Illinois Association of Defense Trial Counsel P.O. Box 7288, Springfield, IL IDC Quarterly Vol. 15, No. 4 ( ) Product Liability

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1 Product Liability By: James W. Ozog Wiedner & McAuliffe, Ltd. Chicago Seventh Circuit Again Rejects Unreliable Expert Testimony: Fuesting v. Zimmer, Inc. 421 F. 3d 528 (7th Cir. 2005) In Fuesting v. Zimmer, Inc., 421 F.3d 528 (7th Cir. 2005), the Seventh Circuit rejected the testimony of an otherwise skilled and qualified expert witness. The court affirmed that requisite credentials alone are not enough to render unreliable expert testimony admissible. The court also reminded trial judges that in keeping with their gatekeeper s duty under Federal Rule of Evidence 702, the court must assess the reliability of the methodology the expert has employed in order to rule upon admissibility. The defendant, Zimmer, manufactured the I/B Knee implant in 1991 for use in the total knee anthroplasty procedure. This procedure involves replacement of three bone surfaces with artificial metal components covered by a polyethylene surface. On February 5, 1992, the plaintiff underwent a knee replacement, which utilized an I/B Knee implant manufactured by Zimmer. By May of 2001, Fuesting began experiencing pain and swelling in the knee. On November 14, 2001, the defendant s physician replaced the Zimmer knee implant with a Johnson & Johnson model. In October of 2002, the defendant brought two claims against Zimmer based on theories of strict liability and negligence related to a design defect of the I/B Knee implant. According to the defendant, the implant was defective based on the way it was sterilized at the time of its manufacture. In 1991, Zimmer sterilized all of its I/B Knee components by way of gamma irradiation in air. (This was a universally employed process at the time.) The plaintiff s knee implant had been sterilized seven months before his procedure, a short time by industry standards. The defendant proffered witness James Pugh, a so called litigation consultant. Pugh opined that Zimmer s method of sterilization, coupled with the implant s time on the shelf, caused the implant s polyethylene to oxidate, resulting in its delamination and ultimate failure. Pugh believed that Zimmer should have been aware of the alternative superior sterilization methods that were available at the time of the I/B Knee s manufacture. The district court denied Zimmer s pre-trial motion in limine to exclude Pugh s opinions on causation and defect as unreliable under Federal Rule of Evidence 702. At trial, Pugh attributed his opinions to basic polymer science and testified that the gamma irradiation in air caused the premature failure in Fuesting s right I/B Knee. He added that any knee implant with a polyethylene Page 1 of 5

2 tibial component sterilized in such a manner would be defective. Based upon his major in chemistry, the defendant s treating orthopedic surgeon, Dr. James McKechni, concurred. Zimmer countered with expert testimony from Dr. William Maloney, an orthopedic surgeon and leading researcher in the field of joint replacement and osteolysis. He testified that the wear and tear in Fuesting s implant was most likely attributable, not to oxidation of its polyethylene component, but to peculiarities in Fuesting s gait and bone growth, exacerbated by the plaintiff s post-implant weightgain. Dr. Albert Burstein, co-inventor of the implant, agreed with Dr. Maloney s conclusion and added that the alternative proffered by Pugh was more dangerous and more likely to cause wear. To oppose the theory of design defect, Dr. Albert Burstein testified that it was virtually universal industry practice to sterilize implants using gamma irradiation in air in Fuesting objected to the testimony, claiming that Burstein failed to disclose the basis of his opinion as required of Rule 702 witnesses by Federal Rules of Civil Procedure 26(a)(2)(A)&(B). Notwithstanding Fuesting s admitted evidence that Zimmer and other manufacturers today sterilize implants in inert (as opposed to open air) environments, the district court barred Dr. Burstein s state of the art testimony, and the jury awarded Fuesting $650, On appeal, Zimmer challenged the denial of its motion to exclude Pugh s testimony on causation and defect. Upon review, the Seventh Circuit first held that the trial court did not conduct an appropriate analysis of the reliability of the expert s testimony under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct (1993) and Federal Rule of Evidence 702. The court observed: The district court must also, in keeping with its gatekeeper s duty, assess the reliability of the methodology the expert has employed in arriving at his opinion. This the district court did not do. Instead, the court made reference to Pugh s deposition, satisfying itself that his analysis was discussed at length throughout the deposition [where] he articulated a scientific reason for the failure of the polyethylene in Fuesting s knee without rely[ing] on generalized analogies or inapplicable scientific principles. But nothing is said as to what exactly that articulate scientific reason is, or how it measures up to Daubert s indicia of reliability. The court invoking again Pugh s deposition as well as his expert report, further found that the expert had sufficiently ruled out Fuesting s weight and activity level as potential causes of polyethylene failure in the plaintiff s implant. But the court made no mention of how Pugh ruled those alternative causes out, let alone whether and why it found that method reliable. To satisfy its essential role, the gatekeeper must do more than just make conclusory statements. A more searching Daubert analysis is required, and we find the district court s examination of Pugh s testimony inadequate.421 F.3d at 535. The Seventh Circuit then conducted a de novo Daubert analysis of Pugh s testimony. Using the standard Daubert guideposts, the Seventh Circuit held that the testimony proved unreliable. Pugh s testimony failed to meet most, if not all of the Daubert factors for reliability. First, the plaintiff s expert did not subject his theory to scientific method by conducting any scientific test or experiments. The failure to test, the court observed, fatally compromised the testimony s reliability. The expert s reliance on basic polymer science was the unjustifiable extrapolation from an accepted premise to an unfounded conclusion. 421 F.3d at 536. Such extrapolation without analysis of the details does not bridge the analytical gap between basic principle and an expert s complex conclusions. Other indications of unreliability included the lack of publication and peer review. This proved that there was no evidence of acceptance of the expert s theory in the scientific community. Finally, it was also clear that the opinion was developed solely and expressly for this litigation. Therefore, the Page 2 of 5

3 Seventh Circuit not only reversed the trial court but remanded the case with an instruction to direct a verdict in the defendant s favor. The Fuesting opinion is another case to keep in your Daubert/Rule 702 file. It is a reminder to all trial judges that they must conduct a thorough and reasoned analysis under Federal Rule of Evidence 702 before admitting expert testimony. The opinion offers another excellent guideline regarding how to apply the Daubert factors in order to expose unreliable expert testimony in a product liability case. Risk-Utility Test Reverses Summary Judgment in Favor of Manufacturer: Calles v. Scripto-Tokai Corp. 358 Ill. App. 3d 975, 832 N.E. 2d 409, 295 Ill. Dec. 258 (1st Dist. 2005) In Calles v. Scripto-Tokai Corp., 358 Ill. App. 3d 975, 832 N.E.2d 409, 295 Ill. Dec. 258 (1st Dist. 2005), the First District answered a straightforward question concerning the reach of tort law. Applying the risk-utility test for determination of a product defect, the court held that the failure to incorporate available inexpensive technology to make a flame lighter child-resistant presented a question of fact regarding whether the design was defective. In March of 1998, Susan Calles purchased a gun-shaped Aim n Flame lighting rod, which formed a flame at the end of the barrel with a pull of its trigger. On March 31, 1998, Ms. Calles put her threeyear-old daughters, Jillian and Jenna, to sleep in their bedroom, leaving them in the care of their oldest sister while she went to the store. Investigators concluded that, in the thirty minutes Ms. Calles was gone, Jenna used the Aim n Flame lighting rod to start a fire in the three-year-olds bedroom. The children were taken to the hospital that night, where Jillian died a few weeks later. Jillian s estate sued Tokai Corporation, the designer and seller of the Aim n Flame, Tokai s subsidiary and distributor, Scripto-Tokai Corporation, Jillian s doctor, Richard Fox and Loyola University Medial Center, where Dr. Fox treated Jillian. Fox and Loyola filed a cross-claim against Tokai and Scripto-Tokai. The estate, Fox, and Loyola sought to recover on theories of strict liability and negligence, with both theories premised upon defective design and failure to warn. Claiming that Illinois law imposes no duty to make products child-resistant, Tokai and Scripto- Tokai moved for summary judgment. Because the rod worked exactly as Ms. Calles expected it to work, the defendants argued that she could not show a design defect. Additionally, the defendants claimed that they had no duty to warn Ms. Calles of the dangers, because she was aware of the open and obvious dangers of the Aim n Flame. Ms. Calles testified in her deposition that the rod worked as she expected it to work, she knew lighters could be dangerous in the hands of children, and she had instructed all of her children about these dangers. She stored the lighter on the top shelf of her kitchen cabinet out of her children s reach, but she admitted that the children could reach the rod by climbing up on to the counter. By affidavit, the plaintiff experts proffered that Tokai was able to design a child-resistant lighting rod with technology available long before Ms. Calles bought the subject Aim n Flame. Producing the child-resistant rod, the experts claimed, would cost only a few cents more than producing the rod without the feature, and the feature would almost certainly have prevented Jenna from using the lighting rod to start the fire. One expert opined that the label required a more conspicuous danger symbol and should have warned that children may be able to operate the lighter. Another expert discovered reports of at least 200 incidents involving accidental fires started with the Tokai Aim n Flame. According to the reports, prior to September 1998, children had started about 250 fires using the Aim n Flame, and more than three-fourths of these fires were started by children under the age of five years. Page 3 of 5

4 Additional reports also summarized the danger of cigarette lighters. Between 1980 and 1985, 120 people died annually in residential fires started by children playing with lighters. Costs were between $300 and $375 million dollars, and between 1988 and 1990, the number of deaths attributable to children playing with lighters increased to 150. Children three to four years old caused most of these fires. These studies estimated that 80 to 105 deaths could be avoided with the implementation of childproof lighters, and $205 to $270 million in costs could be saved. The initial production costs were estimated to approach $50 million, and in 1993, manufacturers were expected to see a one to five percent increase in production costs and a one to five cent increase in per-unit cost. Nevertheless, the trial court held that Tokai and Scripto-Tokai neither owed nor breached any duty imposed upon them by law, and the court entered summary judgment for Tokai and Scripto-Tokai on all counts filed against them in both the estate s complaint and the cross-complaint. 832 N.E.2d at 412, 295 Ill. Dec. at 261. On appeal, the defendant argued that the consumer expectation test should be applied because the lighter was a simple product (citing Scoby v. Vulcan-Hart Corp., 211 Ill. App. 3d 106, 569 N.E.2d 1147, 155 Ill. Dec. 536 (4th Dist. 1991)). In fact, the Seventh Circuit followed the Scoby decision in affirming summary judgment in favor of a cigarette lighter manufacturer in another child death case. Todd v. Societe Bic, S.A., 21 F.3d 1402 (7th Cir. 1994). Based upon the more recent case of Miller v. Rinker Boat Co., 352 Ill. App. 3d 648, 815 N.E.2d 1219, 287 Ill. Dec. 416 (4th Dist. 2004), the court refused to follow Scoby and in particular the Todd case. While acknowledging that some simple products might present obvious dangers that might preclude the application of the risk-utility test, the court observed: That is, the simplicity of the product, and its obvious danger, will not warrant summary judgment for the product s designer unless the balance of all considerations so clearly favors the defendant that no reasonable jury could find for the plaintiff.832 N.E.2d at 416, 295 Ill. Dec. at 265. In this case, the design of the lighter did not outweigh the risk. In particular, the court appeared to be persuaded by the fact that a child-resistant modification would cost only a few cents in contrast to the high social costs of fires started by children playing with cigarette lighters. On a brighter note for the defense, the court did affirm summary judgment regarding the plaintiff s failure to warn claims. In her deposition, Ms. Calles testified that she was well aware that lighters could be dangerous in the hands of children. She also knew that it was necessary to store the lighter in an area where children could not reach it. In light of those admissions the court observed that further warnings could not have helped the plaintiff understand the danger of the product and measures to prevent the children s access to the product. The court concluded: The manufacturer has no duty to add pointless warnings about dangers the consumer already recognizes. 832 N.E.2d 417, 295 Ill. Dec The Calles opinion again demonstrates how difficult it is to defend a summary judgment order if the court has not applied a risk utility analysis to the evidence of defect. As to the vast majority of products, Illinois law permits the plaintiffs to prove up a defect under either the consumer expectation test or risk utility test. Thus, evidence of defect must be eliminated under both theories in order to prevail on summary judgment. Page 4 of 5

5 ABOUT THE AUTHOR: James W. Ozog is a partner in the Chicago firm of Wiedner & McAuliffe, Ltd. He received his undergraduate degree from Northwestern University and law degree from Washington University in Mr. Ozog concentrates his practice in product liability defense matters and commercial litigation. In addition to his Illinois defense practice, he is National Trial Counsel for several product manufacturers. He has appeared as lead defense counsel in over twenty states and tried cases to verdict in seven states besides Illinois. He also represents clients on a regular basis in matters before the United States Consumer Products Safety Commission. He is a member of the American Bar Association, DRI, IDC and the Propane Gas Defense Association. Page 5 of 5