On November 24, 2014, the Food & Drug Administration made another significant step in improving the safety of women. The FDA issued its latest safety alert relating to the widespread use of power morcellators. A power morcellator is a medical device that is used during a number of gynecological surgeries – the removal of […]
Category: Defective Medical Devices
In October of 2014, Endo International PLC (”Endo”) agreed to settle claims stemming from lawsuits that alleged problems with its vaginal mesh products. In the settlement, Endo asserts that the agreements are not an admission of liability. According to Bloomberg BusinessWeek, Endo agreed to pay “more than $400 million to […]
Information is the cornerstone to modern, 21st century society. Transparency and information gives citizens and consumers the power to make informed decisions on who to vote for or which products to consume. Backroom deals, nepotism and corruption operate in the shade of misinformation, disinformation, and unknowable and incomprehensible processes and […]
On August 8, 2014, a Wisconsin federal court dismissed a case based on a defective hip implant because it found that it did not have jurisdiction over a case which did not state a basis for federal jurisdiction. Plaintiff, Yvonne Wright, brought claims against Zimmer Holdings Inc. asserting that she […]
The Food and Drug Administration has identified an information gap in its system of clinical trials and is working to fill it. The gap relates to women. There aren’t enough of them enrolled. “Underrepresentation of women (or minority or ethnic groups) results in a lack of information for these patients […]
On July 11, 2014, Judge Joseph R. Goodwin of the United States District Court for the Southern District of West Virginia, ruled that a lawsuit filed against Boston Scientific in connection with its Obtryx transvaginal mesh device was time barred under Massachusetts’ three year statute of limitations because the plaintiff […]
Morcellator is a surgical instrument sold under the name of Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract, and which are used for division and removal of large masses of tissues during laparoscopic surgery. Morcellators are also used in minimally invasive surgery to perform hysterectomies and in the removal of uterine […]
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued guidances are non-binding and only “represent the Food and Drug Administration’s current thinking […]
The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of debate since the Food and Drug Administration discouraged its use in April. A study by doctors at Columbia University, published […]
It was a year ago February that Linda and Jeff Gross of Watertown, South Dakota were awarded $11.1 million following their four-week defective pelvic mesh trial against Ethicon, a subsidiary of Johnson & Johnson. This week the verdict was upheld in the product liability case. Atlantic County Superior Court Judge […]
