A Medical Device Daily

A federal judge in east Texas has rejected a request by Boston Scientific (Natick, Massachusetts) for a new trial in a patent-infringement case that ended with a judgment totaling $501 million against the company.

Boston Sci said it planned to appeal the Wednesday ruling by U.S. District Judge T. John Ward in a case involving its Taxus drug-eluting coronary stents.

The Taxus Express DES is the company's top-selling product, available in the U.S. since 2004 and also sold globally. The Libert is its next-generation DES product sold internationally.

Dr. Bruce Saffran, a radiologist from Princeton, New Jersey, sued the company, claiming that its stents infringed on his 1997 patent covering technology to deliver injury-healing medication inside the body.

Saffran also has sued the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey), maker of the Cypher DES. That case is pending in the same federal court district in Marshall, Texas, which attracts many patent claims because of its quick handling of cases and a reputation for favoring plaintiffs.

Following a week-long trial in February, a jury in that court deliberated less than two hours before awarding Saffran $432 million (Medical Device Daily, Feb. 13, 2008). Ward later raised the amount by adding $69 million for interest on royalties dating to 2004, when Boston Scientific introduced its Taxus stents in the U.S.

The jury award matched the amount of royalties that Saffran sought from sales of two Boston Sci stents — the Taxus Express and the Libert — from 2004 through September 2007, according to his attorney, Eric Albritton. The figure reflects an 8% royalty on U.S. sales, and a 6% royalty on foreign sales, he said.

In an Associated Press report, one of Saffran's lawyers, Gary Hoffman, was quoted as saying that the judge's ruling supported the view that the jury "weighed the evidence on damages and that there was no basis whatsoever" to reduce the award.

Boston Scientific spokesman Paul Donovan said the company plans to appeal the ruling. "The verdict is unsupported by both the evidence and the law, and we believe we will prevail on appeal," he said.

At the time of the verdict in February, the company issued a statement saying the verdict is "unsupported by both the evidence and the law" and said it would seek to overturn the verdict in post-trial motions before the district court. If that effort failed, as was reflected by Ward's decision this week, Boston Sci said it would appeal to the U.S. Court of Appeals for the Federal Circuit.

Boston Scientific based its motion for a new trial partly on the claim that the judge made prejudicial comments in front of the jury about the conduct of the company's lawyers. Ward wrote that the lawyers repeatedly broke his rules by such tactics as trying to elicit improper testimony from witnesses.

He said that in seeking a new trial, the company was distorting the record of what happened during the trial.

Boston Scientific argued that Saffran's patent differed in design from the company's Taxus stent. In their arguments, lawyers representing the company said Saffran's invention was "insignificant" and that more than 100 companies had declined to pay a license to use it.

While Boston Scientific and Cordis have dominated the market for drug-coated stents, both Medtronic (Minneapolis) and Abbott Laboratories (Abbott Park, Illinois) now have second-generation stents on both U.S. and international markets that are predicted to claim large market shares.

In other legalities:

• Terumo Cardiovascular Systems (Ann Arbor, Michigan) said it has filed a complaint in Germany against two affiliates of Maquet Cardiovascular — Maquet GmbH & Co. and Maquet Vertriebs und Service Deutschland.

The complaint alleges that two Maquet products, Vasoview 6 and Vasoview 7 endoscopic vessel-harvesting systems, infringe a patent for which Terumo CVS owns the rights in Germany.

The complaint also requests an injunction against further sales of the product there.

Terumo Cardiovascular sells the VirtuoSaph Endoscopic Vessel Harvesting System in the U.S. The VirtuoSaph system is distributed in Japan and Asia by Terumo Corp. and in Europe by Terumo's European subsidiary.

"Terumo respects the valid intellectual property of others and expects that its competitors will do the same," said Mark Sutter, president/CEO of Terumo Cardiovascular Systems.

The VirtuoSaph system is used during coronary artery bypass grafting. During the procedure, the surgeon removes a healthy artery or vein from elsewhere in the body, most often the saphenous vein in the leg, and uses it to route blood around a blockage in a coronary artery.

Two law firms — Mark & Associates and McGinnis, Lochridge, Kilgore — have filed a civil suit against Botox maker Allergan (Irvine, California), alleging negligence in the design, manufacturing and marketing of the popular anti-wrinkle drug that they say has caused patient deaths and injuries.

The suit, filed in the Superior Court of California, Orange County, on behalf of 15 plaintiffs from across the nation, seeks unspecified compensatory and punitive damages.

In addition to alleging design and manufacturing flaws, the suit claims that Allergan continues to promote "off-label" uses of Botox for treating patients with cerebral palsy and other uses that have not been approved by the FDA.

The law firms allege that the company also fails to "properly warn Botox users of the possibility of fatal and life-threatening injuries from Botox injections and fails to inform physicians and healthcare providers about all known risks of the drug, including death."