A cracked egg sits against a blue background.
Collage by Cathryn Virginia, Images from Getty 

America’s Unregulated Fertility Industry Offers Patients Few Protections

The case of one California clinic accused of misconduct shows just how little recourse would-be parents have when it comes to concerns about safety and negligence.
October 29, 2020, 6:11pm

Emma and her husband had always known they wanted to have two kids. When Emma was 39, she became pregnant with their first child, a daughter. But after her birth, the couple struggled to get pregnant again. In 2013, when Emma was 42, they visited Lane Fertility Institute, a clinic started by Danielle Lane with offices in San Francisco and Marin County, California. After four unsuccessful rounds of expensive in vitro fertilization that Emma said totaled $80,000, the couple decided to take a break. Lane’s office, they said, was disorganized, and the doctor’s bedside manner was brusque. Still, they knew they would want to try for another child again, and so they kept three of Emma’s viable frozen embryos that were created from Emma’s first round of IVF in the clinic’s laboratory for future use. 

Four years later, the couple was ready to try again. They found a new doctor at the University of California San Francisco hospital, and Emma took hormones in preparation. But according to Emma, on the October morning when she was supposed to have the embryos implanted in her uterus, the doctor came into their exam room with devastating news: The container that was supposed to hold their three embryos didn’t have a single embryo inside. There would be no second child. 

Emma and her husband later sued Lane's clinic and the company that was supposed to transport the embryos in California Superior Court; in court documents, Lane denied all allegations in the suit.  In a brief interview with VICE News, Dr. Lane said, “In general, we recommend people keep their embryos in the space they started.” Emma, whose name has been changed to protect her privacy, was not the only patient who alleges wrongdoing at the Lane Fertility Institute. VICE News spoke with eight former patients and two former employees of the Lane Fertility Institute who say the clinic has a history of negligence and misconduct. The problems at Lane Fertility don’t exist in a vacuum, though, and these charges of misconduct take place in an industry that is largely unregulated and frequently fails to protect patients. Those who desperately want a child and need fertility assistance are often willing to pay—and put up with—almost anything to have one, and even those who have been wronged find they have few options for redress.

“I felt like I was in an abusive relationship,” said Adriana Schrader of her experience with Dr. Lane and the Lane Fertility clinic. Like Emma, Schrader sought fertility treatment from Lane Fertility. At 38, the dental hygienist knew she would have to start taking proactive steps if she wanted to have a child, and she was referred to Lane’s office by her acupuncturist. After reviewing Schrader’s bloodwork and performing an ultrasound, Schrader said, Lane recommended starting with two cycles of egg retrieval—each of which involves two weeks of preparatory hormone treatments and an invasive medical procedure—for subsequent IVF. 

“I felt like I was in an abusive relationship.”

One month later, Schrader told VICE News, she was in her hospital gown, waiting to go under anesthesia, when a medical assistant came into the room and asked her to write down her credit card number. She was confused; she had already paid the nonrefundable fee for the procedure. The employee explained that Lane needed to charge Schrader another $9,729, not for the egg retrieval procedure she was about to have, but for the next one. Schrader said she initially refused, but the employee insisted. Feeling trapped, she eventually complied.

During the year she spent under Lane’s care, Schrader said her family encouraged her to take breaks from the treatments, concerned about how the stress was affecting her mental health. When she broached the subject with Lane, however, she left feeling as though she would never have a child if she didn’t keep going. 

The doctor referenced the clearly stated no refunds policy and refused to return the money, calling the request “abhorrent” and telling Schrader that her “rash” decision to pursue different options at a different clinic was “destined to fail.”

Schrader had three egg retrievals and one, ultimately unsuccessful, round of IVF at Lane Fertility. By the end of her time as a patient of Lane’s, Schrader was borrowing money from her parents. In June 2019, two weeks after Schrader learned the IVF hadn’t been successful, Lane suggested a second round of IVF and agreed to give her a discount, making the full cost of the IVF package $17,500. Schrader paid the fee, had her blood drawn, and underwent an ultrasound. Three days later, she changed her mind. “Physically and emotionally, I just couldn’t do it,” she said. She found an egg donor through a clinic in Southern California and immediately told Lane she would be stopping treatment. She also asked for her $17,500 back. If Schrader had gone to nearby UCSF, she would have found that if cancelling an IVF cycle after beginning it she would have been charged only for services rendered. If she had cancelled before any treatments happened, but after a nurse has made the patient’s “IVF calendar” she would have been charged a $535 cancellation fee. Lane has no such policy. In an email obtained by VICE News, Lane claimed that she repeatedly advised Adriana of her other options, that Adriana knew the risks. The doctor referenced the clearly stated no refunds policy and refused to return the money, calling the request “abhorrent” and telling Schrader that her “rash” decision to pursue different options at a different clinic was “destined to fail.” (When asked about the contents of the email, Dr. Lane responded that she “would never use those words” before declining to answer further questions.) 

Most patients pay out of pocket at fertility clinics, as medical insurance rarely covers these procedures. Only 14 states require private insurance companies to cover fertility treatments, and Medicaid provides coverage only in those states. In 2018, 80 percent of IVF treatments were not covered by insurance. Additionally, most patients usually have to go through multiple cycles before becoming pregnant. Resolve, the national infertility association, states on its website that “The majority of the phone calls we receive at RESOLVE are from men and women with questions about how to finance their treatments.” 

Most patients pay out of pocket at fertility clinics, as medical insurance rarely covers these procedures.

“People pay a lot,” said Nancy Hersh, an attorney in San Francisco who specializes in women’s health and represented Emma and her husband in a lawsuit against Lane Fertility. “They pay cash, and I think that may attract people who are in the business of medicine rather than the practice of medicine.”

Because relatively few insurance plans cover Assisted Reproductive Technology, or ART, services, fertility doctors often have more latitude to set their own prices than doctors in other areas of medicine. One former Lane Fertility employee, who is familiar with the clinic’s billing practices and wanted to remain anonymous because they feared retaliation, told VICE News that charges could vary widely, and would often depend less on the cost of the services and more on the clinic’s needs at the time. Former patients at Lane Fertility, as well as financial documents reviewed by VICE News, indicate that a single IVF cycle at Lane Fertility costs between $20,000 and $24,000, not including medication, the initial consultation, or genetic testing. According to FertilityIQ, the average cost of an IVF cycle in San Francisco is $12,246, excluding those same factors. (Spring Fertility, a fertility clinic less than a mile away from Lane’s San Francisco office told VICE News that after a $450 consult, a cycle of IVF at their clinic costs between $12,000 and $16,000, not including medication and genetic testing.) “Everything is money driven with Lane,” the former employee said. “She would push and push people for money, like ‘Oh, if you want to start with us, you need to pay $1500, just to save a spot.’”

Another former employee, who also wanted to remain anonymous out of fear of retaliation, said the working environment was “stressful” and described Lane as a narcissist. “She’s really smart and funny. She draws you in, she’s interesting to talk to.” But that ended quickly. “She’s a hot mess. She can’t keep on schedule, she blames everyone for everything and never takes responsibility for anything.”

The former employees also claim that while the clinic was making $250,000 a month, their paychecks would regularly bounce.

The two former Lane clinic employees also accused the clinic of financial improprieties behind the scenes. Double billing was common, they alleged, and when lab machinery would break down, the clinic would bill patients to send their blood out for testing, even if they had already paid to have the labs done in-house. At least some of the insurance companies were aware of the double billing, one of the employees told VICE News. “They kept threatening to cancel their contracts with her, but as long as I worked there, they never did.” VICE reached out to several insurance companies who have worked with Lane, but none would discuss their relationship with any particular physician. 

The former employees also claim that while the clinic was making $250,000 a month, their paychecks would regularly bounce. “The person who gave me my paycheck at the end of the week would always tell me to go deposit it at lunch,” one of the former employees said. “Because she knew there wouldn’t be enough money in the account at the end of the day.”  In 2018, a third former employee filed a lawsuit against Lane for unpaid wages. The decision in the case stated that the employee asked for her check on payday and “was told it was unavailable.” The employee quit because, according to the court documents, the “Defendant had been late on payroll or issued non sufficient checks in the past.” The employee submitted copies of the three checks to the court, all received between January 2017 and April 2017. Lane didn’t respond to the complaint, but in an email to the Labor Commissioner, the doctor admitted that she owed the employee as much as $6,912.00, and had tried to pay it, but the employee refused to accept the payment. The employee didn’t return calls for comment. 

The two former employees who spoke to VICE News also claimed that the phones at Lane Fertility Institute would be cut off because the bill hadn’t been paid, and that at least one vendor started asking for payments in cash. According to the employees, another stopped picking up lab samples because it hadn’t been paid in months. One former employee said, “Like every third call I got was from some company saying ‘You owe us money, you owe us money.’” 

VICE News also spoke with two patients who contacted the Marin County District Attorney to recoup their money, as well as three patients who filed small claims cases. The District Attorney declined to comment on any specific case. Court records reveal that in the last four years, six businesses have sued Lane Fertility, including LabCorp, one of America’s largest networks of clinical laboratories. All of them sued for breach of contract, or otherwise claimed that they had either received only partial payment or never been paid at all. In five cases VICE reviewed, Lane defaulted and was ordered to pay the debts, in the sixth, the case was dismissed because Lane paid what she owed before legal proceedings could continue. This past February, the court ordered Lane to pay LabCorp $22,449.71.  (LabCorp did not respond to multiple requests for comment.) 

Complaints about Lane Fertility also concerned safety. In the summer of 2019, Adam, his husband, and their close friend and surrogate sought IVF treatment from Lane Fertility. Adam, whose name has been changed to protect his privacy, claims that Lane didn’t check his surrogate’s medical records before transferring an embryo. A lawsuit filed by the surrogate against Lane Fertility alleges that Adam, his partner, and the surrogate informed Lane of the surrogate’s three previous cesareans at their first appointment, but that Lane never requested the surrogate’s medical records, which “disqualified her from being a gestational carrier on the basis of what the records describe about about obstetrical and medical history.”

“It could have killed her.”

The complaint further alleges that while Lane noted the uterine scar, where the surrogate’s uterine lining was thin, she proceeded with preparation for pregnancy anyway. According to the lawsuit, a saline sonogram prior to the embryo transfer showed that the surrogate had thinning over the uterine scar which she “later learned disqualified her from being a gestational carrier due to the risk of bleeding and death,” a fact the complaint says was further corroborated by two other doctors. Not having been informed of these risks, the surrogate proceeded with the embryo transfer and, the complaint says, miscarried two weeks later, resulting in residual issues for the surrogate, including months of bleeding. (Lane and her attorneys did not respond to multiple requests for comment and detailed questions about the allegations in this article). 

Adam was furious. “Dr. Lane never even asked for those records or investigated [the surrogate’s] history,” he told VICE News. “And it could have killed her.” In court documents, Lane claimed that this issue was "just a difference of opinion between doctors as to whether the woman would be fit to serve as a surrogate, which is an everyday reality in the practice of medicine." In fact, two professional organizations, the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART), issue standards for assisted reproductive technology clinics and say otherwise. ASRM explicitly states that “The carrier [surrogate] should have no more than five previous vaginal deliveries or two previous cesarean deliveries.” SART says it is “advised” that gestational carriers not have more than three cesareans. While ASRM and SART guidelines are voluntary,  Dr. Ruben Alvero, obstetrician and Division Director of Reproductive Endocrinology and Infertility at Lucille Packard Children’s Hospital in Palo Alto, California, said it would be “very abnormal” to deviate from the ASRM or SART guidelines regarding surrogacy and cesareans. 

“Those standards exist for a reason,” he said. “In my experience, everyone follows them.”

And yet, Lane has continued to practice with a clean record from the Medical Board of California. Most states require hospitals and outpatient surgery settings to report adverse events and major avoidable medical errors; however, no such mandate exists when practitioners mishandle genetic material outside the body, like losing or switching eggs, sperm, or embryos. This makes it impossible to know how often such errors occur. In California, when an arbitration proceeding or lawsuit is decided in the patient’s favor, it automatically goes into a database. However, settlements are more complicated. Carlos Villatoro, a spokesperson for the Medical Board of California, told VICE News in an email that malpractice settlements are noted on the state’s medical board website only when there are three or four cases (depending on the physician’s specialty) of at least $30,000 each in a five-year period. Lawsuits over billing practices aren’t reported at all. 

Lane has continued to practice with a clean record from the Medical Board of California.

Although hundreds of thousands of ART cycles are performed in the country every year, the $6 billion fertility industry is largely unregulated. The Society for Reproductive Technology collects data about clinic procedures and success rates, but the data is self-reported by the clinics and the only consequence for not self-reporting data is lack of inclusion on the society’s website. The only mandatory federal regulation regarding ART requires that tissue and other genetic material (like eggs and sperm) be tested for “communicable diseases” such as gonorrhea and chlamydia. California, Indiana, Texas, Colorado, and Florida are the only states with “fertility fraud” laws, and even those were primarily designed in response to stomach-turning instances of physicians using their own sperm to impregnate patients, not to deal with more common cases of lost or damaged genetic material. 

“It’s absurd that there are more regulations for selling used cars and potato chips than there are for an industry that makes babies,” said Debora Spar, a professor at Harvard Business School and author of The Baby Business

“It’s absurd that there are more regulations for selling used cars and potato chips than there are for an industry that makes babies.”

Medical misconduct is also exceedingly difficult to prove in these kinds of cases, said Dr. Marcelle Cedars, the director of UCSF’s reproductive endocrinology division. “If I go to the hospital to get my appendix out, when I leave the hospital I should be assured that my appendix came out. But [reproductive procedures] I’m not assured that when I walk out the door that I’m going to have a baby.”

If Emma had been seeking almost any other medical procedure, she would’ve been protected by layers of bureaucracy. Not so with IVF. “The law has lagged behind the science,” said Hersh. In one of her first fertility-related cases, she represented a party to a custody battle that arose out of a clinic’s use of the wrong sperm. “The biological father sued for partial custody of the child and won,” she said. “The judge likened it to a one-night stand. You can’t tell me we don’t need stricter protections to prevent something like that from happening.”

To be certain, reproductive medicine is more logistically complex than other medical specialties, as it often involves not just a patient and a physician, but also donors who sell their genetic material through corporations and surrogates hired through agencies to carry children to term. Examples of lawsuits in the fertility world abound: Last year, a couple who had undergone IVF sued a New York fertility clinic after giving birth to twins that were not genetically related to the couple. The couple argued that their own embryos were swapped or misplaced. 

While the Federal Trade Commission ostensibly oversees how ART providers market their services, false advertising claims are still made without repercussions, and sometimes with devastating consequences. In 2017, Xytex, one of the largest sperm banks in the country, was sued by a group of patients who purchased sperm from “Donor 9623.” Xytex said it screened all donors based on family health history, physical exams, and chromosomal analysis. It assures customers that “less than 3% of all donor applicants are selected for the program.” In fact, Donor 9623, was actually a man named Chris Aggeles, and a quick Google search of his name revealed that his stated history—perfect physical and mental health, a genius-level IQ, and a clean criminal record—was almost entirely fabricated. In reality, the donor suffered from schizophrenia, bipolar disorder, and narcissistic personality disorder with “significant grandiose delusions.”

When the Zelts, one of the families who purchased Aggeles’ sperm, filed a federal suit against Xytex in the 11th Circuit Court of Appeals, the court called  Xytex’s alleged conduct  “reckless, reprehensible, and repugnant,” but was forced to rule that Xytex did not violate Georgia law and the lawsuit was dismissed. Similar cases filed in Georgia State Court have also had little success because of Georgia’s 1990 state Supreme Court ruling that “life, even with severe impairments, may [never] amount to legal injury.”  Last month, however, a Donor 9623 case against Xytex was allowed to progress on claims that Xytex violated Georgia’s “Fair Business Practices Act.” 

Sean Tipton, the chief spokesperson for the American Society for Reproductive Medicine, told VICE News that he believes reproductive medicine isn’t the only medical field that’s subject to a “patchwork of federal, state, and professional self-regulation,” and is actually regulated just as much as other areas. However, complexities in reproductive medicine have some demanding more consumer protections.

Poor national oversight for the fertility industry in the United States goes back decades.

“This industry–-and it is an industry–-sells what nobody wants to think about as a product,” said Spar. “By and large, people come to the industry when they’re desperate. The last thing they want to do is think about buying a baby because that’s abhorrent on the most basic level.” It’s also why the government has been reluctant to intervene. In the United States, Spar explained, where conception and abortion are such fraught issues, “we get nervous about any kind of legislation that would touch an embryo.”

Industries often have regulations imposed because of political pressure, Spar said. “But with fertility, patients either end up with a baby or they don’t and they don’t really want to talk about it afterwards.” The end result, Spar explained, “is an industry that doesn’t want to be regulated and very few patients pushing for regulation.” 

Poor national oversight for the fertility industry in the United States goes back decades. In 1995, two Republican congressmen Jay Woodson Dickey Jr. and Roger Wicker attached a rider to a spending bill that prohibited federal funding of any activity that destroys embryos. Given that cycles of IVF can produce more embryos than are used (the unused embryos are either destroyed, donated to research, or kept frozen for potential later use),  the U.S. Department of Health and Human Services is prohibited from conducting IVF research. The Dickey-Wicker Amendment has been renewed every year. Attorney Dov Fox, author of Birth Rights and Wrongs: How Medicine and Technology Are Remaking Reproduction and the Law told VICE News, “The Dickey-Wicker Amendment has allowed reproductive technologies to develop unimpeded by government oversight, in the private sphere of for-profit clinics.” These clinics, Fox said, “function less as medical practices and more as very lucrative businesses.”

The lack of regulation affects laboratory services as well. In 2018, liquid nitrogen freezer tanks malfunctioned at Pacific Fertility in San Francisco and the University Hospital in Cleveland, resulting in the loss of thousands of embryos and eggs. Lack of federal oversight might explain why: The FDA doesn’t regulate the types of tanks used in fertility labs because, as NBC News discovered last year, “they aren’t labeled or marketed as medical devices by their manufacturers.” 

Patients who feel they have been wronged by Lane have tried to use the limited legal options afforded to fertility patients, though with limited success.

Meanwhile, the demand for ART has never been higher. The Centers for Disease Control and Prevention estimates that about 12% of women in the U.S. between ages 15 and 44 will seek infertility treatment at some point in their lives. As the number of patients has increased, so has the number of clinics popping up to serve them. “What hasn’t happened yet, but I hope will happen at some point,” added Spar, “is that the good actors in this field—and most of them are good—will come to see that it's actually in their interest to have regulation, because will it penalize bad actors in a more explicit way.”

Patients who feel they have been wronged by Lane have tried to use the limited legal options afforded to fertility patients, though with limited success. PayPal refunded Adriana Schrader for her $5000 deposit for the second cycle; she took Lane to small claims court in December 2019, for $10,000 (the small claims limit) of the remaining $12,500. Despite the fact that the $5000 refund hadn’t come from Lane, Schrader said the doctor argued in court that PayPal’s refund was sufficient. After hearing from both parties, the judge dismissed the case. Adam, his partner, and their surrogate hired Nancy Hersh and have filed medical malpractice lawsuits against Lane, who has denied the claims. The suits are ongoing.  

In December 2017, Emma and her husband sued Lane Fertility for medical malpractice over the loss of their embryos. Lane denied the allegations and claimed that there was no way to know if the embryos were lost at her lab, during transportation by the independent cryopreservation transportation company, or by UCSF. A year and a half later, without admitting liability, Lane’s lawyers offered a settlement: The couple could take it and sign a nondisclosure agreement or enter arbitration, which would cost them $1,000 a day. 

Unable to afford the arbitration fees, they took the settlement in August 2019. For the loss of their three embryos and the chance to have another biological child, they were paid $2,000. Today, the Lane Fertility Institute continues to recruit new patients and practice in California.

All of Emma's interviews were conducted prior to her signing an NDA.

Correction: This story originally said that only California, Indiana, and Texas had “fertility fraud” laws. Colorado and Florida have these laws too.