We haven’t heard the folks on the other side say it much, since ATRA’s pretty much taken over squatter’s rights to the phrase “Hellhole Jurisdiction,” but if they listed theirs, we suspect that Michigan would be right up there at the top of their list – at least where prescription drug product liability litigation is concerned. The reason is Michigan’s statutory presumption of adequacy for FDA-approved warnings:
In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .
Mich. Comp. Laws Ann. §600.2946(5). There are three exceptions to this otherwise conclusive presumption, but two of them – sale of a drug after a recall, and bribery of FDA personnel – are vanishingly rare, and the third, fraud on the FDA, has been held preempted by both Michigan state and federal courts. Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003); Duronio v. Merck & Co., 2006 WL 16285165 (Mich. App. June 13, 2006) (unpublished); Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004); White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023 (W.D. Mich. 2008); Zammit v. Shire US, Inc., 415 F. Supp.2d 760 (E.D. Mich. 2006).
Thus, for all intents and purposes, if a drug complies with the terms of the FDA’s approval and bears the FDA’s approved labeling, that drug isn’t defective or unreasonably dangerous and the defense wins. If only every other state were that straightforward.
But they’re not.
So you can imagine (when we’re done, you won’t have to) that just like plaintiffs try every trick in the book to forum shop defendants into their favorite hellholes, Michigan plaintiffs have tried every trick in the book to flee their home state for somewhere – anywhere – else. We’re happy to report that most of the time they haven’t been successful in avoiding Michigan law.
They came closest in Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767 (N.J. 2007), where a Michigan resident plaintiff brought suit in the courts of the defendant manufacturer’s principal place of business – New Jersey. The trial judge in Rowe did the right thing and applied the law of the plaintiff’s state of residence, but an intermediate appellate court reversed on the ground, essentially, that “New Jersey likes plaintiffs.” Rowe v. Hoffmann-La Roche Inc., 892 A.2d 694, 705 (N.J. Super. A.D. 2006) (citing “New Jersey’s strong interest in encouraging the manufacture and distribution of safe products and, conversely, in deterring the manufacture and distribution of unsafe products within the state”); id. at 709 (citing a “strong governmental interest in deterring the manufacture of unsafe products within [New Jersey’s] borders” and an “interest” in “compensation”).
The New Jersey Supreme Court – in one of those decisions that signified the state’s retreat from hellhole status – reversed. The court held that a Michigan resident who took a drug in Michigan prescribed by a Michigan doctor had no expectation of the application of any law other than Michigan’s, particularly since that plaintiff had never set foot in New Jersey. Under New Jersey’s “flexible governmental interest analysis,” no other result maintained the comity between the states:
[C]omity precludes closing our eyes to Michigan’s interest. . . . The question is not whether Michigan or New Jersey passed the better law; that is a normative judgment best suited for the legislative process. . . . To allow a life-long Michigan resident who received a FDA-approved drug in Michigan and alleges injuries sustained in Michigan to by-pass his own state’s law and obtain compensation for his injuries in this State’s courts completely undercuts Michigan’s interests, while overvaluing our true interest in this litigation.
Rowe, 917 A.2d at 776 (various citations omitted). Michigan’s legislative concern “that unlimited liability for drug manufacturers could add substantially to the cost and unavailability of many drugs” could not be ignored by pro-plaintiff New Jersey courts. Id. at 775 (quoting Garcia, 385 F.3d at 967). Thus, in the context of prescription drugs at least, the blather that allowing out-of-state plaintiffs to get around their home states’ legal restrictions so as to “encourage manufacture of safe products” by New Jersey companies was inoperative.
The court also corrected the lower court’s error of interpreting in favor of plaintiffs a similar non-conclusive New Jersey statutory FDA compliance presumption of adequacy. That didn’t warrant applying New Jersey law because, like Michigan, the New Jersey statute had been enacted to limit manufacturer liability. To cite it as an excuse for broadening liability stood the intent of both the New Jersey and Michigan legislatures on their heads::
The predominant object of the law is not to encourage tort recoveries by plaintiffs, whether New Jersey citizens or not, in order to deter this State’s drug manufacturers. On the contrary, the law limits the liability of manufacturers of FDA-approved products by reducing the burden placed on them by product liability litigation. . . . New Jersey’s interest in applying its law to [plaintiff’s] failure-to-warn issue, when properly discerned, is not antithetical to Michigan’s interest but substantially congruent.
917 A.2d at 774 (more citations omitted).
The role of the FDA – the basis for both the Michigan and New Jersey presumptions – was also important. Because of the FDA’s role in regulating drug manufacturers and the safety of their products, any state’s interest in doing the same through tort actions was correspondingly reduced:
The [New Jersey statute] impliedly accepts that the presumption of adequacy will not be rebutted in all cases. It accepts FDA regulation as sufficient, at least in part, to deter New Jersey pharmaceutical companies from manufacturing unsafe prescription drugs. . . . The Legislature also provides . . . that FDA approval of prescription drugs conclusively prohibits an award of punitive damages in products liability actions. This provision, along with the rebuttable-presumption . . . cede to FDA regulation some of this State’s interest in policing local pharmaceutical manufacturers, thereby reducing New Jersey’s interest in applying its law to this case.
In Devore v. Pfizer, Inc., 867 N.Y.S.2d 425 (N.Y.A.D. 2008), some Lipitor plaintiffs tried the same stunt in litigation against Pfizer, a New York headquartered company. Notably New York did not have a statutory presumption of the sort that figured in the New Jersey Howe decision. Still, the court applied New York’s “interest analysis” approach to conflict of law – telling Michigan plaintiffs, in effect, “you can run, but you can’t hide” from the law of their residence. A “conduct regulating” statute, like the Michigan presumption, should apply to residents of the state enacting the statute:
The Michigan statute in question, since it in effect dictates the standard of care required for a product liability claim against a pharmaceutical company falls within the category of conduct-regulating rather than loss-allocating. When the purpose of the statute is to regulate conduct, the law of the jurisdiction where the tort occurred will generally apply because that jurisdiction has the greatest interest in regulating behavior within its borders. The locus of a tort is generally defined as the place of the injury.
867 N.Y.S.2d at 427-28. Michigan “ha[d] far greater significant contacts” since the plaintiffs lived there and suffered injury there. Id. at 428. Not only that, but the policy of the Michigan law was entitled to deference:
[W]e must recognize that the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability, and its interests in protecting the reasonable expectations of the parties who relied on it to govern their primary conduct and in the admonitory effect that applying its law will have on similar conduct in the future assume critical importance and outweigh any interests of New York State.
Id. Accord Norris v. Pfizer, Inc., 2007 WL 969431 (N.Y. Sup. March 14, 2007) (reaching same result in another Michigan Lipitor case) (unpublished, in table at 839 N.Y.S.2d 434).
New York and New Jersey follow Restatement-based interest balancing in deciding choice of law questions. Indiana – another state to which Michigan plaintiffs fled – does not. That did not change the result, however, in Alli v. Eli Lilly & Co., 854 N.E.2d 372 (Ind. App. 2006). Indeed, the “traditional lex loci delicti rule – the place of the wrong-will apply” is if anything even more conducive to making sure that Michigan plaintiffs can’t forum-shop their way around their home state’s law. The court swatted aside the plaintiff’s claim that the Michigan conclusive presumption was “procedural.” Id. at 378. A statute designed to confer immunity from suit could not possibly be construed as anything other than substantive:
[T]he statute is not procedural. . . . [It] is an immunity statute that has been interpreted by the highest court in Michigan as a legislative determination as a matter of law of when a manufacturer or seller of a prescription drug has acted sufficiently reasonably, solely for the purpose of defining the limits of a cognizable products liability claim under Michigan law. As such, [the statute] is plainly substantive law.
Id. (quoting Taylor, 658 N.W.2d at 137).
The lex loci rule dictated application of the plaintiff’s state of residence in Alli, since: (1) the “last act” necessary to the cause of action – the plaintiff’s injury – occurred there, (2) there was a substantial “connection” to the legal action, since the medical treatment involving the defendant’s drug occurred there; and (3) “public policy” was not offended by applying the Michigan act, there being “nothing immoral, unnatural, unjust, or prejudicial to the general interests of the citizens of Indiana” about Michigan deciding to confer immunity upon drug manufacturers where there has been compliance with FDA regulations.” 854 N.E.2d at 378-80.
Federal courts forced by forum-shopping Michigan plaintiffs to make choice of law determinations have come out in the same way. In In re Prempro Products Liability Litigation, 2008 WL 1699211 (E.D. Ark. April 9, 2008), the court applied Illinois choice of law principles. Why? Because in MDL situations like Prempro the choice of law rules of the transferor court (where the action was originally filed) remain applicable no matter where the MDL court itself happens to be located. Under Illinois interest analysis, Michigan law applied to plaintiffs who “purchased the product in Michigan, used it in Michigan, and w[ere] injured in Michigan.” Id. at *3. The place of injury could hardly be called “fortuitous.” Id. Where, as in Prempro neither plaintiff nor defendant resided in the forum state, that factor was “a wash.” Id. The “center” of the parties’ relationship in a product liability case “is where the plaintiff used the product,” Michigan. Id. Even assuming that the “conduct occurred” in the defendant’s principal place of business, that fact could not outweigh all of the other Michigan contacts. Id. at *3-4.
Likewise in Henderson v. Merck & Co., 2005 WL 2600220 (E.D. Pa. Oct. 11, 2005), Michigan law was applied to a Michigan plaintiff’s Bextra-related claims (Vioxx claims were transferred to an MDL elsewhere). The court applied Pennsylvania’s interest-analysis-based choice of law principles. The plaintiff tried to get some law – any law – other than Michigan to apply, asserting that “Pennsylvania, New York, New Jersey, or Delaware law should apply” because to Michigan supposedly “lack[ed] an interest in the imposition of its law against out-of-state drug manufacturers.” Id. at *3. The various defendants were headquartered in one or the other of these four states. The court found both actual and true conflicts, which necessitated choice of law analysis. Id. at *4-7. Michigan law applied because: (1) plaintiff lived there; (2) the drug was prescribed there; (3) any reliance on inadequate information occurred there, and (4) plaintiff’s injuries occurred there. Id. at *7.
Based upon these contacts, the Court finds that Michigan has a strong interest in applying its law to ensure that Michigan residents, including plaintiff, are not burdened with excessively high payments for prescription drugs, indeed, that such drugs remain financially available for all Michigan citizens, even if that means immunizing non-resident pharmaceutical companies who do business in Michigan from product-related claims brought by a Michigan resident for injuries suffered in Michigan.
Id. The “importance” of principal place of business as a contact was “diluted by the fact that the remaining relevant events took place in Michigan,” and therefore any states’ interests “in applying their product liability laws to such extraterritorial conduct lose vigor.” Id. at *8. Thus:
Michigan has the greatest interest in applying its product liability laws to injuries suffered in Michigan by a Michigan resident based upon the sale, prescription, and consumption of a pharmaceutical drug in Michigan. This determination comports with the expectations of the parties and the policies of all interested states.
Id. Reconsideration was denied in Henderson in 2005 WL 2864752 (E.D. Pa. Oct. 31, 2005), but plaintiffs did not revisit the choice of law ruling.
The only case going even somewhat the other way, Stupak v. Hoffman-La Roche, Inc., 287 F. Supp.2d 968 (E.D. Wis. 2003), did not involve principal place of business as the asserted contrary state interest. Rather, the plaintiff, although a resident of Michigan, had gone to Wisconsin for medical treatment and had been prescribed the drug by a Wisconsin physician. Id. at 971. Wisconsin had a peculiar (and possibly unconstitutional) choice of law rule that “the law of the forum should presumptively apply.” Id. at 970. Because the plaintiff also brought malpractice claims against the Wisconsin physician, and it would have been difficult to apply different tort reform statutes to different defendants, the court in Stupak elected to apply Wisconsin, rather than Michigan law, although the Michigan plaintiff purchased, used, and was injured by the drug in Michigan. Id. at 972-74. The most important interest, the Stupak court held, was Wisconsin’s interest in the adjudication of malpractice claims against a Wisconsin physician. Id. at 973-74.
Most plaintiffs treat with physicians in their home states. Further, most plaintiffs who sue drug companies don’t sue their physicians for malpractice, since that only alienates the prescriber as a witness in the product liability claim. So aside from the peculiar Stupak case (which remains unique), it appears that defendants have been able to corral Michigan plaintiffs with Michigan law, even when (as is frequent) they attempt to flee their home state in search of a more friendly forum.
Now, if we could only convince the other 49 states to follow Michigan’s lead.