In re Sulzer Hip Prosthesis and Knee Prosthesis

• Decision Date: 03 October 2006
• Docket Number: No. 1:01-CV-9000.,1:01-CV-9000.
• Parties: In re: SULZER HIP PROSTHESIS AND KNEE PROSTHESIS LIABILITY LITIGATION This Document Relates to: Howard v. Sulzer Orthopedics, Inc., 1:03CV9006 Burgess v. Sulzer Orthopedics, Inc., 1:04CV9005
• Court: U.S. District Court — Northern District of Ohio

455 F.Supp.2d 709

In re: SULZER HIP PROSTHESIS AND KNEE PROSTHESIS LIABILITY LITIGATION

This Document Relates to: Howard v. Sulzer Orthopedics, Inc., 1:03CV9006 Burgess v. Sulzer Orthopedics, Inc., 1:04CV9005

No. 1:01-CV-9000.

United States District Court, N.D. Ohio, Eastern Division.

October 3, 2006.

COPYRIGHT MATERIAL OMITTED

Andrew M. Greenwell, James R. Harris, Harris & Greenwell, Corpus Christi, TX, Charles R. Parker, Hill & Parker, Houston, TX, Daniel E. Becnel, Jr., Reserve, LA, James R. Dugan, II, Stephen B. Murray, Jr., Murray Law Firm, New Orleans, LA, Don Barrett, Barrett Law Office, Lexington, MS, John L. Davidson, Davidson, Bowie, Sims, Flowood, MS, Michael E. Cox, Biloxi, MS, John R. Climaco, Climaco Lefkowitz Peca Wilcox & Garofoli, R. Eric Kennedy, Weisman, Kennedy & Berris, Timothy A. Spirko, Buckingham, Doolittle & Burroughs, Debra J. Horn, Meyers, Roman, Friedberg & Lewis, Mary B. McKee, Hickman & Lowder, Peter J. Brodhead, Spangenberg, Shibley & Liber, Phillip A. Ciano, Ciano & Goldwasser, Timothy J. Gallagher, Schwarzwald & McNair, Cleveland, OH, Richard S. Wayne, Strauss & Troy, Stanley M. Chesley, Waite, Schneider, Bayless & Chesley, Janet G. Abaray, Burg Simpson Eldredge Hersh Jardine, Cincinnati, OH, Paul L. Jackson, Roetzel & Andress, Akron, OH, John T. Murray, Murray & Murray, Sandusky, OH, David W. Zoll, Zoll & Kranz, Toledo, OH, Sylvia Antalis Goldsmith, Law Office Sylvia A. Goldsmith, Avon, OH, Steven E. Clark, Clark & Mitchell, Oklahoma City, OK, Keith Johnson, Ft. Mitchell, KY, Keith M. Fleischman, Milberg Weiss Bershad Hynes & Lerach LLP, Lee Squitieri, Squitieri & Fearon, New York City, Steven M. Tindall, Lieff, Cabraser, Heimann & Bernstein, San Francisco, CA, Timothy E. Eagle, Varnum, Riddering, Schmidt & Howlett, Grand Rapids, MI, Laura Citrano, Neil Papiano, Iverson Yoakum Papiano & Hatch, Los Angeles, CA, Frank Hilton-Green Tomlinson, Pritchard, Mccall & Jones, K. Dee Hutsler, III, Birmingham, AL, for Plaintiffs.

J. Patrick Herald, Richard M. Franklin, James J. Dries, Baker & McKenzie, Chicago, IL, David W. Brooks, Bradley D. Honnold, Harvey L. Kaplan, Matthew D. Keenan, Lori C. McGroder, Shook, Hardy & Bacon, Kansas City, MO, Jeffrey M. Whitesell, Irene C. Keyse-Walker, Robert C. Tucker, Tucker, Ellis & West, Mary M. Bittence, Baker & Hostetler, Cleveland, OH, Richard F. Scruggs, Scruggs Law Finn, Pascagoula, MS, Sidney. A. Backstrom, Scruggs Law Firm, Oxford, MS, Steven J. Boranian, Reed Smith Crosby Heafey LLP, San Francisco, CA, Werner L. Polak, Shearman & Sterling, New York City, for Defendants.

MEMORANDUM & ORDER

O'MALLEY, District Judge.

This opinion discusses three cases that have been transferred to this Court as related to Multi-District Litigation ("MDL") No. 1401, known as In re: Sulzer Orthopedics Inc. Hip Prosthesis and Knee Prosthesis Products Liability Litigation.¹ The three cases are: (1) Moore v. Sulzer Orthopedics, Inc., case no. 02-CV-9116; (2) Howard v. Sulzer Orthopedics, Inc., case no. 03-CV-9006; and (3) Burgess v. Sulzer Orthopedics, Inc., case no. 04-CV-9005.

The Court earlier issued an opinion granting summary judgment to the defendants in the Moore case. Moore v. Sulzer Orthopedics, Inc., 337 F.Supp.2d 1002 (N.D.Ohio 2004). Sulzer now seeks dismissal of the Howard and Burgess cases, as well. For the reasons stated below Sulzer's request is GRANTED in part; specifically, all of the claims asserted in Howard and Burgess are DISMISSED, except for their claims of negligence per se.

I. History

The Moore, Howard, and Burgess cases share the following factual and procedural similarities. Each plaintiff alleges in his complaint that he underwent knee replacement surgery and received an orthopedic knee implant manufactured by Sulzer known as the "Natural Knee II Tibial Baseplate" (referred to below as the "NK-II"). The NK-II is one component of a system used for complete knee replacements. Each plaintiff further alleges that: (1) his implant was coated with a lubricant during the manufacturing process; (2) Sulzer failed to remove this lubricant completely before the implant was placed in his body; (3) the lubricant then caused the implant to bond improperly to his bones; and (4) he ultimately had to have the implant removed and replaced. Each plaintiff asserts various claims under their applicable state law, such as strict liability for defective design and manufacture, negligence for defective design and manufacture, and failure to warn.

Further, the plaintiff in each case originally filed his lawsuit in a court other this one. Specifically, after Moore filed his case in Florida state court, Sulzer removed the action to the United States District Court for the Middle District of Florida. Howard filed his case in the United States District Court for the Northern District of Oklahoma. And, after Burgess filed his case in Arkansas state court, Sulzer removed the action to the United States District Court for the Western District of Arkansas. Each of the three cases was then transferred to this Court as related to MDL No. 1401.

Unlike Howard and Burgess, however, the Moore case has progressed to a resolution. In Moore, Sulzer moved for summary judgment on the ground that all of Moore's claims were preempted by federal law. The essence of Sulzer's argument was as follows:

(1) Sulzer applied successfully to the FDA for premarket approval ("PMA") of its NK-II, pursuant to the Medical Devices Amendment ("MDA") to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360c et seq. The FDA's PMA process involves rigorous review of the design, manufacturing methods, quality control procedures, clinical investigations, and labeling and marketing of the medical device;

(2) the MDA contains an express preemption clause that precludes a State from "establish[ing] or continu[ing] in effect with respect to [any medical device examined by the FDA in the PMA process] any requirement ... which is different from, or in addition to, any requirement applicable ... to the device" under the MDA itself, 21 U.S.C. § 360k(a); and

(3) the state law causes of action stated by Moore would all work to impose requirements on the NK-II that were "different from, or in addition to," the FDA requirements, and were thus preempted.

Moore's response to Sulzer's syllogism began by observing that there is a split of authority amongst the federal appellate courts regarding the extent of MDA preemption.² For example, in Goodlin v Medtronic, Inc., 167 F.3d 1367, 1371 (11th Cir.1999), the Eleventh Circuit Court of Appeals concluded that common law duties imposed by state tort law are not "requirement[s] that are different from, or in addition to, any requirement applicable ... to the device" under the MDA. Accordingly, the Goodlin court allowed a plaintiff to pursue claims that his FDA-approved pacemaker was defective. In contrast, in Kemp v. Medtronic, Inc., 231 F.3d 216, 221 (6th Cir.2000), cert. denied, 534 U.S. 818, 122 S.Ct. 48, 151 L.Ed.2d 19 (2001), the Sixth Circuit Court of Appeals rejected the Goodlin analysis, concluding that the plaintiffs state-law claims—which related to the same FDA-approved pacemaker discussed in Goodlin—were preempted.

Moore argued that this Court should apply the law from the Eleventh Circuit Coiert of Appeals (as set out in Goodlin) instead of the law froth the Sixth Circuit Court of Appeals (as set out in Kemp ), even though this Court is within the Sixth Circuit. Noting that his case had been transferred to this MDL Court from the Eleventh Circuit, Moore argued that "the transferee forum must apply the law of the transferor court." Moore, 337 F.Supp.2d at 1009. This Court rejected Moore's argument, however, concluding: "this Court's preemption analysis addresses a question of federal law, and this Court is required to apply the Sixth Circuit's interpretations of federal law to any case that is transferred to it." Id. at 1011 (footnote omitted, emphasis in original). Accordingly, the Court granted Sulzer's motion for summary judgment and dismissed Moore's case. Moore did not appeal.

In light of the Court's conclusion in Moore, Sulzer moved the Court to issue an Order requiring all similarly-situated plaintiffs—including Howard and Burgess³— to show cause why their cases should not also be dismissed. The Court acquiesced to this request, and the parties have submitted briefs regarding whether, and the extent to which, the Court's reasoning in Moore should apply to Howard and Burgess.

II. Medical Devices and Preemption.

The Court picks up where it left off in its Moore opinion, the entirety of which is incorporated herein by reference.⁴

Critically, in Moore, the plaintiff advanced only one argument in response to Sulzer's summary judgment motion: that the law of the Sixth Circuit, as set out in Kemp, was not applicable; and that, instead, the Court should apply the law of the Eleventh Circuit, as set out in Goodlin. Because this argument failed, Sulzer's motion carried. But this Court noted that other arguments not advanced by Moore might yield different results:

Conceivably, the Court's easy conclusion that it must apply the Kemp preemption analysis, and not the Goodlin preemption analysis, would not be dispositive of the pending motion. As the Kemp court noted, "a claim premised on the violation of FDA requirements established for a Class III device through the PMA process is not automatically preempted." Kemp, 231 F.3d at 230. Moore could conceivably argue, for example, that Sulzer was negligent in its manufacture of the NK-II he received because Sulzer completely failed to undertake a manufacturing step—say, a product rinse, or a quality control inspection—that is "required" by the FDA. Alternatively, Moore could contend that Sulzer added a manufacturing step or process that was in addition to and materially deviated from the manufacturing processes approved by the FDA. But Moore does not offer any such argument or point to any such fact....