Wollam v. Wright Med. Grp., Inc.
| Decision Date | 30 September 2012 |
| Docket Number | Civil Action No. 1:10-cv-3104-DME-BNB |
| Parties | GLENN A. WOLLAM and BONNIE J. SCHOENSTEIN, Plaintiffs, v. WRIGHT MEDICAL GROUP, INC., a Delaware corporation; WRIGHT MEDICAL TECHNOLOGY, INC., a Delaware corporation; WRIGHT MEDICAL EUROPE S.A., a foreign corporation; JOHN DOE, an individual; and JANE DOE, an individual, Defendants. |
| Court | U.S. District Court — District of Colorado |
This matter comes before the Court on two matters: 1) The motion of Defendants Wright Medical Group, Inc., Wright Medical Technology, Inc., and Wright Medical Europe S.A. (collectively "Wright Medical") to dismiss and for summary judgment (Doc. 133); and 2) the objection of Plaintiffs Glenn A. Wollam and Bonnie Schoenstein ("Plaintiffs") to the magistrate judge's recommendation to deny their motion to amend the complaint a second time in order to request an award of exemplary damages (Doc. 126). After considering these pleadings, as well as the evidence and argument the parties have submitted, the Court 1) GRANTS in part and DENIES in part Wright Medical's motion to dismiss and for summary judgment, and 2) OVERRULES Plaintiffs' objection, ADOPTS the magistrate judge's recommendation and DENIES Plaintiffs' motion to file a second amended complaint.
On April 18, 2005, Plaintiff Glenn Wollam had a double hip replacement. In performing this surgery, Wollam's surgeon, Daniel Ward, M.D., used two artificial joints, known as PROFEMUR® Total Hip Systems, which were designed and manufactured by Wright Medical. These modulating hip systems are each comprised of four parts - a cap, a femoral head, a neck, and a femoral stem. Three and one-half years after Wollam's surgery, on October 30, 2008, the neck of Wollam's right artificial hip broke in two and had to be surgically removed and the artificial joint replaced.
Wollam and his wife, Plaintiff Bonnie Schoenstein, Colorado residents, sued Defendants Wright Medical, citizens of Delaware, Tennessee, and France, alleging twelve causes of action.1 This court has diversity jurisdiction over these claims. See 28 U.S.C. § 1332(a).
In their motion currently before this Court, Wright Medical first seeks dismissal of Plaintiffs' fraud claim (Claim 11), pursuant to Fed. R. Civ. P. 12(b)(6) and (c). Plaintiffs concede that claim should be dismissed.
Wright Medical seeks summary judgment as to Plaintiffs' remaining claims. In response, Plaintiffs concede that their claims alleging negligence per se (Claim 9), negligent misrepresentation (Claim 8), strict product liability due to nonconformancewith representations (Claim 3), and violations of the Colorado Consumer Protection Act (Claim 10) should also be dismissed.
As to Plaintiffs remaining claims, the Court must grant summary judgment if Wright Medical, as the movant, shows that there is no genuine dispute as to any material fact and Wright Medical is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(a).
In Claims 1, 2 and 4, Plaintiffs allege that Wright Medical is liable for the harm caused Plaintiffs as the result of Wollam's right artificial hip joint fracturing, under strict product liability theories. The parties agree that Colorado law governs Plaintiffs' claims.
Colorado has "expressly adopted the doctrine of strict liability in tort, based on the Restatement (Second) of Torts § 402A." Union Supply Co. v. Pust, 583 P.2d 276, 280 (Colo. 1978) (citing Hiigel v. Gen. Motors Corp., 544 P.2d 983 (Colo. 1975)). Applying strict liability to product manufacturing, Colorado recognizes "three general areas of the manufacturing process that lead to strict liability claims . . . : (1) Physical flaws due to improper manufacture; (2) inadequacies in Design; and (3) inadequate Warnings concerning the hazards or proper methods for safe use." Id. at 280 n.1. Plaintiffs allege all three types of strict product liability claims.
The Court will address together Plaintiffs' claims alleging defective manufacture and defective design because they share common elements. Most relevant here, in order to recover for strict product liability based on either a design or a manufacturingdefect, Plaintiffs must establish, among other things, that the product was "in a defective condition unreasonably dangerous" to the user or consumer.2 Barton v. Adams Rental, Inc., 938 P.2d 532, 536 (Colo. 1997); see also Mile-Hi Concrete, Inc. v. Matz, 842 P.2d 198, 205 (Colo. 1992). In moving for summary judgment on these claims, Wright Medical contends that Plaintiffs have failed, as a matter of law, to establish a triable issue of fact as to whether Wright Medical's PROFEMUR® Total Hip System was "in a defective condition unreasonably dangerous" to users and consumers. See Luster v. Vilsack, 667 F.3d 1089, 1096 (10th Cir. 2011) ().
As an initial matter, Wright Medical asserts that, under Colo. Rev. Stat. § 13-21-403(1)(b), its PROFEMUR® Total Hip System should be presumed not to be defective. Section § 13-21-403(1)(b) provides the following:
Wright Medical claims that this rebuttable presumption applies here because Wright Medical obtained the approval of the federal Food and Drug Administration ("FDA") to market its PROFEMUR® Total Hip System.3 Plaintiffs counter that Wright Medical is not entitled to a rebuttable presumption under § 13-21-403(1)(b) because the FDA never considered and approved the safety of the PROFEMUR® Total Hip System, but instead concluded only that Wright Medical's PROFEMUR® Total Hip System was substantially equivalent to an already legally marketed device and therefore Wright Medical was exempt from having to obtain FDA approval of its Total Hip System.
The Court need not resolve this dispute here. If the rebuttable presumption applies, Plaintiffs must come forward with evidence to rebut that presumption and create a triable issue on their claims alleging a manufacturing defect and a design defect. And if the rebuttable presumption does not apply, Plaintiffs still must come forward with such evidence in order to survive summary judgment. Therefore, the question the Court considers here is whether Plaintiffs asserted sufficient evidence to warrant their claims going to the jury. See Bertsch v. Overstock.com, 684 F.3d 1023, 1028 (10th Cir. 2012); see also Mile Hi Concrete, 842 P.2d at 205-06 & n.17 (addressing directed verdict).
In their first claim for relief, Plaintiffs alleged Wright Medical was liable on a manufacturing-defect theory. Under such a theory, the question is whether the product as produced conformed to the manufacturer's specification. See Arkansas-Platte & Gulf P'ship v. Dow Chem. Co., 886 F. Supp. 762, 767 (D. Colo. 1995) (applying Colorado law). In their complaint, Plaintiffs alleged generally that Wright Medical's hip systems "were defective in their manufacture and construction . . . ." (Doc. 20 ¶ 88.) But Plaintiffs failed to define their claim more specifically or to submit any evidence suggesting that there was a manufacturing defect. and Plaintiffs' own experts indicated there was no manufacturing defect in Wollam's artificial hip that broke.
In response to Wright Medical's motion for summary judgment on this claim, Plaintiffs asserted only the following:
Of [Wollam's] two identical Wright Profemur modular necks implanted in his right and left hips on April 18, 2005, the right modular neck has fractured, the left modular neck has not. Defendants cannot explain how or why the testing of two identical Profemur titanium modular necks resulted in one fracture after 546,000 cycles while the other did not fracture after 4.5 million cycles. While there is no physical direct evidence that the Profemur neck implanted in plaintiff's right hip was defectively manufactured, if there are not defects in manufacture, then why, when identical modular necks are subjected to the identical tests or in vivo use, does one fracture and the other does not?
(Doc. 143 at 15-16.) That assertion, however, is insufficient to support a jury finding that Wollam's right hip system was defectively manufactured.
Plaintiffs further contend that they are asserting a "res ipsa argument that, if not a design defect, then the device that failed in [Wollam's] right hip must be defective in its manufacture, while the device in his left hip is not." (Id. at 16.) But res ipsa locquitor is an evidentiary rule providing for a rebuttable presumption that an event would not have occurred absent the defendant's negligence. See Stone's Farm Supply, Inc. v. Deacon, 805 P.2d 1109, 1114 (Colo. 1991). Plaintiffs fail to cite any cases applying that doctrine to a strict product liability claim alleging a manufacturing defect, and the Court declines to apply that doctrine to this claim.
For these reasons, Wright Medical is entitled to summary judgment on Plaintiffs' strict product liability claim alleging that Wright Medical defectively manufactured their hip systems (Claim 1).
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