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In re Mirena IUD Products Liability Litigation

United States District Court, S.D. New York

July 2, 2014

Bayer, 13-CV-7811

Page 346

For Plaintiff: Dr. Shezad Malik, Esq., Dr. Shezad Malik Law Firm PC, Dallas, Texas.

For Plaintiffs' Liaison Diogenes P. Kekatos, Esq., Seeger Weiss LLP, New York, New York.

For Member of the Plaintiffs' Steering Committee: Daniel Gallucci, Esq., Nastlaw LLC, Philadelphia, Pennsylvania; Tina Glandian, Esq., Geragos & Geragos, Los Angeles, California.

For Defendants: Shayna S. Cook, Esq., Goldman Ismail Tomaselli Brennan & Baum, LLP, Chicago, Illinois; William P. Harrington, Esq., Bleakley Platt & Schmidt, LLP, White Plains, New York.

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CATHY SEIBEL, United States District Judge.

Before the Court is Defendants' Motion to Dismiss. (13-CV-7811 Doc. 33; 13-MD-2434 Doc. 881.) For the following

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reasons, Defendants' Motion is GRANTED IN PART and DENIED IN PART.


For purposes of this Motion to Dismiss, I accept as true the facts, but not the conclusions, as set forth in the Second Amended Complaint (" SAC" ). (13-CV-7811 Doc. 29.) I recite only those facts relevant to this decision.

Plaintiff is a resident and citizen of Indiana. (SAC ¶ 1.) Defendants are three related companies that manufacture, design, formulate and package the Mirena intrauterine device (" IUD" ). ( Id. ¶ ¶ 2, 24.) Defendant Bayer Healthcare Pharmaceuticals Inc. is a Delaware corporation with a principal place of business in New Jersey. ( Id. ¶ 3.) Defendant Bayer Pharma AG is domiciled in Germany and is Bayer Healthcare Pharmaceuticals Inc.'s parent or holding company. ( Id. ¶ 6.) Defendant Bayer OY is a Finnish company that owns the Mirena trademark. ( Id. ¶ ¶ 11-12.)

The Mirena IUD is used to prevent pregnancy, ( id. ¶ 23), and is approved to remain in the uterus for up to five years, ( id. ¶ 24). Mirena consists of a T-shaped polyethylene frame with a steroid reservoir that releases a certain amount of levonorgestrel (a synthetic hormone) per day. ( Id. ¶ ¶ 21, 23.) A healthcare provider inserts the Mirena during an office visit. ( Id. ¶ 21.) Although the warning label in effect when Plaintiff's Mirena was inserted states that Mirena may migrate out of the uterus if the uterus is perforated during insertion, it does not warn about spontaneous migration of the IUD after insertion. ( Id. ¶ 26.)

On or about April 30, 2009, a gynecologist, Dr. Cathy Carr, and a gynecological nurse practitioner, Ms. Georgia Steinman, advised Plaintiff about the risks and benefits of using Mirena for contraception. ( Id. ¶ 34.) During this office visit, Dr. Carr and Ms. Steinman examined Plaintiff and reviewed her medical history, and informed Plaintiff that she was a proper candidate for Mirena. ( Id. ¶ 35.) Plaintiff was also given a Mirena medical consent form that she read and signed, and a booklet that Defendants created to educate patients about Mirena. ( Id. ¶ 34.) Based on the information in the booklet and her conversations with Dr. Carr and Ms. Steinman, Plaintiff consented to insertion of the Mirena, ( id. ¶ 35), and the procedure was performed the same day, ( id. ¶ 36). After the procedure, Dr. Carr and Ms. Steinman told Plaintiff that the insertion had gone well and there were no complications or problems. ( Id. ¶ 37.) Plaintiff was instructed to check the Mirena strings monthly and to call her doctor's office if she experienced severe cramps, heavy bleeding or a fever over 100 degrees during the three days following insertion. ( Id.) Plaintiff did not experience, during the first three days after the Mirena was inserted, any of the complications about which she was warned. ( Id. ¶ 38.)

In early July 2011, Plaintiff began to experience nausea and intermittent vomiting, and grew concerned that she might be pregnant. ( Id. ¶ 41.) Plaintiff did not have a fever or vaginal bleeding. ( Id.) During an appointment on or about July 7, 2011, Dr. Carr told Plaintiff that the Mirena strings could not be seen, which meant that the IUD might have moved and that Plaintiff might have an ectopic pregnancy. ( Id.) Plaintiff was told that if the IUD had moved, it would have to be removed, and that Plaintiff should promptly go to an emergency room for further treatment, which would include determining whether she was pregnant, and having the IUD removed. ( Id.)

On or about July 8 and 9, 2011, emergency room doctors and staff, as well as a gynecologist, Dr. Nathalie Castillo, examined

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Plaintiff. ( Id. ¶ 42.) After a pelvic examination revealed that the Mirena strings were not visible, ( id.), further examination and testing showed that the Mirena was in Plaintiff's left lower abdomen -- in other words, that the Mirena had perforated Plaintiff's uterus and migrated into her abdomen, ( id. ¶ 43). Plaintiff also had one or more ovarian cysts. ( Id.) Dr. Castillo performed surgery to remove the Mirena from Plaintiff's abdomen. ( Id.) Plaintiff was not pregnant. ( Id.) In response to Plaintiff's questions regarding her ability to become pregnant, Dr. Castillo told Plaintiff that the Mirena had caused her cervix to thin and the ovarian cysts to form and advised Plaintiff that, if Plaintiff wished to become pregnant again, she would have to be off Mirena for some time so that her cervix could thicken and the cysts could shrink and disappear. ( Id. ¶ 44.)

Plaintiff filed this action on September 26, 2013. ( See 13-CV-7811 Doc. 1.) Plaintiff asserts several claims: defective manufacturing, design defect, negligence (in designing Mirena), failure to warn, strict liability (products liability theory), breach of implied and express warranties, negligent and fraudulent misrepresentation, and fraud by concealment. (SAC ¶ ¶ 48-122.)


A. Standard of Review

" To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell A. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). " A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. " While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555 (alteration, citations, and internal quotation marks omitted). While Federal Rule of Civil Procedure 8 " marks a notable and generous departure from the hyper-technical, code-pleading regime of a prior era, . . . it does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Iqbal, 556 U.S. at 678-79.

In considering whether a complaint states a claim upon which relief can be granted, the court " begin[s] by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth," and then determines whether the remaining well-pleaded factual allegations, accepted as true, " plausibly give rise to an entitlement to relief." Id. at 679. Deciding whether a complaint states a plausible claim for relief is " a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. " [W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged - but it has not 'shown' -- 'that the pleader is entitled to relief.'" Id. (alteration omitted) (quoting Fed.R.Civ.P. 8(a)(2)).

A defendant may raise a statute of limitations defense in a Rule 12(b)(6) motion to dismiss. Gelber v. Stryker Corp., 788 F.Supp.2d 145, 153 (S.D.N.Y. 2011) (citing Ghartey v. St. John's Queens Hosp., 869 F.2d 160, 162

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(2d Cir. 1989)).[1] The plausibility standard announced by the Supreme Court in Iqbal and Twombly applies to motions to dismiss based on statutes of limitations, see George v. Strayhorn, No. 11-CV-3701, 2014 WL 1259613, at *2 (S.D.N.Y. Mar. 24, 2014), and " the Court can only grant a motion to dismiss based on statute of limitations grounds if there is no factual question as to whether the alleged violations occurred ...

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