When many plaintiffs suffer similar injuries as a result of defective prescriptions or medical devices, the United States federal court system will have the cases transferred to one courtroom under one judge. This process is commonly known as uses multidistrict litigation (“MDL”). This process allows common issues to be decided one time and in the same way. Discovery and motions are done one time. Thus, the cases benefit from speed, efficiency and uniformity of rulings. MDL cases. Pending MDL cases as of April 15, 2019 are listed here: https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf.
“The FDA is also increasing its scrutiny of nitinol. Last August, a law firm in Australia launched a class action lawsuit on behalf of patients alleging that their Essure implants corroded and caused them to suffer nickel poisoning.” (https://www.icij.org/investigations/implant-files/us-to-investigate-health-impact-of-nickel-silicone-in-medical-implants/).
“It is estimated, however, that nearly 10,000 of U.S. Essure patients required additional operations after their original procedure. This is due to anything from severe side-effects, the device traveling to different areas of the body, or perforations and tears requiring medical procedures. Dr. Katy Moncivais, PhD, Medical Writer tells me: “Essure fails every test – it’s less safe, less effective, and more side effect prone than most other methods of birth control.” ” (https://www.girlsglobe.org/2019/04/03/womens-reproductive-health-under-attack/).
“The FDA requires a Premarket Approval (PMA) to review and evaluate the safety and effectiveness of Class III medical devices like Essure. FDA regulations require that this takes 180 days, and normally longer, but there are records that show that this process was expedited and several trial candidate’s records were altered to obscure unfavorable data. Some patients were completely thrown out of the clinical trials when their data reflected poorly on the device. According to the citizen’s petition linked above, there were many adverse events that Essure manufacturers and PMA holders failed to report and/or covered up. Additionally, over 16,000 patient complaints were withheld from the FDA. When the manufacturing facilities were inspected, many unsettling thing came to light, starting with the facility’s lack of license. The manufacturer of Essure were operating without a license for three years.” (https://www.hormonesmatter.com/essure-debacle/).
“Her last surgery—ostensibly to remove the mesh—was five years ago. “My surgeon told me the mesh was impossible to remove because it was stuck to my bowel and had even migrated to my intestines. Next up I went to a pain management clinic: I have this constant aching pulling feeling and sharp pains like someone is kicking at me. It started just above my belly button but now the pain has spread… and I’ve been on oxycontin [the brand name for Oxycodone] since 2015.”” (https://www.lawyersandsettlements.com/legal-news/mesh-complications/abdominal-mesh-victim-prescribed-oxycontin-could-pain-have-been–23068.html).
“After almost a decade of campaigning by Good Health, the NHS has admitted the material can ‘migrate’ and disintegrate, becoming embedded in tissue. Last July, it said that the tape should not be used for urinary incontinence.” (https://www.dailymail.co.uk/health/article-6900685/Victims-national-mesh-scandal-reveal-agony-housebound-pain-20-years.html).
Medicine is supposed to be about risk/benefit. And the numbers here are important because the doctors told me that there have been estimated 4 million women worldwide have had mesh implanted. About 5 percent of them have complications. Well, that equals 200,000 people. And from reading about the complications, half of those people with complications require surgery. And the complications are very hard to get rid of. The one thing I was told: removing mesh from the human body is like getting bubblegum out of hair. Another analogy I heard was getting rebar out of concrete. So it’s a lifelong problem.” (https://news.wttw.com/2019/02/12/fda-assessing-risks-vaginal-mesh-amid-thousands-lawsuits).