Lemelle v. Stryker Orthopaedics

Filing 22

REPORT AND RECOMMENDATIONS re 7 MOTION to Dismiss Stryker Orthopaedics and Howmedica Osteonics Corp. filed by Stryker Orthopaedics. the undersigned recommends that the Motion to Dismiss be GRANTED IN PART AND DENIED IN PART, and that plaintiffs claims under LPLA be DISMISSED. Objections to R&R due by 11/27/2009. Signed by Magistrate Judge C Michael Hill on 11/9/09. (crt,Roaix, G)

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UNITED STATES DISTRICT COURT W E S T E R N DISTRICT OF LOUISIANA J O H N JEFF LEMELLE VERSUS S T R Y K E R ORTHOPAEDICS * C I V I L NO. 09-0987 * J U D G E DOHERTY * M A G I S T R A T E JUDGE HILL REPORT AND RECOMMENDATION O N MOTION TO DISMISS P e n d in g before the undersigned for report and recommendation is the Motion to Dismiss S tryk e r Orthopaedics and Howmedica Osteonics Corp. filed by Stryker Orthopaedics (" S tryk e r" ) on August 26, 2009 [rec. doc. 7]. Plaintiff, John Jeff Lemelle ("Lemelle"), filed o p p o s itio n . [rec. doc. 16]. Stryker filed a reply brief. [rec. doc. 20]. For the following reasons, it is recommended that the motion be GRANTED IN PART AND DENIED IN PART. Background L e m e lle filed a Petition for Damages and/or Redhibition in the 27 th Judicial District C o u rt, St. Landry Parish, La., on May 12, 2009, alleging that he was damaged as a result d e f ec tiv e hardware manufactured by Stryker which was used in his 2004 right hip replacement su rge ry. [rec. doc. 1, II]. The petition further alleges that on March 3, 2008, Lemelle's s u rg e o n , Dr. John Cobb, received a letter dated February 28, 2008, from Stryker indicating that th e Trident Hemispherical Acetabular Shells and Trident PSL Acetabular Shells used in L e m e lle 's procedure had been recalled. [rec. doc. 1, III]. Lemelle asserts that on May 13, 2 0 0 8 , he had to undergo a second surgery to replace the cut and screws in his right hip, which c a u s e d him damages. On June 17, 2009, Stryker removed the case to this Court on the basis of federal diversity ju ris d ic tio n . On August 26, 2009, Stryker filed the instant motion to dismiss on the basis that p la in tif f 's state law claims related to the TridentTM System total hip prostheses (the "Trident s ys te m ") were preempted by federal law. L a w and Analysis S ta n d a r d for Motion to Dismiss In deciding a Rule 12(b)(6) motion to dismiss, the court "accepts all well-pleaded facts a s true, viewing them in the light most favorable to the plaintiff." Guidry v. American Public L ife Ins. Co., 512 F.3d 177, 180 (5 th Cir. 2007) (citing In re Katrina Canal Breaches Litig., 495 F .3 d 191, 205 (5th Cir. 2007), petition for cert. filed, (U.S. Nov. 26, 2007) (No. 07-713)). The p la in tif f must plead "enough facts to state a claim to relief that is plausible on its face." Id.; Bell A tl. Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1974, 167 L.Ed.2d 929 (2007). "Factual a lle g a tio n s must be enough to raise a right to relief above the speculative level, on the a ss u m p tio n that all the allegations in the complaint are true (even if doubtful in fact)." Id. at 1 9 6 5 (citation and footnote omitted). In resolving a Rule 12(b) motion, the court is generally limited to considering only those a lleg a tio n s appearing on the face of the complaint. Cyrio v. Hunt, 2007 WL 2772222 at * 4 (E .D . La. Sept. 19, 2007). However, matters of public record, orders, items appearing in the 2 re c o rd of the case and exhibits attached to the complaint may be taken into account. Id. (citing C h e ste r County Intermediate Unit v. Pennsylvania Blue Shield, 896 F.2d 808, 812 (3rd C ir.1 9 9 0 )). "Documents that a defendant attaches to a motion to dismiss are considered part of th e pleadings if they are referred to in the plaintiff's complaint and are central to [the] claim." C a u s e y v. Sewell Cadillac-Chevrolet, Inc., 394 F.3d 285, 288 (5th Cir.2004) (citing Collins v. M o r g a n Stanley Dean Witter, 224 F.3d 496, 498-99 (5th Cir.2000)). P r e e m p tio n S tryk er argues that Lemelle's claims are preempted by the U.S. Supreme Court's d e c is io n in Riegel v. Medtronic, 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Riegel h e ld that the Medical Device Amendments of 1976, 21 U.S.C. 360c et seq. ("MDA"), to the F e d e ra l Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq. ("FDCA"), bars common law c la im s challenging the safety and effectiveness of a medical device given premarket approval (" P M A " ) by the Food and Drug Administration ("FDA"). Specifically, the Supreme Court held th a t plaintiff's New York common law claims of negligence, strict liability, and implied w a rra n ty against the manufacturer, Metronic, were preempted under the MDA. Based on R ie g e l, Stryker argues, Lemelle's Louisiana law product liability claims related to the Trident s ys te m are preempted. The FDCA has long required FDA approval for the introduction of new drugs into the m a rk e t. Riegel, 128 S.Ct. at 1002-1003. Until the statutory enactment of the MDA in 1976, the in tro d u c tio n of new medical devices was left largely for the States to supervise as they saw fit. 3 Id . (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (19 9 6 )). W ith the passage of the MDA, Congress swept back some state obligations and imposed a regime of detailed federal oversight. Under the MDA, medical devices are classified in three c a te g o rie s , depending on the risks they present to the public. Gomez v. St. Jude Medical Daig D i v . Inc., 442 F.3d 919, 929 (5 th Cir. 2006). "Devices that present no unreasonable risk of illn e ss or injury are designated Class I and are subject only to minimal regulation by `general c o n tro ls .' " Medtronic, Inc. v. Lohr, 518 U.S. 470, 476-77, 116 S.Ct. 2240, 135 L.Ed.2d 700 (19 9 6 ) (citing 21 U.S.C. 360c(a)(1)(A)). "Devices that are potentially more harmful are d e sig n a te d Class II" and must comply with a set of regulations coined "special controls." Lohr, 5 1 8 U.S. at 477, 116 S.Ct. 2240 (citing 21 U.S.C. 360c(a)(1)(B)). Devices that present "a p o te n tia l unreasonable risk of illness or injury" or which are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in p rev en tin g impairment of human health" are designated Class III. 21 U.S.C. 360c(a)(1)(C). T h e Trident system is a Class III medical device, meaning that it had received the highest level o f federal oversight provided by the FDA. Hofts v. Howmedica Osteonics Corporation, 597 F .S u p p .2 d 830 (S.D. Ind. 2009); Covert v. Stryker Corp., -- F.Supp.2d --, 2009 WL 2424559 (M .D .N .C . Aug. 5, 2009); Parker v. Stryker Corp., 584 F.Supp.2d 1298, 1300 (D.Colo. 2008). 4 B ef o re a Class III device may be put on the market, the manufacturer must give the FDA " re a s o n a b le assurance" that the device is both safe and effective. Gomez, 442 F.3d at 928 (c itin g 21 U.S.C. 360e(d)(2)). A manufacturer provides "reasonable assurance" through the P M A process. Id. The PMA process requires the manufacturer to "submit detailed information re g a rd in g the safety and efficacy of their devices, which the FDA then reviews, spending an a v e ra g e of 1,200 hours on each submission." Id. (quoting Lohr, 518 U.S. at 477, 116 S.Ct. 2 2 4 0 . Significantly, the FDA's involvement with the devices continues even after the PMA is c o m p le te . See, e.g., 21 C.F.R. 814.80 (prohibiting the production or labeling of any device in a manner inconsistent with any conditions of approval specified in the approval order); 21 C .F .R . 814.3a(d) (requiring an applicant to submit a supplemental application setting forth any p rop o sed changes for FDA approval before implementing any changes). C o n g r e s s provided two exceptions to the PMA process. First, a grandfather clause p e rm its medical devices marketed before passage of the amendments to remain unless and until th e FDA initiates and completes the PMA process. See Lohr, 518 U.S. at 478, 116 S.Ct. 2240 (citing 21 U.S.C. 360e(b)(1)(A); 21 C.F.R. 814.1(c)(1)). Second, devices that are " s u b s ta n t ia ll y equivalent" to a preexisting medical device are exempt from the PMA process a n d instead subject to a streamlined approval process.1 See Lohr, 518 U.S. at 492-94, 116 S.Ct. 2 2 4 0 (describing the significant differences between the PMA and the "substantially similar" p roc ess under 510(k)); 21 U.S.C. 360e(b)(1)(B). 1 This is also known as the "501(k) process," named after the subsection in the original act. 5 T h e MDA includes an express preemption provision that states: " E x c e p t as provided in subsection (b) of this section, no State or political s u b d iv is io n of a State may establish or continue in effect with respect to a device in ten d e d for human use any requirement" ( 1 ) which is different from, or in addition to, any requirement applicable under th is chapter to the device, and " (2 ) which relates to the safety or effectiveness of the device or to any other m a tte r included in a requirement applicable to the device under this chapter." 3 6 0 k (a). (em p h asis added). T h e Fifth Circuit has held that the PMA process "preempts state tort causes of action to th e extent that they relate to safety, effectiveness, or other MDA requirements" if the state-law c la im s impose "substantive requirements" different from, or inconsistent with, the federal law. G o m e z , 442 F.3d at 929 (citing Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001)). M a rtin involved a Class III medical device (Medtronic's pacemaker) subject to the PMA p ro cess. There, the court held that the PMA requirements preempted Texas state p ro d u c t-lia b ility tort claims arising from a Class III medical device, including claims of d e f ec tiv e design, failure to warn, and inadequate labeling, because those claims related to areas s p e c if ic a lly covered in the PMA process and sought to impose requirements that were "different f ro m and, indeed, conflict with" the results of the PMA process. Martin, 254 F.3d at 584. T h e Fifth Circuit requires the district court to look through the general duties imposed b y the state-law causes of action and consider the effect a successful lawsuit asserting those c a u s e s of action would have and determine whether they threaten the federal PMA process 6 re q u ire m e n ts . Gomez, 442 F.3d at 930. Stryker argues that Lemelle's claims of defect under state law are governed by the L o u is ia n a Products Liability Law ("LPLA"), LA. REV. STAT. 9:2800.51 et seq., which is p ree m p ted by the MDA. [rec. doc. 7, pp. 10-11]. The Fifth Circuit has held that the MDA's e x p re ss preemption provision precludes most product liability claims when the product was a p p r o v e d through the PMA process. Gomez, 442 F.3d at 932 (MDA preempted strict liability d ef ec tiv e design and negligent design causes of action under LPLA). L e m e lle acknowledged both in his brief and at oral argument that his state-law product lia b ility claims are preempted by the MDA. Thus, the unsigned recommends that the motion to dismiss be granted as to plaintiff's claims under LPLA. H o w e v e r, Lemelle argues that his redhibition claim under LA. CIV. CODE art. 2520 et s e q . is not preempted. [rec. doc. 16, p. 4]. Specifically, Lemelle argues that his redhibition c la im is not preempted because it does not seek to impose different or additional requirements, b u t only parallels the federal requirements of the MDA. In Riegel, the Supreme Court noted that " 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in s u c h a case `parallel,' rather than add to, federal requirements."). 128 S.Ct. at 1011 (citing L o h r , 518 U.S. at 495, 116 S.Ct. at 2255). Thus, this Court must determine whether Lemelle's re d h ib itio n claim is based on Louisiana requirements that are "different from, or in addition to" th e federal requirements. 7 C o u rts are divided as to whether implied warranty claims are preempted. Gomez, 442 F .3 d at 931 (claim for breach of implied warranty under Louisiana law preempted by MDA)2 ; I n re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2d 1147, 1161 (D .M in n .2 0 0 9 ) (finding breach of express and implied warranty claims, fraud claims and claims f o r deceptive trade practices preempted); Horowitz v. Stryker Corp., 613 F.Supp.2d 271 (E .D .N .Y . Feb.20, 2009) (breach of express warranty, implied warranty of fitness and implied w a r ra n t y of merchantability claims, as well as state-law claim for deceptive trade practices, p re e m p ted ); Parker, supra (breach of express warranty, implied warranty of fitness and implied w a rra n ty of merchantability claims preempted); but cf. Hofts (no preemption found). L e m e lle relies on Hofts, a case also involving the Trident system, to support the position th a t his redhibition claim survives preemption. There, the judge noted that Riegel allows a State to provide a damages remedy for violations of common-law duties when those duties "parallel" f e d e ra l requirements. He determined that, under 21 U.S.C. 360k(a)(1), Riegel, and Lohr, the co u rt had to decide whether plaintiffs' tort, warranty and criminal commercial fraud claims were b a se d on state law requirements which were "different from, or in addition to" the federal re q u ire m e n ts . Id. at 835. In holding that these Indiana state law claims were not preempted, th e court reasoned as follows: A claim for breach of implied warranty arises under the redhibition chapter and allows recovery for damage to the product itself and economic loss. Ivory v. Pfizer, Inc., 2009 WL 3230611, at *7 (W.D. La. Sept. 30, 2009); Dawson Farms, L.L.C. v. BASF Corp., et al, 2008 WL 5220517, at *2 (W.D.La. Dec. 12, 2008). 2 8 ... [T]he specific tort claims addressed in Riegel were not based on the defendant's a lle g e d failure to follow federal requirements, but instead were based on the p la in tif f s' allegations that Medtronic had breached state tort duties even though it had complied with federal requirements. Riegel, 128 S.Ct. at 1006, 1011. H e re it is clear that Hofts bases his tort claims on his allegations that Howmedica f a ile d to meet the FDA's requirements, not on allegations that Howmedica failed to depart from or exceed those requirements. A jury could find that Howmedica b r e a c h e d the duty of care it owed to Hofts by failing to adhere to the FDA's m a n u f ac tu rin g requirements without imposing different or additional re q u ire m e n ts . See Lohr, 518 U.S. at 495, 116 S.Ct. 2240. Similarly, on Hofts' s tric t liability claim, a jury could find that Howmedica's deviation from the FDA's m a n u f a c tu rin g requirements was unreasonably dangerous without imposing d if f e re n t or additional requirements. If supported by the evidence, these results w o u ld be entirely consistent with the legal presumption that the FDA "got it r ig h t" in setting those requirements. A jury verdict could simply enforce those sam e federal requirements. The only state law requirements implicit in Hofts' tort c la im s are thus identical or parallel to the FDA's federal requirements under R ie g e l, so that Hofts' state tort claims are not preempted under section 360k(a). Id . at 836-837. In finding that Hofts' claims were not preempted, the judge distinguished In re Metronic, s u p r a , which is also relied upon by defendants here. There, plaintiffs argued that their state law c la im s , including products liability, negligence per se, breach of express warranty, and breach o f implied warranty, were parallel to the federal MDA requirements and were not preempted. T h e court found that plaintiffs' had failed to allege in detail the federal requirements purportedly v iolated by Metronic under Twombly, reasoning as follows: M e re ly alleging that Medtronic failed to comply with the CGMPs/QSR by using sp o t welding is insufficient without some factual detail about why that violates f e d e r a l standards. Id. Instead, Plaintiffs were required to point to something in the C G M P s / Q S R precluding the use of spot welding in order to state a m a n u f ac tu rin g -d e f ec t claim that is "plausible on its face." Id. at 1974. (e m p h a s is in original). 592 F.Supp.2d at1158 (citing and quoting Twombly, 127 S.Ct. at 19649 6 5 , 1974). The Hofts court found that this was "an unusually stringent application of Twombly a n d Rule 8 of the Federal Rules of Civil Procedure at the motion to dismiss stage." Id. at 838. H e re , plaintiff captioned his complaint "Petition for Damages and/or Redhibition." [rec. d o c . 1, Exhibit A]. In the complaint, he specifically pled that "[t]he redhibitory vices and d e f ec ts in the products were peculiarly within the knowledge of the defendant, who m a n u f ac tu re d the products but were not disclosed to the petitioner prior to his surgery in 2004. F u r th e r , petitioner would not have agreed to the surgery had he known of the defective p ro d u c ts." [rec. doc. 1, Exhibit A, IV). Thus, the court finds that plaintiff has sufficiently p led his redhibition claim under Twombly and FED. R. CIV. P. 8. A s to whether Lemelle's redhibition claim is preempted by MDA, the Fifth Circuit has s p e c if ic a lly addressed this issue. In Piptitone v. Biomatrix, 288 F.3d 239 (5 th Cir. 2002), Mr. P ip ito n e and his wife filed suit alleging causes of action arising under Louisiana tort, products lia b ili ty, and redhibition laws after Pipitone developed a salmonella infection in his knee f o llo w in g an injection with Synvisc, a Class III device under the MDA. On summary judgment, th e district court held that the MDA preempted plaintiff's claims for design defect, inadequate w a rn in g , and noncomformity with express warning under the LPLA, and therefore, dismissed th e se claims with prejudice. However, the district court allowed the plaintiffs' claims for m a n u f a c tu rin g defect and redhibition to proceed. The Fifth Circuit concluded that plaintiffs' redhibition claim survived summary ju d g m e n t. Id. at 250. Next, the court addressed the issue of whether plaintiffs' recovery for 10 d a m a g e s under the Louisiana redhibition law was limited to economy loss only. The court held th a t the district court properly limited the scope of plaintiffs' redhibition claims to economic lo s s only, but remanded the case, allowing it to proceed on the Louisiana redhibition claim. Id. a t 251-52. Considering the Fifth Circuit's opinion in Pepitone 3 , and the Court's reasoning in Hofts, w h ic h the undersigned finds persuasive, the undersigned finds that plaintiff's claim for re d h ib itio n is not preempted by the MDA. The Louisiana redhibition statute provides a private c a u se of action for the alleged failure of the defendant to comply with FDA requirements, but n o thing else. Further, I find that it would be unfair, and violative of Rule 8, to dismiss plaintiff's claim at the pleadings stage. Accordingly, I recommend that the motion to dismiss plaintiff's re d h ib itio n claim be denied. Conclusion B a s e d on the foregoing reasons, the undersigned recommends that the Motion to Dismiss b e GRANTED IN PART AND DENIED IN PART, and that plaintiff's claims under LPLA b e DISMISSED. U n d e r the provisions of 28 U.S.C. 636(b)(1)(C) and F.R.Civ.Proc. 72(b), parties a g g rie v e d by this recommendation have ten (10) business days from service of this Report and R e c o m m e n d a t io n to file specific, written objections with the Clerk of Court. A party may Apparently, both parties in Pepitone agreed that the FDA approval process did not protect the defendant from claims of defective manufacture or construction. The Fifth Circuit saw no reason to disagree, nor does the undersigned. 3 11 re sp o n d to another party's objections within ten (10) days after being served with a copy th e re o f . Counsel are directed to furnish a courtesy copy of any objections or responses to the D is tric t Judge at the time of filing. F A I L U R E TO FILE WRITTEN OBJECTIONS TO THE PROPOSED FACTUAL F I N D I N G S AND/OR THE PROPOSED LEGAL CONCLUSIONS REFLECTED IN T H IS REPORT AND RECOMMENDATION WITHIN TEN (10) DAYS FOLLOWING T H E DATE OF ITS SERVICE, OR WITHIN THE TIME FRAME AUTHORIZED BY F E D .R .C I V .P . 6(b), SHALL BAR AN AGGRIEVED PARTY FROM ATTACKING THE F A C T U A L FINDINGS OR THE LEGAL CONCLUSIONS ACCEPTED BY THE D I S T R I C T COURT, EXCEPT UPON GROUNDS OF PLAIN ERROR. DOUGLASS V. U N IT E D SERVICES AUTOMOBILE ASSOCIATION, 79 F.3D 1415 (5TH CIR. 1996). S ig n e d this 9 th day of November, 2009, at Lafayette, Louisiana. 12

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