This past Sunday, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year. Normally, we host dinner for 20 or so members of our extended family. This year, the entire day before the holiday was occupied by the uber-wedding of the Drug and Device Law Rich Cousin’s daughter. Because we had no time to prepare for the holiday dinner, we opted, for the first time ever, to go out for the meal. We, along with several dozen relatives, descended upon a local (Italian!) restaurant that was hosting hundreds for what was billed as a “traditional” Rosh Hashanah feast. As the courses arrived, our table rang with youthful cries of “that doesn’t look like our gefilte fish/brisket/kugel” answered with a chorus of “it’s close enough.” Such is the case with today’s decision. It does not involve a drug or a medical device, but it is a products case with a strong holding that bolsters arguments we make in the prescription drug context. So it is “close enough” to be relevant for readers of this blog.
Regular readers know that we have blogged many times about the issue of ‘innovator liability” – whether the innovator and manufacturer of a branded drug can be liable for injuries to a plaintiff who took the generic version of the drug, which was not manufactured or sold by the innovator company. Seven years ago, in Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009), the California Court of Appeal came up with the wrong answer to this question, holding that a plaintiff who used a generic drug could sue the manufacturer of the branded version. As Bexis likes to say, the Conte court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell. In the months after Conte was decided, we criticized virtually every aspect of it here, here, here, and here.
n the ensuing years, we have posted about Conte and innovator liability numerous times – you can see all of our posts collected here — as we waited and watched to see which courts would adopt this poorly-reasoned holding that flew in the face of the foundations of product liability law. As we have been happy to report (you can see our innovator liability scorecard here and our 50-state survey of innovator liability here) Conte is now an outlier, with the majority of courts holding that an innovator drug manufacturer cannot be liable for injuries allegedly caused by a generic drug it did not manufacture or sell.
Two weeks ago, in Thorpe v. Bollinger Sports, LLC, et al., 2015 U.S. Dist. LEXIS 119643 (E.D. Pa. Sept. 9, 2015), the United States District Court for the Eastern District of Pennsylvania reached the same conclusion in the context of a non-pharmaceutical product. In Thorpe, plaintiff alleged that he was injured when a piece of a resistance band with which he was exercising flew off and struck him in the eye. Thorpe, 2015 U.S. Dist. LEXIS 119643 at *1. The resistance band was developed by Bell Sports, Inc., which, it was undisputed, sold the product line to Bollinger Sports, LLC before plaintiff purchased his band. Id. Initially, Thorpe and his wife sued Bollinger as well as the sporting goods store that sold him the band, asserting claims sounding in strict liability, negligence, breach of warranty, misrepresentation, and loss of consortium. Plaintiffs later amended their complaint to add Bell as a defendant on a “designer liability” theory, and Bell moved for judgment on the pleadings.
Strict Products Liability
The court noted that, under Pennsylvania law, the Restatement (Second) of Torts § 402A governed plaintiff’s claims, creating liability for “one who sells any product in a defective condition unreasonably dangerous to the use or consumer or his property. . . .” Id. at *4-5, citing Restatement (Second) of Torts § 402A, and that “seller” did not include any “entity that is not engaged in the distribution or marketing, i.e. the chain of distribution, of a product to the public . . . . .” Id. at *5-6 (citations omitted). Neither licensing nor selling a design “to another entity that manufactures, distributes and sells” the product “equate[s] to a role in the chain of distribution.” Id. at *7-8 (citations omitted).
Nicely capturing the policy underpinnings of strict liability, the court explained:
Bell relinquished all control over the band’s design, and, thus, the ability to affect or control the alleged defect, nearly two years before Thorpe’s injury. Extending strict liability to Bell does not further the policy behind the imposition of strict liability, which is to ensure the costs of injuries sustained from purchasing defective products are paid by the manufacturers who put the products on the market and not by the injured persons themselves . . . To allow strict liability to attach here, where there are no allegations that Bell had any involvement in the sale, manufacture or distribution of the resistance band that injured Thorpe would do nothing to further the policy behind strict liability.
Id. at *8-9 (internal punctuation and citations omitted). The court concluded, “Bell is not a seller of the resistance band that injured Thorpe and thus is not subject to strict liability pursuant to § 402A.” Id. at *13 (internal punctuation and citations omitted).
Plaintiffs asserted a claim for “negligent design,” alleging that Bell had a duty to “manufacture and sell the . . . resistance band in a reasonably safe condition for ultimate users of the product.” Id. at *15. That’s more amorphous than strict liability, and thus potentially more dangerous. Bell argued that, “as a prior designer which lacked the ability to control the design and manufacture” of the band plaintiff purchased, it owed plaintiff no such duty. Id. at *15-16. The court agreed with Bell, explaining, “The Court can find no instances in Pennsylvania of the imposition of a duty upon a prior designer that relinquished control over the design prior to a consumer’s injury.” Id. at *16 (citations omitted). This is because, without a finding that “the accident could have been avoided by the exercise of reasonable care” by the defendant, there can be no finding that any act or omission of the defendant proximately caused the plaintiff’s injuries. Id. at *16 (citations omitted). The court concluded that it was “not bound to accept Plaintiffs’ unsupported legal conclusion that Bell owed Thorpe a duty of care. Plaintiffs cannot establish that Bell owed a duty of care to consumers, and, thus, their negligence claim fails.” Id. at *19 (citations omitted). Another novel claim fails.
Warranty and Misrepresentation
In similar fashion, the court dispatched Plaintiffs’ breach of warranty claims, holding that Bell could not be liable when it was not a “seller,”id. at *15, and their misrepresentation claim, holding that Plaintiffs could not show that Thorpe justifiably relied on any misrepresentation by Bell. Id. at *16. As such, neatly and correctly, the court ensured that the concept of “product liability” was not broadened to include a defendant that had nothing to do with the product at the time the plaintiff purchased it. It seems simple, and it seems self-evident, but Conte taught us the peril of complacency.
While Thorpe is not a drug or device case, its reasoning and holding rest on bedrock premises of product liability law and should be persuasive to courts facing “designer liability” claims in the pharmaceutical context or in any other. It is also good to have Thorpe on the books because we have seen non-manufacturing designers sued in some cases as a means of destroying diversity. We applaud the decision and cheer the growing consensus that Conte was nothing more than an unfortunate aberration.