Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort.  One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.

Plaintiffs claimed that “surgical treatments that do not use [bone] screws should be considered alternative designs,” and lost.  On appeal the Fifth Circuit affirmed, recognizing that argument for what it was:  as a backdoor argument that the product should be banned altogether:

[Plaintiff] argues that other products that do not use [bone screws] should be considered as alternative designs. . . .  Underlying this argument is the assumption that all [bone] screws are defective and there can be no system using [them] that would be an acceptable product.  The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the [bone] screws sold by [the defendant].

Theriot v. Danek Medical., Inc., 168 F.3d 253, 255 (5th Cir. 1999) (applying Louisiana law).  Theriot was first appellate prescription medical product case to decide that plaintiffs could not put forward different products or medical procedures as “alternative designs” in jurisdictions where such alternatives were an essential element of a design defect claim.  See also Talley v. Danek Medical, Inc., 179 F.3d 154, 162 (4th Cir. 1999) (bone screw case; whether “procedures using spinal fixation devices were more likely to be successful than . . . procedures that did not use spinal fixation devices” was “irrelevant in a suit against the product manufacturer because “it questioned the medical judgment of doctors”).

While Theriot was on appeal, the Third Restatement of Torts was adopted, and it included alternative design as an essential element of a common-law design defect claim.  Restatement (Third) of Torts, Products Liability §2(b) (1998).  Texas adopted the Third Restatement, and in Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760 (Tex. App. 2009), the court followed Theriot’s rationale:

In Theriot, the court held that a plaintiff who contended that [bone] screws were defectively designed was required to demonstrate a safer alternative design that involved [such] screws, and that the plaintiff was not permitted to point to other products intended to provide biomechanical stability. . . .  Thus, a safer alternative design must be one for the product at issue. . . .  But [plaintiff] does not explain how [defendant’s drug] could have been modified or improved; she instead argues that [the active ingredient should not have been added. . . .  In essence, [plaintiff] argues that the product [at issue] should have been a different product . . . its predecessor. . . .  Texas law does not recognize this sort of categorical attack on a product.

Id. at 770-71 (other citations omitted).

And thus came to be the defense argument that medical treatment not using the product, or using only different products to treat the same condition, could not be considered “alternative” product designs in the increasing number of jurisdictions where an alternative design is an essential element of a design defect claim.

Fast forward to the present.  In the seemingly ubiquitous post-MDL litigation involving pelvic mesh, and in parallel litigation involving other types of surgical mesh, the same alternative-design issue is front and center, because these plaintiffs primary “design” argument is a similar claim that all surgical mesh is defective (because it uses polypropylene plastic (unless it didn’t, in which case it should have)).  The MDL court (following Talley and Theriot) held that “[e]vidence that a surgical procedure should have been used in place of a device is not an alternative, feasible design,” as were “entirely different products, performing different functions.”  Mullins v. Johnson & Johnson, 236 F. Supp. 3d 940, 943-44 (S.D.W. Va. 2017).

In remanded mesh cases across the country, the alternative-design-versus-different-product issue is being litigated.  Perhaps the best discussion we’ve seen yet is in the recent Baksic v. Ethicon, Inc., 2023 WL 1192538 (Mag. W.D. Tex. Jan. 27, 2023), decision.  Baksic addressed, and rejected, several variants of alternative procedure/product arguments commonly used by mesh plaintiffs.

First, Baksic held that “proposed safer alternatives fail because they’re alternative procedures or substantially different products rather than alternative designs.  Id. at *6. Other surgery, representing “an entirely different procedure from the implantation of [the defendant’s] device,” “cannot, as a matter of law, be considered a ‘safer alternative design’ for that device.”  Id. (citing, you guessed it, Brockert and Theriot).  Any procedure that “does not involve a medical device” at all cannot possibly be considered an alternative design for a device.  Id.

[This] so-called alternative effectively required that the [product] should not exist and should instead be transformed into a different product.  Texas law does not recognize this sort of categorical attack on a product.  An entirely organic mesh cannot be an alternative to a synthetic mesh because organic and synthetic mesh are different products.

Id. (Brockert quotations omitted).  Strike one.

Second, another aspect of product liability alternative design mandates is that the claimed “safer alternative” must be “feasible,” and feasibility requires the alternative design to be “available at the time of [plaintiff’s] surgery.”  Baksic, 2023 WL 1192538, at *7.  “A plaintiff must show that its proposed safer alternative design existed at the time of the alleged injury and was technologically and economically feasible.”  Id. (citation omitted).  In Baksic, plaintiffs advanced two “synthetic mesh materials that contain less polypropylene . . . or contain a different synthetic material.”  Id.  However, those claimed alternatives “were not yet cleared by the FDA” for the use at issue in Baksic.  Id.  These mesh plaintiffs − 180º contrary to Bone Screw plaintiffs – were advocating off-label use as an alternative design.  But FDA clearance/approval is an absolute prerequisite to the legal marketing of a prescription medical product in this country, so no go.  “FDA approval is required to show availability.”  Id.

A device must be approved or cleared by the FDA before it can be sold in the United States.  Because mesh such as [plaintiffs advance] were not cleared by the FDA for treatment of [her condition] at the time of [plaintiff’s] surgery, they were not legally available at the time and, in this Court’s view, they do not qualify as safer alternative designs as a matter of law.

Id.  Moreover, the Baksic plaintiffs did not even try to claim that “the FDA would have approved the design had an application been made.”  Id.  Plaintiffs’ final argument, in this regard, relying on “approval of the alternative mesh materials for other purposes and in other countries,” also failed:

[N]one of this creates a genuine fact issue concerning whether these alternative meshes would have been cleared to treat stress [plaintiff’s condition] in the United States had [defendant] sought such approval. . . .  Even assuming arguendo that [the other types of] mesh were alternative designs and were safer, there is no genuine issue of material fact presented regarding their availability . . . at the time of [plaintiff’s] surgery.

Id. at *8 (rejecting evidence that postdated the surgery).  Strike two.

Third, a completely different kind of device, implanted “in a different part of the body using a different surgical method,” was not an alternative design, but rather a different product.  Baksic, 2023 WL 1192538, at *8-9.  “[I]mplantation of a [device], regardless of the material it is made of, [that] involves a different surgical procedure . . . is therefore not an ‘alternative design.’”  Id. at *8.  Moreover, the claim of greater safety in Baksic was myopic, focused solely on that plaintiff’s specific situation.  The legal analysis for evaluating alternative designs is not so limited:

[That device] has many of the same side effects. . . .  And at the same time, [plaintiffs] fail to address whether there are additional complications that can arise from a [that device].  [T]heir expert testified to a long list of adverse effects associated with [it], and [he] did not testify that the [surgical] approach is safer overall.  A safer design must be one that would have prevented or significantly reduced the risk of the [plaintiff]’s personal injury without substantially impairing the product’s utility.”  The design cannot, under other circumstances, impose an equal or greater risk of harm.

Id. at *8-9 (citations and quotation marks omitted).  Strike three – summary judgment appropriate.

Mesh (and other device) cases across the country have been addressing these knotty issues of alternative design, and will continue to do so.  The discussion in Baksic is an excellent primer on why the various alternative-design arguments that plaintiffs advance in such litigation are meritless.