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
United States District Court, N.D. Ohio, Eastern Division.
*710 *711 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.,
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. *713 Medtronic, Inc.,
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,
In light of the Court's conclusion in Moore, Sulzer moved the Court to issue an Order requiring all similarly-situated plaintiffsincluding Howard and Burgess[3] 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:
*714 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 stepsay, a product rinse, or a quality control inspectionthat 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.
Moore,
Howard and Burgess offer two arguments why the reasoning in Moore should not control their case. First, Howard offers additional support for the argument that Kemp should not control, and this Court should apply the law of the transferor court. Second, relying in part on the language quoted above from Moore, Howard and Burgess both argue that, even if Kemp does apply, at least some of their claims survive the doctrine of federal preemption. The Court examines these arguments below.
A. Applicable Law.
Like the Eleventh Circuit Court of Appeals in Goodlin, the Tenth Circuit has suggested that certain 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. See Oja v. Howmedica, Inc.,
For the reasons stated in Moore, however, the Court remains unpersuaded. First, even if this Court were free to choose between the Tenth and Sixth Circuit's analyses of the law of MDA preemption, the Court would choose the latter. See Moore,
Second, the Sixth Circuit Court of Appeals has directed this Court to use the law of this Circuit in precisely these circumstances. In In re Cardizem CD Antitrust Litig.,
MDA preemption analysis set out in Kemp is not unique to the Sixth Circuit, nor is it divergent from the predominant interpretation. See Brooks v. Howmedica, Inc.,273 F.3d 785 , 795 (8th Cir.2001) ("[m]ost courts of appeal have interpreted Lohr to mean that the MDA preempts common law claims to the extent that they interfere or conflict with specific federal requirements") (citing Kemp and other cases). Thus, it is clear that this Court must apply the Kemp preemption analysis, and not the Goodlin analysis.
Id. at 1010. Since then, two additional Courts of appeal have joined the majority view stated in Kemp, making it even more clear that Oja and Goodlin are the divergent cases. See Riegel v. Medtronic, Inc.,
Simply, Howard seeks application of a minority view on the scope of MDA federal preemption, and Cardizem holds that this MDL court must apply the majority view if it has been adopted by the Sixth Circuit. Because Kemp shares the majority view, this Court will apply the law of the Sixth Circuit to Howard's case, not the law of the Tenth Circuit.
B. Preempted Claims.
Howard and Burgess assert a slew of claims against Sulzer, including: (1) strict liability for design defect; (2) strict liability for manufacturing defect; (3) strict liability for defective marketing and/or failure to warn; (4) negligence; (5) breach of implied warranty; (6) breach of express warranty; (7) deceit by concealment; (8) negligence per se; (9) medical monitoring; (10) fraud; and (11) loss of consortium. This Court must determine whether each of these claims is preempted by § 360k(a) of the MDA. Fortunately, this obligation is made easier because seven different Courts of Appeals, including the Sixth Circuit in Kemp and Cupek, have undertaken the same task, examining the preemptive effect of the MDA on a great variety of state law claimsincluding virtually all of the sorts of claims advanced by Howard and Burgess. Taken together, these cases reveal that § 360k(a) preempts, almost every type of state law claim that seeks to hold a defendant liable for a PMA-approved medical device; the only exception is a claim that the medical device failed to conform with the FDA requirements prescribed by the PMA.[8] The Court reviews these cases briefly below.
As an initial matter, to determine whether a particular claim is preempted, all of the appellate courts "require a district court to look through the general duties imposed by the state-law causes of action and consider the effect a successful lawsuit asserting those causes of action would have and determine whether they threaten the federal PMA process requirements." Gomez,
Similarly, the cases are unanimous in concluding that a state law claim for failure to warn is preempted, in light of the fact that the PMA process includes FDA scrutiny of the warning labels that the manufacturer must supply with the medical device.[9] Quoting Gomez again:
The FDA approved [defendant] Kendall's warnings and instructions for physicians contained in the Instructions for Use ("IFU") through the PMA process. That process required the FDA to approve clinical studies and evaluate the results, to specify the labeling requirements, and and approve the label that issued. The FDA also approved the "Patient Guide" used to provide information and warnings to patients, again through the PMA process. Kendall's training requirements were also subjected to, and approved in, the PMA process. To permit a jury to decide Gomez's claims that the information, warnings, and training material the FDA required and approved through the PMA process were inadequate under state law would displace the FDA's exclusive role and expertise in this area and risk imposing inconsistent obligations on Kendall. The district judge correctly found that Gomez's state-law claims that Kendall's labeling, warning, information, and training were inadequate or incomplete are preempted.
Gomez,
The Sixth Circuit agrees entirely with the reasoning of Gomez: "Any claim, under state law, then, that Defendant failed to warn patients beyond warnings required by the FDA, or that Defendant failed to recall a product without first going through the PMA supplement process would constitute state requirements `different from' or `in addition to' the requirements of the federal PMA application and supplement process." Cupek,
*718 The cases are also unanimous in decreeing a similar fate for claims for breach of implied warranty. As explained by the Mitchell court, "an implied warranty claim is based on the accepted standards of design and manufacture of the products. In the case of a product that has gone through the PMA process, these criteria are set by the FDA." Mitchell
Indeed, it is the rare state-law claim that the above-cited federal appellate courts conclude is not preempted by § 360k(a) of the MDA, and those rare examples are instructive. In Martin, two plaintiffs brought a variety of state-law claims against the manufacturer of their pacemaker, Medtronic, including "negligence, gross negligence, strict liability, breach of warranty, and violation of the Texas Deceptive Trade Practices Act." Martin,
Put more simply: "state tort suits that allege, as the basis of their claim, that the approved FDA requirements have not been met are not preempted." Id. at 583. Other state law claims are. Thus, the plaintiffs in Martin were permitted to pursue one claim: that Medtronic had not complied with the FDA-approved manufacturing process. After discovery was complete, however, the district court granted Medtronic's motion for summary judgment, "finding that [the plaintiffs] failed to produce evidence of alleged deviations" from FDA requirements, and the appellate court affirmed. Id. at 575.
The Sixth Circuit reached an identical conclusion in Kemp, where the plaintiffs brought "ten common law and statutory products liability claims under Ohio law" against defendant Medtronic. Kemp,
As in Martin, this conclusion provided cold comfort to the plaintiffs, who then pursued their claim for "negligence per se" for failure to adhere to FDA requirements. The plaintiffs were unable to adduce evidence sufficient to support this claim, and suffered summary judgment. On appeal, the Sixth Circuit Court of Appeals agreed with the plaintiffs "that a claim premised on the violation of FDA requirements established for a [medical] device through the PMA process is not automatically preempted," id. at 230, but also agreed that summary judgment on the plaintiffs' negligence per se claim for lack of evidence was appropriate.[11]
Gomez presents a slight variation on this theme. In Gomez, the district court found that "federal law preempted [the plaintiffs] state-law claims for defective design, failure to warn, breach of express warranty, negligence in, training and consent forms, and redhibition." Gomez,
Martin, Kemp, and Gomez stand for the proposition that virtually all state law claims seeking to hold a defendant liable for injuries caused by an FDA-approved medical device are preempted, except for a claim that the medical device failed to conform with the PMA requirements prescribed by the FDA. Kindred conclusions are also stated in the other cases on point. See Riegel,
To be fair, two courts have concluded that breach of express warranty claims are not automatically preempted. In Riegel, however, there was no discussion of why this claim was not preempted, and the claim was dismissed after discovery revealed that the instructions for the medical device "clearly disclaimed any express warranty." Riegel,
In sum, the only claims stated by Howard and Burgess that are not preempted by § 360k(a) of the MDA are their claims of negligence per se, where they assert that Sulzer failed to conform with the FDA requirements established for the NK-II through the PMA process. Their other claims for design defect, manufacturing defect, defective marketing, failure to warn, negligence, breach of implied warranty, breach of express warranty, and deceit are all preempted.[13]
*721 III. Remaining Evidentiary Issues.
As noted above, the Gomez court permitted a plaintiff to pursue a claim that the defendant failed to manufacture a medical device in accordance with FDA specifications, and further concluded that the plaintiff had adduced enough evidence in support of this claim to survive a Rule 50 motion for judgment as a matter of law. The latter conclusion is unusual to the point of being unique; most plaintiffs who were allowed to pursue similar non-preempted claims, such as the plaintiffs in Martin, Kemp, Riegel, and Brooks, find themselves unable to adduce sufficient evidence of the defendant's failure to adhere to PMA requirements to survive summary judgment.
Sulzer insists the more common result will occur in this case, and further argues that enough discovery has already occurred in the MDL to allow the Court to enter judgment now on Howard's and Burgess's claims for negligence per se. That is, Sulzer insists the state of the evidentiary record shows already that there is no issue of material fact and it is entitled to judgment as a matter of law on Burgess's and Howard's claims of negligence per se.
There is substantial strength to Sulzer's argument. For example, one position Howard has taken to support his claim of negligence per se is that, like those plaintiffs whom this Court certified as members of the MDL settlement class, Howard's NK-II underwent machining after porous coating, thereby allowing machine oil to remain on the surface of the finished implant (which caused the implant not to bond properly to the bone). In response, Sulzer notes that: (1) extensive discovery by all parties leading up to the MDL Settlement Agreement identified all those implants where machining occurred after porous coating, and Howard's implant was not among them; and (2) specific manufacturing records reflect that Howard's implant was machined before porous coating. Having reviewed all of this evidence carefully during the Final Fairness Hearing, and having heard from MDL discovery counsel regarding their extensive efforts at identifying which implants were defective and why, it is hard for the undersigned to imagine that additional discovery will provide Howard with evidence to support his theory that his implant was, in fact, machined after porous coating.
Another position Howard takes to support his claim of negligence per se is to note that he had his implant tested by a chemical laboratory, and the results show the implant had on it traces of chemicals *722 "normally associated with mineral [machine] oil." Howard avers that "it is axiomatic that such residues should not be remain [sic] on the implanted device," and "a manufacturing process that fails to remove such residue would materially deviate from any FDA requirements, because such residue should never be present on such implants at the time of implantation." Howard affidavit at ¶¶ 7, 9.[14] This analysis appears faulty in two respects. First, the Court heard evidence at the Final Fairness Hearing that it is impossible to remove all of the machine oil from an implant.[15] Thus, it is not "axiomatic" that, because Howard's implant may test positive for machine oil residue, Sulzer must have deviated from FDA manufacturing requirements. Second, Howard suggests that the FDA requirements applicable to the NK-II must include cleaning processes and quality controls with mandated maximum levels of residue, and he alleges these maximums were exceeded in his case. It is at least as likely, however, that, while the FDA requirements mandate certain cleaning processes and quality controls, those requirements do not mandate specific, maximum residue levels. That is, the cleaning procedures are mandated, but not the precise results. If so, Howard's claim for negligence per se will fail so long as Sulzer followed the required cleaning processes and quality controls, regardless of how residue-free those manufacturing steps actually left his NK-II. And Sulzer has already adduced evidence that it followed all the required cleaning processes and quality control steps when it manufactured Howard's implant.
Ultimately, however, the Court concludes it would be premature to enter judgment on Howard's and Burgess's remaining claims at this juncture. Howard and Burgess argue they should be allowed to pursue their own discovery to test the veracity of Sulzer's evidentiary submissions, and also to see if they can uncover some other deviation from FDA requirements by Sulzer that caused their particular NK-II implants not to work as intended. The current state of the evidence suggests this may be an uphill battle, but it is theirs to choose to fight. If Sulzer is correct, it may reassert its argument that it is entitled to judgment on Howard's and Burgess's negligence per se claims in the context of Rule 56. Howard and Burgess must each be allowed an opportunity to conduct discovery to uncover factual support for their single remaining claim.
Under separate order, the Court will schedule a telephonic status hearing with the parties to set new discovery and other deadlines.
IT IS SO ORDERED.
NOTES
Notes
[1] Sulzer Orthopedics, Inc. was later renamed Centerpulse Orthopedics, Inc., and then purchased by Zimmer Holdings, Inc. The Court refers to the defendant as "Sulzer."
[2] This split derives from the fractured plurality opinion delivered by the Supreme Court when it confronted the scope of the MDA preemption provision in Medtronic, Inc. v. Lohr,
[3] The Court's Order also applied to three other similarly-situated plaintiffs, whose cases had been transferred to this MDL: McDonough v. Sulzer Orthopedics, Inc., case no. 04-CV-9002; Hulse v. Sulzer Orthopedics, Inc., case no. 03-CV-9009; and Boyd v. Sulzer Orthopedics, Inc., case no. 03-CV-9003. These three cases have already been dismissed, however, either because the plaintiffs stipulated to dismissal or did not respond to the Court's show cause order.
[4] Rather than setting out, again, the history of this MDL and the Court's analysis of federal preemption in the context of the MDA, the Court simply incorporates in full the reasoning and analysis set out in Moore,
[5] In fact, it is not completely accurate to state that the Oja and Goodlin courts reached the same conclusion. The Eleventh Circuit was alone among the Courts of Appeals when it ruled in Goodlin that § 360k(a) does not preempt common law claims involving PMA-approved devices. While the Tenth Circuit had earlier ruled in Oja that the MDA did not preempt common law tort claims against a medical device manufacturer, the device at issue in Oja did not undergo the § 360e(c) PMA analysis; rather it underwent the far less rigorous Investigative Device Exception (IDE) process. Even assuming that Oja stands for the proposition that the Tenth Circuit would adopt fully the Goodlin preemption analysis, however, the Court concludes it is bound to follow Kemp and not Oja.
[6] Burgess does not make a similar argument because the law of the Eighth Circuit, which would control if this Court were to adopt the rule that "the law of the transferor court applies," is consonant with the law of the Sixth Circuit. See Brooks v. Howmedica, Inc.,
[7] The Court finds especially provocativebut ultimately not persuasivethe following twopronged argument, which Moore did not raise but Howard did: (1) the law of the transferor court applies when transfers are made pursuant to 28 U.S.C. § 1404(a), because a defendant should not "get a change of law as a bonus for a change of venue," Van Dusen v. Barrack, 37.
[8] The cases that inform this Court's analysis, listed in order of Circuit Court, are: (Second) Riegel v. Medtronic, Inc.,
[9] A PMA application "shall contain * * * specimens of the labeling proposed to be used for [the medical] device." 21 U.S.C. § 360e(c)(1)(F). If the labeling is found to be "false or misleading in any particular," the application for approval must be denied. Id. § 360e(d)(2)(D).
[10] Also preempted are claims premised on a "post-sale duty to warn," where the plaintiff alleges the defendant was required to provide additional warnings in light of later-received reports of injury to others caused by the same medical device. McMullen,
[11] The trial court and the Sixth Circuit Court of Appeals reached essentially the same conclusions again in Cupek.
[12] It is also worth noting that Howard states his breach of express warranty claims are "based upon the statements contained in the package inserts and other written materials associated with the [NK-II]," and not any independent representations between the parties. Response brief at 27 (docket no. 9). The written materials Howard points to, of course, are reviewed as part of the FDA's PMA process; success on this claim would necessarily create conflict with the FDA's requirements. Burgess does not provide any explanation for the basis of his claim of breach of express warranty.
[13] There are three other "claims" stated by Howard and Burgess. Howard's "claim" for medical monitoring is actually a request for injunctive relief, entitlement to which depends on the success of a substantive claim. Thus, this claim necessarily rises and falls with Howard's other claims. Similarly, Howard's and Burgess's spouses' claims for loss of consortium are derivative, so they are preempted to the extent the underlying substantive claims are preempted.
Finally, with his claim of fraud, Burgess contends that, when Sulzer identified certain lots of NK-II implants it had manufactured improperly, and provided settlement benefits to recipients of these implants pursuant to the MDL Settlement Agreement, Sulzer knew there were additional NK-II implants that were improperly manufactured (such as Burgess's), and Sulzer purposefully excluded recipients of these implants from the settlement. This claim is clearly a collateral attack on this Court's Final Fairness Hearing, at which time the Court heard extensive evidence regarding the efforts that both plaintiffs and defendants undertook to identify all persons who were proper members of the settlement class.
Indeed, Burgess's fraud `allegations fail not only for lack of specificity, but also for lack of any basis in realityit is pure fiction (and insulting) for Burgess to allege that "the members of [the settlement class] were selected wholly upon information supplied by defendants as to which manufacturing lots of the device contained the defective product." Amended complaint at ¶ 24. Two days' worth of testimony at the Final Fairness Hearing convinced this Court otherwise. The time for appealing the Court's determinations regarding class membership is long past, and Burgess may not collaterally attack this Court's conclusions in this regard in his current case.
[14] Howard is himself an orthopedic surgeon who frequently implanted in others Sulzer's NK-II.
[15] See case no. 01-CV-9000, master docket no. 327, exhibit 18, ¶ 11 (affidavit of Dr. Toby Hayes) ("The use of machining and cooling oils in manufacturing operations results in some measurable residual oil on all orthopaedic implants, even with the use of rigorous cleaning procedures. * * * With monitoring, these levels can be maintained below those known in the industry to be safe and effective."); exhibit 25, ¶ 9 (affidavit of Dr. William Maloney) ("Although orthopedic implants commonly contain some amount of [oil] residue, the level of residue in a number of these cases exceeded that which would be normally expected.").