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The nation’s biggest producer of orthopedic devices says it is suspending sales of an artificial hip component that some say is failing at high rates. Zimmer Holdings, based in Warsaw, is also lowering its earnings outlook due to the suspension. The Durom cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006.

Panacryl sutures are a type of absorbable sutures, or stitches, that are commonly used to assist patient's wound healing after surgery. These sutures are intended to be absorbed by the body so there is no need for removal at a later time. Panacryl sutures unfortunately may have been the cause of more harm by not dissolving as intended. (This matter has been successfully resolved by Audet & Partners, LLP. We are thus no longer able to accept new clients on this case.)

GYNECARE Worldwide, a division of Ethicon Inc. of Somerville, New Jersey, notified the FDA in June 2003 that they were withdrawing “GYNECARE INTERGEL Adhesion Prevention Solution” from the market and were urging customers to immediately stop using the device.  This product is intended to be used in open, conservative gynecological surgery as an adjunct to good surgical technique to reduce post-surgical adhesions. GYNECARE conducted this withdrawal to complete an assessment of information obtained during post-marketing experience with the device, including adverse events associated with off-label use in laparoscopy and non-conservative surgical procedures such as hysterectomy.

Composix Kugel Mesh Patch can cause a number of serious and potentially life-threatening complications, such as bowel perforation and/or chronic intestinal fistulae, or abnormal connections of passageways between intestines and other gastrointestinal organs.

Several hospital burn lawsuits involving the “da Vinci Surgical Robot” claim that a number of patients have suffered serious burns. One New York father filed a wrongful death hospital burn lawsuit after his daughter died as a result of burns caused by the robot.

NuvaRing is the trade name for a combined hormonal contraceptive vaginal ring manufactured by Merck (formerly Schering-Plough, formerly Organon), that is available by prescription. It is a flexible plastic (ethylene-vinyl acetate copolymer) ring that releases a low dose of a progestinand estrogen over three weeks. It is considered to be a “third-generation” birth control method. Numerous lawsuits have been filed against the manufacturers, distributors, and marketers of the NuvaRing birth control vaginal ring, and recent court cases are now allowing these cases to proceed.

Mirena IUD, a contraceptive device marketed by Bayer since 2000, has been linked to serious adverse side effects in women.  According to the FDA, the Mirena IUD side effects may include ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus); intrauterine pregnancy (a pregnancy with Mirena in place); group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix.  The device was heavily promoted through "Mirena Parties" which misrepresented the ability of the device to improve a woman's sex life and help her "look and feel great."

The Biomet M2a Magnum metal-on-metal system has been used in hip replacements since 2004.  Serious complications including metallosis and premature prosthetic failure have resulted in lawsuits throughout the United States.