Defective Medical Devices

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The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs.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 […]

The scrutiny that has arisen within the healthcare community over hysterectomies performed by laparoscopic power morcellation has the Food and Drug Administration (“FDA”) thinking twice about the safety of the procedure. A news release issued by the agency includes a list of recommendations for medical professionals who conduct such surgeries, […]

Most women will develop uterine fibroids at some point in their lives.  Fibroids are common, and affect half or more women during their reproductive years.  Most women with fibroids are unaware they have them, but other women can experience symptoms such as anemia, backaches, bleeding between periods, constipation, frequent urination, […]

Johnson & Johnson (“J&J”) has reached a four million dollar settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants.  J&J has recalled 93,000 ASR hip implants, which had a 12% failure rate in five years. David Hart, Oregon’s Assistant Attorney General […]

A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure. The procedure, laparoscopic power morcellation, can spread malignant tissue – if any is present in the patient – beyond the […]

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft.  In its lawsuit filed in federal court in Tennessee’s Western District, Humana […]