The Covid-19 lockdown period is approaching the six-month mark, from mid-March to mid-September. Throughout the spring and summer we have been reading old novels with convoluted plots and surprise endings. Today we take a look at an old case, though only from a prior decade, not a prior century. If the case is convoluted, it is largely because the plaintiffs made it so, though the court also got in on the chaos. As for the surprise ending, it is unclear if that results from the court getting things right as much as it did, or from getting things wrong as much as it did.
Kelley v. Insys Therapeutics, Inc., 2019 WL 329600 (Jan. 25, 2019), caught our attention because it discussed preemption of claims involving an opioid. The federal court deciding the matter sat in Cleveland, though it is not the same one handling the massive opioids MDL. In any event, as alluded to above, the Kelley decision gets some things right, some things wrong, and its plot twists are only slightly easier to follow than a tale by Dickens or Thackeray, albeit without much of the entertainment.
There are plural plaintiffs in Kelley because a husband and wife were involved. The husband is the plaintiff we’ll chiefly be referring to, as he brought the primary claims while the wife sued for loss of consortium. The plaintiff was prescribed an opioid to treat his back and knee pain and his carpal tunnel syndrome. That use for general pain was off-label. The medicine is primarily prescribed for treatment of cancer pain. The plaintiff ended up suffering an overdose, acute respiratory failure, liver failure, stroke, withdrawal symptoms, and other serious consequences. He sued the drug manufacturer under a long list of theories, including, inter alia, strict liability, negligence, negligent misrepresentation, fraud, false advertising, and violations of the Ohio Consumer Sales Practices Act (OCSPA). The defendant moved to dismiss the complaint. The court granted parts of the motion to dismiss and denied others.
The FDCA Impliedly Preempted the Off-Label Claims
The Food, Drug and Cosmetic Act (FDCA) impliedly preempts state law claims that are in substance, even if not in form, claims for violating the FDCA. Several of the claims in Kelley amounted to gripes about off label marketing. They were preempted. Things got a little trickier for those claims that rested on state law grounds independent from the off-label issue.
The FDCA Preempted the Negligence Claim
The negligence claim was devoid of any independent ground. The alleged negligence was promotion of the drug for purposes other than “management of breakthrough cancer claim.” Good bye.
The FDCA Preempted the Inadequate Warning Claim
Similarly, the allegedly missing warning was about the increased risks of off-label use. See ya.
The Misrepresentation and Design Defect Claims Escaped Preemption
Here is where the plaintiffs fared better. The Kelley court concluded that the misrepresentation claims “alleged more than off label promotion.” Rather, the plaintiffs alleged that the defendant “willfully deceived” plaintiffs as to the health risks of the product and failed to disclose material facts regarding the product’s safety. That, according to the Kelley court, circumvents preemption. There is no discussion as to whether there was any new evidence that could have supported a change being effected. It is as if Levine and it progeny never existed.
The Kelley court’s analysis of design defect preemption – or lack of analysis – is even more maddening. Again, the key for the court was that the plaintiffs were not confining their claim to off-label problems. Citing a 2013 N. D. Ohio case (Arters) (a thoroughly awful case that we slammed here), the Kelley court held that preemption was not a problem because the plaintiffs more generally alleged that the drug was not safe and should not have been sold at all. It is as if the SCOTUS Bartlett case never existed. For those of us attending to controlling precedent from the Highest Court in the Land, it is pellucid that if a manufacturer cannot do a certain thing – change a warning or, even more fundamentally, alter the design/formula of a drug – without FDA permission, a plaintiff’s claim that the manufacturer should have done that certain thing is preempted. That bit of news seems not to have made it to the shores of Lake Erie.
The Strict Liability Claims Flunked the Ohio Products Liability Act
The plaintiffs’ strict liability claims made a “passing citation to the entire OPLA” at the end of those counts. The Kelley court said that was not good enough. The plaintiffs needed to specify which portions of the OPLA were in play.
So it is okay to ignore clear SCOTUS precedent, but you’d better not ignore the pertinent parts of the OPLA. Good to know.
“Active” Misrepresentation Claims Survived the OPLA
Remember how disappointed we were above when the Kelley court failed to preempt the failure to warn claims? Well, the court kind of got to the right place by concluding that the OPLA abrogated claims of fraudulent omission. So, again, this court seemed way more attuned to the ins and outs of Ohio law than something as flimsy as SCOTUS case law. Even so, the Kelley court waved along the plaintiffs’ claims that the defendant “affirmatively misrepresented” the drug’s safety. That is because OPLA claims are viable when based on “a general duty not to actively deceive.” It is not as if this doctrinal analysis is all buttoned up, is it? Anyway, just as we wondered to ourselves what affirmative misrepresentations were in play (because usually there are none), the Kelley court ruled that the complaint was bereft of any specificity on this score, so the plaintiffs needed to try again.
The OCSPA Failed Because it Was About Personal Injuries
The plot gets really murky here. Like most consumer fraud statutes, the OCSPA is directed at economic injuries. If you are complaining about personal injuries, you’re in the wrong place. File a claim under the OPLA – this time actually following its specific parts – and take your best shot. But the Kelley court held that even though the claims in the case concerned an alleged failure to disclose risks of physical injuries, it simply could not figure out whether the claims were “primarily rooted in product liability claims.” Really? Then the Kelley court said that “the OPLA does not abrogate plaintiffs’ OCSPA claim to the extent it is based on alleged active misrepresentation.” Double huh?
Right as we began to think that Cleveland might just be another name for Crazytown, the Kelley court held that the OCSPA claim IS a personal injury claim and must, therefore, be dismissed. What a head-spinning dialectic! The court acknowledged that the plaintiffs were clearly seeking compensation for physical injuries. Any request for “restitution of the purchase price” of the drug was a flea on the tail trying to wag the dog. Scram to that flea, tail, dog, and bogus consumer fraud claim.
In the end, the Kelley court mostly got to the right place. But it was a long, strange trip. Earlier, we (clumsily) attempted to draw parallels between this case and baggy, 19th Century novels. That was wrong. Kelley is more like a Bach fugue or the stream of consciousness ending of Ulysses. Parts of it are pleasing and parts pass all understanding.