ParaGard IUD - Birth Control Device MDL Forms in Georgia

Mar 3

Mesh Medical Device News Desk

Paragard is an IUD (intrauterine device) implanted in the uterus to prevent pregnancy. The device is made by Cooper Surgical and received an FDA New Drug application approval in 1984. Among the three IUDs on the market - Mirena, Skyla and Liletta - Paragard is the only one that uses copper, not a hormone.

Unfortunately, there have been thousands of reports of problems in women implanted with Paragard, including at least 15 deaths. In December of last year, the Judicial Panel on Multidistrict Litigation formed a Paragard MDL in the Northern District of Georgia (MDL 2974). As of March 3, there are 123 lawsuits pending before U.S. District Judge Leigh Martin May. The defective product action will include manufacturing defect, defective design, marketing, promotion, labeling, packaging, and distribution, and failure-to-warn, gross negligence, and consumer protection law fraud. The plaintiffs seek punitive damages. The defendants are alleged to have understood the risks from clinical trials and post-marketing complaints but failed to warn and instead concealed and suppressed the dangers, one complaint reads. (Plendl v Teva et al)

Safe for 30 Years

Paragard is made up of flexible polyethylene plastic wrapped with a thin layer of copper coil around the arms and stem. Copper is the active ingredient that continually releases into the uterine cavity. It incites an inflammatory reaction, toxic to sperm and egg that reportedly interferes with sperm transport and egg fertilization, blocking the sperm from reaching an egg and implanting in the uterus.

The device marketing says the FDA approved the copper IUD and it’s been safely used for more than 30 years.

Sales were estimated to be $168 million in the 12-months ending in June 2017, according to one complaint.

There have been no long-term studies on animals to assess the potential of cancer resulting from an implant containing copper.

Cooper Surgical also makes surgical and laparoscopic instruments primarily for women’s surgical needs including devices for hysterectomy, pelvic surgery, and C-section procedures.

Problems with Paragard

Since it’s been on the market, the Food and Drug Administration has received more than 40,000 reports of adverse reactions to the Paragard T380a contraceptive. FDA’s Adverse Events Reporting System (FAERS) has reportedly received more than 15,000 death reports.

In 2019 alone, FAERS received more than 7,000 complication reports about Paragard.

Women have experienced the device breaking during its explant (removal) causing complications and injuries including surgery to remove the pieces, infertility, and pain. Other complications include:

· Organ perforation
· IUD arms embed in uterine wall
· Migration outside of the uterus
· Pieces difficult to locate
· Ectopic pregnancy
· Possible hysterectomy
The FDA has warned that Paragard removal may be difficult because of “partial penetration or embedment of Paragard in the myometrium” (middle layer of the uterine wall). Paragard may “attach to or go through the uterus and cause other problems,” so reports CooperSurgical of Trumbull, Connecticut.
About the size of a pack of sugar, the user is not expected to feel Paragard. Periods may be heavier and longer with spotting in between. Pregnancy with an IUD in place is associated with an increased risk of miscarriage (27%), premature labor, and delivery and sepsis.
Women are told that after removal they should be able to conceive.

Marketing

Television advertisements for Paragard show dancing young women apparently excited about the device. The FDA has taken exception with the ads.

In a letter sent February 2021, the Office of Prescription Drug Promotion of the Food and Drug Administration (FDA) accused CooperSurgical of promoting Paragard “without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”

The letter says the ad fails to mention any risk associated with the product. Paragard remains on the market and has not been subject to any recalls.

IUDs

The most notorious IUD was the Dalkon Shield of the 1970s, which negatively impacted hundreds of thousands of women causing pelvic inflammatory disease, infertility, spontaneous abortions, and death.

Dalkon Shield encouraged the passage of the Medical Device Amendments of 1976, that for the first time, gave the FDA some control over medical devices.

The Dalkon Shield episode had a negative impact on all IUDs. Bayer offered a $12.2 million settlement in 2018 with thousands of claimants over complications associated with Mirena IUD.

The new drug application (NDA) for ParaGard was previously held by Teva Women’s Health, Inc. from November 10, 1995 to August 11, 2017. Most of the actions filed so far name Teva Pharmaceuticals USA, Inc Et Al. Previously, Duramed Pharmaceuticals, Inc. a division of Barr Pharmaceuticals Inc. DBA Teva Women’s Health Inc. acquired FEI (Finishing Enterprises Inc.) Women’s Health in 2005. The deal included ParaGard IUD. Duramed Was acquired by Teva USA in 2008. Cooper Companies, a Delaware Corporation with headquarters in Pleasanton, California purchased assets of ParaGard IUD in September 2017 for $1.1 billion. Cooper Surgical is a subsidiary of Cooper companies.

Under Georgia law, successors-in-interest are liable.

Contributed by www.meshmedicaldevicenewsdesk.com