Thursday, February 01, 2007

Deconstructing the Duty to Test

Even with the rise (and fall) of new and unusual theories of liability, the bulk of what we defend against still consists of inadequate warning claims. We’ve been down this road so often that we know in our sleep when we’ve got a slam dunk defense to one of these. We’re ready to file our summary judgment motions when one of two things – preferably both – have been established: (1) our client’s warnings specifically discuss the risk the plaintiff claims and state everything that was known about it at the time, and/or (2) the prescribing doctor already knew all that information and didn’t bother to review our package insert anyway.

When that happens, we usually win. We like to win. What we don’t like particularly is to get something bizarre from a trapped plaintiff that tries to change all the rules of the game, such as adequacy as a matter of law, warning causation under the learned intermediary rule, and the state of the art defense. One of those things is an allegation that the defendant violated a “duty to test” the product, and that if the defendant had tested “properly” additional information would have been discovered sooner. You can see where this is heading. The plaintiff wants to use the duty to test to defeat the adequacy of the warnings and the physician’s personal knowledge.

Well, we’re happy to tell you that there’s no such thing as an independent duty to test. It doesn’t exist – at least not separately – not any more. There are some mostly older cases where courts used loose language about “testing duties, but those courts did so in the context of the standard product liability claims for warning/design/manufacturing defects, not as a claim standing separate and apart. See Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 140-41 (3d Cir. 1973); Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1399-1402 (8th Cir. 1969); Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290, 1307 (D. Colo. 1984); Taylor v. Wyeth Laboratories, Inc., 1362 N.W.2d 293, 296-97 (Mich. App. 1984), Ferrigno v. Eli Lilly & Co., 1420 A.2d 1305, 1320 (N.J. Super. Law Div. 1980). Those cases didn’t really deal with the existential question either, being more concerned with whether the claims had been proven.

The first case that really came to grips with whether a separate and independent cause of action for duty to warn case was even logical was Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517 (D. Minn. 1989). The judge, while otherwise making a variety of really awful rulings, did get this one right. He concluded that the idea of an independent duty to text just didn’t make sense. Rather, “[t]he duty to test is a subpart of duties to design a product non-negligently, manufacture a product non-negligently, and provide adequate warnings.” Id. at 1528. The problem is that the alleged breach – failure to test – just doesn’t cause injury by itself. Something that isn’t done can’t be causal unless and until it is combined with something that does happen – such as a product later marketed with inadequate warnings, an untested design, or a manufacturing problem that escapes detection because it wasn’t adequately tested. In short, lack of a test only causes harm when it gives rise to one of the three well-established categories of defect. Thus, in Kociemba, the supposed duty to test was just became part of the underlying duty to warn claim:


Defendant argues. . .that this duty [to test] is subsumed in one of the three [usual product liability] causes of action. . . . The Court finds defendant’s argument persuasive. Presumably, the reason that manufacturers are under a duty to test their products is to discover defects or dangers associated with use of the products. Once the manufacturer has discovered a defect or danger the manufacturer should either change the product’s design or manufacturing process, or warn consumers of the danger associated with using the product. Thus, unless the manufacturer’s breach of its duty to test leads the manufacturer to produce a product that is defective in design, manufacture, or warning, no injury can result. If the manufacturer designs the product safely, manufactures the product safely, and provides an adequate warning of dangers inherent in the use of the product, then a failure to test the product cannot, standing alone, cause any injury. The duty to test is a subpart of the other three duties because a breach of the duty to test cannot by itself cause any injury.
Id. at 1527-28.

The result of this view is that once the traditional (usually warning) claim is defeated for whatever reason, the testing claim evaporates. Fortunately this is the view that has prevailed in almost every prescription drug and medical device litigation over the last decade and a half – the defendant manufacturer cannot independently be held liable for failure to test. Vassallo v. Baxter Healthcare Corp., 428 Mass. 1, 696 N.E.2d 909, 921 (Mass. 1998); Adams v. G.D. Searle & Co., 576 So. 2d 728, 730-31 (Fla. App. 1991); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 264-65 (Cal. App. 1999); Theriot v. Danek Medical, Inc., 168 F.3d 253, 256 (5th Cir. 1999); Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991); Graham v. Medtronic, Inc., 2006 WL 2194012, at *2 (M.D. Fla. Aug. 2, 2006); In re Prempro Products Liability Litigation, 2006 WL 1897267, at *4 (E.D. Ark. July 11, 2006); Miller v. Pfizer Inc., 196 F. Supp.2d 1095, 1124 n.97 (D. Kan. 2002); Linsley v. C.R. Bard, Inc., 2000 WL 343358, at *6 (E.D. La. Mar. 30, 2000); Harris v. Danek Medical, Inc., 1999 WL 1117106, at *3 (M.D. La. July 22, 1999); Clark v. Danek Medical, Inc., 1999 WL 613316, at *3 n.4 (W.D. Ky. Mar. 29, 1999); Barrow v. Bristol-Myers Squibb, 1998 WL 812318, *28 n.248 (M.D. Fla. Oct. 29, 1998); In re N Phenylpropanolamine Litigation, 2002 WL 244858, at *1 (Pa. C.P. Feb. 5, 2002).

Duty to test claims don’t just arise in the kind of cases we normally do. Rather, the claim pops up now and then in all sorts of product liability cases. The theory hasn’t fared much better in those areas. Claims asserting independent testing duties have generally been rejected across the board. Here’s a representative sample of cases: Mercer v. Pittway Corp., 616 N.W.2d 602, 627 (Iowa 2000); American Tobacco Co., v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997); Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 540-41 (Pa. Super. 2003); Lambert v. General Motors, 79 Cal. Rptr.2d 657, 661 (Cal. App. 1998); Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. 1992); Anderson v. Owens Illinois, Inc., 799 F.2d 1, 5 (1st Cir. 1986); LaBelle v. Philip Morris, Inc., 243 F. Supp.2d 508, 519 n.12 (D.S.C. 2001); Dahlman Farms, Inc. v. FMC Corp., 240 F. Supp.2d 1012, 1019 (D. Minn. 2002); Bergfeld v. Unimin Corp., 226 F. Supp.2d 970, 981 (N.D. Iowa 2002); Messer v. Amway Corp., 210 F. Supp.2d 1217, 1234 (D. Kan. 2002); McClain v. Metabolife International, Inc., 193 F. Supp.2d 1252, 1257 (N.D. Ala. 2002).

Another major conceptual problem with the idea of a separate testing duty is that it nullifies the state of the art defense by letting plaintiffs argue that more testing would have discovered sooner (always soon enough to save the plaintiff in the case) that the drug or medical device had some sort of unexpected risk (always the risk that the plaintiff suffers from). Most courts – and all the recent ones – recognize and do not tolerate this subterfuge. After all, no duty to test could be broader than the legal duty of a defendant to warn about what the testing would have discovered:


In calling for an independent duty to test, appellant posits that appropriate testing for long term effects would have revealed different information from what was known or knowable in the scientific community. . . . Appellant forgets that [defendant] was charged with an ongoing duty to warn of side effects known or knowable in the scientific community. In this light, imposition of liability for breach of an independent duty to conduct long-term testing, where the causal link to the known harm to plaintiff is the unknown outcome of testing that was not done, would be beyond the pale of any. . . tort doctrine we can identify.
Valentine, 81 Cal. Rptr.2d at 265. Other courts rejecting claims that testing duties can embrace otherwise unknowable risks include. Vassallo, 696 N.E.2d at 921, 923; Richter v. Limax International, Inc., 45 F.3d 1464, 1467-68, 1471 (10th Cir. 1995); Miller, 196 F. Supp.2d at 1124 n.97; Cipollone v. Liggett Group, Inc., 683 F. Supp. 1487, 1499 (D.N.J. 1988).

As defense attorneys it’s our job to keep the system as rational as we can – because where the law is rational, we’ll usually win. An independent duty to test just isn’t rational, which is why so many courts have rejected it. It’s one of those theories that tries to move the goalposts. With some amorphous, open ended common-law testing duty, no warning would ever be good enough, and no doctor learned enough, since every presently unknown risk could always be discovered sooner with tests that 20-20 hindsight say should be done.

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