A Medical Device Daily

CoreValve (Irvine, California) said that the lawsuit filed against it last week by Edwards Lifesciences (Irvine) is “without merit.” Edwards filed the suit last week in the U.S. District Court in Delaware charging infringement of three of its Andersen family of patents for transcatheter heart valve technology by CoreValve’s ReValving System (Medical Device Daily, Feb. 14, 2008)

CoreValve said it will “vigorously defend” against the suit and continue to develop its ReValving System for percutaneous aortic valve replacement in high-risk patients with advanced aortic valve disease.

Last May Edwards initiated litigation against CoreValve in the District Court of Dusseldorf, Germany, for infringement of a related Andersen patent, EP 0 592 410 B1; similar litigation is pending in the UK. These suits address the sale of CoreValve’s alleged infringing valves, according to Edwards. It says that the suit just filed targets CoreValve’s manufacturing of valves in the U.S. for export and sale in Europe.

U.S. patents, No. 5,411,552, No. 6,168,614 and No. 6,582,462 — part of the Andersen patent portfolio — relate to a valve prosthesis for implantation by means of a catheter.

In other legalities:

• Federal Judge Thomas Whelan has denied a temporary restraining order (TRO) filed by Hooper, Lundy & Bookman on behalf of plaintiffs Sharp HealthCare (San Diego), Scripps Health (San Diego) and Internist Laboratory of Oceanside (Oceanside, California), in their complaint against the U.S. Health and Human Services Agency, alleging the government’s attempt to impose a “flawed” bidding process for clinical laboratory services.

The complaint seeks to halt a competitive bidding process imposed on clinical labs serving Medicare beneficiaries in the San Diego, Carlsbad, and San Marcos communities.

The court denied the TRO based on the government’s argument that any challenge to the Lab Project was premature because no winners or losers have been decided, so no one has been harmed. It further argued that the federal court is precluded from reviewing the legality of the project, due to jurisdictional and other legal impediments unique to the Medicare program.

“The court has given the plaintiff laboratories additional time to address these arguments in light of the fact that they were not previously given that opportunity due to the lateness of the government’s briefing,” said plaintiff’s attorney Patric Hooper. “I am not particularly surprised by the court’s decision, given the representations made by the government at the 11th hour.”

Hooper said that once the plaintiffs’ briefs will give the court a clear understanding of why immediate injunctive relief is necessary and why the court is empowered to grant such relief. He said he recently overcame similar arguments advanced by the government in another court case involving Medicare payment for lab services.

The court set a deadline of Feb. 29 for the plaintiff laboratories to address the jurisdictional issues raised. However, Hooper said he will be asking the court to issue a preliminary injunction prior to the April 11 date for the Medicare agency to decide who the winning bidders are.

The plaintiffs originally filed suit in federal court against the federal government on Jan. 29 to halt a Medicare Demonstration Project slated for the San Diego-Carlsbad-San Marcos region (MDD, Jan. 31, 2008). The demonstration project will irreparably harm vital laboratory testing services for thousands of Medicare beneficiaries if allowed to move forward, according to the complaint.

• Hill-Rom (Batesville, Indiana), the med-tech business of Hillenbrand Industries (Bartesville), reported receiving a subpoena from the U.S. Attorney’s Office in Tennessee, according to a filing with the Securities and Exchange Commission.

The Health and Human Services’ Office of Inspector General has asked Hill-Rom to supply documents covering 1999 to the present concerning “claims for payment for certain durable medical equipment, including specialized support beds,” the filing said.

Hill-Rom said it is cooperating with the investigation and that no claims have been filed against it at this time.