Personal Injury News & Developments

Medical device maker Ethicon is one of the two chief manufacturers of surgical staplers in the U.S.  Surgical staplers are widely marketed and used as an alternative to manual sutures made by surgeons to close internal wounds, their greatest benefit being reducing a patient’s time in surgery. However, Ethicon and other stapler makers have long been dogged by reports that their products frequently malfunctioned, causing serious injury and even death to patients.

Now Ethicon has initiated a recall of more than 8,000 of its Echelon Flex Endopath staplers, announced by the U.S. Food and Drug Administration in October. The FDA has identified this as a Class I recall, which indicates the devices could cause life-threatening injuries or death. As of October 3, seven serious injuries and one death had been reported to Ethicon for the affected products.

The Echelon Flex Endopath staplers are designed for use on only one patient, in major or minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries. They were manufactured between July 18 and August 3, 2019, and distributed to healthcare providers between August 1 and September 26.

In late 2019, the U.S. Food and Drug Administration announced recalls of multiple drugs believed to be contaminated with a carcinogenic substance called NDMA. Those recalls affected both prescription and over-the-counter versions of the heartburn and ulcer medication ranitidine, known by the name brand Zantac but also sold as a prescription and over-the-counter generic. The FDA had earlier recalled several types of blood pressure medications—losartan, valsartan, and irbesartan—because of contamination with NDMA. It believes there has been NDMA contamination in those drugs for up to four years.

What Is NDMA?

NDMA is short for N-Nitrosodimethylamine, an organic chemical. It’s present in low levels in certain foods, particularly smoked or cured foods, but most often found as a manufacturing and water treatment by-product. It’s also used in biological science as a way to create cancer in laboratory rats, and according to the World Health Organization, the International Agency for Research on Cancer believes it probably causes cancer in humans. The U.S. Environmental Protection Agency says NDMA comes from a family of known and powerful carcinogens.