FDA Calls for Black Box Warning for Power Morcellators

Chris Welsh, Esq. The FDA now demands a ‘Black Box Warning’ for power morcellators, a device used in performing hysterectomies and to remove fibroid tumors. The warning is the most serious that the agency issues. The warning for power morcellators will state the following: “Uterine tissue may contain contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.” Reportedly, the device has been available for two decades to break up tissue into …


Judge Urges Transvaginal Mesh Supplier to Settle

Chris Welsh, Esq. The tide in transvaginal mesh litigation took an unusual move last month. A federal judge overseeing multidistrict litigation urged defendant supplier, C.R. Bard, to settle the thousands of lawsuits or face the likelihood of billion dollar rewards by juries. “I base that billions of dollars business on some of the rather large verdicts we’ve had,” he said at the hearing. Reportedly, there are roughly 10,000 cases pending against C.R. Bard in that particular multidistrict litigation, which is taking place in West Virginia. The litigation follows big decisions against suppliers of defective transvaginal devices, including C.R. Bard, Boston …


Jury Finds Boston Scientific Liable for Transvaginal Mesh Device, Awards $18.5 Million to Injured Women

Chris Welsh, Esq. Medical device developer and manufacturer Boston Scientific has been found liable for the second time this month for its sale of defective vaginal mesh implants. The devices, commonly called “TVM” devices, are mesh implants used to treat stress urinary incontinence and pelvic organ prolapse. They have been widely defective and harmful, causing serious health problems and pain after eroding in the body. Complications include organ perforation, intense pain, infection, inability to have sexual intercouse, and multiple revision surgeries. Boston Scientific faces thousands of claims, 14,000 of which have been consolidated in a multidistrict litigation. Most recently, …


Toyo and Nitto Brand Tires Recalled for Safety Hazard

Chris Welsh, Esq. Another auto recall is in effect. Toyo Tire Holdings of Americas Inc. is recalling approximately 175,000 Toyo Tires and Nitto brand tires for potential risk of tread/belt separation and loss of pressure, causing tire failure and accidents. The tires are made for light trucks, SUVs, and vans (including commercial). Issues during production may have created conditions that put undue stress on the belt edge of the tire. Tires potentially affected include select Toyo® Open Country® H/T Nitto® Dura Grappler® Highway Terrain tires manufactured in Japan between November 2008 and June 2013. Tires can be identified by …


Hobby Lobby Candles Recalled After 29 Incident Reports, Fire Hazard Risk

Chris Welsh, Esq. CoScentrix is recalling DD brand candles sold exclusively at Hobby Lobby from July to October of this year. The candle’s high flame can ignite the surface of the candle and cause a fire. The company has received 29 reports o f the candle’s surface igniting, nine reports of property damage, and one injury. Approximately 256,000 candles were sold in 5 oz, 10 oz, and 13 oz scents. For a list of scents and sizes, click here. Consumers should stop using the candles immediately and return them to the nearest Hobby Lobby. Buyers with receipts will be refunded, …


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