Bass v. Stryker Corp.

• Decision Date: 31 January 2012
• Docket Number: No. 11–10076.,11–10076.
• Citation: 669 F.3d 501
• Parties: Alton BASS, Plaintiff–Appellant, v. STRYKER CORPORATION; Stryker Sales Corporation; Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics, Defendants–Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

669 F.3d 501

Alton BASS, Plaintiff–Appellant,

v.STRYKER CORPORATION; Stryker Sales Corporation; Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics, Defendants–Appellees.

No. 11–10076.

United States Court of Appeals, Fifth Circuit.

Jan. 31, 2012.

Monica Celeste Vaughan (argued), Houssiere, Durant & Houssiere, L.L.P., Houston, TX, for Plaintiff–Appellant.

Gene Marion Williams (argued), Manuel Lopez, Martin Scott Michelman, Shook, Hardy & Bacon, L.L.P., Houston, TX, for Defendant–Appellee.

Appeal from the United States District Court for the Northern District of Texas.Before JONES, Chief Judge, HAYNES, Circuit Judge, and CRONE, District Judge.^*HAYNES, Circuit Judge:

Plaintiff Alton Bass (“Bass”) appeals from the district court's dismissal of his state-law tort claims against Stryker Corporation, Stryker Sales Corporation, and Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics (collectively, “Stryker”) pursuant to Federal Rule of Civil Procedure 12(b)(6). In his complaint, Bass alleged that a hip replacement product manufactured by Stryker malfunctioned and caused him injury. Bass argues that the district court erred in concluding that Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), forecloses his state-law claims because: (1) the Trident PSL Acetabular Shell (or “Shell”) manufactured by Stryker was not subject to pre-market approval (“PMA”) testing and therefore Riegel is inapplicable; and (2) even if Riegel is applicable, his state-law claims merely “parallel” the federal requirements and therefore are expressly allowed under Riegel. Bass also challenges the district court's holding that his claims, even if parallel, are impliedly preempted by 21 U.S.C. § 337(a). For the reasons that follow, we AFFIRM the dismissal of Bass's strict liability, design defect, negligence, and Texas Deceptive Trade Practices Act (“DTPA”) claims to the extent they are premised on a failure to warn or a marketing defect; AFFIRM as to Bass's breach of express warranty claims; and REVERSE and REMAND the following: (1) Bass's strict liability and negligence claims, to the extent they are based on manufacturing defects that violate the Food and Drug Administration's (“FDA”) Current Good Manufacturing Practices (“CGMPs”) or are inconsistent with Stryker's manufacturing processes or procedures that were approved by the FDA; (2) his claim for breach of an implied warranty to the extent it relies on the failure to comply with the FDA's requirements; and (3) his DTPA claim, to the extent that it relies on a breach of an implied warranty.

I. FACTS AND PROCEDURAL HISTORY

Alton Bass underwent left hip replacement surgery in August 2007. As a part of the surgery, the surgeon implanted a hip replacement consisting of four components, each manufactured by Stryker: (1) a Shell; (2) an Accolade TMZ Plus Hip Stem # 4.5; (3) a V40 Alumina Femoral Head; and (4) a Trident 0 Alumina Insert. Following the hip replacement, Bass allegedly began to experience pain in his left hip, despite following all of his surgeon's instructions after surgery. For the next two years, Bass complained to his surgeon about increasing pain in his left hip. Bass then underwent a revision of his hip replacement. The surgeon determined that the Shell was too loose and revised it. Bass alleges that the looseness was caused by manufacturing residuals on the Shell which prevented bony ingrowth to the Shell.

On October 23, 2009, Bass filed suit against Stryker in the Northern District of Texas, asserting diversity jurisdiction. Bass raised a number of state-law claims, including strict liability, negligence, breach of warranty, and violation of the DTPA. Stryker filed a motion to dismiss, claiming that Bass's state-law claims were preempted by the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetics Act (“FDCA”), see 21 U.S.C. § 360c et seq., and by 21 U.S.C. § 337(a). The district court granted Stryker's motion to dismiss on preemption grounds. Bass filed a timely notice of appeal.

II. STANDARD OF REVIEW

This court reviews the district court's grant of a motion to dismiss de novo. Wampler v. Sw. Bell Tel. Co., 597 F.3d 741, 744 (5th Cir.2010). All well-pleaded facts in the complaint are accepted as true and viewed in the light most favorable to the nonmovant. Jebaco Inc. v. Harrah's Operating Co., 587 F.3d 314, 318 (5th Cir.2009). Dismissal is appropriate when the plaintiff has not alleged enough facts to state a claim to relief that is plausible on its face or has failed to raise his right to relief above the speculative level. Wampler, 597 F.3d at 744.

III. DISCUSSION

A. Whether the district court erred in finding that the Shell was subject to PMA testing.

Before addressing Bass's first argument, we provide a brief overview of the statutory scheme applicable to medical devices. In response to the concern that state-law governance of medical devices was inadequate, Congress passed the MDA, giving the FDA authority to regulate medical devices and expressly preempting certain state regulations. See Riegel, 552 U.S. at 315–16, 128 S.Ct. 999; see also 21 U.S.C. § 360k.

The devices at issue in this litigation are Class III devices, which receive the most federal oversight. Riegel, 552 U.S. at 317, 128 S.Ct. 999; see also Funk v. Stryker Corp., 631 F.3d 777, 779 (5th Cir.2011) (“Trident is a Class III device under the [FDCA].”). Most Class III devices are approved by a review determining that the device is “substantially equivalent” to another device exempt from the PMA process. See Riegel, 552 U.S. at 317, 128 S.Ct. 999. This is referred to as a § 510(k) approval. Id. The remaining devices are approved through the “rigorous” PMA process. Id.

A state-law tort claim to recover for injuries allegedly caused by a medical device is preempted if: (1) “the Federal Government has established requirements applicable to [the device]”; and (2) the claims are based on state-law requirements that are “ ‘different from, or in addition to’ the federal ones, and that relate to safety and effectiveness.” Id. at 321–22, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)(1)). Devices that are approved through PMA procedures automatically satisfy the “federal requirements” prong. Id. at 322, 128 S.Ct. 999 (“Premarket approval ... imposes ‘requirements' under the MDA as we interpreted it in [ Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)].”). In contrast, the § 510(k) approval process does not impose federal requirements on a device. See Lohr, 518 U.S. at 493–94, 116 S.Ct. 2240 (“[E]ven though the FDA may well examine § 510(k) applications for Class III devices ... with a concern for the safety and effectiveness of the device, ... it did not ‘require’ Medtronics' pacemaker to take any particular form for any particular reason.” (internal citation omitted)).

Bass argues that the district court wrongfully concluded that the Shell, which malfunctioned, was subject to PMA testing. He argues that: (1) the district court was required to credit his allegation that the FDA had not granted PMA approval to the Shell as true; and (2) even if the district court was not required to accept the truth of his pleading, the district court nonetheless erred in determining that the FDA documents indicate that the FDA considered the Shell to be a part of the Trident hip replacement system. We address both arguments in turn.

1. Whether the district court erred by failing to accept Bass's allegation that the Shell was not subject to PMA testing.

The district court's decision that the Shell was subject to PMA testing was based upon publicly available documents from the FDA. Although a district court ruling on a motion to dismiss is required to accept all well-pleaded facts as true, “courts ‘are not bound to accept as true a legal conclusion couched as a factual allegation.’ ” See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986)).

We conclude that the determination of whether the Shell was subject to the PMA process is a question of law. We have held that where underlying facts are not disputed, the significance of those facts becomes a question of law. See, e.g., House v. Am. United Life Ins. Co., 499 F.3d 443, 448 (5th Cir.2007) (“We have frequently stated that the existence of an ERISA plan within the statutory definition is a question of fact.... However, where the factual circumstances are established as a matter of law or undisputed, we have treated the question as one of law to be reviewed de novo.”); AT&T Corp. v. PUC, 373 F.3d 641, 645 (5th Cir.2004) (“The material facts in this case are not in dispute, therefore we review de novo the district court's preemption decision and the interpretation of the TA96.”). Bass does not dispute that testing was done or that the documents describing the FDA's approval process are subject to judicial notice; rather, Bass's allegation asks the court to make a conclusion as to the legal significance of these tests and the FDA's subsequent approval of the Trident system. Therefore, we treat Bass's allegations that the Shell did not receive PMA testing as a legal conclusion that the district court was not required to accept as true.

2. Whether the district court erred in concluding that the FDA documents showed that the Shell was approved through the PMA process.

Bass alleges that the district court erroneously concluded that the Shell was subject to PMA testing. Bass points to statements made at the FDA public hearing in which a Stryker employee indicated that “only the ceramic inserts are under investigation in these systems.” See Medical Devices Advisory Committee, Summary Minutes of the Orthopedic and Rehabilitation Devices Panel, at 12 (July 20, 2000), available at http:// www. fda. gov/ ohrms/ dockets/ ac/ 00/ minutes/ 3633 m...