PBM must face negligence suit over elderly woman’s death

Negligence charges against a pharmacy benefits management firm that delivered the wrong medications to an elderly woman who took the pills and later died have been reinstated by a federal appeals court.

Bertha Small was accustomed to receiving medications in the mail from a unit of Centennial, Colorado-based WellDyne Inc., according to Wednesday’s ruling by the 4th U.S. Circuit Court of Appeals in Richmond, Virginia, in Michael A. Small v. WellDyne Inc. et al.

WellDyne was under a contract with Tampa, Florida-based Exactus Pharmacy Solutions Inc., a Tampa, Florida-based specialty pharmacy, to fill and ship prescription medication to Exactus’ customers.

Exactus placed an order with WellDyne to fill and ship a package of prescription medications to an Exactus customer in California, but WellDyne mistakenly shipped the package to Ms. Small instead.

Although the outside of the package contained Ms. Small’s name and address, the label on each bottle listed the California patient’s name, his prescribing doctor and the medication’s name. But Ms. Small, who was elderly and barely literate, did not read the bottles’ labels before taking the pills.

After ingesting them, she began to experience confusion and hallucinations. A few days later, she fell and fractured her leg. She was admitted to the hospital for her leg, but stayed for almost a month, when she was treated for several other medical problems that arose. She died on Jan. 2, 2014, about 10 days after being discharged.

Ms. Small, who was 74 when she took the wrong pills, was taking prescription primarily for kidney dysfunction, while the medication she took was for hypertension, according to the case’s plaintiff attorney Willie D. Gilbert II, a Wilson, North Carolina-based solo practitioner.

Ms. Small’s son, Michael Smith, filed suit against WellDyne and Exactus on charges including negligence, and alleged Exactus was vicariously liable for Exactus’ actions.

The U.S. District Court in Elizabeth City, North Carolina, granted the defendants summary judgment dismissing all charges. A three-judge appeals court panel unanimously reinstated the negligence charges against WellDyne.

“Summary judgment is rarely appropriate for issues of contributory negligence because ‘the standard used in contributory negligence cases, that of reasonable care, usually requires a jury determination,’” said the panel, in citing an earlier ruling.

The defendants argue “that the evidence establishes, as a matter of law, Ms. Small failed to use ordinary care when she took the misdelivered medications without reading the labels on the medication.”

The plaintiff argues in response “that a reasonable jury could find that she acted reasonably under the circumstances of this case. Ms. Small was a barely literate, geriatric patient who received a familiar-looking package of medications from a familiar pharmacy, addressed to her,” and the pills appeared similar in sizer and shape to her regular medication, said the ruling.

“We … cannot say that as matter of law that Ms. Small was contributorily negligent for failing to read the labels on the medications,” said the ruling, in reversing the U.S. District Court on the issue of contributory negligence.

The appeals panel said also the issue of whether there was sufficient evidence to “create a dispute of material fact” that the misdelivered medications were the cause of her injuries and her death should also be considered by a jury.

Experts in the case have “described a chain of events beginning with the ingestion of the medications and ending in Ms. Small’s death,” the ruling said.

The District Court had held “the relationship between cause and effect is too attenuated such that plaintiff cannot demonstrate proximate cause,” said the ruling.

But the expert testimony, “if admissible is evidence for which a jury could conclude that Ms. Small’s ingestion of the misdelivered pills was the proximate cause of her death,” said the ruling, which also upheld the lower court’s summary judgment dismissal of Exactus from the case.

Mr. Gilbert said he was pleased with the ruling. It will be particularly significant within the 4th Circuit, where, under its doctrine of contributory negligence, if plaintiffs are shown to be even 1% negligent in causing their own injury, “they are completely barred from recovering from a defendant.” It may also be influential in other circuits, he said.

Attorneys for WellDyne and Exactus did not immediately respond to a request for comment.