Guidant Corporation, the nation’s second-largest producer of pacemakers and heart defibrillator implants, issued an alarming number of alerts and recalls from May to September 2005. The company may now also be the target of a Food and Drug Administration (FDA) criminal investigation, the New York Times reported.

A Guidant news release dated September 22, 2005 confirmed that the FDA had completed an inspection of its manufacturing plant in St. Paul, MN. The FDA reported “several observances of non-compliance,” with specific mention of its popular Nexus and Insignia lines of pacemakers. As a result, the FDA requested that Guidant send out letters to all doctors informing them of potential problems with these pacemakers.

However it may be a case of too little, too late. The New York Times cited unnamed sources confirming that a criminal investigation was underway, but the FDA had no official comment stating that “as a matter of policy” it does not confirm or deny investigations. Guidant stated that it was not aware of any criminal investigations, but knew that some past employees had been interviewed.

If there is an investigation, it is probably relating to Guidant’s handling of known problems, specifically in its reporting procedures. The FDA has strict regulations about how a company must report on drug test findings and, in the case of Guidant, medical equipment defects. The rash of recent Guidant recalls may be an effort to meet these guidelines by reporting its backlog of defects.

At least one of these dates back over three years. A woman in Portland, Oregon has filed a suit against Guidant because her implanted Ventak Prizm 2 Dr Model 1861 defibrillator was known to be defective before she received it. In February 2002, Guidant found out that a manufacturing defect could short-circuit the device, causing it to stop working. It changed the design in April 2002 – the month of the Portland woman’s surgery. The company did not remove existing models off the market, and it did not notify any patients, doctors, or the FDA about the problem.

Guidant included this model of defibrillator in its June recall announcements and the FDA classified the recall as a “Class I” which is the highest level of priority. The pending lawsuit maintains that the company released information about the defects when it found out the New York Times was developing a story about the device and its connection to the death of a patient.

If you or a loved one has a Guidant pacemaker or defibrillator, contact your physician to find out whether or not it has been recalled, and what your medical options are.

Then contact the experts at Jim S. Adler & Associates to find out your legal rights. We have over 30 years experience helping victims who have been injured due to someone else’s negligence. You have the right to trust in the medical devices you rely on to live a better life. And if you have been injured by a Guidant product or you must undergo another surgery to have it replaced, you have the right to seek compensation for your medical bills as well as your pain and suffering. Contact us today for a free case review.

Additionally, Jim S. Adler & Associates has offices at City Place Building, 2711 North Haskell Ave., Suite 2100 LB40, Dallas, Texas 75204-2887;  San Pedro Plaza, 7330 San Pedro Ave., Suite 700, San Antonio, Texas 78216-6237; and Bank of America, 12605 East Freeway, Suite 400, Houston, Texas 77015-5619 (serving Channelview, Texas).