Timeline-04-07-10.jpgSometimes, 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.

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Boston%20Scientific%20ICD%202-03-16-10%29.JPGHeart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed Sprint Fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subjected to recalls and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

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The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.
In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

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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.

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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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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

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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.