When we discuss the learned intermediary rule, it is typically in the context of protecting our drug and device manufacturer clients. If a manufacturer warned the doctor, it discharged its duties, and a plaintiff should not be able to claim that he or she was not directly warned. We do not often represent pharmacies, but
We are going to take today’s decision a little out of order because we think the outcome is fairly easily surmised from our title – plaintiff couldn’t sustain his claim because he didn’t have admissible expert testimony. But before we get to the substance of the opinion, at the end the court was called on…
It’s been a few years since we talked about the conundrum facing pharmacies if they suspect prescriptions are medically unnecessary or improper. Back in 2015, two cases were decided within days of each other that allowed claims to go forward suggesting that a pharmacy could be potentially liable for both filling suspect prescriptions (see here…
What follows is a post authored by Jaclyn Setili, a Reed Smith associate. She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously proposed as theoretically possible, but had yet to see. As always, our guest posters are entitled to 100% of the credit (and any blame) for their blogposts.
As a Mitten native (that’s Michigan for the uninitiated), this guest blogger is regularly on the lookout for good news connected with her home state. Typically this involves events of the sporting championship variety, but cause for celebration has been scarce of late on that front (see, e.g., Michigan football, an impressive early season dominance culminating in two close late season losses and a devastating defeat in the Orange Bowl; the Red Wings, currently sitting in last place in their division and slipping progressively further away from a Stanley Cup title since their last championship win in 2008; and the Lions, every year, forever). Even reports of Detroit’s flourishing restaurant scene and a slot in the New York Times’ 52 Places to Go in 2017 fail to inspire much collective awe from this guest blogger’s big-coastal-city friends and colleagues.
As it turns out, however, we need only look a few months back to the In re Lipitor MDL (which we have blogged about before, most recently here, and in which all but one of the cases have now been dismissed) for such news. In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016), the district court ultimately granted plaintiffs’ motions to remand, but in the process became the first court ever (as far as we know) to apply impossibility preemption to bar warning claims against a pharmacist selling a branded drug.
The details: The two actions at issue were originally filed in Michigan state court; each plaintiff alleged that Lipitor caused her to develop Type II diabetes, and that the manufacturer failed to properly disclose the risks associated with the drug. That defendant removed both cases to the Eastern District of Michigan based on diversity jurisdiction; from there the cases were transferred to the MDL court. Plaintiffs named a local pharmacy in order to destroy diversity. While the parties agreed that the pharmacy and at least one named plaintiff in each case were residents of Michigan, defendants claimed that the pharmacy was fraudulently joined and that the non-Michigan plaintiffs were fraudulently misjoined. Plaintiffs moved to remand.
As we and the MDL court know all too well, to establish that a nondiverse defendant has been fraudulently joined, a removing party in the Fourth Circuit must show either: (1) “outright fraud” in plaintiff’s pleading of jurisdictional facts, or (2) that there is no possibility that plaintiff would be able to establish a cause of action against the in-state defendant in state court. 2016 WL 7368203, at *1 (emphasis added). That is always an uphill battle. Here, defendants argued that there was no possibility that plaintiffs could state a claim against the pharmacy where plaintiffs allegedly purchased the drug under Michigan law for four reasons: (a) their claims were preempted by federal law, (b) Michigan’s seller immunity statute bars pharmacy claims, (c) the pharmacy had no duty to warn plaintiffs, and (d) the learned intermediary theory further barred plaintiffs’ claims.
Of primary importance for our purposes is the court’s analysis of the first ground, preemption. The court first noted plaintiffs’ admission that they “may not have a claim regarding labeling with respect to . . . a pharmacy.” Id. at *2. The court swiftly concluded that even if it were possible to state such a claim, it would be preempted by federal law because, under the Federal Drug and Cosmetic Act, “a pharmacy has no authority to unilaterally change a drug’s label.” Id. Thus, any claims based on labeling were preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2571 (2011). In other words, the court concluded that there was no possibility that plaintiffs could establish a cause of action against a pharmacist based on labeling. That result is a first, and could be a big deal.
Our learned intermediary rule “head count” lists Oklahoma as solidly in support of the doctrine:
Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974).
The “head count” lists every state supreme court decision to follow the learned intermediary rule, and the Oklahoma Supreme Court’s four decisions applying the doctrine are exceeded only by Ohio’s six (plus a statute) and Kansas’ five opinions.
Oklahoma courts had never applied the rule to pharmacists, however. As we’ve discussed before, the learned intermediary rule helps pharmacy defendants by precluding claims that pharmacies, as intermediate sellers of prescription drugs, should have some sort of independent duty to warn patients. Just as the rule recognizes physicians as learned intermediaries in passing along relevant warnings from prescription medical product manufacturers to their patients, learned intermediary principles also preserve the physician-patient relationship by precluding imposition of independent warning duties on other possible interlopers – such as pharmacies – who otherwise might be legally required to confuse patients by providing information that conflicts with what prescribing physicians tell their patients. Back in 2011, on occasion of the Arkansas decision Kowalski v. Rose Drugs, Inc., 378 S.W.3d 109 (Ark. 2011), we did a 50-state survey post on this issue, and Oklahoma was missing in action.
Not any longer. In Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016), the court applied the learned intermediary rule to pharmacy-related claims in essentially the same fashion as the previous cases in our survey post. Carista involved a plaintiff (or more precisely, a plaintiff’s decedent) who took too many painkillers – it appears, from the opinion, illegally − overdosed, and then attempted to blame someone else, in this case the pharmacy where the prescriptions were allegedly filled. The case was dismissed, and the plaintiff appealed. Recognizing the issue as one of first impression, the court followed what it concluded, rightly, was the majority rule:
Many other states appear, however, to have adopted the [learned intermediary] doctrine, with limited exceptions, to shield pharmacists from being required to “second guess” a physician’s medical decisions embodied in an otherwise authorized and legally made prescription.
This post comes from the non-Reed Smith side of the blog.
As we noted yesterday, we aren’t much for New Year’s resolutions. But this blogger was recently invited to the home of friends who have a slightly different tradition. On New Year’s Eve, as you leave their home, you are invited to take a slip of paper from a basket sitting by their front door. On each paper is written a random word. What you do with the word is up to you. I was told some people tape them to their computer monitor or tack them on a bulletin board. Others tuck them in their wallets or purses. The idea is simply to contemplate the word. What does it mean? What does it mean to you? Does it make you want to do something or not do something? It is more about reflection than resolution. Maybe that reflection will lead to something positive – maybe not. But we find the exercise intriguing. The idea that just one ordinary, everyday word might have a profound impact. We are only day 5 into the New Year, but having a 5-minute daily time out to “contemplate” has so far been very relaxing. If nothing else comes of it, that would still be a win.
And speaking of wins . . . . let’s talk about Hernandez v. Walgreen Company, 2015 Ill. App. LEXIS 986 (Ill. App. Ct. Dec. 28, 2015). Here a single word made all the difference as well – duty. Actually the lack thereof is what is important. Suit was brought on behalf of the estate of the decedent who died allegedly from methadone intoxication. Id. at **2. Plaintiff sued the decedent’s doctor who had prescribed the methadone for back pain and the pharmacies that had filled the prescriptions. Id.
The Texas Supreme Court answered yes in its recent decision Randol Mill Pharmacy v. Miller, 2015 WL 1870058 (Tex. Apr. 24, 2015). And while the decision is full of statutory interpretation of the Texas Medical Liability Act, which wouldn’t normally draw our interest, when we read this one we saw some implications for pharmacy liability we didn’t like. That’s bad for pharmacies. It is also bad for manufacturers who look to get pharmacy defendants who may create a bar to federal removal dismissed as fraudulently joined.
The facts are fairly straightforward. Plaintiff’s physician prescribed and administered weekly injections of lipoic acid to treat plaintiff’s hepatitis C. Plaintiff suffered an adverse reaction to one injection and alleges she has been left blind as a result. Id. at *1. Plaintiff sued both the pharmacy who compounded the lipoic acid and several of its pharmacists. The pharmacy and pharmacists moved to dismiss for plaintiff’s failure to serve an expert report within 120 days of filing as required by the Medical Liability Act. Plaintiff argued that her claims against the pharmacy/pharmacists were products liability claims, not healthcare liability claims and therefore the statute did not apply. Both the trial and intermediate appellate courts agreed with plaintiff concluding that the pharmacists were not healthcare providers. Id.
Plaintiff’s allegations against the pharmacy defendants include:
- negligence in manufacture, design and warning;
- breach of implied warranties in the design, manufacture, inspection, marketing, and/or distribution;
- and what essentially sounds like strict liability manufacturing, design and warning claims (“inappropriate warnings and instructions for use,” the produce “was defective, ineffective and unreasonably dangerous.” Id.
On Friday, we posted about a Florida court that allowed negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written (Oleckna). As you can imagine, we had some reservations about the ruling. Well, those reservations were driven home when we happened upon another recent pharmacy liability case, this one in Indiana – Kadambi v. Express Scripts, 2015 U.S. Dist. LEXIS 13607 (N.D. Ind. Feb. 5, 2015).
If we call Oleckna a “damned if you don’t” case, then Kadambi is the example of “damned if you do.” Which leaves the question – what is a pharmacy to do?
Plaintiffs in Kadambi are an endocrinologist, Dr. Kadambi, and 8 of his patients for whom he prescribed human growth hormone (HIGH). While plaintiffs allege that the prescriptions were medically necessary, the defendant pharmacies refused to fill HIGH prescriptions from Dr. Kadambi because they believe the prescriptions might violate federal law making it a “crime to knowingly distribute HIGH” for improper purposes. Id. at *3. Defendants alleged that they had a good faith belief that Dr. Kadambi was prescribing HIGH for non-medically acceptable reasons and/or that he was affiliated with organizations that advocate
off-label use of HIGH. Id. at *4.
Plaintiffs advanced essentially two causes of action against the pharmacies – violation of Indiana’s statute governing pharmacies and defamation. While the court dismissed the statutory claim, it allowed the defamation action. We’ll go through the court’s ruling, but our real interest lies in the fact that both Kadambi and Oleckna are moving forward.
A pharmacy case from Florida caught our eye this week. We still have fresh in our minds the survey that Bexis posted a few days ago of state laws limiting the liability of non-manufacturing sellers of prescription medical products. It was an impressive collection, as Bexis-prepared surveys tend to be, and it covered the potential liability (or lack thereof) of distributors, suppliers, pharmacies, etc. You know, anyone in the chain who did not manufacture the drug or device and who typically would have no role in developing the product or its warnings. It comes up a lot for us in the context of removal jurisdiction, where plaintiffs fraudulently join local or non-diverse defendants in an attempt to prevent removal to federal court. The plaintiffs never—and we mean never—actually pursue claims against the local defendants, and we routinely resist their motions to remand cases to state court with arguments that there are no viable claims against mere pass-through sellers of pharmaceutical products and medical devices.
In this regard, the result in Oleckna v. Daytona Discount Pharmacy, No. 5D13-3057, 2015 WL 477841 (Fla. Dist. Ct. App. Feb. 6, 2015), is not helpful because it allows negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written. In Oleckna, the patient was being treated for stress, and his doctor prescribed Xanax and narcotic pain medication over a period of two years. Id. at *1. The patient, sadly, died allegedly “due to combined drug intoxication” of the prescribed medications, and his estate sued the physician who wrote the prescriptions and a pharmacy who filled many of them—allegedly more than 30 prescriptions. Id.