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From Products Liability Law Daily, December 17, 2013

Claims that drug manufacturer failed to warn of withdrawal risks barred by learned intermediary doctrine

By John W. Scanlan, J.D.

A patient’s claims that he was injured as a result of a drug manufacturer’s failure to adequately warn his doctors of the risk of withdrawal symptoms from discontinuing his medication were barred by the learned intermediary doctrine, the U.S. District Court for the District of South Carolina held. The patient was unable to establish proximate cause because he could not prove that his doctors would have changed their treating decision had they known of the higher risk associated with stopping use of the drug (Carnes v. Eli Lilly and Co., December 16, 2013, Currie, C.).

Background. Clayton “Scott” Carnes suffers from chronic pain as the result of a significant spinal cord injury. He has been treated at Palmetto Tri-County Medical in Lancaster, South Carolina, since 2008, first by Dr. Knight, and then by Dr. Anupama Singaraju after Dr. Knight’s departure. When Carnes informed Dr. Knight in 2011 that he wished to stop taking Lyrica, Dr. Knight prescribed 60 mg daily of Cymbalta. At his first visit with Dr. Singaraju in March 2012, Carnes informed her that he wished to switch to a different medication, and she reduced his Cymbalta dosage to 30 mg daily as part of a tapering-off method to avoid potential side effects from stopping its use suddenly. In June, she told him to stop Cymbalta and restart Lyrica. Carnes alleged that he began to experience “severe and dangerous withdrawal symptoms” after discontinuing Cymbalta, and continues to experience “shakes.” Carnes brought claims for, inter alia, defective design, negligence, failure to warn, strict liability, and breaches of express and implied warranty against Eli Lilly, the manufacturer of Cymbalta, alleging that Eli Lilly overstated Cymbalta’s effectiveness and understated its withdrawal side effects.

Carnes presented a 2005 article stating that 44.3 percent of all Cymbalta patients experienced discontinuation symptoms, rather than the 1 percent stated on the label, and that 9.6 percent of users experienced severe withdrawal effects. A 2012 study reported withdrawal symptoms in 44 to 50 percent of patients abruptly discontinuing it at the end of clinical studies for depression. Dr. Knight and Dr. Singaraju testified that they were unaware of these articles and studies prior to prescribing Cymbalta to Carnes. Dr. Knight stated that had he been aware of them, he would have been more aggressive in counseling patients about Cymbalta, but he still would have prescribed it to Carnes in 2011. Dr. Singaraju testified that she still would have tapered Carnes off Cymbalta had she known the information. Eli Lilly moved for summary judgment based on the learned intermediary doctrine.

Learned intermediary doctrine. The patient could not establish that the manufacturer’s failure to adequately warn of the risk of withdrawal symptoms associated with Cymbalta was the proximate cause of his injuries. Under South Carolina’s learned intermediary doctrine, as it applies to prescription drug manufacturers, the manufacturer’s duty to warn extends only to the prescribing physician, who assumes responsibility for advising the individual patient of the associated risks. A patient must establish that the treating physician would have changed his or her decision to prescribe the product had the additional information been known. Dr. Knight had independent knowledge of the risk of Cymbalta withdrawal symptoms and the frequency of that risk, based upon having learned about it in medical school, during his residency, and from his own patients, having prescribed it to about 50 patients himself. The fact that he stated that he would still have prescribed it to the patient had he been presented with a stronger warning from the manufacturer indicated that the allegedly inadequate warning to Dr. Knight was not the proximate cause of the patient’s injuries. Similarly, although Dr. Singaraju did not make the original decision to prescribe Cymbalta to the patient, she testified that she still would have tapered the patient off Cymbalta even if the label had contained a stronger warning. Therefore, the patient had not established that the manufacturer’s alleged failure to adequately warn Dr. Singaraju of the risk of withdrawal symptoms proximately caused his injuries.

The case number is 0:13-591-CMC.

Attorneys: Gerald D Jowers, Jr. (Janet Jenner and Suggs) for Clayton Carnes. James F Rogers (Nelson Mullins Riley and Scarborough) for Eli Lilly and Co.

Companies: Eli Lilly and Co.

MainStory: TopStory WarningsNews DrugsNews SouthCarolinaNews

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