Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida. True, Justified was set in Kentucky. But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first, I shot him”), and the big criminal organization he often contended with hailed from Detroit. Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida. Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt.
There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania. We live in Pennsylvania. Our courts and laws seem inordinately fond of drug and device law plaintiffs. By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours.
Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law. In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015). The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence. The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents. The plaintiffs disagreed. They needed Pennsylvania law to apply, otherwise they would lose.
Michigan’s Product Liability Act is a thing of beauty. Behold its splendor and majesty: "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 for safety and efficacy by the United States food and drug administration,and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller." Mich. Comp. Laws § 600.2946(5). Like a supermodel with a mole, the Michigan law possesses an imperfection that almost enhances its beauty. The Act contains two exceptions to this blanket immunity granted to drug manufacturers. First, a drug manufacturer will not be immune if it “intentionally withholds from or misrepresents” information from the FDA, whereas the provision of such information would have either prevented FDA approval to begin with or would have prompted the FDA to withdraw approval. Second, bribery of an FDA official would call off the immunity.
Pennsylvania law is not quite as good. Or let’s put that a different way. If the Michigan law is the Mona Lisa of American product liability law, Pennsylvania’s version is more like an episode of Bowling for Furniture, or a YouTube cat video. Let’s leave it at this: there is a conflict of laws.
We know which law we would apply. And, happily, the Pennsylvania court agreed. Pennsylvania’s choice of law rule combines the approach of the Restatement (Second) on Conflicts of Law and the interests of the state analysis. Michigan was the place of alleged injury for each of these cases. The conduct causing the injury occurred in both Michigan, where the plaintiffs and their prescribing physicians received any misrepresentation regarding Risperdal and where the plaintiffs were prescribed, purchased, ingested and allegedly injured by the drug, and Pennsylvania, where one of the defendants was alleged to have concealed material information regarding the safety of Risperdal. A review of the legislative history of Michigan Products Liability Act shows that it was passed for the express purpose of limiting the liability of drug manufacturers. By contrast – and here we confess to being almost amazed that our local court had such a moment of enlightenment, Pennsylvania has no interest in becoming “a repository for cases filed by Michigan residents seeking to avoid application of the Michigan Products Liability Act.” Even if the Michigan Product Liability Act seems “harsh” (that was the word the Philly court used; we prefer “sound,” “logical,” “lovely,” or “calipygian”) it governs the case of these Michigan plaintiffs.
So, saddled with the law of the jurisdiction where they live, vote, and root for the hapless Lions, the plaintiffs presented three arguments why the Products Liability Act does not apply. First, they argued that Risperdal was not, in fact, approved for safety and efficacy by the FDA because its label did not contain an indication for adolescent use. Second, the plaintiffs argued that they met the first exception to the Products Liability Act because the defendants withheld information from the FDA and a question of fact existed as to whether Risperdal would have been approved, or maintained its approval, if the withheld information had been supplied to the FDA. Finally, the plaintiffs argued that a prior guilty plea by one of the defendants was tantamount to a federal finding of fraud on the FDA.
Each one of those arguments was a swing and a miss – something seen often this season with the surprisingly crummy American League Detroit baseball franchise. First, a physician’s decision to use a pharmaceutical for an “off-label” purpose is not only an acceptable practice, but also “an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” The “off-label” use did not somehow render the label unapproved. Second, the issue of whether the defendant lied to the FDA in getting its label opens up once more the issue of whether such an exception is preempted by Buckman. The Michigan state courts have not yet addressed the issue of whether § 600.29(5)(a) is preempted by the FDCA. As we have mentioned many times before, the federal courts are split on the preemption issue. The Sixth Circuit, which includes the federal courts in Michigan, decided that § 600.29(5)(a) is implicitly preempted. Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir., 2004). Conversely, the Second Circuit went the other -- that is, wrong – way. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2nd Cir., 2007), aff’d by an equally divided court sub nom, Warner-Lambert Co., LLC v. Kent, 552 U.S. 440, 128 S.Ct. 1168 (2008) (per curiam)(4-4 decision).
We wish the Philly court would have come down on the side of Garcia, but it concluded that it did not need to, because (1) there had been no federal finding of fraud, and (2) even if there was a federal finding of fraud, the plaintiffs produced no facts showing that “the drug would not have been approved, or the [FDA] would have withdrawn approval for the drug if the information were accurately submitted.” Indeed, in response to a citizen’s petition, the FDA recently declined to withdraw Risperdal from the market, stating “based on review of clinical data submitted by the sponsor, published literature, and postmarketing surveillance, there is no evidence … that would warrant revocation of the pediatric indication of [Risperdal]."
That leaves the plaintiffs' argument that a November 2013 guilty plea showed fraud. And here we must confess, ala a classic Elmore Leonard story, to withholding a fact that registered a bigger impact upon delayed disclosure. That guilty plea related to promotion of the drug for the treatment of dementia in the elderly. That guilty plea was, in other words, “wholly irrelevant” to the question of whether the defendants submitted accurate information to the FDA concerning the frequency of developing gynecomastia after taking Risperdal during adolescence.
There are one or two other rulings in the case. They are minor characters. Leonard famously issued his Ten Rules for Writing. One of them was “Try to leave out the part that readers skip.” Perhaps we have already violated that rule. This is the punchline: the Philly court did a fine job, it chose the right law, any merit to the plaintiffs’ arguments was out of sight, and the summary judgment in favor of the defendants was entirely justified.