More MDL Panel Empirics

We're delighted when our blog gives people food for thought.

So we were tickled pink when Daniel A. Richards, a student at Fordham University School of Law, told us that one of our blog posts had given him a topic for his law review note. And Daniel was kind enough to send us a link to his just-published note, "An Analysis of the Judicial Panel on Multidistrict Litigation's Selection of Transferee District and Judge." (As we reported a couple of months ago, two distinguished scholars examined this question in their recent paper, "Between Cases And Classes: The Decision To Consolidate Multidistrict Litigation" (SSRN link here). In that empirical analysis, three factors stood out as statistically significant in the Panel's selection of transferee courts: (1) districts containing a tag-along (later-filed) case, (2) districts supported by the defendants, and (3) districts represented by a judge serving on the Panel. As for the selection of transferee judge, the factors cited by the Panel most frequently were "experience with similar or complex cases" and "appropriate workload." The judges chosen to serve the transferee role were fairly experienced, with a mean of 13 years serving as a judge. And service as the chief judge of the transferee district (at some point during the judge's career) increased the likelihood that the Panel would pick that judge.)

Richards' note addresses the same subjects, but not as empirically. Rather, he read (God love him) every MDL transfer order entered between 2003 and 2008. He then identified the factors that the Panel cited most frequently in those decisions to justify its selection of transferee court and judge.

And the conclusion is . . .

"In general, when the JPML is explaining its reasoning for selecting a transferee district and judge, it most frequently cites the docket conditions of a transferee district or judge, the preference of the parties, the concentration of constituent actions, and the location of an important party in the litigation." 78 Fordham L. Rev. at 343.

Richards also breaks down the data by the nature of the MDL proceedings -- antitrust, product liability, securities, etc. He then identifies factors that seem to be more important in one category of case than another. For example, "[a]lthough the general experience of the transferee judge is likely an important factor in products liability MDLs, it is less so in securities MDLs. Also, geographic centrality is an important factor in products liability MDLs and is less important in antitrust MDLs." Id. at 345.

Sadly, all of this work doesn't lead to very concrete conclusions. It's still awfully hard to guess how the MDL Panel will apply in any one case the many variables that go into its selection of transferee court and judge, and it remains terribly difficult to advise clients on this subject.

But we're delighted to see that a law student has joined the ranks of those wrestling with these issues, and perhaps we'll see more work in this field in the future.

A Safe Harbor In Arkansas

No, we're not talking about the McClellan Kerr Project that turned Little Rock and Tulsa, of all places, into seaports. We're talking consumer protection lawsuits against pharmaceutical companies (aren't we always).

We've mentioned a couple of times before that a lot of consumer protection laws contain "safe harbor" provisions that bar suits over conduct that was "authorized"/"approved"/"permitted" (the statutory language varies) by governmental agencies. On several occasions, detailed in these prior posts, courts have dismissed consumer protection claims that attacked FDA-approved actions (usually labeling) after finding that the challenged conduct falls within one of these "safe harbor" provisions.

Well, that other day it happened again - in Arkansas - in the Supreme Court of Arkansas, to be precise. The case is DePriest v. AstraZeneca Pharmaceuticals, L.P., slip op. (Ark. Nov. 5, 2009). The drug involved in Nexium, and the claim was that the defendant fraudulently marketed this drug as better than older drugs that - allegedly - did essentially the same thing. Slip op. at 2. The form of suit in DePriest, predictably enough, was an economic-loss-only class action. There was no allegation that the drug didn't work, hurt people, or anything like that - only that it wasn't as "new" as the defendant claimed it was. Classic strike suit - the only worthwhile claim is by the plaintiffs' lawyers for fees.

The Arkansas Supreme Court got an appeal after the trial court dismissed the case because, among other things, the attack on the defendant's labeling was barred by the safe harbor provision of the Arkansas consumer protection statute, Ark. Code Ann. §4-88-101(1). See DePriest v. AstraZeneca Pharmaceuticals, L.P., 2008 WL 3242562 (Ark. Cir. July 31, 2008). Arkansas has one of the broader safe harbor provisions around, precluding suit over "actions or transactions permitted ... [by] a regulatory body," either federal or state. "Permitted" is one of several safe harbor variants, and shows up, in addition to Arkansas, in Connecticut, Florida, Indiana, Maine, Masssachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Washington, and Wyoming (look 'em up in Bexis' book, page 2.14-8).

In DePriest, the court rejected California precedent - decided under a statute without an equivalent "safe harbor" provision, and held that everything in the defendant's advertising was "permitted" by the drug's FDA-approved labeling. Slip op. at 14-15 ("[t]he FDA-approved labeling did, in fact, indicate that the approved dose of [the drug] was superior to the approved dose of [the precursor drug] at healing [the condition at issue]"). The same ruling applied both to physician and direct-to-consumer advertising. Id. at 15-16.

The information included in the labeling of a new drug reflects a determination by the FDA that the information is not "false or misleading." By approving information to be included in the drug labeling, the FDA has determined the information complies with its rules and regulations. Therefore, if the FDA labeling supports the statements made in the advertising for an FDA-approved drug, the statements are not actionable under the [Arkansas consumer protection statute].

Slip op. at 16 (citations omitted). The court held that all the statements were adequately supported, thereby affirming the dismissal. Slip op. at 16-17.

Accordingly, we conclude that [defendant's] advertisements constituted actions permitted under the laws administered by the FDA, and therefore, the [Arkansas statute], by its own terms, does not apply to the challenged conduct.

Slip op. at 19.

DePriest is the first state supreme court decision in the country to affirm dismissal of a consumer fraud action against an FDA-regulated defendant based upon a safe harbor provision relating to government regulated conduct. Congrats to AZ and its lawyers.

Oh, BTW: for those who are interested in common-law claims, the court in DePriest affirmed dismissal of the following other claims for the following reasons:

• Fraud - Statements supported by FDA-approved labeling were, as a matter of law, neither false nor misrepresentations. Slip op. at 20.
• Unjust enrichment - Because there were no false statements, there was no tortious conduct, and thus nothing "unjust" for equity to remedy. Slip op. at 20-21.
• Promissory estoppel - An advertisement simply isn't a quasi-contractual promise that can support such a theory. Slip op. at 22.

Finally, talk about sore losers, the plaintiffs tried to recuse the judge that dismissed their case. We've expressed ourselves on this general subject already. We'll leave it at that. Suffice it to say that, on appeal, the court gave the recusal claim the back of its hand. Slip op. at 24 (trial court hadn't "prejudged" the case; it was granting the defendant's motion).

Defense counsel should always check out the relevant state's consumer protection safe harbor language (if any) carefully. DePriest is the latest opinion demonstrating that decisive defenses can lurk in that language.

Conte's First Anniversary

Jeff Pilkington and Geoff Klingsporn of Davis Graham & Stubbs contributed the following guest post noting the passage of one year since the Conte decision came down. Jeff and Geoff get all the credit for what follows; all we do is thank them for their work:

On November 7, 2008, a “grotesque chimera of product liability and misrepresentation [was] set loose to lumber across the California landscape.” One year later, the good news is that this frightening beast, more formally known as Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), has not been allowed to wander far.

In Conte, a California appellate court held that the manufacturer of name-brand Reglan® could be sued for injuries caused by a patient's ingestion of metoclopramide, the generic version of that product. One might expect, therefore, that the initial impact of the decision would be in other cases involving Reglan® and metoclopramide.

But so far, no other court since Conte has bought this argument. In the past twelve months, seven courts have considered the issue, and each of the seven has declined to follow its reasoning or adopt its novel holding. These cases are:

Burke v. Wyeth, Inc., No. G-09-00082 (S.D. Tex. Oct. 7, 2009) (Froesschner, Mag. J.) (report and recommendation), adopted, (S.D. Tex. Oct. 29, 2009) (Hoyt, J.)

Stoddard v. Wyeth, Inc., 630 F. Supp. 2d 631, 634 (E.D.N.C. June 24, 2009)

Fields v. Wyeth, Inc., 613 F. Supp. 2d 1056 (W.D. Ark. 2009)

Moretti v. Wyeth, Inc., No. 2:08-CV-00396-JCMGWF, 2009 WL 749532, at *3-*4 (D. Nev. Mar. 20, 2009)

Schrock v. Wyeth, Inc., No. CIV 08-453-M, 2009 WL 635415, at *4-*5 (W.D. Okla. Mar. 11, 2009)

Cousins v. Wyeth Pharm., Inc., No. Civ. A 3:08-CV-0310-N, 2009 WL 648703, at *2 (N.D. Tex. Mar. 10, 2009)

Huck v. Trimark Physicians Group, No. LACV018947, Order at 1-2 (Iowa Dist. Ct. Feb. 27, 2009)

(For those keeping score, this makes 31 courts in 19 states that have refused to impose liability on a brand name drug manufacturer for injuries caused by its competitors’ generic drugs.)

Some of these courts have been emphatic in rejecting Conte. The federal court in neighboring Nevada looked at the cases and concluded that “with the exception of Conte, every other court that has considered this issue has rejected Plaintiff's arguments. Those courts have correctly held that brand name manufacturers do not have a legal duty to warn about the risks associated with their competitors' generic drugs. Simply put, Conte stands alone and is contrary to Nevada law and public policy.” Moretti at *4.

Likewise, just in the past month the Eastern District of Texas dismissed “[t]he California court’s holding in Conte” as “anomalous.” Burke, Report and Recommendation at 6.

What explains the limited impact of Conte? First and foremost, the decision was simply bad law. It ignored decades of products liability jurisprudence – including the bedrock principle that liability for allegedly defective products rests with the company that profited from their sale and that controls their safety. The Conte court created a duty based on foreseeability alone, without giving proper weight to the social policy considerations flowing from such a duty. As noted on this blog at the time, “Conte is bad law and worse policy.”

Second, the Supreme Court’s post-Conte decision in Wyeth v. Levine removed the most significant incentive for courts after Conte to even consider stretching products liability so far out of shape: generic preemption. In Conte the generic manufacturer defendants had already been let out of the case on preemption grounds, which left the California court with an unappetizing prospect: if the brand name manufacturers weren’t liable for plaintiff’s injuries, then no one would be. After Levine, generic manufacturers are finding it much more difficult to win their preemption motions.

In fact, Conte’s lack of traction may make it more likely that courts will reject generic preemption: For instance, in Bartlett v. Mutual Pharmaceutical Co., a New Hampshire federal court cited “the widespread rejection” of innovator liability as another reason to deny preemption, since such “rejection supports the view that, if failure-to-warn claims against generic drug makers are indeed pre-empted, those injured as a result … have no recourse.” Slip op. at *25 n.40.

No doubt plaintiffs’ attorneys will keep arguing for innovator liability across the country – including in jurisdictions where such “innovator liability” was rejected before Conte, on the theory that the California decision undermines or unsettles prior law on this issue. But so far, no court has shown any inclination to agree. We will see what happens in another year.

On Punitive Damages

The Eighth Circuit’s recent overturning (technically, affirming the district court's blow out) of a large punitive damages award in a hormone replacement therapy case got us thinking about punitive damages again. See In re Prempro Products Liability Litigation, ___ F.3d ___, 2009 WL 3518245 (8th Cir. Nov. 2, 2009).

Thinking, but not necessarily talking about that case, that is. Herrmann represents Wyeth (which won’t be just Wyeth much longer) in a lot of things. Bexis has been involved in HRT litigation (for somebody else), so neither of us can say anything substantive in public about that particular case – sorry.

Nor are we addressing constitutional aspects of punitive damages today. For those topics, readers can go here and here (punitive damages class actions), here and here (territoriality - one state can't impose punitives for conduct in different states), here (ratio), and here (conduct directed against nonparties).

But what role should punitive damages play in prescription medical product liability litigation anyway?

Should there be any?

Even we’re not willing to go as far as saying there should never be any role for punitive damages. If some drug or device company actually were to authorize and finance the sort of conduct at issue in the so-called "Body Snatchers" litigation (see our post here) – deliberately and illegally (indeed, criminally) harvesting body parts from corpses without anybody's consent and without testing for certain diseases – and somebody got infected from a product as a result, well that seems to us to be sufficiently malicious, in conscious disregard, whatever, to justify punitive damages.

But that’s about as far as we’ll go. We don’t think, for instance, that there’s any room for punitive damages where, instead of some Chinese pig farm operating in an essentially unregulated environment, the relevant aspects of a product are regulated and approved by the FDA’s detailed regulatory scheme. Compliance with such standards is incompatible with the “actual malice” standard ordinarily applicable to punitive damages. Sloman v. Tambrands, Inc., 841 F. Supp. 699, 703 n.8 (D. Md. 1993). That’s why a lot of states either preclude punitive damages altogether, or provide a strong presumption against punitive damages where there’s been regulatory compliance. See Ariz. Rev. Stat §12-701, Fla Stat. §768.1256; Ind. Code §34-20-5-1), Kan. Stat. §60-3304(a), Mich. Comp. L. §600.2946(4), N.J. Stat. §2A:58C-4, N.C. Gen. Stat. §99B-6(b)(4), N.D. Cent. Code §28-01.3-09); Tenn. Code §29-28-104, Tex. Rev. Civ. Prac. & Rem. C. §82.007), Utah Code §78-15-6.

It’s not just statutes. A lot of courts have also held that regulatory compliance logically precludes imposition of punitive damages. The reasoning is simple. Governmental regulation sets a standard that is objectively reasonable. A company that conducts itself in accordance with that standard cannot have acted with sufficient reprehensibility to warrant the exaction of punitive damages. And most of these cases aren’t even drug cases. Instead, they involve other regulatory schemes that aren’t nearly as comprehensive and onerous as what the FDA imposes.

The Supreme Court took a look at this question in the civil rights context in Kolstad v. American Dental Ass’n, 527 U.S. 526 (1999). The punitive damages standard for Title VII isn’t much different from common-law tort actions – “with malice or with reckless indifference” to protected civil rights. See 42 U.S.C. §1981a(b)(1); Kolstad, 527 U.S. at 537 (“[w]e assume that Congress, in legislating on punitive awards, imported common law principles”). The Court held that “good faith” efforts to comply with the law would defeat punitive damages.

Holding employers liable for punitive damages when they engage in good faith efforts to comply with Title VII, however, is in some tension with the very principles underlying common law limitations . . . . Where an employer has undertaken such good faith efforts at Title VII compliance, it demonstrates that it never acted in reckless disregard of federally protected rights.

527 U.S. at 544 (citation and quotation marks omitted).

Back to product liability. In Clark v. Chrysler Corp., 436 F.3d 594, 603 (6th Cir. 2006) (Kentucky law), the court found a “good faith dispute” whether certain tests should have been done, 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. Because of the “good faith dispute,” the state of mind necessary to support a punitive damages award did not exist. Id.

Other courts have done the same thing. In Satcher v. Honda Motor Co., 52 F.3d 1311, 1316-1317 (5th Cir. 1995), the court vacated a punitive damages award under Mississippi law, inter alia, because the government did not require the safety device advocated by the plaintiffs. Then there’s 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), where the court held that “[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.

The issue has come up a lot in Georgia since that state’s 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); In re Stand ‘N Seal, Products Liability Litigation, 2009 WL 2145911, at *9 (N.D. Ga. July 15, 2009); Welch v. General Motors Corp., 949 F. Supp. 843, 845 (N.D. Ga. 1996). Thus the older, contrary decision, Watkins v. Ford Motor Co., 190 F.3d 1213, 1216-18 (11th Cir. 1999), is no longer a valid prediction of Georgia law.

The same is true in Florida. In Chrysler Corp. v. Wolmer, 499 So.2d 823 (Fla. 1986), the defendant’s compliance with federal motor vehicle standards hat “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. Again, a state supreme court put the kebosh on the contrary federal prediction, Dorsey v. Honda Motor Co., 655 F.2d 650, 656-657 (11th Cir. 1981), which erroneously interpreted Florida law the other way.

More stuff along the same lines. In Phillips v. Cricket Lighters, 883 A.2d 439 (Pa. 2005), one factors leading to a holding that “as a matter of law” there was insufficient evidence of “outrageous” conduct permitting punitive damages was that “at the time this [product] was sold, it complied with all safety standards.” Id. at 447. “Evidence of [a defendant’s] good faith effort to comply with all government regulations. . .would be evidence of conduct inconsistent with the mental state requisite for punitive damages.” Malcolm v. Evenflo Co., 217 P.3d 514 ¶99 (Mont. 2009). Similar evidence – that the defendants’ “system [] met and exceeded federal safety standards” – led the court in Brand v. Mazda Motor Corp., 978 F. Supp. 1382, 1393-1394 (D. Kan. 1997), to conclude that “no reasonable jury could find that the defendants deliberately or recklessly failed to either correct a defect or prevent an injury. In Richards v. Michelin Tire Corp., 21 F.3d 1048, 1059 (11th Cir. 1994) (Alabama law), compliance with government warning requirements precluded a finding of “wantonness” necessary to support punitive damages. See also 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); McWilliams v. S.E. Inc., 2009 WL 3625173, at *8 (N.D. Ohio Oct. 29, 2009); Boyette v. L.W. Looney & Son, 932 F. Supp. 1344, 1348 (D. Utah 1996).

There are even some courts that go further and refuse to permit punitive damages where a particular product was designed in conformity with expert safety consensus at the time of manufacture, even if there were other “experts” at the time who disagreed. This happens most frequently in Iowa: Mercer v. Pittway Corp., 616 N.W.2d 602, 618 (Iowa 2000) (reasonable disagreement among experts insufficient to hold defendant liable for punitive damages); Hillrichs v. Avco Corp., 514 N.W.2d 94, 100 (Iowa 1994) (“an award of punitive damages is inappropriate where room exists for reasonable disagreement over the relative risks and utilities of the conduct and device at issue”); Burke v. Deere & Co., 6 F.3d 497, 511 (8th Cir. 1993) (Iowa law) (entering judgment n.o.v. because “[a]n award of punitive damages is not appropriate when room exists for reasonable disagreement over the relative risks and utilities of the conduct at issue”). But similar law exists in some other juristictions. Loitz v. Remington Arms Co., 563 N.E.2d 397, 407 (Ill. 1990) (punitive award reversed in light of good-faith metallurgical disagreement among experts); Owens Corning Fiberglas Corp. v. Garrett, 682 A.2d 1143, 1163-68 (Md. 1996) (punitive award reversed where there was a genuine scientific safety-related dispute); Satcher v. Honda Motor Co., 52 F.3d 1311, 1317 (5th Cir. 1995) (Mississippi law) (punitive award vacated; “there is a genuine dispute in the scientific community as to whether leg guards do more harm than good”).

Compliance as a defense to punitive damages may also relate to a jurisdiction's basic standard for punitive damages. Not all punitive damages are awarded equally. Some states require a stronger finding of intent than others. Or, to put it another way, what’s reprehensible enough to support punitive damages in one jurisdiction, may not fly in another. Some states allow punitive damages for what sounds a lot like negligence. The Arkansas statute cited in Prempro is one of those. Ark. Code. §16-55-206 (liability for punitives where defendant “knew or ought to have known” that what it was doing “would naturally and probably” cause harm). Other states, like Pennsylvania, make it clear that no form of negligence, however gross, supports punitive damages. Phillips, 883 A.2d at 445 (“a showing of mere negligence, or even gross negligence, will not suffice to establish that punitive damages should be imposed”).

This distinction is manifested in the Restatement Second of Torts. The Restatement defines “recklessness” in §500, and that definition is incorporated into Restatement §908, concerning punitive damages. Comment a to §500 defines two distinct types of reckless conduct which represent very different mental states. The first definition requires conscious knowledge throughout: “(1) where the ‘actor knows, or has reason to know,. . .of facts which create a high degree of risk of physical harm to another, and deliberately proceeds to act, or to fail to act, in conscious disregard of, or indifference to, that risk.’” Restatement §500, comment a. The second, less restrictive definition does not require conscious knowledge: “(2) where the ‘actor has such knowledge, or reason to know, of the facts, but does not realize or appreciate the high degree of risk involved, although a reasonable man in his position would do so.’” Id. (emphasis added).

States that disfavor punitive damages adopt the Restatement’s first definition of recklessness:

The first type of reckless conduct described in §500 demonstrates a higher degree of culpability than the second on the continuum of mental states which range from specific intent to ordinary negligence. An “indifference” to a known risk under Section 500 is closer to an intentional act than the failure to appreciate the degree of risk from a known danger. . . . Under Pennsylvania law, only the first type of reckless conduct described in comment a to Section 500, is sufficient to create a jury question on the issue of punitive damages. Thus, punitive damages are awarded only for outrageous conduct, that is, for acts done with a bad motive or with a reckless indifference to the interests of others.

SHV Coal, Inc. v. Continental Grain Co., 587 A.2d 702, 704-05 (Pa. 1991) (various citations and internal quotation marks omitted); accord Hutchison v. Luddy, 870 A.2d 766, 771-72 (Pa. 2005). “It is not sufficient that the defendant failed to appreciate a risk; rather, there must be indifference to a known risk.” In re One Meridian Plaza Fire Litigation, 820 F. Supp. 1460, 1488 (E.D. Pa. 1993). To be assessed punitive damages, a defendant must have “created an unreasonable risk of physical harm that was substantially greater than that which is necessary to make its conduct negligent.” Steffy v. Home Depot, Inc., 2009 WL 904966, at *21 (M.D. Pa. March 31, 2009).

What can this heightened standard for punitive damages mean for defendants? A lot actually. It gets rid of one of the plaintiffs’ favorite refrains – for only a “few [cents/dollars] more, the defendant could have designed a ‘safer' product.” Look what happened in the Phillips case:

[W]e flatly reject [plaintiff’s] assertion that [defendants’] weighing of financial concerns in determining whether to incorporate additional safety features into its product on a unilateral basis establishes that Appellants acted wantonly. Rather, it shows simply that [defendants] were considering all of the myriad elements that affect decisions a for-profit entity must make in manufacturing and marketing commercial products.

883 A.2d at 447.

Tougher scienter aspects for punitive damages have other favorable consequences for defendants faced with such clams. Failure to conduct tests not mandated by government regulators is not sufficiently malicious to warrant punitive damages. Montgomery v. Mitsubishi Motors Corp., 2006 WL 1030272, at *4 (E.D. Pa. Apr. 19, 2006); Olsen v. Ford Motor Co., 521 F. Supp. 59, 70 (E.D. Pa. 1981). Warnings are not evidence of some sort of guilty knowledge – rather, they “indicate that Defendant was, if anything, attempting to minimize the risk of accidents through th[e] warning language,” which “cannot be considered recklessly indifferent.” Richetta v. Stanley Fastening Sytems, L.P., ___ F. Supp.2d ___, 2009 WL 2707549, at *10 (E.D. Pa. Aug. 21, 2009). A defendant may choose to warn rather than redesign a product. Id.

Thus, at least in Pennsylvania, punitive damages claims have been rejected as a matter of law in a number of cases involving FDA compliant drugs and medical devices. See Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 756 (E.D. Pa. 2007); Nelson v. Wyeth, 2007 WL 4261046 (C.P. Philadelphia Co. Dec. 5, 2007); Daniel v. Wyeth, 2007 WL 5528724 (C.P. Philadelphia Co. Apr. 23, 2007). Litigators in states that allow punitive damages on less proof should factor that into account in their trial and appellate strategy – especially since “reprehensibility” now has constitutional overtones – especially as to the amount of punitive damages that a jury can award.

Erichson On "All-Or-Nothing" Settlements

Professor Howard Erichson, of Fordham Law School, has posted on SSRN (here) and discussed at the Mass Tort Litigation Blog (here) his new paper, "The Trouble With All-Or-Nothing Settlements." Erichson's thesis is that defendants' demands for global peace in mass torts create ethical tensions.

The abstract describes the seven tensions:

"First, all-or-nothing settlements create client-client and lawyer-client conflicts of interest. Second, such settlements exacerbate problems concerning the allocation of settlement funds, including incentives to misallocate. Third, they create a risk of strategic hold-outs as savvy clients may attempt to extrt additional money by withholding consent. Fourth, they create an incentive for lawyers to keep settlement money in reserve as a slush fund to ensure full participation, leading to problems of misallocation and client deception. Fifth, they generate loyalty problems by pressuring lawyers to withdraw from representing non-settling clients. Sixth, they create special problems concerning clients’ informed consent to aggregate settlements. And seventh, they introduce a risk of collusion as the interest of plaintiffs’ counsel aligns with the defendant’s interest in getting every plaintiff to sign on to the deal."

Although the abstract doesn't make this clear, the text of the article correctly notes that those ethical tensions are all on the plaintiffs' side of the "v": The defendant demands global peace in a mass tort, and plaintiffs' counsel must then struggle with their ethical obligations.

(We struggled mightily with several versions of a concluding sentence to the preceding paragraph, and then decided that silence was the only was to control ourselves. We want a prize for self-restraint.)

Erichson's proposed solution is that parties might negotiate "most-or-nothing" settlements -- in which, say, 90% of mass tort claimants must participate -- to reduce these ethical tensions.

That's nice in theory, but much tougher in practice.

Defendants want global peace for good reasons. If defendants buy 90% peace, then the 90% of the plaintiffs with crappy claims take the dough, and the 10% of the plaintiffs with more legitimate cases choose not to participate. The settlement thus costs the defendant a lot of money, but it doesn't cure the headache.

Erichson would say, we assume, that the cost of the settlement should be much lower if it resolved only 90% of the claims (and none of the strong ones). And it should be. But defendants in mass torts are concerned only partly (and often only minimally) with sweeping away the chaff; they also want to identify, and deal with, the wheat.

We're going to think harder about Erichson's proposal. There's more to this than what we've written here, and we look forward to hearing what others have to say on this subject.

Poison Pill In Healthcare Bill

We're not the first to mention this, but we want to make sure our readers know. The recently released House version of the administration's healthcare reform package contains what is billed as pilot projects for "medical liability reform." It's a brief nod in the direction of the elephant in the room - limiting the incessant litigation that drives up the expense of every aspect of healthcare in this country, from the doctors, to the hospitals, to the EMTs, to the drugs and devices that patients use.

But this "incentive" project is really a poison pill for those states that have already enacted certain types of tort reform. It's §2531, slipped in at pp. 1431-33 of the almost 2000-page bill. The "incentives" for "alternative liability laws" in this section (which isn't even funded) are only available if "the law does not limit attorneys' fees or impose caps on damages." See §2531(a)(4)(B). In other words, states that cap either fees or damages need not apply - unless, of course, they first repeal their own reforms.

In short, these "incentives" are worse than nothing.

Beware of Congress bearing gifts (with apologies to Virgil and Laocoon).

Cleaning Up The Accutane MDL IBD Cases

Sometimes, we feel as though we're writing in code.

Take the headline of this post, for example, which talks about the Accutane MDL IBD cases.

So be it, we suppose: There's not a very good alternative.

Two years ago, Judge Moody, who's overseeing the Accutane MDL, granted Hoffman-La Roche Inc's motion to exclude plaintiffs' general causation expert who sought to link the ingestion of Accutane to inflammatory bowel disease, or "IBD." (Ever vigilant, we posted about that decision here.)

Last week, Judge Moody granted summary judgment dismissing the second group of cases in the IBD track. Here's a link, for the curious, although there's not much legal substance to Judge Moody's order. This ruling is more factually interesting than legally important.

The summary judgment ruling necessarily flowed from Judge Moody's earlier exclusion of the general causation expert. The plaintiffs had, however, filed a motion asking the court to defer ruling because of supposedly "newly discovered" evidence. The court rejected that argument, and this new ruling dismisses five of the cases that avoided dismissal in the first Daubert ruling.

This leaves only one IBD case pending against Roche in the Accutane MDL.

We can hear the fat lady warming up.

Three Things Around The Web

1. Although it happened last week, we just saw that the Department of Justice has again indicted individual officers of a device company for allegedly having participated in an illegal marketing scheme. This time, it's the former president of Stryker Biotech. Here's a link to the DoJ's press release, and to coverage of the story at the In Vivo Blog. That turns up the heat pretty high at drug and device companies.

2. Pharmalot, which was a great blog covering the sandbox in which we play, had gone silent back in January. We're pleased to report that Pharmalot is back! Here's a link for the curious, and we've again put Pharmalot in our blog roll over there in the right-hand column.

3. It's funny as is, but it would have been better if it said "Iq'ed in the Bals."

More on Mousepads

We must be pretty poor bloggers. Our throwaway piece on there not being mousepads in hotel rooms drew (for us) a record 3500+ hits last Friday, courtesy of links from Above the Law and Instapundit. That's second only to Wyeth v. Levine. And it generated over 1000 hits on Saturday and another 800+ on Sunday - both records for those days of the week.

Newsflash: more people care about mousepads than about drug and medical device product liability litigation. What does that say about what we do for a living? About our chosen topic? About us? Don't answer that last one - we get enough comments along those lines from our families and coworkers (we won't even mention our friends).

We also got 27 comments - also a record. Most fell into three categories. The first (at least we'll put it first) agreed with us and thought we were right to call the hospitality industry to task for not providing mousepads for guests with computers. Why inconvenience your guests?

Not too many of those, though.

The second group thought we were just annoying whiners, and that we should suck it up and carry mousepads with us. Well, most of the time we do, but sometimes we're cheap and use firm-issued laptops, and these aren't standard equipment. But why should we? The same proposition applies to coat hangers, soap - heck, even toilet paper. It's the "hospitality" industry - not the rooming industry. They're supposed to be hospitable, aren't they? They provide "free" (yeah, we know, that means part of overhead - just like "free" Internet service itself) hair dryers, shower caps, shoe shining (some places), stationery, etc. Why not mousepads?

A third group criticized us as technicological slackers for even using computer mouses (mice?) that need friction to operate. Get an optical mouse, or a trackball, they say. As for them - we don't care. The mouse in use at the moment in preparing this post has a little red light on the bottom; what does that mean it is? We've proudly proclaimed ourselves to be the blogging Luddites already. Heck, we just got used to broadband. As far as we're concerned, critics of that ilk can take their optical mice and run them all they want on the glass tabletops in their hotel rooms.

Finally, one comment seems to advocate a government mandate. That's silly. Between healthcare reform, the economy, global warming, Afghanistan, and lots of other things, the government has plenty to keep it busy right now. We advocate just the opposite - that some smart hotelier will get a competitive edge by providing customers with mousepads with their logos (and contact information, of course) on them - and even encourage their guests to take them with them on their travels.

That's free enterprise, and we suspect, good business.

Shook Hardy's Asleep At The Wheel

We have rules at this blog: We don't criticize drug and device companies, and we don't criticize defense law firms.

But we're making an exception here, and we bet you can understand why: Shook Hardy won an interesting case last week involving the sleeping pill Ambien. More than a dozen folks from Shook Hardy subscribe to this blog. Yet none of those subscribers told us about the firm's victory! We learned about the Ambien decision only when we read about it on the AmLaw Litigation Daily.

Hence our headline: "Shook Hardy's Asleep At The Wheel." And hence too this public shaming: In the future, we expect to hear about Shook Hardy's great victories promptly, and from folks at Shook Hardy. Got that, guys?

Okay, on to business.

On March 12, 2006, Darlene Gibson took an Ambien sleeping pill at about 7:30 at night. Gibson v. Sanofi-Aventis U.S., No. 3:07CV-192-S, slip op. (W.D. Ky. Oct. 27, 2009) (link here, courtesy of AmLaw Lit Daily). Gibson then "applied a cosmetic facial mud mask and put curlers in her hair." Id. at 2 (although, we must admit, this is really more than we care to know). At 8:19, dressed for bed and still wearing her mud mask and curlers, and without wearing her eyeglasses, she crashed her car into a utility pole a mile from her home. Id. Gibson's physician at the hospital said that Gibson had decided to drive herself to the hospital for cardiac symptoms and had fallen asleep at the wheel because she had popped a sleeping pill (or maybe two) before she got in the car. Id. Gibson, on the other hand, blamed Sanofi-Aventis, saying that she had been engaged in involuntary "sleep-driving." Id. at 3.

The package insert for Ambien was pretty good for the defense. It listed somnambulism as a rare event. It warned to "use extreme care while doing anything that requires complete alertness such as driving a car." Id. at 4. And it instructed: "You should only take Ambien right before going to bed." Id.

On the other hand, after Gibson's accident, a March 2007 "Dear Doctor" letter told physicians that Ambien's labeling had been revised, at the FDA's initiative, to include a precaution for patients about reported incidents of "sleep-driving." Id.

Plaintiff's experts, however, appear to have been asleep at the wheel. Neither one of them "were asked to render nor were they rendering opinions concerning the adequacy of the warning in the Ambien labeling at the time of the accident." Id. at 5-6. And the FDA's decision to revise the labeling in 2007 "does not alone establish inadequacy in the prior labeling." Id. at 6. (Nice quote there. Make a mental note of it for later use.)

Gibson's prescribing physician testified "that she would have prescribed Ambien for Gibson under either version of the Ambien labeling." Id. And Gibson herself never read any product materials that accompanied her Ambien prescription. Id. The failure-to-warn claim thus failed.

Additionally, Gibson failed to establish "but for" causation, because she did not "rule out all other possible causes of the accident but the alleged involuntary act." Id. When Gibson arrived at the hospital, she said that she had tried to drive herself to the hospital because she was experiencing chest pain and shortness of breath. If that were true, then her accident was not caused by "sleep-driving." Because multiple causes of the accident were possible, Gibson could not blame sleep-driving for her accident under the doctrine of res ipsa loquitur. Id. at 7.

That's a pretty good decision, but it gets better. The court went on to exclude Gibson's expert reports under Daubert. Her expert reports said that it was "medically probable" or "highly probable" that her accident was caused by sleep-driving. But "there are no clinical studies linking the ingestion of Ambien to the behavior of sleep-driving." Id. at 8. And the experts based their conclusions only on "anecdotal reports of a number of other 'sleep-driving' experiences." Id. "There is nothing 'expert' about such a conclusion," so as to require expert testimony, and the opinion that Gibson was sleep-driving was "sheer speculation void of any scientific basis." Id.

The court thus granted summary judgment in favor of Sanofi-Aventis.

Nice work, Shook Hardy -- except for the failure to let us know about this decision promptly. We're giving you an "A" for legal work, but an "F" for reportage. We don't expect this to happen again.

Friday Frivolity

It's not a big deal, but why does this happen?

We've been on the road a lot recently, so we've stayed in a lot of hotels. We've stayed in fancy hotels (the del Coronado in San Diego and the Hay-Adams in DC) and we've stayed in Holiday Inn Expresses in little towns.

We're bloggers. That means we carry our laptops with us when we travel.

The internet access at hotels has been generally improving. It's usually free, now - a change from even just a year ago. The hotels are also doing better with the hardware (plugs and ethernet cable connections) than they used to.

But no mouse pads.

Almost every hotel we've stayed at provides us some sort of glass-topped desk. That's fine, except that kind of surface doesn't generate enough friction to work a computer mouse very well.

We need mouse pads. We've used newspapers, magazines, room service menus, etc. to get suitable friction.

We wonder if our readers share our frustrations. It would be so easy for hotels to supply mouse pads in their rooms - they could even put their logos on them.

So this is a plea, and a question, to all you hoteliers out there. Help us out here. If you're going to provide internet access, and a glass-topped table for our computers, please stick a mousepad in the desk drawer along with the Gideons and the stationery.

End of rant.

Two Items On The Web Worth Reading

Now that our birthday celebration is behind us, it's back to work.

Consider taking a look at these two items recently posted on other blogs:

First, the Civil Procedure & Federal Courts Blog collects in one place scholarship analyzing the Supreme Court's decision in Wyeth v. Levine. Whether or not you have a taste for scholarship generally, if you play in our sandbox, you should be aware of that literature.

Second, Point of Law collects in one place the abstracts of three papers discussing whether third parties should be permitted to finance litigation. That was once called "champerty;" today, it's called "business as usual."

Wait! That was a joke! If one of us is ever opposing you in litigation, we believe that having a third party finance your litigation -- whether litigation costs, attorneys' fees, or expert witness fees -- is probably wrong, and we are not waiving our rights in that regard by publishing this blog post. (See? Three years of blogging and we've turned paranoid. What will we look like at four?)

Three At Last, Three At Last!

Thank God Almighty, we're three at last!

The two of us -- Beck and Herrmann, the blogging fools -- started the Drug and Device Law Blog three years ago today, on October 30, 2006.

Here's how we celebrated on October 30, 2007.

We turned philosophical on October 30, 2008.

And today, at three, we're just old.

Here's how old:

1042 posts.

Nearly 500 readers subscribing by our Google group (that is, by typing their e-mail addresses in the blank over in the right-hand column of the blog).

Just north of 250 subscribing by RSS feeds. (That's "really simple syndication," although it doesn't seem so simple to us. If you don't understand RSS feeds, we're surely not the ones to explain.)

Roughly 350 subscribing by Twitter. (They receive only the headlines of our posts and must then choose to read the bodies.)

And 20,000 to 30,000 more pageviews each month from non-subscribers who just come to take a look.

We can no longer tell how many folks have visited our blog, because people who subscribe by the Google group (and thus receive every post by e-mail) don't show up in the tracking system. But we've surely had more than 600,000 pageviews since we started this gig, and it's possible we're pretty far north of that figure.

That's many more readers than we anticipated would come when we started typing three years ago, and we're gratified by the response.

We particularly appreciate the many folks who contact us off-line to pass on breaking news, share strategies, and otherwise help us to keep our ears close to the ground. (With our ears on the ground and our fingers on the keyboard, we're a sight to be seen.)

Thanks for visiting -- and have a piece of cake, on us!

Sprint Fidelis - It's Not Just Preemption

The other day, we did a quickie post on the state court Sprint Fidelis win for Medtronic here, as soon as we got it. If you're a subscriber then that's where you probably learned about the case, since we were first on the Internet with it.

Today, we’re going to look at certain aspects of the decision (now also available at 2009 WL 3417867). Specifically, we want to go over the non-preemption aspects of the decision.

Why? you ask. Aren’t we supposed to be “all preemption, all the time”?

Well – no. For one thing, as we mentioned in the quickie post, the state court Sprint Fidelis preemption analysis largely tracked the earlier federal court decision on the same subject. In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009). We already analyzed that preemption analysis at quite some length, here, shortly after the federal decision came down. Except for citing some newer precedent, most notably Covert v. Stryker Corp., ___ F. Supp.2d ___, 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) (which we told you about here), it’s not so much different on preemption to warrant a new long post on that subject.

Second, since the Supreme Court has decided the basic preemption framework for both drugs and devices, there’ve been other things in the drug/device universe than the FDA and preemption.

Like Twombly/Iqbal, for instance?

Yeah, that’s a good start. Maybe we’ll become all pleading all the time.

Anyway, one of the more interesting things that we noticed in what we’ll call “state Sprint Fidelis” or SSF for short, is footnote 9 (slip op. pp. 16-17). It’s not even about anything the court decides.

So what’s up?

Footnote 9 contains news we didn’t know – specifically that the Minnesota Supreme Court has a pending appeal in which it will consider whether to interpret the Minnesota state version of Fed. R. Civ. P. 8 in accordance with Bell Atlantic v. Twombly, 550 U.S. 544 (2007). We don’t know how that Minnesota appeal (having nothing to do with drugs/devices) will turn out, but just the fact that it exists points to an important issue:

A lot of states’ rules of civil procedure mirror the federal rules. Thus, these states could – although they don’t have to – apply the Supreme Court’s improved pleading standards to their own state court litigation. As good as Twombly/Iqbal is, our clients face at least as many (and often more) suits in state court as in federal court. We'd like for Twombly/Iqbal to apply in state court, too.

Being the compulsive types we are, we decided to see if there were any states where any appellate court had adopted Twombly/Iqbal. We're in luck. There are some.

In addition to the Minnesota intermediate appellate court decision now under review, Bahr v. Capella University, 765 N.W.2d 428, 437 (Minn. App. 2009), Twombly/Iqbal has made inroads in several other states.

Most notably, the Supreme Judicial Court in Massachusetts specifically “t[oo]k[] the opportunity to adopt the refinement” to the pleading standards that Twombly enunciated:

We agree with the Supreme Court's analysis of the Conley language. . ., and we follow the Court’s lead in retiring its use. The clarified standard for rule 12(b)(6) motions adopted here will apply to any amended complaint that the plaintiffs may file.

Iannacchino v. Ford Motor Co., 888 N.E.2d 879, 890 (2008). That’s one.

The South Dakota Supreme Court has also followed Twombly/Iqbal. See Gruhlke v. Sioux Empire Federal Credit Union, Inc., 756 N.W.2d 399, 409 (S.D. 2008); Sisney v. State, 754 N.W.2d 639, 643 (S.D. 2008); Sisney v. Best, 754 N.W.2d 804, 80809 (S.D. 2008) (“adopt[ing] the Supreme Court’s new standards”). That’s two.

The Maine Supreme Court, noting that the state’s relevant rule was “practically identical” to Fed. R. Civ. P. 8, followed Twombly in Bean v. Cummings, 939 A.2d 676, 680 ¶ 10 (Me. 2008). That’s three.

And, perhaps reflecting its federal roots, the highest court in the District of Columbia has applied Twombly/Iqbal pleading standards several times, in Murray v. Motorola, Inc., ___ A.2d ___, 2009 WL 3459991, at *_ & n. 32(D.C. Oct. 29, 2009) (that’s today folks – presumably why there’s no page number); Grayson v. AT & T Corp., ___ A.2d ___, 2009 WL 2957812, at *4 nn.16-21 (D.C. 2009), and Clampitt v. American University, 957 A.2d 23, 29 (D.C. 2008). That’s four.

The Georgia Supreme Court cited Twombly with approval in Charles H. Wesley Education Foundation, Inc. v. State Election Board, 654 S.E.2d 127, 132 n.7 (Ga. 2007). That may be five, but we haven’t seen anything since out of the Peach State on this subject, so we’re reluctant to call that one on the basis of a single footnote.

Intermediate appellate courts in some other states also have followed Twombly/Iqbal. In Tennessee, the Middle Division of the state’s intermediate appellate court found Twombly “consistent with” state law, and therefore followed it, in Hermosa Holdings, Inc. v. Mid Tennessee Bone and Joint Clinic, P.C., 2009 WL 711125, at *3 (Tenn. App. Mar. 16, 2009). It’s kept it up ever since: Western Express, Inc. v. Brentwood Services, Inc., 2009 WL 3448747, at *9-10 (Tenn. App. Oct. 26, 2009); Deja Vu, Inc. v. Metropolitan Government, 2009 WL 3270195, at *5 (Tenn. App. Oct. 12, 2009). A Louisiana appellate court adopted Twombly in a state antitrust action in Tuban Petroleum, L.L.C. v. SIARC, Inc., 11 So.3d 519, 523 (La. App. 2009). Ohio joined the parade in Gallo v. Westfield National Insurance Co., 2009 WL 625522, at *2 ¶9 (Ohio App. Mar. 12, 2009), applying several aspects of the Twombly pleading standards.

All in all, we're pleasantly surprised by the degree of acceptance of Twombly/Iqbal by state courts. On the merits, significantly more states have adopted it than have declined. Indeed, almost all of the state courts not following the new federal standard have done so only because they were intermediate courts, and the existing standard were set by their supreme court’s interpretation of the state’s equivalent to Rule 8 (usually following Conley), which they were obliged to follow.

Anyway, that’s one interesting non-preemption point raised in SSF. There are others relating to violation claims that bear discussion.

On page 40 of the SSF slip opinion, the court addressed a claim that, supposedly, the defendant violated some FDA regulation that required it to submit a supplemental PMA application for each and every modification to the device, no matter how trivial. After holding that there was no such regulation, the court said something else of interest: “claims predicated upon the alleged failure to submit PMA Supplements do not seek to enforce any common-law duty.” Id.; see also id. at 42 n.28.

That’s important not only as a statement of a preemption principle (that a claim isn’t “parallel” if there’s no analogous state law claim), but also as an interpretation of the common law itself. The common-law principle is that mere lack of a government-mandated license does not create a common-law “violation” claim for all injuries suffered by anyone as a result of the defendant’s unlicensed activities. This comes up most often where unlicensed auto drivers are sued. Failure to have a license does not make non-negligent driving into a tort.

Before most of our readers had ever heard of us, we discussed this proposition at more length in one of our earlier posts on “Defenses to FDCA-Based Negligence Per Se.” We’re glad (but not surprised) to see that Medtronic recognized and raised the licensing point as an alternative, non-preemption based way of disposing of this sort of allegation. It's an argument we've been trying to popularize ever since we more or less invented it (in the FDCA context) in the Bone Screw litigation.

For a complete discussion of why failure to obtain FDA approval – the equivalent of an FDA license to market a particular product – isn’t a valid claim under state law, we invite you to take a look at that earlier post. Another good post to review is here, where we discuss Iacangelo v. Georgetown University, 595 F. Supp.2d 87 (D.D.C. 2009), which holds quite explicitly that:

As a result, it is no more logical to infer a causal connection between [the drugs’] unapproved status and [plaintiff’s] injuries than it is to infer a causal connection between a driver’s lack of a drivers license and injuries he causes while driving.

Id. at 93.

Additional (non-drug/device) cases for the proposition that mere failure to have a government license does not establish negligence per se as to injuries suffered as a result of the unlicensed activity include: Cousin v. Enterprise Leasing Company-South Central, Inc., 948 So.2d 1287, 1290 (Miss. 2007) (driver’s license); State v. LaFlam, 965 A.2d 519, 522-23 (Vt. 2008) (commercial driver’s license); Mousseau v. Schwartz, 756 N.W.2d 345, 352-53 (S.D. 2008) (medical license); Florida Marine Transporters, Inc. v. Sanford, 255 Fed. Appx. 885, 888 (5th Cir. 2007) (admiralty law) (shipmaster’s license); State v. Smith, 771 N.W.2d 151, 155 (Neb. App. 2009) (child care facility license); West v. Levee Lift, Inc., 2009 WL 2192746, at *5 (Ky. App. July 24, 2009) (driver’s license); Vanalkemade v. Hitsman, 2009 WL 1864055, at *4 (Ohio App. June 30, 2009) (commercial driver’s license); Bell v. American Traffic Solutions, Inc., 633 F. Supp.2d 305, 314-15 (N.D. Tex. 2009) (investigator’s license); Garrett v. Land West Ventures, Inc., 2007 WL 2071615, at *3-4 (D. Colo. July 19, 2007);. All of these cases have been decided since our January, 2007 post on this subject.

So the second point that defense counsel should draw from SSF is that you don’t need preemption to beat a negligence per se/violation claim where the claim is based on an allegation that the product did not have the necessary FDA approval. That kind of claim fails for separate, independent reasons of state law: a defendant doesn’t commit a tort just because it doesn’t have a license required by the government – including the FDA.

Our third interesting non-preemption point gleaned from SSF is on page 42 of the slip opinion, where the court states: “Where a statute expressly precludes a private right of action to enforce its provisions, litigants cannot avoid these limits by crafting negligence per se claims for violation of the statutory scheme.” This is yet another way to defeat negligence per se claims without preemption. Many states – not all, but a lot – do not permit negligence per se claims where doing so would be contrary to the intent of the legislature. Since Congress specifically stated, in the FDCA (21 U.S.C. §337(a)), that only the government could enforce it, negligence per se claims cannot lie due to their conflict with congressional intent. E.g., Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1231 (D. Nev. 2009).

Again we're proselytizers on this, since it's something else we invented in Bone Screw. Legislative intent is another of the state law defenses to negligence per se that we discussed at length in the early 2007 post. SSF is important as another case recognizing this defense specifically in the FDCA context.

As the previous post explains in great detail, conflict with legislative intent is a defense to negligence per se that isn’t found in the black letter law of the Second Restatement of Torts. It’s out there, though, in the law of most states. Here are some more cases that have been decided on this point since our January, 2007 post: Lombard v. Colorado Outdoor Education Center, Inc., 187 P.3d 565, 574 (Colo. 2008) (premises liability statute); P.S. v. San Bernardino City Unified School District, 94 Cal.Rptr.3d 788, 793 (Cal. App. 2009) (child abuse reporting statute); Young v. Carran, 289 S.W.3d 586, 589 (Ky. App. 2008) (HIPAA); In re Carter, 653 S.E.2d 860, 866-67 (Ga. App. 2007) (sickle cell anemia reporting statute); Chilcutt v. Ford Motor Co., ___ F. Supp.2d ___, 2009 WL 3259418, at *6 (S.D. Ohio Oct. 7, 2009) (OSHA); Deacon v. Metro North Railroad Co., 2009 WL 3059128, at *4-5 (D. Conn. Sept. 22, 2009) (OSHA); Mazzeo v. Gibbons, ___ F. Supp.2d ___, 2009 WL 1872978, at *14-15 (D. Nev. June 29, 2009) (various statutes criminalizing assault); Lee v. K&P Brothers, Inc., 2008 WL 839791, at *1-2 (N.D. Ohio March 27, 2008) (false imprisonment statute); Innis Arden Golf Club v. Pitney Bowes, Inc., 514 F. Supp.2d 328, 335-36 (D. Conn. 2007) (state water pollution statute); Garrett v. Land West Ventures, Inc., 2007 WL 2071615, at *3 (D. Colo. July 19, 2007) (federal firearms statute). Every one of these cases holds, with respect to whatever statute is at issue, that because the legislature didn't intend for there to be private claims, negligence per se is precluded as a matter of law.

SSF demonstrates that the legislative intent argument can be a winner with or without preemption. SSF also demonstrates that savvy defense counsel raise this argument when they’re dealing with FDCA-based negligence per se claims. All readers should make sure to have this arrow in their quivers the next time they confront one of these. In other words, don’t be like the defense lawyers, here.