Professional Negligence: When Practice Goes Wrong

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


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

In This Article

Case Analysis

Most of the issues raised by the case presented here are probably evident after consideration of the various levels of negligence, but it is useful to look briefly at the behavior of Dale McIntosh in some detail, as an example of actions to avoid.

Ordinary Negligence and Per se Negligence

One of the most important issues being addressed at the state and national level by lawmakers and healthcare professionals is the lack of uniform standards of care for out-patient, office-based care and the various professions that support that care. Free-standing plastic surgery centers and oncology treatment centers are among the several areas that have drawn attention. State statutory law mandates elaborate protections for free-standing treatment centers, and federal law expands those protections through Medicare and Medicaid regulations. However, unless a facility directly bills CMS or falls within the state guidelines of the definition of a surgical center, remarkably little statutory law applies to either the physician's office or any of the services that support a physician's office. Dale's privately owned pharmacy was therefore not subject to any significant amount of state or federal oversight beyond the ordinary business laws that govern commercial transactions.

The public often assumes a level of safety in a pharmacy that is not present in all situations. Therefore, the only protection commonly afforded patients who received medications from Cornerstone Pharmacy would be the postevent recovery possible under Dale's malpractice insurance policy, combined with any restraint Dale might feel based on either the threat of a malpractice suit or on his personal professional/ethical standards. Most malpractice suits are brought due to ordinary negligence. The proof of ordinary negligence is a fact-intensive enquiry, subject to the judgment of a jury based on all of the facts at hand. Dale's carelessness in the purchase of the Botox and his failure to ensure normal product quality would be the central issues for the jury to consider.

Gross Negligence

The essential element of a finding of gross negligence is the determination of a willful or wanton disregard for the safety of others. Dale noticed a difference in the packaging of the Botox that he purchased from Mexico, suggesting to his trained eye that repackaging or fraudulent packaging was being done. Repackaging or intentional mislabeling exposes the consumer to an unpredictably high risk because it ignores the normal safeguards. By ignoring this risk to make a profit, Dale willfully disregarded the safety of the patients who received the Botox that he sold. He will almost certainly be found liable for gross negligence.

Criminal Negligence

Dale sold the Botox to a physician who represented the risk to his patients, based on the reputable use of the product. Since the patient's informed consent to the use was obtained without knowledge of Dale's misrepresentation (a fraud), no actual informed consent was obtained. Therefore, the physician committed a battery by injecting the Botox, but the battery was perpetrated by Dale's fraud, with the physician taking the position of an involved but innocent party. A battery that causes death is a homicide, with or without a specific intent to harm. Dale faces a difficult task to prove his innocence.

Medicare Fraud

Medicare and Medicaid law consists of a complex volume of regulations and case law, well beyond the scope of this discussion on negligence.[10] However, Dale's misrepresentation of the strength of the 3 chemotherapeutic agents will probably constitute Medicare fraud. Simply defined, it is fraud to receive payment for a product or service provided to a Medicare recipient that is significantly other than the product or service billed. Diluted, altered medications would fall under this definition. Even if the diluted drugs did not harm anyone, Dale would be liable for Medicare fraud and subject to severe fines and penalties. Dale's malpractice insurance would not cover this liability.


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