A Medical Device Daily

A U.S. federal judge dismissed a key part of a lawsuit brought by Johnson & Johnson (J&J; New Brunswick, New Jersey) against the American Red Cross (ARC; Washington) seeking to restrict the Red Cross’s use of its emblem on first aid, health, safety and emergency preparedness products. The judge’s ruling dismissed entirely J&J’s claim that the Red Cross promised not to engage in the sale of first aid, health, safety and emergency preparedness products.

“I appreciate the court’s decision and hope that Johnson & Johnson will reassess their actions and drop the case altogether,” said Mark Everson, president/CEO of the ARC.

Following a hearing on October 29, at the U.S. District Court for the Southern District of New York, Judge Jed Rakoff ruled that the “promissory estoppel” claim, a very significant portion of the pharmaceutical company’s lawsuit against the ARC, was “dismissed with prejudice.” The judge’s ruling also means that J&J cannot refile arguments on this claim.

The judge’s order comes nearly three months after J&J filed suit against the Red Cross for the use of its emblem on productsARC sells to the public. (Medical Device Daily, Aug. 7, 2007).

The court set a schedule to hear the remaining claims early next year.

In other legalities:

• MedCath (Charlotte, North Carolina) reported that Arizona Heart Hospital (AHH, Phoenix) and two groups of doctors associated with that facility have settled with the U.S. Department of Justice (DOJ) and the U.S. Attorneys’ Office in Phoenix under the federal Civil False Claims Act in a case that involved implanting devices without an approved investigational device exception (IDE).

The hospital will pay about $5.8 million to settle and obtain a release from any civil or administrative monetary claims related to the DOJ’s investigation. Two other entities, Arizona Heart Institute and AHI Cardiovascular Surgeons, paid an additional $900,000 as part of the settlement.

The settlement stems from Medicare claims submitted between June 1998 and October 2002 for physician services involving the implantation of certain endoluminal graft devices to treat aneurysms. The devices had not received final marketing approval from the FDA and were either implanted without an approved IDE or were implanted outside of the approved IDE protocol.

The DOJ’s allegations related solely to whether the procedures were properly reimbursable by Medicare. Quality of patient care was not an issue.

AHH denies any wrongdoing or illegal conduct, and the settlement agreement does not contain an admission of liability. The hospital also has entered into a five-year corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services under which the hospital will continue to maintain its existing corporate compliance program and which relates to clinical trials conducted at the hospital.

• Ra Medical Systems (Carlsbad, California) reported it won a lawsuit filed by PhotoMedex (Montgomeryville, Pennsylvania) in the U.S. District Court, Southern District of California, in a case that involved alleging false advertising and unfair business practices.

PhotoMedex sued Ra Medical and its founder, Dean Irwin, in January 2004 claiming that Ra Medical Systems misrepresented its FDA status, and misrepresented specifications of its laser system. Ra Medical won all of its claims. The court also found that Ra Medical’s founder did not misrepresent himself when stating he invented PhotoMedex’s laser system.

In a related matter, PhotoMedex sued Ra Medical for trade secret theft, false advertising, not being properly licensed, and unfair competition. Ra Medical prevailed on those claims as well but the court allowed Ra’s claim that PhotoMedex sold lasers without a valid medical license to stand.

“This effectively ends PhotoMedex’s efforts to tie us up with frivolous legal claims. We welcome competition as it benefits the consumer,” said Irwin, Ra’s president.

Ra sued PhotoMedex for malicious prosecution in state court in November 2004 based on an action brought by PhotoMedex in 2003. Ra resolved the case earlier this year after winning the anti-SLAPP motion and PhotoMedex’s appeal. The terms of the settlement were not disclosed.

• Parker Waichman Alonso, (New York) along with Smith & Nevares and Becnel Law Firm (Reserve, Louisiana) said they have filed a lawsuit on behalf of a man who had surgery to have a recalled Medtronic (Minneapolis) Sprint Fidelis Lead replaced after it malfunctioned.

The suit was filed on behalf of the victim in the U.S. District Court for the District of Puerto Rico.

According to the lawsuit, the victim, a resident of North Carolina, received a cardiac pacemaker/defibrillator combination (ICD). The ICD was attached to his heart with a Sprint Fidelis Lead wire system implanted on Jan. 26, 2006. The Medtronic Sprint Fidelis Lead was replaced on April 13, 2007. The victim claims he has suffered and will continue to suffer severe physical injuries, severe emotional distress, and economic losses as a result of the defective product.

Medtronic suspended sales and recalled all unused Sprint Fidelis Leads on Oct. 15, 2007 after receiving reports of at least five fatalities linked to lead fractures (Medical Device Daily, Oct. 16, 2007).

The Sprint Fidelis Lead was first introduced by Medtronic in 2004, and has been used with most of the company’s implantable defibrillators since then. This component is used in cardiac defibrillators and not in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those are among the devices that use the Sprint Fidelis Lead.