Chambers v. Osteonics Corp., 96-1742

Decision Date03 April 1997
Docket NumberNo. 96-1742,96-1742
Citation109 F.3d 1243
Parties, 32 UCC Rep.Serv.2d 111, Prod.Liab.Rep. (CCH) P 14,909 William E. CHAMBERS and Beverly Chambers, Plaintiffs-Appellants, v. OSTEONICS CORPORATION, Defendants-Appellees.
CourtU.S. Court of Appeals — Seventh Circuit

F. Boyd Hovde (argued), Indianapolis, IN, for plaintiffs-appellants.

William P. Wooden (argued), Mary Titsworth Chandler, Wooden & McLaughlin, Indianapolis, IN, for defendant-appellee.

Before WOOD, Jr., KANNE and ROVNER, Circuit Judges.

ILANA DIAMOND ROVNER, Circuit Judge.

Osteonics Corporation ("Osteonics") designed and manufactured a hip prosthesis consisting of a hip stem, femoral head and acetabular component ("hip stem") which was used to replace William E. Chambers' ("Chambers") arthritic right hip in 1985. In 1992, Chambers slipped and fell and the hip stem fractured. Surgical replacement of the fractured hip stem cost Chambers $43,000 in medical expenses, and resulted in chronic pain and a severe limp. Before the fracture, Chambers was able to walk pain-free, with no limp, and was able to play golf. Now, Chambers requires a cane to walk the minimal distances he can handle. He can no longer play golf or engage in recreational activities that require walking. Chambers brought suit against Osteonics, claiming that the hip stem was defective and unreasonably dangerous for its intended use as a hip prosthesis because it was subject to corrosion and weakening, and was incapable of supporting the weight of the average man under reasonably expected forces. This claim was further refined as a result of discovery and the summary judgment process as will be described below. Chambers' wife, Beverly, joined the suit with claims for loss of services, society and consortium. Beverly Chambers agrees that her claims rise and fall with her husband's case.

The FDA authorized Osteonics to manufacture the hip stem, a Class III medical device, under an "investigational device exemption" (an "IDE"). Class III medical devices are those which operate to sustain human life, are of substantial importance in preventing impairment of human health, or pose a potential unreasonable risk of illness or injury. See 21 U.S.C. § 360c(a)(1)(C) and 21 C.F.R. § 860.3(c)(3). The IDE process allows a manufacturer with an experimental device to obtain FDA approval for the device with a less rigorous review process than usual. The purpose of the exemption is to encourage experimentation that would lead to new developments. See 21 U.S.C. § 360j(g). In order to obtain an IDE, a manufacturer must provide the FDA with information about, among other things, the device, its manufacture, and the experimental plan for its use. In this case, as part of the information provided to the FDA, Osteonics represented to the FDA that the metal hip stem would meet the specifications of ASTM Standard F-75, including the recommended hardness specification for that standard. Osteonics further represented to the FDA that as part of the manufacturing process, it would x-ray each newly manufactured hip stem, examine the x-ray for metallurgical and other defects, and discard any flawed hip stems. Osteonics also agreed as part of the FDA-approved manufacturing procedures that it would never discard these x-rays. The parties now dispute whether the hip stem met the hardness specification that Osteonics represented to the FDA. Chambers' experts have filed affidavits stating that testing of the hip stem on its removal from Chambers shows that the hip stem did not meet the requisite hardness, and that the hip stem contained numerous metallurgical flaws that weakened it and made it unfit for use as a hip replacement. Osteonics disagrees, but concedes for the purposes of summary judgment that whether the hip stem met the hardness standard or contained other flaws are fact questions. Moreover, Osteonics now admits that it developed a policy of discarding hip stem x-rays about six months after they were taken, rather than retaining them, as it promised the FDA it would.

In the district court, Osteonics moved for summary judgment, arguing that Chambers' claims were preempted by the Medical Device Amendments of 1976 (the "MDA"). Chambers responded that a claim arising from a defect that occurred as a result of failing to follow or negligently following the FDA-approved procedures for manufacture of the device is not preempted. Both parties submitted affidavits to the court, Chambers to show that Osteonics had been negligent in the manufacture of the hip stem, and Osteonics to show that it had followed the FDA-approved procedures. The district court granted summary judgment in favor of Osteonics, holding that all of Chambers' claims were preempted by the MDA except for the negligent manufacture claim, and that Chambers had produced insufficient evidence on that point to survive a motion for summary judgment.

On appeal, Chambers argues that the affidavits of its experts, in combination with Osteonics' disposal of the x-ray of the hip stem in contravention of the FDA-approved procedures, are enough to create a genuine issue of material fact about whether Osteonics negligently manufactured the hip stem. Chambers also argues on appeal that the strict liability claim and breach of implied warranty claim, in addition to the negligence claim, are not preempted. Osteonics, in turn, argues that all of Chambers' claims are preempted, and argues alternatively that even if the negligent manufacturing claim is not preempted, Chambers' failure to identify the particular negligence in the manufacturing process is fatal to his claim.

DISCUSSION

We review the district court's grant of summary judgment de novo. Green v. Shalala, 51 F.3d 96, 99 (7th Cir.1995). Summary judgment is appropriate when there is no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c). The two issues facing us are whether Chambers' claims are preempted, and if not, whether Osteonics has met its burden of showing that there is no genuine issue of fact and it is entitled to judgment as a matter of law. Chambers' complaint sweeps broadly, claiming that "[t]he hip stem was defective and unreasonably dangerous for its intended use as a hip prosthesis in that it was subject to corrosion and weakening with the resultant incapability of maintaining the weight of the average male person under reasonably expectable forces to the prosthesis without fracture." According to Chambers, implicit in this complaint are claims for negligent manufacture, strict liability, and breach of implied warranty.

The principle of preemption arises from the Supremacy Clause of the Constitution which states that "the Laws of the United States ... shall be the supreme Law of the Land ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. Art. VI, cl. 2. Pursuant to this authority, Congress may preempt state law. Because the intent of Congress controls on issues of preemption, "[i]f the statute contains an express preemption clause, the task of statutory construction must in the first instance focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' preemptive intent." CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664, 113 S.Ct. 1732, 1737, 123 L.Ed.2d 387 (1993). The MDA contains such an express preemption clause:

Except as provided in subsection (b) of this section, no 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 chapter 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 chapter.

21 U.S.C. § 360k. The parties here are arguing only over the first prong of the express preemption clause--whether state law claims for strict liability, breach of the implied warranty of merchantability and negligence impose requirements on Osteonics that are different from or in addition to the requirements already imposed by the MDA. Section 360k confirms that Congress intended to preempt some state law claims but does not address the scope of Congressional intent.

The Supreme Court recently analyzed the scope of preemption under the MDA with respect to devices which enter the market under the expedited "section 510(k) process" used for devices that are substantially similar to those already on the market. Medtronic, Inc. v. Lohr, --- U.S. ----, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). In identifying the domain expressly preempted by § 360k, the Court held that we must interpret the preemptive language in the context of certain presumptions about the principle of preemption. "First, because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action." Lohr, --- U.S. at ----, 116 S.Ct. at 2250. Thus, in those cases where Congress has legislated in an area traditionally occupied by the States, we begin with the presumption that the "historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Id. Second, the "purpose of Congress is the ultimate touchstone" in every pre-emption case, which requires a review of not only the pre-emption statute, but the statutory framework, and the structure and purpose of the statute as a whole. Id., --- U.S. at ---- - ----, 116 S.Ct. at 2250-51. Where language in the statute is ambiguous, and where Congress has authorized a federal agency on the matters contained in the statute, we give substantial weight to the agency's view of the statute. Id., --- U.S. at ---- - ----, 116 S.Ct. at 2255-56.

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