## Facts

- Patients received Proplast temporomandibular joint (TMJ) interpositional implants intended to restore jaw mobility.
- Plaintiffs alleged the implants failed, abraded surrounding bone, and caused pain and bone damage.
- The finished implants were invented, designed, tested, manufactured, packaged, and sold by Vitek, Inc., a separate company.
- Du Pont supplied PTFE resin (sold under the Teflon trademark) and Durafilm supplied FEP film; both were generic industrial raw materials incorporated by Vitek into the implants.
- Plaintiffs did not allege Du Pont or Durafilm designed, manufactured, or marketed the finished implant device.
- Record evidence indicated Vitek was told Du Pont’s Teflon products were not made for medical applications, and literature raised concerns about Teflon in load-bearing joints.
- The district court, in MDL proceedings consolidating numerous TMJ implant cases, granted summary judgment for Du Pont and Durafilm; plaintiffs appealed.

## Issues

1. Whether suppliers of non-defective raw materials may be held liable for injuries caused by a finished product designed and manufactured by another company when the raw materials themselves are not shown to be defective.
2. Whether a component supplier’s knowledge of potential risks in certain uses, and failure to intervene in the downstream manufacturer’s design decisions, creates a duty to ultimate users.

## Decision

- The Eighth Circuit affirmed summary judgment for Du Pont and Durafilm.
- The court held that suppliers of non-defective raw materials are not liable for alleged design defects in a finished product made by a third party absent proof the material was defective or the supplier substantially participated in the finished product’s design or integration.
- The court rejected the argument that knowledge of possible risks in a particular application imposed a duty to police or second-guess the downstream manufacturer’s medical-device design.

## Legal Principles

- Products-liability claims against a component or bulk supplier generally require a defect in the supplier’s product as sold; injury caused by a downstream manufacturer’s design choices does not, by itself, establish supplier liability.
- A supplier of generic, non-defective raw materials used in many applications ordinarily has no duty to investigate, refuse sales to, or control the design decisions of a sophisticated intermediary that incorporates the materials into a complex finished product.
- Component-supplier liability may arise if the component itself is defective or if the supplier substantially participates in the design, selection, or integration of the component into the finished product in a manner tied to the alleged defect.

## Conclusion

The court affirmed dismissal of design-defect and related claims against upstream raw-material suppliers because plaintiffs failed to show any defect in the supplied materials or meaningful supplier involvement in the finished implant’s design; responsibility for the alleged defect lay with the finished-product manufacturer.


In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050 (8th Cir. 1996)