Opinion
CASE NO. 1:06-CV-526.
February 4, 2008
REPORT AND RECOMMENDATION ON MOTION FOR SUMMARY JUDGMENT
The District Court referred this matter to the undersigned United States Magistrate Judge, at Beaumont, Texas, for consideration of pretrial motions and proceedings and/or entry of a report and recommendation on dispositive motions pursuant to 28 U.S.C. § 636(b) and the Local Rules for the Assignment of Duties to United States Magistrate Judges. Defendants MTG Divestitures LLC ("MTG"), Howmedica and Pfizer Inc.'s ("Defendants") Motion for Summary Judgment [Clerk's doc. #37] is pending before the Court.
The referral of pretrial duties to a magistrate judge under 28 U.S.C. § 636(b)(1)(A) without the consent of the parties does not extend to the final determination of a motion for summary judgment. See also FED. R. CIV. P. 72(b); McGinnis v. Shalala, 2 F.3d 548, 551-52 (5th Cir. 1993); Archie v. Christian, 808 F.2d 1132, 1135-36 (5th Cir. 1987), on remand 812 F.2d 250. Accordingly, this document is submitted as a report and recommendation to the District Court under 28 U.S.C. § 636(b)(1)(B). See also Judge Heartfield's order of referral.
In the motion for summary judgment, Defendant MTG Divestitures LLC ("MTG") represents that it was incorrectly sued as Howmedica, Inc. MTG further states that it was formerly known as Howmedica Inc. and also formerly known as MTG Divestitures Inc.
Defendants also explain that Pfizer divested the stock and assets of its subsidiary, Howmedica to Stryker Corp., which formed a new separate entity named Howmedica Osteonics Corporation. MTG was formed by Pfizer and became the successor to Howmedica for purposes of satisfying judgments or paying claims for products sold by Howmedica before Pfizer divested its stock and assets. Howmedica is the entity that designed, manufactured, distributed and sought regulatory approval for the Simplex product at issue here. According to the Defendants' motion, Pfizer did not design, manufacture, engineer, market or sell the product implanted in Plaintiff. The Plaintiff has not offered any evidence suggesting otherwise.
BACKGROUND
A. Plaintiff's Claims
Plaintiff Terry Scott filed this civil action seeking recovery for personal injuries he allegedly sustained from the implantation of a medical device after he underwent hip replacement and resurfacing surgeries. In the live pleading, Plaintiff alleges that he was implanted with defective implants, specifically including Simplex P. Radioplaque Bone Cement ("Simplex"), and that he has suffered damages in the form of pain, emotional distress, loss of earnings, loss of earning capacity, and medical expenses. He has generally asserted causes of action sounding under products liability based upon the allegedly defective implants, including specific claims for strict products liability, breach of warranty, negligence, strict liability for failure to warn, misrepresentation and malice and fraud. Defendants' motion for summary judgment also explains that Plaintiff identified Defendant Wright Medical Technology Inc. ("Wright") as the manufacture of the separate femoral component — a Conserve Femoral Resurfacing Component — allegedly implanted in the Plaintiff, and MTG as the manufacture and seller of the Simplex. The Simplex bone cement is the allegedly defective product at issue before the Court for purposes of the Defendants' motion for summary judgment.
Plaintiff originally filed his claims in the 136th Judicial District Court of Jefferson County, Texas. The Defendants removed the case to this court on August 31, 2006, based upon federal diversity jurisdiction. See Notice of Removal [Clerk's doc. #1]. After Defendant Wright Medical Technology filed a motion to dismiss, the District Court directed Plaintiff to re-plead his complaint to comply with Federal Rule of Civil Procedure 9(b). On May 22, 2007, Plaintiff filed his amended petition, which is the live pleading before the Court. Defendant Wright Medical Technology Inc. again responded to that pleading with another motion to dismiss some of Plaintiff's claims and a motion for a more definite statement field pursuant to Federal Rules of Civil Procedure 9 and 12. That motion is also pending before the Court. Defendant Wright Medical also recently filed a motion for summary judgment on the merits of Plaintiff's claims, and the MTG Defendants have requested joinder in that motion. If necessary, those will be considered separately once ripe for a ruling by the Court.
B. Motion for Summary Judgment and Corresponding Briefs
The Defendants' motion for summary judgment argues that there is no genuine issue of material fact as to whether the Plaintiff's state common law claims conflict with federal preemption requirements under the Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360k. In support, the Defendants contend that the United States Food and Drug Administration ("FDA") has approved the Simplex bone cement's chemical composition, packaging and labeling. Based upon federal preemption law and the Medical Device Amendments ("MDA"), they contend that Plaintiff's state common law product liability claims are preempted by Section 360k of the MDA. The Defendants, therefore, argue that because Plaintiff's claims against them are preempted as a matter of law, Defendants are entitled to summary judgment.
After being ordered to do so by the District Court, the Plaintiff filed a response in opposition to the motion for summary judgment. See Plaintiff's Response to Defendants Pfizer Inc., Howmedica Inc., and MTG Divestittures, Inc.'s Motion for Summary Judgment [Clerk's doc. #48]. In the response, Plaintiff argues that FDA approval does not preempt a manufacturing defect when the defendant deviates from the manufacturing process approved by the FDA. He further contends that Defendants failed to comply with the FDA-approved manufacturing process and they must be held liable for that deviation. Finally, he argues that his negligence cause of action would be preempted because it is not a product liability cause of action.
See Order to Plaintiff to File Responses [Clerk's doc. #41].
The Defendants responded to the Plaintiff's arguments with a reply in support of their motion. See Reply [Clerk's doc. #49]. The Defendants contend that Plaintiff's opposing arguments fail because (1) he did not assert a claim that the Simplex bone cement deviated from FDA-approved specifications, and (2) even if he did assert that claim, there is ample evidence in the record that the Simplex bone cement was manufactured and packaged pursuant to the FDA specifications without any discrepancies between the product and the product requirement. They further reply by contending that Plaintiff's negligence claim would indeed be preempted because (1) it is based on products liability and (2) it conflicts with the determinations and requirements of the FDA, thereby necessitating preemption under federal law.
DISCUSSION
A. General Summary Judgment Standard
Summary judgment should be granted only "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED. R. CIV. P. 56(c). This rule places the initial burden on the moving party to identify those portions of the record which it believes demonstrate the absence of a genuine issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S. Ct. 2548 (1986) (quoting Rule 56(c)); Stults v. Conoco, Inc., 76 F.3d 651, 655-56 (5th Cir. 1996) (citations omitted). The movant's burden is only to point out the absence of evidence supporting the nonmovant's case. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 913 (5th Cir. 1992).
When the moving party has carried its burden of demonstrating the absence of a genuine issue of material fact, the nonmoving party bears the burden of coming forward with "specific facts showing that there is a genuine issue for trial." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). In considering a motion for summary judgment, "the evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S. Ct. 2505 (1986). However, the non-movant may not rest on the mere allegations or denials of its pleadings, but must respond by setting forth specific facts indicating a genuine issue for trial. Webb v. Cardiothoracic Surgery Assocs. of North Texas, P.A., 139 F.3d 532, 536 (5th Cir. 1998).
An issue is genuine if the evidence is sufficient for a reasonable jury to return a verdict for the non-moving party. Anderson, 477 U.S. at 255-56. The admissibility of evidence is subject to the same standards and rules that govern the admissibility of evidence at trial. Donaghey v. Ocean Drilling Exploration Co., 974 F.2d 646, 650 n. 3 (5th Cir. 1992).
Local court rules also govern consideration of motions for summary judgment. Local Rule CV-56(b) states:
Any response to a motion for summary judgment must include (1) any response to the statement of issues; and (2) any response to the "Statement of Undisputed Material Facts." The response should be supported by appropriate citations to proper summary judgment evidence as set forth below [in Local Rule CV-56(d)]. Proper summary judgment evidence should be attached to the response in accordance with the procedure contained in section (d) of this rule.
B. Federal Preemption of Plaintiff's Claims
1) Applicable Law
As discussed above, at the crux of Defendants' motion is whether, based upon Defendants' contended compliance with the FDA's pre-market approval procedure ("PMA"), the Plaintiff's common law products liability tort claims are preempted by 21 U.S.C. § 360k, the Medical Devices Amendments ("MDA") to the Food, Drug, and Cosmetic Act. See Motion for Summary Judgment, see also Martin v. Medtronic Inc., 254 F.3d 573, 575 (5th Cir.), cert. denied 534 U.S. 1078 (2002).
As the United States Court of Appeals for the Fifth Circuit explained in Martin,
"Under [the] PMA process, the manufacturer must give the FDA a "reasonable assurance" that the product is safe and effective. Although this term does not sound excessively demanding, the PMA process is rigorous. It requires manufacturers to submit detailed information regarding the safety and efficacy of their devices. This includes, among other things, full reports of all information that is known by the applicant, samples of both labeling and the device itself, and a full description of the methods and facilities used for manufacturing and installation of the device. See 21 U.S.C. § 360e(c)(1) (describing the components of a PMA application). The FDA then reviews the application, spending an average of 1,200 hours on each submission before granting marketing approval. The statutory basis for this process, and its exceptions, are set forth at length in Lohr , 518 U.S. at 477, and need not be reiterated here.Martin, 254 F.3d at 576. Martin also explains that 21 U.S.C. § 360k(a) is the preemption provision of the MDA governing the extent to which the MDA preempts state law. Id. at 577. It applies to situations arising under the PMA process. Id. Section 360k(a) states as follows:
"[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —
(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act."21 U.S.C. § 360k(a). The FDA has followed suit by promulgating regulations interpreting Section 360k. Those regulations state are codified in Title 21 of the Code of Federal Regulations. See 21 C.F.R. § 808.1, et seq.
Medtronic v. Lohr, 518 U.S. 470, 116 S. Ct. 2240 135 L. Ed. 2d 700 (1996).
Martin also explains and compares the scope of MDA preemption of state law claims regarding products subject to the Section 510(k) notification process, an exception to the far more demanding PMA review process. See Martin, at 576. The Martin Court goes on to analyze and distinguish the Section 510(k) process and the PMA process as applied to preemption after the Lohr decision. Id. at 578-79. After applying Lohr, the Martin Court reaffirmed that a medical device manufacturer's compliance with the FDA's PMA process will preempt state tort law claims brought with respect to that approved device and relating to the safety, effectiveness or other MDA requirements when the substantive requirements imposed by those claims potentially conflict with PMA approval. Id. at 585. Because the Defendants' summary judgment motion establishes that the product at issue here went through the PMA process for approval, the Court need not delve into the parameters of the less rigorous Section 510(k) process and its effect on preemption after Lohr as discussed by Martin. Finding Martin on point, the Court will apply its holding in this case involving the PMA approval process.
In Martin and other cases, the Fifth Circuit has held that product liability claims involving PMA-approved devices are preempted by Section 360k of the MDA. See Martin, at 585; see also Gomez v. St. Judge Medical DAIG Division, Inc., 442 F.3d 919 (5th Cir. 2006); Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir. 1993). Also, as cited in the Defendants' motion, the United States Court of Appeals for the Eighth Circuit and a District Court in the Western District of Louisiana have further held that state law claims involving the specific product at issue here — the Simplex bone cement — are preempted by federal law. See Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir.), cert. denied 535 U.S. 1056 (2002); Rousseau v. DePuy Orthopaedics, Inc., No. CIV A 06-0517, 2006 WL 3716061 (W.D. La. Dec. 13, 2006).
In Brooks, the Court of Appeals engages in a thorough analysis of the Simplex bone cement, explaining the history of the heavy regulation of Simplex dating to the 1970s (when it entered the market), including the FDA review and examinations, the warnings Howmedica attached to the product in accordance with the FDA's directives, and the ultimate PMA approval of the product. See Brooks, 273 F.3d at 788-791. The Court went on the analyze the plaintiff's specific state law claims for failure to warn, in addition to her argument that Howmedica failed to comply with FDA rules and regulations. Id. at 798-99. The Eighth Circuit then concluded that the specific state requirement that the Plaintiff was seeking to establish by her common law claim would interfere with the specific federal requirements set for Simplex. Id. at 799." Her claim is therefore preempted under § 360k of the MDA because it would impose a specific state requirement `different from, or in addition to' specific federal requirements." Id. The Eighth Circuit also found no showing that Howmedica violated federal regulations and accordingly affirmed the district court's decision on preemption and grant of summary judgment. Id.
Accordingly, the above cases analyzing federal preemption under the MDA in products liability cases similar to this one have found that preemption is proper under Section 360k. The Court will now apply that precedent to the facts of this case, the summary judgment evidence presented by Defendants, and Plaintiff's arguments in opposition.
2) Analysis
In this case, the summary judgment evidence clearly establishes that the Defendants' Simplex product is in compliance with the FDA's PMA process. See Exhibit 3 to Motion for Summary Judgment; Affidavit of Karen Ariemma ("Ariemma Affidavit") (Senior Regulatory Affairs Specialist for Defendant, describing approval of Simplex bone cement, FDA regulation of Simplex, Howmedica's compliance, and Simplex's classification as a Class III Pre-Market Approved Device under the MDA); see also Brooks, supra. The Ariemma Affidavit explains that "because Simplex bone cement had been subject to exhaustive FDA review in the NDA [New Drug Application] process as a requirement of its approval in October 1971, FDA regulations did not require completion of the Pre-Market Approval (PMA) process normally required before a Class III device can be sold." Ariemma Affidavit, at p. 13. This is further explained in Brooks:
Devices such as Simplex, which had been treated as drugs prior to the amendments to the 1938 Act, were automatically reclassified by the MDA as Class III medical devices. 21 U.S.C. § 360j(l)(1). The statute provided that these devices were deemed to have PMA approval if they had gone through the NDA approval process. Id. at § 360j(l)(3)(A). Beginning in 1976 Simplex was accordingly treated as a Class III medical device with PMA approval.Id. at 789. Accordingly, it is undisputed that the Simplex bone cement at issue here is treated as having PMA approval. This is supported by the Defendant's summary judgment evidence. See Ariemma Affidavit and Attached Correspondence (Letters from FDA and Department of Health, Education, and Welfare); Motion for Summary Judgment, at pp. 4-7.
Also, as explained in the Ariemma Affidavit and the Brooks case, the federal regulations were later amended to reclassify bone cement as a Class II device instead of Class III, but this change occurred more than four years after the Simplex at issue here was manufactured and distributed. See Brooks, at 789 n. 5; see also 21 C.F.R. 888.3027 The Court will accordingly treat the Simplex at issue in Mr. Scott's case as a Class III device as discussed herein, as the 2002 reclassification has no bearing on the Simplex that he has made the subject of his claims.
As discussed supra, product liability claims involving PMA-approved devices, such as the Simplex product at issue in this case, are preempted by Section 360k of the MDA. Plaintiff's claims, all sounding in state common law governing products liability and based upon the PMA-approved Simplex bone cement, fall clearly within the preemption scope of Section 360k. If he were to prevail on his claims as pled — including breach of warranty, strict products liability, negligence, failure to warn, misrepresentation and malice and fraud, all based upon the Simplex bone cement — it would result in the imposition of a state requirement which is "different from, or in addition to" the requirements and regulations already imposed by the FDA. See 21 U.S.C. § 360k(a); see also Rousseau v. DePuy Orthopaedics, Inc., No. CIV A 06-0517, 2006 WL 3716061 (W.D. La. Dec. 13, 2006) (analyzing each of plaintiff's similar claims — for breach of warranty, defective manufacture, and non-compliance with FDA-approved specifications — separately and reaching same conclusion in a case involving Simplex bone cement).
Thus, based on Brooks and the statutory language, read in conjunction with Martin and its analysis of Fifth Circuit and Supreme Court precedent, the Plaintiff's state law claims are subject to preemption under the statutory preemption language of Section 360k(a) of the MDA. The Defendants have accordingly carried their burden in establishing that they are entitled to judgment as a matter of law based on this preemption of the Plaintiff's claims in their entirety. Having done so, the Court will now turn to Plaintiff's arguments in opposition and any evidence offered in contravention.
See Lohr. see also Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir. 1993).
D) Plaintiffs' Arguments in Opposition
Because the Court has found that Defendants carried their burden in demonstrating that no issue of genuine material exists on any of Plaintiff's claims against the MTG Defendants, the burden now shifts to the Plaintiffs to set forth affirmative facts creating a genuine issue of material fact. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256 (1986). At the outset, the Court notes that the Plaintiff has provided no evidence in rebuttal of the summary judgment evidence submitted by Defendants on the preemption issue. The Ariemma Affidavit and supporting documentation which establish preemption under Section 360k(a) are uncontroverted.
Instead, Plaintiff argues that his claims are not preempted because the Defendants failed to comply with the manufacturing process approved by the FDA. See Plaintiff's Response. He contends that the FDA approval of the Simplex accordingly does not preempt his claims. In support, he cites In re Medtronic Polyurethane Insulated Pacing Lead Prod. Liability Litig., 96 F. Supp. 2d 568 (E.D. Tex. 1999). Plaintiff cites the Medtronic case for the proposition that plaintiffs can bring a cause of action based on a manufacturing defect on the grounds that the defendants failed to comply with FDA requirements regarding manufacturing.
In re Medtronic was a class action case here in the Eastern District of Texas involving allegedly defective pacemakers. In that opinion, citing much of the precedent discussed herein and applying the MDA preemption analysis and "based on the overwhelming weight of this authority," United States District Judge David Folsom held that all of the plaintiffs' state claims related to the pacemaker at issue were preempted, with the exception of the claims that hinge on a defendant's failure to follow FDA requirements. In re Medtronic, at 571.
First, the Medtronic opinion is distinguishable in that it analyzed the FDA approval process of the specific product at hand in that case — the allegedly defective pacemaker. Other cases, cited herein, have more bearing on this case in that they apply the same analysis to the exact same product at issue here — the Simplex bone cement — as discussed in detail above.
Secondly, Judge Folsom's holding in Medtronics, a correct reading of the Supreme Court's opinion in Lohr (as applied to the pacemaker at hand in that case), does not change this court's ruling because the facts and evidence set forth in this case clearly establish that the Defendants did, in fact, comply with all necessary FDA requirements during the approval process of the Simplex bone cement. In Medtronics, there was an issue of genuine fact on whether the defendants had manufactured the pacemaker in a way that materially deviated from the FDA requirements. Id. at 572. Here, the Defendants have already set forth summary judgment evidence establishing that they did follow the necessary FDA requirements in manufacturing Simplex. See Amierra Affidavit. In arguing differently, the Plaintiff's response offers no evidence opposing this conclusion. Accordingly, his argument that his claims are not preempted because the Defendants did not comply with FDA regulations fails and he has not carried his burden in overcoming summary judgment. See Littlefield v. Forney Indep. Sch. Dist., 268 F.3d 275, 282 (5th Cir. 2001) (if the defendant demonstrates the absence of a genuine issue of material fact, the plaintiff must go beyond the pleadings and designate specific facts showing there is a genuine issue for trial); see also Sorina-Washington v. Mobile Mini, Inc., No. 03-3643, 2005 U.S. Dist. LEXIS 1292, at *9, 2005 WL 221557, (E.D. La. Jan. 27, 2005) (citing Hugh Symons Group v. Motorola, Inc., 292 F.3d 466, 468 (5th Cir. 2002); Celotrex, 477 U.S. at 324) (mere conclusory allegations are not competent summary judgment evidence and are insufficient to overcome a summary judgment motion).
Even assuming, arguendo, that there was evidence creating a genuine issue of material fact on whether Defendants failed to comply with the FDA-approved manufacturing process, the Plaintiff's pleadings fail to set forth a claim that Defendants failed to comply with FDA requirements. See Amended Petition. The plaintiff cannot, in a summary judgment response, save his claims by deviating from those pled in his petition.
Finally, the Plaintiff argues that his claim for negligence is not preempted because it does not sound in products liability. This argument was addressed by the Eighth Circuit in Brooks, where the court concluded that if a jury were to find negligence in the use of a medical device which met the requirements imposed during the regulation of the device, the plaintiff's common law negligence claim would be imposing a specific state requirement which is "different from or in addition to" specific federal requirements and, thus, would be preempted. See Brooks, 273 F.3d at 799. To hold otherwise would impose state requirements in such negligence cases which would conflict with federal requirements regulating medical devices. It would also conflict with the clear purpose of the MDA in establishing national uniformity for the regulation of products. See id. at 797. The Court is accordingly unpersuaded by Plaintiff's attempt to carve his negligence claims out of the products liability claims to avoid preemption and summary judgment. All claims are based upon the allegedly defective product, and, therefore, are preempted as discussed herein.
The Plaintiff has not rebutted Defendants' presentation of the facts and law entitling them to summary judgment based on federal preemption of Plaintiff's claims. Accordingly, Defendants have established that, as a matter of law, no genuine issue exists on the federal preemption of Plaintiff's claims, and Defendants are entitled to summary judgment.
CONCLUSION AND RECOMMENDATION OF THE MAGISTRATE
The undersigned United States Magistrate accordingly recommends that the District Court grant Defendants Pfizer, Howmedica and MTG's Motion for Summary Judgment [Clerk's doc. #37]. It is further recommended that the Court dismiss Plaintiffs' claims against those Defendants with prejudice, and enter judgment for Defendants Pfizer, Inc., Howmedica, Inc., and MTG Divestitures LLC on all of Plaintiffs' claims against those Defendants.
OBJECTIONS
Within ten (10) days after receipt of the magistrate's report, any party may serve and file written objections to the findings of facts, conclusions of law, and recommendations of the magistrate judge. 28 U.S.C. § 636(b)(1)(c). Failure to file written objections to the proposed findings of facts, conclusions of law and recommendations contained within this report within ten (10) days after service shall bar an aggrieved party from de novo review by the district judge of the proposed findings, conclusions and recommendations, and from appellate review of factual findings and legal conclusions accepted by the District Court except on grounds of plain error. Douglass v. United Serv. Auto. Assn., 79 F.3d 1415 (5th Cir. 1996) ( en banc); 28 U.S.C. § 636(b)(1); FED. R. CIV. P. 72.