Lawsuit alleges that Paragard IUD’s arm broke off inside woman during removal

A lawsuit filed on February 26 in the United States District Court, Northern District of Georgia alleges that a Paragard IUD’s arm broke off inside a woman during a removal procedure, necessitating a removal surgery.

The woman, according to the complaint, had the IUD implanted on November 21, 2016, and went to a doctor to have it removed on July 29, 2020. The doctor, according to the complaint, attempted to remove the IUD as instructed by defendant Teva Pharmaceuticals, by grasping the device and pulling gently. However, according to the complaint, the IUD broke inside the woman when the doctor did this and the woman was told she would need the broken piece remaining inside of her removed via surgery.

The complaint argues that this event caused the woman to suffer from significant bodily and mental injuries, severe pain and suffering, loss of reproductive health, disfigurement, mental anguish, embarrassment, inconvenience, loss of earning capacity and earnings, and past and future medical expenses.

The Paragard IUD, according to the complaint is an intrauterine drug which provides birth control for up to 10 years without hormones. Copper wire which is coiled around the device is the “active ingredient” of the IUD, according to the complaint: it produces inflammation which is toxic to egg and sperm.

The IUD consists of a T-shaped plastic frame composed of barium sulfate and poyethylene, according to the complaint, which states the IUD has a monofilament polyethylene thread tied through its tip, creating two white threads which help with detection and removal of the IUD.

Teva Pharmaceuticals, according to the complaint, knew or should have known the Paragard IUD was defective and unreasonably dangerous because it has a propensity to break at the arm during removal procedures, leaving the arm inside patients. Teva, however, according to the complaint, failed to warn the public or the plaintiff about this tendency of the device to break during removal.

Teva knew about this injury risk from studies they performed, post-marketing complaints and experience, and third-party studies, according to the complaint, which states that instead of warning about or fixing the problem, they “concealed, suppressed and failed to disclose or fix this danger.”

The complaint alleges that marketing for the Paragard IUD “served to overstate the benefits of Paragard IUD and minimize and downplay the risks,” and that the plaintiff and her doctor decided to have the IUD implanted based on this marketing, thinking it would be safe and effective from implantation to removal.

The complaint claims the plaintiff would have never agreed to having the Paragard IUD implanted, and the plaintiff’s doctor would have never prescribed the Paragard IUD, had the defendants adequately warned about the product’s dangers.

The FDA has seen over 1,600 reports of Paragard IUDs breaking, according to the complaint, which alleges that over 700 of these reports were classified as serious.

The complaint seeks to recover damages based on negligence, alleging that the defendants breached their duty to exercise reasonable care in the manufacture, labeling, design, warnings, instructions, marketing, sale, distribution and safety surveillance of the Paragard IUD in order to prevent foreseeable and unreasonable harm from occurring.

Negligence is the failure to be reasonably careful to prevent harm. The complaint alleges the defendants knew the Paragard IUD could break during removal but failed to fix or warn about this danger. The complaint implies that a reasonably careful entity would fix or warn about a device’s tendency to break during removal if they knew about the tendency.

Alternately, the complaint implies, if the defendants didn’t know about this tendency, they should have known about it, meaning they failed to adequately test the safety of the Paragard IUD before putting it on the market. The complaint implies that a reasonably careful entity would adequately test a product’s safety before selling the product.

The complaint alleges that the Paragard IUD is defective, and that it contains either a design defect or a manufacturing defect.

Products with manufacturing defects are defective because something went wrong during the manufacturing process which was not intended. Products with design defects, however, are defective because they are unreasonably dangerous when manufactured and used correctly and/or in a reasonably foreseeable way.

The complaint alleges that the Paragard IUD is defective because its arms and strings lack the structural integrity to withstand the normal forces of removal procedures.

The complaint seeks to recover damages based on strict liability marketing defect, claiming that the defendants marketed the Paragard IUD as being safe and effective when, in fact, it was not safe because of its tendency to break during removal procedures.

Common law fraud damages are sought by the complaint, which claims that the defendants have “falsely and fraudulently” represented the safety of the Paragard IUD. The defendants, according to the complaint, knew or should have known the representations were false, and “willfully, wantonly, and recklessly disregarded” the inaccuracies in their representations of the Paragard IUD’s safety.

These misrepresentations, according to the complaint, were made “with the intent of defrauding and deceiving,” and inducing people to prescribe and purchase the Paragard IUD.

Negligent misrepresentation is alleged by the complaint, which claims that the defendants breached their duty of reasonable care when they misrepresented the Paragard IUD as being safe when it was unsafe.

Breach of express warranty and breach of implied warranty of merchantability are alleged by the complaint, which argues that the defendants expressly and impliedly warranted that the Paragard IUD was safe when it was not.

Gross negligence is alleged by the complaint, which argues that this gross negligence warrants punitive damages. Gross negligence is acting negligently while being aware that you are acting negligently. The complaint claims that the conduct of the defendants exhibited “conscious indifference to the rights, safety, or welfare of others.”

For more information on Paragard IUD lawsuits, visit Nadrich & Cohen Accident Injury Lawyers.