By Jennifer P. Viegas*
December 5, 2008
Arizona Appeals Court Allows Lawsuit Against Researchers For Alleged Misuse of Blood Samples to Proceed
On November 28, an Arizona appeals court panel ruled that the Havasupai Indian tribe can proceed with a lawsuit that claims university researchers misused blood samples taken from tribal members.
A split Arizona Court of Appeals panel overturned a judge's 2007 dismissal of the case, and said the Havasupai and other plaintiffs had provided enough information to go to trial or at least enough to go forward in trial court, pending further proceedings.
The northern Arizona tribe claims Arizona State University and University of Arizona researchers misused blood samples taken from more than 200 tribal members for diabetes research in the 1990s by also using it for research into schizophrenia, inbreeding, and ancient population migration.
The tribe claims the additional research was conducted without its permission and constituted an invasion of privacy. According to the tribe, some members now fear seeking medical attention as a result of the unauthorized research.
Attorneys for the university system and individual researchers have argued that tribal members supplied the blood samples voluntarily and that there is legitimate public interest in data that can advance disease research.
Paul Davenport, Court revives Ariz. tribes lawsuit over research, ASSOCIATED PRESS, Nov. 29, 2008.
IOM Stresses Need to Limit Medical Residents' Fatigue
A new report from the Institute of Medicine that recommends a sixteen-hour maximum shift for medical residents drew early mixed reviews from the medical community.
The committee believes additional steps must be taken to improve patient safety and ensure that residents get the experience they need to safely practice medicine. Further, studies have shown that fatigue increases the chances of errors.
The report, Resident Duty Hours: Enhancing Sleep, Supervision and Safety, recommended retaining the current eighty-hour-per-week work limit, but suggested a maximum shift of sixteen continuous hours, or a thirty-hour shift, provided residents get a five-hour break for sleep after working sixteen hours. The report also suggested restricting moonlighting during off-hours and increasing days off.
Some physician groups are concerned that further reductions in duty hours would increase the number of risky patient handoffs and interrupt continuity of care. The groups fear that these reductions will create a new generation of surgeons with reduced surgical experience and expertise.
Jennifer Lubell, IOM Stresses Need to Limit Medical Residents' Fatigue, Modern Healthcare's Daily Dose (Dec. 2, 2008) (note: registration is required to view this content).
Annual Ranking Finds No Improvement in U.S. Health
The health of Americans has failed to improve for the fourth consecutive year, according to an annual ranking from the United Health Foundation. First published in 1990, America's Health Rankings analyzes twenty-two different health measures, which include health determinants and health outcomes. This year's ranking included the metrics of air pollution and geographic disparity.
Twenty-seven other industrialized nations exceed the U.S. in life expectancy, while thirty-eight other countries have a lower infant mortality rate. Some speculate that there are three factors which are most responsible for America's overall health: tobacco smoking, obesity, and the number of uninsured.
Vermont maintained its number one position, with Hawaii, New Hampshire, Minnesota, and Utah following closely behind. Meanwhile, the bottom five states are Texas; Tennessee; South Carolina; Mississippi; and, dropping one spot to 50th, Louisiana, respectively.
Jessica Zigmond, Annual Ranking Finds No Improvement in U.S. Health, Modern Healthcare's Daily Dose (Dec. 4, 2008) (note: registration is required to view this content).
Federal Trial Court Enters Protective Order Covering Disclosure of Nonparty Documents
A federal trial court hearing private litigation brought by individuals allegedly injured by the merger of Evanston Northwestern Healthcare Corp. (ENH) and Highland Park Hospital ruled that an expanded protective order is needed to protect the trade secrets of nonparties (In re Northshore University HealthSystem f/k/a Evanston Northwestern Healthcare Corp. Antitrust Litigation, N.D. Ill., No. 07 CV 4446, 11/26/08).
The U.S. District Court for the Northern District of Illinois, which in May allowed the private parties' Sherman Act and Clayton Act claims against the hospital system to proceed, said an existing protective order should be expanded to cover documents Northshore University HealthSystem (NUH), f/k/a Evanston Northwestern Healthcare Corp., received from eight nonparties and produced in response to a Federal Trade Commission investigation.
The protective order will ensure that confidential documents containing trade secrets and other sensitive commercial information that ENH produced to the FTC will not be improperly disclosed outside the litigation. The protective order also will promote the disclosures sought, minimize the need for discovery litigation, and not unnecessarily thwart the public's interest in access to court proceedings, the court said.
The court said the protective order covers relevant documents ENH produced to the FTC that were generated as part of the system's commercial dealings with Vista Health Systems, St. Alexius Hospital, Blue Cross Blue Shield of Illinois, Swedish Covenant Hospital, Humana Inc., Unicare Healthcare Plans of the Midwest Inc., Private Healthcare System Inc., and Interplan Health Group Inc. f/k/a the Chandler Group of Companies.
These eight entities objected to disclosure the plaintiffs sought from NUH under the existing protective order, arguing that the existing protections were insufficient to prevent inadvertent disclosures during depositions of individuals affiliated with their competitors. The court agreed that the information was sensitive, and that the defendants were not likely to protect confidentiality of this information as zealously as necessary without a revised protective order.
The order is the most recent development in this litigation brought by individuals who purchased medical care from ENH, the three-hospital system that became NUH in September.
In its May decision, the court rejected a statute of limitations defense asserted by the merged hospital system. It ruled that the allegations of the amended class action complaint filed in the case did not support ENH's argument that the plaintiffs either knew or should have known of their merger-related injuries at the time the merger was consummated in January 2000.
The administrative complaint filed in February 2004 by the FTC, which challenged the merger on many of the same grounds as the class complaint, had the effect of tolling the statute of limitations applicable to the class claims.
The ruling came just a month after the FTC issued a final order in its administrative enforcement case that sets the terms ENH will be required to follow in negotiating contracts with managed care organizations and certain government payers.
That order, imposed after the FTC ruled in August 2007 that ENH's acquisition of Highland Park Hospital violated Section 7 of the Clayton Act, calls for Highland Park and ENH—comprised of Evanston Hospital and Glenbrook Hospital—to establish separate and independent negotiating teams for most payor contracts for all hospital services.
Federal Trial Court Enters Protective Order Covering Disclosure of Nonparty Documents, BNA'S HEALTH L. REP. (Dec. 4, 2008) (note: registration is required to view this content).
Illinois Hospital Agrees to $36 Million Settlement
Condell Medical Center located in Libertyville, IL, has agreed to pay Illinois and the federal government $36 million to head off a potential False Claims Act lawsuit over agreements with physicians that the Department of Justice (DOJ) concluded were in violation of the Stark law and anti-kickback statute.
The agreement, which does not constitute an admission of liability on Condell's part, comes on the same day the 283-bed hospital closed a previously announced $180 million deal to become the ninth hospital in Advocate Health Care, based in the Chicago suburb of Oak Brook.
Using information that Condell voluntarily disclosed to the government, the DOJ found that a number of Condell's arrangements with physicians between 2002 and 2007 created kickbacks and relationships prohibited under the self-referral law known as Stark. Specifically, the government questioned reimbursement paid to physicians without written agreements, space in Condell-owned buildings leased to physicians at below-market rates, and a variety of loans and support agreements granted to physicians and their groups without regard to community need.
Advocate was not a party to the settlement agreement, but resolution of the matters was a condition to the deal's closing.
The U.S. attorney involved in this investigation praised Condell for self-reporting the arrangements, which were identified during due diligence with Advocate.
Gregg Blesh, Illinois Hospital Agrees to $36 Million Settlement, Modern Healthcare's Daily Dose (Dec. 1, 2008) (note: registration is required to view this content).
FDA to Post Public Health Advisories, Consumer Updates, Safety Information on Dedicated WebMD Webpage
FDA and WebMD announced an agreement that will allow the agency to post public health advisories, consumer updates, and safety information on food, medications, and cosmetic products on a dedicated WebMD webpage. Under the agreement, FDA will post the information on a dedicated webpage separate from the main WebMD site that includes no advertisements. The webpage also will feature FDA user polls. In exchange, FDA will publish consumer updates in a bimonthly print magazine produced by WebMD. Neither FDA nor WebMD will receive payments under the agreement.
The information currently appears on the FDA website, but the dedicated WebMD page will allow more consumers to access the information. WebMD has nearly 50 million unique users monthly and about nine million individuals read the magazine.
This site will allow users to receive more information on anything from outbreak of a food illness to a concern over a contaminated product or the availability of a new innovative solution to a disease process. This website is a multiplex way of trying to get that information to the public. This is a step forward to form partnerships to help bring timely safety alerts and other public health information to a wider audience in the most effective and convenient way.
Kaiser Daily Health Policy Report, FDA To Post Public Health Advisories, Consumer Updates, Safety Information on Dedicated WebMD Web Page, (Dec. 4, 2008).
Pennsylvania Hospital Settles Whistleblower Lawsuit
A Pennsylvania hospital will pay the United States $1.9 million to settle a whistleblower's allegations that it defrauded the Medicare program by inflating charges to qualify for higher reimbursements. (United States ex. rel. Kite v. Besler Consulting, D.N.J., No. 05-cv-3066, settlement announced 11/24/08).
The civil settlement filed in U.S. District Court for the District of New Jersey resolves allegations against St. Vincent Health System Inc., which is based in Erie, PA, by whistleblower Anthony Kite, a private healthcare strategic planning and financial management consultant.
The complaint was filed under the qui tam provisions of the False Claims Act and alleged that the hospital inflated its charges for inpatient and outpatient care to Medicare patients from 2001 to 2003 to make its costs appear higher than they really were. By doing so, the hospital was able to obtain supplemental payments, known as outlier payments, to which it was not entitled.
The health system made no admission of wrongdoing or liability under the settlement.
Pennsylvania Hospital Settles Whistleblower Lawsuit, BNA'S HEALTH L. REP. (Dec. 4, 2008) (note: registration is required to view this content).
*We would like to thank Jennifer P. Viegas, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.