A Medical Device Daily

Personal injury lawyers may not chase ambulances any more. Current preferred strategies would appear to be the Internet and press statements.

And the recent reports of problems with implantable cardioverter defibrillators (ICDs) has come with the not-surprising potential for a lengthy lineup of liability suits.

Personal injury firm Weitz & Luxenberg (New York) last week issued a statement saying that is seeking “to help” patients “injured” by malfunctioning ICDs made by Guidant (Indianapolis) and Medtronic (Minneapolis).

The firm’s statement said: “it is alleged, that despite knowing that the device contained a flaw that could cause a short-circuit,” and that Guidant failed to inform doctors or the 24,000 people implanted with its ICDs for about the problem for three years.

The defibrillator, a Ventak Prizm 2 Model 1861, has been linked to 26 short-circuiting incidences, including one death of a 21-year-old cardiac patient.

The instances of malfunction were initial reported by The New York Times (Medical Device Daily, May 25, 2005) and these problems – and reported incident totals – were subsequently confirmed in a statement from the company (MDD, May, 27, 2005).

“Doctors say that if they had been notified of the flaw earlier, they would have replaced the patient’s device, possibly saving his life,” Weitz & Luxenberg said in the released statement.

The firm also noted problems with Medtronic ICD products, citing the company’s notice to doctors this past February that “a battery used in one of its models was draining much faster than it should have, affecting about 87,000 devices.”

While acknowledging that no deaths or injuries have been reported as a result of these battery problems, the firm said that Medtronic “warned that the battery problem could get worse over time, causing concern in .2% to 1.5% of its units. Since Medtronic’s announcement, the company has said doctors worldwide have replaced 13,000 of one of its models.”

The law firm directed cardiac patients “who have under- gone replacement surgeries or who have suffered other injuries due to malfunctioning defibrillators” to go to its web site for more information.

The company said it has “built a reputation as one of the country’s foremost medical device law firms, helping thousands of patients receive significant financial compensation for their injuries.”

In other legalities: Discus Dental (Culver City, Oklahoma) reported that it is filing suit in U.S. District Court in San Francisco against BriteSmile (Walnut Creek, California) for trade libel, unfair competition and tortious interference. Discus’ attorneys said that, contrary to public statements issued by BriteSmile, the federal court has not issued any ruling that Discus’ products infringe a patent of BriteSmile and that “no such finding is likely.”

The attorneys said that the court issued a ruling May 13, including an interpretation of scientific terms strengthening its position that BriteSmile “has no basis for bringing suit against Discus.”

Discus, which has requested an accelerated schedule for the case, said it believes that BriteSmile, in an attempt to delay a ruling, “has requested to lengthen the schedule through the middle of calendar year 2006.”

Michael Treiman, general counsel for Discus, called BriteSmile’s public statements concerning the dispute “a gross mischaracterization of the facts of this case . . . If BriteSmile actually thought it had a meritorious case, I don’t believe [it] would be attempting to delay this case.”

Discus Dental distributes aesthetic and clinical products to dental professionals.