A Corpus Christi, Texas, man has filed a lawsuit against Guidant (Indianapolis), claiming that the company “concealed” what it has itself acknowledged to be a life-threatening flaw in the implanted cardioverter defibrillator (ICD) he was implanted with.

Louis Motal – who was implanted with his ICD at Corpus Christi’s Bay Area Medical Center in 2001 – charges that he was shocked more than five times when the device malfunctioned and that he should have received a newer, im-proved version of the ICD made by the company.

In a suit filed July 5 in the 94th State District Court in Nueces County, Motal claims that Guidant knew the Ventak Prizm 2 Model 1861 ICD sold to him was a seriously flawed older version.

Besides making a variety of damage claims against Guidant – including those for pain and suffering – Motal is asking the company “to provide and pay for” medical tests to monitor whether his defibrillator is still working and, if not, to cover the cost of having it removed.

“Next time I need this thing to work, it might not,” Motal said. “That’s not a feeling with which I want to live. It’s hard to accept that I might need surgery to fix something that Guidant could have prevented if only they were honest to begin with.”

The FDA on July 1 said potential electrical flaws in these devices create “a reasonable likelihood of serious injury or death,” and it designated three of Guidant’s units, including the Prizm 2 model, as Class I actions, the highest risk level (Medical Device Daily, July 6, 2005).

Bob Hilliard, Motal’s attorney and a partner in Hilliard & Munoz (Corpus Christi), said that “[i]nstead of looking out for Louis’ safety, Guidant put a time bomb inside of him.” And he estimated up to 37,000 people implanted with Guidant ICDs in the same situation as Motal. “They think they have been given a life-saving device, but they could be dead wrong.”

In a securities class action related to the Guidant recall, the law firm of Scott + Scott (Colchester, Connecticut) reported that the former class period for the shareholder suit it filed against the company – from Dec. 15, 2004, to June 17, 2005 (MDD, June 28, 2005) – has been expanded to include securities purchases between Dec. 15, 2004, and June 23, 2005.

The suit charges that with the June 24 announcement of its recall of “suspect devices,” the company’s shares fell $4.70 to close at $63.90 on “unusually heavy volume.”

And the complaint alleges that insiders at Guidant committed this “fraudulent scheme” in order to sell Guidant stock at artificially inflated prices, and that Guidant insiders sold nearly 900,000 shares for gross proceeds of more than $65. 7 million.

In other legalities:

• Refocus Group (Dallas), which is focused on developing treatments for the eye, said that the U.S. District Court for the Central District of California has dismissed a lawsuit filed by dental laser firm Biolase Technology (San Clemente, California) in February.

Biolase sought a declaratory judgment that Refocus’ U.S. patent No. 5,489,299 titled, “Treatment of Presbyopia and Other Eye Disorders,” is invalid, unenforceable and not infringed by Biolase. The patent covers Refocus’ principal products and scleral spacing/expansion technology and medical procedures.

In the order dismissing the case without prejudice, the court found that Biolase failed to show that it had “reasonable apprehension of suit” at the time the case was filed, Refocus said.

Refocus said it would vigorously defend any appeal of the decision.

Biolase in February reported a licensing agreement with Surgilight (Orlando, Florida) regarding certain presbyopia laser patents. Concurrently, Biolase had been seeking a similar license from Refocus regarding patent rights, including rights related to the use of lasers for treating presbyopia.

Refocus’ flagship product is its scleral implant and related automated scleral incision handpiece and system.

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