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From Products Liability Law Daily, July 15, 2015

Claim that Lexapro® maker failed to warn of suicide risks not preempted

By John W. Scanlan, J.D.

A state law failure to warn claim brought by the widow of a patient who committed suicide after taking a prescription antidepressant was not preempted because there was no evidence that the Food and Drug Administration (FDA) would have rejected an enhanced suicidality warning on the drug’s label, the U.S. District Court for the District of Utah ruled. The questions of whether a different warning label would have affected the actions of the patient’s health care providers and whether the efforts by the U.S. sponsor of the drug to provide warnings were reasonable were for a jury to decide. Further, even though the U.S. sponsor was not the manufacturer of the drug, it could be held liable because it facilitated FDA approval of the drug and was responsible for the label (Shipley v. Forest Labs, Inc., July 13, 2015, Campbell, T.).

Background. Kurt Shipley (Shipley) began taking Lexapro® in June 2003 after he was diagnosed with “anxiety syndrome, panic disorder, and depression, with physical symptoms of palpitations.” He discontinued it in October 2003. On April 12, 2004, he reported to his nurse-practitioner that he was experiencing various symptoms of anxiety, and the nurse-practitioner prescribed Lexapro. He reported additional symptoms to his physician on April 27 and described having “horrendous thoughts,” but denied that he would ever commit suicide. His physician continued him on Lexapro and added a prescription for Wellbutrin. However, on April 29, Shipley committed suicide.

Lexapro, an antidepressant, is manufactured by Forest Laboratories Ireland Limited, and Forest Laboratories, Inc. (Forest) is the U.S. sponsor for Lexapro and also drafted the warnings for Lexapro. Lexapro is a “selective serotonin reuptake inhibitor” (SSRI). After the FDA found in a clinical review for Paxil, another SSRI from GlaxoSmithKline, a number of adverse events involving suicidal behavior, the FDA asked other drug sponsors, including Forest, to reanalyze their data. On March 22, 2004, the FDA issued a Public Health Advisory stating that it had asked sponsors of certain antidepressant drugs, including Lexapro, to update their labels to include “a statement that recommends close observation of adult and pediatric patients treated with these agents for worsening depression or the emergence of suicidality.” The new warning would advise health care providers to “carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of treatment” and to “instruct patients, their families and their caregivers to be alert” for emerging suicidality and to immediately report such symptoms.

Three days earlier, the FDA wrote to Forest asking for updates to the Lexapro label; Forest responded with suggested edits; and on April 19, 2004, the FDA issued a final warning label, which it said should be issued immediately as a CBE (“changes being effected”) supplement that would allow Forest to update its label immediately without waiting for FDA approval. On April 30, Forest sent its final label to the FDA and stated that it would include the new label in Lexapro practices on May 31, 2014, and the FDA approved the changes on May 20.

Elaine Shipley, the patient’s wife, brought a claim for failure to warn against Forest. (She also brought design and manufacturing defect claims, but later conceded that summary judgment should be granted to Forest on these claims.) The case was transferred to the court handling MDL No. 1736, but was later remanded to the District of Utah. Forest moved to exclude the testimony of the wife’s specific causation expert. It also filed two motions for summary judgment, asserting that her failure to warn claim was preempted and that it did not owe a duty to warn about the effects of Lexapro, that any duty it had was met by its warnings to Shipley’s health care providers, and that she could not prove causation.

Preemption. The patient’s wife’s failure to warn claims were not preempted because the court found that there was no clear evidence that the FDA would have rejected a heightened warning about the correlation between SSRIs and suicide. The U.S. Supreme Court said in Wyeth v. Levine, 555 U.S. 555 (2009), that preemption of state law failure to warn claims does not apply “absent clear evidence that the FDA would not have approved a change to [the drug’s] label.” Even though Forest argued for the application of the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), that case was distinguishable from the present one because it involved a generic drug and, thus, the CBE process was not available. Lexapro is a name-brand drug, and Wyeth controls in this case. Therefore, Forest’s preemption defense could not succeed without clear evidence that before the patient’s 2004 death the FDA would have rejected an enhanced suicidality warning in Lexapro’s labeling.

The evidence showed a developing body of “new information” that would have allowed Forest to use the CBE process. After receiving a reanalysis of pediatric data from SSRI sponsors, including Forest, the FDA sent a letter to Forest in March 2004 acknowledging a “long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients.” The court noted that Forest did not request approval of an increased suicidality warning for the Lexapro labeling that was rejected by the FDA and did not use the CBE process for that purpose. Further, in the March 2004 letter, about a month before the patient’s death, the FDA directed Forest to enhance the Lexapro labeling to warn that the drug could induce suicide, and required updates to health care providers to closely monitor patients for suicidal thoughts and behaviors; this was exactly the type of warning the patient’s wife alleged should have been in place.

Duty/proximate cause. Although under the learned intermediary rule Forest’s duty to warn was limited to the patient’s health care providers, the evidence did not establish as a matter of law that his providers had the necessary warnings information when they prescribed Lexapro to him. The testimony of his physician and his nurse indicated that they may have been generally aware of the need to monitor patients for suicidal behavior, but general awareness was not the same as a specific warning to closely watch patients who are taking a specific drug for suicidality. Because the court found that Forest had not rebutted the heeding presumption, it presumed that the patient’s physician and nurse would have provided additional warnings to the patient and his wife if they had been included in the labeling, noting that both providers testified that label changes affect their practice and that their patient counseling has changed with the updated Lexapro label. Although Forest provided contrary evidence, the court found that this confirmed the presence of a disputed issue of fact for a jury to decide.

Whether Forest had improperly delayed its implementation of the FDA’s required updates also was a question for a jury to decide. Forest knew that as early as March 19, 2004, the date of the FDA letter, the agency was requiring changes to Lexapro’s labeling to warn of the risk of emerging or increasing suicidality. While the FDA instructed Forest to use the CBE process to immediately change the labeling while waiting for FDA approval, Forest instead submitted an updated label to the FDA for advanced approval, which the FDA gave on May 20, 2004. A jury could agree with the patient’s wife that Forest could have done more to inform providers of upcoming changes, such as sending “Dear Doctor” letters and instructing sales representatives to alert providers of the changes instead of telling them not to proactively discuss the new labeling.

Expert testimony. The court declined to exclude the testimony of Dr. George Glass, M.D., the patient’s wife’s expert on specific causation, who will testify that the use of Lexapro was a significant contributing factor to the patient’s suicide and the primary method by which it contributed was through worsening depression. His opinion was consistent with the testimony of the wife’s general causation expert, even though that expert did not identify worsening depression as one of three mechanisms of suicide induction, because the general causation expert explicitly stated that worsening depression was a symptom experienced by those adversely affected prior to suicide. Further, the three mechanisms identified by the general causation expert were the most common but not the exclusive ways by which Lexapro could induce suicide. The court further found Dr. Glass’s “psychological autopsy” modification of the standard “differential diagnosis” methodology was a reliable and scientific method, and Forest’s criticisms of it could be raised on cross-examination. While Dr. Glass could not entirely rule out Wellbutrin instead of Lexapro as a potential cause of the patient’s suicide, its possible effects go to the weight to be given to his testimony, not its admissibility. The court added that Dr. Glass could testify only as to how he considers and responds to warning labels and label changes in his own practice, and could not testify as to how the patient’s doctor, nurse, or other provider would have reacted to a change.

The case is No. 1:06-cv-00048-TC.

Attorneys: Arnold Anderson Vickery (The Vickery Law Firm) for Elaine J. Shipley. Christopher P. Fisher (Ulmer & Berne LLP), and Tracy H. Fowler (Snell & Wilmer) for Forest Laboratories.

Companies: Forest Laboratories

MainStory: TopStory PreemptionNews ExpertEvidenceNews WarningsNews DrugsNews UtahNews

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