In re Inter-Op Hip Prosthesis Liability Litigation

U.S. District Court8/31/2001
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Full Opinion

*335 MEMORANDUM AND ORDER

O’MALLEY, District Judge.

On August 29, 2001, this Court provisionally certified a class and granted preliminary approval to the parties’ settlement agreement. This memorandum sets forth the Court’s reasoning.

I. Background.

Sulzer Orthopedics, Inc. (“Sulzer Orthopedics”) is a designer, manufacturer and distributor of orthopedic implants for hips, knees, shoulders, and elbows. One of its products is known as the “Inter-Op acetabu-lar shell,” which is one component of a system used for complete hip replacements. Specifically, the Inter-Op shell is a socket-like device inserted into the acetabulum, which is a part of the pelvis; the shell is designed to receive a separate, ball-like device, which is inserted into the femur, or thigh bone. The two components thereby replace the articulating ball-and-socket structure of the hip joint. The Inter-Op shell is regulated by the federal Food and Drug Administration (“FDA”).

Proper surgical attachment of these replacement components in the body is critical. Orthopedic implants are often cemented or screwed into position. Some implants are also designed to allow the bone to grow into and around them, holding them securely in place. The Inter-Op acetabular shell was designed to bond with the natural bone.

Unfortunately, a manufacturing defect apparently prevented some of Sulzer Orthopedics’ Inter-Op shells from bonding with the acetabulum. In early December of 2000, Sul-zer Orthopedics announced a voluntary recall of certain manufacturing lots of its Inter-Op shells. Most of the recalled products were manufactured during or after October of 1999, but a limited number were produced as early as June of 1997. The recall stated that Sulzer Orthopedics had “received reports of post-operative loosening” of some of the Inter-Op shells, apparently “related to a reaction of the body to a slight residue of lubricant used in the manufacturing process.” Sulzer Orthopedics recalled approximately 40,000 units of its Inter-Op shell, of which about 26,000 had already been implanted in patients.1 About 90% of these implants occurred in the United States.

One of the documents issued by Sulzer Orthopedics in connection with the voluntary recall included the following explanation:

Sulzer Orthopedics is the manufacturer of a hip implant that you received during hip replacement surgery. We sincerely regret to inform you that we have recently learned that a small number of the many implant parts that we manufactured may have a trace of lubricant residue on the surface that was not completely removed during the manufacturing process.
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The hip implant part is the acetabular “shell” which was implanted into the upper part of your hip called the acetabulum. Normally, the bone would form an integrated bond with the shell; however, it appears that bone does not always bond with shells when the lubricant residue is present. Reported symptoms include severe groin pain and inability to bear weight on your leg. These symptoms are caused by the shell being loose from the bone. Only a small number of patients who received the shell during their total hip replacement have experienced loosening of the shell.

In fact, to date, about 2,400 of the patients who received implants of the Inter-Op shells have undergone “revision surgery” — removal of the defective2 implant and replacement with a new one. For a variety of reasons, *336not all of the patients who were implanted with recalled Inter-Op shells will undergo revision surgery. For example, some patients will not experience any bone-bonding failure; other patients may suffer severe failure but be medically ineligible for revision surgery. Ultimately, Sulzer Orthopedics estimates that approximately 4,500 patients will undergo revision surgery to replace the defective Inter-Op acetabular shells, and that the need for revision surgery will, in virtually all instances, become manifest within the next two years.

Shortly after Sulzer Orthopedics issued its voluntary recall in December of 2000, a number of plaintiffs around the country filed lawsuits, in both state and federal courts. To date, there are pending about 1,300 civil suits nationwide, about 200 of which are in federal court. These cases involve about 2,000 named plaintiffs, primarily including implant recipients and their spouses. Over 90% of the state court actions have been filed in California, Texas, Florida, or New York. About 19 of the state court cases are styled as class actions, as are about 34 of the federal court cases. The defendants named in these lawsuits include not only Sulzer Orthopedics, but also: (1) Sulzer Medica USA Holding Company (“Sulzer Medica USA”), a holding company that owns Sulzer Orthopedics; (2) Sulzer Medica Ltd., a Swiss holding company that owns Sulzer Medica USA;3 (3) Sulzer AG, a Swiss company that previously owned a majority of the stock of Sulzer Med-ica Ltd.; (4) various other Sulzer-related entities; and (5) various surgeons, hospitals, and medical supply companies connected to the distribution or implantation of the defective product. The causes of action in these lawsuits include claims for defective design, marketing and manufacture; breach of express and implied warranties; negligence; strict liability; and other legal theories of recovery. Trial proceedings have already begun in at least one state court case.4

Pursuant to 28 U.S.C. § 1407, three different federal plaintiffs filed motions with the Federal Judicial Panel on Multi-District Litigation (“MDL Panel”), seeking to consolidate and centralize 30 of the federal lawsuits.5 MDL docket no. 1401. On June 19, 2001, the MDL Panel granted these motions, consolidating and transferring all related pending federal litigation to the Northern District of Ohio and assigning oversight of the MDL proceedings to the undersigned. Thus, virtually all of the federal cases involving the Inter-Op acetabular shell have either been transferred to this Court or are in the process of being transferred to this Court.6

On July 7, 2001, this Court issued an Order setting out the “practices and procedures” it would follow during its administration of the MDL proceedings. Among other things, this Order: (1) temporarily appointed liaison and co-lead counsel for plaintiffs; (2) set an initial case management conference for August 17, 2001; and (3) directed counsel to submit an agenda for this conference, to include a discovery plan and also proposed deadlines for amendment of pleadings, expert *337and non-expert discovery, dispositive motions, expert reports, and so on. Shortly before this conference, however, counsel for the parties informed the Court that they planned to submit an agenda including another significant item: discussion of a proposed class certification and class settlement. The parties then filed motions for an order conditionally certifying a class, motions for preliminary approval of a class settlement, and motions to enjoin related litigation pending final approval of a class settlement.7 As the Court had previously required, plaintiffs’ liaison counsel forwarded copies of these motions, including a copy of the proposed settlement agreement, to counsel for all plaintiffs whose cases had been consolidated in the MDL proceedings. In addition, plaintiffs’ liaison counsel made available the same materials to virtually every plaintiffs’ counsel pursuing litigation against Sulzer Orthopedics, both in federal and state court.

Given the quickly changing nature of the litigation, the Court used the initial case management conference to question the parties in open court regarding their motions for class certification and class settlement. The Court directed its questions to plaintiffs’ liaison and co-lead counsel, and also defendants’ counsel. Given the wide publication of the pending motions, about 125 attorneys from around the country, representing plaintiffs and groups of plaintiffs, also attended the hearing. The Court permitted any attorney present to address the Court. The Court heard from those proposing preliminary Certification and approval, and also heard from a number of counsel, including counsel representing the interests of various state court plaintiffs who are not parties to the MDL proceedings but whose interests could be affected by class treatment of the Sulzer-relat-ed claims. Some spoke strongly in favor of the proposed certification and settlement, while others strongly opposed it.

During the course of the hearing, it became apparent that the proposed settlement agreement, as drafted, contained provisions that did not accurately reflect the understanding of the parties. Accordingly, the Court directed the parties to submit an amended proposed class settlement agreement by August 24, 2001. The Court then indicated it would allow any person (including persons not parties to any federal proceeding) wishing to offer additional objections to the proposed class and amended proposed class settlement agreement to submit their positions in writing by August 24, 2001. The Court received about 41 such comments, all of which it has reviewed in detail.8

Finally, on August 28, 2001, the Court held an additional hearing on the pending motions for class certification and preliminary approval of class action settlement. Having now received extensive argument regarding the facts of this case and the applicable legal standards, the Court sets out its analysis below.

II. The Nature and Context of the Issues Presented.

Neither the Court’s analysis nor the effect of its rulings can be understood without consideration of the context in which both occurred. The parties have jointly approached the Court, seeking only conditional certification of this matter as a class action and preliminary approval of their proposed settlement. As the parties understand, their motion, if granted, is only the first step in an extensive and searching judicial process, which may or may not result in final approval of a settlement in this matter.

As the Manual on Complex Litigation indicates, this threshold inquiry often involves no more than an informal presentation of the parties’ proposals to the Court. Manual for Complex Litigation, § 30.41, at 236 (3rd *338ed.1995) (“in some cases this initial [fairness] evaluation can be made on the basis of ... informal presentations by the settling parties”). This is true because the Court’s conditional certification and preliminary approval: (1) triggers a mechanism for more formal notice to all potential class members; (2) determines whether opt-out rights are to afforded putative class members; (3) defines the scope of discovery to be conducted from that point forward — that is, focuses discovery on the fairness and adequacy of the proposed settlement to the class, as well as on any issues which might call into question the propriety of final certification of the matter as a class action; (4) sets in motion those judicial processes that will culminate in a detailed, full, and final fairness hearing (at which time the question of fairness is reviewed de novo); and (5) establishes procedures for class members to register with the Court objections to or support for the proposed settlement.

Thus, while it is certainly not the role of this Court to simply “rubber-stamp” a motion for conditional certification or preliminary approval (or, for that matter, any motion), the Court also must be mindful of the substantial judicial processes that remain to test the assumptions and representations upon which the parties’ motions are premised.

It is true that, to date, this case has been somewhat unusual. Partly because of wide publicity within the plaintiffs’ bar and the general public, the Court has allowed the breadth and extent of the inquiry already conducted with respect to the pending motions to far exceed what it might normally employ. Indeed, the objections raised by some of the class members and their counsel, together with the Court’s own probing, have already resulted in substantial revisions to the proposed settlement agreement. The process employed to date, however, as searching as it has been, is clearly preliminary and is no substitute for that which can be, and now in this case will be, accomplished through a full fairness inquiry.

For these reasons, the Court must, to a large extent, premise its determinations at this stage of the proceedings upon certain of the representations and assumptions made by the movants, at least to the extent those representations and assumptions have been supported by sworn declarations or statements of counsel and are not, on their face, suspect. The Court reserves for another time the right and obligation to test all of the premises behind the parties’ motions and the Court’s ruling, through the most probing of inquiries.

III. Class Certification.

The Court first examines the propriety of conditional certification of the proposed class. On August 15, 2001, plaintiffs’ co-lead counsel filed an amended complaint in this case, stating claims under the following legal theories: (1) strict liability, (2) negligence, (3) breach of implied warranty, (4) breach of express warranty, (5) “fear of future product failure” (infliction of emotional distress), (6) misrepresentation, (7) equitable relief via medical monitoring, and (8) punitive damages.9 The amended complaint also states that plaintiffs are seeking relief “on their own behalf and as representatives of a class.” Complaint at 111. In their complaint, the plaintiffs define the class as consisting of: “all citizens or residents of the United States who have had Affected Inter-Op acetabular shell hip implants placed in their bodies, ... or their estates, administrators or other legal representatives, heirs or beneficiaries, and any other person asserting the right to sue independently or derivatively.” Id.10 The plaintiffs also define two subclasses: “Subclass 1 consists of those Class members who have had Affected Inter-Op shells placed into their bodies and have already undergone revision surgery prior to the Final Judicial *339Approval Date and Subclass 2 consists of Class members who may need to undergo revision surgery after the Final Judicial Approval Date to correct problems with the Affected Inter-Op shells.” Id. (emphasis added).

In plain English, the plaintiffs propose that the class be made up of all Americans in whom were implanted a recalled Inter-Op acetabular shell, together with their loved ones. This class would then be divided into two sub-classes: those who have already had revision surgery, and those who have not had (but yet may have) revision surgery. The plaintiffs ask the Court to certify this class under Fed.R.Civ.P. 23(b)(3). The plaintiffs also ask the Court to certify the class under Fed.R.Civ.P. 23(b)(2), for the limited purpose of obtaining injunctive relief in the form of medical monitoring.

A Rule 23(a).

The plaintiffs have submitted their motion to certify a class in the context, and for the primary purpose, of consummating a settlement of this case. Although there is certainly “nothing inherently wrong with this practice,” this Court “must pay ‘undiluted, even heightened, attention’ to class certification requirements in a settlement context.” Hanlon v. Chrysler Corp., 150 F.3d 1011, 1019 (9th Cir.1998) (quoting Amchem Prods., Inc. v. Windsor, 521 U.S. 591, 620, 117 S.Ct. 2231, 138 L.Ed.2d 689 (1997)). “Strict adherence to Rule 23 in products liability cases involving drug or medical products which require FDA approval is especially important.” In re American Medical Systems, Inc., 75 F.3d 1069, 1089 (6th Cir.1996) (emphasis in original) (hereinafter, “AMS ”).

Rule 23(a) “states four threshold requirements applicable to all class actions,” including actions involving proposed certifications of a “settlement-only” class. Amchem, 521 U.S. at 613, 117 S.Ct. 2231. These threshold requirements are:

(1) numerosity (a “class [so large] that joinder of all members is impracticable”); (2) commonality (“questions of law or fact common to the class”); (3) typicality (named parties’ claims or defenses “are typical ... of the class”); and (4) adequacy of representation (representatives “will fairly and adequately protect the interests of the class”).

Id. (quoting Fed.R.Civ.P. 23(a)(l-4)). “Subsection (a) of Rule 23 contains four prerequisites which must all be met before a class can be certified. Once those conditions are satisfied, the party seeking certification must also demonstrate that it falls within at least one of the subcategories of Rule 23(b).” AMS, 75 F.3d at 1079.

1. Numerosity.

In this case, it is clear that the proposed class is so numerous that joinder of all the proposed class members is impracticable. “There is no strict' numerical test for determining impracticability of joinder.” AMS, 75 F.3d at 1079. Rather, “[t]he numerosity requirement requires examination of the specific facts of each case and imposes no absolute limitations.” General Tel. Co. v. EEOC, 446 U.S. 318, 330, 100 S.Ct. 1698, 64 L.Ed.2d 319(1980). “When class size reaches substantial proportions, however, the impracticability requirement is usually satisfied by the numbers alone.” AMS, 75 F.3d at 1079. The Sixth Circuit Court of Appeals has affirmed the certification of a class made up of less than 100 individuals. See Haytcher v. ABS Industries, Inc., 1991 WL 278981 at *1-2 (6th Cir. Dec.27, 1991) (“approximately 61 individuals”). The numerosity requirement is also satisfied more easily upon a showing that there is wide “geographical diversity of class members,” which makes joinder of all the class members more impracticable. Council of and for the Blind of Delaware County Valley, Inc. v. Regan, 709 F.2d 1521, 1529 (D.C.Cir.1983).11

*340In this case, the proposed class of persons who received implantation of a recalled Inter-Op shell includes over 26,000 people — not including persons, like spouses, who have derivative claims. Over 2,400 of these people have already had revision surgery. Furthermore, these class members reside throughout the entire United States. The undisputed evidence shows that the plaintiffs have earned their burden of showing that the proposed class is so large that joinder of all members is impracticable.

2. Commonality.

The commonality requirement states that there must be “questions of law or fact common to the class.” The commonality test “is qualitative rather than quantitative, that is, there need be only a single issue common to all members of the class.” AMS, 75 F.3d at 1080 (quoting 1 Herbert B. Newberg & Alba Conte, Newberg on Class Actions, § 3.10, at 3-47 (3rd ed.1992)). On the other hand, the reason behind the commonality requirement is that “the class-action device saves the resources of both the courts and the parties by permitting an issue potentially affecting every [class member] to be litigated in an economical fashion under Rule 23.” Califano v. Yamasaki, 442 U.S. 682, 701, 99 S.Ct. 2545, 61 L.Ed.2d 176 (1979). Thus, if questions of law or fact common to all of the class members are far outweighed by differences, then class certification is inappropriate.

With regard to mass torts, like the defective hip implants at issue in this litigation, there are special considerations. The Sixth Circuit Court of Appeals has explained:

In mass tort accidents, the factual and legal issues of a defendant’s liability do not differ dramatically from one plaintiff to the next. No matter how individualized the issue of damages may be, these issues may be reserved for individual treatment with the question of liability tried as ■ a class action. Consequently, the mere fact that questions peculiar to each individual member of the class remain after the common questions of the defendant’s liability have been resolved does not dictate the conclusion that a class action is impermissible.
* * * * * >;ÂŤ
In complex, mass, toxic tort accidents, where no one set of operative facts establishes liability, no single proximate cause equally applies to each potential class member and each defendant, and individual issues outnumber common issues, the district court should properly question the appropriateness of a class action for resolving the controversy. However, where the defendant’s liability can be determined on a class-wide basis because the cause of the disaster is a single course of conduct which is identical for each of the plaintiffs, a class action may be the best suited vehicle to resolve such a controversy.

Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1197 (6th Cir.1988).

The Court concludes that, in this case, there do exist questions of law or fact common to all members of the class.12 The. most obvious of these common questions is “[w]hether the Inter-Op acetabular shells designed, developed, manufactured, distributed, fabricated, supplied, advertised, promoted and/or sold by [Sulzer Orthopedics] had a defect(s).” Complaint at 1126a. Other questions common to each class member are whether the defendants adequately tested the safety of their product, when the defendants learned of the defect, and whether they timely took action upon learning the defect might exist. All of these questions go to Sulzer Orthopedics’ course of conduct, and when “the cause of [a] disaster is a single course of conduct which is identical for each of the plaintiffs, a class action may be the best suited vehicle to resolve such a controversy.” Velsicol, 855 F.2d at 1197. There are also common questions pertaining to the relationships between the various “Sulzer-related” corporate entities and, hence, the potential liability of those entities for the activities of Sulzer Orthopedics, Inc. These questions, necessitating detailed factu*341al inquiry and complex legal analysis, are common to all class members and can be resolved most efficiently in a class action context.13

It is true, of course, that there are also substantial differences of fact and law between class members. For example, some class members may suffer no adverse medical affects, while others may suffer (and have suffered) terribly. Some class members may live in states where the law allows them to recover only if they suffer actual physical injury, while the state law applicable to other class members may allow them to recover even absent actual physical injury. And, even under legal theories normally allowed to class members by all states (e.g., negligence or strict liability), the legal formulation of those theories may vary from state to state. See generally In re Northern Dist. of Calif., Dalkon Shield IUD Prods. Liab. Litig., 693 F.2d 847, 854 (9th Cir.1982), cert. denied, 459 U.S. 1171, 103 S.Ct. 817, 74 L.Ed.2d 1015 (1983) (on issues of negligence, strict products liability, adequacy of warnings, fraud, and conspiracy, “commonality begins to be obscured by individual case histories”). The Court concludes, however, that the questions of fact and law that are common to the members of the class are substantial, and are not outweighed by questions of fact and law idiosyncratic to each plaintiff. Accordingly, the Court concludes that the plaintiffs have carried their burden of showing that the proposed class meets the requirement of Rule 23(a)(2).

S. Typicality.

The typicality requirement is meant to ensure that the named parties’ claims are typical of the claims advanced by the entire class. A plaintiffs claim is typical “if it arises from the same event or practice or course of conduct that gives rise to the claims of other class members, and if his or her claims are based on the same legal theory.” AMS, 75 F.3d at 1081 (quoting 1 New-berg, supra, § 3-13, at 3-76 (footnote omitted)). The typicality requirement ensures that the representative plaintiffs’ interests are aligned with those of the proposed class, and in pursuing their own claims, the named plaintiffs will also advance the interests of the class members. Id. “Sometimes the issues are plain enough from the pleadings to determine whether the interests of the absent parties are fairly encompassed within the named plaintiffs claim, and sometimes it may be necessary for the court to probe behind the pleadings before coming to rest on the certification question.” General Telephone Co. of Southwest v. Falcon, 457 U.S. 147, 160, 102 S.Ct. 2364, 72 L.Ed.2d 740 (1982).

In the plaintiffs’ amended complaint, there are five named representative plaintiffs: Harlan and Brenda Herman, Linda Wells, and George and Mary Jean Yasenchack. Harlan Herman was implanted with a recalled Inter-Op shell, but has not undergone a revision surgery. The same is true of Linda Wells. George Yasenchack was implanted with a recalled Inter-Op shell and, on April 9, 2001, underwent revision surgery to correct problems he was experiencing with the implant.

Based on these allegations, Harlan Herman and Linda Wells appear to have claims common to the proposed “Subclass 2” of plaintiffs — persons who may need, but have not yet undergone, revision surgery to correct problems with the Affected Inter-Op shells. Harlan’s wife, Brenda, appears to have claims common to those plaintiffs in Subclass 2 who have derivative claims, such as loss of consortium.

Similarly, George Yasenchack appears to have claims common to the proposed “Subclass 1” of plaintiffs — persons who have already undergone revision surgery to correct problems with the Affected Inter-Op shells. And George’s wife, Mary Jean, appears to have claims common to those plaintiffs in Subclass 1 who have derivative claims, such as loss of consortium.14

*342The Court’s review of those cases that have been transferred to the undersigned pursuant to the MDL Panel’s orders — including other putative class actions — reveals that, in fact, the claims asserted by the five named representative plaintiffs in this case are altogether typical of the claims asserted by other prospective class members. Repeatedly, the plaintiffs in these other lawsuits' invoke the same theories of liability against the same defendants as do Wells and the Yasenchaks and the Hermans, and assert that the defendants’ liability stems from the same course of conduct.

It is worth noting that some of the plaintiffs in these other, transferred cases refer to particular models of the Inter-Op shell implants they received. The Court’s own research allowed it to view a copy of Sulzer Orthopedics’ original recall notification to the FDA.15 The notification makes clear that Sulzer Orthopedics is recalling four different models of Inter-Op acetabular shells. See letter from Larry Beeman to Sherry Krolczyk (Dec. 14, 2000) at 1, ¶ 3 (stating Sulzer Orthopedics was recalling the “Rim Flare, Hemispherical, Revision and Protrusio” models of the Inter-Op acetabular shell). That there exist different models of the recalled implants raises concerns that typicality may not exist. See AMS, 75 F.3d at 1082 (“[E]ach plaintiff used a different model, and each experienced a distinct difficulty. * * * These allegations fail to establish a claim typical to each other, let alone a class.”). The evidence presented to the Court shows, however, that, in fact, the different models of Inter-Op shells are really just different sizes, made to attach to different pelvic configurations, and that the underlying function of the models are entirely equivalent. See Beeman letter at 6 ¶ 7 (“The Inter-Op Acetabular Shell is provided in four basic configurations and is offered in various sizes within these configurations”); see also Beeman’s Supplemental Declaration (docket no. 52) (same).

Furthermore, the evidence shows that the alleged reason for the failure of each of these implant models is the same — the differences in model configuration are essentially irrelevant to their reason for failure. Thus, the Court is satisfied that the claims asserted by the five named representative plaintiffs are typical, notwithstanding the fact that the implants they received may bear different model numbers than the implants received by other class members. •

In sum, the Court concludes that the representative plaintiffs’ interests are aligned with those of the proposed class, and in pursuing their own claims, the named plaintiffs will also advance the interests of the class members. As such, the plaintiffs have carried their burden of showing that the proposed class meets the requirement of Rule 23(a)(3).

k. Adequacy.

The adequacy requirement ensures that the named representative plaintiffs “will fairly and adequately represent the interests of the class.” Fed.R.Civ.P. 23(a)(4). The Sixth Circuit Court of Appeals has “articulated two criteria for determining adequacy of representation: 1) the representative must have common interests'with unnamed members of the class, and 2) it must appear that the representatives will vigorously prosecute the interests of the class through qualified counsel.’” AMS, 75 F.3d at 1083 (quoting Senter v. General Motors Corp., 532 F.2d 511, 525 (6th Cir.1976), cert. denied, 429 U.S. 870, 97 S.Ct. 182, 50 L.Ed.2d 150 (1976)). Essentially, the ade*343quacy requirement is meant to test “the experience and ability of counsel for the plaintiffs and whether there is any antagonism between the interests of the plaintiffs and other members of the class they seek to represent.” Cross v. National Trust Life Ins. Co., 553 F.2d 1026, 1031 (6th Cir.1977). “The adequate representation requirement overlaps with the typicality requirement because in the absence of typical claims, the class representative has no incentives to pursue the claims of the other class members.” AMS, 75 F.3d at 1083.

There does not appear to be any serious question of inadequacy in this case. At the hearing, even those attorneys who expressed some concern regarding the propriety of class certification agreed that proposed class counsel had the ability and experience to prosecute the case as a class action, and had reputations for doing so quite vigorously in other, similar cases. The Court has appointed the following individuals as class co-counsel: (1) John R. Climaco, of Climaco Lefkow-itz Peca Wilcox & Garofoli (Cleveland, Ohio); (2) R. Eric Kennedy, of Weisman, Goldberg & Weisman (Cleveland, Ohio); (3) Donald Barrett, of Barrett Law Office, P.A. (Lexington, Mississippi); (4) Keith M. Fleischman, of Milberg Weiss Bershad Hynes & Lerach, LLP (New York, New York); (5) Richard S. Wayne, of Strauss & Troy (Cincinnati, Ohio); (6) Stanley M. Chesley, of Waite, Schneider, Bayless & Chesley Co. LP (Cincinnati, Ohio); (7) Wendell H. Gauthier, of Gauthier, Downing, LaBarre, Beiser & Dean (Metairie, Louisiana); and (8) Daniel E. Becnel, Jr., of The Law Offices of Daniel E. Becnel, Jr. (Reserve, Louisiana). These individuals and their experience in representing plaintiffs in other national class action lawsuits is known to the Court and appears to be known, to an even greater extent, to those many attorneys who have attended the hearings conducted to date in this matter.

Furthermore, there does not appear to be any antagonism between the interests of the named plaintiffs and other members of the class they seek to represent. As noted, the proposed class is separated into two subclasses — implantees who have not yet had revision surgery, and implantees who have. The five named plaintiffs, themselves, are split between these subclasses. As the Supreme Court has noted, these subclasses might have interests that do not completely align: “for the currently injured, the critical goal is generous immediate payments,” but “[t]hat goal tugs against the interest of exposure-only plaintiffs in ensuring an ample, inflation-protected fund for the future.” Amchem, 521 U.S. at 626,117 S.Ct. 2231. Thus, “a class divided between holders of present and future claims ... requires division into homogeneous subclasses under Rule 23(c)(4)(B), with separate representation to eliminate conflicting interests of counsel.” Ortiz v. Fibreboard Corp., 527 U.S. 815, 856, 119 S.Ct. 2295, 144 L.Ed.2d 715 (1999) (citing Amchem, 521 U.S. at 627, 117 S.Ct. 2231).

In this case, plaintiffs have provided “structural assurance of fair and adequate representation for the diverse groups and individuals affected,” by dividing the class into homogeneous subclasses and providing each subclass with its own counsel. Amchem, 521 U.S. at 627, 117 S.Ct. 2231. Subclass 1 is separately represented by Mr. Kennedy, and subclass 2 is separately represented by Mr. Wayne. Thus, to the extent there exists any “antagonism” between the interests of the named plaintiffs amongst each other, and as against other class members, the plaintiffs have cured this conflict by the use of separately represented subclasses.

In light of this structure, the only real “adequacy” concern asserted by some objectors is that class counsel cannot be deemed adequate, within the meaning of Rule 23(a)(4), because they have not “adequately” protected the interests of those individuals who might choose to opt out of the proposed settlement. This argument makes no sense. While it is true that “opt-out claimants” are entitled to certain procedural and even constitutional protections, which this Court must safeguard (a point discussed further below), it is not true that class counsel is charged with negotiating a settlement as beneficial to “opt-out claimants” as to claimants who choose to participate in the settlement. If class counsel does their job “adequately,” moreover, the structure of the settlement will contain protections designed *344to assure that class participants actually do receive the payments they have agreed to accept. And, if class counsel does their job “adequately,” the sums promised, along with any assurances of payment, will be such that few claimants, if any would hesitate to participate in that settlement.

What these objectors fail to recognize is that “opt-out” claimants not only opt out of the. settlement, but opt out of the class as well. As long as a claimant’s right to opt out remains intact — a point which, again, is discussed further, below — class counsel has no further obligation to protect the interests of that claimant. Indeed, the • objectors would place an impossible and inherently irreconcilable obligation upon class counsel' — to negotiate a class-wide settlement which is fair, adequate, and beneficial to its participants, while leaving completely unaffected the interests of those who would choose not to participate in it. The Court does not believe that Rule 23 imposes any such burden on class counsel and does not believe “adequacy,” within the meaning of that Rule, is to be measured in such a fashion. Tellingly, the objectors provide no case law supporting their interpretation of Rule 23 and class counsel’s obligation to opt-out claimants.

Accordingly, the Court concludes that the plaintiffs have carried their burden of showing that the named representative plaintiffs will fairly and adequately represent the interests of the class in this case.

B. Class Definition.

Notably, over the course of the last few weeks, the parties have presented the Court with different class definitions. For example, the first version of the proposed settlement agreement defines the settlement class to include persons having an unsatisfied claim involving: (1) Inter-Op shells “identified in the Safety Alert dated December 5, 2000;” (2) “Natural Knee Tibial Baseplates identified in a Special Notification dated May 17, 2001;” and (3) “Reprocessed Shells.” Proposed agreement at § l.l(d & eee). The most recent version of the proposed settlement agreement does not include in the settlement class persons having unsatisfied claims related to “reprocessed shells,” and the class proposed in the amended complaint does not refer to persons having unsatisfied claims related to knee implants. Thus, the Court addresses here the precise definition of the conditionally certified class.

The Court conditionally certified the following class:

“All citizens or residents of the United States who have had Affected Inter-Op acetabular shell hip implants placed in their bodies, together with their associated consortium claimants.”16 Further, this class shall be divided into two subclasses, as follows: Subclass 1 shall consist of those class members who undergo revision surgery prior to the Final Judicial Approval Date to correct problems with the Affected Inter-Op shells, and their associated consortium claimants. Subclass 2 shall consist of class members who may need to undergo revision surgery after the Final Judicial Approval Date to correct problems with the Affected Inter-Op shells, and their associated consortium claimants.17

For two primary reasons, this conditional class does not include persons in whom were implanted reprocessed shells. First, the parties explicitly excluded such persons from the settlement class definition used in the most recent version of the proposed settlement agreement. Second, even had the parties not excluded persons asserting claims related to reprocessed shells, the Court had serious concerns whether commonality, typicality, and adequacy existed in connection to these claims. Because it appears that there may exist significant factual and legal differences between (a) persons who received Inter-Op *345hip implants bearing lubricant residue on their surface and (b) persons who received implants that, at one time, had lubricant residue on their surface but were first reprocessed and cleaned, it is appropriate that the parties agreed not to include the latter claimants in the class.

Turning to knee implant claimants, in the most recent version of the proposed class settlement agreement, the parties did include in the settlement class persons having unsatisfied claims involving certain knee implants. For at least three separate reasons, the Court concludes that the conditionally certified class cannot include these persons (and, therefore, that the parties must submit an am

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In re Inter-Op Hip Prosthesis Liability Litigation | Law Study Group