Drug & Device News

A $20 Million Pelvic Mesh Verdict

On April 28, a Philadelphia jury awarded the plaintiff in a pelvic mesh lawsuit $20 million, most of it in the form of punitive damages. In Engelman v. Ethicon, C.P. Philadelphia No. 021103888, plaintiff Margaret Engelman stated that she had been implanted with Ethicon's TVT-Secur mesh, which began falling apart just two months later, requiring her to undergo three further surgeries. Portions of the device remain in her body to this day, causing ongoing pain and urinary dysfunction. The manufacturer defended by asserting in its memorandum that Engelman offered no evidence that the harm she suffered was not a known risk to pelvic floor surgeons and “[u]nder New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians.” This defense did not fly with the jurors, all 12 of whom agreed that the manufacturer was guilty of failure to warn, and that that failure was the cause of Engelman's injuries.

FDA Approves Use of Drug to Treat ALS

In a May 5 release, the U.S. Food and Drug Administration (FDA) announced its approval of Radicava (edaravone), a drug already being used in Japan to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. http://bit.ly/2sJUpR8. ALS attacks the nerve cells that control muscles, causing them to become inactive, weak and, eventually, paralyzed. Most ALS sufferers die of respiratory failure within three to five years of the first onset of symptoms.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.” The medication will be made available in the United States by Mitsubishi Tanabe Pharma America, Inc.

A $20 Million Pelvic Mesh Verdict

On April 28, a Philadelphia jury awarded the plaintiff in a pelvic mesh lawsuit $20 million, most of it in the form of punitive damages. In Engelman v. Ethicon, C.P. Philadelphia No. 021103888, plaintiff Margaret Engelman stated that she had been implanted with Ethicon's TVT-Secur mesh, which began falling apart just two months later, requiring her to undergo three further surgeries. Portions of the device remain in her body to this day, causing ongoing pain and urinary dysfunction. The manufacturer defended by asserting in its memorandum that Engelman offered no evidence that the harm she suffered was not a known risk to pelvic floor surgeons and “[u]nder New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians.” This defense did not fly with the jurors, all 12 of whom agreed that the manufacturer was guilty of failure to warn, and that that failure was the cause of Engelman's injuries.