FDA Black Box Warning for Power Morcellators
The FDA has hammered the laparoscopic power morcellator devices with the strongest warning possible, requiring the morcellators to have a black box warning concerning the risk of cancer spread.
Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.
FDA Black Box Warning for Power Morcellators
The FDA has hammered the laparoscopic power morcellator devices with the strongest warning possible, requiring the morcellators to have a black box warning concerning the risk of cancer spread.
Lina Medical reportedly has agreed to settle Scott Burkhart’s wrongful death claim of his wife, who had undiagnosed leiomyoscarcoma spread throughout her body by a Lina power morcellator.
Burkhart’s case was the first of several hysterectomy morcellation lawsuits, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, and failed to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery.
What is Invokana?
Johnson & Johnson’s Janssen Pharmaceuticals unit manufactures and distributes Invokana (canagliflozin), for patients with type-2 diabetes, to control their blood-sugar levels. The drug has achieved blockbuster status, in that it is set to blow past a billion dollars in sales in 2015.
According to sources, more than 11,600 of the “personalized” artificial knee components have been recalled less than three years after the novel design was introduced.
FDA Warning and Class 2 Recall
The is a silver lining to the litigation. Recently, Medtronic’s Covidien unit agreed to settle more than 11,000 transvaginal mesh lawsuits filed by women who experienced serious and severe complications with the products.
What is Transvaginal Mesh and why is it Dangerous?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
The settlement deal would average about $275,000 for each case, and would be the first settlement in the four year old litigation over the type 2 diabetes drug.
Any settlement deal would average about $275,000 for each case, and would be the first in the four year old litigation over the diabetes drug. The global settlement will be finalized at the next federal court hearing which is set for May 22.
Actos Settlement Details