Metropolitan News-Enterprise


Monday, June 23, 2014


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C.A. Allows Suit Over Drug Monograph to Go Forward

Panel Says Plaintiff May Prevail on Claim That Medication’s Risks Were Minimized




A woman who claims she suffered total blindness and other deleterious effects as a result of taking an anti-epilepsy drug can sue the distributor of a monograph she claims understated the drug’s risks, the First District Court of Appeal has ruled.

Div. Three Thursday affirmed an Alameda Superior Court judge’s denial of an anti-SLAPP motion brought by PDX, Inc.

The company’s contention that distribution of the monograph was protected activity in connection with a public issue raised “an interesting issue,” Justice Peter Siggins wrote. But the court need not rule on it, he said, because the plaintiff showed a sufficient likelihood of prevailing on her claim to survive the motion under Code of Civil Procedure §425.16.

Kathleen Hardin alleged that after she began taking Lamotrigine, the generic form of Lamictal, she learned it carries a significant risk of causing Stevens-Johnson syndrome and associated toxic epidermal necrolysis, particularly when taken in combination with her other medications.

She and her husband sued several defendants, including PDX and Wolters Kluwer Health, Inc.

PDX provides software that can be used by pharmacies to access monographs, published by Wolters Kluwer, summarizing information about various prescription drugs. The pharmacies then provide the monographs—which are not regulated or reviewed by the government—to patients when they fill their prescriptions.

The version of the monograph that Hardin received was a five-paragraph abbreviation of an eight-paragraph document. What was omitted, under an agreement between Safeway, which operated the pharmacy, and PDX was a “Black Box” warning reading:

“SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. . . .  Contact your doctor immediately if you develop rash symptoms, including red, swollen, blistered or peeling skin.  Treatment with this medication should be stopped unless it is clearly determined that the medicine did not cause the rash.  Even if the medicine is stopped, a rash caused by this medicine may still become life-threatening or cause serious side effects (such as permanent scarring).”

Hardin said in her court filings that had she been provided such a warning, she would not have taken the medication.    

PDX and Wolters Kluwer both filed anti-SLAPP motions. Judge Gail Brewster Bereola granted Wolters Kluwer’s motion but denied PDX’s.

The judge reasoned that while the claim against Wolters Kluwer stemmed solely from its protected publishing activities, the claim against PDX stemmed from its agreement with Safeway to abbreviate the monograph, an action beyond mere distribution of the monographs.

Siggins, writing for the Court of Appeal, said Hardin presented evidence that would support a judgment against PDX under the “negligent undertaking” doctrine.

The justice cited Restatement (Second) of Torts §324A, which sets out circumstances in which a party who “ render services to another which he should recognize as necessary for the protection of a third person or his things” may be held liable “for physical harm resulting from his failure to exercise reasonable care to [perform] his undertaking.”

The requisite circumstances, according to the Restatement, are when the failure to exercise reasonable care increases the risk of harm, when the party undertakes to perform the duty owed by another to the injured party, or the injury results from the injured party’s reliance on the undertaking.

Siggins wrote:

“Here, Hardin presented evidence that PDX knew that enabling Safeway to print the abbreviated monograph could place patients at risk, including, notably, the acknowledgement in its 2006 agreement with Safeway that providing the full eight-section version would better enable patients to ‘use the medication properly and appropriately, receive the maximum benefit, and avoid harm.’ This record sufficiently makes out a claim that PDX assumed a duty of care by undertaking to render services to Safeway ‘of a kind [it] should have recognized as necessary for the protection of third persons. . . .’”

The justice rejected the claim that PDX is immune under §230 of the Communications Decency Act, which protects the operator or user of an “interactive computer service” from liability for content contributed by third parties. PDX, he noted, is not being because of content provided by a third party, but “because it intentionally modified its software to allow Safeway to distribute abbreviated drug monographs that automatically omitted warnings of serious risks.”

The case is Hardin v. PDX, Inc., 14 S.O.S. 3108.


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