Advocates Push For Passage of Medical Device Safety Bill Enabling Victims To File Lawsuits


Defective Medical Device Lawsuits Contend Such Products As Essure And Power Morcellators Cause Serious Complications And Even Death.

Medical Device LawsuitsAs litigation for medical device lawsuits continues in federal courts over Essure, Mirena and other medical devices, Congressional members and advocacy groups rallied in Washington D.C. Monday to urge Congress to pass a bill that allows medical device injury victims to file lawsuits in state court against the devices’ manufacturers. Thousands of lawsuits contend medical devices, including Essure, power morcellators, and Mirena IUD, are unsafe and cause serious and fatal injuries.

The Essure Problems Group and the Breast Implant Victim Advocacy Group organized a rally to support the Medical Device Safety Act (H.R. 2164). The bi-partisan bill holds Class III medical device manufacturers liable at the state and local levels if their device received premarket approval from the U.S. Food and Drug Administration (FDA) and injured patients. Currently, manufacturers are protected from state court lawsuits by federal preemption, which overrides any state law that conflicts with federal law.

Beside contraceptives, the bill covers defibrillators, pacemakers, hip implant systems, breast implants, and other devices. Class III devices sustain or support life, are implanted, or present potential unreasonable risk of illness or injury, according to the FDA. Congresswoman Rosa DeLauro (D-CT), the bill’s co-sponsor, said that faulty medical devices have “tragically injured, or even killed, thousands of Americans” nationwide.

“Because we represent numerous men and women in medical device lawsuits, our attorneys have seen the devastating effects faulty medical devices have had on men and women,” says Dr. François Blaudeau, who is also a practicing obstetrician/gynecologist.

Essure Birth Control Lawsuits

Essure Problems Group, whose members call themselves E-Sisters, has repeatedly called for the FDA to ban the Essure. Women contend in lawsuits that Essure causes ectopic pregnancy, miscarriages, chronic pain, auto immune diseases, organ perforation, hysterectomies, and other complications. Bayer, Essure’s manufacturer, recently announced that it would halt sales of Essure, except in the United States. Bayer maintains it is protected from lawsuits because Essure received premarket approval from the FDA.

Mirena Pregnancy Lawsuits

Bayer also manufactures the Mirena Intrauterine device, which lawsuits allege causes serious birth injuries in babies. Southern Med Law represents women who became pregnant while using the Mirena IUD and lost their babies. Lawsuits also allege Mirena causes intracranial hypertension, vision problems, and other serious complications. (In Re: Mirena IUD Products Liability Litigation, MDL No. 2434)

Power Morcellator Lawsuits

Controversy continues over power morcellators which are used during a hysterectomy or fibroid removal. Lawsuits claim the device spreads undetected cancer, including a rare and aggressive form of cancer called, leiomyosarcoma. The morcellator’s blades shred uterine tissue into fragments for removal through small incisions in the abdomen. Undetected cancer cells in the uterine tissue can spread the sarcoma through the abdomen and pelvis, according to morcellator cancer complaints.

Dr. Blaudeau was the first to file a power morcellator lawsuit in federal court in 2014. The case against LiNA Medical APS, Kebomed AG and LiNA Medical USA was settled in 2015 for an undisclosed amount. Since then, the law firm has filed and settled 10 morcellator cancer lawsuits against morcellator manufacturer, Ethicon Inc., a subsidiary of Johnson & Johnson.

Southern Med Law continues to represent numerous men and women in medical device litigation. The firm is dedicated to achieving justice for men and women who were harmed by high-risk medical devices. If you suffered injuries from a defective medical device and want to speak with one of the firm’s experienced attorneys, call 1-205-547-5525 or fill out a contact form on the firm’s website at

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526

This entry was posted in Southern Med Law | Article. Bookmark the permalink.