Drugs/Medical Legal News Articles & Interviews

New Jersey When NJ gynecologist Carolyn Delucia, MD suggests to NewBeauty readers that “you can go back to your gynecologist any time to get [Paragard IUD] removed,” it makes you wonder what bubble she is living in. Since 2010, the FDA has received more than 1,600 reports of ParaGard breakage, with more than 700 classified as serious.

Newark, NJ It’s a toss-up: whether to send 80 Elmiron vision loss lawsuits to Pennsylvania or New Jersey. Currently the latter seems to be the best bet. Lawyers have so far filed 80 Elmiron lawsuits and they anticipate hundreds more.

Santa Clara, CA Federal hernia mesh lawsuits filed against C.R. Bard are proceeding with the first bellwhether trial scheduled for January 2021 (it was postponed due to COVID), despite numerous efforts by the medical device maker to have the case dismissed. This trial may well indicate the future of hernia mesh litigation and significantly impact up to 10,000 pending hernia mesh cases.

Santa Clara, CA Hypophosphatemia, an abnormally low level of phosphate in the blood, may be due to longer term or excess of certain drugs such as bisphosphonates, including Injectafer, but that may depend upon researchers conducting the clinical trials and the amount of the iron-deficiency drug treatment.

Washington, DC  A recently published study links breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to implants manufactured by seven pharmaceutical companies. In addition to Allergan, the manufacturer of Biocell textured breast implants, the study names Mentor Worldwide, a unit of Johnson & Johnson, Silimed Polyurethane, Eurosilicone, Nagor, Orion, and Poly Implant Prothèse. Allergan faces at least 150 product liability and class action lawsuits. Mentor faces a smaller number, and none of the others are yet facing litigation.

New York, NY Five more women have recently filed lawsuits against Cooper Surgical and Teva Pharmaceuticals claiming its ParaGard IUD broke while being removed. The ParaGard website warns consumers that its device sometimes gets stuck in the uterus, requiring surgical removal, but does not include a problem with it breaking apart.

Santa Clara, CA More Elmiron lawsuits are being filed in the U.S. and Canada has filed two class action lawsuits, all alleging the interstitial cystitis drug can cause permanent vision damage.

Somerville, NJ In mid-October 2019, the FDA recalled Ethicon Echelon Flex surgical staplers because of a dangerous manufacturing failure that could cause serious health damage or even death. This followed, by only a few months, a recall of Ethicon Endo-Surgery curved intraluminal staplers, a defective medical product that posed similar dangers to patients.

Silver Spring, MD  On August 20, the U.S. Food and Drug Administration provided an update on adverse events relating to breast implants, including breast implant-associated anaplastic large cell lymphoma. The new FDA update on BIA-ALCL reports a total of 733 cases and 36 patient deaths globally, an increase of 160 new cases and 3 deaths since July 2019. Of those 733 cases, 84.6 percent involved Allergan implants.

Santa Clara, CA Almost two years after Bayer stopped selling Essure in the U.S., and four years after the FDA told Bayer its birth control device needed a black box warning regarding potential serious side effects, the pharma giant will pay $1.6 billion to settle Essure lawsuits brought by nearly 39,000 women in the U.S. who suffered serious health complications as a result of Essure fallopian tube implants.