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Pamela Coleman, et al v. Boston Scientific Corporation

April 20, 2011

PAMELA COLEMAN, ET AL.,
PLAINTIFFS,
v.
BOSTON SCIENTIFIC CORPORATION, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Oliver W. Wanger United States District Judge

MEMORANDUM DECISION REGARDING MOTION TO DISMISS (Doc. 9)

I. INTRODUCTION.

Plaintiffs Pamela Coleman ("Coleman"), Mary Bower ("Bower"), and Kathleen Paison ("Paison") (collectively "Plaintiffs") proceed with an action for damages against Boston Scientific Corporation ("Defendant") and various Doe Defendants.

Defendant filed a motion to dismiss Plaintiffs' complaint on February 26, 2011. (Doc. 9). Plaintiffs filed opposition to the motion to dismiss on March 28, 2011. (Doc. 13). Defendant filed a reply on April 4, 2011. (Doc. 17).

II. FACTUAL BACKGROUND.

Plaintiffs are three individuals who underwent medical procedures described as "transvaginal tape, bladder sling, urethral suspension, and cystocele repair" in the United States between August 2005 and December 2006. Coleman, a resident of Bakersfield, California, underwent her procedures in December 2006. Bower, a resident of Grand Rapids, Michigan, underwent her procedure in April 2006. Paison, a resident of Westland, Michigan, underwent her procedure in August 2005. The complaint does not allege where each Plaintiff had her procedure performed.

Defendant designed, researched, developed, manufactured, tested, marketed, advertised, promoted, distributed, and sold synthetic surgical mesh devices purported to correct and restore normal vaginal structure secondary to pelvic organ prolapse. Plaintiffs' received implants of mesh devices manufactured, marketed, and sold by Defendant in connection with their respective transvaginal tape, bladder sling, urethral suspension, and cystocele repair procedures. Since implantation of the mesh devices, Plaintiffs have suffered from erosion, shrinkage, and extrusion of mesh from one or more of the mesh devices, causing urinary retention, severe persistent pain, including dyspareunia, and numerous surgical procedures to remove the mesh devices.

At all times relevant, the mesh devices were widely advertised and promoted by Defendants as a safe and effective treatment for pelvic organ prolapse, rectocele, enterocele, and stress urinary incontinence. Defendants minimized the risks posed to patients by implantation of the mesh devices. At all times relevant, Defendants knew that the devices were not safe because the mesh eroded and otherwise malfunctioned causing injuries from erosion, extrusion, infection, sepsis, chronic foreign body invasion, dense adhesions, and worsening dyspareunia. Defendants made false representations regarding the consistency, safety, reliability, and performance of the mesh devices in published literature and adverse event reports. Defendants failed to disclose to physicians, patients, or Plaintiffs that their mesh devices were subject to erosion or scar tissue formation causing injuries.

Defendants continued to promote the mesh devices as safe and effective even when no clinical trials had been done; in doing so, Defendants concealed the known risks and failed to warn of known or scientifically knowable dangers and risks associated with the mesh devices for pelvic organ prolapse, rectocele, enterocele, and stress urinary incontinence.

III. LEGAL STANDARD.

Dismissal under Rule 12(b)(6) is appropriate where the complaint lacks sufficient facts to support a cognizable legal theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir.1990). To sufficiently state a claim to relief and survive a 12(b) (6) motion, the pleading "does not need detailed factual allegations" but the "[f]actual allegations must be enough to raise a right to relief above the speculative level." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). Mere "labels and conclusions" or a "formulaic recitation of the elements of a cause of action will not do." Id. Rather, there must be "enough facts to state a claim to relief that is plausible on its face." Id. at 570. In other words, the "complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, --- U.S. ----, ----, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (internal quotation marks omitted).

The Ninth Circuit has summarized the governing standard, in light of Twombly and Iqbal, as follows: "In sum, for a complaint to survive a motion to dismiss, the nonconclusory factual content, and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief." Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir.2009) (internal quotation marks omitted). Apart from factual insufficiency, a complaint is also subject to dismissal under Rule 12(b)(6) where it lacks a cognizable legal theory, Balistreri, 901 F.2d at 699, or where the allegations on their face "show that relief is barred" for some legal reason, Jones v. Bock, 549 U.S. 199, 215, 127 S.Ct. 910, 166 L.Ed.2d 798 (2007).

In deciding whether to grant a motion to dismiss, the court must accept as true all "well-pleaded factual allegations" in the pleading under attack. Iqbal, 129 S.Ct. at 1950. A court is not, however, "required to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences." Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir.2001). "When ruling on a Rule 12(b)(6) motion to dismiss, if a district court considers evidence outside the pleadings, it must normally convert the 12(b)(6) motion into a Rule 56 motion for summary judgment, and it must give the nonmoving party an opportunity to respond." United States v. Ritchie, 342 F.3d 903, 907 (9th Cir.2003). "A court may, however, consider certain materials-documents attached to the complaint, documents incorporated by reference in the complaint, or matters of judicial notice-without converting the motion to dismiss into a motion for summary judgment." Id. at 908.

IV. DISCUSSION.

A. Product Identification

As an initial matter, Defendants contend that the complaint does not allege facts sufficient to permit identification of the particular "mesh products" underlying Plaintiffs' claims. Defendants argue that, absent identification of a specific product, the complaint fails to plead the specific facts required to raise a plausible claim for relief. (Doc. 9, MTD at 3-4). Defendants cite Timmons v. Linvatec Corp., 263 F.R.D. 582, 584-85 (C.D. Cal. 2010) and Adams v. I-Flow Corp., Adams v. I-Flow Corp., 2010 WL 1339948 *3 (C.D. Cal. 2010); 2010 U.S. Dist. LEXIS 33066, for the proposition that "if a plaintiff fails to specifically identify the product at issue in their Complaint, they [sic] ...


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