A Medical Device Daily

Biopure (Cambridge., Massachusetts) reported that it had filed an action for injunctive relief and damages against Charles Natanson, MD, who co-authored an article and several letters about Hemopure, hemoglobin glutamer-250 (bovine), Biopure's oxygen therapeutic product for human use.

The action was filed on Oct. 10 in U.S. District Court for the District of Columbia. Natanson is senior investigator and head of the anesthesia section of the Critical Care Medicine Department, Clinical Center, of the National Institutes of Health.

The complaint alleges that in publishing the article, "Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death," published by the Journal of the American Medical Association online on April 28, 2008, and writing a number of letters to regulatory authorities in jurisdictions where Biopure is active, Natanson engaged in activity that injured Biopure.

Biopure sent a letter to the Journal of the American Medical Association (JAMA) asking for a retraction and apology this past summer (Medical Device Daily, June 11, 2008).

The company seeks injunctive relief and damages for defamation, trade libel/injurious falsehood and intentional interference with prospective business advantage. Natanson has not yet filed an answer or any other response.

Biopure develops pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues.

In other legalities:

• A U.S. District Court judge in Oregon reported that it will grant Smith & Nephew Endoscopy's (S&N Andover Massachusetts) request for an injunction that will prohibit privately held Arthrex (Naples, Florida), from manufacturing or selling medical devices that infringe a patent exclusively licensed to Smith & Nephew by John Hayhurst, MD, of Portland, Oregon.

A jury determined in June that Arthrex willfully infringed this patent by marketing and selling Bio-SutureTak, Peek SutureTak, Bio-PushLock and Peek PushLock suture anchors used in various minimally invasive soft tissue repair surgeries, and awarded Smith & Nephew Endoscopy $14.7 million for past infringement through 2005.

The court ruled in S&N's favor, and effective 60 days after the court enters final judgment — expected sometime around the end of the year — Arthrex must stop manufacturing and selling the infringing Bio-SutureTak and Peek SutureTak anchors.

The injunction will not affect sales of current Arthrex PushLock anchors. During the case Arthrex stopped selling the infringing first-generation PushLock anchors and replaced them with modified PushLock Anchors.

Smith & Nephew and Hayhurst have filed a second lawsuit against Arthrex seeking an injunction against the newer versions of PushLock anchors as well as Arthrex's Bio-Composite SutureTak anchors.

In addition to granting Smith & Nephew's injunction, the judge:

– Granted pre-judgment interest in the amount of $1.5 million.

– Ruled that the court will award additional damages for Arthrex's infringement after 2005.

– Also ruled that the Oregon federal district court will not stay the injunction pending Arthrex's appeal.

• The law firm of Hagens Berman Sobol Shapiro filed a class-action lawsuit on behalf of people who purchased Spectranetics (Colorado Springs, Colorado) stock claiming the company, its CEO and CFO violated U.S. securities laws through illegal marketing practices and false statements about the company's financial health.

Last week, Spectranetics reported the appointment of Chairman Emile Geisenheimer to president/CEO (MDD, Oct. 24, 2008), ousting John Schulte, a named defendant in the class-action suit. Geisenheimer issued a statement that he has an "understanding of the challenges before us, and the board of directors and I are confident that we are taking an important step toward putting these challenges behind us so that we can build a stronger future for our company."

The class-action suit was filed after a former employee filed suit against the company, claiming Spectranetics fired him after he informed senior management of potentially illegal marketing practices with some of the company's products.

According to court documents, shortly thereafter, the Denver office of the Securities and Exchange Commission (SEC) began its own investigation into the company sparking further speculation about the company and its practices.

The lawsuit seeks to represent anyone who purchased or acquired company stock between April 19, 2007, and Sept. 4, 2008.

The lawsuit alleges company executives issued false and misleading statements concerning operations and finances, which caused company stock to trade at an artificially inflated price. Defendants knowingly shared misinformation and failed to communicate accurate reports, the complaint states.

The shock came to investors on Sept. 4, 2008 when reports surfaced that federal officials raided the company (MDD, Sept. 8, 2004). Almost immediately, Nasdaq halted trading of Spectranetics stock.

According to court documents, Spectranetics issued a press release revealing more information about the search warrants, disclosing the company was jointly served by the FDA and U.S. Immigration and Customs Enforcement regarding the promotion, use, testing, marketing and sales of certain Spectranetics products. The warrants also addressed payments made to medical personnel.

The complaint alleges the defendants, which include Spectranetics, John Schulte, president/CEO, and Guy Childs, vice president and CFO, violated several sections of the 1934 Securities Exchange Act.