Source: https://www.rxrobolaw.com/2016/01/following-aubin-v-union-carbide-will-complex-medical-device-manufacturers-face-an-uphill-battle-in-defending-against-strict-liability-design-defect-claims-in-florida/
Timestamp: 2019-04-25 00:32:33+00:00

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Home > Litigation > Following Aubin v. Union Carbide, Will Complex Medical Device Manufacturers Face an Uphill Battle in Defending Against Strict Liability Design Defect Claims in Florida?
In Florida, there are two tests that a jury may apply in determining whether a product is defectively designed under a strict liability theory: the “consumer expectation test” and the “risk-utility test.” Plaintiffs usually prefer the consumer expectation test because it is generally easier for them to prove, while defendants prefer the “risk-utility test.” Late last year, the Florida Supreme Court issued its opinion in Aubin v. Union Carbide Corp., 177 So.3d 489 (Fla. 2015). Almost immediately, a number of commentators argued that Aubin spelled the end of the exclusive application of the risk-utility test in all Florida cases involving strict liability design defect claims. But is that really true?
In Aubin, a laborer who developed malignant peritoneal mesothelioma following exposure to construction products that contained asbestos, brought a products liability action against an asbestos manufacturer on theories of strict liability design defect, strict liability failure to warn, and negligent failure to warn. At trial, the jury was instructed on the consumer expectation test and returned a verdict for the plaintiff. On appeal, the Third District Court of Appeal reversed after making several findings, including that the trial court erred in failing to apply the Restatement (Third) of Torts, which exclusively adopts the risk-utility test for all design defect claims and imposes on plaintiffs the requirement of proving a reasonable alternative design. But the Florida Supreme Court rejected the Third District’s adoption and application of the Third Restatement, quashed that decision, and remanded the case with directions that the judgment for plaintiff be reinstated. See id. at 512, 520.
Though a number of commentators have since argued that Aubin paved the way for the application of the consumer expectation test in all cases involving strict liability design defect claims, a careful reading of Aubin, the Florida Standard Jury Instructions Committee’s notes, and other relevant case law strongly suggests that Aubin’s impact may in fact be more limited. Indeed, even after Aubin, a very strong argument can be made that it is still up to the individual trial court judges to decide whether the consumer expectation test and the risk-utility test should be given alternatively or together depending on the individual circumstances presented in each case.
“We do not direct, at this point, whether the standard jury instructions should be modified in light of this opinion. The parties may, in proving or defending against such claims, present evidence that a reasonable alternative design existed and argue whether the benefit of the product’s design outweighed any risks of injury or death caused by the design.” Id. at 512.
In its comments, the Florida Standard Jury Instructions Committee declines to offer an opinion about whether the consumer expectation test and the risk-utility test should be given alternatively or together. According to the Committee, moreover, the jury instructions provide language suitable for either standard, or both, determined by the trial court to be appropriate.
Consistent with the Florida Standard Jury Instructions Committee’s position that the two tests may be given alternatively and considering the complexity of some products like prescription drugs and medical devices, a number of courts applying Florida law have concluded over the years that the consumer expectation test should not be applied to design defect claims involving such products.
“Some products may, in fact, be too complex for an ordinary consumer to have any expectations concerning their proper operation. Seatbelts seem to be one of those products on the cusp. … We conclude that there may indeed be products that are too complex for a logical application of the consumer-expectation standard. We leave the definition of those products to be sorted out by trial courts. With respect to seatbelts, however, we believe that the cases finding that they may be tested by the consumer-expectation standard are better reasoned and more persuasive.” 879 So. 2d 103, 109-10 (Fla. 5th DCA 2004) (emphasis added).
In In re Fosamax Products Liability Litigation, the plaintiff alleged that she developed osteonecrosis of the jaw as a result of taking Fosamax. The jury was unable to reach a verdict on any of the plaintiff’s claims. Thereafter, the defendant filed a motion for judgment as a matter of law in part arguing that no reasonable jury could have found for the plaintiff on her design defect claims due to a lack of evidence that the drug was unreasonably dangerous. The court denied the defendant’s motion as to the design defect claims, but—applying Florida law and relying on Force and Tran v. Toyota Motor Corp., 420 F.3d 1310, 1314 (11th Cir. 2005)—ruled that only the risk-utility test applied to the plaintiff’s design defect claims because “prescription pharmaceuticals [are] too complex for the straight-forward application of the consumer expectation test.” 2010 WL 1257299, at *6 n.4 (S.D.N.Y. Mar. 26, 2010); see also In re Fosamax Products liability Litigation, 742 F.Supp. 2d 460, 470 at n.4 (S.D.N.Y. Oct. 4, 2010) (denying defendant’s motions for judgment as a matter of law and for a new trial).
“While the court in Force ultimately determined that seatbelts were not so complex as to preclude instructing the jury on a consumer expectation theory, it did find that ‘[s]eatbelts seem to be one of those products on the cusp.’ If seatbelts were ‘on the cusp,’ then it would appear that the device in this case—plainly more complex and foreign to ordinary consumers than seatbelts—falls on the other side of the line. Moreover, [the defendant manufacturer] directs this Court to In re Fosamax Products Liability Litigation, where the court, applying Florida law, ‘repeatedly denied Plaintiffs[’] requests to apply the consumer expectation test … because prescription pharmaceuticals are too complex for the straight-forward application of the consumer expectation test.[’] In this respect, the Court finds that the prescription medical device in this case is closer to prescription drugs than to seatbelts and other products routinely operated by consumers. For these reasons,…the Court concludes that the consumer expectation theory does not apply in this case.” Rydzewski v. DePuy Orthopaedics, Inc., 2012 WL 7997961, at *3 (S.D. Fla. Aug. 14, 2012) (emphasis added).
“In cases involving complex products, such as those in which pharmaceutical companies are selling prescription drugs, the learned intermediary doctrine applies. See Stone v. Smith, Kline & French Labs., 731 F.2d 1575, 1579–1580 (11th Cir.1984). Under the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. Id. This standard is ‘an understandable exception to the Restatement’s general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products.’ Id. at 1579 (internal citation omitted). As such, we rely on the expertise of the physician intermediary to bridge the gap in special cases where the product and related warning are sufficiently complex so as not to be fully appreciated by the consumer.” Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313-14 (11th Cir. 2000) (emphasis added).
“Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.” Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1366 (S.D. Fla. 2007) (emphasis added).
Echoing the rationale for the implementation of the learned intermediary doctrine, the court in Rydzewski declined to apply the consumer expectation test in determining whether the prescription medical device at issue in that case—a hip implant—was defectively designed. The court reasoned that such a product is just “too complex” for an “ordinary consumer” to form any expectations about its proper operation. Rydzewski, 2012 WL 7997961, at *2, *3.
Thus, both the question of whether the learned intermediary doctrine applies to failure to warn claims, and the question of whether the consumer expectation test applies to design defect claims are entirely dependent upon the complexity of the product at issue. While these two doctrines may diverge in their areas of application—the former to warnings claims, the latter to design claims—they share a common rationale. The learned intermediary doctrine applies precisely because the product at issue is so complex that an ordinary consumer cannot form expectations about its proper operation, and if that is the case, then the consumer expectation test cannot be used to prove design defect. Any other conclusion would be nonsensical.
For instance, it would defy reason to apply the learned intermediary doctrine to a warnings claim involving a complex medical product, but then apply the consumer expectation test to a design claim involving that same product. If the product is too complex to be available without a prescribing physician to convey the device’s risks to the patient, it cannot simultaneously be simple enough for a consumer to form reasonable expectations about its performance. A product cannot be complex for one purpose, and yet not complex for another. A product is either complex or it is not. Complexity is the threshold determination. The applicable legal principles merely follow.
Further, the Florida Supreme Court, along with most other jurisdictions, approved the risk-utility analysis almost two decades before the Third Restatement was issued in 1998. In Auburn Machine Works Co., Inc. v. Jones, 366 So. 2d 1167 (Fla. 1979), the Florida Supreme Court explained that to determine whether a product is unreasonably dangerous, “one must: ‘(balance the) likelihood of harm to be expected from a machine with a given design and the gravity of harm if it happens against the burden of precaution which would be effective to avoid harm.’” Id. at 1170 (citing 2 Harper and James, The Law of Torts § 28.4 (1956)); see also Cassisi v. Maytag Co., 396 So. 2d 1140, 1145 n. 9 (Fla. 1st DCA 1981) (noting that the risk-utility “balancing approach was implicitly approved” in Auburn Machine Works).
Thus, since the Florida Standard Jury Instructions remain unchanged, since certain products are too complex to permit the logical application of the consumer expectation test, and since opinions like Rydzewski did not rely on the Third Restatement in declining to apply the consumer expectation test, Aubin may have a much more limited impact than some would argue.

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