American Association for Justice
New AAJ Report Highlights Problem with Unsafe Medical Products and Lack of Accountability for Manufacturers
Analysis of Past Hazardous Women’s Products Released for National Women’s Health Week
Washington, DC—Michelle Garcia (Miami, FL) never thought a simple doctor’s office procedure for birth control would result in the removal of both of her fallopian tubes. Yet last year Michelle underwent surgery to remove Essure, a medical device marketed as a “surgery-free permanent” birth control procedure. It was supposed to be Michelle’seasy solution for birth control for life; instead, it was her worst nightmare. One of Michelle’s coils* broke and pierced her abdomen, requiring surgery to remove the coil and both damaged fallopian tubes.
Women suffer disproportionately from faulty drugs and medical devices, and Michelle is just one example. As part of National Women’s Health Week, the American Association for Justice (AAJ) has released “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices,” an analysis detailing a history of a few of the many products that have harmed women over the years.
Because of a Supreme Court ruling (Riegel v. Medtronic), Michelle will never be able to recover any medical expenses for her surgery from the manufacturer of Essure, even though the product was defective and became a hazard to her health.
“For decades women have suffered enormously from unsafe medical products,” said AAJ President Mary Alice McLarty of AAJ’s new report. “Essure could turn out to be another example of a medical manufacturer putting profits ahead of women’s health. Unfortunately, because the manufacturer is shielded from litigation, we will never learn the truth about what the company knows about the safety and effectiveness of their product,” added McLarty.
The report examines dangerous and defective products from the past several decades, from the Dalkon Shield in the 1970s, to the intrauterine device (IUD) Cooper-7 in the 1980s, vaginal mesh in the 1990s, and Prempro and other hormone replacement therapies in the 2000s. Most recently, DePuy metal-on-metal hips have proven to not only release metallic debris into the body, but have a 29 percent higher risk of failure in women than men, according to a study published in the Journal of the American Medical Association.
The makers of Essure are shielded from litigation because the Supreme Court ruled in Riegel v. Medtronic (2008) that medical devices that have gone through the FDA’s premarket approval process (PMA) cannot be held responsible for injuries, even when the device is defective or has been recalled.
“Lawsuits serve as a valuable tool to uncover undisclosed or unknown risks and provide an incentive for manufacturers to promptly disclose safety risks,” added McLarty. “Unfortunately, Essure’s maker has a ‘get-out-of-jail-free’ pass from the Supreme Court’s Riegel decision.”
*Essure is a coil inserted in each fallopian tube that is supposed to create a "natural barrier,” or scar tissue in the tube to prevent pregnancy by blocking the tube. In Michelle’s case, one coil broke and migrated to her abdomen, where it could have pierced a vital organ. Other women have reported getting pregnant, coils piercing organs, coils migrating to other parts of the body, and having complete hysterectomies because of complications from Essure birth control.
See “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices, for more information about dangerous women’s products and the role lawsuits played in product safety.