Soufflas v. Zimmer, Inc.
| Decision Date | 21 February 2007 |
| Docket Number | Civil Action No. 04-4753. |
| Citation | 474 F.Supp.2d 737 |
| Parties | Marguerite J. SOUFFLAS, Plaintiff, v. ZIMMER, INC., Defendant. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
John P. Kopesky, Sheller Ludwig & Badey, Philadelphia, PA, for Plaintiff.
Andrea Roberts, Thomas G. Stayton, Baker & Daniels, Indianapolis, IN, Anita
J. Murray, Eckert Seamans Cherin & Mellott, LLC, Philadelphia, PA, for Defendant.
Before the Court is Defendant Zimmer's contemporaneously filed motions to exclude Plaintiff's experts, Drs. Hetzel and Sidor, and its motion for summary judgment. As the ultimate outcome of defendant's motion for summary judgment is dependant upon the Court's ruling regarding the admissibility of Plaintiff's experts' opinions, the Court will address Defendant's motion to exclude plaintiff's experts and Defendant's motion for summary judgment seriatim.
This is a product liability case in which Plaintiff Marguerite J. Soufflas claims that three polyethylene tibial components implanted during two total knee arthroplasties and manufactured by Defendant, Zimmer, Inc. (Zimmer), were defectively designed and manufactured as a result of the method in which they were sterilized. Ms. Soufflas's complaint contains nine counts: (1) defective design and manufacture, (2) failure to warn, (3) violation of Pennsylvania consumer protection act, (4) fraud, (5) breach of implied warranty of merchantability, (6) breach of implied warranty of fitness for a particular purpose,1 (7) breach of express warranty, (8) negligent design and manufacture, and (9) punitive damages. Zimmer has moved for summary judgment on all nine counts.
Ms. Soufflas has a long history of problems in both knees. In 1975, she tore the cartilage in her left knee, causing significant pain and swelling. To repair the damage, Ms. Soufflas underwent three separate left knee surgeries to remove the torn cartilage and "reshape" and "clean" her knee.
In 1998, Plaintiff again experienced problems with both of her knees. After seeking treatment for a "burning" pain in her right knee, she decided to undergo knee replacement surgery, also known as bilateral total knee arthroplasty, on both knees.
On March 30, 1999, Plaintiff underwent bilateral total knee replacement surgery, during which Zimmer's Insall-Burstein II Modular Knee System was implanted into each knee. Each device consisted of a femoral component, tibial tray, tibial insert articular surface (tibial insert) and patella button. The tibial insert, which is at issue in this litigation, is made of a type of plastic called ultra high molecular weight polyethylene (UHMWPE), and is placed in the tibial tray to provide the surface on which the femoral component rotates or articulates.
In September 2002, Ms. Soufflas felt something in her right knee "break." Soufflas Dep. at 110-11. She subsequently had pain and swelling in her right knee and instability when walking. Ms. Soufflas's surgeon fit her knee for a brace and ordered physical therapy, but after a month, neither measure resolved her pain and swelling. Although her surgeon could not definitively determine the cause of Ms. Soufflas's instability, he advised her that she "may have loosened one or more of her parts, and she clearly need[ed] a polyethylene enhancement to restore stability." Soufflas Dep. at 135.
On January 7, 2003, Plaintiff underwent surgery to replace the tibial insert (called "revision surgery") in Plaintiff's right knee with a thicker Insall-Burstein Tibial Insert. Despite receiving a thicker tibial insert, Ms. Soufflas continued to experience instability in both knees.
Within months of the January 2003 surgery, Ms. Soufflas's right knee began "locking."2 She was treated again for instability and swelling in her right knee. As a result, the surgeon informed her that the revision surgery "did not take" and that she needed "to have that [right] knee replaced completely." Soufflas Dep. at 178, 179-180.
In mid-to-late February 2004, Ms. Soufflas's right knee locked again and she fell, landing on her left knee. On March 5, 2004, during a visit related to the upcoming right knee replacement surgery, x-rays revealed that Ms. Soufflas's left knee also needed to be "revised." On March 23, 2004, Ms. Soufflas underwent knee revision surgery on both knees.
On December 21, 2004, she filed her complaint against Zimmer. In the complaint, Plaintiff alleges that Zimmer is liable because Zimmer's method of sterilizing the tibial inserts, by gamma irradiation in air, "caused premature wear and degradation of UHMWPE [and] resulted in artificial joint failure." Compl. ¶ 35.
Whether the tibial insert used in Ms. Soufflas's artificial knee was, in fact, sterilized by gamma irradiation in air or by some other sterilization process, and whether that sterilization process caused the ensuing fracture of the insert and the need for further surgeries, remain disputed issues of fact in the case.
Defendant's expert, Dr. Maloney, will testify that both the 2003 tibial insert and the left tibial insert from Ms. Soufflas's 1999 surgery were packaged and sterilized in nitrogen, as opposed to gamma irradiation in air. On the other hand, Plaintiffs expert, Dr. Hetzel, opines that all three of Plaintiffs tibial inserts were sterilized by gamma irradiation in air. Hetzel Report at 8; see also Hetzel Dep. at 66, 132.
Under Daubert, a "trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Expert testimony is admissible only where "the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue." Id. at 592, 113 S.Ct. 2786.
In order to constitute "scientific knowledge," the expert's proposed opinion "must be derived by scientific method ... and supported by appropriate validation, i.e., `good grounds.'" Id. at 590, 113 S.Ct. 2786. Expert testimony is deemed to assist the trier of fact to understand or determine a fact in issue where "the expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute." Id. at 591, 113 S.Ct. 2786. "The consideration has been aptly described ... as one of `fit.'" Id. In other words, Daubert requires a "valid scientific connection to the pertinent inquiry as a precondition to admissibility" of expert testimony. Id. at 592, 113 S.Ct. 2786. "This requires a preliminary assessment of whether the reasoning or methodology underlying the [proposed] testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." Id. at 593, 113 S.Ct. 2786.
Factors that may guide a district court's preliminary assessment of these requirements include (1) whether the methodology can and has been tested; (2) whether the technique has been subjected to peer review and publication; (3) the known or potential rate of error of the methodology; and (4) whether the technique has been generally accepted in the proper scientific community. Heller v. Shaw Industries, Inc., 167 F.3d 146, 152 (3d Cir.1999) (citing Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786). The district court's role as the gatekeeper is a "flexible one" and "the factors are simply useful signposts, not dispositive hurdles that a party must overcome in order to have expert testimony admitted." Heller, 167 F.3d at 152.
In addition to the factors listed above, the Third Circuit has suggested that the district court consider additional factors, including (1) the existence and maintenance of standards controlling the technique's operation; (2) the relationship of the technique to methods which have been established to be reliable; (3) the expert witness's qualifications; and (4) the nonjudicial uses to which the method has been put. Heller, 167 F.3d at 152 (citing In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 742 n. 8 (3d Cir.1994)); see Johnson v. Vane Line Bunkering, Inc., No. 01-5819, 2003 WL 23162433 at *2-3 (E.D.Pa. Dec.30, 2003) (Robreno, J.).
Dr. Hetzel, a scientist in the field of organic chemistry, opines that (1) the tibial insert implanted in Ms. Soufflas's knee was sterilized using gamma irradiation in air, (2) the effect of this sterilization method is to chemically degrade the insert, weakening it over time, (3) this weakening ultimately caused the tibial insert to fracture, (4) based on the polymer literature, Zimmer knew or should have known of the dangers of this sterilization process, (5) alternate sterilization processes were available at the time of manufacture of the tibial insert used in Plaintiff, and (6) the tibial insert contained voids or air bubbles, which are manufacturing defects.
Zimmer attacks Dr. Hetzel's proposed testimony as unreliable and inadmissible under Federal Rule of Evidence 702 and Daubert. Dr. Hetzel will be permitted to offer some but not all of the proposed opinions.
Dr. Hetzel's testimony will be limited to the sterilization methods available at the time Zimmer sterilized the tibial insert used on Ms. Soufflas, the chemical effects caused by gamma irradiation in air on UHMWPE, the indications of these effects and what he examined in the inserts extracted from Ms. Soufflas's knee. This evidence is both relevant and reliable under Daubert's standards.
It is relevant in that it provides one possible explanation for the failure of Ms. Soufflas's tibial inserts — that it was weakened by the chemical effect the sterilization process used had on the particular polymer. As an organic chemist, Dr. Hetzel is...
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