Boston Scientific Corp. and its subsidiaries — Guidant LLC, Guidant Sales LLC and Cardiac Pacemakers Inc. — have agreed to pay $30 million to settle allegations that it sold defective heart devices. The lawsuit accuses Guidant, which was purchased by Boston Scientific in 2006, of knowingly selling defective implantable defibrillators between 2002 and 2006 to health care facilities that in turn implanted the devices into Medicare patients. The devices were used in patients at risk of cardiac arrest due to an irregular heartbeat.
According to the lawsuit, two of Guidant’s implantable defibrillators – the Prizm 2 and the Renewal 1 and 2 – contained a defect that resulted in “arcing.” Arcing is caused when the device detects the irregular heartbeat and delivers a shock that “arcs” back to the device, instead of traveling to the heart, and short circuits the device as a result.
Although Guidant learned of the defects as early as April 2002 and took corrective action to fix the defects, the lawsuit claimed that it continued to sell its remaining stock of the defective versions of the devices and took steps to hide the reasons for the defect from patients, doctors, and the FDA.
Guidant previously pled guilty in February 2010 to criminal charges of misleading the FDA and failing to submit a label change to the FDA for the defective devices.
Since defective medical devices – including pacemakers, hip implants, and transvaginal mesh – can cause serious injuries and even death, it is important that patients and consumers are able to rely on product manufacturers to make safe products and inform the public when they become aware of device defect. As Stuart F. Delery, assistant attorney general for the Justice Department’s Civil Division, said in a statement, “Medicare patients who depend on cardiac defibrillators should not have to worry about whether their devices will work when they are needed.”
Like all manufacturers, medical device manufacturers have an obligation to provide consumers with safe and effective products. If a medical device is found to be dangerous or defective, the manufacturer may be liable for any resulting injuries. Moreover, medical device manufacturers are subject to a number of laws and regulations designed to ensure product safety.
At Ankin Law Office, LLC, our Chicago medical device lawyers are committed to helping the victims of defective medical devices and unsafe pharmaceuticals obtain full and fair financial recovery. After listening to the circumstances of your situation, we will conduct a thorough analysis of any possible legal claims, including product liability and medical malpractice claims. We will explain your legal rights to you so that you can make an informed decision about how to proceed, and we will vigorously advocate on your behalf to get you the compensation that you deserve.
If you or a loved one has been injured as a result of a defective medical device, contact Ankin Law Office, LLC at (312) 600-0000 to schedule a free consultation with one of our Chicago personal injury lawyers.