Wrongful death lawsuit filed over heart attack caused by unapproved erectile dysfunction drug

by Eric Pearson

A 39 year-old man, David R. McElwee of Kansas City, suffered a loss of blood pressure that ultimately led to a fatal heart attack after taking a supplement sold under the brand name Stiff Nights, according to a lawsuit filed on behalf of his children. McElwee purchased the supplement at an adult products store called Erotic City in September 2012, ingested it two days later and died September 25, according to a pharmaceutical liability lawsuit filed against the makers of the drug.

In addition to Erotic City, the lawsuit names two companies that are accused of manufacturing and marketing the products: NovaCare LLC of Salt Lake City, and Impulsaria LLC of Grand Rapids, Mich. Both companies have previously 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. Sulfoaildenafil may cause dangerously low blood pressure by interacting with prescription drugs known as nitrates, including nitroglycerin.

“Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk,” Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance, said at the time. “In fact, this product is illegally marketed and can cause serious complications.” The 2010 voluntary recall involved Novacare LLC products sold under the a variety of names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

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.”

The FDA released a Consumer Update in 2009 warning the public about dietary supplements sold to treat erectile dysfunction. These supplements are often sold with labeling suggesting that they are all-natural alternatives to prescription drug products that have been approved by the FDA for treating erectile dysfunction. As a result, consumers are led to believe the products are completely safe when they may be laced with potentially hazardous ingredients that are not even listed on the label.

In recent years, the FDA has found issues with numerous “supplements” claiming to be safe and effective for erectile dysfunction:

  • Passion Power pills (for men and women) were recalled from the market in October, along with MasXtreme capsules, after company tests showed the products contained sulfoaildenafil. The manufacturer, Natural Wellness LLC, working with the FDA, voluntarily agreed to the recall.
  • Love Fuel and Whatz Up Rx sex pills were among 28 supplements recalled in April 2010 after tests uncovered the ingredient sulfoaildenafil in them.
  • Red Rooster pills were pulled from the market after the FDA cited the manufacturer for touting its pills as treatments for erectile dysfunction and impotence, medical conditions that must be treated with prescription drugs.
  • Duro Extend Capsules for Men were the subject of an expanded recall after tests showed they contained sulfoaildenafil.
  • STUD Capsules for Men and XOX For Men were cited in October because the products contain sildenafil, or sildenafil and tadalafil combined — active ingredients in prescription erectile dysfunction drugs.

In August 2013, we reported that Jack Rabbit Inc. was conducting a voluntary nationwide recall of one lot of the company’s dietary supplement for sexual enhancement sold under the name Jack Rabbit. FDA analyzed the supplement and the product was found to contain Sildenafil and Tadalafil, which are active ingredients of FDA-approved drugs for erectile dysfunction, making Jack Rabbit an unapproved drug. According to the FDA, the undeclared ingredients in Jack Rabbit may interact with nitrates found in some prescription drugs such as Nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease are among those who often take nitrates. Other side effects of the undeclared ingredients in Jack Rabbit include headaches and flushing.

HO&P Fighting for Drug Safety

At Heygood, Orr & Pearson, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to Yaz, Actos, Avandia and Accutane, we have made it a career priority to hold drug manufacturers accountable and responsible for their actions.

The lawyers at Heygood, Orr & Pearson are trial attorneys in the truest sense. We are as comfortable before a judge and jury as we are drafting a legal brief. In fact, every one of our attorneys has trial experience, ranging from auto accident cases to commercial fraud cases to pharmaceutical liability cases. Our attorneys have tried over 200 cases to verdict and we have achieved verdicts and settlements for our clients totaling more than $200 million. Most importantly, we are all committed to bringing the highest standards of ethics and a passion for justice to every client and every case.

Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us for a free consultation to find out more about your legal options.

by Eric Pearson

Eric Pearson is a licensed attorney and a partner at HO&P who handles commercial and personal injury lawsuits. Eric has been selected to the Super Lawyers List, a Thomson Reuters publication.