A Medical Device Daily

Medtronic (Minneapolis) reported that the U.S. Judicial Panel on MultiDistrict Litigation has issued a transfer order centralizing 49 separate federal lawsuits relating to the recovery, processing and distribution of allograft tissue used in back surgeries.

The cases will be coordinated for pretrial proceedings, Medtronic said, in the District of New Jersey, before U.S. District Judge William Martini.

The cases, which include putative class actions by recipients of allograft tissue, involve Spinal Graft Technologies, a Medtronic unit that distributes allograft tissue used in certain back surgery procedures.

The cases also include defendants Regeneration Technologies and Tutogen Medical (both Alachua, Florida).

In a separate but related case, an Iowa resident has filed a liability suit as a result of being treated with unscreened cadaver tissue at Mercy Medical Center – North Iowa (Mason City). He filed the lawsuit against Medtronic; tissue harvester Biomedical Tissue Services (Fort Lee,New Jersey) and its founders; and two New York funeral homes. The lawsuit was entered in U.S. District Court in Cedar Rapids.

Keith Bruns, a construction worker, underwent spinal surgery for a work-related injury in mid-2005 at the hospital, the procedure employing human tissue harvested from corpses, the material distributed by Medtronic Sofamor Danek (Memphis; Tennessee).

Bruns subsequently received a letter informing him that tissue products marketed by the company were being recalled due to a lack of proper screening and that they may have been obtained without proper consent. He is asking for more than $75,000 for compensatory and punitive damages.

Bruns' attorney said he underwent a battery of tests which came back negative for any diseases he may have acquired from the tissue but that he will have to submit to future tests because some ailments aren't always detectable immediately.

Biomedical Tissue Services has been named in four other lawsuits in northern Iowa, since April, in connection with possibly tainted tissue grafts.

In other legalities: Gen-Probe (San Diego) reported that it and Bayer HealthCare, a member of the Bayer Group (Leverkusen, Germany) have agreed to end a series of disputes involving multiple patent litigations and contract arbitrations between them.

As part of the agreement, Bayer will pay Gen-Probe certain lump sum royalties over the next 18 months, the amounts not disclosed.

Gen-Probe said it will withdraw its patent litigation against Bayer and will grant Bayer immunity from suit with respect to all existing and future Gen-Probe patents for all of Bayer's current nucleic acid diagnostic products. Additionally, future Bayer products will be immune from suit under four specified Gen-Probe patent families. Bayer also will grant Gen-Probe immunity from suit under certain Bayer patents with respect to Gen-Probe's current TIGRIS instrument and future instruments.

Finally, Gen-Probe and Bayer have agreed to a final decision in the companies' separate arbitration related to their collaboration for viral products. This final decision incorporates the interim awards previously awarded by the arbitrator. Bayer, however, will not be required to reimburse Gen-Probe $2 million for legal expenses, as originally ordered by the arbitrator.

Henry Nordhoff, Gen-Probe's president/CEO and chairman, said, “We are pleased to have concluded our legal disputes with Bayer, and to gain additional revenue that will enable us to invest in commercially attractive, previously unfunded development projects that will drive future growth.”

Gen-Probe manufactures rapid nucleic acid tests used primarily to diagnose human diseases and screen donated human blood.