## Facts

- Five Texas plaintiffs received DePuy’s Pinnacle hip system with an Ultamet metal liner, creating a metal-on-metal articulation.
- Plaintiffs alleged the design generated excessive metal debris and ions (cobalt and chromium), causing metallosis, pain, tissue damage, and early device failure requiring revision surgeries.
- Plaintiffs presented evidence that cross-linked polyethylene metal-on-plastic designs were available, reduced osteolysis, and avoided the alleged metal-debris risks associated with metal-on-metal designs.
- The case was tried as a multi-plaintiff bellwether trial in federal court as part of a multidistrict litigation (MDL) centralized in the Northern District of Texas.
- A jury returned a combined verdict of about $502 million, largely for noneconomic and punitive damages; punitive damages were later reduced under Texas’s statutory cap.
- Defendants sought judgment as a matter of law, a mistrial, and dismissal of Johnson & Johnson (J&J) for lack of personal jurisdiction; the district court denied those requests.
- Defendants appealed, and plaintiffs cross-appealed challenging the constitutionality of the Texas exemplary-damages cap.

## Issues

1. Whether the evidence permitted a finding of design defect under Texas law, including proof of a safer alternative design and unreasonable danger.
2. Whether the evidence supported failure-to-warn and marketing-based misrepresentation liability under Texas law, including application of the learned-intermediary doctrine.
3. Whether a Texas federal court had specific personal jurisdiction over J&J based on its alleged involvement in the product’s design, marketing, and related forum-directed conduct.
4. Whether attorney misconduct and related evidentiary errors so prejudiced the trial that a new trial was required.
5. Whether Texas’s statutory cap on exemplary damages is unconstitutional as applied.

## Decision

- The Fifth Circuit vacated the judgment and remanded for a new trial based on cumulative trial prejudice from attorney misconduct and evidentiary errors.
- The court held that the record contained sufficient evidence for a reasonable jury to find design defect, including that a safer alternative design (cross-linked polyethylene metal-on-plastic) existed and that the metal-on-metal configuration was unreasonably dangerous.
- The court held that sufficient evidence supported the failure-to-warn and misrepresentation theories, including evidence that risk information was downplayed or misleadingly framed to physicians and others.
- The court affirmed the exercise of specific personal jurisdiction over J&J based on evidence of purposeful forum-directed activities tied to the claims.
- The court rejected the constitutional challenge to Texas’s exemplary-damages cap and affirmed application of the cap.

## Legal Principles

- Under Texas design-defect law, a plaintiff must prove the product was unreasonably dangerous as designed and that a safer alternative design existed that would have reduced or prevented the injury without substantially impairing utility.
- A “safer alternative design” may be shown through evidence that a different configuration within a product line was available and would materially reduce risk while preserving function.
- Under Texas’s learned-intermediary rule, warning adequacy focuses on the information provided to prescribing physicians; evidence that a manufacturer minimized or obscured known or knowable risks can support liability.
- Specific personal jurisdiction exists when a defendant purposefully directs relevant conduct toward the forum and the claims arise out of or relate to that forum-connected conduct; parent-corporation status alone is insufficient, but direct involvement in the challenged activities can support jurisdiction.
- A verdict may be vacated when improper advocacy and evidentiary overreach cumulatively deny a fair trial, even if some liability evidence could support a verdict.
- Texas’s statutory cap on exemplary damages is enforceable absent a successful constitutional challenge.

## Conclusion

The Fifth Circuit ordered a new trial after finding that repeated improper argument and evidentiary violations tainted a high-stakes MDL bellwether trial, while also sustaining key rulings that the liability evidence could support design-defect and warning-based claims, that Texas courts could exercise specific jurisdiction over J&J on the record presented, and that Texas’s punitive-damages cap applied and was constitutional.


In re DePuy Orthopaedics, Inc. (Pinnacle Hip Implant Prods. Liab. Litig.), 888 F.3d 753 (5th Cir. 2018)