BRIAN A. JACKSON, Chief Judge.
Before the Court is Defendants'
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, Howmedica Osteonics Corp., Stryker Corporation, and Holly K. Pisarello,
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 S1 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-1/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 posterolateral... 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 combinatory 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
In early 2006, Stryker's employees and surgical consultants informed it of the adverse effects and lack of efficacy associated with the OP-1/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).
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:
Neitzke v. Williams, 490 U.S. 319, 327, 109 S.Ct. 1827, 104 L.Ed.2d 338 (1989) (internal citations omitted). When a complaint fails to satisfy these principles, "this basic deficiency should be exposed at the point of minimum expenditure of time and money
The Louisiana Products Liability Act ("LPLA") establishes "the exclusive theories of liability for manufacturers for damage caused by their products." La. Rev.Stat. Ann. § 9:2800.52. Thus, a claimant may not recover on the basis of any theory not set forth in the LPLA. Jefferson v. Lead Indus. Assoc., Inc., 106 F.3d 1245, 1250-51 (5th Cir.1997).
To properly state a claim under the LPLA, a plaintiff has the burden of proving that (1) the defendant is a manufacturer; (2) the damage sustained was proximately caused by a characteristic of a product that made it "unreasonably dangerous" in one of four ways; and (3) that injury resulted from a reasonably anticipated use. La.Rev.Stat. Ann. § 9:2800.54. A product may be held to be unreasonably dangerous because of: (1) defective design; (2) defective composition or construction; (3) inadequate warning; or (4) breach of an express warranty. La.Rev.Stat. Ann. § 9:2800.54(B). Boutte's petition invokes three of these four theories. Each will be considered in turn.
To state a viable claim that a product is "unreasonably dangerous in design," a plaintiff must demonstrate that at the time the product left the manufacturer's control, (1) "[t]here existed an alternative design for the product that was capable of preventing the claimant's damage;" and (2) "[t]he likelihood that the product's design would cause the claimant's damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product." La.Rev.Stat. Ann. § 9:2800.56.
Stryker contends that Boutte's design defect claim should be dismissed pursuant to 12(b)(6) because it "makes the exact type of conclusory allegations" that are impermissible under Twombly and Iqbal. (Doc. 12-1 at p. 7). Specifically, Stryker argues that Boutte has failed to allege any affirmative evidence of the existence of an alternative design. (Id.). Stryker further avers that Boutte's summary assertion that the likelihood that this "unidentified alternative design" would prevent his injury outweighs the burden of adopting the alternative design is similarly insufficient. (Id.).
In opposition, Boutte contends that his "petition provides detail[ed] allegations as to the shortcomings in the design of the combinatory OP-1/Calstrux device." (Doc. 18 at p. 14). The Court agrees. First, Boutte has alleged that the nature of the alleged defect is the deterioration of the combinatory product, which could "result in unwanted bone growth and migration of the bone to sensitive nerve areas exacerbating his pain and necessitating the need of additional surgeries." (See Doc. 1-2 at ¶¶ 95, 102). On just these facts, it appears as though Boutte has at least implicitly pled an alternative design — a combination that would not deteriorate the way the instant product mixture did.
More specifically, however, Boutte avers that the alternative design would have been to not promote the unapproved/off-label combined use of OP-1/Calstrux. (Doc. 18 at p. 15). Stated differently, the alternative design was for Stryker to "promote OP-1 as it has been approved by the FDA," and "to not impermissibly revamp OP-1's design by instructing surgeons and hospital technicians to combine it with Calstrux."
Boutte has also pled sufficient facts with respect to the second element, the likelihood that the product's design would cause the claimant's damage and that the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design. La.Rev.Stat. Ann. § 9:2800.56. Boutte alleges that after learning that the product caused "serious adverse events," and lacked "efficacy," Stryker "rejected the advice of their own employees to pull Castrux from the market." (Doc. 1-2 at ¶¶ 55, 56). Boutte further alleges that Stryker considered sending a "Dear Doctor" letter to surgeons cautioning them about the combinatory product, and specifically urging that they "refrain[] from implanting OP-1 combined with Calstrux in patients until such time that the safety and efficacy of OP-1 Implant combined with Calstrux is established," but ultimately chose not to because disclosure would "hurt the OP-1 business." (Id. at ¶¶ 59, 64). In 2009, Stryker ceased manufacturing Calstrux and removed it from the market. (Id. at ¶ 56).
As Boutte highlights in his memorandum in opposition, it bears noting that although the standards of Twombly and Iqbal certainly govern this Court's decision, neither case was a products liability suit. (Doc. 18 at p. 16). Thus, while the holdings of Twombly and Iqbal are absolutely applicable, this is a complex medical device case in which almost all of the evidence is in Stryker's possession or governed by a protective order that prohibits Boutte's counsel from publicly disclosing the documents. (Id.). Moreover, much of the evidence offered in support of Boutte's claims will almost certainly be technical in nature, and as a result, stating more specific allegations regarding defects in manufacture and design without first having the benefit of discovery and of expert analysis, may be nearly impossible at this stage. (Id.). See Winslow v. W.L. Gore & Assoc, Inc., No. 10-116, 2011 WL 866184 at *2 (W.D.La. Jan. 21, 2011) report and recommendation adopted as modified sub nom. Winslow v. W.L. Gore & Associates, Inc., No. 10-116, 2011 WL 873562 (W.D.La. Mar. 11, 2011).
To comply with Rule 8(a)(2), a plaintiff must "`give the defendant fair notice of what the ... claim is and the grounds upon which it rests.'" Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (quoting Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 103, 2 L.Ed.2d 80 (1957)). Based on the foregoing, the Court finds that Boutte's petition has met this standard at this preliminary stage. Accordingly, Stryker's motion to dismiss Boutte's design defect claim is denied.
To state a viable claim that a product is "unreasonably dangerous because of inadequate warning," a plaintiff must demonstrate
Accepting Boutte's factual allegations as true, Stryker's motion to dismiss must be denied. In his petition, Boutte asserts that the mixture of OP-1 and Calstrux "had been proven ineffective and ... the mixture of the[] two ... could lead to unwanted bone growth, leakage and other serious medical complications which would require additional surgeries to remedy." (Doc. 1-2 at ¶ 102). With respect to Boutte's own injuries, he avers that the mixture "resulted in migration" that caused "extensive and substantial unwanted/ectopic bone overgrowth, exacerbated pain and nerve damage which has caused significant pain and suffering and has negatively impacted [his] personal and professional life." (Id. at ¶ 103). Accepting these allegations as true, Boutte has demonstrated that the first element, "the product possessed a characteristic that may cause damage," is met.
Boutte has also alleged sufficient facts to establish the second element, that "the manufacturer failed to use reasonable care to provide an adequate warning of such characteristic and its danger." In his petition, he alleges that the mixture of the two products "had never been approved by the FDA." (Id. at ¶ 101). Regardless, Stryker "illegally promoted these products beyond the legal and limited uses for which they had been approved," and failed "to inform physicians, hospitals and the public regarding the limited uses for which they have been approved," or that the mixture could result in severe complications. (Id. at ¶¶ 101-102).
In support of its motion, Stryker avers that the package insert that accompanied the OP-1 Putty expressly warned of the side effect Boutte complains of — "localized ectopic or heterotopic bone formation ... outside the treatment site." (Doc. 12-1 at p. 9; Doc. 12-2). However, Boutte's petition concerns side effects resulting from the mixture of OP-1 and Calstrux, which could fairly be viewed as a third, separate product. In addition, Boutte's claim is further supported by his allegation that Stryker ultimately removed Calstrux from the market, but only after the FDA performed an inspection and issued a formal reprimand to Stryker arising out of its illegal off-label promotion and its failure to report serious adverse effects associated with the OP-1/Calstrux mixture. (Doc. 18 at p. 10-11; Doc. 1-2 at ¶¶ 56, 83-85). Given this, the Court holds that Boutte's petition contains sufficient factual matter, which, if accepted as true, states a claim of inadequate warning that is plausible on its face. Therefore, Stryker's motion to dismiss Boutte's inadequate warning claim is denied.
Finally, to state a viable claim that a product is "unreasonably dangerous because of nonconformity to express warranty," a plaintiff must demonstrate that (1) an express warranty existed, (2) he or she was induced to purchase the product due to the warranty, and (3) his or her damage was proximately caused because the express warranty was untrue. La.Rev.Stat. Ann. § 9:2800.58.
Stryker contends that Boutte's breach of express warranty claim should be dismissed, citing to an case from the Western District of Louisiana involving similar allegations of aggressive promotion of a dangerously defective product for support. (Doc. 12-1 at pp. 9-10); Kennedy v. Pfizer,
Boutte further alleges that in addition to withholding information from the medical community, Stryker's sales team and management convinced the company that issuance of a warning would undermine sales. (Doc. 1-2 at ¶¶ 58-64, 61) ("If we eliminate the ability to mix these two together, we will be in jeopardy of losing a significant portion of our core OP-1 sales."). In reliance upon Stryker's representations, Boutte's surgeon then mixed OP-1 with Calstrux and used the combinatory product in Plaintiff's surgery. (Id. at ¶¶ 71, 93, 94, 107, 124). The mixture migrated, resulting in the development of unwanted bone growth, which caused injury, damage, and significant pain. (Id. at ¶¶ 96-98; Doc. 18 at p. 17). Therefore, Boutte has pled sufficient facts to establish the elements of his breach of express warranty claim.
Finding that Boutte has plead "factual content that allows the [C]ourt to draw the reasonable inference that the defendant is liable for the misconduct alleged," Iqbal, 556 U.S. at 678, 129 S.Ct. 1937, the Court will deny Stryker's motion with respect to Boutte's breach of express warranty claim.
Under Louisiana law, a seller "warrants the buyer against redhibitory defects, or vices, in the thing sold." La. Civ.Code art. 2520.
Stryker contends that Boutte's redhibition claim must be dismissed because Boutte was not the purchaser of OP-1 or Calstrux. (Doc. 12-1 at p. 14). However, as Boutte highlights in his memorandum in opposition, Stryker makes this assertion without citation to applicable authority. (Doc. 18 at p. 18). Moreover, Stryker reiterates its contention that "the products performed as expected and Plaintiff experienced
Given that Boutte's petition states competent evidence of defect, and finding that other courts have allowed plaintiffs to proceed with redhibition claims under similar circumstances, the Court will reject Stryker's argument regarding the validity of Boutte's redhibition at this stage, and preserve Boutte's claim for further proceedings. See Harris v. Merck & Co., Inc., et al., No. 12-1446, 2012 WL 5384720 (Nov. 1, 2012) (permitting a redhibition claim by a plaintiff who took prescription medication as prescribed by her doctor against a drug manufacturer); Nelson v. Mylan Pharmaceuticals, Inc., No. 10-0592, 2010 WL 3339274 (W.D.La. Aug. 3, 2010) report and recommendation adopted by, No. 10-0591, 2010 WL 3363039 (W.D.La. Aug. 24, 2010) (allowing a redhibition claim seeking economic damages filed by survivors to proceed against manufacturers of medication).
In his memorandum in opposition, Boutte abandons his claim regarding fraud in acknowledgement that it falls outside the purview of the LPLA.
Stryker avers that like Boutte's fraud claim, his negligence claim against Defendant Stryker Corporation is precluded by the exclusivity provision of the LPLA. (Doc. 12-1 at p. 15). In opposition, Boutte contends that "in other pending litigation, the Stryker defendants have generally taken the position that only Stryker Biotech, LLC was the manufacturer for Calstrux and OP-1, and that Stryker Corporation (who is the parent company of Stryker Biotech, LLC) was not involved in the manufacturing" of the products. (Doc. 18 at pp. 19-20). Accordingly, Boutte argues that should Stryker adopt a similar position in the instant case, his negligence claim would not be subject to LPLA exclusivity, and therefore, dismissal would not be appropriate. (Doc. 18 at p. 20). Alternatively, Boutte offers that if Defendant Stryker Corporation is willing to stipulate that it was a manufacturer of OP-1 and Calstrux, and therefore subject to the LPLA, then Boutte will agree to dismiss his negligence claim as well. (Id.).
In its reply memorandum, Stryker does not agree to stipulate that Stryker Corporation is a manufacturer, but instead, reiterates that the exclusivity bar of the LPLA extends to claims against parent
Accordingly,
The motion is
