Erotic City is being sued after a man died after taking a sexual stimulant called Stiff Nights

David McElwee died after taking a product labeled “male sexual stimulant,” which he had bought from Erotic City. Now McElwee’s family is suing the adult bookstore and the pills’ manufacturers, the Nevada-based NovaCare LLC and Impulsaria LLC.

A lawsuit filed in Jackson County Circuit Court against Erotic City’s parent company, Enlightened Reading Inc., and the above-named companies alleges that 37-year-old McElwee bought a male-enhancement product called Stiff Nights from the Truman Road adult bookstore on September 22, 2012. The lawsuit says McElwee took “all or a substantial” amount of the Stiff Nights pills on September 24 and the next day suffered a loss of blood pressure and then cardiac arrest, resulting in his death.

The lawsuit is being brought by McElwee’s ex-wife, Trisha Hale, on behalf of their two minor children. Hale’s attorneys, Michael Yonke and co-counsel Hans van Zanten, did not return messages left by The Pitch for this story.

John Michael Waldeck, Erotic City’s defense attorney, also did not return a call seeking comment.

The lawsuit alleges that Stiff Nights contains sildenafil citrate and sulfoaildenafil, which it calls a “controlled ingredient” not labeled on the product as “unreasonably dangerous.” The lawsuit contends that Stiff Nights yields significant side effects: headaches, blushing, upset stomach, hypotension and heart failure. It claims that the U.S. Food and Drug Administration has banned the use of products containing sildenafil citrate and sulfoaildenafil in over-the-counter sales.

Stiff Nights’ website is now offline, but among cached pages, a list of ingredients is still visible. Sildenafil citrate and sulfoaildenafil are not among its labeled “active ingredients.” The site boasts that the product is “100% Natural. 100% Safe” and “the ultimate sexual pleasure for men.”

“Stiff Nights is comprised of a special blend of Herbs, Mushrooms and Greens,” the site claims. “This particular blend has taken us 7 years to perfect. It is this special blend that makes Stiff Nights so potent while being 100% natural.”

Stiff Nights CEO Jamie Greene weighs in under a link on the site titled “Regain the Thunder”: “Virtually all men reported that it increased their physical stamina and delayed their ejaculation. Honestly, we don’t know how this happens. Yet customer after customer is reporting the same experience to us. We’re just happy to make so many men feel good about themselves.”

On November 5, 2009, the FDA issued a consumer warning that Stiff Nights contained “an ingredient that can dangerously lower blood pressure and is illegal.”

The FDA warned: “Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.”

The FDA cited “a consumer complaint” regarding Stiff Nights that led the government agency to determine that the product contained sulfoaildenafil.

“This is a chemical similar to sildenafil, the active ingredient in Viagra,” the FDA release says. “Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.”

The release quoted Deborah M. Autor, then the FDA director of the Center for Drug Evaluation and Research Office of Compliance: “Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk. In fact, this product is illegally marketed and can cause serious complications.”

According to the lawsuit, the FDA inspected NovaCare’s Salt Lake City manufacturing facility in March 2010 and found that Stiff Nights contained sulfoaildenafil, which is an analogue to sildenafil. Later that year, the FDA determined that sulfoaildenafil is a synthetic, active pharmaceutical ingredient and not a dietary ingredient defined by the Food, Drug and Cosmetic Act.

The FDA considered Stiff Nights a “prescription drug” and a “new drug,” meaning it couldn’t be sold without an FDA-approved application.

On August 10, 2010, NovaCare announced a nationwide voluntary recall of 21 products that contained sulfoaildenafil, including Stiff Nights; the ingredient was undeclared on those products’ labels.

The recall included products dated prior to June 17, 2010. The FDA noted that the recall was “a precautionary measure” and that “no illnesses or adverse effects have been reported to the company to date in connection with these products.”

The recall advised consumers to stop using the products immediately and to consult a physician if they had experienced health issues following use.

The FAQ section of Stiff Nights’ website warned anyone with “any medical condition” against taking the pills. “This is including but not limited to anyone on prescription medications, or anyone with a history of cancer, heart disease, stroke, migraine headaches, renal failure, liver failure, severe allergies, or other condition. You should consult your physician before starting this nutritional supplement. Stiff Nights is not recommended for anyone under 18 years of age.”

Under a question about whether to take more than the recommended dosage, Stiff Nights’ FAQ page answers: “ABSOLUTETELY [sic] NOT!!! Stiff Nights is EXTREMELY POTENT. Users have reported headaches and some other mild side effects if they take more than one capsule per 24 hours.”

Addressing whether Stiff Nights is FDA-approved: “Stiff Nights is an all-natural nutritional supplement, therefore it is not approved or disapproved by the FDA. If you [sic] a health condition, consult your health care professional before taking this product.”

As for side effects, the site notes: “Stiff Nights has not been clinically tested and a formal study has not been conducted. On our informal studies, a small percentage of the users reported headaches as the number one side effect. Reported less often was some minor flushing of the face, and heartburn. If you do get a headache, we have found that EATING is the best cure. You may also want to drink something with caffeine in it such as coffee or cola.”

Finally, a question about whether Stiff Nights contained any pharmaceuticals such as Viagra, Cialis or Levitra, the response reads: “Absolutely Not!! Nor do the active ingredients in Stiff Nights contain any of the base material contained in any of the above products. Our lab does random tests to make sure this NEVER happens.”

McElwee’s obituary says he was born in Independence on November 27, 1974. He graduated from William Chrisman High School in 1993 and from Truman University with a bachelor’s degree in 1998 and a master’s degree in creative writing and rhetoric in 2000. He worked at Park University as an educational technology support administrator for Park Distance Learning for seven and a half years.

McElwee’s family is seeking unspecified damages in excess of $25,000 on each count. A jury trial is scheduled for September 15, 2014.