Professional Negligence: When Practice Goes Wrong

Curtis E. Harris; Warren Richards; Jack E. Fincham

Disclosures

The Annals of Pharmacotherapy. 2006;40(7):1377-1382. 

In This Article

Case Presentation

Dale McIntosh owns Cornerstone Pharmacy. Cornerstone has been at the same location, next to Mercy Hospital, since 1956. Many things have changed in the past 50 years, but most of the changes have occurred since he bought the pharmacy from his former partner 20 years ago. Dale has seen a successful business, based on professional service and community loyalty, gradually morph into a small compounding pharmacy, providing the few products not on the shelves of MegaPharm, the national chain pharmacy that moved into the area 18 months ago. After a sobering look at his books, Dale has realized what he has known for more than a year: unless he can do something drastic to improve his bottom line, he will soon be out of business.

Mercy Hospital recently opened a new international cancer treatment center, a service that has been very successful, drawing patients from a 3 state area. Dale tried to obtain the contract to provide premixed chemotherapeutic agents to the private oncology offices at Mercy, but he was outbid by MegaPharm. However, the annual renewal bidding process will begin next month, and Dale is desperate to win this time. He has spent hours in the medical library, and he thinks he knows how to undercut MegaPharm. He decides to dilute 3 of the 9 chemotherapeutic agents by 25% from the concentrations required in the contract, sell the solutions at 5% less than the MegaPharm price, and therefore make just enough profit to stay in business and cover his overhead. From all he can learn, Dale concludes that the 3 agents are almost as effective at the diluted strength as at the full strength and may even cause fewer adverse effects if diluted. While this step will require Dale to be deceptive, he is convinced that he will harm no one.

Dale also received a call last week from "A New You," a group of 5 plastic surgeons who practice at Mercy. Their office manager was looking for a less expensive source for Botox injections than MegaPharm could provide and wondered whether Dale could help. Dale has made a number of contacts over his long career, including some less-than-reputable suppliers. As it happens, one of them had just told him how he could buy deeply discounted Botox from Mexico at a fraction of the price he would pay in the US. Seeing his opportunity, Dale placed an order. When the first shipment arrived, Dale recognized the package markings as irregular, suggesting that the source of the Botox was not the national pharmaceutical company printed on the label. When he called his supplier, he was told that the Botox was "good stuff" and that if he wanted more, he needed to adopt a "don't ask, don't tell" attitude. Dale decided he wanted more Botox.

Everything went well for the next 2 years until one afternoon when one of the plastic surgeons called Dale, panicked and distraught. A young woman he had injected with Botox from Cornerstone had just been admitted to the emergency department with nausea, vomiting, and shortness of breath. She had quickly developed severe respiratory distress and cardiac arrest and had died. The physician wanted to know whether the Botox he had used had anything to do with his patient's death.

When the coroner's report confirmed the death to be due to a massive dose of botulism toxin, an investigation ensued. The problem became evident quickly. The discounted Botox Dale had received in the most recent shipment was 100-fold more concentrated than expected and of a crude grade. Dale had simply assumed the shipment was the same as in the past and had labeled it as he usually did. What Dale did not know was that this formulation of Botox came from a small, backroom repackaging operation in Brownsville, Texas, and that the material used there was not approved by the Food and Drug Administration for human use in the US.

Dale has been arrested and charged with negligent homicide. An investigation of his pharmacy records has also revealed his fraudulent formulation of the chemotherapeutic solutions. The district attorney has turned this finding over to the Cancer Treatment Center and to the Centers for Medicare and Medicaid (CMS). He has asked the hospital to investigate the possibility of any excess morbidity and mortality during the time they had been using Cornerstone for their pharmacy needs and for CMS to investigate the possible violation of any federal laws (ie, whether Dale had defrauded the government by selling diluted medications to Medicare/Medicaid patients).

Finally, Dale has been served (along with the plastic surgeon) in a wrongful death malpractice suit by the husband of the woman who died from the Botox injection. Dale is concerned by something his attorney has just told him: his malpractice insurance policy does not cover willful or intentional misconduct. The malpractice carrier has notified Dale's attorney that it is considering denying coverage based on the outcome of the felony charge.

Dale understands that he has been sloppy in his business practices, possibly even negligent, but he maintains that he has not intentionally hurt anyone, that he was deceived like everyone else by the supplier of the illegal Botox, and that no one was actually hurt by his practice of diluting the 3 chemotherapeutic drugs. Dale does not understand how anyone could accuse him of homicide.

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