Tag Archives: Mirena

Mirena, IUD

Defective Product Lawsuit Against Bayer Fails Without Medical Expert Testimony

A defective medical products claim with 1,300 joint female plaintiffs has been dismissed four months after a New York federal judge prohibited medical expert witnesses from testifying.  The case has limped along since the plaintiffs suffered a devastating ruling against their expert testimony this year before finally being put to rest last week for lack of evidence against the device manufacturer.

High Profile Defective Device Lawsuit Dismissed in New York Federal Court

US District Judge Cathy Seibel in New York dismissed a complaint filed by 1,300 women against medical device manufacturer Bayer for lack of evidence the company caused the plaintiffs’ injuries.  The claim originated from complaints about Bayer’s Mirena intra-uterine contraceptive device (IUD) which allegedly perforates women’s uteruses after it has been surgically inserted.  According to the plaintiffs, the Bayer Mirena IUD caused internal injuries after surgery, and the company failed to provide warning about that possibility when it marketed the product to surgeons and patients.

Bayer has not denied the fact that the 1,300 plaintiffs suffered internal injuries, but responded to the complaint by arguing that the damage occurred during surgical insertion and is therefore the responsibility of the doctors and hospitals rather than the company.  The company also warns about the possibility of uterus perforation during insertion, and argues the plaintiffs understood the risks associated with the product.  Bayer has maintained the position that the Mirena IUD is not defective throughout the lawsuit, and successfully argued for a dismissal last week by showing that the plaintiffs failed to provide evidence that injuries occurred after surgical insertion due to a defect in the device.

Bayer’s argument for dismissal was made easier in March when Judge Seibel dismissed expert witnesses hired by the plaintiffs to argue that the Mirena IUD can cause internal damage.

Plaintiffs in Bayer IUD Case Lose Expert Witness Testimony

At the outset of the case, the 1,300 plaintiffs hired medical expert witnesses to conduct an analysis of the types of injuries they suffered and Bayer’s Mirena IUD product to see if a defect contributed to their harm.  The plaintiffs’ expert witnesses included two ob-gyn professionals and a uterine physiologist who were prepared to testify that the uterus perforation occurred after the IUD’s were inserted due to a defect in the design and manufacture.  After reviewing the content of the proposed expert testimony, Judge Seibel banned four of the experts from testifying at all and severely limited two others to the point where they would have been of very little help to the plaintiffs’ case.

According to Judge Seibel, several of the Bayer IUD plaintiffs’ experts were unqualified to speak on the issue, and those who were offered opinions and hypotheses rather than proven fact.  The judge determined that the expert testimony was not based on sound scientific findings, but instead on anecdotal theories prepared specifically for the litigation by a collection of medical professionals.  Under the Daubert standard of expert witness testimony used in federal courts, the plaintiffs’ experts could not be allowed to testify without providing scientifically accepted research.

Judge Seibel further weakened the plaintiffs’ position by allowing several of Bayer’s expert witnesses to testify because they had documented medical research regarding the performance of the company’s Mirena IUD.

Bayer Mirena IUD Lawsuit Fails after Lawyers Forego Expert Testimony

Rather than abandon the case or seeking other qualified experts after Judge Seibel’s decision against the plaintiffs’ expert witnesses in March, attorneys representing the women decided to pursue the case without medical expert support.  According to the attorneys, Bayer’s admission that the women’s harm was caused by the Mirena IUD was sufficient to prove liability, despite the fact that Bayer argued the injuries occurred during insertion – something the company warned about and was not liable for.

Ultimately the strategy to move forward without viable and qualified medical expert witnesses failed, and the dismissal of the complaints against Bayer last week confirms an outcome that many have suspected was forgone.  The failed lawsuit against Bayer’s Mirena IUD provides a cautionary tale to plaintiffs and their attorneys that defective product lawsuits are unlikely to succeed without qualified medical expert testimony.  Medical experts must be ready to provide testimony which is supported by scientific research, not prepared specifically for the trial, and backed by the expert’s qualifications in the field.

Mirena, IUD

Expert Witnesses Barred In Mirena IUD Case

The plaintiffs in a lawsuit against Bayer Healthcare recently faced a legal hurdle when four of their expert witnesses were barred from testifying. Bayer Healthcare is the maker of the Mirena intrauterine device or IUD, a contraceptive. Plaintiffs claim that the Mirena IUD can puncture the uterus and end up elsewhere in the body.

Plaintiffs in the lawsuit are 1,200 women who filed lawsuits against Bayer Healthcare. These lawsuits were consolidated. The women bringing these suits claim that Bayer failed to warn of the risk that the IUD could puncture the uterine wall, an injury called a secondary perforation. A secondary perforation is a risk even when it is inserted correctly by a physician.

Expert Witnesses

Plaintiffs’ expert witnesses included two ob-gyn witnesses and a uterine physiologist. Judge Cathy Seibel ruled that plaintiffs’ experts were either unqualified to testify, unreliable, or both. She allowed two of plaintiffs’ other experts, but limited the scope of their testimony. She also limited the scope of two of Bayer’s witnesses. Judge Seibel found that excluded witnesses’ testimony was based on hypothesis rather than scientific evidence. She stated that one of the experts “was given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it might occur” and criticized another expert’s opinions for lack of support by the medical community.

Bayer contends that these women have no case because they haven’t shown that they were injured or that the Mirena IUD is to blame. On May 4, 2016, Bayer filed a motion for summary judgment, arguing that the plaintiffs will not be able to prove that the IUD could puncture the uterine wall, even if properly inserted, because nearly all of their experts have been excluded.

The Case

The women argue that they can prove their case without experts and assert that Bayer’s own admissions about the dangers of Mirena are enough to prove their case. They state that “[f]or years, Bayer has admitted – everywhere but in the courtroom – that Mirena can perforate the uterus after being properly inserted.” They argue that “A party’s admissions are admissible evidence, and when such evidence shows that a defendant has admitted general causation — that is, admitted that the complained — of injury can occur – no expert testimony on that subject is required.”

In January 2013, the FDA approved Bayer’s IUD called “Sklya,” a slightly smaller version of Mirena. Sklya comes with a warning label that warns that uterine perforation may occur “most often during insertion” but may not be detected until later. This same language was approved for use on Mirena’s label in May 2014. Bayer has also been using same warning message for Mirena since 2010 in Canada.

One of the experts who was excluded by the court, Dr. Roger C. Young, opined that Mirena can exert a force of 390 pounds per square inch, which is enough force to puncture the uterus.

The case is still pending as In re: Mirena IUD Products Liability Litigation, case number 7:13-md-02434, in the United States District Court for the Southern District of New York.