Tag Archives: bayer iud lawsuit

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.