Thursday, August 08, 2013

On Alternative Design

A ReedSmith team, including our own Eric Alexander, recently won a nifty little summary judgment decision, Schmidt v. C.R. Bard, Inc., 2013 WL 3802804 (D. Nev. July 22, 2013).  It’s a surgical (not vaginal) mesh case, and the plaintiff claimed a “rare and severe inflammatory reaction” to the product.  Id. at *1.  The warning claims failed, (1) because the plaintiff lacked expert testimony that the defendant’s warnings were inadequate, and (2) because the prescribing surgeon didn’t “ever review[]” the warnings in the first place.  Id. at *2.  The other informational claims (warranty and consumer fraud) failed for reason #2 above – lack of reliance by the surgeon.  Id. at *2-3.  All nice, but those rulings wouldn’t have prompted this post.

One of the grounds for dismissal of the design defect claim did that.

The design claim also failed for lack of expert testimony, id. at *2 (expert “concedes that he is not qualified to offer . . . medical device design testimony”), but more significant to us was the court’s holding about alternative design:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not supports Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt, 2013 WL 3802804, at *2 (emphasis added).

That eminently reasonable legal proposition – that an alternative method of medical treatment not utilizing the product at all is not an “alternative design” – brings back memories.  Back in the Bone Screw litigation, plaintiffs repeatedly made the same argument, that surgery without any of the screws in question could be an alternative design.  This argument, of course, is a disguised form of absolute liability, that is, it’s another way of saying that the product should simply not have been used at all, that “nonuse” is the alternative design.  Fortunately, the courts back then saw the argument for what it was:

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

Theriot v. Danek Medical, Inc., 168 F.3d 253, 255 (5th Cir. 1999).  Theriot is only one of a raft of Bone Screw decisions adopting this reasoning.  First, there are a bunch of other Bone Screw cases under Louisiana law that follow Theriot – most because they were bound (by Theirot) to do so.  See Hornbeck v. Danek Medical, Inc., 2000 WL 1028981, at *1 (5th Cir. 2000) (in table at 226 F.3d 641) (“alternative methods of treatment are not alternative designs”); McDowell v. Smith & Nephew Richards, Inc., 1999 WL 980159, at *1 (E.D. La. Oct. 27, 1999) (“that the [product] can be applied with hooks rather than with screws . . . goes to an alternative treatment, not an alternative design”); Williams v. Danek Medical, Inc., 1999 WL 639555, at *1 (E.D. La. Aug. 23, 1999) (“plaintiff has not produced evidence of an alternative design”; “testimony goes to an alternative treatment [is] not an alternative design”); Harris v. Danek Medical, Inc., 1999 WL 1117106, at *2 (M.D. La. July 22, 1999) (“that there are alternatives to using” the product at all “does not provide an alternative design”); McMillen v. Danek Medical, Inc., 1999 WL 1117104, at *2 (E.D. La. July 16, 1999) (“plaintiff and his experts have confused the existence of alternative methods with alternative designs”); Doucet v. Danek Medical, Inc., 1999 WL 1129648, at *2 (W.D. La. June 28, 1999) (“a different procedure is not an alternative product design”); Bell v. Danek Medical, Inc., 1999 WL 335612, at *3 (E.D. La. May 24, 1999) (“Plaintiff confuses choice of treatment with alternative design”) (all courts following Theriot under Louisiana law); McCarthy v. Danek Medical, Inc., 65 F. Supp.2d 410, 412 (E.D. La. 1999) (“plaintiffs and their experts have confused the existence of alternative methods with alternative designs”); Toll v. Smith & Nephew Richards, Inc., 1998 WL 398062, at *2 (E.D. La. July 14, 1998) (“Plaintiffs have only suggested alternative methods of [surgery]”; “plaintiffs have not established an alternative design”) (both reaching same conclusion before Theriot).

But that’s not all.  A Tennessee appellate court also reached the same result in a Bone Screw case:

[Plaintiff’s expert] did not propose an alternative design. . . .  Instead, he recognized the existence of alternative . . . devices which do not utilize pedicle screws. . . .  [S]uch dissimilar devices described by [the expert] have been determined not to be alternative designs.

King v. Danek Medical, Inc., 37 S.W.3d 429, 449 (Tenn. App. 2000).  So did a court applying Texas law.

Plaintiffs must offer evidence, at the summary judgment phase, of a safer design for the same specific purpose that would be equally effective and not unreasonably expensive.  An alternative design that did not use pedicle screws would not suffice for a showing of design defect.

Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 738 (N.D. Tex. 2000).

But the proposition that alternative products/procedures are not alternative designs is hardly limited to orthopedic bone screws.  “[A]n alternative design must not be an altogether essentially different product.”  Torkie-Tork v. Wyeth, 739 F. Supp.2d 895, 900 (E.D. Va. 2010).  Most recently (before Schmidt, that is) the court in Massa v. Genentech, Inc., 2012 WL 956192 (S.D. Tex. Mar. 19, 2012), rejected “competitive” products made by other manufacturers when offered as supposed alternative designs:

A plaintiff cannot demonstrate the existence of a safer alternative design by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product.  A safer alternative design must be one for the product at issue, not a different product. [Plaintiff’s] argument that [the drug] could have been formulated with a number of alternative underlying compounds is not an argument that [it] should have been safer; it is an argument that [the drug] should have been a different product.  The argument is insufficient to satisfy [the legal] requirement that a plaintiff demonstrate a safer alternative design.

Id. at *7 (citations and quotation marks omitted).  Linsley v. C.R. Bard, Inc., 2000 WL 343358 (E.D. La. March 30, 2000), another mesh case, held that, while “there existed “alternative techniques” for the surgery, such techniques did not prove an “alternative design” for the product.  Id. at *3.  The Texas Court of Appeals similarly held, in a hormone therapy case:

[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product. . . .  Thus, a safer alternative design must be one for the product at issue. . . .  [Plaintiff] does not explain how [the drug] could have been modified or improved. . . .  In essence, [plaintiff] argues that the [drug] should have been a different product. . . .  But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.

Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009).  Likewise, in In re Propulsid Products Liability Litigation, 2003 WL 367739 (E.D. La. Feb. 18, 2003), another drug case, the court held:

The testimony does show that there were alternative or different methods for treating her symptoms.  This, however, is not sufficient to prove an alternative design.

Id. at *4.  See Wolfe v. McNeil-PPC, Inc., 773 F. Supp. 2d 561, 572 (E.D. Pa. 2011) (“[t]here exists no FDA-approved alternative form of [the drug], meaning there is no available alternative design of the drug for defendants to adopt”).

Nor is the proposition from Theriot even limited to drugs and devices.  See Restatement (Third) of Torts §2 comment f, illustration 9 (1998) (a full-size automobile is not an "alternative design" for a compact car); illustration 10 (other models of bullet-proof vests that provide more extensive protection are not alternative designs "the mere fact of the availability of a wrap-around vest does not render defective the vest that provides only front-and-back protection").  “Alternative designs” that would in fact advance different products are not viable alternatives:

A motorcycle could be made safer by adding two additional wheels and a cab, but then it is no longer a motorcycle.  A convertible can be made safer by fully enclosing the cab, but then it is just an ordinary car. . . .  It is not rational, however, to impose liability in such a way as to eliminate whole categories of useful products from the market.

Caterpillar v. Shears, 911 S.W.2d 379, 384-85 (Tex. 1995).  Accord Evans v. Lorillard Tobacco Co., 990 N.E.2d 997, 1017 (Mass. 2013) (citing same example).

An alternative to a cigarette, that isn’t really a cigarette, is not a valid alternative design:

[A] manufacturer cannot be held liable for failing to adopt an alternative product design that has not been shown to retain the inherent usefulness the product offers when manufactured according to the more risky (but otherwise lawful) design that was actually used.

Rose v. Brown & Williamson Tobacco Corp., 855 N.Y.S.2d 119, 120 (N.Y.A.D.), aff’d, 900 N.E.2d 966 (N.Y. 2008) (citation and quotation marks omitted).  Accord Evans, 990 N.E.2d at 1016 (“[w]e agree . . . that, in a case where the allegedly defective product is a cigarette, the reasonable alternative design must also be a cigarette”); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 539 n.4 (Pa. Super. 2003) (“we fail to see how these [noncombustable] 'cigarettes’ are an alternative”), aff’d, 881 A.2d 1262 (Pa. 2005).

In Burks v. Abbott Labs, 2010 WL 1576779 (D. Minn. April 20, 2010), the court rejected liquid infant formula as an alternative product in a case involving powdered infant formula.  “To the extent that [plaintiffs] claim that liquid infant formula is a suitable alternative design, [they] appear to confuse the existence of an alternative ‘design’ with an alternative ‘product’.” Id. at *4.  In Junk v. Terminix International Co., 2008 WL 5191865 (S.D. Iowa Nov. 3, 2008), a pesticide case, the plaintiffs offered the same sort of remove-from-the-market rationale as an alternative “option” in lieu of proving an alternative design.  The court had none of it:

[The] options submitted by [plaintiff] are not reasonable alternative designs that [defendant] could have utilized for the design of [the product].  Rather, they are alternative methods of pest control that do not include the use of [the product].  [Those] options submitted by [plaintiff] do not relate to [this defendant].

Id. at *5; see id. (rejecting “removal from the market” when offered as an “alternative design”).  See Felix v. Akzo Nobel Coatings Inc., 692 N.Y.S.2d 413, 414 (N.Y.A.D. 1999) (no alternative design where significant “functional difference” between fast- and slow-drying sealant was “critical to the products’ performance”); Pinello v. Andreas Stihl AG & Co., 2011 WL 1302223, at *15 (N.D.N.Y. March 31, 2011) (“an entirely different type of tool” or “an entirely different product” cannot be an alternative design).

So that completes our latest stroll down Bone Screw memory lane.  But while we won a lot of design defect claims in Bone Screw on alternative design, that requirement is even more a friend of defendants in design defect claims involving prescription drugs.  That’s because, in most prescription drug litigation, the product is a chemical – a molecule with a specific atomic structure that can’t be changed (no alternative possible) without creating a different product.  The recognition of that fact is one of the reasons we like the Supreme Court’s recent decision in Bartlett:

[R]edesign was not possible . . . [as defendant] cannot legally make [the drug] in another composition.  Indeed, were [defendant] to change the composition of its [drug], the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. . . .  [B]ecause of [the drug’s] simple composition, the drug is chemically incapable of being redesigned.

133 S. Ct. at 2475 (citations omitted).  See In re Temporomandibular Joint (TMJ) Implants Products Liability Litigation, 97 F.3d 1050, 1057 (8th Cir. 1996) (“If [defendant]  had designed Teflon otherwise, it would not have been Teflon. . . .  The design of Teflon was not, in this context, defective.”) (quoting Klem v. E.I. Du Pont De Nemours Co., 19 F.3d 997, 1003 (5th Cir. 1994)).

Conceivably we missed some on-point cases, particularly decisions concerning products other than drugs and medical devices.  If you know of any, feel free to tell us.

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