DUTY TO WARN LITIGATION

Pharmaceutical “duty to warn” litigation is, without doubt, one of the fastest growing areas of legal practice. Pharmacies are the most recent additions to this practice area, with plaintiffs around the country suing them on various theories surrounding the pharmacies’ sales of prescription medication.

Our office represents a number of retailers as pharmacy liaison counsel in the on-going Baycol litigation in California. In that vein, we recently won a demurrer (or motion to dismiss) that eliminated dozens (if not hundreds) of lawsuits brought by plaintiffs against numerous pharmacies in the State.

As most readers will be aware, there were approximately 7,800 lawsuits in state and federal courts regarding Baycol – a statin drug used in the treatment of elevated cholesterol. In addition to suing the manufacturer of the drug and the drug’s co-promoter, as well as many doctors who prescribed Baycol, many plaintiffs also sued the pharmacies who dispensed the medication. Fortunately, in large part due to the Court’s ruling that a pharmacy/retailer does not have a generalized duty to warn, virtually all of the California state Baycol cases involving pharmacies and retailers have been dismissed.

In California’s coordinated action, Plaintiffs’ “Master Complaint” asserted causes of action against the pharmacy defendants for, among other things, products liability, breach of warranty, and unfair business practices. Plaintiffs also contended that a general negligence duty to warn existed or was imposed by California Code of Regulations, Title 16, §1707.2 (which generally discusses a pharmacist’s obligations regarding patient counseling). Similar regulations exist in many states.

As liaison counsel, we challenged the plaintiffs’ ability to state a claim against the pharmacies based, in large part, on the California Supreme Court’s opinion in Murphy vs. E.R. Squibb & Sons, Inc. (1985) 40 Cal.3d 672. There, the Court expressly held pharmacies immune from strict products liability arising out of the mere act of filling a prescription. The Murphy Court recognized that the pharmacist who fills a prescription is providing a service to the doctor and is in a different position than that of an ordinary retailer, because he cannot offer a drug for sale without the prescription of a doctor. The Court also noted that it would be unfair and burdensome to expose a pharmacy to strict liability, since a pharmacist may provide the drug only on a doctor’s prescription, which they must strictly follow.

Accordingly, we argued that Murphy precluded the imposition of “negligence” liability arising out of nothing more than a pharmacist filling a valid prescription. If a plaintiff could not state a strict products liability claim predicated on such conduct, changing the name of the theory to a “negligent” failure to warn should not create a different result. Additionally, we argued that there was no authority supporting plaintiffs’ argument that §1707.2 imposed a duty of care on the part of the pharmacists. Further, we argued that the “learned intermediary” doctrine precluded imposition of liability on the pharmacies.

Subsequently, the Court held in favor of the pharmacies, finding that there was no generalized duty to warn on the part of the pharmacy concerning the dispensing of an allegedly defective drug and that §1707.2 did not create a private right of action. In turn, all of plaintiffs’ causes of action were held to be improper and judgment was entered in all but the few cases where plaintiffs’ attorneys were able to specifically allege a particular contraindication or other action that went beyond a “general” duty to warn.

It is hoped that this ruling on the pharmacy/retailer’s duty to warn will cause plaintiffs’ counsel to reconsider suing pharmacies in future pharmaceutical litigation (most are included to defeat diversity jurisdiction.) However, only a clear published court of appeal case will ensure that pharmacies need not face similar litigation in the future.
By Jonathan Allan Klein

Mr. Klein is a partner with Kelly, Herlihy & Klein LLP in San Francisco. He specializes in the representation of pharmacies in professional negligence, general pharmaceutical and employment-related actions.