Thomas A. Moore and Matthew Gaier ()
The provision of health care has never been the exclusive province of doctors, nurses and hospitals, and in recent decades the number of different professions involved in providing medically related services has seemingly grown almost exponentially. When the providers of these allied health care fields perform their functions in a negligent manner, the ramifications can be as severe as any medical malpractice. Pharmacists are professionals who have long had a close and important relationship to the provision of medical care. Some 16 years ago, we explored the boundaries of pharmacists’ liability for negligence,1 and we revisit the subject in this month’s column.
The Court of Appeals set the standard for the liability of a pharmacy in New York just over a century ago in Willson v. Faxon, Williams & Faxon, 208 N.Y. 108 (1913). The plaintiff in that case purchased a box of pills called Kascara Kathartics from the defendant pharmacy. The label indicated that they were manufactured by the pharmacy and that they were intended for use as a laxative. The plaintiff, who had theretofore treated constipation with a preparation called cascara sagrada, testified that the pharmacy’s clerk told her that this product was the same, only in pill form. However, after the plaintiff used the product, she developed a condition known as mercurial salivation, which apparently results in a metallic taste in the mouth and excessive salivation.
She sued the pharmacy, which defended by demonstrating that another company had in fact manufactured the pills. It was stipulated that this was a “proprietary medicine,” meaning it was patented by the manufacturer, which sold them to the defendant with a special label, and that it was not the custom of retail druggists to analyze proprietary medicines. The Appellate Division found, in pertinent part, that the proof was insufficient to establish negligence by the pharmacy because it purchased the pills from a reputable manufacturer and did not know they were dangerous. In reversing, the Court of Appeals found that the pharmacy could be liable for negligence because it held itself out as the manufacturer of the drug without taking any action to ascertain the true character of the compound. In so holding, the court set forth the following standard for pharmacy liability:
The negligence which must be established to render a druggist liable in such a case as this is measured by his duty; and while this is only to exercise ordinary care, the phrase ordinary care in reference to the business of a druggist must be held to signify “the highest practicable degree of prudence, thoughtfulness and vigilance, and the most exact and reliable safeguards consistent with the reasonable conduct of the business in order that human life may not constantly be exposed to the danger flowing from the substitution of deadly poisons for harmless medicines.” (Tremblay v. Kimball, 107 Maine, 53.)
That is essentially the standard that continues to be the law of this state to this day. Modern decisions have described the standard as “the highest practicable degree of prudence, thoughtfulness and vigilance commensurate with the dangers involved and the consequences which may attend inattention.”2 Additionally, the courts have distilled the following rules to assess the liability of pharmacies for negligence relative to filling prescriptions:
Generally, a pharmacist cannot be held liable for negligence in the absence of an allegation that he or she failed to fill a prescription precisely as directed by the physician or was aware that the customer had a condition that would render the prescription of the drug at issue contraindicated. In addition, liability or culpable conduct on the part of a pharmacy may be found where there was some active negligence on the part of the pharmacist. Brumaghim v. Eckel, 94 A.D.3d 1391 (3d Dept. 2012) (citations omitted).
Applying these rules, the Third Department in Brumaghim dismissed a complaint against a pharmacy in which the plaintiffs alleged that the defendant doctor prescribed an inadequate dosage of the blood thinner Coumadin, and that the pharmacy was negligent in failing to contact the doctor to inquire as to whether the prescribed dosage was correct. In an attempt to fit the case within the analytical framework set forth above, the complaint alleged that the pharmacy filled an incorrect and inconsistent prescription of a contraindicated dosage for the plaintiff.
The court found while other jurisdictions “have concluded that pharmacists have a duty to be alert for, and take corrective measures to address, patent errors on the face of a prescription, such as inadequacies in the instructions or incompatible prescriptions…, plaintiffs make no such claim here.” Instead, the plaintiffs were asserting that the prescription was for a dosage that was inappropriate and inadequate for the plaintiff in particular, as differentiated from a dosage that would be inappropriate under any circumstance. The court concluded that there were no sound policy reasons to impose a duty on a pharmacist to question the physician’s judgment whenever there is a change in a prescription that is otherwise within medically acceptable ranges.
Subsequently, in Burton v. Sciano, 110 A.D.3d 1435 (4th Dept. 2013), the Fourth Department affirmed dismissal of a complaint alleging that a pharmacy was negligent in filling a prescription for Prednisone without contacting the physician to double check the dosage or advising the patient that it was a very high dosage and of the attendant risks. Citing Brumaghim, the court noted that there was no allegation that the dosage exceeded the medically acceptable range that should be provided under any circumstance, that the pharmacy did not follow the prescription or that it was aware that the drug was contraindicated for the plaintiff. The plaintiff submitted an expert affidavit from a pharmacist, asserting that the profession had created a standard of care that requires the pharmacy to undertake the measures cited by the plaintiff. The court rejected this because it did not reference any scientific basis for the assertions.
In Eberle v. Hughes, 77 A.D.3d 1398 (4th Dept. 2010), the same court affirmed the denial of a pharmacy’s summary judgment motion where the plaintiff alleged that the pharmacist failed to take into account her medical history, failed to adhere to pharmaceutical recommendations regarding the drug, and failed to contact the prescribing physician regarding contraindications and suggest pharmaceutical substitutes.
The evidence established that after the pharmacy filled a prescription for the antibiotic Clindamycin, the plaintiff read a warning on the patient information sheet that persons with a history of ulcerative colitis should notify the physician or pharmacist before taking the medication. The plaintiff testified that because she had such a history she returned to the pharmacy and informed the pharmacist, who told her that the warning “was applicable to extreme cases and that she should not be ‘paranoid’ and should take the medication.” Based on that evidence, the court concluded that a trier of fact could determine that the pharmacy breached its duty of ordinary care.
In Raynor v. St. Vinvent’s Hosp. & Med. Center of N.Y., 12 A.D.3d 298 (1st Dept. 2004), the court found issues of fact as to whether the defendant medical and pharmacy professionals saw, or should have seen, from the decedent’s escalating use of prescription steroids meant only for short-term, acute asthma, that his asthma was out of control. This raised questions as to whether the physicians and the pharmacist breached their duties to the decedent to see that his asthmatic condition was not left inadequately addressed.
The mere fact that a pharmacy negligently fills a prescription with the wrong medication does not necessarily mean that there is liability. In Ostrow v. New London Pharmacy, Inc., 278 A.D.2d 158 (1st Dept. 2000), the pharmacy mistakenly dispensed sulfadiazine rather than sulfasalazine, and the plaintiff alleged that the error caused a worsening of her ulcerative colitis. The defense experts testified that the injuries were caused by steroids that the plaintiff had been taking. The jury’s finding of negligence but no causation was affirmed on appeal.
When previously addressing the issue of pharmacy liability, we discussed the First Department’s decision in Bichler v. Willing, 58 A.D.2d 331 (1st Dept. 1977), a products liability action involving DES—a drug ingested during pregnancy that caused injuries in the offspring years later—in which the court dismissed all claims against the pharmacist who filled the prescription. Subsequently, in Elliot v. A.H. Robins Company, 262 A.D.2d 132 (1st Dept. 1999), appeal dismissed, 94 N.Y.2d 835, lv. denied in part and dismissed in part, 94 N.Y.2d 895 (2000), a product liability action involving a diet drug, the same court dismissed the complaint against pharmacists who filled the prescription because there were no allegations that they failed to fill them as directed or that the plaintiffs had conditions for which the drug was contraindicated and of which the pharmacists were aware.
Our prior column on the subject also discussed Ullman v. Grant, 114 Misc.2d 220 (Sup. Ct., Kings Co. 1982), where the court dismissed a negligence claim against a pharmacy based on its substitution of one drug for another, and did not warn the plaintiff of the potential side effects. The plaintiff had an adverse reaction. In dismissing the claim, the court, citing Bichler, stated that a “pharmacist is not negligent unless he knowingly dispenses a drug that is inferior or defective,” and that the plaintiff had made no such allegation. The citation to Bichler referred to a statement in that decision that “in view of the absence of any showing of a difference between the DES chosen by the druggist and other available brands, his choice of the particular name brand of DES cannot be classified as negligence.”
Both of those decisions were relied upon by the plaintiff in Winters v. Alza Corp., 690 F.Supp.2d 350 (S.D.N.Y. 2010), whose decedent died after being given a generic version of a fentanyl patch by the defendant pharmacy. The official New York State form for the prescription expressly indicated that a generic drug could be used unless the prescribing physician checked a box to the contrary, and the box was not checked. The court noted that the plaintiff conceded that the patch was FDA-approved at the time it was dispensed and that the pharmacy filled the prescription as instructed by the doctor. It further noted that the plaintiff did not allege that it was filled in a manner inconsistent with the manufacturer’s information.
Nevertheless, the plaintiff alleged that the generic version of the patch that the pharmacy gave the decedent was defectively designed. It utilized a reservoir design that allegedly permitted the gel to leak out and increase the level of the drug, and that this is why the decedent died. The plaintiff also alleged that prior to filling the prescription this type of patch had been the subject of a recall, that there were other generic patches that used a safer, multi-laminate design, and that the pharmacy knew that the patch it dispensed to the decedent was inferior. It was the plaintiff’s theory that the pharmacy was required to fill the prescription with the safer of two competing alternative generic medications.
The court rejected that theory and concluded that the pharmacy could not be held liable. In reaching that result, the court dismissed as dicta the plaintiff’s reliance on the statements in Bichler and Ullman, cited above. Putting aside that dicta, which certainly appear to support the plaintiff’s claim in Winters, we think that the court’s decision was inconsistent with the very essence of the standard that governs pharmacy liability under the law of New York. If, as alleged, the pharmacist in Winters was aware of the difference between the types of generic patches and that there had been a recall of the one dispensed, unless he had some other valid reason for choosing the patch he chose (such as it offered some additional benefit or the other patch had some other risk), his choice was inconsistent with “the highest practicable degree of prudence, thoughtfulness and vigilance commensurate with the dangers involved and the consequences which may attend inattention.” The allegations at least provide a basis upon which a jury could reasonably have found that the standard was violated.
Finally, in Fagan v. Amerisourcebergen Corp., 356 F.Supp.2d 198 (E.D.N.Y. 2004), the court held that a pharmacy that delivered medications to the plaintiff via mail could be held liable for negligence in selling drugs that were counterfeit. The medications were injected into the plaintiff following a liver transplant, and he claimed that they caused him to suffer anemia and excruciating side effects. The court found that the complaint stated a cause of action against the pharmacy by alleging that it incorrectly filled the prescription by delivering 1/20th the prescribed dosage, and by failing to inspect the label of the drugs, which contained information that would have revealed that they were counterfeit.
Negligence by pharmacists can have severe repercussions on patients’ health. As profits continue to be an overriding force in the various industries involved in prescription medications, pharmacists must be alert to protect their customers from errors, abuses and other problems that may result. While the legal standards of pharmacy liability remain essentially the same as they have for the past century, the circumstances which may satisfy that standard should evolve along with the role of the pharmacist.
Thomas A. Moore is senior partner and Matthew Gaier is a partner of Kramer, Dillof, Livingston & Moore.
1. See Moore and Gaier, “The Liability of Pharmacies,” NYLJ, Dec. 2, 1997, p. 3.
2. See Burton v. Sciano, 110 A.D.3d 1435 (4th Dept. 2013); Brumaghim v. Eckel, 94 A.D.3d 1391 (3rd Dept. 2012); Eberle v. Hughes, 77 A.D.3d 1398 (4th Dept. 2010); Hand v. Krakowski, 89 A.D.2d 650 (3d Dept. 1982).