From the Desk of Kyle Riley: In this case, the Washington Court of Appeals declined to expand existing Washington drug manufacturer warning standards to include diagnostic tips for physicians who may treat complications that arise from use of the drug. Further, the Court declined to increase the scope of a drug manufacturer’s duty to warn regarding side effects.
Claims Pointer: Drug manufactures may only be required to reference a particular side effect by name in the warning label to sufficiently inform consumers and physicians. Warning labels do not need to include diagnostic tips, even when misdiagnosis is known.
Falsberg v. GlaxoSmithKline et al. in the Court of Appeals of the State of Washington, Division I, No. 67702-1-I, (Unpublished March 18, 2013).
David Falsberg was a patient who developed toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) after using GlaxoSmithKline’s drug, Lamictal, an anticonvulsant. The relevant warning label advised of serious side effects, including rashes requiring hospitalization, SJS and rare cases of TEN. The label also advised that the drug “ordinarily should be discontinued at the first sign of rash” and that it is difficult to tell the difference between a serious and benign rash. The patient information section also instructed patients to seek immediate attention from a physician at the first sign of a rash.
Falsberg’s prescribing doctor was Dr. Conway. When initially prescribing the medication he warned that after using the medication rashes would develop in rare instances. He instructed Falsberg to stop using the medication if that happened. Dr. Conway also told Falsberg to increase his dose by 25 milligrams per day until he reached a dose of 150 milligrams per day. After Falsberg increased his dose to 150 milligrams, he developed flu-like symptoms, eye, mouth and throat pain, and blistered in the area surrounding his mouth. When he learned of these symptoms, Dr. Conway advised Falsberg to reduce the medication to 75 milligrams. The following day Falsberg’s wife found him slumped over a computer with a high fever and rash. The symptoms progressed at the medical clinic, and Falsberg was misdiagnosed with a respiratory infection. The next day Falsberg’s wife took him to the emergency room where he was diagnosed with SJS and treated for TEN. Following these visits he was placed in a medically induced coma and had surgery. After the surgery, it was determined his symptoms were caused by Lamictal.
Falsberg sued GlaxoSmithKline and Dr. Conway alleging the warning labels were inadequate. The trial court did not agree, and granted summary judgment to the defendants. Falsberg appealed.
On appeal, Falsberg argued that the trial court should not have dismissed his claims against GlaxoSmithKline and Dr. Conway because the warning label inadequately warned of the risks related to use of the drug. Specifically, he claimed the warnings were misleading because it was difficult to determine the difference between a serious and benign rash. Falsberg claimed that the labels should warn that “SJS/ TEN is a rash plus mucosal involvement” and that the label should offer diagnostic advice because of the known risk of misdiagnosis. Falsberg further argued that Washington should change its standard to require warnings to every “healthcare provider,” which is the standard followed in Oregon.
In declining to recognize Falsberg’s argument, the Court explained that a drug manufacturer satisfies its duty when it gives adequate warning to the physician who prescribes it, and any reasonable physician who read the warning label would be aware of the risks of SJS and TEN. The Court noted there was no precedent to support Falsberg’s claim that a warning label must go beyond warning of side effects to include diagnostic tips, or otherwise instruct a doctor on how to practice medicine. Because Lamictal’s warning labels warned of SJS and TEN by name, the appeals court held the warnings were adequate as a matter of law.
The Court also declined to require a warning to every healthcare provider that comes in contact with the patient, noting that it is the physician who prescribes medication to a patient, and a physician ordinarily will not prescribe a product that he does not consider reasonably safe to a patient.
NOTE: This opinion has not been published. It is provided to demonstrate how the court approaches the issues involved in the case. It cannot be cited as authority to a court of law.
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