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Current News and Issues

FTC Charges IPAs with Price Fixing

The Federal Trade Commission asserted that two Independent Practice Associations engaged in a price-fixing scheme when they and individual physician members refused to deal with health care plans except on capitated pricing terms agreed to by the IPA even though individual members otherwise competed against one another for physician services provided on a fee-for-service basis. The price-fixing and refusals to deal violated Section 5 of the FTC Act according to the FTC's Complaint and Proposed Consent Order.
(www.ftc.gov/opa/2006/08/newcentury.htm)

"Failure-to-Warn" Claims Against Pfizer Pre-empted by FDC Act; Deceptive Advertising Claims Go Forward

A federal court for the Northern District of California decided that state law failure-to-warn claims were pre-empted because they conflict with FDA's drug labeling regulations. The court gave deference to the agency's pre-emption position included in a final rule on drug labeling earlier this year. However, the court found that FDA had not taken a similar position on drug advertising, leaving intact state claims alleging false or deceptive advertising.
(In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, Northern District of California, 71 Fed.Reg. 3935, 2006)).

FDA Issues Draft Guidance on Regulation of IVD Multivariate Index Assays

The Food and Drug Administration published a draft guidance outlining the Agency's proposed oversight of In Vitro Diagnostic Multivariate Index Assays (IVDMIA). These products use a combination of in vitro assays and demographic data to produce patient specific variables which are then integrated into complex, software driven algorithms that yield patient specific assessment or predictive conclusions such as the likelihood of recurrence of a cancer or the need for chemotherapy. FDA proposes to treat IVDMIAs as Class II or Class III medical devices, based on an assessment of risk, thus requiring either a 510(k) premarket notification or a PMA.
(www.fda.gov/cdrh/oivd/guidance/1610.html)

AHIP Argues That Lack of Interoperability in Health Information Technology Presents Antitrust Risks

AHIP (America's Health Insurance Plans) commissioned a legal opinion on the anti-competitive effects of proposed federal legislation that would remove the interoperability requirement from the recently enacted exceptions to the Anti-Kickback Statute and the Stark physician self-referral law for electronic health records and e-prescribing technology. The legal memorandum asserts that dominant market participants may be able to exclude competition in violation of federal anti-trust laws by providing proprietary (non-interoperative) systems to health care providers who admit patients to the dominant hospital. House and Senate conferees have been at odds over the interoperability issue and no resolution is expected before a lame duck session of Congress after the November elections.

Voluntary Dismissal of Malpractice Complaint Before Department of Insurance Constitutes Dismissal with Prejudice

A patient, who gave notice to the Indiana Department of Insurance voluntarily withdrawing her complaint of malpractice, even though she asked that her file remain open, was foreclosed from later pursuing her case. The patient's "open and voluntary renunciation" was deemed to be a retraxit by the Court, which operated as a dismissal with prejudice.
(Hodge v. Johnson, 852 N.E. 2d 650 (Ind.Ct.App. 2006))