A Medical Device Daily

A federal court judge in Portland, Oregon, has issued a permanent injunction against Stryker (Kalamazoo, Michigan), prohibiting the company from further sales of its T2 Proximal Humeral Nail used in the treatment of shoulder fractures.

In September of 2005, a jury found that Stryker’s product infringed a patent covering a device to treat shoulder fractures held by much smaller orthopedic developer Acumed (Hillsboro, Oregon) (Medical Device Daily, Sept. 23, 2005).

Stryker appealed that ruling, and in June 2007, the U.S. Court of Appeals for the Ninth Circuit affirmed the jury’s verdict of willful infringement, and remanded the case for a determination by Judge Anna Brown of the U.S. District Court for the District of Oregon as to whether a permanent injunction should be issued.

According to evidence presented at trial, Acumed ssaid that its invention, the Polarus Humeral Rod was a commercial success and helped build the company.

Stryker had no product in the proximal humeral nail market, and Acumed reportedly rejected acquisition enquiries by Stryker, beginning in 2002. Thereafter, according to Acumed’s attorneys, Stryker copied the invention and attempted to drive Acumed out of the market that it essentially had created.

Alan Kozlowski, president of Acumed, said of the case, “It can be intimidating when the largest player in the marketplace targets you. We can handle legitimate competition, but they took our invention.”

Acumed was represented by attorneys from the firm of Niro, Scavone, Haller & Niro.

Stryker was represented by attorneys from the firm of McAndrews, Held & Malloy.

In other legalities: A California law firm has reported that 20 more liability suits were filed this week against contact lens solution maker Advanced Medical Optics (AMO; Santa Ana, California) in California state courts in Los Angeles and Orange Counties.

The lawsuits seek damages for injuries that the plaintiffs say were caused by AMO’s Complete brand of contact lens disinfectant solutions.

Complete MoisturePlus multi-purpose solution was voluntarily recalled by AMO on May 25 of this year at the request of the FDA after the Centers for Disease Control (Atlanta) linked the solution to an outbreak of serious corneal infections known as Acanthamoeba keratitis (AK) (MDD, May 30, 2007).

The plaintiffs contend that AMO knew that its solution was ineffective against the organism that causes the infection, that the company then changed the formula in a way that increased the likelihood of contracting the disease, and that AMO failed to issue warnings concerning the risk.

The firm said that new lawsuits add to at least 48 other lawsuits involving more than 80 individual plaintiffs against AMO in connection with the recall, including several class actions.

“We anticipate that there will be many more cases filed as lawyers continue to evaluate the medical records of potential claimants,” said Mark Robinson of Robinson Calcagnie & Robinson (Newport Beach, California), one of three firms representing the new plaintiffs.

AK is associated with a high rate of permanent vision loss and the need for corneal transplant surgery. “These are just horrific injuries,” Robinson said, adding that a number of the cases involve children, including four of the newly filed lawsuits.

The newest filings follow a ruling by a California judge granting a plaintiff’s request to have all current and future California lawsuits involving AMO’s solutions coordinated in a single court.

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