A Medical Device Daily

Third Wave Technologies (Madison, Wisconsin) reported that it has responded to the U.S. District Court for the Western District of Wisconsin’s recent ruling granting a motion by Qiagen (Venlo, the Netherlands) for dismissal of the antitrust claims brought against Digene (Gaithersburg, Maryland) by Third Wave.

“We respectfully disagree with the court’s ruling Friday on our antitrust claims and are considering our options,” said Kevin Conroy, president/CEO of Digene. “We have completed our HPV clinical trial enrollment and CE marking certification of our 1-type high-risk HPV screening and have appointed our first European HPV-product distributors. We look forward to finishing the clinical trial and to submitting two HPV products — the 14-type high-risk screening test and a genotyping test for types 16 and 118 — to the FDA in the first quarter of 2008. The market continues to seek a higher-quality, more-innovative HPV testing solution, and Third Wave is focused on meeting that unmet need.”

In January 2007, Digene, since acquired by Qiagen (Medical Devie Daily, June 5, 2007) ,filed suit against Third Wave, alleging infringement of a Digene patent related to the human papillomavirus (PV.) Third Wave responded by denying infringement and alleging anti-competitive business practices and annti-trust violations by Digene.

Digene in October 2007 said it could not prevail in its patent infringement suit against Third Wave without a successful appeal of the court’s July 2007 Markman order favorable to Third Wave. Digene made its statement after it unsuccessfully asked the court to reconsider its Markman order in September 2007.

Conroy said, “Third Wave won the most important battle in our dispute with Digene last October when Digene said it couldn’t win its patent suit unless it successfully appealed the court’s Markman order that constructed the patent claims at issue in Third Wave’s favor.” And he said that this maintains Third Wave’s ability “to operate in the valuable HPV testing market.”

In other legal news, the Keenan Law Firm (Atlanta) reported that it has followed through with its promise of filing suit against tissue processor CryoLife (Kennesaw, Georgia), charging that tissue processed by the company was contaminated and “severely maimed” its client, Michael Hohenbery (Medical Device Daily, Jan. 14, 2007). That suit seeks $110 million in damages.

CryoLife issued a statement denying liability in the case, and on Monday Hohenbery issued a statement responding to CryoLife’s release.

CryoLife’s statement of Jan. 11 said: “Shortly after the infection was discovered, Cryolife notified the FDA of the incident as it was required to do.”

Hohenbery replied with the following: “The clostridium infection sustained by Michael Hohenbery from the Cryolife cadaver tissue was acknowledged by Cryolife in writing on Feb. 8, 2007. Cryolife made no effort to notify other physicians or hospitals who had received tissue from this cadaver for at least a month, and the FDA reflects posting five months later in the Weekly Enforcement Report a Class I recall of certain cadaver tissue by Cryolife.”

CryoLife’s Jan. 11 statement said: “Regrettably, the lawyers representing this individual have chosen to make untrue public statements against our company and our tissue processing services in an effort to force us into a monetary settlement of the case.”

Hohenbery’s statement responded by saying: “Cryolife was invited to and agreed to attend two different mediations to attempt to resolve the claims. Cryolife unilaterally cancelled each of those mediation dates at the last minute.”