A Medical Device Daily

Law firm Schiffrin & Barroway (Radnor, Pennsylvania) reported still another in the continuing lineup of lawsuits vs. Guidant (Indianapolis) related to its recall of implantable cardioverter defibrillators (ICDs).

The case, identified by Schiffrin & Barroway as Perusich v. Guidant, seeks to inform the public that users and consumers of Guidant ICDs are at an increased risk of harm, establish a fund “so that every consumer may be tested and treated for the adverse effects of Guidant ICDs” and provide product reimbursements as well as compensation to “all victims for personal injuries and death.”

The lawsuit, filed in the Eastern District of Pennsylvania, names as defendants Guidant and Guidant Sales “due to their responsibility in manufacturing, promoting, marketing, distributing and/or selling” the ICDs. The suit names 11 devices recalled, identified by the FDA as a Class I recall.

The plaintiff, simply identified as Perusich, was implanted with the company’s Ventak Prizm, Model 1861 in May 2002, and must now undergo surgery for removal and replacement, according to the firm.

In other legalities:

A federal judge has ruled that Richard Jenkins, former CFO of McKesson (San Francisco), is not guilty of charges that he conspired in an accounting fraud that served to wipe out half of the company’s value in 1999.

The fraud was uncovered after McKesson bought HBO & Co. (Atlanta), a software manufacturer for $12 billion. After the acquisition, the company acknowledged that HBOC had greatly inflated its revenues, causing McKesson’s stock to fall about $9 billion.

Hawkins is the first of seven former executives charged in the scam to be cleared of criminal charges in the non-jury trial. He resigned from the company six years ago.

In the “oops – that’s not exactly what the study said” category, the Federal Trade Commission has filed a complaint charging Robert Chinery Jr., Tracy Chinery and their company, RTC Research & Development, with making false weight loss claims for the popular dietary supplement Xenadrine EFX.

The complaint alleges that the defendants advertised Xenadrine EFX in print and on TV, and disseminated Spanish language ads, claiming use of the product resulted in rapid, substantial weight loss without diet or exercise and is clinically proven. According to the FTC, Chinery commissioned studies of Xenadrine EFX, none of which demonstrated this. In one study, those taking Xenadrine EFX lost an average of 1.5 pounds over a 10-week period, while a placebo control group lost an average of 2.5 pounds over the same period.

The ads also relied on customer testimonials claiming loss of more than 100 pounds. According to the FTC, the endorsers lost weight by engaging in rigorous diet and exercise programs and were paid from $1,000 to $20,000 for their testimonials.

A one-month, 120-tablet supply retailed for about $40, and since 2002 Xenadrine EFX sales have topped $160 million.

A consent order requires the respondents to pay $100,000 to the FTC.

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