New Lawsuits Describe Serious Paragard IUD Complications

August 14, 2020, 7:00PM. By Anne Wallace

Defective medical device linked to patient injuries in California, New York and Illinois

East St. Louis, ILParagard IUD defective medical device lawsuits are popping up in courts throughout the country. Huitt v. Teva Pharmaceuticals was filed in the Eastern District of California on May 11. Lewis v. Teva Pharmaceuticals was filed in the Southern District of New York on May 26, followed on July 30 by Harnish v. Teva Pharmaceuticals. Parker v. Teva Pharmaceuticals was filed in the Southern District of Illinois on May 28. This is in addition to roughly 20 Paragard IUD lawsuits now consolidated for multidistrict litigation (MDL) in the Philadelphia Court of Common Pleas.

Plaintiffs describe a variety of complications, including permanent loss of fertility, perforation of the uterine wall or cervix and damage to other organs. These complications can be fatal. The Parker complaint is representative of the more recent lawsuits.

Beth Parker’s experience

Paragard IUDs involve a T-shaped plastic frame made of polyethylene and barium sulfate that is inserted into the uterus. Copper wire coiled around the IUD produces an inflammatory reaction that is toxic to sperm and egg. The basic problem is that the Paragard IUDs are likely to break on removal. The T-shaped arm segments break off and may subsequently cause serious injuries.

Beth Parker had her Paragard IUD implanted by a doctor in 2008. A young, healthy woman, she chose it because it is a reversible form of birth control that would allow her to have a family later. Many women also prefer non-hormonal forms of birth control. The Paragard IUD is non-hormonal, unlike many other IUDs.

She went to have it removed by a doctor in May, 2018. Her doctor followed the procedures outlined by the manufacturer; however, during the removal process one of the arms of the T broke off. The first attempt to remove the broken piece by means of a hysteroscopy in June 2018 was unsuccessful.

A July ultrasound ultimately located the piece in the lower right quadrant of her uterus, and in August, the missing piece was finally removed. Ms. Parker endured pain, suffering and mental anguish from the multiple procedures that it took to remove the last fragment. In addition, she is out of pocket for considerable medical expenses. Neither she nor her doctor was ever warned by the manufacturer of the danger of breakage on removal.

The legal arguments

Product liability lawsuits, like those against Teva Pharmaceuticals, are generally brought under the provisions of state law. Even on the basis of nearly identical facts, the lawsuits are likely to vary somewhat because of differences in state statutes.

Even so, the arguments generally contain several of the same basic elements:

• The Paragard IUD is a defective device, either because of a design flaw or a manufacturing flaw or both;
• Because of the defects, it is dangerous to patients;
• The corporations involved in manufacturing, designing, marketing and distributing the Paragard IUD knew about the dangers;
• They had a duty to warn patients and healthcare providers, so that they could make reasonable and informed decisions about using it;
• They failed to do so; and
• Because of that, patients were hurt.

A deep dive into the Parker complaint

The Parker complaint alleges that the facts of the case amount to eleven distinct breaches of Illinois law. Count I charges the defendants with negligence, which involves a duty to warn and the failure to do so, which resulted in harm. Counts II, III and IV allege strict liability. This means that the product was so dangerous in its design or manufacture or with respect to the warnings that could have been given, that it could not be regarded as safe in any circumstance.

Count V charges Teva Pharmaceuticals and the other defendants with common law fraud based on misrepresentations concerning the device’s safety and effectiveness. Count VI alleges negligent misrepresentation, which differs from common law fraud in that the false statement need not be intentional. This could occur, for example, if the named defendants relied on statements made by testing companies that were not accurate.

Counts VII and VIII allege breach of express and implied warranty claims. At the very least, every product sold comes with an implied warranty that it will not hurt the user if it is used as intended. Count IX alleges violations of Illinois consumer protection laws that prohibit unfair methods of competition that involve deceptive acts or practices. Count IX alleges gross negligence, and Count XI is a request for punitive damages, which is usually reserved for intentional, outrageous and shockingly bad conduct.

That, as they say, just about covers the waterfront.

Where to go from here?

All of the lawsuits, including the multidistrict litigation are still in the early stages. The cases are beginning to pile up, though. Court watchers suspect that many will be consolidated into the Philadelphia MDL. This is one to watch.