This post is from the non-Reed Smith side of the blog only.
Last week we mentioned the decision in Watts v. Medicis Pharmaceutical Corp., 2015 Ariz. App. LEXIS 12 (Ariz. Ct. App. Jan. 29, 2015) in a breaking news post when it first hit the wires and promised more detail would follow. Well that day has come.
We take a lot of abuse here in New Jersey: waste dumps, wise guys, Jersey Shore; Chris Christie. But as drug and device products liability lawyers in New Jersey, we bear another burden -- Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999) – the decision that makes New Jersey the only state to adopt a direct-to-consumer (“DTC”) exception to the learned intermediary rule (putting aside West Virginia’s use of DTC as an excuse for rejecting the rule altogether). But it is a burden we are more than happy to bear on our own. Texans managed to dodge a bullet and avoided joining our ranks in 2012. And the DTC issue has been rather quiet in our world in the last few years.
Unfortunately, in Watts an Arizona intermediate appellate court has decided to see whether it wants to keep New Jersey company. Arizona is one of the relatively few states where the highest court has never passed on the learned intermediary rule. But heretofore, its appellate courts have gotten it right – adopting and applying the doctrine. That is, until now.
Watts involves the prescription only acne medication, Solodyn. Plaintiff was prescribed two twenty-week courses of treatment with the drug. Watts, at *2. Plaintiff alleges that she received information about the drug from a card given to her by her prescriber that outlined a discount purchase program for the medication and from an information sheet provided by her pharmacy. Id. at *3. The first warned that the safety of using the drug for more than 12 weeks had not been studied and was unknown; the second warned that the plaintiff should consult her doctor if her symptoms did not improve within 12 weeks. Id. The package insert for the drug, which is provided to physicians, warned that the possible side effects of long-term use are a lupus-like syndrome and autoimmune hepatitis. Id. at *3-4. Plaintiff was diagnosed with both of these conditions. Id. at *4.
Application of the learned intermediary doctrine would therefore foreclose a failure to warn claim in this case where the manufacturer, in its FDA-approved labeling, warned about the very risks of which plaintiff is complaining. So would even the standard DTC exception, since the information in question wasn’t directly from the manufacturer to the consumer, but instead went through the traditional learned intermediary channel, as we discussed in connection with the recent Texas case. But, that isn’t what the Watts court did. They reached the conclusion that the DTC referenced by plaintiff altered the equation and put application of the learned intermediary doctrine at odds with Arizona’s comparative fault system.
Before we explore that logic in greater detail, let’s start with what we believe to be the court’s somewhat flawed view of “the realities of modern-day pharmaceutical marketing.” Id. at *20. While it is true that physicians are no longer necessarily a patient’s “sole source of information about the effects, benefits, and risks of the medications he or she takes,” they remain the primary and most-influential source. For prescription drugs, the physician remains the only person who brings to the table knowledge of the drug, of the medical condition, and of the patient. Even more critically, the physician’s role remains essential. Without a doctor’s prescription, the patient doesn’t get the drug, legally anyway. It is solely up to the physician whether to prescribe a certain medication, at a certain dosage, and for a certain duration. The learned intermediary doctrine is based in part on a recognition by the courts that we shouldn’t be interfering in that doctor-patient relationship. It’s also based on the legal reality that only doctors can provide access to prescription drugs (and devices).
Perhaps even more off-base is the court’s belief that DTC prompts patients to “pressure their medical providers to prescribe these brand-name medications.” We certainly hope that patient-pressure isn’t driving prescribing decisions in this country. What the Arizona court describes would be professional dereliction of duty, almost certainly amounting to medical malpractice. For that reason, even if it does happen, we doubt you’ll find a doctor who concedes as much.
But, even if the court is right that DTC is causing pressure on doctors to prescribe – that must mean that the allegedly injured plaintiff saw the DTC before her physician prescribed the drug. That’s not the case here. There was no “direct” manufacturer contact with plaintiff Watts. She claims that she received an information sheet from her pharmacy at the time she filled her first prescription -- after the prescribing decision had already been made. Id. at *3. Plaintiff also alleges that her doctor gave her a discount card for the drug. Now, while it isn’t spelled out in the decision, we’ll go dollars to donuts that that card was provided to plaintiff after her doctor recommended Solodyn and was given to her to offer her financial assistance in filling the prescription. Again, information provided after the prescribing decision was made by her physician.
So, the facts of the case don’t even support the court’s rationale for wanting to carve out a DTC exception. We’ve previously and pretty thoroughly discussed here why this rationale doesn’t warrant a DTC carve-out to the learned intermediary doctrine – so we won’t go through it all again here. But if you go to that post, what you’ll read is our belief that in the extraordinarily rare case where DTC did impact the prescribing decision -- some inadequacy in the DTC advertising in fact causes the patient to do something that in turn causes the doctor to prescribe the drug when otherwise he wouldn't, then there’s a potential failure to warn claim under the learned intermediary doctrine – no exception needed. In all other cases, like in Watts, the DTC would be non-causal -- again no exception needed. That’s a traditional superseding cause analysis. We doubt that superseding cause has ever been considered incompatible with statutes governing contribution between joint tortfeasors. In fact, that’s a good subject for another post.
That’s our big picture on DTC generally. The next question is how did this court interpret the law to get at that result – the Uniform Contribution Among Tortfeasors Act (UCATA). We’ll need to take this one step-by-step. The court leads off with discussion of the adoption and application of the learned intermediary doctrine in Arizona. In this discussion, it is clear that the court is attempting to fit the manufacturer and the physician into a stream of commerce relationship. The pharmaceutical company manufacturers the product and the doctor “prescribes, installs or facilitates” use of the product. Id.at *16. This is a not-so-subtle attempt to make pharmaceutical companies sound like carburetor manufacturers and doctors sound like mechanics (if not Manny Moe & Jack). Putting that rabbit in the hat is important in any analysis of the court’s discussion of Arizona’s comparative fault system.
Skipping the history lesson provided in the opinion, Arizona is a several liability only or pure comparative fault state. Id. at *17. This means that each co-defendant in a tort case is liable for no more than his respective percentage of fault. Or as the court put it: “the various participants in the chain of distribution are liable not for the actions of others, but rather fortheir own actions in distributing the defective product.” Id. at *18. Hence the court’s auto part manufacturer-mechanic analogy. It needed the pharmaceutical company-doctor-patient relationship to fit that mold. How else do you reach the conclusion that:
protecting a prescription drug manufacturer from possible liability for its own actions in distributing a product, simply because another participant in the chain of distribution is also expected to act, is inconsistent with UCATA.
Id. at *18-19. Talk about belittling the doctor’s role – a “participant in the chain of distribution”? Are doctors in Arizona strictly liable for defects in the products they prescribe as intermediate suppliers? We doubt it. We also think most doctors believe they do a bit more than that. And that larger role is the foundation of the learned intermediary doctrine – it’s right there in the title after all. While the analysis in the decision goes on for a few more paragraphs, it is mostly a repetitive emphasis on the court’s belief that UCATA requires that warning adequacy needs to be determined by looking at “the actions of all involved in the chain of distribution.” Id. at *21.
It doesn’t work that way in a warning case when one party’s conduct (prior knowledge, failure to read, something else) makes it impossible for the allegedly inadequate warning to get to the plaintiff. That appears to be true in Arizona. We excerpt the following from our post last year on failure to read warnings:
Gebhardt relied on Gosewisch v. American Honda Motor Co., 737 P.2d 376 (Ariz. 1987) (superseded by statute on other grounds as stated in Jimenez v. Sears, Roebuck & Co., 904 P.2d 861, 865 (Ariz. 1995) (product misuse)), in which the Arizona Supreme Court held generally, where the plaintiff admitted never reading the owner’s manual (plaintiff testified that he “requested but did not receive” the manual when he bought the product used from a relative), “it cannot be said that a failure to warn was a proximate cause of the injury.” Id. at 380.
That’s the Arizona Supreme Court speaking inGosewisch, and it didn’t find that UCATA or anything else required “the actions of all involved in the chain of distribution” must be considered even where the facts demonstrated that the warning did not reach the plaintiff through no fault of the defendant.
In Watts the court’s willingness to buy into the plaintiff’s UCATA argument is solely focused on the fair allocation of fault – again a situation not presented by the Watts case. The prescriber isn’t a defendant in the case. This is yet another misconception driving the court’s reasoning – that the doctors and the manufacturers are standing shoulder-to-shoulder in the courtroom. The court is concerned that the doctor may improperly bear all of the responsibility when a “consumer” is given an inadequate warning. Id. at *19. Note the use of “consumer” instead of “patient.” But, in practice, plaintiffs who sue drug/device manufacturers infrequently also sue their prescribers (or at least reach some sort of settlement). When they do, they often shoot themselves in the foot. To maintain a lack of informed consent claim against the doctor, plaintiff has to allege that the doctor already knew all the risk information (whether from the manufacturer, or more likely from professional experience and study) but didn’t provide it. In other words, it often comes close to a concession of causation as against any manufacturer failure to warn. And the manufacturers are loath, for obvious reasons, to file third-party claims against the prescribers. So fault allocation and learned intermediary are more like ships passing quietly in the night – they shouldn’t be on a collision course.
On the one hand, this feels to us like a decision that shouldn’t have legs. And while we don’t want to read too much into it and certainly don’t want to do our opponents work for them, whenever a door gets opened a crack we worry about the battering ram slamming into it. Hopefully, Arizona will go the way of the similarly lousy ruling in Texas – overturned in the supreme court.