Lawsuit claims Paragard IUD fractured during removal, permanently injuring woman

A lawsuit filed in federal court in North Carolina in November claims that a Paragard IUD fractured during removal, permanently injuring a woman. The lawsuit names Teva Pharmaceuticals and The Cooper Companies, among others, as defendants.

The heart of the complaint is the claim that the defendants knew or should have known that the IUD had a tendency to break during removal, yet failed to warn the public about this tendency.

The lawsuit states the IUD is an intrauterine device which is regulated as a drug and placed in the uterus for conception prevention. The complaint states it can provide long term birth control for up to 10 years without the use of hormones. Copper wire coiled around the IUD is the method of conception prevention: it produces an inflammatory reaction which is toxic to sperm and egg. The IUD includes a T-shaped barium sulfate and polyethylene frame.

“ParaGard IUD has a propensity to break at the arms upon explant resulting in serious injuries,” the complaint claims.

The woman, a North Carolina resident, was implanted with the IUD in 2011 and it was removed in 2018, resulting in injuries, according to the lawsuit.

“Plaintiff’s healthcare provider attempted to remove the Paragard IUD as instructed by defendants, by grasping the Paragard IUD and pulling gently. Despite following the instructions provided by defendants, only a portion of the Paragard was retrieved with one arm missing,” the complaint states. The complaint notes that the plaintiff and her doctors were never warned of the risk of failure during removal.

The complaint states that, as a result of this breakage, the plaintiff suffered from “significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and earning capacity, and have and will incur past and future medical expenses,” adding that she has also suffered from a loss of reproductive health.

The lawsuit claims that the defendants marketed the IUD “as being safe and effective, and promising fewer side effects than other birth control methods,” claiming that the marketing “served to overstate the benefits of Paragard IUD and minimize and downplay the risks.”

The complaint states this marketing occurred while the defendants “fraudulently withheld important safety information from health care providers and the public.”

The complaint claims that the defendants knew or should have known the Paragard IUD’s arms are prone to breaking upon removal “from the trials they performed, their post-marketing experience and complaints, third party studies, and their own analysis of these studies.”

The complaint claims that, instead of warning about this risk, the defendants “concealed, suppressed and failed to disclose or fix this danger.”

The complaint argues that the Paragard IUD product warnings were “vague, incomplete or otherwise wholly inadequate to alert prescribing physicians and patients to the actual risks associated with Paragard IUD.”

The complaint claims the plaintiff, “based upon these representations,” upon which her and her physician relied, had the IUD implanted, “believing it would be safe and effective, for the entire duration it was implanted and upon removal.”

The lawsuit states that the FDA has received over 1,600 reports of Paragard IUDs breaking, claiming over 700 of the reports are serious. The lawsuit claims the defendants failed to adequately report the Paragard IUD injuries to the FDA.

The lawsuit accuses the defendants of “knowingly, purposely, and deliberately” failing to warn the public of the risk of injury associated with IUD removal.

The lawsuit seeks to recover financial compensation based on many causes of action, including:

Negligence: The lawsuit accuses the defendants of negligence. Negligence is failing to use reasonable care to prevent harm from occurring. A reasonably careful entity would adequately test their products and warn consumers about any risks associated with their products. The lawsuit claims that the defendants were negligent by failing in their duty to use reasonable care in designing, manufacturing, marketing and selling the Paragard IUD by failing to conduct adequate product testing and failing to warn the public about the risks associated with the IUD.

Strict liability design defect: The lawsuit states that the IUD “is inherently dangerous and defective, unfit and unsafe for its intended use and reasonably foreseeable uses and does not meet or perform to the expectations of patients and their health care providers.”

The complaint claims the IUD’s risks of harm exceed its claimed benefits, and that it was used by the plaintiff and her physician in a reasonably foreseeable manner.

As a result of the foregoing design defects, Paragard IUD created risks to the health and safety of its users that were far more significant and devastating than the risks posed by other products and procedures available to treat the corresponding medical conditions, and which far outweigh the utility of Paragard IUD,” the lawsuit states.

Strict liability manufacturing defect: The lawsuit claims the IUD implanted in the plaintiff “contained a condition or conditions, which defendants did not intend, at the time the Paragard IUD left defendants’ control and possession.”

The lawsuit states that this condition or these conditions caused the product to fail to perform as safely as ordinary consumers would expect, leading to an injury when used in a reasonably foreseeable way.

“As a proximate result of the defendants’ manufacture of Paragard IUD, plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss of enjoyment of life, loss of care, comfort, and economic damages,” the complaint states.”

Strict liability failure to warn: The complaint states that the defendants “knew or should have known that the drug presented an unreasonable danger to users of the product when put to its intended and reasonably anticipated use.”

Specifically, defendants knew or should have known that Paragard IUD posed a significant risk that one of the arms of the drug could break upon removal, resulting in significant injuries,” the complaint adds.

The complaint states the defendants had a duty, which they failed, to warn about the risk of harm associated with the use of the IUD.

Common law fraud: The complaint claims the defendants misrepresented the IUD’s safety “with the intent of defrauding and deceiving” the public, demonstrating “a callous, reckless, willful, and depraved indifference to the health, safety, and welfare of” the plaintiff.

Negligent misrepresentation: The complaint argues that the defendants’ misrepresentation of the IUD’s safety was negligent since it constituted a violation of the duty to exercise reasonable care in the design, manufacturing, marketing and sales of a product in order to prevent consumers from being harmed by the product.

Breach of express warranty: The complaint argues the defendants expressly warranted the IUD was safe when it was not.

Breach of implied warranty: The complaint argues the defendants impliedly warranted the IUD was safe when it was not.

Violation of consumer protection laws: The lawsuit argues the defendants violated multiple laws, “including but not limited to the North Carolina General Statutes, N.C. Gen. Stat. Ann. § 75-1, et. seq.”

Gross negligence: The lawsuit argues the defendants’ negligence “was specifically intended to cause substantial injury to” the plaintiff and represented “conscious indifference to the rights, safety, or welfare of others.”

Punitive damages: The lawsuit argues punitive damages are deserved because the defendants knew their product could hurt others, didn’t warn anyone about it, and this conduct was “willful, wanton, careless, reckless, conscious, and deliberate.”