Stanger v. Smith & Nephew, Inc.
| Decision Date | 30 November 2005 |
| Docket Number | No. 4:04CV839 HEA.,4:04CV839 HEA. |
| Citation | 401 F.Supp.2d 974 |
| Court | U.S. District Court — Eastern District of Missouri |
| Parties | Linda STANGER and, Richard Stanger Plaintiffs, v. SMITH & NEPHEW, INC., et al., Defendants. |
A. Laurie Koller, Patrick E. Carr, Carr and Carr, Tulsa, OK, for Plaintiffs.
Peter Von Gontard, Andrew D. Ryan, Sandberg Phoenix & Von Gontard, P.C., James R. Cantalin, Carmody MacDonald P.C., St. Louis, MO, for Defendants.
This matter is before the Court on defendant Thomas Satterly, Jr.'s (Satterly) Motion for Summary Judgment, [Doc. No. 68], plaintiffs' Motion for Partial Summary Judgment, [Doc. No. 90], defendants Smith & Nephew, Inc., (S & N), Larry Gross and Larry Gross & Associates, Inc., (Gross), Ted Toler and Ted Toler & Associates, Inc.'s (Toler), Motions for Summary Judgment, [Doc. No.'s 97, 98 and 99], plaintiffs' Motion for Partial Summary Judgment on Negligent Failure to Warn, [Doc. No. 112], and plaintiffs' Motion for Partial Summary Judgment on Strict Liability Product Defect against Defendant Smith & Nephew, [Doc. No. 113]. For the reasons set forth below, defendants S & N, Toler-Gross' Motions for Summary Judgment are granted in part and denied in part; plaintiffs' Motion for Partial Summary Judgment on their Strict Liability Product Defect Claim is denied; plaintiffs' Motion for Summary Judgment on their Negligent Failure to Warn Claim is granted; plaintiffs' Motion for Partial Summary Judgment on the Learned Intermediary Defense, is granted and defendant Satterly's Motion for Summary Judgment is granted.
Plaintiffs initiated this action based on allegations of design, manufacturing and/or marketing defects relating to S & N's Genesis I medium left 15 mm articular insert (the tibial insert) which was implanted in plaintiff Linda Stanger. Plaintiffs contend that the Ultra-High Molecular Weight Polyethylene (UHMWPE) insert was defective and unreasonably dangerous because it was sterilized using gamma irradiation in air. Gamma irradiation in air causes oxidation of UHMWPE. The greater the length of time for exposure to the air of the gamma-irradiated UHMWPE, the more it oxidizes. Due to the length of time the insert was exposed to air, the insert failed eight months after implantation into Plaintiff Linda. Plaintiff Linda was required to undergo revision surgery. Plaintiffs seek compensatory and exemplary damages from defendants S & N, Toler and Gross and compensatory damages from defendant Satterly based on theories of strict liability, negligence, breach of implied warranties, and misrepresentation. Plaintiff Richard Stanger seeks recovery for loss of consortium and services of his wife Linda.
S & N manufactured and marketed artificial knee joints known by the brand name, Genesis I. The Genesis I has several components. One of the components is a UHMWPE `tibial insert.' This type of artificial knee device was implanted into Linda Stanger on April 15, 2002.
On March 12, 1991, Smith & Nephew Richards, Inc., the predecessor to S & N, manufactured and packaged a Genesis I medium left 15 mm articular insert bearing catalog number 724519, lot number 1A09964. According to plaintiffs' expert William H. Damaska, in 1991, the tibial insert was appropriately branded and labeled. According to plaintiffs' expert Robert Schiff, in 1991, the FDA did to require a serial number on the tibial insert that would allow the tibial insert to be traced. The tibial insert was not taken out of its original packaging anytime prior to April 15, 2002.
On March 24, 1991,1 the tibial insert was sterilized using gamma irradiation in air. In 1991, gamma sterilization of these type tibial inserts was virtually the universal industry practice and methodology in the United States.2 In 1991, it had not been determined that there was a shelf life on gamma irradiated tibial inserts. By 1996, information became available that problems regarding gamma sterilized polyethylene with a shelf life in excess of five years causes the tibial insert to lose its intended strength and makes it unsuitable for implantation. Gamma sterilization, in and of itself is not immediately detrimental. However, this sterilization process initiates long-term chemical changes within the polyethylene, including oxidation. A consequence of oxidation is that, over time, the material properties are reduced. The chemical changes that take place in UHMWPE are a function of time after sterilization, and the time frame between sterilization and implantation is referred to as the "shelf life" of the component. The oxidation of the tibial insert continued while it was in its packaging. The oxidation of the tibial insert caused delamination. The packaging insert for the tibial insert did not warn about the dangers of gamma sterilization in air and shelf aging. Within the years 1994-1997 S & N initiated efforts to remove gamma sterilized components from the field due to the likelihood of failure.
According to plaintiffs' expert William H. Damaska, the tibial insert was not misbranded or mislabeled in 1991 because it was not until 1996 that there was a body of evidence indicating the tibial insert was not safe and S & N and the industry in general became aware of the information. Further, Damaska does not believe the FDA required the removal of gamma sterilized polyethylene products from the market. Furthermore, he does not believe the FDA took affirmative action to have gamma sterilized polyethylene products removed from the market.
S & N's records establish that on April 2, 1991, a Genesis I medium left 15 mm articular insert, catalog number 72419, lot number 1A009964 was delivered to Larry Gross, an independent sales representative of S & N. This insert was sold to Phelps County Regional Medical Center on May 6, 1991. There is no record of any other instance of the sale of a Genesis I medium left 15 mm articular insert to Phelps County Regional Medical Center.
During the time period from 1989 through 1997, almost all of Phelps County Regional Medical Center's medical device inventory was owned by the Hospital. Phelps County Regional Medical Center has no records of the tibial insert implanted into plaintiff, in that all records prior to the conversion of its record keeping system in 1993 were destroyed.
On April 15, 2002, plaintiff Linda Stanger underwent total arthroplasty at the Phelps County Regional Medical Center. Defendant Satterly implanted S & N's Genesis I artificial knee, which included the tibial insert. Eight months later, on December 9, 2002, Linda was required to undergo revision surgery to replace the insert.
Sometime within the years 1994-1997, S & N developed and executed a plan to exchange tibial inserts that were sterilized in air and shelf aged longer than 5 years. S & N undertook to advise distributors to exchange old UHMWPE product for new ethylene oxide product.
The standards for summary judgment are well settled. Summary judgment is appropriate when there exists no genuine issue as to any material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The moving party has the burden to establish both the absence of a genuine issue of material fact and that it is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Once the moving party has met this burden, the nonmoving party may not rest on the allegations in his pleadings but by affidavit or other evidence must set forth specific facts showing that a genuine issue of material fact exists. Fed.R.Civ.P. 56(e); Anderson, 477 U.S. at 256, 106 S.Ct. 2505; Krenik v. Le Sueur, 47 F.3d 953, 957 (8th Cir.1995). Hitt v. Harsco Corp., 356 F.3d 920, 923 (8th Cir.2004). To survive a motion for summary judgment, the Putman v. Unity Health System, 348 F.3d 732, 733-34 (8th Cir.2003). "[A] complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Celotex, 477 U.S. at 323, 106 S.Ct. 2548.
Pending before the Court are defendants' motion for summary judgment and plaintiffs' motion for partial summary judgment on plaintiffs' strict liability product defect claim. Defendants argue that they are entitled to judgment because the tibial insert was not defective at the time it entered the stream of commerce; plaintiffs argue that the product was defective at the time it was manufactured and further argue that there are issues of material fact as to when the tibial insert was sold.
The Court's jurisdiction over this matter is based upon diversity of citizenship. In this regard, neither party objects to the application of Missouri law to the products liability issues in this case. ...
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