By Leah Voigt Romano
November 7, 2008
Supreme Court Hears Oral Arguments on FDA Labels and State Tort Statutes
On Tuesday, the United States Supreme Court heard oral arguments in a case that will determine whether the Food and Drug Administration (FDA) drug labeling rules trump state product liability laws.
Wyeth v. Levine deals with a sixty-two year-old musician, Diana Levine, who arrived at an emergency room in Vermont with a severe migraine and associated nausea. She was given an intramuscular injection of promethazine hydrochloride (Phenergan), but returned later, still in pain. A physician assistant then gave her an intravenous push of the drug. The agent came in contact with arterial blood, which led to gangrene and eventually to amputation of her hand and forearm.
According to a brief filed by attorneys for Wyeth, the FDA-approved labeling of the drug "repeatedly and prominently warned of the hazard of arterial exposure," and expressly recommended extreme measures to avoid serious injury, including "gangrene requiring amputation."
But Levine's attorneys said the labeling should have barred IV push injection all together, in light of the risk of such a serious injury. A Vermont jury awarded her $6.7 million in damages, and the state's supreme court upheld the judgment. Wyeth petitioned the Supreme Court to take the case, arguing that the FDA's labeling guidelines preempt state liability laws.
If the court rules that the FDA's requirements preempt state liability laws, it would effectively put an end to thousands of state-level lawsuits against drug companies and take away future legal recourse of patients who were injured from an FDA-approved drug, according to those who support Levine. But if the court decides that injured patients should be able to sue pharmaceutical companies in state courts for injuries caused by their drugs—even if the drug's risks were disclosed—then states would have the power to undercut the regulatory and oversight functions of the FDA, according to those who support Wyeth.
Emily P. Walker, High Court Hears Oral Arguments on FDA Labels v. State Tort Statutes, MedPageToday (Nov. 3, 2008).
Michigan Voters Pass Stem Cell, Marijuana Measures
The University of Michigan welcomed passage of a ballot proposal amending the state's Constitution to allow stem-cell research involving discarded embryos created for fertility treatment. The successful initiative, approved with about 53% of the vote in Tuesday's election, loosens what researchers complained was one of the country's most restrictive laws on such inquiry.
"This is a great day for the state that allows us to strengthen our life sciences sector and to advance critical medical research with energy and hope," the director of the University's Center for Stem Cell Biology said in a statement.
The Michigan Health & Hospital Association took no position on the stem-cell proposal. The Association did, however, join the Michigan State Medical Society and several other healthcare groups to oppose a ballot proposal legalizing medical marijuana, which voters approved by a comfortable margin. Hospitals and doctors warned the law would invite lawsuits over whether patients should be allowed to smoke the drug in smoke-free hospitals and doctors offices. More than 60% of Michigan voters made their state the thirteenth to allow use of marijuana for certain medical conditions.
Greg Blesch, Stem-Cell, Marijuana Measures Approved in Mich., Modern Healthcare's Daily Dose (Nov. 5, 2008) (note: registration is required to view this content).
Children Living with Smokers May Go Hungry
According to a recent study published in the November issue of Archives of Pediatrics and Adolescent Medicine, children who live in households with smokers may not get enough to eat. Researchers found that rates of food insecurity—the inability to access enough food every day—were nearly doubled for children living in homes with smokers.
About thirteen million children in the U.S. live in households where there is not a stable, adequate amount of food, and that can negatively affect physical health, neuropsychological development, and quality of life, according to the researchers. Families with at least one smoker spend
2 to 20 % of their income on tobacco, potentially draining financial resources needed to provide their kids with enough food. However, the relationship between household smoking and food insecurity has not been studied previously, the researchers said.
To assess the relationship, researchers analyzed data on 8,817 households with children under eighteen from the National Health and Nutrition Examination Survey (NHANES). Food insecurity was assessed using the U.S. Department of Agriculture Food Security Survey Module.
Almost a quarter of the households had an annual income below the poverty level, and almost half were classified as low-income families. About 23% of households with children included at least one adult smoker, and 32% of children in low-income households lived with a smoker, compared with 15% of those in more affluent households.
Overall, 15% of adults and 11% of children experienced some degree of food insecurity during the previous twelve months, with 6% of adults and 1% of children experiencing severe food insecurity. The highest rates of food insecurity were in children living in low-income households with smokers. "Families with low income, in general, are more likely to . . . spend less on food and spend a larger percentage of available money on tobacco compared with more affluent families," the researchers said.
C. Cutler-Triggs et al., Increased Rates and Severity of Child and Adult Food Insecurity in Households with Adult Smokers, 162 ARCHIVES PEDIATRIC ADOLESCENT MED 1056 (2008).
Kristina Fiore, Children Living with Smokers May Go Hungry, MedPageToday (Nov. 3, 2008).
CMS Seeks More Comments on Proposed Stark Exception for "Gainsharing" Programs
The Centers for Medicare & Medicaid Services (CMS) did not finalize an exception to the physician self-referral rule that would allow for shared savings programs between doctors and hospitals, but instead asked for more comments on how such an exception should be tailored. The decision not to finalize the exception was praised by a medical technology group that said such gainsharing programs could create incentives for the use of less expensive, older medical technologies.
The exception would have been in the final 2009 Medicare physician fee schedule rule released October 30. CMS had asked for detailed comments in the proposed rule, issued July 1, and published in the July 7 Federal Register, about how a Stark rule exception could be designed to allow hospitals to pay incentives to doctors as part of pay-for-performance programs, gainsharing arrangements, and other so-called shared savings programs.
But CMS said it received too few comments with substantial ideas about how to craft the exception, and again sought more detailed input from the healthcare community. "We believe that, if ultimately provided through the extended public comment process, the additional information we are requesting will assist us in finalizing an exception or exceptions for incentive payment and shared savings programs," CMS said.
The final physician fee schedule rule will appear in the November 19 Federal Register and will become effective January 1, 2009. CMS will accept comments on the shared savings exception for ninety days after the rule is published in the Federal Register.
Access the proposed rule.
CMS Seeks More Comments on Proposed Self-Referral Exception for Shared Savings, BNA HEALTH L. REP. (Nov. 6, 2008) (note: registration is required to view this content).
Possibilities for HHS Secretary, FDA Commissioner in Obama Administration
Democratic congressional staffers and others have begun "floating names for top health posts" in the administration of President-elect Barack Obama that include several possibilities for Secretary of Health and Human Services (HHS). According to staffers, possibilities for HHS secretary include former Senate Majority Leader Tom Daschle (D-S.D.); former Director of the National Institutes of Health Harold Varmus; and Democratic National Committee Chair Howard Dean, a physician. Daschle has written a book that calls for an independent agency to oversee the healthcare system.
In addition, some individuals in "contact with the president-elect's health care advisers" have cited Kansas Governor Kathleen Sebelius (D) as a possibility for HHS secretary. Sebelius attempted to pass healthcare reform legislation and in 2003 became the first state insurance commissioner to formally reject a proposal for a BlueCross BlueShield Association plan to convert from a nonprofit organization to a for-profit company.
Democratic congressional staffers said that possibilities for FDA commissioner in the Obama administration include Steven Nissen;
a cardiologist at the Cleveland Clinic and an adviser to the Obama campaign; Mike Taylor, a former deputy FDA commissioner; Duke University cardiologist Robert Califf; Mary Pendergast, a former FDA official and a consultant to the pharmaceutical industry; and FDA Center for Drug Evaluation and Research Director Janet Woodcock.
Kaiser Daily Health Policy Report, Possibilities for HHS Secretary, FDA Commissioner in Obama Administration Discussed, Henry J. Kaiser Fam. Fdn. (Nov. 6, 2008).
Court Blocks White House Push on Medicare Expenses
A federal court has blocked the Bush administration's effort to save money on Medicare by paying for only the least expensive treatments for particular conditions. Congress sets Medicare payment rates and never intended to give officials broad discretion to alter them, the court said in an important test case involving drugs used to treat chronic obstructive pulmonary disease. Judge Henry H. Kennedy Jr., of Federal District Court in New York, said the policy of paying for only "the least costly alternative" was not permitted under the Medicare law.
The administration's position would give the health and human services secretary "enormous discretion" to determine the amount paid for every item and service covered by Medicare, without reference to the detailed formulas set by Congress, Judge Kennedy said. "This flies in the face of the detailed statutory provisions," he added.
Over the years, Medicare officials have often tried to adopt regulations that allow them to consider cost in deciding whether the program should cover various goods and services. Healthcare providers, manufacturers, and some patients' advocates have resisted these efforts, saying that coverage decisions should be made based on clinical effectiveness and not cost.
Federal health officials said the decision would make it more difficult to rein in Medicare costs. Judge Kennedy found that Medicare and some of its contractors had unlawfully limited payments for DuoNeb, an inhalation drug taken through a nebulizer, which turns the medicine into a fine mist. The drug makes breathing easier by opening up the bronchial tubes. A single dose provides a combination of two commonly prescribed bronchodilators, albuterol, and ipratropium.
Robert Pear, Court Blocks White House Push on Medicare Expenses, N.Y. TIMES (Nov. 3, 2008).
*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.