Guidant Settles Lawsuits
DEVICE LINKED TO DOZENS OF DEATHSOct 18, 2003 | Mercury News The owner of a Menlo Park company that made a medical device linked to dozens of deaths has reached an out-of-court settlement of nine lawsuits that claimed malfunctions of the product.
The lawsuits had been filed over the past two years against EndoVascular Technologies, a Menlo Park subsidiary owned by medical-device giant Guidant and were dismissed late last month.
Terms of the settlement weren't disclosed. The cases had been filed with U.S. District Judge Jeremy Fogel in San Jose.
``I am not at liberty to talk about the cases at all or what occurred. We did resolve them, in a mutually satisfactory manner,'' said Rachel Abrams, an attorney at Hersh & Hersh, the San Francisco law firm that brought the lawsuits on behalf of nine families, including relatives of two dead patients.
A telephone call to the media spokesman for Guidant, the Indianapolis medical company that owns EndoVascular, was not immediately returned Friday afternoon.
None of the patients who filed the nine suits alleging they were injured by the device lived in the Bay Area. But people who sued the company included Helen Gaines of Missouri, who has suffered chronic pain and the loss of all sensation in her right foot since her procedure to implant the device, called the Ancure endograft, in 1998.
The Ancure device was made by Guidant's subsidiary, EndoVascular Technologies. That division pleaded guilty in June to 10 felonies involving the Ancure device, including making false statements to government regulators. The subsidiary agreed to pay a $92.4 million fine to the government in the largest settlement of its kind to date for failing to report medical device malfunctions to the FDA, as required by law.
The device was made to patch weak spots in a major blood vessel, called the aorta, that runs from the heart through the abdomen. Without reinforcement, weak spots in the aorta can swell like a balloon and burst, potentially causing death from internal bleeding.
In its settlement with the Justice Department, EndoVascular admitted to concealing more than 2,600 incidents where the device malfunctioned or caused serious injury or death from 1999 to 2001.
A Mercury News examination earlier this year found that the numerous Ancure malfunctions that went unreported to the FDA were widely known within the subsidiary. Overall, at least 75 patients died and 991 were injured after receiving the implant, the examination found. The lawsuits charged that, in some cases, the implant was at fault.
At the time Guidant announced it would no longer sell the Ancure device, the company said it would continue to offer long-term assistance to patients with the implants and their physicians. Guidant officials have insisted that the device itself is safe, saying any malfunctions were caused by equipment used to insert the Ancure and those problems were corrected in 2001.
Abrams said another lawsuit asking to be certified for class-action status also is pending before Fogel that asks the company to pay for the cost of mandatory lifelong monitoring for patients implanted with the Ancure device.