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The Drug and Device Law Son is attending a college with a curriculum that is both catholic and Catholic. Thus, in addition to his courses in Business Dynamics, Calculus, and Russian, he is required to take a course in Religion. His first assignment was to write out an argument that religion and science are similar and fundamentally compatible. That topic is one that might get a lot of people excited, maybe even exercised.  (We wanted to say “exorcised,” if only for the fun of it, but the grammar police here pointed out that such usage had the drawback of being utterly wrong.  It would be almost as bad as abusing the word “fulsome,” which happens within our earshot at least twice a day.) The religion-science contest has, in fact, been the subject of some dramatic courtroom battles. The Scopes trial in Tennessee is perhaps the most famous, but only a couple of years ago a federal judge in Harrisburg, PA had to wrestle with a case challenging the place of creationism in the science classroom.

The likes of Hawkins and Hitchens have suggested that what distinguishes science from religion is the concept of falsifiability. A theory is scientific if one can conceive of facts that would disprove it. But if any set of facts can coexist with a belief because one can always point to mystery, miracles, or faith, then that belief looks not so scientific and more like religion. That is not necessarily to say one is right or wrong, but it is to say that there is a difference. Maybe you can take shots at that difference (more on that in a minute), but it is at the very least a difference of degree. As the brilliant and opaque Hegel was fond of saying, quantitative differences after a point become qualitative.  The almost as brilliant and never opaque Bexis pointed out to us that one of our heroes, the Harvard sociobiologist E.O. Wilson, is adamant that religion and science are fundamentally incompatible.  Wilson has spent a lot of time writing about ants.  It is certainly true that ants are incompatible with a church picnic.  If he is saying anything beyond that, we confess to being too frightened to comment.

Occasionally we will encounter plaintiff experts who pretend to be engaging in science, but it drearily becomes clear that something else is afoot. Again, it comes down to the concept of falsifiability. When you encounter these experts and dangle in front of them possible facts and ask if such facts would undermine their bought-and-paid-for conclusions, these experts find ways to wriggle out of admitting that anything would cause them to change their minds and thereby disappoint their clients. These experts are no longer practicing science; they are worshipping at the altar of Mammon.

But back to the alleged convergence of religion and science. The DDLS wrote his paper without any help from us. He received a good grade. For that, our eyes turned toward the Heavens, and definitely not in a scientific sense.  We might posit that there is a cause and effect relationship between our nonparticipation and the good grade.   But if we had been given the opportunity to contribute our thoughts to the paper, we probably would have said something about how science is ineluctably based on certain articles of faith. One of those articles of faith would be the concept of cause and effect. Even the Bradford-Hill criteria arguably announce a creed as much as a scientific concept.

Causation is a crucial and powerful concept in the law. We recently mourned the passing of Ronald Coase, a Nobel prize-winning professor of law and economics from our alma mater. He authored the single most cited law review article of all time, “The Problem of Social Cost” (1960). That article applied a law-and-economics analysis to show that legal rules would be irrelevant if parties could bargain their way to rational resolutions, but that externalities and asymmetries of costs could justify the right sort of legal rules.  The Law and Economics school has had many brilliant scholars, such as Posner, Director, Landes, Bork, and others, but Coase towered over them all. We took a Law and Economics course at the University of Chicago. How could we not have done? It would be a pity to spend three years in Hyde Park and not at least shake hands with that discipline. While Law and Economics is usually thought of as making especially rich contributions to business-oriented fields, such as antitrust, securities law, and contracts, it also has a lot to offer to the way we think of torts. In particular, we remember that there was a formula for assessing proximate cause. We sheepishly admit that we do not remember exactly how that formula goes, but we remember thinking at the time that the logic behind it was unassailable. One reason we do not remember the formula is because we have never, ever seen it applied by courts. Let’s be honest: too many courts are too cavalier about the concept of causation. If complaints, claims, arguments, and expert reports were really scrutinized rigorously through the lens of causation, there would be a lot less nonsense polluting our courts’ dockets. So much of what is filed, served, and sputtered about in front of a jury is much ado about nothing. It is talking about stuff that did not really matter. It is like arguing that a company should be held liable for leaving out a sufficiently lurid warning because, hey, look at this video of a company employee kicking his dog.

When we see a court take a serious look at proximate cause, we are grateful for something that looks like a near miracle to us.  Such a near miracle arrived in our inbox last week in the form of Payne v. Novartis Pharmaceuticals Corp., 2013 WL 4779571 (E.D. Tenn. Sept. 6, 2013). The Payne case was part of the Aredia-Zometa MDL. As with all those cases, the plaintiffs asserted that a patient treated with Aredia and Zometa ended up suffering from osteonecrosis of the jaw (ONJ).  Aredia and Zometa are bisphosphonates. The plaintiffs brought the following claims under Tennessee law against the defendant: (1) strict liability; (2) failure to warn; (3) breach of warranty of merchantability; (4) negligence and negligence per se (the plaintiffs ultimately abandoned their negligence and negligence per se claims); (5) wantonness; (6) fraud, misrepresentation, and suppression; and (7) loss of consortium.  Despite all those theories, the plaintiffs admitted that all their claims boiled down to a failure to warn theory.  So what else is new?  The gravamen of the plaintiffs’ case in Payne was that the drug labels inadequately warned of the risk of ONJ. The defendant moved for summary judgment dismissing the case because the plaintiff failed to demonstrate proximate cause between the inadequate warning and her injury.   That is, we are talking about the drug and defense lawyer’s BFF, warning causation.  (Okay, sometimes we think that preemption is our BFF.  Or TwIqbal.  Or Daubert.  Call us fickle.  It’s all about what-have-you-done-for-me-lately.)  The defendant prevailed and got the Payne case dismissed, but getting there was by no means a gimme.

The plaintiff’s treater, Dr. Johnson, prescribed Aredia to the plaintiff in 1999. Dr. Johnson did not provide to the plaintiff any warnings regarding Aredia and the doctor was unaware at the time that Aredia was linked to ONJ. So right away we can see how the defense argument faces a challenge.  Normally, we defense hacks start salivating over a warning causation defense when we get one of three fact situations (or maybe all of them): (1) the treater already knew of the risks that were not in the warning; (2) the treater says that the new information, assuming it really was new, would not have done anything to alter the treatment of the plaintiff; and/or (3) the treater never read the label, so any enhanced warning could not possibly have made any difference.  As we have already seen, the first ‘out’ was not in the Payne case.  Back to our story.  In 2001, after the plaintiff had been taking Aredia for over two years, Dr. Johnson discussed changing her medication from Aredia to Zometa. Dr. Johnson did not discuss any other potential side effects of the new drug. Indeed, Dr. Johnson testified that he was unaware of the risk of ONJ at the time he prescribed Zometa. Okay – once again, we do not have that first ‘out.’ What about the second ‘out’?  Well … Dr. Johnson now discusses the risk of ONJ with patients and advises them to undergo a dental examination and to discuss any necessary dental work with a dentist prior to beginning the treatment.  That advice is premised on the understanding that it is possible ONJ can be caused not simply by bisphosphonates, but by dental work that is performed after initiation of bisphosphonate therapy.  At this point, the plaintiffs must be thinking they can shake an argument out of their cuffs that will fend off dismissal.  By the way, we have no hint that the third ‘out,” that the doctor never read the label, applied.

Just because the Payne case does not look like a lay-down on warning causation does not mean that the defense does not apply.  The defense might have to do a little work.  So might the court.  But the facts in Payne do ultimately show that there was no cause and effect relationship between the allegedly inadequate warning and the plaintiff’s ONJ.  Around October 2005, Dr. Johnson became aware that bisphosphonates were associated with ONJ.  When he subsequently noticed an uptake in the plaintiff’s mandible, Dr. Johnson suspended her Zometa treatments and advised her to see a dentist. The plaintiff eventually visited an oral surgeon who removed several of her teeth.   There were problems in the course of her dental treatment, and a dentist eventually diagnosed the plaintiff with ONJ.

The Payne court correctly saw the key issue as being whether an adequate warning would have altered Dr. Johnson’s conduct.  Remember how above we emphasized the fact that Dr. Johnson now discusses the risks of ONJ with his patients?  That is a good fact for the plaintiffs.  But there is also this good fact for the defendant:  Dr. Johnson testified that he still prescribes bisphosphonates to his patients in spite of his knowledge of the risk of ONJ.  The course of the treatment of the plaintiff validates the doctor’s testimony.  After Dr. Johnson learned of the relationship between ONJ and bisphosphonates, he kept the plaintiff on Zometa until her bone scan demonstrated an uptake in her mandible. It was not until the plaintiff’s uptake was discovered that Dr. Johnson decided to discontinue the Zometa treatment, although he had known about the risk of ONJ for nearly a year at that point.

The plaintiffs performed the usual maneuver, trying to shift the decision from the doctor to the patient.  The plaintiff argued the plaintiff would not have taken the drugs at all had she been warned of the risk of ONJ.  The plaintiff offered an affidavit to that effect.  Big surprise.  Talk about the quintessential self-interested affidavit. The plaintiffs also pointed to Dr. Johnson’s testimony that he now explains the relationship between A-Z and ONJ and recommends that his patients receive a dental examination before beginning A-Z therapy to determine whether dental work is needed before treatment begins.   Those are not bad arguments.  But they are also not winning arguments.

The court held that the issue was not whether a warning or discussion by the doctor might have scared the patient into not taking the drug.  Instead, the issue was whether the patient would have heeded the doctor’s specific warning.  In Payne, Dr. Johnson’s new discussion with patients, after he had learned of the possible connection between ONJ and bisphosphonates, was not that the patient maybe should not take bisphosphonates. Rather, it was that the patient should undergo a dental exam before such treatment.   The court emphasized that the plaintiffs provided no evidence to demonstrate that an earlier dental exam “would have prevented the onset of ONJ.”  The plaintiff visited a dentist in 2001 after she had been taking Aredia for two years and only months before she switched to Zometa.  No problems were identified at that time.  Moreover, when the plaintiff underwent the extractions in 2005, the ONJ risk was common knowledge among oral surgeons at the time. One of the doctors said this:

[B]y 2005 you were kind of under a rock if you’re an oral surgeon if you don’t know where there’s a bisphosphonate issue.

The court concluded that an ONJ warning would have no effect on the plaintiff’s outcome. Dr. Johnson now suggests to patients that they undergo dental examinations prior to beginning treatment so as to avoid any dental-treatment-induced ONJ. But ONJ can either be induced by dental work or can occur spontaneously.  The evidence presented in Payne demonstrated that the plaintiff’s ONJ was not induced by dental work that could have been avoided by a pre-treatment examination.   Even if a more knowledgeable-aware-warned Dr. Johnson would have suggested that the plaintiff receive a dental examination, there was no evidence that such an examination would have prevented her ONJ.

As we have said before — indeed, with respect to the Aredia-Zometa litigation — it really pays off for defense counsel to be persistent and creative in pursuing a defense of no warning causation.  Do not let the absence of the most obvious ‘outs’ deter you from digging through the facts and demonstrating that a different warning would have made no difference.

The lack of warning causation also undermined the plaintiffs’ other claims.  For instance, the claim for breach of the implied warranty of merchantability was premised on the alleged failure to adequately label the drugs.  Again, there was insufficient evidence that a different label would have changed the facts that matter.  Similarly, the court dismissed the plaintiffs’ claims for fraud, misrepresentation, and suppression for want of causation.  The plaintiffs, in an effort to get around the requirement of intent to deceive, claimed constructive fraud based on concealment of information about ONJ.   Once again, there was no proof that the alleged concealment caused the ONJ.

A ruling like this restores our faith in the legal system, and we thank Joe Hollingsworth for sending it our way.