We’ve already posted a number of items about Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007), but like a kids in a candy store, we’re still looking at the case to try to figure out all the things that defendants might be able to do with it. We closed our last post on the subject with a few musings on the implications of Williams’ holding that “the Due Process Clause prohibits a State from punishing an individual without first providing that individual with an opportunity to present every available defense.” Id. at 1063.
What might those defenses be? Well, in a lot of cases that would include the right to full proof that the defendant complied with applicable FDA standards. There’s a raft of cases out there for the proposition that regulatory compliance at minimum mitigates the reprehensibility of a defendant’s conduct in product liability cases and often precludes punitive damages as a matter of law.
One of the as-a-matter-of-law cases, Sloman v. Tambrands, Inc., 841 F. Supp. 699 (D. Md. 1993), even involves FDCA compliance. Sloman dismissed the all the plaintiff’s claims on preemption, but as to punitive damages provided this alternative holding in a footnote:
[I]f Plaintiff was entitled to punitive damages, she would have to prove under Maryland law by “clear and convincing evidence” that [the defendant] acted with “actual malice.” Since defendant successfully proved that it complied with federal regulations, the Court concludes that [defendant] did not act with malice in its TSS warning and thus plaintiff is not entitled to punitive damages.
Id. at 703 n.8.
FDCA compliance thus seems to be an absolute defense to punitive damages under Maryland law. Under Williams, then it seems like prescription medical product defendants have a constitutional right to present their compliance defense to the jury.
So what else to we have that’s at least analogous to Sloman? The most recent case we know about on the subject is Flax v. DaimlerChrysler Corp., 2006 WL 3813655 (Tenn. App. Dec. 27, 2006). Although Flax has some wretched evidentiary holdings, it vacated a large punitive damages award due to undisputed evidence of regulatory compliance – combined with a state statute giving compliant defendants the benefit of a presumption.
“[W]e cannot ignore that our legislature has afforded a presumption against an unreasonably dangerous product to manufacturers when the product complies with relevant government regulations. . . . We believe that [defendant’s] compliance . . . weighs heavily in [it’s] favor against a clear and convincing finding of recklessness that might warrant punitive damages.
Id. at *25. Prescription medical product manufacturers can make the Flax argument about legislative recognition of compliance in the following states: Arizona (Rev. Stat §12-701); Florida (Stat. Ann. §768.1256); Indiana (Code §34-20-5-1); Kansas (Stat. Ann. §60-3304(a)); Michigan (Comp. L. §600.2946(4); New Jersey (Stat. Ann. §2A:58C-4); North Carolina (Gen. Stat. §99B-6(b)(4); North Dakota (Cent. Code §28-01.3-09); Tennessee (Code Ann. §29-28-104); Texas (Rev. Civ. Prac. & Rem. C. §82.007); and Utah (Code Ann. §78-15-6).Another very recent case is Clark v. Chrysler Corp., 436 F.3d 594, 603 (6th Cir. 2006) (applying Kentucky law). Clark found a “good faith dispute” whether a certain product test should have been conducted, and described how the relevant governmental agency evaluated the test and decided not to require it. Id. at 603. “[B]ecause the test was neither required by the government nor used by other manufacturers, we cannot conclude that [defendant’s] failure to adopt the test indicates a level of indifference to or reckless disregard for the safety of others sufficient to weigh in favor of reprehensibility.” Id. Given that “good faith dispute,” the state of mind necessary to support a punitive damages award did not exist. Id. We’ve also got most of the deep south. There’s Mississippi, where Satcher v. Honda Motor Co., 52 F.3d 1311, 1316-1317 (5th Cir. 1995), where the court vacated a punitive damages award for several reasons, including that the government did not require the safety device advocated by the plaintiffs. Next door in Alabama, compliance with government warning requirements precluded a finding of “wantonness” necessary to punitive damages in Richards v. Michelin Tire Corp., 21 F.3d 1048, 1059 (11th Cir. 1994). In Georgia, the Supreme Court held that “[w]hile compliance with the law will not preclude a finding [of liability]. . .such compliance does tend to show that there is no clear and convincing evidence of” a state of mind permitting an award of punitive damages. Stone Man, Inc. v. Green, 435 S.E.2d 205, 206 (Ga. 1993); accord Barger v. Garden Way, Inc., 499 S.E.2d 737, 743 (Ga. App. 1998); Welch v. General Motors Corp., 949 F. Supp. 843, 845 (N.D. Ga. 1996). The Florida Supreme Court concurs. In Chrysler Corp. v. Wolmer, 499 So.2d 823 (Fla. 1986), it described in some detail the defendant’s compliance with federal motor vehicle standards before concluding that “an award of punitive damages in this case not only is unjust, but also ignores the threshold requirements for such an award.” Id. at 826.As Flax, Clark, Satcher, Welch, and Wolmer already demonstrate, auto cases seem to be a particularly good source of favorable compliance opinions. In Miles v. Ford Motor Co., 922 S.W.2d 572 (Tex. App. 1996), rev’d in part on other grounds, 967 S.W.2d 377 (Tex. 1998), the court held “[w]hen a seller relies in good faith on . . . conclusions by the governmental agencies charged with administering safety regulations in the area of its product . . ., it cannot be said to have acted with an entire want of care showing conscious indifference” so as to justify punitive damages. Id. at 589. There’s also Brand v. Mazda Motor Corp., 978 F. Supp. 1382, 1393-1394 (D. Kan. 1997), in which evidence that the defendants’ “system  met and exceeded federal safety standards” established that “no reasonable jury could find that the defendants deliberately or recklessly failed to either correct a defect or prevent an injury.There’s also favorable law on the subject in Missouri and Utah, Alcorn v. Union Pacific Railroad Co., 50 S.W.3d 226, 249 (Mo. 2001); Lopez v. Three Rivers Electrical Cooperative, Inc., 26 S.W.3d 151, 160 (Mo. 2000); Boyette v. L.W. Looney & Son, 932 F. Supp. 1344, 1348 (D. Utah 1996).There’s a little bit of bad law to beware of, especially a hideous recent decision out of California, Buell-Wilson v. Ford Motor Co., 46 Cal. Rptr.3d 147, 177-179 (Cal. App. 2006). Other than Buell, the two worst decisions are federal predictions of state law that have both since been rejected by the Supreme Courts of the states whose law they purported to predict. See Watkins v. Ford Motor Co., 190 F.3d 1213, 1216-1218 (11th Cir. 1999) (supposedly applying Georgia law), and Dorsey v. Honda Motor Co., 655 F.2d 650, 656-657 (11th Cir. 1981) (supposedly applying Florida law).Anyway, just like the plaintiffs try to hammer us with supposed noncompliance with FDCA standards whenever they can, we’re happy to wrap ourselves in the flag of FDCA compliance whenever we can. Under Williams, if the plaintiffs are seeking punitive damages, it looks like our right to present our full compliance case is constitutionally protected.