Penis injections at cash-only Alabama men’s clinic caused erection damage, lawsuits claim

Drug abuse

Dr. Tobias Kohler, a urologist at the Mayo Clinic, said these impotence clinics sell a powerful tool: TriMix, a drug injected directly into the penis. But sometimes erectile dysfunction is more psychological than physical and can be corrected with lower-risk drugs.

Michael Forkner, 51, walked into the exam room at the Alabama Men’s Clinic in Birmingham and sat down in front of an employee named Tony. It was 2016, and Forkner had heard the clinic’s advertisements on his favorite sports radio station, ads that promised an easy, discreet solution to his problem. Sometimes he had trouble maintaining an erection during intercourse.

He assumed there would be options, pills or something, but he said that’s not what Tony offered.

“At first,” said Forkner, “I said ‘No way am I going to do this. I’m not sticking a needle into my deal.’”

Medical experts say a similar scenario plays out in cash-only clinics every day from Cincinnati to Seattle, from Oklahoma City to Minneapolis: Lots of advertising, emphasis on injectable medication to combat erectile dysfunction, and subscription plans costing thousands of dollars a year.

Dr. Tobias Kohler, a urologist at the Mayo Clinic, said these impotence clinics sell a powerful tool: TriMix, a drug injected directly into the penis. But sometimes erectile dysfunction is more psychological than physical and can be corrected with lower-risk drugs.

“It’s like using a grenade to handle a small problem,” Kohler said.

When Forkner decided to try the treatment, Dr. John Justin Caulfield came into the room. He consulted with Forkner and then gave him an injection. He saw results within a few minutes.

“It just jumped up,” said Forkner. “That’s going to sell a man right there.” Then came the sales pitch. Caulfield left the room and Tony came back in, said Forkner, “and that’s where the money part comes in.”

While Forkner was experiencing an erection due to the medication, Tony sold him a three-month supply of the shots for about $1,500, he said. “It was the biggest mistake I ever made,” Forkner told AL.com.

Now Forkner and another man have filed separate lawsuits against the Alabama Men’s Clinic in Birmingham, both arguing they were permanently disfigured as a result of clinic treatments.

But Kyle Fisk, spokesman for the Alabama Men’s Clinic, said the clinic has treated more than 20,000 patients, and most have been satisfied with their care.

“Alabama Men’s Clinic has been open since 2012 and these are the only two lawsuits they have received,” Fisk said. “I’d say they have a pretty good track record.”

He also said the clinic offers a full spectrum of treatments, including vacuum pumps, pills and injections.

“Patients receive personalized ED solutions, it is not a one-size fits all,” Fisk said. “TriMix is not one vial of the same thing used for all patients, rather its three FDA approved ingredients that are mixed at different ratios depending on the unique situation. Different compounds are used in individual patients to achieve the best outcomes and adjusted over time as needed. And as stated previously multiple other treatment options are also available.”

‘The biggest mistake’

The Alabama Men’s Clinic radio ads, which run on talk and sports radio stations in Birmingham, guaranteed “Results after your first visit, or it’s free!” The ads offer a $99 first visit, which includes a “test dose” of medication.

Dr. Jim Dupree, a urology professor at the University of Michigan Medical School, said TriMix is an effective treatment for erectile dysfunction that works well for some patients, especially those who don’t respond to pills. The main downside is the needle – which can be daunting for some men.

It can also cause serious side effects, including bleeding, infection and an increased risk of priapism – long-lasting and painful erections Kohler described as “a heart attack of the penis.”

“The longer it goes untreated, the more permanent damage is done,” Kohler said.

“Priapism can occur with the pills too,” said Dupree, “but it’s more likely with injections because they are stronger.”

After Forkner started using TriMix, he experienced erections that lasted four, five and even six hours after intercourse, he said. Some were painful. Each time he called the clinic to ask what to do, he said Tony told him to take a cold shower or “put a cold rag on it.”

Sometimes that worked, he said; sometimes it didn’t.

TriMix is a combination of three drugs: alprostadil, papaverine and phentolamine. Kohler said employees at men’s clinics around the nation have been known to promise customized blends but often use the standard dose for every patient.

It’s not the best treatment for every individual suffering from erectile dysfunction, the urologist said.

Even when used appropriately, he said, the shots cause scarring and disfigurement in a small number of cases.

Misshapen

No one at the Alabama Men’s Clinic told Forkner about potential side effects, he said.

Fisk could not comment directly on Forkner’s case, but said the clinic provides information about all treatments they provide.

“All patents fill out initial paperwork before being treated,” Fisk said in a statement. “That includes a consent form for treatment including the understanding of possible side effects.”

He also said literature is provided to patients with lists of side effects.

“And finally, they take a medication pamphlet with them when they leave that includes side effects,” Fisk said. “A patient claiming they were not fully informed of side effects is simply untrue.”

Forkner continued to inject the TriMix solution regularly for about a year.

“After being assured that there’s nothing wrong with this medication, that there’s nothing that could ever happen, I really and truly believed that,” Forkner said. “But one night I did the shot and went to perform and, well, it wasn’t working right.”

This was in February 2017. He called the clinic, alarmed, and scheduled an appointment. During the exam, he said, Caulfield told him to stop using the injections and to come back in a few weeks.

But his penis was misshapen and substantially curving upward, he said. He never went back to the Alabama Men’s Clinic.

He’d learn later, from a urologist in Tuscaloosa, that the damage would likely never heal on its own. He said he can no longer have intercourse. He said the urologist diagnosed him with Peyronie’s Disease, a condition in which scar tissue in the penis causes significant and painful curvature.

Dupree, the urology professor, said researchers don’t fully understand the causes of Peyronie’s Disease, but injections do appear to increase the risk.

In Forkner’s case, he said his urologist told him the best option was surgical reconstruction of the penis with an implant.

Alabama men's clinic

Michael Forkner sued the Alabama Men's Clinic in 2018. He says injection medication he was given caused irreversible penile damage.

Another lawsuit

In March 2016, Robert Snell of Jefferson County also sued Caulfield and the Alabama Men’s Clinic for negligence and a breach of standard of care.

Snell had gone to the clinic in 2014 for treatment for premature ejaculation, according to his lawsuit. Like Forkner, he’d been attracted by the radio ads. During the exam, Snell was given an injection in his penis that caused an erection that would not subside. He said the clinic gave him a second injection “in an attempt to fix” the prolonged erection.

However, according to the lawsuit, “the second injection resulted in a calcification which caused Mr. Snell’s penis to be permanently bent at a 90-degree angle.”

A jury sided with the clinic in Snell’s case, but a judge later vacated the verdict and granted a new trial after “improprieties by several jurors” were found, according to Snell’s attorney, Gusty Yearout of Birmingham. Because Caulfield and the clinic have appealed the judge’s decision to the Alabama Supreme Court, he said, his client could not comment.

The clinic claimed the treatment was administered appropriately and deny his condition was the result of any treatment or procedure that was administered.

“In open court the plaintiff’s own urologist testified that the curvature present was there when the patient was treated by that urologist before he ever came to the Alabama Men’s Clinic for treatment,” Fisk said. “We’re confident in the medical services provided to these two patients and are confident in the outcome of these judicial proceedings.”

The website for the Better Business Bureau shows 11 complaints against the Alabama Men’s Clinic. At least six of those patients requested full or partial refunds and described high bills for prescriptions they couldn’t fill or didn’t want.

David Smitherman, president and CEO of the Better Business Bureau of Central and South Alabama, said the organization expelled the clinic in 2014 due to an unresolved complaint.

“Their rating fell below the minimum required for accreditation,” Smitherman said.

A valuable service?

The Alabama Men’s Clinic is a private, for-profit business that does not disclose its medical practitioners on its website. A doctor oversees the treatment that’s often provided by physician assistants or medical technicians. It’s connected to similar clinics in at least three other states.

Fisk, spokesman for the clinic, told AL.com the clinic typically charges $99 for an initial visit and, if the doctor deems it appropriate, a trial injection is administered at the appointment. If it doesn’t work, the patient gets a refund.

“What that means in very blunt terms is if you don’t get an erection, then you get that money back,” Fisk said.

Once Forkner signed up for the three-month subscription of TriMix, he said, the clinic set up a recurring payment plan. He would be automatically billed whether he came to pick up his monthly bag of injections or not.

He spent several thousand dollars on the injections, he said, over the following year.

Kohler, the Mayo Clinic urologist, said most pharmacies will sell about 20 doses of TriMix for $100. Impotence clinics typically sell the drug at a much higher price.

“It’s roughly 20 times cheaper at the pharmacy than at one of these clinics,” Kohler said.

Unlike a typical urology office, the Alabama Men’s Clinic does not accept any kind of health insurance.

Fisk said the clinic offers treatment at a competitive price. Although clinic owners do not accept insurance, he said, they have offered discounts to patients who need it.

“They have been able to give tens of thousands of men their sex lives back,” Fisk said. “It is a valuable service.”

Dr. Daniel Shoskes, a urology professor at the Cleveland Clinic, said some erectile dysfunction clinics recently closed in Ohio, sending several former patients to his practice.

They were often shocked to discover they could pay $7 to $10 per dose of medication, he said. Many had been paying thousands of dollars for similar treatment at cash-only clinics.

“I think that’s the business model,” Shoskes said. “In the advertising, they say if you don’t get an erection you get your money back. The fact is, if you give a high dose of this medication, you will get an erection.”

The lack of follow-up care for complications is the other problem with the clinics, Shoskes said. When priapism occurs, patients need urgent treatment.

“In the end, a lot of these men come to my emergency room or other emergency rooms,” he said.

Reality star and roving doctor

Dr. John Justin Caulfield is still affiliated with the Birmingham Men’s Clinic, but has moved to Baton Rouge, La., and no longer supervises the medical providers in Birmingham, Fisk confirmed. The website for the Baton Rouge Men’s Clinic says Caulfield “serves as the medical director for several medical practices across the country.” It also offers the $99 consultation.

Physician assistants and medical technicians provide much of the patient care at the Alabama Men’s Clinic under the supervision of at least one doctor, Fisk said.

The website for the Alabama Men’s Clinic provides no information about providers, but medical board documents from Alabama, Louisiana, Tennessee and North Carolina reveal some details about Caulfield, who was named in both lawsuits. He has not been publicly disciplined in Alabama or Louisiana, but the North Carolina Medical Board issued a public letter of concern in 2011 over a 1997 investigation by the South Carolina Board of Medical Examiners into allegations of missing Valium in connection with Caulfield.

Caulfield and another physician, Dr. Larry Mitchell, are listed as manager and co-founder of the Tennessee Men’s Clinic in Nashville, which has a website nearly identical to the one for the Birmingham Men’s Clinic. They’re also both listed in business license paperwork for AMMC P.C., which does business as the Alabama Men’s Clinic.

A review of the business licenses for all three clinics show that reality TV star Evan Bass, once a contestant on “The Bachelorette” and “Bachelor in Paradise” television shows, has also been a registered agent or president for each clinic. Bass’s occupation on the shows was listed as “erectile dysfunction expert.”

Fisk said the Alabama Men’s Clinic shares a management group with several similar practices across the country, but it’s not part of a chain.

He also said the Alabama Men’s Clinic has undergone a management change in the last year and that the new supervising physician is named Dr. Robert Cater.

“Alabama Mens Clinics is a professional medical clinic using urologist directed treatments with trained and licensed medical providers seeing patients,” Fisk said. "Patients are also educated on their overall health such as good nutrition, exercise, blood pressure management and the like. "

Fallout

Forkner’s longtime girlfriend left him shortly after the injury to his penis. His confidence took a nosedive, he said, and he struggled to keep a steady job for a while. He went to counseling.

“Everything for me has changed,” he said. “Now I pretty much stay home. I had a little social life, but I find myself more at home now, doing things around the house.”

He doesn’t date anymore.

“Being a man, we look forward to a relationship where you can have closeness and bonding, and a sexual aspect is part of it,” he said. “It’s a big part of your life.”

He’s now seeing a urologist in Tuscaloosa. He sued Caulfield and the Alabama Men’s Clinic in January 2018. He’s represented by Goldasich, Vick & Fulk in Birmingham. The lawsuit is still making its way through the courts.

“I want to seek justice because I felt like I’d been lied to,” he said. “Other people out there really need to know what they’re getting into before they walk through those doors.”

Updated at 9:31 a.m. on Friday, Feb. 1 to include more information about all the treatment available at the Alabama Men’s Clinic, and to correct the name of the supervising physician, Dr. Robert Cater.

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