One of the newest Mirena IUD lawsuit has been filed recently by a woman from Georgia. Plaintiff Rebecca D. claims that she developed Mirena Migraine after using the device for approximately three months without warning. According to the complaint, Rebecca had experienced numerous episodes of painful migraine attacks lasting from thirty minutes to one hour. She further claims that during these episodes, her life has been drastically changed and she has lost significant quality of life. In addition, according to the complaint, she has lost the ability to perform the majority of her daily tasks due to her inability to sufficiently focus on them. In addition, she has suffered from a myriad of other physical ailments as a result of the defective device and its failure.
The following paragraphs summarize the major issues currently being considered in the Mirena IUD lawsuit. As previously stated, this is a very important case, with potentially huge implications for both plaintiffs and defendants. Specifically, plaintiffs contend that the manufacturer of Mirena knew about the risk of long term migraine occurrences even prior to introducing the IUD into the marketplace, yet still sold the device. Specifically, plaintiffs claim that this relates to the recall issued by the FDA in February of 2021 in which the Mirena IUD was recalled due to the presence of potentially dangerous pseudo-epilepsy behaviors.
On the opposing side, defendants assert that they did take measures to notify their patients of the risks of their product. Additionally, they maintain that their warnings, which are located on the Internet and in the patient’s physician’s office, were effective in informing their patients of the potential risks associated with the IUD. Finally, defendants maintain that there were sufficient warnings provided through direct mail and telephone communications to adequately inform their patients of the risks associated with the IUD. Accordingly, these parties seek summary judgment as to both parties’ respective claims of breach of warranty. Specifically, defendants seek an award from the Court granting them summary judgment as to whether they violated the Act or whether they properly warned their patients of the risks associated with the Mirena IUD.
Pursuant to the foregoing discussion of the merits of this case, the Court has reviewed the factual basis of plaintiffs’ complaint-fraud. In assessing this issue, the Court has concluded that there is a reasonable probability that the claim could be valid. Accordingly, the complaint should be denied consistent with the reasons underlying the denial of a Rule 11(a) motion. Accordingly, the plaintiff should submit its supplemental claim to the Court by April 1, 2021.
Accordingly, plaintiffs are also seeking another ruling as to whether the FDA’s warning of a two year statute of limitation on filing such a claim is sufficient under the circumstances. Pursuant to FDA v. Evans, 4th Circuit Judge, the plaintiff must move for summary judgment as to whether it can move forward with its claim based on the knowledge that the manufacturers of Mirena knew that their product posed a very real threat, in the form of cancer, even before the statute of limitations expired. The plaintiffs contend that the manufacturers, through their failure to warn consumers about the risks associated with their product, have engaged in fraudulent conduct. Plaintiffs further argue that, in light of the evidence that the manufacturers knew of the risks posed by their product, they should be held liable for injuries that arose as a result of those warnings.
On a side note, the plaintiff’s attorney has filed a petition for summary judgment. Assuming the truth of plaintiffs’ argument as to the likelihood of their claim being valid, and assuming the Court believes that summary judgment is appropriate, the Parties would resolve this dispute at the conclusion of this litigation. Accordingly, the parties are directed to submit their supplemental claim to the Court by April 1, 2021, if no Claim in the complaint is currently pending. This supplemental claim will contain a detailed accounting of all discovery that was made in the above-mentioned action. The date set forth in the supplemental claim is a tentative date, and not a final date.