United States District Court, D. Colorado
R. BROOKE JACKSON, District Judge.
This matter is before the Court on Defendant's Motion to Dismiss [ECF No. 28] for failure to state a claim upon which relief may be granted. On August 1, 2014 the Court issued a show cause order asking the parties to explain why this case was not preempted by the Medical Devices Amendment to the Food, Drug & Cosmetic Act [ECF No. 36]. Upon review of each party's response [ECF Nos. 37 & 38] the Court is satisfied that this case can move forward under Colorado state law. The Court exercises jurisdiction over this action pursuant to 28 U.S.C. § 1332. For the reasons discussed below, the motion is granted in part and denied in part.
Since we are at the pleading stage, the Court considers true the plaintiff's factual allegations that are plausible on their face. On or about September 27, 2011 plaintiff Edward Haffner underwent a total knee arthroplasty in which Dr. Roger Greenberg surgically removed his left knee and replaced it with a Stryker Triathlon Total Knee System ("the Knee System"). The Knee System contained cobalt and nickel. At the time of the surgery, Mr. Haffner was unaware that the Knee System contained these metals. It also appears he was unaware that he was allergic to either of these metals, one or both of which caused him to suffer an allergic reaction resulting in pain, inflammation, swelling, bone loss, and limited mobility. On August 7, 2012 Mr. Haffner underwent a total knee arthroplasty revision surgery to remove and replace the Knee System.
Mr. Haffner filed a tort action in Weld County, Colorado District Court on October 14, 2013. The defendants Stryker Corporation, Stryker Sales Corporation, and Howmedica Osteonics Corporation d/b/a Stryker Orthopaedics (collectively "Stryker") removed the case to this Court on the basis of diversity jurisdiction on January 22, 2014 [ECF No. 1] and filed their original motion to dismiss on February 3, 2014 [ECF No 11]. Mr. Haffner filed his First Amended Complaint on February 24, 2014 [ECF No. 13] and subsequently filed his Second Amended Complaint on April 1, 2014 [ECF No. 24]. Mr. Haffner states four causes of action against Stryker: (1) strict products liability; (2) negligent products liability; (3) breach of implied warranties of merchantability and fitness; and (4) breach of express warranty. On April 22, 2014 Stryker filed its current motion to dismiss for failure to state a claim upon which relief can be granted [ECF No. 28].
The Court views a Rule 12(b)(6) motion in the light most favorable to the nonmoving party and accepts all well-pleaded allegations as true. Teigen v. Reffrow, 511 F.3d 1072, 1079 (10th Cir. 2007). However, the facts alleged must be enough to state a claim for relief that is plausible, not merely speculative. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 570 (2007). A plausible claim is a claim that "allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Pleadings that offer only "labels and conclusions or a formulaic recitation of the elements of a cause of action will not do." Id. at 678 (quoting Twombly, 550 U.S. at 555).
"[I]n general, a motion to dismiss should be converted to a summary judgment motion if a party submits, and the district court considers, materials outside the pleadings." Prager v. LaFaver, 180 F.3d 1185, 1188 (10th Cir. 1999). However, "the district court may consider documents referred to in the complaint if the documents are central to the plaintiff's claim and the parties do not dispute the documents' authenticity." Jacobsen v. Deseret Book Co., 287 F.3d 936, 941 (10th Cir. 2002).
A. Strict Liability.
"Colorado has expressly adopted the doctrine of strict liability in tort, based on the Restatement (Second) of Torts § 402A.'" Wollam v. Wright Med. Grp., Inc., No. 10-CV-3014-DME-BNB, 2012 WL 4510695, at *2 (D. Colo. Sept. 30, 2012) (quoting Union Supply Co. v. Pust, 583 P.2d 276, 280 (Colo. 1980)). Section 402A is entitled "Special Liability of Seller of Product for Physical Harm to User or Consumer, " and it describes the tort liability faced by sellers of all types of consumer products. In at least one prescription medical device case the Colorado Court of Appeals has adopted a rule from the Restatement (Third) of Torts § 6. See O'Connell v. Biomet, Inc., 250 P.3d 1278, 1281 (Colo.App. 2010). Section 6 is entitled "Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices, " and it describes the tort liability surrounding manufacturers of prescription drugs and medical devices. The Restatement (Second) of Torts was published in 1965 and the Restatement (Third) in 1988.
There appear to be few medical device tort cases in Colorado. This may be a result of the Medical Devices Amendments of 1976, which have preempted many of these lawsuits. See Show Cause Order [ECF No. 36]. The only Colorado state court case concerning medical device products liability and citing the Restatement (Second) of Torts § 402A of which this Court is aware was decided in 1984, several years before the Restatement (Third) was published. See Palmer v. A.H. Robins Co., 684 P.2d 187 (Colo. 1984). I found two cases from the District of Colorado also citing § 402A in medical device cases, one from 1984 and another from 2012. See Hawkinson v. A.H. Robins Co., 595 F.Supp. 1290 (D. Colo. 1984); Wollam, 2012 WL 4510695.
As noted above, a medical device case decided by the Colorado Court of Appeals in 2010 cites the Restatement (Third) of Torts § 6, though only to adopt the learned intermediary doctrine. See Biomet, 250 P.3d at 1281. Sitting in diversity, I am bound to apply the law I believe the Colorado Supreme Court would apply. Given the decision in Biomet alongside the specific provision on prescription medical devices in the Restatement (Third) of Torts, the Court will look to both Restatements for guidance in determining the outcome of this motion.
1. Design Defect
In order to state a claim for defective design a plaintiff must allege that "(1) the product is in a defective condition unreasonably dangerous to the user or consumer; (2) the product is expected to and does reach the consumer without substantial change in the condition in which it is sold; (3) the design defect caused the plaintiff's injury; (4) the defendant sold the product and is engaged in the business of selling products; and (5) the plaintiff sustained damages." Wollam, 2012 WL 4510695 at *2 n.1. Under the risk-utility test, a product is "unreasonably dangerous" if its risks outweigh its benefits. Armentrout v. FMC Corp., 842 P.2d 175, 183 (Colo. 1992). The Restatement (Second) of Torts takes into account that there may exist "unavoidably unsafe products, " which are "especially common in the field of drugs." Restatement (Second) of Torts § 402A cmt. k. It is for this very reason that these products "cannot legally be sold except to physicians, or under the prescription of a physician." Id. The Colorado Supreme Court has recognized comment k as establishing a defense for the makers of certain drugs and medical products. See, e.g., Fibreboard Corp. v. Fenton, 845 P.2d 1168, ...