Oja v. Howmedica, Inc.

• Decision Date: 16 April 1997
• Docket Number: 95-1104,95-1123,Nos. 95-1085,s. 95-1085
• Citation: 111 F.3d 782
• Parties: , Prod.Liab.Rep. (CCH) P 14,912, 97 CJ C.A.R. 560 Maureen G. OJA, Plaintiff--Appellee/ Cross--Appellant, v. HOWMEDICA, INC., a Delaware corporation, Defendant--Appellant/ Cross--Appellee. Product Liability Advisory Council, Inc.; Health Industry Manufacturers Association; Association of Trial Lawyers of America, Amici Curiae.
• Court: U.S. Court of Appeals — Tenth Circuit

Page 782

111 F.3d 782

65 USLW 2760, Prod.Liab.Rep. (CCH) P 14,912,

97 CJ C.A.R. 560

Maureen G. OJA, Plaintiff--Appellee/ Cross--Appellant, v. HOWMEDICA, INC., a Delaware corporation Defendant--Appellant/ Cross--Appellee Product Liability Advisory Council, Inc.; Health Industry Manufacturers Association; Association of Trial Lawyers of America, Amici Curiae.

Nos. 95-1085, 95-1104, 95-1123.

United States Court of Appeals Tenth Circuit.

April 16, 1997.

Malcolm E. Wheeler, Parcel, Mauro, Hultin & Spaanstra, Denver, CO, appearing for Defendant-Appellant/Cross-Appellee.

Elizabeth C. Moran, Pryor, Johnson, Montoya, Carney & Karr, Englewood, CO (Peter W. Pryor, Pryor, Johnson, Montoya, Carney & Karr, Englewood, CO, and Thomas L. Roberts, Roberts & Zboyan, Denver, CO, with her on the briefs), appearing for Plaintiff-Appellee/Cross-Appellant.

Robert N. Weiner and Steve J. Boom, Arnold & Porter, Washington, DC, and Hugh Young, Jr., Product Liability Advisory Council, Inc., Reston, Virginia, for amicus curiae Product Liability Advisory Council, Inc.

Bruce N. Kuhlik and Jennifer A. Johnson, Covington & Burling, Washington, DC, and Donnellda Rice, Health Industry Manufacturers Association, Washington, DC, for amicus curiae Health Industry Manufacturers Association.

Pamela A. Liapakis, President, Association of Trial Lawyers of America, Washington, DC and Jeffrey Robert White, Washington, DC, for amicus curiae Association of Trial Lawyers of America.

Before TACHA, BRISCOE, and MURPHY, Circuit Judges.

TACHA, Circuit Judge.

Maureen Oja brought a products liability action against Howmedica, Inc., the manufacturer of a prosthetic hip replacement system, asserting three claims relevant to this appeal: (1) negligence, (2) negligent failure to warn, and (3) strict liability. At the close of the plaintiff's case, the district court granted The jury returned a general verdict for Howmedica on the negligence and remaining strict liability claims. The jury, however, found for Oja on her negligent failure to warn claim. The jury awarded Oja $896,921 in compensatory and $896,921 in punitive damages. The district court reduced the damage award to $448,460.50 and $612,535.96, respectively, and awarded Oja prejudgment interest from the date the action accrued.

Howmedica's motion for a directed verdict on Oja's strict liability manufacturing defect claim. The court, however, permitted Oja to proceed with her strict liability claims based on design and warning defects.

On appeal, Howmedica argues that: (1) the Medical Device Amendments of 1976 ("MDA") preempts Oja's negligent failure to warn claim; (2) the jury's finding of negligent failure to warn is inconsistent with its verdict for Howmedica on the strict liability and negligence claims; (3) the district court erred in submitting both a "negligence" and "negligent failure to warn" claim to the jury without properly instructing the jury about the elements and burdens of proof on each claim; and (4) punitive damages cannot be awarded as a matter of law because the evidence was insufficient to show that Howmedica acted wantonly or recklessly.

In her cross-appeal, Oja raises two issues. Oja argues that the district court erred in (1) dismissing her strict liability claim based on a manufacturing defect and (2) awarding her prejudgment interest from the date that her action "accrued" as defined by the relevant statute of limitations rather than the date of her injury.

We exercise jurisdiction pursuant to 28 U.S.C. § 1291. For the reasons set forth below, we affirm the district court's ruling that the MDA does not preempt Oja's negligent failure to warn claim. We reverse and remand for a new trial, however, because we conclude that the jury's finding of negligent failure to warn is irreconcilably inconsistent with its verdict for Howmedica on the strict liability claim. We also reverse the district court's order granting a directed verdict for Howmedica on the strict liability manufacturing defect claim. Because we remand for a new trial, we do not address the remaining issues on appeal.

BACKGROUND

The Porous-Coated Anatomic One-Piece Acetabular Component hip ("PCA hip") consists of three components: (1) a metal stem that is inserted into the central canal of the patient's large upper leg bone, (2) a cup that is inserted into the patient's hip socket, and (3) a rounded metal femoral head that is rigidly attached to the top of the metal stem and is fitted into the cup. The cup is composed of an outer metal shell and an inner polyethylene liner. The liner attaches to the metal shell by an integral staking peg projecting from the back of the liner through a hole in the metal shell. An "anti-rotation lug" prevents the liner from rotating in the metal shell. Unless the liner is prevented from rotating, the liner will wear and shed microscopic debris. Such debris may cause a patient to suffer from severe bone dissolution or "osteolysis."

On July 2, 1984, Oja underwent surgery to replace her existing artificial hip with a PCA hip. Her orthopedic surgeon, Dr. McElhinney, implanted the PCA hip without using cement because he had concluded that Oja's existing bone structure provided little area for cement fixation.

By early 1992, Oja began experiencing severe pain in her hip in the area of her PCA hip implant. Dr. Richard Evans, an orthopedic surgeon, recommended immediate surgery. On July 29, 1992, he removed the PCA hip. The surgery revealed that the staking peg was missing, that the polyethylene liner had completely disengaged from the metal cup, and that debris had spread into Oja's hip joint. Moreover, osteolysis had left large defects in Oja's hip, especially in the area of the hole in the cup. On April 21, 1993, Oja filed this products liability suit against Howmedica.

DISCUSSION

I. PREEMPTION OF OJA'S NEGLIGENT FAILURE TO WARN CLAIM

a. Overview of the Medical Device Amendments

Howmedica argues that the MDA preempts Oja's negligent failure to warn In 1976, Congress enacted the MDA "to provide for the safety and effectiveness of medical devices intended for human use." Pub.L. No. 94-295, 90 Stat. 539, 539 (1976) (preamble). The MDA classifies medical devices into three categories (classes I, II and III) based on the amount of risk they pose to the public. Class I devices are subject only to "general controls" because they pose little threat to public health and safety. 21 U.S.C. § 360c(a)(1)(A). Class II devices are subject to special controls because "general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device." 21 U.S.C. § 360c(a)(1)(B). Class III devices are subject to the most stringent MDA controls because they present "a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C).

                claim. 1  Because Congress's intent is the "ultimate touchstone" in every preemption case, see Retail Clerks Int'l Ass'n v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 223, 11 L.Ed.2d 179 (1963), we begin our preemption analysis by outlining the purposes and statutory framework of the MDA
                

The MDA automatically classifies a device as a class III device unless the device fits within one of three exceptions listed. First, a device placed in commercial distribution prior to May 28, 1976, avoids class III status through a grandfathering provision. 21 U.S.C. § 360c(f)(1)(A)(i)(I). Second, a post-1976 device may escape classification as a class III device if the FDA has reclassified the device as a class I or II device. 21 U.S.C. § 360c(f)(1)(A)(i)(II); 21 U.S.C. § 360c(f)(1)(B). Finally, a device may avoid class III device status if it is "substantially equivalent" to a grandfathered device or a post-1976 device that the FDA has classified as a class I or II device. 21 U.S.C. § 360c(f)(1)(A)(ii).

Manufacturers intending to market any new medical device must submit a premarket notification to the FDA. 21 U.S.C. § 360(k). In addition to the premarket notification (also known as the " § 510(k) process"), Class III devices must undergo a comprehensive premarket approval ("PMA") process before marketing. 21 U.S.C. § 360e. The purpose of the PMA is to provide the FDA with "reasonable assurance" that the device is safe and effective. 21 U.S.C. § 360e(d)(2).

While the MDA contemplates that most Class III devices will reach the market only through the PMA process, a manufacturer may obtain market approval through any of three alternative processes. First, the MDA contains a grandfathering provision which allows pre-1976 devices to remain on the market without FDA approval until the FDA completes the PMA. 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1). Second, the MDA contains an investigational device exemption ("IDE") for new devices under clinical investigation to determine their safety or effectiveness. See 21 U.S.C. § 360j(g). In order to foster the development of useful devices, IDE procedures allow manufacturers to begin limited marketing of new devices without undergoing the rigorous PMA process. 21 U.S.C. § 360j(g)(1). Finally, a Class III device may reach the market without undergoing the PMA procedures if the FDA determines, on the basis of the § 510 process, that the device is "substantially equivalent" to a device already on the market. 21 U.S.C. § 360e(b)(1)(B).

b. Regulation of the PCA Hip Under the MDA

On April 25, 1983, Howmedica filed a premarket notification submission with the On August 10, 1983, the FDA granted Howmedica permission to market the PCA hip for use with bone cement pursuant to the § 510(k) process "subject to the general controls provision of the Federal Food, Drug & Cosmetic Act." The FDA also imposed several specific limitations on Howmedica: (1) the PCA hip could not be labeled or promoted for non-cemented use, (2) the PCA hip could only be used with low-viscosity cement, and (3) fixation of the PCA hip without cement would be considered an investigational procedure...