A Medical Device Daily

LMA International, through its wholly owned subsidiary, LMA Deutschland (Munich, Germany/San Diego), has filed a patent infringement suit against Tyco Healthcare Deutschland (Grevenbroich/Halberstadt), an affiliate of Tyco International (Pembroke, Bermuda), accusing the Tyco affiliate of distributing and importing laryngeal masks in Germany that infringe LMA’s European patent No. EP 0 794 808 B1.

Tyco markets its mask under the trade names Mallinckrodt and LaryngoSeal.

LMA says the patent at issue relates to a feature that appears in certain of its laryngeal mask airway devices used to ventilate the lungs of a surgical patient. If an instrument is passed through the mask, the epiglottis may interfere with the path of the inserted instrument, and the cited technology reduces interference by introducing a bar that stretches across the air supply aperture of the mask.

Tyco’s LaryngoSeal mask also is designed to lift the epiglottis away from the aperture of the mask when an instrument is introduced and therefore allegedly infringes the LMA patent.

LMA says that this feature is incorporated into three of its products: the re-usable and single-use LMA-Fastrach airways and the LMA-CTrach airway.

Paul Molloy, chief operating officer of LMA, said that the decision to sue “confirms our policy of enforcing our intellectual property rights wherever such infringement occurs.” LMA said that a judgment by the Regional Court of Dusseldorf is expected in 10 to 12 months.

LMA says that the laryngeal mask is its principle product and was cleared by the FDA in 1991.

In other legalities, the Federal Trade Commission (FTC) this week reported a consent order settling charges that an independent practice association, New Millennium Orthopaedics (NMO), representing two orthopedic groups in Cincinnati, violated antitrust laws by jointly negotiating contracts regarding the rates its physician members would charge health plans and other payers.

The consent settles the commission’s complaint against NMO; Orthopaedic Consultants of Cincinnati, dba Wellington Orthopaedics & Sports Medicine; and Beacon Orthopaedics & Sports Medicine. NMO will be disbanded and its two constituent groups will be prohibited from similar collective bargaining.

The FTC alleges that Wellington and Beacon formed NMO in 2002 to act as their negotiating agent with health plans and that, through NMO, they proposed prices to health plans for the services their physicians provided and in 2002 sent letters to the four major health plans in Cincinnati proposing a guaranteed base fee schedule and bonus scheme for NMO’s participating physicians.

The bonus scheme proposed to reward all NMO physicians with higher base rates if NMO, as a whole, met established performance targets for increasing the percentage of surgical procedures performed by some NMO physicians at ambulatory surgery centers (ASCs).

The commission also alleges that NMO performed no role in enhancing the ability of the physicians to increase the number of procedures performed at ASCs instead of at hospitals. NMO, for instance, the FTC said, implemented no enforcement mechanisms to monitor and control the physicians’ compliance with the bonus scheme.

The FTC said that one of the health plans agreed to the terms, but three others did not and that NMO continued to negotiate with them. NMO then enforced its negotiation efforts with one of the resistant health plans by refusing to deal with it except under a contract favorable to the group. Both Wellington and Beacon later jointly terminated their individual agreements with the health plan to pursue contracts through NMO.

As defined in the order, a “qualified risk-sharing joint arrangement” must satisfy two conditions: “all physician participants must share substantial financial risk through the arrangement and thereby create incentives for the physician participants jointly to control costs and improve quality; and, any reimbursement agreement or other terms or conditions . . . must be reasonably necessary to obtain significant efficiencies through the joint arrangement.”