593 F.Supp.3d 1086
D. Colo.2022Background
- Wright Medical designed and sold metal-on-metal (MoM) hip systems, including the Dynasty Total Hip System, whose components included a Thin Shell acetabular component that was widely used from 2003–2011 but not 510(k)-cleared until 2012.
- Clinical IDE testing of the Thin Shell showed high failure/revision rates (reported as 18.6% at 24 months; FDA found under-reporting and even higher failure rates), yet Wright continued marketing and selling MoM devices using the Thin Shell without adequate FDA submissions or disclosure.
- Wright allegedly knew of MoM risks (e.g., elevated cobalt/chromium ions, metallosis, tissue necrosis) and received surgeon complaints about debris, pseudotumors, and revisions, but did not disclose these problems to surgeons or patients and promoted devices as durable and biocompatible.
- Plaintiff received a Dynasty implant with the Thin Shell in June 2010 based on surgeon recommendations and marketing; he later developed pain, elevated cobalt/chromium levels, metallosis, and underwent revision surgery in April 2019.
- Plaintiff sued asserting eight claims (negligent design/failure to warn, negligent misrepresentation, fraud by concealment, fraudulent misrepresentation, strict products liability—design, manufacturing, failure-to-warn, and punitive damages). Defendant moved to dismiss several claims under Fed. R. Civ. P. 12(b)(6) and Rule 9(b).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Sufficiency of negligent- and fraudulent-misrepresentation pleadings under Rule 9(b) | Dean alleges Wright made false safety/efficacy representations to surgeons and marketing materials that he relied on for surgery. | Wright argues plaintiff failed to plead the who/what/when/where/how of specific false statements, so Rule 9(b) is not satisfied. | Court: Dismissed negligent misrepresentation and fraudulent misrepresentation with prejudice for failure to plead with particularity under Rule 9(b) and 12(b)(6). |
| Sufficiency of fraudulent-concealment claim (fraud by omission) | Dean alleges Wright concealed material facts (Thin Shell clinical failures, surgeon complaints, lack of testing for metal ions), intentionally omitted them from marketing and surgeon communications, and plaintiff relied on those omissions. | Wright contends plaintiff failed to identify method, actors, intent, and timing with particularity. | Court: Denied dismissal; fraudulent concealment pleaded with sufficient particularity (identified omitted information, method of concealment, intent, and an adequate time frame). |
| Sufficiency of strict liability manufacturing-defect claim | Dean alleges the implanted Dynasty Device was manufactured such that it generated metal debris/fretting/corrosion and that manufacturing failed to conform to federal requirements. | Wright argues plaintiff failed to plead how the product differed from others and that the alleged defect is just a design defect (not manufacturing). | Court: Denied dismissal; manufacturing-defect claim plausibly alleged and alternative pleading of design vs. manufacturing is permitted. |
| Claim for punitive/exemplary damages as standalone count | Dean pleads punitive damages as a separate claim and requests exemplary relief. | Wright argues punitive damages are not a separate cause of action. | Court: Granted dismissal of standalone punitive-damages claim (dismissed without prejudice to seeking punitive damages in the prayer for relief). |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (pleading must show more than possibility of misconduct)
- Khalik v. United Air Lines, 671 F.3d 1188 (10th Cir. 2012) (Rule 12(b)(6) plausibility discussion)
- Scheidt v. Klein, 956 F.2d 963 (10th Cir. 1992) (fraud pleadings on information and belief)
- George v. Urb. Settlement Servs., 833 F.3d 1242 (10th Cir. 2016) (Rule 9(b) and information in defendant's exclusive control)
- Bloskas v. Murray, 646 P.2d 907 (Colo. 1982) (elements of negligent misrepresentation causing physical harm)
- BP Am. Prod. Co. v. Patterson, 263 P.3d 103 (Colo. 2011) (elements for fraudulent concealment/omission)
- Walker v. Ford Motor Co., 406 P.3d 845 (Colo. 2017) (Colorado adoption/application of strict products liability principles)
- Union Supply Co. v. Pust, 583 P.2d 276 (Colo. 1978) (adoption of Restatement §402A strict liability doctrine)
- Kirk v. Denver Pub. Co., 818 P.2d 262 (Colo. 1991) (punitive damages are subsidiary to underlying claim)