The 43-year-old patient lay unconscious on the operating table, arms outstretched as if nailed to a cross. An oxygen tube snaked out of his mouth, and wires ran from patches on his chest to an electrocardiogram machine, which tracked his heartbeat with a metronomic pulse. He was a portly man—220 pounds, a few inches shy of six feet—and his nude torso was covered in a blue sheet except for a square opening that framed his groin. A surgical technician stood to the man’s right, using a metal clamp to pull tight the loose skin of his scrotum. Across the table, James Elist, a cherubic urologist with a thick Persian accent, switched on his electrosurgical scalpel.
Bending over the patient, the 74-year-old physician made a shallow, crescent-shaped cut at the base of his penis with the penlike instrument, which uses a high-frequency electric current to burn through tissue. A thin plume of white smoke and the acrid smell of singed skin rose from the incision. As the surgical tech held the cut open with a retractor, Elist worked a gloved finger inside the scrotal sac and up the shaft of the penis. Then, like a magician performing sleight of hand, he deftly flipped the penile skin inside out to reveal a tubular, milky white organ about the size of a forefinger. “This is the penis without the skin,” Elist told me. It looked like some sightless creature found in the ocean depths, where sunlight never penetrates.
Setting the penis down, he picked up a translucent silicone sheath that opened along one side, like a hot dog bun. Elist squeezed the device to demonstrate its flexibility. The Penuma, a portmanteau of “Penis New Man,” is the world’s first and only FDA-cleared cosmetic penile implant. Since patenting the invention, in 2002, Elist has implanted thousands of Penumas at his private practice in Beverly Hills, California, where I was observing this surgery. The prosthetic goes beneath the penile skin, adding up to two inches of girth, and comes in five sizes, ranging from L to XXL. “Nobody,” Elist explained, “wants a medium.”
Supersizing your penis does not come cheap. The 45-minute surgery costs $17,000, which patients must pay out of pocket, because health insurance companies consider it an elective procedure. Still, the device has become so popular, thanks partly to coverage in magazines such as GQ and Men’s Health, that physicians from around the country have made pilgrimages to Beverly Hills to train with Elist—a requirement for becoming an authorized Penuma surgeon.
Among them was Houston urologist Robert Cornell, who shadowed Elist in the operating room for a day, in March 2018. But Cornell never completed the training. Instead, he developed his own cosmetic penile implant, one intended to correct what he considered the Penuma’s deficiencies. He recruited a group of prominent Texas physicians to help design the device, which he called the Augmenta.
It took eighteen months for Elist to learn about Cornell’s project, time that the industrious Houstonian used to build an Augmenta prototype, secure a patent, and raise nearly $1 million from investors. Cornell was in the final stages of receiving FDA clearance to begin implanting the Augmenta when Elist sued him and his partners in federal court, alleging that they stole his trade secrets.
After three years of grinding litigation, involving dozens of high-priced attorneys in two states, the lawsuit went to a jury trial in Los Angeles in June. At stake were millions of dollars in potential damages, as well as access to the burgeoning international market for cosmetic penile implants.
The case may also carry implications for patient safety. Though Elist says he has thousands of satisfied customers, the implant has been dogged by reports of horrific side effects. In a separate civil lawsuit, a Penuma patient from Hidalgo County, in the Rio Grande Valley, is suing Elist for allegedly misrepresenting the device’s safety record. Cornell contended that preventing the Augmenta from coming to market, as Elist’s lawsuit sought to do, would deprive men of a safer way to enlarge their penises. (Through his attorney, Cornell and his codefendants declined requests to be interviewed for this story. The following account of their actions is based on their statements in depositions and other legal filings.)
To Elist, the case has always been simple. The way he sees it, his life’s work was stolen by a band of medical pirates trying to make their fortune off someone else’s sweat. “It took twenty years for me to reach this point [with the Penuma],” he told me. “How can someone who never came out with any kind of innovation or new idea in a matter of months come up with this idea? There’s no way. It’s impossible.”
Penis enlargement is an ancient obsession. The Kama Sutra, written around the fourth century, advises men to rub their private parts with wasp venom to induce swelling. An Indigenous people of sixteenth-century Brazil were rumored to favor snake bites. In the 1930s, anthropologist Margaret Mead observed Polynesian men stretching their penises with weighted objects, a practice that also has been documented in parts of Africa and South America. A strenuous penile exercise regimen known as jelqing is believed to have emerged in the Middle East. In recent decades, some who feel shortchanged by nature have turned to injecting their penises with silicone gel or with fat taken from another part of the body. These injections can have grotesque side effects, but that hasn’t stopped men from seeking them out.
In the mid-nineties, victims of botched procedures began showing up at James Elist’s office. Born into a wealthy Sephardic Jewish family in Iran, Elist earned his medical degree from the Tehran University of Medical Sciences before moving to Washington, D.C., in 1976, to complete a residency at George Washington University Hospital. He was planning to return to Tehran to practice medicine when the Iranian Revolution broke out. Because the country’s Jewish minority was under attack from revolutionary leaders, Elist opted to join a urology practice in Los Angeles. Later he was able to bring much of his family to California, though they had to abandon most of their wealth. “I had to start over from scratch,” he told me.
In Beverly Hills, Elist established a specialty in treating erectile dysfunction. He published a research paper linking smoking to impotence and was among the first urologists to implant inflatable penile prostheses, which use an air pump concealed in the scrotum. As his practice grew, he started seeing more patients experiencing complications that arose after penile injections. “They had gotten silicone injections, gel injections,” he told me. “Their penises had been damaged. Totally deformed.” Most of the time there was little Elist could do. “I’ll never forget the face of this young man—twenty-three, twenty-four years old. He was standing in my office crying, saying, ‘Dr. Elist, do something for me.’ Unfortunately I could not do anything, because he had gotten fat injections.”
Elist started thinking about a safer alternative. Living in Los Angeles, he couldn’t help noticing the growing popularity of silicone breast implants. Why couldn’t there be a similar implant for penises? His colleagues were skeptical. “The idea of putting something under the penile skin was not acceptable to most of the urologists at that time,” he recalled. “They would say, ‘James, it isn’t going to work. When they have sexual activity, it’s going to perforate the skin.’ There were a lot of negative feelings about it.”
Undeterred, Elist hired a Sacramento manufacturer to build a series of ultrasoft silicone prototypes, which he began testing in cadavers—a standard practice for new medical devices. He experimented with different implant sizes, surgical techniques, and sutures before receiving the first of several patents for technology related to what would become the Penuma. Like many others, Elist then took advantage of a regulatory loophole in seeking the FDA’s blessing.
Known as a 510(k) clearance, it sets aside the requirement of a full safety review for biomedical inventions that are determined to be “substantially equivalent” to products that were on the market before the passage of new federal regulations on medical devices, in 1976. Elist argued that his implant was similar to the silicone implants long used in ear, nose, and throat surgeries. The FDA agreed, in 2004, granting Elist permission to begin implanting the device “for use in the cosmetic correction of soft tissue deformities.”
Deformity, Elist believes, lies in the eye of the beholder. He began advertising his invention, named the Penuma at his son Jonathan’s suggestion, as the “first FDA-cleared penile implant for cosmetic male enhancement.” Thousands of men flocked to his clinic for the surgery, and most seemed happy with the results. One of them, a 52-year-old nurse from California whom I’ll call Marco, told me that his flaccid penis used to retract almost completely into his scrotum, like the head of a frightened turtle—a condition known as buried penis. The Penuma prevented this disappearing act, giving Marco more confidence with women and improving his sex life. He said it feels natural enough that his sexual partners can’t tell it’s there: “I walk naked around the room now and don’t have any issues.”
The Penuma has received positive (albeit snarky) coverage in Cosmopolitan, GQ, HuffPost, Men’s Health, and Vice. TMZ hailed Elist as the “Thomas Edison of penis surgery.” The urologist appeared on a Los Angeles radio show with one of his patients, who happily dropped his pants in front of the hosts. Yet horror stories about the procedure also began to circulate online, in places such as the Reddit forum PenumaProblems. In March the news website Insider published a story based on interviews with several patients who said the operation had permanently damaged their penises.
In 2018 the Medical Board of California filed an accusation against Elist on behalf of a 54-year-old anesthesiologist from Texas who had sought treatment a few years earlier to correct scarring from a hernia surgery. On his intake form, the man had indicated that he was also dissatisfied with the size of his penis, leading Elist to recommend the Penuma—even though the man’s dimensions were, according to Elist’s own notes, within the average range.
The man agreed to the surgery, but upon returning to Texas he reportedly experienced irritation and swelling, found sex painful, and had trouble urinating and ejaculating. After consulting another urologist, who told him the Penuma was compressing his urethra, he elected to have the device surgically removed, which left his penis scarred and 2.5 inches shorter than its original length. In 2019 the California medical board elected not to discipline Elist for negligence, but it did censure him for failing to “maintain adequate and accurate medical records” about the man’s case. To keep his license, Elist agreed to enroll in a course on medical recordkeeping.
At least fifteen Penuma patients have filed complaints about Elist, thirteen of which led, in late 2021, to a second investigation by the California medical board. If the board finds that he committed the alleged acts of gross negligence, incompetence, and failure to maintain adequate and accurate medical records, his medical license could be suspended or revoked. “Penuma is an innovative procedure, and innovative procedures are routinely reviewed by regulators,” said Elist’s attorney in a statement to Texas Monthly. “We are working to fully resolve the matter with the Board.”
Elist insists that the Penuma is safe so long as the patient complies with his instructions for postsurgical care, including refraining from sexual activity for six to eight weeks. In 2018 Elist coauthored a paper in the Journal of Sexual Medicine that tracked a sample of four hundred men who received the Penuma between 2009 and 2014. The study found that the patients experienced an average 57 percent increase in penis circumference, or girth, with 81 percent reporting “high” or “very high” satisfaction. (The Penuma added around one inch to the length of flaccid penises; the study did not measure the effect on erect ones.) The most frequently reported complications were scar formation (8 percent), seromas (buildups of fluid; 4.8 percent), and infection (3.3 percent). About 3 percent of patients had to have the implant removed because of one or more complications.
“There is no way you can find a procedure that has no complications,” Elist told me. Even in commonly performed operations such as vasectomies or circumcisions, he pointed out, things sometimes go wrong. “There are no minor procedures,” he quipped. “Only minor surgeons.”
In photographs, Robert Cornell has the confident, blandly handsome look of a TV weatherman. The 52-year-old Pennsylvania native earned his medical degree from Columbia University and completed his residency at Baylor College of Medicine, in Houston, before opening his own practice. Sometime around 2017, he realized he had a problem.
Like Elist, he had developed a specialty in inflatable penile prostheses. In recent years, though, insurance companies increasingly declined to pay for those operations. “So with what is, you know, a fundamental part of my clinical practice becoming less and less available to more and more patients, you know, expanding and broadening my service offering to more patients was a priority of my business,” Cornell would recall in a 2020 deposition. “I understood that there was a single device available for cosmetic male enhancement, and I pursued more information there.”
Cornell had already received several inquiries about the Penuma from patients at his downtown Houston urology office before he traveled to San Antonio, in October 2017, to attend a four-day meeting of the Sexual Medicine Society of North America. There he met Tom Hopper, president of Gesiva Medical, the Minnesota-based company that distributed the Penuma. He told Hopper he was interested in setting up a trip to Beverly Hills to train with Elist, who had only recently begun authorizing other surgeons to implant his invention.
The San Antonio conference also happened to host the first meeting of an advisory board of experienced urologists Elist convened to help develop and market the Penuma. Among the board members was Run Wang, then president of the SMSNA, whom Hopper had known for years and considered “a recognized key opinion leader in urology.” The 62-year-old Chinese American physician was a professor of urology at UTHealth’s McGovern Medical School and MD Anderson Cancer Center, in Houston. Wang signed an eight-page consulting-services agreement with International Medical Devices, the company founded by Elist in 2013 to commercialize the implant. The agreement included a confidentiality clause prohibiting Wang from disclosing any proprietary information he learned through his role on the board.
The CEO of International Medical Devices was Elist’s 38-year-old son, Jonathan, a Stanford MBA who had left his job as a management consultant at McKinsey & Company to run his father’s business. Jonathan served as his father’s representative at the advisory board’s first meeting, in a conference room at the Marriott Rivercenter hotel. The meeting’s highlight was a live demonstration of the Penuma by one of Elist’s patients, who allowed the urologists to inspect his silicone-enhanced penis. “They grabbed gloves, put them on, and just tried to get as close as they could,” Jonathan recalled. “Some were on their knees. They wanted to not only see it; they wanted to inspect it to know how natural it felt.”
After the examination, several of the urologists asked to train with Elist so that they could offer the Penuma at their own practices. Wang was among the first to complete the training. Delighted to have one of the country’s most prominent urologists on his advisory board, Elist even paid for Wang’s travel to Los Angeles.
In a 2021 deposition, Wang explained that he was aware of patient complaints about the Penuma, but he believed he could help Elist improve the device. “As a professor, as an academic physician, the patient safety is my number one priority,” he said, according to the deposition transcript. “My intention was that, as [an] expert in sexual medicine society and in [the] sexual medical field, if I could do something—contribute something to help this procedure . . . that was my professional job.”
Cornell flew to Los Angeles for his own Penuma training in March 2018. He observed Elist perform four back-to-back procedures during a single day, in a windowless operating room at the Beverly Hills South Pacific Surgery Center, across Wilshire Boulevard from Elist’s office. According to Gesiva representative Duncan Louie, Cornell moved around the room to get different perspectives—even standing on a stool at one point—and peppered Elist with questions while scribbling notes.
Surgical tech Minerva Acosta, who was assisting Elist that day, would later recall that Cornell “asked many more questions than other visiting doctors I have observed” and “seemed extremely interested in the design and use of [the] Penuma.” Cornell, she said, appeared particularly focused on the sutures and polyester mesh used to attach the device to the penis and inquired about “changes or improvements planned or considered for [the] Penuma.” Elist recalled telling Cornell about his plans to incorporate absorbable sutures, mesh tabs, internal air pockets (to increase the device’s softness), and an antibiotic coating in future versions of the implant. (In a 2020 deposition, Cornell said there “wasn’t much dialogue between me and Dr. Elist” during the surgeries.)
Before leaving for the day, Cornell signed a three-page nondisclosure agreement stipulating that he would use what he learned only “for purposes of discussing and proposing the terms of a possible agreement/collaboration” and that he would not “use directly or indirectly the Confidential Information for [his] own benefit or benefit of any other person.” (Through his attorneys, he would later deny being “provided any non-public information related to Penuma before or after signing the Penuma NDA.”)
Three days later, back in Houston, Cornell received a list of the instruments and supplies used in Penuma operations, information he had requested from Louie. “I will work on a return date in late May for training cases with Dr. Elist,” Louie wrote to him in an email. “Let me know if you need anything additional. Looking forward to it!” Over the next several weeks, Cornell continued to correspond about the May trip, giving Louie the impression that he intended to complete his Penuma training.
Yet Cornell was already working on his own design for a penile implant. In a sworn statement filed as part of the subsequent lawsuit, he wrote that “while observing the Penuma device and implant procedures at Dr. Elist’s facility, I noticed several issues that could be problematic. For example, the excessive rigidity and bulkiness of the Penuma device increased the risk of skin erosion, patient and partner discomfort, and the need for device removal.” Cornell did not share these concerns with Elist. Instead he “began considering designing a cosmetic penile implant that differed dramatically from the Penuma device.”
Cornell showed a copy of the NDA he had signed in Beverly Hills to his attorney, who assured him that, since the document wasn’t a noncompete agreement, he could proceed. “I wanted to know that I could legally pursue an implant that I believed would be safer,” Cornell later explained. “I didn’t want to waste my money or anyone else’s time or money, nor did I want to infringe on anyone else’s intellectual property.”
Under U.S. law, inventors can apply for a patent to cover “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” After examining Elist’s patents, Cornell seemed satisfied that his implant would represent enough of an improvement upon the Penuma to meet that standard.
To aid in the device’s design, Cornell assembled an informal group of advisers, most of them urologists from Houston. Huck Medical Technologies, a company based in the East Texas town of Jacksonville, was tapped to develop a silicone device that Cornell dubbed the Augmenta. (The name was suggested by Hans Mische, a biomedical engineer who had done some early work on the device.) Cornell’s longtime friend Richard Finger (an investment adviser who, in his spare time, wrote, directed, and acted in low-budget movies) provided $300,000 through a special-purpose company called Lata Lignum—Latin for “wide wood.”
On July 23, 2018, less than four months after visiting Elist in Beverly Hills, Cornell filed his first provisional patent application for “penile implants that facilitate tissue expansion.” The Augmenta would feature air pockets embedded in the silicone to make the implant lighter and more flexible. (This wasn’t entirely a new idea; the concept was patented in 1992 by French physician Louis Subrini.) In addition to these air pockets, the Augmenta—unlike the Penuma—would incorporate mesh tabs along the length of the penis, as well as absorbable sutures and an antibiotic coating.
Cornell’s team pitched the Augmenta to colleagues and potential investors at SMSNA’s 2018 meeting, in Miami Beach, Florida. Attendees were shown a slide deck that emphasized how the Augmenta would be softer than the Penuma, offer a “natural-feeling penile shaft,” and prevent the “common Penuma complaint of implant buckling and deformity during shaft compression.” The presentation pegged Elist’s annual revenue on the Penuma implant at about $20 million, based on an estimated manufacturing cost of $250 per implant for about one thousand surgeries per year. (Jonathan Elist would not disclose the Penuma’s revenue, but he said it was less than $20 million a year.)
The slides concluded with a series of Augmenta revenue projections, based on a proposed sales price of $4,000 and a onetime $10,000 certification fee for each doctor wishing to perform the operation. If 75 surgeons were certified the first year, the company’s net revenue would be around $3.1 million. Using those figures, Augmenta LLC offered shares at $12,000 in exchange for a 0.1 percent ownership stake—giving the company a $12 million valuation.
The slides concluded with a series of Augmenta revenue projections, based on a proposed sales price of $4,000 and a onetime $10,000 certification fee for each doctor wishing to perform the operation. If 75 surgeons were certified the first year, the company’s net revenue would be around $3.1 million. Using those figures, Augmenta LLC offered shares at $12,000 in exchange for a 0.1 percent ownership stake—giving the company a $12 million valuation.
In eventually raising about $1 million, Cornell and Finger felt the need to disclose the risk of a lawsuit. They sent a memora dum to potential investors noting that Elist “may threaten or commence litigation relating to intellectual property rights.”
The first Augmenta prototypes were ready by December 2018. Sometime that month, Cornell and Larry Lipshultz, a Houston urologist and Augmenta investor, implanted the devices in a pair of human cadavers. A few days later Cornell conducted another pair of cadaver surgeries, this time with Run Wang and Wang’s former medical fellow Jonathan Clavell, a 38-year-old urologist who had recently joined Cornell’s practice.
Wang had learned about the Augmenta earlier that year and signed an NDA with Augmenta LLC in November 2018. At the time, he was still a member of the Penuma advisory board. He did not tell Elist about his involvement with Cornell, nor did he tell Cornell about his confidentiality agreement with Elist. (In a deposition, Wang said he couldn’t recall whether he discussed his Augmenta work with Elist’s team.) Wang received one share in Augmenta LLC for his help designing the implant.
Cornell’s team was encouraged by the results of the cadaver surgeries. In an email to investors, Finger, who had taken on an advisory role with the company and was one of its largest investors, wrote, “We learned a lot of great things, and Huck is busy making a few minor modifications to further improve the Augmenta.” According to Cornell, those modifications included adjustments to the size and shape of the air pockets to achieve better elasticity. The Augmenta ultimately went through twelve iterations before arriving at its final design.
A few weeks after the first cadaver tests, Cornell filed a nonprovisional patent application, with Mische and Huck Medical’s CEO, David Nichols, listed as coinventors. “Currently available cosmetic penile enhancement devices suffer from a number of limitations and deficiencies,” the application reads. “Some comprise a rigid, inelastic silicone block that increases the risk of external erosion, patient discomfort, and an unnatural flaccid penis look and feel.” The Augmenta, on the other hand, “greatly reduces these untoward complications” by using an antibiotic coating, absorbable sutures, mesh tabs, and internal air pockets.
The United States Patent and Trademark Office rejected the application, concluding that the invention was too similar to the Penuma and other patented devices. Cornell, Nichols, and their attorney appealed to a patent examiner in a phone call in April 2019, pointing to how the air pockets made their invention different from Elist’s. The examiner emphasized the need for the diagrams in their patent application to feature the elements they were claiming as unique to the Augmenta. An amended application was soon filed, with drawings that more clearly labeled the air pockets, along with other changes. That September the PTO granted the Augmenta patent. (About a year and a half later, Cornell and his coinventors received a second patent for implants with variable density.)
All that remained before Cornell could begin implanting the device in patients was FDA clearance. He didn’t think that would take long. In an email to his advisers around this time, he wrote, “I expect a swift 510(k) approval based on historical predicate experience. Sizing kits with further instructions will be available shortly and each of you can soon expect to receive actual implant-grade models for your review.” In preparation for the implant’s debut, Cornell built a flashy Augmenta website, compiled a list of potential patients, and began hiring employees.
Then he learned he was being sued.
Clicking the link led him to a recently issued patent that included thirteen pages of images and diagrams purportedly depicting the device. He was surprised to find among these a screenshot of the Penuma that appeared to have been taken from one of his own training videos.
In October 2019 James Elist was taking a break between Penuma operations at the Beverly Hills South Pacific Surgery Center when he received a Google alert on his phone for “penile implant.” Of the listed inventors, he’d never heard of David Nichols and had only briefly met Hans Mische at a conference, but he remembered Robert Cornell well. As Elist read the patent, he was stunned to find many of the design changes he planned for future versions of the Penuma—changes he says he had discussed with Cornell. Elist felt betrayed. “It’s like you invite someone back to your home for dinner, and then they steal your valuables,” he told me.
He immediately emailed the patent to his son. “My heart sank at that moment,” Jonathan recalled. “Then, once I took a look at the patent and saw the claims, I was livid. I knew these were future design concepts that we had discussed with Implantech [the company that manufactures the Penuma], that were part of our catalog of trade secrets. Seeing it right there in the patent, under Cornell’s name, was infuriating.”
Jonathan, too, had reason to remember Cornell. Shortly after the Houston physician visited Los Angeles, he started identifying himself as a “Penuma Penile Enhancement Specialist” on his website, urosurgeryhouston.com, despite never completing the training. The website also featured a search engine–optimized Penuma question-and-answer page, with a link for patients to book an appointment. Around the same time, Cornell started paying Google to display ads for his practice next to search results for “Penuma.” The website of his colleague Clavell also featured at least one Penuma reference.
Jonathan emailed Cornell, in June 2018, to demand the removal of all Penuma references from his website and advertising. Cornell agreed to do so but appears to have slow-walked the process; a year and a half later, when Elist discovered Cornell’s Augmenta patent, the website still featured Penuma content. As the Penuma team grew more suspicious of Cornell, it hired Los Angeles attorney Ryan Baker, a specialist in intellectual property law.
In April 2020 Baker filed a 36-page civil complaint against Cornell and Clavell in the U.S. District Court for the Central District of California, based in downtown Los Angeles. The complaint alleged misappropriation of trade secrets, breach of contract, breach of good faith and fair dealing, and unfair competition. Baker also threw in charges of trademark and copyright infringement because of the Penuma references on Cornell’s website and the borrowed image in the Augmenta patent application. The complaint described Cornell’s visit to Beverly Hills as “nothing more than a ruse to steal trade secrets”—secrets that Cornell used to design the Augmenta.
“Of course, Dr. Cornell wrongfully claims inventorship,” it continued. “But he did not invent; he stole.”
Cornell and Clavell’s attorney fired back at the lawsuit with a nineteen-page response denying each of Elist’s allegations. The response acknowledged that Cornell added Penuma references to his website after returning to Houston, “in anticipation of being approved for using the device.” But these references were merely “descriptive” and did not constitute trademark or copyright violations. At first the defendants denied using a Penuma screenshot, but they would later acknowledge including the image in the patent application.
As for the most serious allegation, misappropriation of trade secrets, the response laid out what would become the heart of Cornell’s defense: the Houston urologist could not have stolen Elist’s trade secrets because the information Elist disclosed to him was not secret. All of the supposedly proprietary design features that Elist and Cornell allegedly discussed—absorbable sutures, antibiotic coating, mesh tabs—were widely known and commonly used surgical techniques. The plaintiffs responded that, common though the techniques may be, they had not previously been used in penile-enhancement implants.
University of Houston law professor Aman Gebru, an expert in intellectual property law who is not involved in the case, told me that the dispute hinged on two questions. Did Elist’s planned uses of these design features in future versions of the Penuma constitute trade secrets? And did Elist take reasonable precautions to protect those secrets? “To the extent you can prove you’ve [protected the secrets] through NDAs and other similar measures, you can say you have a trade secret,” Gebru said—as long as the plaintiffs can show that “nobody has ever combined these features in this industry.”
The case was assigned to Judge Consuelo Marshall, who soon had to decide whether to grant a preliminary injunction barring the defendants from seeking FDA clearance for the Augmenta. In a sworn statement, Cornell said his company had already spent about $500,000 on development and that putting the Augmenta on ice would cost another $7 million to $10 million in lost revenue. The plaintiffs countered that allowing the Augmenta to go to market would cause irreparable harm to Elist by cutting into sales of the Penuma. They argued that the defendants’ actions had already cost them approximately $5 million in lost revenue; if the Augmenta were allowed to proceed to market, they said, their losses could run as high as $100 million.
In January 2021 Marshall issued the injunction, ordering Cornell and his codefendants to stop “commercializing, marketing, advertising, promoting, offering for sale, and/or profiting from the Augmenta implant.” Cornell would also have to return or destroy the notes he made at the Beverly Hills surgery center and the list of Elist’s surgical instruments and supplies that he had been given. Marshall allowed the defendants to keep their Augmenta patent and continue pursuing their 510(k) clearance, but that hardly mattered, given that they were forbidden to sell the Augmenta until the case was decided.
Meanwhile, through the discovery process Elist’s attorneys learned of the involvement of Run Wang, who still sat on the Penuma advisory board. “That really shocked me,” Elist recalled. “Dr. Wang was one of my best confidantes. I shared everything with him. He was from MD Anderson, a highly reputable surgeon and physician. He was president of the SMSNA. It was really an honor just to have him as part of our advisory board.”
Elist says Wang had privileged access to information about future plans for the Penuma. He demanded that the Houston urologist cut ties with Cornell and denounce him to the Texas Medical Board. When Wang refused, Elist removed him from the Penuma advisory board and added him as a defendant in the lawsuit. “If there’s evidence of collusion with the member of the advisory board for the plaintiff, that is going to be damning evidence for the defendant,” Gebru predicted. In a sworn statement, Wang denied ever having knowledge of Elist’s trade secrets.
In addition to Wang and Cornell, the defendants now included Richard Finger, Hans Mische, and David Nichols. (Shortly before the trial, the plaintiffs dropped the charges against Clavell.) More defendants meant more discovery requests, more depositions, more legal motions. The plaintiffs hired experts in prosthetic urology and biomedical engineering to write declarations supporting their claims, so the defendants hired their own experts to rebut those claims. Both sides continued to add attorney after attorney in attempts to gain the upper hand.
The acrimony reached a peak in November 2021, after Cornell published a paper in the journal Sexual Medicine about his Augmenta cadaver tests. Elist was infuriated. His attorneys believed the paper violated Marshall’s injunction by disclosing trade secrets and promoting the Augmenta, which the paper described, falsely, as “newly commercially available.” Cornell argued that the paper presented research necessary for the Augmenta’s 510(k) application, which Marshall had allowed to continue. He also tried to appease the plaintiffs by issuing a correction clarifying that the Augmenta was not commercially available.
After nearly a year of legal arguments over the paper, Marshall found the defendants in contempt of court for violating her injunction. She imposed a penalty of $5,000 per day on the defendants until the article was removed from the Sexual Medicine website and ordered them to reimburse Elist for all legal expenses incurred while litigating the journal article. It wasn’t the plaintiffs’ only pretrial victory. Marshall also issued two summary judgments, ruling that Wang had breached his consulting-services agreement with Elist and that Cornell, Mische, and Nichols violated Elist’s copyright by using the Penuma image in their patent applications. For those charges, all the jury would decide was how much those defendants owed in damages.
Amid the legal wrangling, the trial date was repeatedly postponed. A court-ordered mediation session failed to produce an agreement. Desultory settlement talks went nowhere. So in early June, the defendants and their attorneys packed their bags, said goodbye to their families, and headed to California.
I ’m going to go out on a limb and guess that none of you, when you showed up to jury duty yesterday, thought you would be listening to lawyers talking about male private parts.”
Ryan Baker, a lanky middle-aged attorney with close-cropped gray hair, stood in a Los Angeles federal courtroom, delivering his opening argument to the eight jurors—four men and four women—who would decide International Medical Devices, Inc. et al. v. Robert Cornell et al. “This case, however, is not really about male private parts,” he continued. “It is about ideas. And it is about what happens when somebody takes ideas that another [person] has developed over tens of thousands of hours, and decades, and discloses them to the world.”
Sitting at the defense table to Baker’s left was Cornell, wearing a light blue suit and flanked by four attorneys from Houston firm AZA Law. Just behind them, the other four defendants—Richard Finger, Hans Mische, David Nichols, and Run Wang—occupied two rows of wooden benches in the public seating area. Across the aisle, James and Jonathan Elist sat next to each other, whispering occasionally in Farsi.
Baker picked up a hollow silicone cylinder and brandished it above his head like a religious icon. “This is the Penuma implant,” he announced, “and this is what this case is about. It is important, because this implant actually does make life better for some people—or can make life better. It is an important technology.” (Judge Marshall had barred the defense lawyers from raising questions about the Penuma’s safety record during the trial, ruling that those concerns were irrelevant to a trade secrets case.)
Defense attorney Weining Bai began his opening statement by acknowledging that his client had falsely advertised himself as a Penuma surgeon, but argued that because Cornell never sold any of the implants, there was no “market confusion” or “actual harm.” Bai also admitted that Cornell had included a Penuma image in his patent application. This too was a mistake, he explained, one that Cornell attempted to remedy by sending Elist a check for $1,650. “That was the economic damages [the plaintiffs] told us that they wanted for this claim. We tried to pay them,” Bai said. “They still have the check. They could cash it now.”
After dispensing with the trademark and copyright claims, he turned to the central issue of trade secret theft. Bai told the jury that three of the four alleged secrets—internal pockets, mesh tabs, and absorbable sutures—were widely known among prosthetic urologists and biomedical engineers. As for the fourth, the Penuma instrument list, he contended that it comprised common surgical tools. One month before Cornell’s visit to Beverly Hills, he pointed out, Elist had uploaded video of a Penuma surgery to a peer-reviewed web journal. “If in early 2018 you actually wanted to know how Dr. Elist did a Penuma procedure and what tools he used to do it, [you could] just go on the internet,” Bai said.
The Augmenta, he insisted, was not a Penuma copy but rather a new cosmetic penile implant developed with Cornell’s clinical experience and Huck Medical’s engineering know-how. “We took our own R and D path,” Bai asserted. “We took an independent path to end up at a different design. Independent development. No theft.”
After opening statements, the plaintiffs called Elist as their first witness. He became visibly upset as he described how Cornell and Wang violated the “sanctuary” of his operating room. “They asked me question [sic] in the operating room, and I shared with them as a surgeon,” he told the jury. “Unfortunately, months later, I find out that all the information, trade secret, trademark, copyright, anything which I have been working for almost—more than—twenty years to build has been exposed and has been used for their own benefit. I felt at that point, you know, that I had been betrayed, stabbed in the back.”
During his cross-examination, defense attorney Jason McManis showed Elist several decades-old patents for prosthetic implants with internal pockets and mesh tabs. Elist dismissed the patents, explaining that they were for therapeutic implants meant to correct erectile dysfunction, not cosmetic implants such as the Penuma. McManis then asked why, if the alleged trade secrets were so valuable, had Elist not incorporated them into the Penuma. When the surgeon said he lacked the money, McManis got Elist to acknowledge that the Penuma had generated roughly $50 million in revenue over the previous two decades. Yet the defendants, McManis noted, needed less than $1 million to develop the Augmenta.
“Sir, the real reason for this lawsuit is a sharp-elbowed business practice to try to stop a competitor, isn’t it?” McManis asked.
“No,” Elist shot back.
Perhaps the most effective moment of the cross-examination came when McManis forced Elist to admit his unfamiliarity with the specifics of his own lawsuit. Under questioning, Elist could name just two of the five defendants—Cornell and Wang.
Q: Do you know who you sued, sir?
A: No. I don’t know.
Q: Richard Finger. Does that name ring a bell?
A: I heard the name.
Q: Okay. Can you point him out here in the courtroom?
A: I never met him personally.
Q: Which one of the four trade secrets that you have alleged did you share with Mr. Finger?
A: I don’t know.
After court ended for the day, I walked over to Finger and introduced myself, hoping to get his thoughts on the proceedings. “You see what a piece of s— he is?” he asked, gesturing to Elist before stalking angrily away.
Early in the second week of the trial, the plaintiffs’ attorneys called Cornell to the stand. Under questioning from Baker, the Houston urologist denied having learned any trade secrets during his March 2018 visit to Beverly Hills. In fact, Cornell said, he had asked Elist just three questions over the course of four Penuma procedures. That testimony was contradicted during the trial by Elist, surgical tech Minerva Acosta, and Penuma distributor Duncan Louie, all of whom were in the room during the surgeries and recalled Cornell asking an unusually large number of questions.
As he cross-examined Cornell, defense attorney Shahmeer Halepota played portions of the Penuma-surgery video that Elist posted online in 2018, while also displaying the notes Cornell took the day he observed the surgeries. Halepota’s apparent aim was to show that Cornell came up with Elist’s supposedly secret techniques on his own, in reaction to what he perceived as deficiencies in Elist’s method. Only a few minutes into the video, though, two jurors passed notes to the judge. “The graphics, real-life videos and images are making me uncomfortable,” one juror wrote. “I’m on the verge of passing out,” wrote the second.
Marshall granted the jurors a brief recess while she discussed the matter with the attorneys. “I don’t want anyone passing out,” she said. “But we do have a nurse in the building.” Halepota offered to stop playing the video, and the trial resumed.
After nine days and fifteen witnesses—including two pairs of experts in prosthetic urology and biomedical engineering, one each for the plaintiffs and the defendants—the case went to the jury on the afternoon of Friday, June 16. The lawsuit had taken three years to come to trial, but the jurors needed less than three hours to render their verdict.
All five defendants were found liable for stealing trade secrets, and Cornell was found liable for breach of contract, trademark infringement, and use of a counterfeit mark. The jury ordered Cornell, Mische, and Nichols to pay Elist $1,650 in damages for using the Penuma image in his Augmenta patent application and ordered Wang to pay Elist $1 for breaching his consulting-services agreement. (The plaintiffs had requested nominal damages from Wang.) Perhaps most significantly, the jury invalidated Augmenta’s two patents.
An exultant Elist called the verdict “a major milestone in the history of medicine” because trust would be lost among physicians exchanging information if they feared their trade secrets could be stolen. His attorneys are asking for more than $60 million in damages, based on their valuation of Augmenta LLC and the stolen trade secrets.
In response to a set of written questions from Texas Monthly after the trial, Halepota said he and his clients “do not agree with the verdict and firmly believe we will be fully vindicated upon appeal.” In mid-July, the defendants filed a motion urging Marshall to dissolve parts of the injunction preventing them from commercializing the implant. They may have lost their two patents, but they still have 510(k) clearance from the FDA for a version of the device that they argue does not incorporate any of the trade secrets at issue in the lawsuit.
The plaintiffs, not surprisingly, see it differently. “Throughout the course of the litigation, [the defendants] have shown a brazen intent to do whatever it is they want to do, without regard to the legal basis,” Baker told me. “After they were found liable on almost every single claim, they can’t just go out and act like nothing happened.”
Around the time of the trial, Elist debuted the latest version of the Penuma, which features embedded mesh to streamline the implant procedure. To emphasize how different it is from previous models, Elist and his son gave the device a new name: the Himplant. In October, the California medical board will hold a hearing on the allegations of negligence, incompetence, and failure to maintain adequate records brought by thirteen of Elist’s former patients.
The same month, Marshall will hold a hearing on how much the trial defendants owe Elist and whether to dissolve the injunction. Whatever she decides, the defense attorneys have signaled that they intend to appeal the case to the Ninth Circuit Court of Appeals, in Pasadena, California. The Ninth Circuit’s decision, in turn, could be appealed to the U.S. Supreme Court. An ending to the penis war—happy or not—may be years away.