With the increasing popularity of the anticoagulant Xarelto, doctors and hospitals are seeing more adverse bleeding events than before. Without a formal antidote approved by the FDA, hospitals are implementing new protocols to reverse the effects of Xarelto.
Essure is a non-surgical form of permanent female sterilization, designed to prevent pregnancy, developed by Conceptus Inc., a company owned by Bayer. This form of birth control works by causing scar tissue to build up in the fallopian tubes around its metal coil, preventing sperm from fertilizing any eggs.
Trouble started for Johnson and Johnson (J&J) and its subsidiary, Janssen Pharmaceuticals, in 2012, when the company reached a settlement with the State of Texas for $158 million. Texas claimed that the company falsely advertised its medication, Risperdal, for uses not approved by the FDA.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.