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Archive for the ‘Health Law’ Category

In 2003, Arizona requested a waiver from the Secretary of Health and Human Services (“the Secretary”) to expand its mandatory Medicare co-payments for (1) childless, nondisabled adults who earn up to 100% of the federal poverty level and (2) former recipients of state health care benefits in order to lower health care costs and close a $1 billion budget gap. The Secretary granted the waiver in 2004.

After the waiver was granted, a group of "economically vulnerable" Arizonans filed a class action against the Secretary and the director of Arizona’s Medicaid agency, alleging that (1) the increased and expanded mandatory co-payments violated the Medicaid Act’s cost-sharing restrictions, (2) the waiver was illegal, and (3) they had received inadequate notice of the changes. The trial court ruled that the plaintiffs, while vulnerable, were not defined as a "medically needy" population under the Medicaid Act. Because Arizona’s state health care plan does not cover them, the trial court found that the state was exempted from the law’s cost-sharing provisions as an "expansion population."

On appeal, the Ninth Circuit Court of Appeals agreed on this point, but remanded the case for a new look at the waiver and notice issues because of the following:

There is little, if any, evidence that the secretary considered the factors [federal statute] requires her to consider before granting Arizona’s waiver. . . . The record is not sufficient for this court to review the agency’s consideration of the impact Arizona’s demonstration project would have on the economically vulnerable.

For the full story, click here.

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Kristen Parker tested positive for hepatitis on her first day of work in 2008 as a "scrub tech" for Rose Medical Center in Denver, Colorado. She noted she probably contracted the disease by sharing heroin needles, a practice that developed with a prescription for painkillers after jaw surgery in 2001. While Parker worked at the hospital, she repeatedly stole fentanyl from operating room anesthesia carts, injected the painkiller into her system with syringes, and returned the used syringes to the carts. Fentanyl is a powerful, synthetic, opioid painkiller 80 to 100 times stronger than morphine. Parker was fired after testing positive for the drug in March 2009. She used similar tactics to get drugs at the next hospital that hired her, the Audubon Surgical Center in Colorado Springs.

Around that time, the Colorado Department of Health began investigating an outbreak of Hepatitis C. After Parker was indicted in August 2009, her former employers contacted about 6,000 patients who could have been exposed to Parker’s strain of hepatitis C. Genetic testing of 17 patients who tested positive for the disease showed a 97% chance that their strain was genetically linked to Parker’s.

At Parker’s sentencing hearing, the judge rejected her plea bargain and sentenced her to 30 years imprisonment, instead of the 20 recommended in sentencing guidelines. The judge noted the following:

The repeated theft and abuse of fentanyl, one of the most puissant drugs on the planet for selfish, personal gratification to get high while exposing so many innocent, unsuspecting, undeserving people to this insidious and incurable disease is as incomprehensible as it is unconscionable. She finally and thankfully got caught.

Parker appealed the sentence, calling it unreasonable and an abuse of discretion. The Tenth Circuit Court of Appeals, however, upheld the order, stating that the sentence was reasonable in light of all the circumstances. The court further noted that “. . . Parker’s crime stands out as particularly repugnant. [She] displayed a callous disregard for human suffering. By stealing fentanyl from operating carts, Parker deprived surgical patients of needed anesthesia. At least one of her victims awoke mid-surgery in severe pain."

For the full story, click here.

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After A.G., a minor, had two benign moles removed in 2004, his doctor gave him a prescription for ibuprofen. His parents, the Gaetas, bought an over-the-counter generic ibuprofen manufactured by Perrigo Pharmaceuticals (“Perrigo”). Later, A.G. developed a high fever and had to be rushed to the hospital and treated for liver failure. A.G. needed a liver transplant less than two weeks after the mole surgery and later had dead tissue from his fingers and toes amputated. Doctors determined that the ibuprofen had clashed with the anesthetic Halothane, which had been administered during the mole-removal surgery. Halothane is hepatotoxic or known to cause liver failure in some circumstances.

The Gaetas sued Perrigo and other manufacturers of generic ibuprofen, alleging defective design, defective marketing, breach of express and implied warranties, negligence and gross negligence, and deceit by concealment. The Gaetas claimed that Perrigo failed to warn doctors and consumers that ibuprofen could cause liver injury if mixed with other drugs. In response, Perrigo argued that the Gaetas’ state-law failure-to-warn claims were preempted by the labeling and marketing regulations of the Food and Drug Administration (“FDA”) governing generic drugs. The trial court agreed, concluding that since federal law required generic drugmakers to conform to the approved labeling of brand-name drugs, Perrigo could not have changed its labeling without violating federal law.

The Gaetas appealed the decision to the Ninth Circuit Court of Appeals. While the appeal was pending, the United States Supreme Court issued its opinion in Wyeth v. Levine, holding that approval of medication by the FDA does not shield a manufacturer of brand-name medications from liability under state law. After Levine, the Gaetas won a limited remand from the Ninth Circuit so that the trial court could reconsider its decision with the Supreme Court ruling in mind. The trial court denied the motion for reconsideration, however, and ruled that the high court’s decision only applied to brand-name drug manufacturers.

The Gaetas again appealed the trial court’s decision. With its holding, the Ninth Circuit joins the Fifth and Eighth Circuits in applying Levine to generic drugs as well. The court noted that (1) manufacturers are primarily responsible for warning consumers about possible drug dangers because they have better access to information about their products than the FDA, and (2) there is nothing in Levine that limits this responsibility to brand-name drug manufacturers. The court stated that both sets of manufacturers must take specific steps when they learn of new risks associated with their products. Finally, the court concluded that compliance with both state and federal law was not “impossible.” Accordingly, the court remanded the case to the trial court for further proceedings.

For additional information, click here.

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Elliot Spiegel sued Daniel “Tiger” Schulmann and UAK Management Co., claiming his weight got him fired as a karate instructor at the Tiger Schulmann Karate School in Stamford, Connecticut. Spiegel stated he has a medical condition called hypogonadism that prevents him from losing weight. He alleged invasion of privacy (based on Spiegel’s photos in a weight-loss advertisement), retaliation, and violations of the Americans with Disabilities Act (“ADA”) and state and city human rights laws.

The trial court dismissed the lawsuit entirely. On appeal, the Second Circuit Court of Appeals agreed that most of the case was meritless, including Spiegel’s bid for a different judge on remand. He argued that U.S. District Judge Sandra Townes was biased and “had undertaken to scour the record to find a basis for knocking out plaintiffs’ claims.”

However, the Second Circuit revived Spiegel’s claim that the karate school violated the New York City Human Rights Law barring employers from firing workers “because of an actual or perceived . . . disability” because no New York appellate court had yet addressed whether obesity alone could constitutes a disability the law.

For the full story, click here.

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In 2003, Disability Advocates, a nonprofit legal group, sued New York Governor David Patterson, the state’s Department of Health and Mental Health, and other defendants “on behalf of individuals with mental illness residing in, or at risk of entry into, ‘impacted adult homes’ in New York City.” The complaint alleged that adult homes are for-profit, large warehouse-like facilities that house hundreds of residents.

After a five-week trial last year, U.S. District Judge Nicholas G. Garaufis found that the state “denied thousands of individuals with mental illness in New York City the opportunity to receive services in the most integrated setting appropriate for their needs,” adding that “these actions constitute discrimination” under the Americans with Disabilities Act and the Rehabilitation Act. The court noted that “virtually all” of the 4,300 mentally ill residents of adult homes were not in the most “integrated settings appropriate to meet their needs.” The judge then ordered the state to place all qualified mentally ill individuals in supported housing, if they choose, within four years.

In his most recent opinion, the judge criticized the state’s remedial proposal, saying it “scarcely begins to address the violations identified by the court.” The state proposed to create 200 supportive housing units per year over the next five years, for a total of only 1,000 new units. The judge wrote as follows:

The court is disappointed and, frankly, incredulous that defendants sincerely believe this proposal would suffice. As if failing to provide a meaningful remedy for current adult home residents were not bad enough, defendants also make absolutely no provision of supported housing for potential future adult home residents, ensuring that the violations found by this court will inevitably recur.

The judge also stated he will appoint a monitor to make sure the state complies with the order. For the full story, click here.

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In 2005, Illinois adopted a law that limited jury awards for pain and suffering to $500,000 against doctors and $1 million against hospitals. Illinois medical and business industries supported the cap, claiming jury awards against medical providers had led to astronomical malpractice insurance rates, which in turn, had driven doctors out of the state. Trial lawyers and patient-rights groups argued that the real factor behind medical malpractice insurance rate hikes is the insurance industry. The Illinois Supreme Court called the law a legislative branch infringement on an issue that should be decided by the courts:

The separation of powers clause prohibits one branch of government from exercising ‘powers properly belonging to another. Thus, the inquiry under the separation of powers clause is not whether the damages cap is rationally related to a legitimate government interest but, rather, whether the legislature, through its adoption of the damages cap, is exercising powers properly belonging to the judiciary.

For the full story, click here.

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Honey Torretti, a diabetic women residing in Pennsylvania, complained of pain and discomfort during a routine pregnancy checkup with her doctor, who sent her to a hospital for additional monitoring of her high-risk pregnancy. There, Torretti gave birth to her second child via emergency caesarean section.  She later sued Main Line Hospitals and several doctors under the Emergency Medical Treatment and Active Labor Act (“EMTALA”) after her son was born with “traumatic brain injuries.” EMTALA was enacted in the 1980s to stop emergency rooms from, among other things, refusing care to patients and transferring them to other hospitals without stabilizing them first, or “patient dumping.”

The trial court granted Main Line Hospitals summary judgment, ruling that Torretti had not presented sufficient evidence that her doctor knew a medical emergency was imminent when he sent her to another hospital for monitoring. On appeal, Torretti argued that, because she is a diabetic and had a high-risk pregnancy, each visit to her doctor would qualify as “presentment of an emergency medical condition to trigger EMTALA coverage.” However, the Third Circuit Court of Appeals noted that such a trigger would broaden the scope of EMTALA beyond Congress’s intent, stating the following:

We believe it is clear that Congress did not intend EMTALA to cover these individuals every time they come to the hospital for their [routinely scheduled] appointments, even though they suffer from serious medical conditions that risk becoming emergent.

The court also noted that EMTALA was “not a federal malpractice statute,” although Torretti may be able seek recovery in some other form.

For the full story, click here.

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