On Tuesday, the Food and Drug Administration (FDA) announced it is investigating a possible increased risk for heart failure associated with the diabetes drug Saxagliptin, manufactured by Bristol-Myers Squibb and AstraZeneca and marketed as Onglyza and Kombiglyze XR. The FDA has requested full data from the results of a recent clinical trial assessing the cardiovascular safety and efficacy of many current medications used to treat type 2 diabetes, including Saxagliptin (SAVOR trial). The FDA intends to further investigate the 27% increased risk of hospitalization for heart failure among patients taking the Saxagliptin reported in the study. The findings were first reported in August of 2013 at the European Society of Cardiology meeting and subsequently published in the New England Journal of Medicine.… Read More

Posted by Marilyn McGoldrick on Feb 3, 2014 3:32:00 PM On Friday, the federal judge overseeing the Ethicon transvaginal mesh (TVM) litigation ruled that Johnson & Johnson (J&J) and its subsidiary, Ethicon, will not be allowed to introduce evidence that the FDA had previously approved surgical sutures made out of the same polypropylene used in Gynecare… Read More

Today there are multiple news reports of great interest to people suffering from defective hip replacements: Johnson & Johnson’s subsidiary DePuy Orthopaedics has agreed to a tentative settlement of over 4 billion dollars to resolve thousands of DePuy Articular Surface Replacement (ASR) hip implant lawsuits. This would make it the largest recorded settlement for a defective medical device in US history.… Read More

Posted by Thornton Law Firm LLP on Sep 25, 2013 4:30:00 AM Dr. Frances Oldham Kelsey Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with a mother’s ingesting Thalidomide… Read More

The FDA and DePuy have issued a class-1 recall, the highest alert, of DePuy’s femur and tibia implant called the LPS Lower Extremity Dovetail Intercalary Component. This is because this device has the potential to fracture when the patient walks normally or conducts normal activities – like ascending stairs, or rising from a chair. People weighing over 200 pounds or with high activity levels are at higher risk of fractures.… Read More

Posted by Thornton Law Firm LLP on Jul 29, 2013 7:23:00 AM In a 5-4 decision, last month, the Supreme Court of the United States ruled that generic drug manufacturers are shielded from lawsuits arising from adverse side effects caused by their drugs. From now on, only ‘branded’ drugs manufacturers can be held liable for… Read More