What the Mirena IUD Case Means for Expert Testimony

Womens Health

In 2011, the first personal injury complaint was made against Mirena, a plastic intrauterine device (IUD) used by over 2 million women worldwide. Manufactured by Bayer Healthcare Pharmaceuticals, one of the world’s largest pharmaceutical companies, Mirena is a T-shaped IUD coated with the hormone levonorgestrel. Designed to offer up to five years’ protection against unintended pregnancies, it is Bayer’s most popular IUD model and marketed as safe and effective.

Yet over a thousand women came forward alleging that Mirena can migrate once it is inserted into the uterus – perforating the uterus or cervix. Lawsuits allege that Bayer failed to adequately warn doctors and women about the risk of uterine perforation. Most of these women sued Bayer rather than their personal medical professionals. Their attorneys took the position that their medical side effects come from the IUD itself and not from an OB-GYN error in inserting the device.

The plaintiffs also claimed that Mirena’s label was misleading: it did not specify any necessary action other than having a doctor confirm the device’s placement. It only identified uterus perforation as a risk during the insertion, but not afterward. They allege that Bayer failed to warn patients of the risks associated with the IUD.

While marketing the drug, Bayer Healthcare sponsored “Mirena Parties” at which a nurse would make a scripted presentation on the benefits of using this IUD. Some plaintiffs claim that the different risks associated with its use were never elaborated upon. After these “parties” made their rounds, the FDA warned Bayer in writing that their marketing campaign was misrepresenting the issues with Mirena and to modify their advertising and presentations. This 2009 correspondence stated that the company had overstated Mirena’s efficiency, omitted information about its risk, and ultimately made a serious of false or misleading statements in its advertising.

Three years later, a study found that nearly half of doctors were not informed of the risks associated with the device. Bayer’s legal position, on the other hand, was that it was not aware of those side effects at the time of the marketing campaign and that they did not act irresponsibly.

Quality in expert witnesses

Expert witnesses were poised to testify that Mirena could cause uterine perforation after being inserted. The judge, however, found that these witnesses’ opinions were not supported by scientific literature and had been developed for the purpose of the lawsuit. In doing so, the defendants’ motion successfully barred these expert witnesses from even testifying.

Without established experts supporting their case, plaintiff attorneys countered that experts weren’t really needed to establish general causation. But the problem was that they had already named some to support their case. The court decided that it was well beyond the common understanding of lay jurors to discuss the uterus’s anatomy, the strength of its muscles, and the medical ramifications that could be caused by an IUD insertion procedure, and how existing technology could spot them. Thus, an expert on general causation testimony was not simply optional.  So when plaintiff counsel claimed that the Mirena IUD lawsuits were “simple soft-tissue cases” that didn’t require expert opinions, their argument fell flat.

The plaintiffs also tried to argue that a series of purported party admissions of wrongdoing under 801(d)(2) could substitute for the required expert proof.  The court, however, found that to substitute for expert testimony, it would have to be “the clearest and most unambiguous admission that the product or device in question can cause the alleged injury.” After walking through each case claiming a defendant admission, the plaintiff attorneys’ arguments still fell far short. Both individually and collectively, these admissions weren’t sufficiently clear, concrete, or detailed “to permit a jury to consider intelligently the existence, or not, of secondary perforation.”

The Mirena plaintiffs argued that the jury could and should assess what the defendants’ statements actually meant. But again, without expert testimony, a jury coming out of the general population could not be expected to have either the scientific or medical background to accurately evaluate these statements. They would speculate about whether a medical procedure could have caused the patients’ injuries, even though they had no information or training with which to make an informed decision.

This type of speculation is precisely why expert testimony is required. Without it, no jury would have a sound basis to find in favor of plaintiffs. The plaintiffs’ counsel had nothing to show they could carry their burden on general causation. A judgment was entered in favor of the defendant in all of the cases – all 1300 of them.

Legal nurse consultants: bridging the gap

How could things go so wrong for the plaintiffs when they had a damning FDA letter and study that supported their case? Clearly, drug and medical device causation calls for quality expert testimony that cannot be easily challenged in a court of law. And when it comes to medical negligence, so many health issues – both physical and emotional – are challenging to quantify.

Here is where a legal nurse consultant’s expertise is of particular value. Upon studying the files and medical records, this uniquely qualified consultant can formulate his or her own conclusions and recommend the right specialists for the case – from medical specialists to ancillary professionals like physical therapists and pharmacists. For a case like IUD negligence, an LNC would find an expert witness in obstetrics and gynecology. This OB-GYN would need to be familiar with the specific brand in order to explain that device’s specifics and any follow-up treatment. The LNC may also research literature and product issues relevant to the impending lawsuit.

With accusations of improper warnings, a legal nurse consultant can recruit a medical device labeling expert to explain the proper procedures and any existing warnings for the device. A mental health expert can best help lay jurors appreciate the full impact of the defendants’ error on the plaintiff’s life and well-being. Most importantly, both the LNC and the expert witnesses would convey both the causation and its consequences in terms that any member of the jury could understand.

While it is true that these professionals are hired to work for healthcare organizations as risk managers or risk reduction experts, they are also an enormous boon for mass torts and class action lawsuits, as well as individual suits.   Legal nurse consultants are in a unique position to build the strongest, most manageable court case for their clients – and seek justice and relief for individuals who have suffered due to medical negligence.