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.”