United States: No Causation, No Claim

Last Updated: January 6 2014
Article by Steven Boranian

Most Read Contributor in United States, October 2017

Today we feature a case that exemplifies two principles that we routinely encounter in our practices, but rarely at the same time. First, there is no more sympathetic plaintiff than a disabled military veteran. We come across and write on cases involving sad facts with some regularity, which is an occupational hazard of our practice in the drug and medical device arena. The most compelling cases we see involve patients who have experienced actual injuries, a fact that we always bear in mind as we report on what the law is and what we believe the law should be. Moreover, while everyone has a point of view on what kinds of cases provoke the greatest sympathy, we have learned in our many years on Reed Smith's Pro Bono Committee that disabled veterans garner the broadest imaginable support. Some people champion children's issues; others promote immigration reform, or perhaps they favor housing rights. But everyone gets behind programs supporting disabled veterans. And rightfully so. Today's veterans are young men and women who have completed their service and have their whole lives ahead of them, often with significant challenges.

The second principle that today's case brings to mind is that civil litigation cannot and should not provide a remedy if the law and facts are not there to support one, no matter how sympathetic the plaintiff may be. The district court's order granting summary judgment in Carnes v. Eli Lilly& Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16, 2013), brings together these two principles by presenting a disabled Army veteran and physicians who prescribed prescription drugs with full knowledge of all the relevant risks. In Carnes, the plaintiff injured his spinal cord while attempting to rescue fellow soldiers in Iraq, and as a result he is wheelchair bound, has significant physical limitations, and suffers from chronic pain. Id. at *1. One physician prescribed Lyrica, an antiepileptic drug indicated for treating pain associated with spinal cord injury, but after about three years on the drug, the plaintiff asked to stop. Id. at *2. The doctor therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake inhibitor that is also indicated for treatment of chronic pain. After a few months, the plaintiff changed doctors and asked to switch his medication again because he thought the drug was causing him to gain weight. Id. at *2. The new doctor therefore tapered the plaintiff off Cymbalta and restarted Lyrica. Id. at **2-3. According to the doctor, she tapered the plaintiff's dose "to avoid potential side effects from stopping Cymbalta suddenly." Id. at *3.

As the second doctor's remarks suggest, discontinuing Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and which the product's label disclosed at all relevant times. Id. at **4-5. The physician who first prescribed the drug similarly was aware of the risk of withdrawal symptoms "having learned about them in medical school, during his residency, and from patients who experienced withdrawal symptoms." Id. at *16. Alas, the plaintiff experienced post-discontinuation symptoms that he attributed to the drug, including sharp headaches, nightmares, anger, and shaking. He therefore sued the drug's manufacturer, who moved for summary judgment under South Carolina's learned intermediary doctrine.

The district court's order granting summary judgment is useful on multiple levels. To start, the court observed that "[p]rescription drugs are neither defective nor unreasonably dangerous if accompanied by proper direction and warnings," which reiterates to us that South Carolina applies comment k across the board to all prescription drug cases. Id. at *9. In addition, the court confirmed that South Carolina applies the learned intermediary doctrine in prescription drug cases and that "a plaintiff must not only show that the drug manufacturer's warning was inadequate, but 'also that the inadequacy of the warning was the proximate cause of the plaintiff's injury.'" Id. at *10. Lots of courts have made statements like this under various states' laws, and our readers will find the statement a familiar truth. This court, however, went a helpful step further and explained exactly what warnings causation means, i.e., that different or additional information would have changed the physician's prescribing decision. As the court put it,

In light of the learned intermediary doctrine, 'the burden remains on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff.'"

Id at *10. This is not an extraordinary holding, but it is reassuring to see a court lay out the rule so clearly and completely. We have often said that warnings causation is a powerful element because it forecloses liability for failure to warn in the abstract. Maybe the labeling could reasonably have been stronger or more complete in some conceivable way. Or maybe it could not have. We have no reason to believe that the warnings at issue in Carnes were in any way less than adequate, but either way, we do know that the court asked the correct question: Would additional warnings have made any difference for this actual plaintiff vis-à-vis his physician's decision to prescribe the drug?

This court clearly understood the law and properly placed the burden on the plaintiff. With regard to the doctor who initially prescribed the drug, the plaintiff argued that certain study results should have been disclosed in the label, but the doctor "testified that had he been provided the warning Plaintiffs allege would have been adequate, he still would have prescribed." Id. at *14. There is no more clear break in the causal chain than this, particularly where the plaintiff has set forth specific information that the alternate "adequate" label allegedly should have included. We think every plaintiff claiming inadequate warnings should have to set forth a proposed alternative, but many get away with leveling only vague criticisms.

Nor was the plaintiff able to salvage his warnings-based claims by taking the doctor out of the equation. The plaintiff argued that he as a patient would not have taken the drug if he personally had known about the risk of withdrawal, thus attempting "[w]ithout any legal authority . . . to displace the learned intermediary doctrine." Id. at *14. But the court correctly ruled that the law "requires the court to focus on the physician's decision to prescribe the drug." Id. at *15 (emphasis added). With regard to the doctor who tapered the plaintiff off Cymbalta, she too testified that even if the label had included information that the plaintiff said should have been there, she still would have gradually reduced his dose, just as she did when she made her actual treating decisions. Id. at *21. Case closed.

The court's disciplined order is all the more admirable because it was filed nine days before Christmas, a time of year when the sympathy toward a disabled war hero might have been heightened. However, in light of the evidence as the court described it, this is the correct result based on correct reasoning, and the court's very clear restatement and application of the learned intermediary doctrine is a good example to file away for future use.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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