A Medical Device Daily

C. R. Bard (Murray Hill, New Jersey) reported that a U.S. District Court jury in Arizona found that certain of W. L. Gore & Associates’ (Flagstaff, Arizona) ePTFE vascular grafts and stent-grafts infringe Bard patent number 6,436,135. The jury upheld the validity of the patent and awarded $185 million in past damages. The jury also found that Gore willfully infringed the patent.

In a second phase of the trial, the court is currently assessing Gore’s assertion that the patent is unenforceable due to inequitable conduct.

Bard said it expects that Gore will file post-trial motions with the court with respect to the jury’s decision.

After a judgment is entered, the case may be appealed to the Court of Appeals for the Federal Circuit.

C. R. Bard is a developer of medical technologies in the fields of vascular, urology, oncology and surgical specialty products

Wright Medical Group (Arlington, Tennessee) and Exactech (Gainesville, Florida) became the latest orthopedic companies to have their consultation arrangements with doctors called into question. Both reported this week that they received subpoenas from the U.S. Department of Justice through the U.S. Attorney for the District of New Jersey.

The subpoenas are seeking documents for the period January 1998 through the present related to any consulting and professional service agreements with orthopedic surgeons in connection with hip or knee joint replacement procedures or products.

Recently five orthopedic device implant makers made settlements with the U.S. government to resolve fraud allegations, with four of those companies agreeing to pay about $311 million and consenting to federal monitoring and other reforms (Medical Device Daily, Sept. 28, 2007). The agreements were made to settle a government probe into improper consulting contracts with surgeons, federal prosecutors said.

The settlements were reached with Biomet (Warsaw, Indiana); DePuy Orthopaedics (Raynham Massachusetts), a unit of Johnson & Johnson (J&J; New Brunswick, New Jersey); Smith & Nephew (S&N; London); and ZimmerHoldings (Warsaw, Indiana).

A fifth company, Stryker (Kalamazoo, Michigan), paid no civil settlement, but it was part of the pact and has agreed to the reforms, including 18 months of federal monitoring, according to the statement.

Both Wright and Exactech said they intend to fully cooperate with the Department of Justice request.

Stryker launches anesthesia e-site

Stryker (Kalamazoo, Michigan), in collaboration with OR-Live, a source of live and on-demand surgical video, has launched a web portal concerning anesthesia awareness, that occurs when a patient under general anesthesia stays or becomes conscious during surgery but can’t move or talk.

“We’re entering the market at an important moment in time, when the energy to do all that can be done to reduce anesthesia awareness is at an all-time high,” said Curt Hartman, president of Stryker Instruments, sponsor of the forum. “We are pleased to offer this portal, a resource for professionals, patients and consumers. As the maker of SNAP II, a new option in level of consciousness monitoring, we are committed to doing our share as industry leaders in advancing this critical patient safety goal.”

The portal is at www.OR-Live.com/AnesthesiaAwareness.