Drug Maker Not Liable in Death Caused by User, Maryland Court Rules

September 12, 2008

The Maryland Court of Appeals has ruled that drug manufacturer Eli Lilly was not liable for a fatal accident caused by a user of one of its diabetes drugs who blacked out while driving and crashed into another vehicle.

Ellen Crews, a diabetic who took insulin medications while driving, struck an automobile driven by Isaac Gourdine, killing him. Gourdine’s wife filed suit against Eli Lilly and Co., the manufacturer of the insulin medications taken by Crews, alleging fraud, negligence and strict liability for failure to warn of known concealed defects.

The Circuit Court for Prince George’s County granted summary judgment in favor of Lilly, finding that Lilly did not owe a duty of care to Gourdine to warn Crews of the dangers that were allegedly associated with the specified medications. The state’s highest court, The Court of Appeals has now affirmed.

Gourdine’s wife had argued that it was foreseeable for Lilly that Crews, allegedly suffering an adverse reaction to the medications, would cause injury and death to third persons while she was operating a motor vehicle, when she had not been adequately warned about the dangers that allegedly were associated with the specified medications. This foreseeability created a duty owed to Gourdine, she argued.

Gourdine’s attorneys claimed that “Lilly breached its duty by failing to warn consumers that a high percentage of Type I diabetics were at greatly increased risk of drug-induced hypoglycemia, neuroglycopenia and drowsiness at mid-day.”

Lilly’s lawyers counter argued that Lilly did not owe a duty to warn the accident victim Gourdine, who did not use or consume Lilly’s insulin products.

The “learned intermediary” doctrine adopted by Maryland courts “imposes on a manufacturer of prescription drugs or devices a duty to give adequate warnings to physicians, dentists, and other licensed health care professionals, including nurses, who may prescribe these products. Under the doctrine, a manufacturer which has adequately warned the physician, in almost every circumstance, has no duty to warn a patient,” the lower court found in siding with Lilly.

The high court offered the same reasoning and ruled that “it follows that if a pharmaceutical manufacturer does not have a duty to give patients using their products warnings, they do not have a duty to warn the people with whom those patients interact.”

The high court also found that even if Lilly’s warnings were inadequate, the injuries to Gourdine were not foreseeable as the plaintiff alleged.

“It cannot be said that Lilly should have reasonably foreseen that Crews, with her history of hypoglycemia, would ignore her doctor’s orders to discontinue her morning insulin, drive a car, suffer a hypoglycemic episode, lose control of her car, strike Gourdine’s car, push it into the back of an illegally parked tractor-trailer, and fatally injure Gourdine. Indeed, to impose a duty on Lilly in these circumstances would create an indeterminate class of potential plaintiffs,” the court said.

The case is Mary Gourdine v. Ellen Crews et al., No. 134, September Term 2007.

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