A Kansas City man died last year after taking an unapproved erectile dysfunction drug allegedly labeled as a dietary supplement, a Jackson County lawsuit says.
David R. McElwee, 39, suffered a loss of blood pressure, which ultimately led to a fatal heart attack, after taking a product sold under the brand name Stiff Nights, according to the lawsuit filed in August on behalf of his children.
McElwee purchased it at the Erotic City adult products store on Sept. 22, 2012, ingested it two days later and died Sept. 25, according to the lawsuit.
In addition to Erotic City, the lawsuit named two companies that it accused of manufacturing and marketing the products: NovaCare LLC of Salt Lake City, and Impulsaria LLC of Grand Rapids, Mich.
Both companies have come under scrutiny for sales and distribution of Stiff Nights.
In November 2009, the Food and Drug Administration warned the public that Impulsaria’s Stiff Nights product could endanger users’ health.
The following year, NovaCare ordered a nationwide recall of its sexual enhancement products, including Stiff Nights, after an FDA inspection determined they contained sulfoaildenafil, a drug similar to sildenafil, the active ingredient in Viagra.
In a letter sent the following December, the FDA warned NovaCare that it could not label its products as “dietary supplements” when they contained an unapproved drug. The agency also noted that the packaging did not bear warnings that when sulfoaildenafil was combined with medications commonly used to treat diabetes, high blood pressure, high cholesterol or heart disease it may “lower blood pressure to dangerous levels.”
Neither NovaCare nor Impulsaria have responded to the lawsuit.
In a filing this month, lawyers representing Erotic City acknowledged that the company sold the product at its location in the 8400 block of East Truman Road but denied all other allegations in the lawsuit.
In Erotic City’s defense, its lawyers said the store had no control over how McElwee used the product and had nothing to do with its design, manufacturing or labeling.
The lawyer representing McElwee’s children in the wrongful-death lawsuit declined to comment Thursday.