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FDA Warning-Black Salve Is Fake Cancer Cure-Found Irrelevant for Blemish Use Injury


A patient presented to a naturopathic physician for a thyroid issue and discussed an irruption or blemish on her nose and her desire to remove it. The following months, the patient returned to the naturopathic physician’s office where he applied to the patient’s nose black salve, an escharotic agent - a caustic or corrosive substance that has the strength to burn tissue. The naturopathic physician sent the patient home with instructions to return. A few days later, the patient returned, and the naturopathic physician reapplied black salve to her nose.

 

The woman went to an urgent care complaining of facial swelling and burning. The urgent care physician diagnosed her with an infected third-degree burn on her nose, which was 4 mm deep and dime sized. The urgent care continued to treat the woman until she healed.

 

Unhappy with the appearance of her nose, the woman underwent plastic surgery about six weeks later. The plastic surgeon repaired the indent with a rotational flap repair. To maintain a scar free appearance the woman requires surgical injections twice a year.

 

The woman sued the naturopathic physician for medical malpractice. The complaint stated that black salve was an unapproved new drug, the marketing of which violated the Food, Drug, and Cosmetic Act (FDCA). The complaint also stated that as early as 2008 the FDA determined black salve is a fake cancer cure and warned consumers not to use it.

 

Prior to trial, the naturopathic physician moved to exclude evidence and argument relating to the FDA letters that warned consumers about black salve as a fake cancer cure and that the FDCA prohibited selling, marketing, or manufacturing drugs not approved by the FDA. The motion argued the FDCA prohibition and FDA warning letters were irrelevant and overly prejudicial as the complaint addressed the practice of medicine, not the manufacturing, marketing, or selling of black salve. Further, the motion argued that the naturopathic physician never claimed to be curing cancer with black salve. The Eighteenth Judicial District Court, Gallatin County, granted the naturopathic physician’s motion to exclude, finding the evidence irrelevant and overly prejudicial.

 

Prior to trial the woman filed a motion to exclude testimony from the naturopathic physician’s expert naturopathic physician on the standard of care for a naturopathic physician. The motion claimed that the expert was not an expert regarding the use or discharge of black salve. The naturopathic physician contended that the expert was qualified to be an expert on the practice of naturopathic medicine, not the use of a specific product such as black salve. The trial court denied the woman’s motion to exclude, finding the expert satisfied the expert witness requirements.

 

After a trial, the jury found that the naturopathic physician departed from the standard of care applicable to a naturopathic physician. The jury awarded damages but declined to award punitive damages. The jury determined that the woman failed to prove by clear and convincing evidence that the naturopathic physician acted with actual malice. The jury awarded the woman $139,500 plus costs of $5,847.08, for a total of $145,347.08.

 

The Supreme Court of Montana affirmed. The court held that the trial court did not abuse its discretion when it granted the naturopathic physician’s motion to exclude evidence of the FDCA prohibition against selling, marketing, or manufacturing drugs not FDA approved and the FDA warning letters regarding the use of black salve as a cure for cancer; the trial court did not abuse its discretion when it denied the patient’s motion to exclude a naturopathic physician’s expert opinion testimony; and substantial evidence supported the jury’s refusal to award punitive damages.

 

The trial court did not abuse its discretion when it granted the naturopathic physician’s motion to exclude evidence of the FDCA prohibition against selling, marketing, or manufacturing drugs not FDA approved and the FDA warning letters regarding the use of black salve as a cure for cancer. Evidence that the FDA letters warned consumers about black salve as a fake cancer cure and that the FDCA prohibited selling, marketing, or manufacturing drugs not approved by the FDA was irrelevant. The patient did not allege the salve was prescribed as a cancer treatment. Montana law allowed the naturopathic physician to administer escharotic agents, such as black salve. The naturopathic physician did not violate the FDCA prohibition.

 

The trial court did not abuse its discretion when it denied the patient’s motion to exclude a naturopathic physician’s expert opinion testimony. The expert naturopathic physician was qualified to testify as an expert regarding the applicable standard of care, even though the naturopathic physician did not consider himself an expert on the use of black salve as an escharotic. The naturopathic physician’s education included a four year undergraduate degree in biology and chemistry, followed by four years of study at a naturopathic school and a two-year postgraduate residency.

 

Substantial evidence supported the jury’s refusal to award punitive damages. The jury instructions clearly indicated what was required for the jury to find the naturopathic physician acted maliciously. Based on the evidence presented, the jury did not find by clear and convincing evidence that the naturopathic physician acted with malice. Persuaded by the facts in the case and informed by the clear jury instructions, the jury refused to award punitive damages.

 

The Supreme Court of Montana affirmed the trial court’s entry of judgment on a jury verdict awarding compensatory, but not punitive, damages to the patient.

 

See: McColl v. Lang, 2016 WL 5900207 (Mont., October 11, 2016) (not designated for publication).

 

See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability

 

See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results 

 

 

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