Pharmacists Mutual Insurance Co. v. Advanced Specialty Pharmacy LLC

230 So. 3d 380
CourtSupreme Court of Alabama
DecidedNovember 18, 2016
Docket1140046
StatusPublished
Cited by2 cases

This text of 230 So. 3d 380 (Pharmacists Mutual Insurance Co. v. Advanced Specialty Pharmacy LLC) is published on Counsel Stack Legal Research, covering Supreme Court of Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pharmacists Mutual Insurance Co. v. Advanced Specialty Pharmacy LLC, 230 So. 3d 380 (Ala. 2016).

Opinion

PARKER, Justice.1

Advanced Specialty Pharmacy LLC,2 Meds I.V., Inc. (Advanced Specialty Pharmacy LLC and Meds I.V., Inc., are hereinafter referred to collectively as “Meds I.V,”3), and several individual defendants were sued by individuals asserting various wrongful-death and personal-injury claims (“the claimants”). Meds I.V., a company that performs pharmaceutical services, is insured by Pharmacists Mutual Insurance Company (“Pharmacists Mutual”). Pharmacists Mutual filed an interpleader complaint in the action and submitted $4 mil[382]*382lion to the Jefferson Circuit Court (“the circuit court”), which Pharmacists Mutual alleged was the policy limits of Meds I.V.’s insurance policies with it, and requested that the circuit court divide the insurance moneys among the claimants. The claimants alleged that the policy limits of Meds I.V.’s insurance policies with Pharmacists Mutual were $7 million rather than $4 million. The parties filed cross-motions for a summary judgment, and the circuit court entered a summary judgment in favor of the claimants. We affirm in part, reverse in part, and remand.

Facts and Procedural History

During the time relevant to this case, Meds I.V. produced total parenteral nutrition (“TPN”) that was used by hospitals and administered to patients. TPN is “widely used in healthcare settings to deliver critical nutrients to patients unable to tolerate enteral4 feeding.” Neil Gupta et al., “Outbreak of Serratia marcescens Bloodstream Infections in Patients Receiving Parenteral Nutrition Prepared by a Compounding Pharmacy,” 59 Clinical Infectious Diseases 1 (May 13, 2014)(Exhibit B to the claimants’ motion for a summary judgment). TPN is nutrition “maintained entirely by central intravenous injection or other nongastrointestinal route.” Sted-man’s Medical Dictionary 1245 (27th ed. 2000). The “ ‘intravenous formulation is intended to provide all daily nutritional requirements, such as electrolytes, amino acids, dextrose, and lipids, and is considered to be one of the most complex pharmaceuticals to prepare because of the need for careful titration and combination of multiple components.’ ” The claimants’ motion for a summary judgment (quoting Gupta et al., “Outbreak of Serratia mar-cescens Bloodstream Infections,” 59 Clinical Infectious Diseases 1).

According to a memorandum from the Centers for Disease Control and Prevention (“the CDC”), attached as Exhibit A to the claimants’ motion for a summary judgment, at Meds I.V.’s facility, “TPN products were compounded by a pharmacy technician in consultation with a licensed pharmacist.” Most ingredients for TPN, including an amino-acid solution, were provided by a manufacturer in sterile, multi-dose vials. However, as a result of a shortage in the manufacturer’s supply of amino-acid solution, Meds I.V. began preparing its own amino-acid solution. According to the same memorandum, to prepare the amino-acid solution, Meds I.V. mixed amino-acid “[pjowders ... with sterile water in a 100-liter non-sterile container.” Then, pursuant to a prescription written by a physician, Meds I.V. compounded the amino-acid solution with other ingredients to produce the prescribed TPN. The affidavit of Donald Bendure, an independent consultant hired by the claimants whose expertise included matters pertaining to risk management, commercial insurance, and insurance litigation, described Meds I.V.’s process for producing TPN:

“[Tjhere were two separate and distinct operations by Meds I.V. that led to the final TPN product delivered from Meds I.V. to the end-user patients: 1) a bulk manufacturing process of [amino-acid solution] not subject to a prescription requirement ... which were [sic] then stored for future use as one ingredient ..., followed by 2) a series of subsequent compound drug preparations, each according to specific individual prescri-ber/patient/pharmacist requirements

[383]*383(Emphasis omitted.) Meds I.V. received requests daily from physicians to fill prescriptions for TPN.

In October 2010, Pharmacists Mutual issued to Meds I.V. two insurance policies: (1) the Business Owners Special Policy (“the business-owners policy”) and (2) the Commercial Umbrella/Excess Liability Coverage Policy (“the excess policy”) (the business-owners policy and the excess policy are hereinafter referred to collectively as “the policies”). The policies provided coverage to Meds I.V. from October 28, 2010, until October 28, 2011, during which the events giving rise to this case occurred.

The business-owners policy has a “general aggregate limit” of $3 million, a “products/completed work hazard aggregate limit” of $2 million, and :an “each occurrence limit” of $1 million, as detailed on the declarations page of the policy. The excess policy provides additional coverage in conjunction with Pharmacists Mutual’s obligation to provide coverage under the business-owners policy. Under the excess policy, Pharmacists Mutual agreed to pay, “up to [its] limit, all sums in excess of ‘underlying insurances’ [the business-owners policy] for which [Meds I.V.] becomes legally obligated to pay as ‘damages’ to which this insurance applies.” The excess policy has an “each occurrence limit” of $1 million, a “general aggregate limit” of $1 million, a^d a “products/completed work hazard aggregate limit” of $1 million, as detailed on the declarations page of the policy.

The business-owners policy provides two main categories of coverage: “Property Coverages” and “Commercial Liability Coverages.” “Commercial Liability Coverages” include four coverage categories: “Coverage L—Bodily Injury and Property Damage Liability”; “Coverage M—Medical Payments”; “Coverage O—Fire Legal Liability”; and “Coverage P—Personal and Advertising Injury Liability.” It is undisputed that “Coverage L” of the business-owners policy, which covers bodily injury, is the only coverage applicable in this case.

In March 2011, the CDC was notified of five patients in a hospital located in Birmingham, Alabama, who had contracted bloodstream infections (“BSIs”) as a result of the presence in their bodies of bacteria Serratia marcescens (“S. marcescens”). According . to the memorandum from the CDC, S. marcescens is “an opportunistic pathogen of the respiratory tract, urinary tract, and wounds [that] has been implicated in outbreaks of [BSIs] associated with contamination of intravenous products.” After receiving notification that those patients had contracted BSIs, the CDC began an investigation and determined that the BSIs were caused by TPN produced by Meds I.V. that was .contaminated with S. marcescens. Later, the CDC discovered at least 19 patients in 6 Alabama hospitals who had contracted BSIs as a result of contaminated TPN produced by Meds I.V. between January 2011 and March 2011; of those patients, 17 tested positive for the presence of S. marcescens. Nine deaths occurred as a result.

Concerning the cause of the contamination of the TPN that resulted in the BSIs in the claimants or those whom the claimants represent, Don McGuire, general counsel for Pharmacists Mutual, stated in an e-mail to Pharmacists Mutual’s reinsurer that one “pharmacy technician” at Meds I.V. had indicated that there were “a number of procedure violátions that could have resulted in a contaminated solution” of the TPN, and that “[o]ne important lapse was that ... on at least 3 occasions, bags were not quarantined and tested prior to 'their being used in compounding patient orders.” McGuire further explained that “[i]t [384]

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230 So. 3d 380, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pharmacists-mutual-insurance-co-v-advanced-specialty-pharmacy-llc-ala-2016.