By Leah Voigt Romano*
Pfizer Agrees to Pay $894 Million to Settle Pain Medication Lawsuits
Late last week, Pfizer announced that it has agreed to pay $894 million to resolve a series of lawsuits involving its pain medications Celebrex and Bextra. According to the pharmaceutical company, it has reached agreements in principle to resolve "substantially all" of the personal injury and consumer fraud lawsuits filed against it over the pain medications, as well as claims by state attorneys general involving Bextra. In addition, the company said, litigation involving Celebrex would be resolved as part of the proposed settlements.
Pfizer said in its announcement that a finalization of agreements with a number of law firms and approval by "the appropriate courts" still is required.
Bextra and Celebrex belong to a class of nonsteroidal anti-inflammatory drugs (NSAIDs) known as COX-2 inhibitors, so-named because they suppress the body's production of the COX-2 enzyme, associated with pain and inflammation. After studies showed an increased risk of cardiovascular and other side effects associated with the COX-2 medications, Pfizer withdrew Bextra from the market in 2005 at the request of the FDA. The agency also issued stronger labeling requirements for Celebrex, as well as for NSAIDs available over the counter.
According to Pfizer, the proposed settlements include payments of
$745 million to resolve personal injury lawsuits alleging the pain medications caused heart attacks, strokes, or other injuries. Those payments will resolve more than 90% of the known personal injury claims, the company said. Pfizer said it would seek to recover a portion of the personal injury payments from its insurers.
Pfizer also has agreed to pay $60 million and adopt certain compliance measures to resolve claims brought by thirty-three states and the District of Columbia, primarily related to promotional practices for Bextra. Pfizer said it will "adopt compliance measures that complement policies and procedures previously established by the company."
Pfizer Agrees to Pay $894 Million To Settle Pain Medication Lawsuits, BNA'S HEALTH L. REP. (Oct. 21, 2008) (note: registration is required to view this content).
Medicaid Fiscal Report: Spending Expected to Outpace Economic Growth
Medicaid spending will outpace national economic growth by more than 60% over the next ten years, according to the first fiscal report from the federal-state program since it began forty-two years ago.
Total Medicaid expenditures will reach $674 billion annually by 2017, representing an annual growth rate of 7.9%, Michael O. Leavitt, the secretary of Health and Human Services, said at the annual meeting of the National Association of State Budget Officers. In contrast, the U.S. economy is projected to have an annual growth rate of 4.8% over the same time period. Total healthcare costs are expected to increase by 6.7% per year.
"This report should serve as an urgent reminder that the current path of Medicaid spending is unsustainable for both federal and state governments," said Leavitt. "If nothing is done to reign in these costs, access to healthcare for the nation's most vulnerable citizens could be threatened."
The Centers for Medicare and Medicaid Services (CMS) periodically generates seventy-five-year projections for Medicare spending. However, the fiscal report from the CMS Office of the Actuary is a first for Medicaid. In 2006, Medicaid represented 40% of federal expenditures on health services. Unlike Medicare, all federal spending on Medicaid comes from general revenue.
The full report is available online.
Charles Bankhead, Medicaid Spending Expected to Outpace Economic Growth, MedPage Today (Oct. 17, 2008).
Embolic Filter Captures "Hanging Chads" Left by Carotid Stenting
An investigational embolic protection system for carotid stenting was associated with a thirty-day event rate of 3%, the safety threshold recommended by the American Heart Association (AHA). A month after stenting, the mortality rate was 0.4%, the stroke rate 2.1%, and the myocardial infarction rate 0.9%. Investigators reported these results of the 237-patient EPIC trial (Evaluating the Use of the FiberNet Embolic Protection System In Carotid Artery Stenting) at the AHA's Transcatheter Cardiovascular Therapeutics meeting.
The stroke rate in the SAPPHIRE trial, which compared carotid stenting with endarterectomy, was 4.9%—results that were hailed as "landmark" when reported at the AHA meeting in 2002. With the FiberNet system, a filter wire expands to a form a plug distal to the carotid lesion. This plug allows blood to flow but embolic debris cannot pass.
After the stent is deployed, an aspiration catheter sucks out all downstream debris as well as "hanging chads, the disrupted plaque that may be hanging in the stent," the lead investigator said at a press briefing. He said that the aspiration needs to be carefully and completely performed—about sixty cc are usually aspirated—in order to be sure that all embolic debris are removed. The filter wire is then compressed and withdrawn. In the EPIC trial, which was conducted at twenty-six sites in the United States, the technical success rate was 97.5%, the FiberNet device success rate was 94.1%, and "90.9% of the filters capture visible debris," investigators reported.
Peggy Peck, Embolic Filter Captures "Hanging Chads" Left by Carotid Stenting, MedPage Today (Oct. 17, 2008).
U.S. Medical School Enrollment Reaches Record High; Officials Remain Concerned About Meeting Demand
Medical school enrollment in 2008 increased by 1.6% over last year, resulting in a record-high 17,759 first-year medical students, with the number of Latino students increasing by 10%, according to a study by the Association of American Medical Colleges (AAMC). The study found that the total number of applicants reached 42,315, and the nearly 32,000 first-time applicants also was a record high. According to the study, eleven U.S. medical schools increased enrollment by at least 10% from last year. Since 2003, first-year enrollment has increased by 10% or more in forty-nine U.S. medical schools; another eighteen medical schools have increased by at least 5%.
Darrell Kirch, president and CEO of AAMC, attributes the growth to a higher capacity at medical schools and the establishment of new branch campuses across the country. Dan Scheirer, associate dean at Duke University's Trinity College, said the medical profession seems attractive to potential applicants because of depictions in popular culture, such as the television shows House and Grey's Anatomy.
AAMC data are available online.
Kaiser Daily Health Policy Report, U.S. Medical School Enrollment Reaches Record High, Officials Remain Concerned About Meeting Demand, Henry J. Kaiser Fam. Fdn. (Oct. 22, 2008).
First-Time Medical School Applicants Down
Enrollment figures may be up, but the number of first-time applicants to U.S. medical schools declined slightly this year, according to the data released by the AAMC.
First-year enrollment at the nation's medical schools in 2008 increased nearly 2% over 2007 to more than 18,000 students, the highest enrollment in history, the AAMC reported. Various ethnic groups helped boost this figure, with the number of Latino and Native American first-year enrollees increasing by more than 10% and 5% respectively.
The AAMC reports that more than 42,200 applied to medical schools in 2008. While the overall applicant pool is one of the largest in more than a decade, "the number of first-time applicants decreased by 3%," the association reported. On average, there were more than two applicants for every available opening at a medical school. "In a time of great economic uncertainty, interest in the healing profession of medicine remains stable," said AAMC president and CEO Darrell Kirch, summarizing the results in a written statement.
According to the AAMC, applicants to medical school this year were among the most academically qualified in history. There was also an increase in the number of applicants who had community service experience and medical research experience on their premedical resumes.
Jennifer Lubell, First-Time Med School Applicants Down, Modern Healthcare's Daily Dose (Oct. 21, 2008) (note: registration is required to view this content).
Minorities and Uninsured Have Poorer Trauma Survival
According to a recent registry study, race and insurance status work independently to worsen mortality risks for trauma patients. The study, published in the October issue of the Archives of Surgery, reports that risk of death after trauma was 17% higher for African Americans, and 47% higher for Hispanics, than for whites.
In the study, lack of insurance raised a trauma patient's odds of death by almost 50% compared with insured patients across race and ethnic groups. These findings reinforce the universality of health disparities based on race, income, and insurance status already documented in cancer, general surgery, and for other treatments and conditions, the investigators said.
"Access to trauma care is near universal, so one would not expect such dramatic differences in patients with and without insurance," the study's lead investigator said. One reason may be that uninsured patients hesitate to call 911 and delay care; however, the report cautions that further study is needed to determine the reasons.
A.H. Halder et al., Race and Insurance Status as Risk Factors for Trauma Mortality, 143 ARCHIVES OF SURGERY 945 (2008).
Crystal Phend, Minorities and Uninsured Have Poorer Trauma Survival, MedPage Today (Oct. 17, 2008).
Court Orders Medical Records Discovery, Encourages Settlement of Zyprexa Lawsuit
This week, a federal trial court accepted a magistrate judge's recommendation that five states that are litigating claims against Eli Lilly and Co. for its alleged fraudulent marketing of Zyprexa should be compelled to produce de-identified Medicaid patient records in response to the company's discovery requests (In re Zyprexa Products Liability Litigation, E.D.N.Y., No. 04-MD-1596, Oct. 21, 2008).
Senior Judge Jack B. Weinstein of the U.S. District Court for the Eastern District of New York ruled that requiring production of medical records sought by the company would not violate any state law privileges and that the state attorneys general had, in any event, waived any privilege that might attach to the records by raising claims and fact issues to which the company had a right to respond.
The court said that the attorneys general (AGs) were attempting to use the privilege as a "'shield' to disable a defendant," adding that "utilization of privilege by a plaintiff to cripple a fair defense would violate due process." The court acknowledged the burden on the parties and nonparty providers of producing the documents, but said the burden had to be considered relative to the "billions of dollars in damages and fines" the AGs seek.
The court confirmed a September 24 recommended decision by Magistrate Judge Roanne L. Mann, that found discovery should be allowed to proceed because the Health Insurance Portability and Accountability Act, by giving no protection to de-identified patient records, preempts state laws that do. Weinstein, however, stayed the affect of his ruling for thirty days to give the parties a chance to pursue settlement discussions with the help of a special settlement master.
Peyton M. Sturges, Court Orders Medical Records Discovery, Encourages Settlement of Zyprexa Lawsuit, BNA HEALTH L. REP. (Oct. 21, 2008) (note: registration is required to view this content).
Uninsured Not Responsible for Emergency Department Overcrowding, Study Finds
According to a study published this week in the Journal of the American Medical Association (JAMA), insured patients represent the majority of the increased use of U.S. emergency departments (EDs) over the past decade—not the uninsured as is widely assumed. For the study, researchers at the University of Michigan gathered news reports and 127 medical research papers about uninsured patients visiting EDs with available ED data.
The study, which was supported by the Robert Wood Johnson Foundation, found that nearly one in five papers published between 1950 and 2008 included an assumption that uninsured patients contributed to ED overcrowding, and more than 20% of the papers made assumptions that the uninsured use EDs for non-emergency care.
The authors of the latest study found other reasons for ED overcrowding, including understaffed inpatient hospital wards, ED closures, a shortage of inpatient beds, and a growing elderly population with chronic illnesses. According to the study, "[o]n a national level, 75% of the increase in ED use over the last decade is attributable to increased use per person, mostly by insured patients. The remaining amount is predominately due to an increase in population size." However, the authors noted that patients without insurance still accounted for most of the visitors at hospital EDs located in areas with high uninsured rates.
ARTICLE ABSTRACT: Manya F. Newton et al., Uninsured Adults Presenting to US Emergency Departments: Assumptions vs. Data, 300 JAMA 1914 (2008).
Kaiser Daily Health Policy Report, Uninsured Not Responsible for Emergency Department Overcrowding, Study Finds, Henry J. Kaiser Fam. Fdn. (Oct. 22, 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.