New York City agrees to pay $2 million for death of patient after ED wait.

The New York Times (5/28, A24, Chan) reports, "New York City has agreed to pay $2 million to the family of a woman who died last year on the floor of the psychiatric [emergency department (ED)] at Kings County Hospital after waiting more than 24 hours to be treated." In doing so, "the city's Health and Hospitals Corporation accepted full responsibility for the death of the woman...and said it had taken steps to relieve crowding and increase the size of the staff to provide mental health services at the hospital." A February 2009 report from the federal Department of Justice "that found, among other problems, that patients were not treated for suicidal behavior, were routinely subdued with physical restraints and drugs instead of receiving individualized psychiatric treatment, and were abused by other patients."
The AP (5/28, Matthews) notes that the "report became public when Alan Aviles, president of the city's Health and Hospitals Corp., announced reforms at the hospital including the replacement of its top two administrators and the addition of 200 medical personnel." He explained that "the improvements would shorten the average time patients wait in the psychiatric [ED] to eight hours, down from 27 hours."

US Supreme Court rejects Chrysler appeal of $13 million damage award.

Bloomberg News (5/26, Stohr) reported, "The U.S. Supreme Court rejected Chrysler LLC's appeal of a $13 million punitive damage award to the family of an 8-month-old who died in a 2001 Tennessee accident while riding in a Dodge Caravan." The car company "argued unsuccessfully that the award violated constitutional limits on damages laid out in previous Supreme Court cases."
The AP (5/26) reported, "The lawsuit claimed 8-month-old Joshua Flax was riding in the back seat of a 1998 Dodge Caravan in Nashville, Tenn., in 2001 when the vehicle was rear-ended, causing the front passenger seat to collapse and the passenger to strike him, fracturing his skull."

Preemption Victory for Ordinary Consumers

Today, President Obama issued a Directive to the Heads of all Executive Branch Departments and Agencies stating it is the policy of his Administration that “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.” Preemption of state common law will no longer be presumed or asserted by regulatory agencies absent “explicit preemption by Congress or an otherwise sufficient basis under applicable legal principles.”

In order to ensure that executive departments and agencies include statements of preemption in regulations only when such statements have a sufficient legal basis, the President’s directive provides that:

"1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.

2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption…

3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.”

House lawmakers hear debate over medical device preemption.

CQ HealthBeat (5/14, Kim) reports that the House Energy and Commerce Committee's Health Subcommittee "heard witness testimony on a measure that would allow consumers to sue companies under state law for injuries sustained by sophisticated medical devices" on Tuesday. Supporters of HR 1346, the Medical Device Safety Act of 2009, said "that the bill would ensure product safety and consumer protection, while opponents argued that the bill would stifle life-saving medical innovation and impose unnecessary regulation on medical device companies." The bill is in response "to a Supreme Court ruling issued last year that states that under the Medical Device Amendments of 1976, certain medical devices that must go through Food and Drug Administration (FDA) pre-marketing approval are preempted from being sued for liability under state law." That decision "has already resulted in 1,400 injury cases being thrown out of court, said Committee Chairman Henry A. Waxman (D-CA) [a] co-sponsor of the bill. It's the possibility of litigation that is one of the most powerful incentives to safety, Waxman said."
NPR (5/13, Silberner) reported, "The U.S. Supreme Court ruled in February 2008 that an OK from the Food and Drug Administration for a high-tech medical device is all a manufacturer needs to avoid being sued in state court." Now, "Rep. Frank Pallone (D-NJ) wants to change that." He said, "There are problems with medical devices that arise outside of the FDA approval process because that process is limited. ... And we should not preclude people from suing and recovering damages if something comes up."
Modern Healthcare (5/13, Rhea) reported that House lawmakers "listened to testimony from experts and patients and argued the merits of the Medical Device Safety Act of 2009." The act is "sponsored by Rep. Frank Pallone Jr. (D-N.J.)" and "would negate the Supreme Court's decision in last year's Riegel vs. Medtronic case, which involved a Medtronic-manufactured balloon catheter that ruptured inside the patient during coronary artery surgery."

Missouri appeals court restores $17 million verdict against American Family Mutual.

The AP (5/6, Twiddy) reports, "A Missouri appeals court on Tuesday reinstated a $17 million verdict against American Family Mutual Insurance Co. as part of a class-action lawsuit over aftermarket vehicle parts." The appeals court said that "Jackson County Circuit Judge Edith Messina was wrong when she overturned a jury's decision last year against the Madison, Wis.-based insurer." The appeals court added that "the plaintiffs 'presented sufficient evidence for a reasonable juror to conclude that aftermarket parts are not of like kind and quality to (original manufacturer) parts and that American Family breached its contacts with its policyholders when it paid to return the damaged vehicle to pre-loss condition based on the nature and cost of aftermarket parts.'"

Iovate recalls 14 Hydroxycut products following FDA warning to consumers.

The Wall Street Journal (5/2, Favole) reported, "Consumers should 'immediately stop' using Hydroxycut weight-loss products amid concerns they may cause jaundice and liver failure, the U.S. Food and Drug Administration said Friday." Responding to "23 serious reports of health problems with Hydroxycut products and one death in a 19-year-old male who had used the weight-loss products," regulators are "strongly" advising "people against using 14 Hydroxycut products," according to Linda Katz, interim chief medical officer in the FDA's food safety and nutrition division.
The Los Angeles Times (5/2, Stein) reported that Hydroxycut manufacturer, Iovate Health Sciences Inc., is "recalling most of its Hydroxycut products from the market." Meanwhile, regulators remain unsure "which ingredients or dosages could be causing the problems," as "the recalled products contain several ingredients, among them herbal extracts." The health problems reported to the FDA included "jaundice, elevated liver enzymes, liver damage (requiring a transplant), seizures, and cardiovascular disorders."
The New York Times (5/2, B3, Singer) reported that two Iovate products, "Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall." The company's move follows "a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection." Dietary supplements, "which can offer general health benefits but cannot claim to treat specific diseases or symptoms," do not require "FDA approval to go on sale."
The AP (5/2, Alonso-Zaldivar) reported, however, that "regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems." Katz noted that "part of the problem is that the FDA looks at dietary supplements from a post-market perspective," relying on "voluntary reports to detect...problems." Bloomberg News (5/2, Larkin Gaoette) and the Los Angeles Times (5/1, Stein) Booster Shots blog also covered the story.

Iowa family receives $17 million in medical malpractice settlement.

The AP (5/1) reports, "The family of an Iowa County girl permanently disabled by a surgeon has received a $17 million settlement from the state's medical malpractice fund." According to court documents, the physician "used a blender-like device to help remove the" patient's spleen, "but caused internal damage that left the" patient "with permanent brain injuries." The patient now "cannot speak, uses a feeding tube, and requires around-the-clock care." For his part, the physician claims "he hadn't used the device before and didn't tell the girl's parents he would be using it."