Caseflicks

District Court, N.D. Alabama • 1995

In Re Silicone Gel Breast Implants Products Liability Litigation

887 F. Supp. 1463 | 1995 U.S. Dist. LEXIS 12221

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Takeaway

In short, this case holds that a bulk supplier of a nondefective material with many safe uses is not liable to remote users for risks created by a specialized finished product, particularly where the product manufacturers knew more about the relevant risks and any omission could not have caused the injury.

Background

Scotfoam manufactured polyurethane foam in bulk buns or rolls for numerous generally safe applications, including furniture padding, carpet underlay, cosmetic applicators, and blood filters. It sold foam to distributors and fabricators rather than directly to patients or physicians, and advised buyers that it did not recommend the foam for a particular use and that buyers were responsible for determining whether an application was appropriate.

Wilshire Foam Company bought Scotfoam foam, cut it into thin sheets, and had it specially washed. Wilshire then sold the resulting “clean wipes” to implant manufacturers. Those manufacturers attached the foam to breast implants, heat-sealed and sterilized the finished implants, and distributed them to physicians. Scotfoam learned by at least 1984 that some foam sold through Wilshire was being used in breast implants, although the parties disputed whether it knew earlier. Scotfoam never recommended that use and advised against it when asked in 1987.

Plaintiffs alleged that degradation of polyurethane foam could release TDI and TDA, chemicals associated with cancer in laboratory animals, and that Scotfoam knew of this potential hazard but failed to warn Wilshire, implant manufacturers, physicians, or implant recipients. They asserted failure-to-warn and defective-product theories under Restatement (Second) of Torts §§ 388, 389, and 402A, as well as negligence and fraudulent-misrepresentation claims.

In this multidistrict litigation, Scotfoam moved for summary judgment after discovery, briefing, and oral argument. The court granted the motion, severed the claims against Scotfoam and its related entities, dismissed them with prejudice, and directed final judgment under Rules 42 and 54(b).

Issues

Issue #1

Whether the transferee court in this multidistrict diversity proceeding had to apply the substantive and choice-of-law rules that the transferor courts would have applied.

Holding

Yes. The court applied the substantive law, including choice-of-law rules, applicable in the transferor forums, while concluding that no pertinent state law would impose liability on these facts.

Reasoning

A federal court receiving cases through multidistrict transfer applies the substantive law that the transferor courts would have applied. Because the cases were based on diversity jurisdiction, that includes each transferor forum state's choice-of-law rules under Klaxon.

The cases involving Scotfoam came from 39 jurisdictions, so differences in state law or in the evidence about a particular implant could in principle produce different results. But after examining the relevant state authorities, the court concluded that the same dispositive principle controlled: a supplier of a nondefective, non-inherently-dangerous raw material does not owe the asserted warning duty to remote users of a specialized finished product.

Issue #2

Whether Scotfoam, as a bulk supplier of polyurethane foam, owed breast-implant recipients or their physicians a duty to warn about potential hazards of using foam as an implant coating.

Holding

No. Scotfoam had no duty under Restatement §§ 388, 389, or 402A, or under analogous state-law doctrines, to warn patients or physicians about hazards associated with the specialized use of its foam in breast implants.

Reasoning

Under Restatement § 388, a supplier may be liable only if it knows or has reason to know that its product is or is likely to be dangerous for the use for which it is supplied, has no reason to believe users will appreciate the danger, and fails to exercise reasonable care to inform them. Scotfoam could not be liable for any period before it knew its foam was being used in breast implants; the central question was whether a duty arose once it acquired that knowledge.

The foam that reached patients was not the bulk foam Scotfoam sold. Wilshire cut and specially washed it, and implant manufacturers attached it to implants, heat-sealed it, and sterilized the final product. This substantial processing made it doubtful that the implanted foam remained in substantially the same condition as when Scotfoam sold it, a fact that further weakened product-liability theories even though the court did not treat that point as essential to its ruling.

Scotfoam's foam had a wide range of apparently safe uses, and plaintiffs did not claim it was defectively manufactured. Although plaintiffs offered evidence that degraded foam might release chemicals linked to cancer in laboratory animals, that evidence did not make bulk polyurethane foam an inherently dangerous material like a toxic chemical or contaminated food.

Courts generally limit liability for raw-material and component suppliers when the supplier neither designed nor built the final product and the raw material is not inherently dangerous or defective. The court distinguished the unusual fireworks case cited by plaintiffs because the supplier there knowingly furnished chemicals for an illegal and highly dangerous final use; Scotfoam's sale of widely useful foam for a lawful but highly specialized medical application was fundamentally different.

Only a minute fraction of Scotfoam's total production—less than .00001 percent—was used in breast implants. Requiring a bulk supplier to warn patients and physicians about every specialized downstream use would impose an impractical burden, especially because Scotfoam had no feasible direct means to reach prospective implant recipients or their doctors. The manufacturers that selected foam for this particular medical use were more directly responsible for evaluating and warning about that use.

Issue #3

Whether any failure by Scotfoam to warn Wilshire or implant manufacturers was a proximate cause of the plaintiffs' alleged injuries.

Holding

No. Even assuming Scotfoam owed a warning duty to its immediate purchasers, its omission was not a proximate cause because the implant manufacturers already possessed at least as much relevant information as Scotfoam.

Reasoning

The undisputed evidence showed that Scotfoam never represented its foam as suitable for human implantation and affirmatively advised against that use when asked. Thus, it did not induce the manufacturers to select foam as an implant coating through an assurance of safety.

Scotfoam had no information about the possible consequences of implanting foam that was unknown to the manufacturers purchasing Wilshire's clean wipes. The manufacturers in fact had greater knowledge of the medical use and its risks, having conducted or relied on research concerning polyurethane-coated implants and having represented to Scotfoam that the foam had been used for years without problems.

Because the manufacturers already knew everything material that Scotfoam could have supplied, a warning from Scotfoam would not have altered their decisions or prevented the asserted injuries. The causal link required for liability was therefore absent.

Issue #4

Whether plaintiffs could maintain independent negligence and fraudulent-misrepresentation claims against Scotfoam.

Holding

No. The negligence claim failed for lack of duty and proximate cause, and the fraud claim failed for lack of evidence that any plaintiff or physician relied on a Scotfoam statement or omission.

Reasoning

Negligence requires a duty, breach, proximate cause, and damages. The same conclusions that defeated the warning-based product claims also defeated negligence: Scotfoam had no duty to warn patients or physicians about this specialized downstream use, and any omission directed toward Wilshire or the implant manufacturers did not cause plaintiffs' alleged injuries.

Plaintiffs produced no evidence that they or their physicians relied on any statement by Scotfoam. Nor was there evidence that disclosure of Scotfoam's limited information would have led a physician or patient to choose differently about a breast implant. Without reliance and a resulting different decision, the fraudulent-misrepresentation theory could not proceed.