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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The Menaflex Collagen Scaffold orthopedic knee device received fast track approval from the FDA to repair and reinforce the meniscus, a C-shaped disk in the knee that acts as a cushion and helps lubricate the joint. Last week, the FDA said approving this device was a mistake. The Food and Drug Administration has taken the unusual step of admitting that it made a mistake when it approved a device used to repair damaged knees.

The “bravo to the FDA for admitting a mistake” is somewhat lessened because they can point to President Bush’s FDA for the mistake. Still, the rank-and-file FDA folks are largely the same, at least those who have not jumped on the revolving “FDA to Industry Shuttle Bus.”

Now, patients with this device are looking at surgery to have the device removed because it has been absorbed and replaced with new tissue.

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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).

Exhibit A is Guidant’s plea in federal court on Monday. Guidant (recently acquired by Boston Scientific) pleaded guilty to criminal violations of the Federal Food, Drug, and Cosmetic Act. Specifically, it pleaded guilty to two violations:

  1. making a materially false statement in a required submission to the FDA (Ventak Prizm 2DR)
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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.

The drug at issue in Wyeth v. Levine was Phenergan, an antihistamine. The drug was administered using a method known as an “IV push,” however the drug was inadvertently injected into Dina Levine’s artery. She developed gangrene, the arm had to be amputated (Diana Levine is a musician, and the tragedy of her injury is simply incomprehensible. See John Bratt’s blog post).

The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is a deep muscular injection and that subcutaneous injection is contraindicated.”

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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).