The U.S. Court of Appeals for the 7th Circuit in Chicago addressed the issue of the need for expert testimony on causation when the issue is beyond the understanding of laypersons. The product liability claim here involved the allegation of a defective intrauterine device (IUD) that broke when it was…
The plaintiff, Jo Huskey, and her husband filed a product liability lawsuit against Ethicon Inc. and Johnson & Johnson. After a nine-day trial, the jury returned a general verdict in the amount of $3.27 million for the Huskeys on their design defect, failure to warn and loss of consortium claims.…
In August 2010, the Federal Drug Administration (FDA) posted a letter it sent to a medical device manufacturer regarding the safety of its metal hip implants. The letter informed the medical device manufacturer that the FDA had become aware that it had not obtained marketing approval before releasing its metal-on-metal…
Medtronic, the maker of Sprint Fidelis, a heart defibrillator cable, has taken its product off the market. But the problem with it still being used by some 150,000 people around Illinois and the country has resulted in several deaths in removing the defective cable. Medtronic estimates that the cable has…
In 2007 Medtronic recalled their heart device, the Sprint Fidelis Cardiac Leads, which has caused the deaths of at least 13 people. Essentially the product, the Sprint Fidelis cardiac leads, connects the patient’s heart to a defibrillator. Along with deaths, the Federal Drug Administration (FDA) has received about 2,200 reports…
A February 2008 decision by the Supreme Court stands as a barrier to patients who desire to sue for medical device liability. The Supreme Court ruling in Riegel v. Medtronic, Inc. holds that patients or their surviving heirs would be barred from suing makers of complex medical devices like the…
U.S. District Court Judge Virginia M. Kendell denied a Chicago woman’s medical device liability claim that her left knee injuries were caused by her knee replacement device. The complaint was removed to the federal court from Chicago’s Cook County Circuit Court and contained claims of negligence, strict liability and breach…
Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits…
The U.S. Food and Drug Association is responsible for ensuring that new medical devices are safe enough to be put on the market. As a federal agency, the FDA controls regulation nationwide and within Illinois and Chicago. But what most consumers don’t know is that the process for approving these…
A California Appellate Court supported a trial court’s ruling that the Medical Device Amendments (MDA), Title 21 USC §360k(a), preempts any state law imposing safety requirements on manufacturers of a medical device. So even though the medical device did not pass all of the state’s safety requirements, in Blanco v.…