Boutte v. Stryker Biotech, LLC

67 F. Supp. 3d 732, 2014 U.S. Dist. LEXIS 175921, 2014 WL 7251162
CourtDistrict Court, M.D. Louisiana
DecidedDecember 22, 2014
DocketCivil Action No. 14-00456-BAJ-SCR
StatusPublished
Cited by12 cases

This text of 67 F. Supp. 3d 732 (Boutte v. Stryker Biotech, LLC) is published on Counsel Stack Legal Research, covering District Court, M.D. Louisiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Boutte v. Stryker Biotech, LLC, 67 F. Supp. 3d 732, 2014 U.S. Dist. LEXIS 175921, 2014 WL 7251162 (M.D. La. 2014).

Opinion

RULING AND ORDER

BRIAN A. JACKSON, Chief Judge.

Before the Court is Defendants’ Rule 12(b)(6) Motion to Dismiss for Failure to State a Claim (Doc. 12), filed by Stryker Biotech, LLC, Howmedica Osteonics Corp., and Stryker Corporation, seeking an order from this Court dismissing William F. Boutte, Jr.’s claims against them, pursuant to Federal Rule of Civil Procedure (“Rule”) 12(b)(6). Boutte opposes the motion. (Doc. 18). Stryker filed a reply memorandum in opposition. (Doc. 21). [734]*734Boutte filed a sur-reply in response. (Doc. 25). Boutte also filed an Alternative Request, pursuant to Rule 15(a), requesting leave to amend his petition should the Court grant any aspect of Stryker’s contested motion to dismiss. (Doc. 23). Oral argument was heard on December 3, 2014. (Doc. 33). The Court has jurisdictioii pursuant to 28 U.S.C. § 1332.

I. Background

William F. Boutte, Jr. (“Boutte”) commenced the instant action in the Nineteenth Judicial District for the Parish of East Baton Rouge on June 17, 2014, against Stryker Biotech, LLC, Howmediea Osteonics Corp., Stryker Corporation, and Holly K. Pisarello,1 (collectively, “Stryker”), seeking damages for injuries allegedly associated with the combination of two prescription medical devices, OP-1 Putty and Calstrux. (Doc. 1-2). On July 22, 2014,, following service of the petition, Stryker timely removed the action to the United States District Court for the Middle District of Louisiana on the basis of diversity jurisdiction. (Doc. 1). Boutte’s claims include liability for defective products, redhibitory defects, negligence, and fraud. (See Doc. 1-2).

In short, Boutte’s petition alleges that on November 15, 2006, his surgeon, Dr. Kyle Girod, “performed a Posterolateral fusion procedure” on him to address “a broken screw at his SI disc from a previous spinal fusion surgery.” (Id. at ¶¶ 90-92). The following day, “Dr. Girod performed a second spinal fusion surgery known as a two-level Anterior Lumbar Interbody Fusion,” which included implanting Boutte with “two PEEK cage (also manufactured by the Stryker Defendants), filled with a combination of OP-1 Putty and Calstrux, in his L4-5 and L5-S1 disc space.” (Id. at ¶ 93). Boutte alleges that the use of the OP-l/Calstrux mixture in his surgery resulted in serious adverse effects, including, but not limited to migration of OP-1 and Calstrux, which caused the development of unwanted ectopic bone overgrowth, nerve damage, exacerbated pain, and the need for further remedial surgery. (Id. at ¶ 96-98).

OP-1 Putty is a bone morphogenetic protein that can “stimulate, repair, and regenerate bone” by transforming cells in the body to new bone. (Id. at ¶ 18). On April 7, 2004, the Food and Drug Administration (“FDA”) granted a Humanitarian Device Exemption for OP-1 Putty for “use as an alternative to autograft in compromised patients requiring revision postero-lateral ... lumbar 'spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion.” (Id. at ¶ 20). By contrast, Calstrux is a bone void filler intended to provide a structure on which new bone may grow. (Id. at ¶ 34). Calstrux was developed “to be mixed with the OP-1 products ... to increase the volume and improve the handling qualities of OP-1.” (Id. at ¶ 29). On August 26, 2004, the FDA approved the marketing of Calstrux as “a bone filler for voids or gaps that are not intrinsic to the stability of the bony structure. It [was] indicated for surgically created osseous [bony] defects or osseous defects resulting from traumatic injury.” (Id. at ¶ 34).

Though OP-1 and Calstrux were independently approved by the FDA, the com-binatory product has never been approved, and indeed, Stryker’s application for approval was formally denied because of safety concerns. (Id. at ¶¶ 32-33, 39-48). Despite the FDA’s denial, Stryker began to promote the use of OP-1 and Calstrux [735]*735in combination for unapproved/off-label procedures. (Id. at ¶¶ 48-76).

In early 2006, Stryker’s employees and surgical consultants informed it of the adverse effects and lack of efficacy associated with the OP-l/Calstrux mixture. (Id. at ¶ 55). Several employees, including “the vice president of regulatory,” drafted a “proposed ‘Dear Doctor’ letter to warn surgeons not to mix Calstrux with OP-1.” (Id. at ¶ 59). Specifically, the letter would have cautioned surgeons to “refrain from implanting OP-1 combined with Calstrux in patients until such time that the safety and efficacy of [the] OP-1 implant combined with Calstrux is established.” (Id.). However, several sales representatives convinced the company to not send the warning letter as it would seriously affect OP-1 sales. (Id. at ¶¶ 60-65). Allegedly fearing the loss of sales, Stryker chose not to send the “Dear Doctor” letter. (Id. at ¶¶ 63-64).

With respect to the instant case, Boutte alleges that Stryker and its sales representatives “directly and indirectly promoted, trained and encouraged Dr. Girod and the hospital staff to engage in the off-label procedure of mixing Calstrux with OP-1 Putty.” (Id. at ¶ 94). Boutte asserts that as a result of Stryker’s practices, he “suffered debilitating injuries” due to Stryker’s “off-label implantation of the ineffective and unsafe Calstrux/OP-1 in his lumbar spine,” and initiated the instant action to seek redress for his injuries. (Doc. 18 at p. 6).

II. Standard of Review

A Rule 12(b)(6) motion to dismiss tests the sufficiency of the complaint against the legal standard set forth in Rule 8, which requires “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). “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 Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). “Determining 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. at 679, 129 S.Ct. 1937. “[F]acial plausibility” exists “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. at 678, 129 S.Ct. 1937 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). Hence, the complaint need not set out “detailed factual allegations,” but something “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action” is required. Twombly, 550 U.S. at 555, 127 S.Ct. 1955.

Further, the United States Supreme Court has noted that Rule 12(b)(6) requires dismissal whenever a claim is based on an invalid legal theory:

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67 F. Supp. 3d 732, 2014 U.S. Dist. LEXIS 175921, 2014 WL 7251162, Counsel Stack Legal Research, https://law.counselstack.com/opinion/boutte-v-stryker-biotech-llc-lamd-2014.