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finding that an expert could not testify on the specific legal requirements of FDCA and FDA regulations and whether the defendant complied with these requirements, but that the expert could explain the general FDA process and whether the defendant's “actions were reasonable or appropriate”
Summary of this case from Sorin Grp. USA, Inc. v. St. Jude Med., S.C., Inc.Opinion
Civil Nos. 03-2919 (JRT/FLN), 03-2920 (JRT/FLN).
February 16, 2005
Daniel A. O'Fallon and Stephanie J. Kravetz, ROBINS, KAPLAN, MILLER CIRESI L.L.P., Minneapolis, MN, for plaintiffs.
Kim Schmid, Courtney Candalino, BOWMAN BROOKE, L.L.P., Minneapolis, MN. Albert J. Dahm and Michael Elvin, DAHM ELVIN, L.L.P., Fort Wayne, IN, for defendant.
MEMORANDUM OPINION AND ORDER
Defendant Zimmer, Inc. ("Zimmer") designs and manufactures prescription prosthetic devices including the Centralign Option femoral hip stem. Plaintiff Evelyn Reiling ("Reiling") received a Centralign hip implant in March 1995. The hip stem loosened and, in April 2000, Reiling required a revisionary procedure. Plaintiff Allen Lillebo ("Lillebo") received a Centralign hip implant in November 1994. Lillebo's hip stem also loosened, requiring a revision in May 2000. Reiling and Lillebo (together, "plaintiffs") assert that the Centralign is a defective product that caused their stems to loosen prematurely. Plaintiffs allege claims of negligence and strict liability. Plaintiffs' spouses assert claims of loss of consortium.
BACKGROUND
These facts are gleaned from the submissions of the parties and should not be taken as findings of the Court.
Reiling was diagnosed in mid-1994 with left central acetabular osteoarthritis. The orthopedic surgeon who examined Reiling, Dr. Dworak, initially treated her with a cortisone injection, but eventually recommended a left total hip arthroplasty. Reiling underwent a cemented total hip replacement on her left hip on March 15, 1995.
Lillebo began experiencing bilateral hip and right knee pain in 1993. In September 1993, Lillebo was examined by Dr. Dworak, who diagnosed him with severe osteoarthritis in both hips and eventually recommended total hip arthroplasty of both hips. Lillebo elected to have the right hip replacement performed first, on January 26, 1994. Lillebo's left hip was replaced on November 14, 1994.
Before each of the surgeries, Dworak discussed with plaintiffs the risks and benefits of hip replacement surgery, including infection, thrombophlebitis, neurovascular injury, leg length discrepancy, fracture, dislocation, that the stem attaching the implant to the femur might loosen over an undetermined period of time, requiring correction, and that the results of the procedure could not be guaranteed. According to Dworak, the Centralign Option stem could be expected to last for at least 15 years. Both plaintiffs decided to go ahead with the surgery, and signed consent and release forms acknowledging that each understood the risks of the procedure.
Dworak chose to use a Centralign Option femoral hip stem manufactured by defendant. The Centralign Option is a femoral stem forged from cobalt-chromiummolybdenum alloy with macro-surface texturing on portions of the stem. According to Dworak, he chose the Centralign Option stem because Zimmer and the Centralign Option's designer touted the stem as the "next Charnley," and the Centralign Option was less expensive than another Centralign model, the Centralign Precoat.
The Charnley stem was one of the original successful cemented stem models.
The Centralign Option was available in six sizes. Reiling received a size 2 stem; Lillebo received a size 4 stem. It is important that the stem implanted in any given patient be small enough to allow creation of a sufficient cement mantle. A uniform cement mantle provides the best chance of a positive result. It is also important to center the stem in the canal in order to achieve maximum success. A non-continuous cement mantle, one with voids, and/or non-central placement of the stem in the medullary canal can lead to early loosening of the stem. Dworak later noted that the placement of Reiling's stem was slightly asymmetric and the cement mantle was not perfect. Dworak noted that Lillebo's left stem was placed slightly varus, or off center.
Manufacturing records for the implants plaintiffs received reflect no design or manufacturing deviations and indicate that the devices met specifications in all respects. Dworak did not read the package insert provided with plaintiffs' implants, and does not recall ever reading the package insert provided with the Centralign product. However, Dworak believes he read promotional materials for the Centralign Option product at some point.
Reiling's surgery was initially successful, with both Reiling and Dr. Dworak noting positive progress in the months following surgery. In July 1998, Reiling had her final follow-up appointment with Dworak. X-rays taken at that time showed no sign of loosening, and Reiling was told to follow-up every eighteen months to check for accelerated polyethylene wear or osteolysis.
Osteolysis is bone destruction.
In October 1999, Reiling began experiencing hip pain again, and returned to Dworak. Dworak x-rayed Reiling's left hip, but observed no sign of loosening or accelerated polyethylene wear. On March 9, 2000, Reiling again returned to Dworak, complaining of progressive pain in her left hip. X-rays revealed debonding of the femoral component, and Dworak recommended a revision surgery. Reiling obtained a second opinion from a Dr. Kyle, who also recommended revision total hip arthroplasty. Kyle performed the revision surgery on April 25, 2000. Approximately six weeks later, Reiling dislocated her left hip twice. On June 14, 2000, Dr. Kyle performed a second revision surgery to replace the acetabular liner.
Lillebo's left hip replacement was also initially successful, with both Lillebo and Dworak noting improvement in the months following surgery. In October 1998, Lillebo had a follow up appointment with Dworak. X-rays taken at that time showed no sign of loosening, accelerated polyethylene wear, or osteolysis.
Lillebo's right hip replacement was successful, and remains in place today.
In March 2000, Lillebo began experiencing pain again, and returned to Dworak. Dworak x-rayed Lillebo's left hip, and observed debonding of the femoral component. Dworak recommended a revision surgery. Lillebo obtained a second opinion from Dr. Spirt-Jones, and a third opinion from Dr. Sim, both of whom also recommended revision surgery. Sim performed Lillebo's revision surgery on May 3, 2000.
Zimmer's first Centralign product was the Centralign Precoat. The Centralign Precoat was a smaller implant than previous implants, with an increased offset. These features were designed to allow creation of a larger cement mantle than previous implants had permitted. However, as the inventor of the Centralign observed in a grant proposal in 1997, the smaller size and increased offset "worked to decrease torsional stability." (Pls.' Mem. Opp. SJ Ex. 8 at 57.) The Centralign Precoat has a macro-textured and precoated surface and centralizers that were intended to counteract this decreased stability. The Centralign Option, the lower cost Centralign product that both plaintiffs received, had the same macro textured surface, but did not have either the precoating or the centralizers.
According to Zimmer, plaintiffs' stems loosened because of an inadequate cement mantle at the time of initial placement, exacerbated by the placement of the stem in a less than optimal position. According to plaintiffs, the stems loosened and failed prematurely because of the decreased torsional stability caused by the smaller stem design and increased offset of the Centralign products, and because the decreased stability was not, in the Centralign Option, offset by a precoating or centralizers. Additionally, plaintiffs contend that the macro-texturing of the Centralign Option may have decreased the strength of the cement bond. The parties and their experts agree that loosening of a cemented femoral component is generally multifactorial.
Plaintiffs assert that Zimmer knew that the Centralign product had decreased torsional stability that could cause the cement mantle to fracture and fail prematurely. According to plaintiffs, Zimmer nevertheless marketed the Centralign Precoat stem as achieving superior fixation and increased longevity through the proximal and distal centralizers, shape of the stem, precoating, and the thicker more uniform cement mantle that the Centralign Precoat allowed. When Zimmer added the Centralign Option to its product line, it marketed the Centralign Option alongside the Centralign Precoat and, according to plaintiffs, represented that the Centralign Option was based on and would achieve results similar to those of the Centralign Precoat without adequately detailing the differences between the products.
Plaintiffs also assert that Zimmer inadequately tested the Centralign product, including the Centralign Option, and had no clinical data to support its claims of increased longevity, long-term implant stability, superior performance, or reduced stress on the cement mantle. Plaintiffs contend that better, more extensive, and more rigorous testing was available and common in the industry. Zimmer argues that it thoroughly tested its products in accordance with all industry standards.
Finally, plaintiffs contend that although Zimmer knew of the risk of failure associated with the Centralign stems and by 1996 had learned of an increased failure rate associated with the Centralign products, Zimmer took no steps until at least 1998 to warn doctors and patients of these risks.
Plaintiffs have brought claims of negligence and strict liability, supported in part by expert testimony from Dr. Suzanne Parisian and Albert Lippincott. Zimmer moves to exclude these experts' testimony. Zimmer also moves for summary judgment on all claims. The Court will first address Zimmer's motions to exclude, and then turn to Zimmer's motion for summary judgment.
ANALYSIS
The Court acknowledges and has studied the transcripts of proceedings and the court's opinions in Robert G. Oakberg v. Zimmer, Inc., Civil Docket No. 03-47-BU-SHE, a case pending in the United States District Court for the District of Montana. However, based on the circumstances, facts, and law involved in the cases pending in this Court, the Court reaches different conclusions.
Zimmer moves to exclude the testimony of two of plaintiffs' experts, Dr. Suzanne Parisian and Albert Lippincott.
A. Legal Standard
The admissibility of expert testimony is governed primarily by Rule 702 of the Federal Rules of Evidence. Under Rule 702, proposed expert testimony must satisfy three prerequisites to be admitted: First, evidence based on scientific, technical, or specialized knowledge must be relevant; second, the proposed witness must be qualified; third, the proposed evidence must be reliable or trustworthy in the evidentiary sense. See Lauzon v. Senco Prods. Inc., 270 F.3d 681, 686 (8th Cir. 2001). These requirements reflect the analysis enunciated by the Supreme Court in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), as codified in Rule 702. Id. The Eighth Circuit has noted that "[t]he rule clearly 'is one of admissibility rather than exclusion.'" Id. ( quoting Arcoren v. United States, 929 F.2d 1235, 1239 (8th Cir. 1991)).
Expert testimony is relevant if it "will help the jury understand the evidence or decide a fact in issue." Hartley v. Dillard's, Inc., 310 F.3d 1054, 1060 (8th Cir. 2002); Fed.R.Evid. 702. An expert may opine on ultimate issues of fact. Fed.R.Evid. 704. However, "an expert's testimony need not relate directly to the ultimate issue that is to be resolved by the trier of fact, it only need be relevant to evaluating a factual matter." Smith v. BMW N. Am., Inc., 308 F.3d 913, 919 (8th Cir. 2002); see also Clark v. Heidrick, 150 F.3d 912, 915 (8th Cir. 1998) (noting that experts offering a global understanding of the possible causes of an injury are useful to a jury). The testimony must, nevertheless, be "sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute." Concord Boat Corp. v. Brunswick Corp., 207 F.3d 1039, 1055 (8th Cir. 2000). "A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered" for the opinion to be useful to the jury. General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). However, doubts regarding usefulness should generally be resolved in favor of admissibility. Clark, 150 F.3d at 915.
"Trial courts have substantial latitude to determine whether specific expert testimony is reliable." United States v. Reed Sons P'ship, 280 F.3d 1212, 1215 (8th Cir. 2002); In re Air Crash at Little Rock, Ark., 291 F.3d 503, 514 (8th Cir. 2002). The Court's focus should be on whether the testimony is grounded upon scientifically valid reasoning or methodology. United States v. Dico, Inc., 266 F.3d 864, 869 (8th Cir. 2001).
"As a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination. Only if the expert's opinion is so fundamentally unsupported that it can offer no assistance to the jury must such testimony be excluded." Bonner v. ISP Techs., Inc., 259 F.3d 924, 929-30 (8th Cir. 2001) (internal citations and quotations omitted).
1. Dr. Parisian
a. Qualifications
Parisian is a pathologist who spent nearly four years working for the FDA. Her first two years were spent advising the FDA on health risks presented to patients by medical devices and providing clinical support on medical device issues. Over that two year period, she was responsible for 162 health risk assessments. Her last two years were spent reviewing premarket activities and applications for medical devices. Since 1995, Dr. Parisian has acted as a consultant on FDA issues similar to those she worked on at the FDA. The Court is satisfied that Parisian's experience examining and evaluating medical device safety and efficacy qualify her to offer the opinions discussed below.
b. Relevance
Regulation of medical devices, including the marketing of such devices, is governed by the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended by the Medical Device Amendments of 1976 (MDA), 90 Stat. 539, 21 U.S.C. § 301, and related regulations. See generally, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). Plaintiffs seek to admit, through Parisian's testimony, evidence that Zimmer violated the FDCA and various FDA regulations by failing to submit the Centralign for so-called 510(k) approval and report adverse events in support of their negligence claim. In a defective design claim, negligence is established if "the manufacturer fails to exercise that degree of care in his plan or design so as to avoid any unreasonable risk of harm" to a person using the product in the intended manner or in an unintended but reasonably foreseeable manner. Mozes v. Medtronic, Inc., 14 F. Supp. 2d 1124, 1127 (D. Minn. 1998) (quotation omitted). Evidence of a regulatory or statutory scheme and its alleged violation can constitute evidence of negligence. See Gray v. Badger Mining Corp., 676 N.W.2d 268, 275 (Minn. 2004). However, such a violation is not required to prove negligence and, even if proven, might not necessarily establish negligence.
The Court is concerned that permitting Parisian to detail the FDCA's and FDA's cumbersome and complex standards and offer an opinion as to Zimmer's violation of these standards will improperly convert plaintiffs' ordinary negligence claim into a de facto claim of negligence per se. Breach of a regulatory or statutory duty may be regarded as negligence per se. See Gray, 676 N.W.2d at 275. However, ordinary negligence and negligence per se present separate theories of liability. See Gradjelick v. Hance, 646 N.W.2d 225, 234 (Minn. 2002). Therefore, in order to proceed under a theory of negligence per se, plaintiffs are required to have pled that theory. See Leatherman v. Tarrant County Narcotics Unit, 507 U.S. 163, 168 (1993) (reiterating that a plaintiff is not required to set out in detail the facts upon which he bases his claim, but a complaint must include a short and plain statement "that will give the Defendant fair notice of what the Plaintiff's claim is and the grounds upon which it rests"); Fed.R.Civ.P. 8(a)(2). The complaint contains no mention of any facts indicating a claim of negligence per se, and thus a negligence per se claim cannot be pursued.
Therefore, Parisian will not be permitted to testify concerning the specific legal requirements of the FDCA and FDA regulations and whether or not Zimmer's actions comply with those requirements. However, Parisian will be permitted to testify to the general nature of the approval and regulatory process, the FDA's general expectations with respect to testing and marketing of new products, Zimmer's actions in that respect, and Parisian's opinion as to whether those actions were reasonable or appropriate. Had Zimmer proceeded differently with respect to seeking FDA approval of the Centralign, Zimmer might have realized a need to conduct more extensive testing of the product. Such testimony is relevant to plaintiffs' contention that Zimmer failed to conduct adequate testing of the Centralign product.
Parisian also offers the opinion that Zimmer's advertising and promotional statements were false and misleading and exacerbated the risk to plaintiffs caused by problems with the Centralign design. Plaintiffs did not plead negligent failure to warn, see Section II(C), infra, or any other violation involving false and misleading statements. Therefore, whether Zimmer's advertising and promotional statements were false and misleading, whether Zimmer failed to properly warn patients and physicians of the risks associated with the product, and whether the statements contributed to plaintiffs' injuries, is irrelevant, and Parisian will not be permitted to offer those opinions. However, Parisian will be permitted to offer her opinion as to whether statements such as those made in Zimmer's advertising and promotional materials describe such significant product changes that Zimmer should have supported the statements with more extensive testing. Such testimony is relevant to whether Zimmer adequately tested the Centralign product as part of its design process.
Finally, Parisian offers the opinion that Zimmer could have and should have tested the effects of femoral stem surface changes prior to marketing the Centralign product, and that plaintiffs' stems failed due to problems with the Centralign design, all of which were known or knowable to Zimmer prior to marketing the Centralign. These opinions are clearly relevant to plaintiffs' claims.
c. Reliability
Based on the record now before the Court, the Court is satisfied that Parisian's opinions are reliable. Parisian's opinions are based on her experience and were formed through application of the same methodology she used at the FDA. Zimmer's objections regarding the reliability of Parisian's opinions relate almost entirely to the factual basis for her opinions. "The factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility." Bonner, 259 F.3d at 930 (citation omitted). "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional appropriate means of attacking shaky but admissible evidence." Daubert, 509 U.S. at 596.
2. Albert Lippincott
Lippincott holds a bachelor of science degree in materials science and has over twenty years of experience in industry and research related to orthopedic products including prosthetic hip implants. More specifically, and pertinent to this motion, Lippincott has experience in the manufacture, design, development, testing, and regulation of orthopedic implants. Lippincott's opinions in this case are based on his review of pertinent Zimmer documents, the medical records of the plaintiffs, medical and scientific literature, Lillebo's explanted stem, and his education and experience. The Court is satisfied that Lippincott is sufficiently experienced to offer expert opinion in this case, and that his experience allows him to draw reliable conclusions from the varied and complex documents and evidence that will be of assistance to the jury.
The Court has carefully reviewed Lippincott's expert report. Lippincott appears to offer the following opinions: Zimmer's Centralign stem is defective and unreasonably dangerous because the surface texturing, rather than provide the promised benefits, can contribute to premature loosening and osteolysis; Zimmer knew or should have known that the product was defective and unreasonably dangerous; and Zimmer could have and should have conducted more extensive testing of the Centralign. These opinions are clearly relevant to the plaintiffs' claims of defective design and inadequate testing.
Lippincott also offers the opinions that Zimmer's marketing and advertising claims concerning the Centralign stem were not supported or justified by testing; and that Zimmer could have and should have warned physicians about the potential for the above problems so that an informed choice could be made. As discussed in section II(C), infra, this case does not include failure to warn claims. Therefore, these opinions are not relevant and will not be permitted.
Additionally, Lippincott will not be permitted to testify that Zimmer denied and then covered-up the defective and dangerous nature of the Centralign product by encouraging physicians to switch to a different product. The jury may draw that conclusion from the evidence presented, but it does not require expert assistance to do so. Finally, the Court finds that whether plaintiffs' stems would have lasted longer if they received a smooth or polished femoral stem with no precoating, roughened, or macrotextured surfaces, is too broad and falls outside the scope of Lippincott's expertise and experience.
II. MOTION FOR SUMMARY JUDGMENT
A. Standard of Review
Rule 56(c) of the Federal Rules of Civil Procedure provides that summary judgment "shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56. Only disputes over facts that might affect the outcome of the suit under the governing substantive law will properly preclude the entry of summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Summary judgment is not appropriate if the dispute about a material fact is genuine, that is, if the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Id. Summary judgment is to be granted only where the evidence is such that no reasonable jury could return a verdict for the nonmoving party. Id.
The moving party bears the burden of bringing forward sufficient evidence to establish that there are no genuine issues of material fact and that the movant is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The nonmoving party is entitled to the benefit of all reasonable inferences to be drawn from the underlying facts in the record. Vette Co. v. Aetna Casualty Surety Co., 612 F.2d 1076, 1077 (8th Cir. 1980). However, the nonmoving party may not merely rest upon allegations or denials in its pleadings, but it must set forth specific facts by affidavits or otherwise showing that there is a genuine issue for trial. Forrest v. Kraft Foods, Inc., 285 F.3d 688, 691 (8th Cir. 2002). B. Defective Design
The Minnesota Supreme Court has determined that strict liability and negligent defective design claims are properly analyzed using the same standard. Bilotta v. Kelley Co., Inc., 346 N.W.2d 616, 622 (Minn. 1984). The following analysis therefore applies both to plaintiffs' strict liability defective design claims and to their negligent design claims.
In a products liability case, a plaintiff must demonstrate that (1) the product was in a defective condition unreasonably dangerous for its intended use, (2) the defect existed when the product left the manufacturer's control, and (3) the defect proximately caused the plaintiff's injuries. Patton v. Newmar Corp., 538 N.W.2d 116, 119-20 (Minn. 1995) (citations omitted). A product is "in a defective condition unreasonably dangerous for its intended use" if "the manufacturer fails to exercise that degree of care in his plan or design so as to avoid any unreasonable risk of harm to anyone who is likely to be exposed to the danger when the product is used in the manner for which the product was intended, as well as an unintended yet reasonably foreseeable use." Mozes v. Medtronic, Inc., 14 F. Supp. 2d 1124, 1127 (D. Minn. 1998) (quoting Bilotta v. Kelley Co., 346 N.W.2d 616, 621 (Minn. 1984)). Zimmer argues that plaintiffs' claims must fail because although any hip prosthesis is inherently unsafe to some degree, the Centralign is not unreasonably dangerous and because plaintiffs cannot establish causation.
1. Unreasonably Dangerous
The hallmark of a products liability claim under Minnesota law is proof that a product is "defective" and "unreasonably dangerous." See Holm v. Sponco, 324 N.W.2d 207, 212-13 (Minn. 1982). In determining what constitutes "unreasonably dangerous," the Minnesota Supreme Court "rejected the 'consumer expectation' standard of strict liability in favor of a negligence-like 'reasonable care' standard which focuses on the conduct of the manufacturer rather than the condition of the product." Kociemba v. G.D. Searle Co., 695 F. Supp. 432, 434 (D. Minn. 1988) (citing Holm, 324 N.W.2d at 212-13). The central inquiry of this reasonable care balancing test focuses on whether the manufacturer's choice of design "struck an acceptable balance among several competing factors" including risk and utility to the consumer. Bilotta, 346 N.W.2d at 622 (quoting Holm, 324 N.W.2d at 212); see also Kallio v. Ford Motor Co., 407 N.W.2d 92, 98 (Minn. 1987). The manufacturer has a duty to adequately test its product and design as part of determining whether the risks associated with the product are outweighed by the benefits. Kociemba, 707 F. Supp. at 1527.
Plaintiffs have presented evidence relating to the tests that Zimmer conducted, and the tests that Zimmer could have conducted but either failed to conduct until after the product was on the market or failed to conduct entirely. Further, plaintiffs' experts have clearly opined that the Centralign is defective and unreasonably dangerous — that is, taking into account the regular occurrence of eventual failure, the Centralign fails within an unacceptably short timeframe. From this evidence, a jury could conclude that the actual risk of implant failure outweighed the benefits of the surgery, and/or that Zimmer did not do sufficient testing to appropriately determine whether the benefits of the device outweighed the risks it posed. Defendants vigorously dispute the accuracy and sufficiency of the evidence offered, and will no doubt do so at trial. However, it is the province of the jury, not this Court, to consider conflicting factual evidence and determine whether, in these cases, the risks are outweighed by the benefits.
2. Causation
Zimmer asserts that plaintiffs cannot, as a matter of law, demonstrate causation because they do not offer any admissible expert testimony, do not offer sufficient admissible evidence, and do not offer evidence excluding other possible causes for the failure of plaintiffs' devices.
Under Minnesota law, expert testimony is required to prove causation in cases involving complex medical issues with which a jury is unlikely to have experience. Willert v. Ortho Pharmaceutical Corp., 995 F. Supp. 979, 983 (D. Minn. 1998) (citing Stahlberg v. Moe, 166 N.W.2d 340, 345 (Minn. 1969)). Parisian offered the opinion that the failure of plaintiffs' Centralign implant could be attributable to design defects. Additionally, plaintiffs' physician stated that "it was . . . possibly a design problem . . .; definitely there was some type of problem." (Dworak Dep. at 167.) The Court finds that plaintiffs have submitted sufficient expert testimony regarding causation.
Minnesota law requires a plaintiff to establish a link between the alleged defect and the injury sufficient to allow a jury to conclude that the defect caused the injury. See, e.g., J W Enterprises, Inc. v. Economy Sales, Inc., 486 N.W.2d 179, 181 (Minn.Ct.App. 1992). Zimmer argues that in order to establish this link, plaintiffs must be able to conclusively identify the Centralign as the cause of plaintiffs' injuries by excluding all other causes of loosening of the stem.
This Court recently determined in a related case that a plaintiff is not required to exclude all possible other causes of his injury. Johnson v. Zimmer, 2004 WL 742038, at *7 (D. Minn. Mar. 31, 2004). Zimmer disputes this determination, relying on Bruzer v. Danek Medical, Inc., 1999 WL 613329 (D. Minn. March 8, 1999), and Saaf v. Duluth Police Pension Relief Ass'n, 59 N.W.2d 883 (Minn. 1953). The Court finds that neither case supports Zimmer's argument. The Court in Bruzer noted that "[plaintiff's expert did] not attempt to rule out any alternative potential causes for [plaintiff's] continuing and increasing pain." Bruzer, 1999 WL 613329 at *8. However, this observation followed the Court's more important finding that plaintiff could not establish causation because he had not "identif[ied] a defect in the design of the TSRH device or any other reason attributable to any of the Defendants." Id. Rather than hold, as Zimmer suggests, that a plaintiff must eliminate all possible external causes of his injury, the Court in Bruzer merely came to the unremarkable conclusion that a plaintiff who can neither identify the cause of his injury nor rule out other possible causes of his injury cannot prevail. The court in Saaf noted that the evidence of causation "need not be expressive of absolute certainty," but determined that, in that case, the evidence of causation had been too general and speculative, and insufficiently related to the particular facts of the case, to support a finding of liability. 59 N.W.2d at 65-66. Both Bruzer and Saaf confirm that a plaintiff may present evidence excluding other possible causes of his injury and, indeed, is probably well advised to do so. However, neither requires such evidence.
In this case, plaintiffs have identified the shape and textured surface as defects in the design of the Centralign that caused their injuries. Lippincott has opined that the texturing on the Centralign creates unfilled spaces that cause the stem to loosen prematurely and to create cement debris, leading to osteolysis, when it does loosen. Dworak testified that he did an average to above average job of cementing both plaintiffs' stems, that is, of ensuring that voids and unfilled spaces were not created. This evidence, taken together, would be sufficient to allow a jury to find that the Centralign product caused plaintiffs' injuries by preventing safe implantation.
C. Failure to Warn
Federal Rule of Civil Procedure 8(a) provides that "[a] pleading which sets forth a claim for relief, . . . shall contain . . . a short and plain statement of the claim showing that the pleader is entitled to relief." The claim generally need not contain any particular language, but it must give the opposing party fair notice of the claim. See Leatherman v. Tarrant County Narcotics Unit, 507 U.S. 163, 168 (reiterating that a plaintiff is not required to set out in detail the facts upon which he bases his claim, but that a complaint must include a short and plain statement "that will give the Defendant fair notice of what the Plaintiff's claim is and the grounds upon which it rests"). The complaint contains two claims: one for negligence and the other for strict liability. In accordance with Rule 8, each claim includes the short and plain explanation that the claim is based on "defendant's negligent design and/or manufacturing." (Reiling Complt. ¶¶ 12-24.) Neither claim provides any indication, however, of a failure to warn theory. Plaintiffs have had substantial time in which to amend the complaint to include additional theories of liability. As it stands, however, the Complaint does not provide any notice at all of plaintiffs' intention to pursue claims of failure to warn.
D. Loss of Consortium
Lillebo's wife, Patricia, and Reiling's husband, Paul, also brought claims for loss of consortium. A claim for loss of consortium is necessarily derivative of an underlying tort claim. Kohler v. Fletcher, 442 N.W.2d 169, 173 (Minn.Ct.App. 1989) ( citing Peters v. Bodin, 65 N.W.2d 917, 922 (Minn. 1954)). Because Lillebo's and Reiling's claims for defective design survive, so too do their spouses' claims for loss of consortium.
The Court notes that Paul Reiling passed away in August 2004.
III. MOTION TO CONSOLIDATE CASES
Plaintiffs move to consolidate their cases for trial. Federal Rule of Civil Procedure 42(a) permits a court to consolidate for trial actions involving common questions of law or fact in order to avoid unnecessary cost or delay. Fed.R.Civ.P. 42(a); EEOC v. HBE Corp., 135 F.3d 543, 550 (8th Cir. 1998). In this case, the plaintiffs were diagnosed and operated on by the same physician and received the same implanted device. The plaintiffs were operated on within months of each other, and both plaintiffs' devices failed approximately five years after implantation due to stem loosening. Both plaintiffs assert claims of negligence and strict liability based on a theory of defective design. Plaintiffs and Zimmer have engaged the same experts in both cases, and arguments and issues raised by both parties have been virtually identical in the two cases. In short, the Court finds that multiple common questions of law and fact are present in these cases.
The Court is mindful that each plaintiff must establish each element of his or her claims, and the jury will be carefully instructed that each plaintiff is to be considered separately. Additionally, the Court is confident that parties will thoroughly discuss the differences between the plaintiffs' cases. The Court therefore finds that, in the interests of avoiding unnecessary costs and eliminating further delay in resolving these cases, consolidation of plaintiffs' cases is appropriate.
This case will be placed on the Court's next available trial calendar.
ORDER
Based on the foregoing, all the records, files, and proceedings herein, IT IS HEREBY ORDERED that:
1. Defendant's motions for summary judgment [File No. 03-2919, Doc. No. 59; File No. 03-2920, Doc. No. 51] are GRANTED in part and DENIED in part in accordance with the above opinion;
2. Defendant's motions to exclude expert testimony [File No. 03-2919, Doc. Nos. 63 and 67; File No. 03-2920, Doc. Nos. 55 and 59] are GRANTED in part and DENIED in part in accordance with the above opinion; and
3. Plaintiffs' motions to consolidate cases for trial [File No. 03-2919, Doc. No. 103; File No. 03-2920, Doc. No. 83] are GRANTED.