Malissa Pineda was lying on her living room couch when her cellphone rang.
The caller’s voice sounded calm but insistent. It was her fertility doctor. “I need you to come into the office right away,” she remembers him saying.
This struck Pineda as strange, because two days earlier, he had put her on bed rest to improve the chances that her in vitro fertilization would take.
A half-hour later, Pineda and her husband, David, arrived at the Pacific Reproductive Center in Torrance, California. They met with Dr. Rifaat Salem, the medical director, and the clinic’s embryologist, Sandra Arias, who looked like she had been crying.
There’s been an issue, Salem said.
Over the course of his 30-year career, Salem had performed one miracle after another. Four years earlier, he’d done the same for Pineda when her daughter Piper Joy was born. His clinic boasts one of the highest IVF success rates in the country.
But, as Pineda would learn, a lot can be hidden behind an impressive success rate.
That day in the clinic’s conference room, Salem let his embryologist explain. Arias sounded tiny and quiet, as though she were speaking from the bottom of a well. She had gone into the lab the day before to preserve Pineda’s leftover embryos and found something that didn’t add up. They had fertilized 14 eggs, and because Salem had transferred three into Pineda’s uterus, Arias expected to find 11 in the petri dish.
Instead, all 14 were still there.
Pineda was confused. Her husband sat with his arms crossed, looking annoyed. “So what are you saying?” she asked Salem.
For millions of American women who have struggled to get pregnant, fertility treatment has been the medicine of miracles. The price is steep, both financially and emotionally. Failure can be especially devastating.
A round of in vitro fertilization can cost upward of $20,000. Unsuccessful patients often are motivated to try again. And again. And perhaps again.
Yet even as IVF has made technological advancements, an outdated measurement system and weak consumer protections continue to obscure the differences between the best doctors in the business and those who run troubled clinics.
Created by Congress 25 years ago, success rates are the primary government metric consumers have to go by when choosing a fertility clinic. That ranking, an investigation by Reveal from The Center for Investigative Reporting has found, not only provides a veneer of legitimacy for troubled clinics such as the Pacific Reproductive Center, but also incentivizes a common practice that puts mother and baby at unnecessary risk.
IVF can be practiced in a way that largely avoids the serious complications that might come with carrying twins, triplets or more.
However, the quest for speedy success by both patients and doctors has encouraged nearly 8 in 10 clinics nationwide to routinely use more than one fertilized egg at a time, according to Reveal’s analysis of government data from 2015, the most recent year available. That’s despite warnings against the practice from the government and industry groups worried about the country’s high twin rate.
Patients get little help from consumer protections.
The fertility industry is regulated like most fields of medicine, despite being fraught with ethical quandaries and driven by constant innovation. Government regulators focus primarily on lab practices, clinic advertising and data collection. Professional organizations issue guidelines, but they are voluntary. Insurance companies, which can impose cost and quality control measures, are not required to cover IVF in most states. Medical boards offer little transparency about misbehaving doctors.
“It’s an intense competition among the various groups,” said Dr. Omid Khorram, a professor of obstetrics and gynecology at UCLA and medical director of his own clinic. “And all sorts of schemes, all sorts of programs are put in place to attract patients, and unfortunately, there is a lot of dishonesty. And the patients who are not aware of the science, how things work, they can be fooled.”
With Salem, the Pinedas experienced both the good and the bad with a fertility clinic. He gave them a healthy child. And he left them with one of the industry’s horror stories.
On the day Salem called Malissa Pineda back to the clinic, she was led to an operating room, where she laid down on an exam bed and put her feet in metal stirrups. Pineda said that because she had eaten breakfast, Salem told the nurse that he’d proceed without sedation.
The doctor sat down on a stool and inserted a speculum. Almost immediately, Pineda said she could feel her body tightening against the pain. Unlike a regular exam, she felt a burning sensation as Salem used some kind of instrument to scratch the interior of her uterus. She compared the feeling with scraping out the inside of a pumpkin on Halloween.
As the pain intensified, Pineda recited the ABCs and the Hail Mary to herself. She remembers a nurse standing at her shoulder, whispering: “You’re OK, sweetheart. Just stay still.”
On the ride home, Pineda told her husband that something bad had happened. Reserved and protective, David Pineda tried to console her. But he also trusted the doctor. He figured his wife was upset because their visit to the clinic had been so emotional and rushed.
The next day, Malissa Pineda returned to the clinic. The nurse who had been in the exam room the day before asked her how she was doing as she gave her a shot.
“I can’t believe you went through that,” the nurse said.
“Went through what?” Pineda asked. “What did he do?”
That’s when Pineda remembers the nurse catching herself: “Well, you’re going to have to call Dr. Salem for that,” she said.
An intense man now in his 70s, Salem was a pioneer of fertility medicine when he began his medical career in the 1980s, not long after the first “test tube baby” was born.
When IVF first hit the market, the technology was met with voracious demand. That demand has only grown as more Americans delay having families until later in life and struggle with infertility.
In IVF, one of the most expensive fertility treatments available, a woman’s eggs are combined with sperm in a lab to create embryos. It is now a $3 billion industry in the U.S., responsible for more than 1 million babies.
Salem started at one of the first private IVF clinics in the country, the Northern Nevada Family Fertility Clinic. He co-wrote one of the first studies on ways to reduce a potentially life-threatening complication from fertility medications and in the years since has pulled off success for people who had little hope of becoming a parent.
He is particularly proud of his work with a woman who, after having been shot at age 3, had seven surgeries on her abdomen. Thanks to IVF treatment with Salem, she has two healthy children.
Salem carries himself with the confidence of someone with the ability to create human life. Today, he oversees a multimillion-dollar fertility clinic empire in Southern California, one that’s rewarded him well.
In 2011, court records estimated his annual income at $3 million. His multimillion-dollar home in Palos Verdes Estates has a stunning view of the Pacific Ocean.
One of the major selling points of Salem’s Pacific Reproductive Center is its success rate. In a promotional video, the doctor tells prospective patients that “if you look at our statistics compared to the rest of the clinics, I think our statistics stand tall.”
There’s truth to his advertising. According to government data, he has one of the highest success rates in the country. Women under 35 who went to Salem’s four U.S. clinics had a 66 percent chance of having a baby each time they tried in 2015. The clinic’s motto: “Our success is measured in birthdays.”
But those rates obscure evidence of a troubled practice.
Over the course of his career, Salem has been sued 10 times for medical malpractice in Southern California. He is among the 1 percent of doctors in the United States who have made four payouts for malpractice claims since 1990. Yet he continues to be in good standing with the Medical Board of California.
Andrew Vorzimer, an attorney who represents fertility clinics and patients, said the volume of lawsuits Salem has faced is an “extraordinary number of cases” for one doctor.
“We’re either dealing with someone with a tremendous amount of arrogance that can’t admit a mistake, or there’s a serious problem going on in that IVF facility,” Vorzimer said. “It doesn’t bode well for that doctor.”
In one case filed in 2007, a jury found that Salem gave patients false hope that they’d be successful with IVF when it would have been almost medically impossible.
In a case that settled in 2006, a woman alleged that Salem had botched a fertility treatment, which required follow-up surgery. The most recent lawsuit, which is ongoing, claims that he pressured a couple to do IVF even though they weren’t good candidates, double-billed their insurance and pushed them to financial ruin.
Salem says all the lawsuits were filed by “angry patients.” “Patients who come so emotionally here and they do not get pregnant, they point the finger to anybody,” he said.
In addition, court records show that Salem’s Pacific Reproductive Center has had a mold problem in its lab in Irvine where embryos are created and stored. And inspection reports of the on-site surgical centers show that the clinics have been cited for not properly training staff and storing drugs. One patient has sued Salem’s surgical center, claiming she almost bled to death during a basic operation because it failed to stock a critical blood coagulant.
Then there’s what happened to the Pinedas in February 2014.
Now in her early 40s, Malissa Pineda is organized, upbeat and warm. A longshoreman at the Port of Long Beach, she’s also no-nonsense. She’s the main breadwinner, and David’s a stay-at-home dad. The couple met as teenagers, but they’d reunited only recently on the docks and gotten married in their mid-30s. They are a blended family with four kids, three of whom live with them in their one-story ranch house in a pleasant Inland Empire subdivision.
They relish their domestic life and wanted to continue expanding their family. But Malissa Pineda’s latest encounter with Salem had traumatized her. She started having fits of rage and anger. She was crying all the time. She couldn’t sleep. She did her best to push those feelings out of her mind because she believed staying positive would help her get pregnant more easily.
“I was so overwhelmed,” she said. “But mind you, I had to be focused. I had to have my babies.”
The Pinedas say the only thing they clearly understood after their meeting with Salem was that there had been a mistake and that all of their embryos had been preserved. He promised to give Malissa a baby – and cover the costs.
But deep down, she says she knew that Salem had done something to stop her from getting pregnant. It turns out that the painful scraping she’d experienced at the clinic had been part of a dilation and curettage, a procedure that can be used for first-trimester abortions. It wasn’t until she filed a lawsuit against the doctor and the clinic a few months later that she fully understood the reason why.
When asked to spell out things during litigation, Salem said he had accidentally put someone else’s embryos inside her. In that rushed procedure in the exam room, he had removed them.
During his deposition, Salem blamed the mix-up on the embryologist, Sandra Arias.
Instead of handing him a catheter with three of Pineda’s embryos, he said Arias had loaded someone else’s genetically abnormal embryos, which were waiting to be discarded. Distracted by the death of her brother-in-law, Arias told him she had forgotten to check the name on the petri dish.
A second nurse was supposed to verify Pineda’s embryos were being used. But that nurse hadn’t shown up that morning.
The doctor and the Pinedas disagree on one crucial point: The couple say they didn’t give Salem permission to terminate an impending pregnancy.
“We had no clue what was about to take place, because if he had said all the things that took place, I would have looked at him and said, ‘You’re crazy. We’re going home,’ ” David Pineda said.
Salem claims that when he met with the Pinedas in the clinic conference room, he clearly explained the problem before giving them two options: Remove the embryos that day or remove them the following day, when more staff were available.
“And they both responded, ‘I think we want to have them out today,’ ” Salem said during his deposition.
Immediately after the procedure, Salem prescribed a shot to induce a chemical abortion to eliminate any remaining chance that Malissa Pineda would get pregnant. She says she was led to believe it would stop the bleeding, but Salem says he had explained what he was doing.
But there’s nothing in the court records to prove the doctor’s claims. Even his own expert witnesses say he didn’t follow basic standards of care: He didn’t document the medical advice he was offering the couple. He didn’t get Pineda’s written consent before he started the procedure. And he should have given her more time to think about what she wanted to do, including offering her the option of doing nothing.
Psychologist Karen Hall, one of Salem’s expert witnesses, said the doctor should have given Pineda up to 48 hours to think about whether she wanted the procedure.
“In my opinion, that should have been one of the options for her,” Hall said in her deposition. “And I don’t – it doesn’t seem to me that that was given to her.”
On the day that the Pinedas’ case was set to go to trial in September, Salem settled the lawsuit by offering the couple $250,000. Pineda says the thought of sitting in the courtroom was giving her panic attacks.
By settling, Salem didn’t have to admit wrongdoing. He also escaped the scrutiny of the Medical Board of California, which gives the public only limited information on malpractice suits.
Many legal settlements also shield cases from public view. The Pinedas are able to discuss their case because they did not sign a confidentiality agreement.
In other fields of medicine, an error is more obvious – the wrong arm gets amputated or a patient dies after being given the wrong medication. When something goes awry in IVF, mistakes might be remedied quietly.
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“If a doctor screws up in the lab, they can do another IVF cycle,” said Andrew Vorzimer, the attorney who specializes in fertility medicine. “If the doctor makes a mistake and transfers the wrong embryo, they can terminate the pregnancy and rectify the situation. So more often than not, these cases tend to go under the radar.”
Salem’s troubled history might not be easy to find, but the doctor’s success stories are on full display. Every year, Salem hosts a baby reunion where hundreds of his ex-patients and their children turn up for food and entertainment. For the clinic, it’s the perfect photo op.
He also has helped people get pregnant in the most difficult of circumstances.
Last year, Lenee Kehnt got a text message from her husband, Jeremi, a Marine and motorcycle enthusiast. After two previous accidents, he told her that if anything should happen to him, she should find a way to have their child.
Two months later, he was killed in a motorcycle accident. Kehnt fulfilled his wish: A doctor rushed to the coroner’s office to extract sperm from her husband’s body. She sent the sperm to Salem, who used it to help her conceive through IVF.
The baby arrived early. On April 21, a month before the anniversary of her husband’s death and weeks before her 35th birthday, Kehnt gave birth to a girl, Remi, who weighed 5 pounds, 13 ounces.
She remains grateful to Salem. “It gave me a reason to live,” she said. “I can’t thank him enough for helping me realize this dream.”
In doing so, however, Salem pushed the boundaries of best practices endorsed by industry groups and the government. It had nothing to do with extracting sperm from a corpse.
And it caused Kehnt more despair.
Still reeling from the grief of losing her husband, Kehnt had a decision to make before finishing her IVF cycle. Dr. Rifaat Salem had created two healthy embryos. He wanted to put both in her at once, she said.
“It was my intention to only do one,” Kehnt said. “But when it was time to do the transfer, Dr. Salem said, ‘I recommend putting in two.’ ”
She said she followed the doctor’s advice, but Salem says Kehnt must have asked for two embryos. Regardless, Kehnt was delighted when she heard the pitter-patter of double heartbeats from the two embryos in her womb. She immediately bought two cribs and matching sets of clothes.
“I was ready to become a twin mom,” she said.
Seven weeks into the pregnancy – less than five months after her husband’s death – Kehnt miscarried one of the embryos. “My heart was broken again,” she said.
Kehnt was a strong candidate for using one embryo at a time. It would have offered the best chance of having a baby without increasing the chance of having twins and a miscarriage.
She was under 35, she didn’t have a history of infertility, she had never tried IVF before, and genetic testing had shown that the two embryos slated for transfer were likely to take. Industry and government guidelines currently recommend one embryo at a time in cases like hers.
By gambling with Kehnt’s health and that of her embryos, Salem gave himself the chance to score another point in the game of success rates.
Salem could have transferred one embryo at a time and waited to see whether each one held. However, the Centers for Disease Control and Prevention would have counted only the first transfer – giving him one opportunity to tally a success.
The clinic increased its chances of boosting its rates. Kehnt didn’t significantly increase her chances of having a child over the long run.
By transferring more than one embryo at a time, Salem is like many of his colleagues in the industry.
According to a Reveal analysis of 2015 CDC data, nearly 80 percent of in vitro fertilization clinics in the country routinely transfer more than one embryo at a time into the youngest patients. These are typically the women who are the least likely to need an extra boost from the transfer of multiple embryos.
About 1 in 7 IVF clinics performed no single-embryo transfers when there was more than one available in women under 35 in 2015.
Fertility doctors say there are times when it may be appropriate to use more than one embryo, especially if a patient has failed several rounds of IVF or is having difficulty producing quality embryos.
The CDC keeps more detailed data that would make it easier to distinguish between clinics that are ignoring best practices and ones that take on patients with the hardest diagnoses. But it keeps that data secret.
The agency says it withholds data that might cause harm to clinic personnel and to prevent “embarrassment, persecution and potentially legal and physical harm” to clinics and patients.
Clinics also must work with patients who want twins. And some IVF consumers struggling to pay for treatments out of pocket welcome multiple-embryo transfers because they believe it will improve their odds of immediate success.
The trend has helped drive up the twin birth rate in America, which has increased by more than 75 percent since 1980. Today, nearly 4 in 10 children conceived through IVF are twins.
Women carrying twins are more likely to give birth to premature babies who require expensive hospital care. Those babies are more likely to experience complications, too, including physical or developmental disabilities.
Mothers carrying twins are more likely to experience complications such as high blood pressure, blood clots and gestational diabetes.
In the case of IVF, these increased risks are largely preventable.
Dr. L. Michael Kettel, head of the San Diego Fertility Center, says fertility doctors aren’t to blame for the high number of multiple-embryo transfers.
“It’s what couples want,” said Kettel, whose clinic produced one of the highest number of twins in California in 2014.
Kettel agrees that the industry is transferring too many embryos, but he thinks things are getting better. He says he won’t draw a clear line at one embryo as some clinics do.
“It’s something that we feel like we want to give the patient a major role in that decision-making process,” Kettel said. “Do those patients know they’re at risk of having twins? Yes. Do many of them want twins despite that risk? Yes.”
George Annas, a bioethicist at Boston University’s School of Public Health, says that for too long, clinics have used patient demand to justify using multiple embryos at once.
“They’ll all tell you that the patients demand it,” he said. “(In) no other field of medicine would the excuse for not doing good medicine be ‘the patients demand it.’ That’s ridiculous.”
He believes clinics have continued to transfer multiple embryos for a simple reason: to boost their success rates. “They just try to keep their numbers up,” he said.
Change has been slow in coming. Recently, the leading industry groups, the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, have tweaked their guidelines and the way they analyze and publish data to encourage more single-embryo transfers and remove incentives to pump up success rates.
Many northern European countries and Australia have instituted policies promoting single-embryo transfers to reduce multiple pregnancies. They’ve seen their twin rates plummet.
Although the U.S. system has been criticized for incentivizing bad practices since the 1990s, the CDC won’t begin publishing improved data that addresses the problem until 2019.
Success rates are easy to misunderstand and easy to manipulate. In addition to transferring too many embryos at once, clinics might take on only the easiest cases. They can push patients with low chances for success into other treatments not tracked by the CDC. Some clinics choose to advertise pregnancy rates instead of live-birth rates, knowing that miscarriages will inevitably happen.
Even when success is measured by live births, the numbers can be deceiving. For the purpose of statistics, it doesn’t matter whether babies or mothers suffer health complications before, during or soon after birth. In Salem’s case, Kehnt’s newborn – even following the miscarriage of her twin – will count as a success.
The health risks related to twins might seem to exist in the domain of statistics and theoretical chance. But for Janet Farrell Leontiou, the effects are real.
Beginning in her late 30s, she tried IVF several times, each time agreeing to have multiple embryos implanted on the advice of her doctor, who was not Salem. When 2 out of 3 embryos implanted, she was ecstatic. At 45 years old, she was going to be the mother of twins.
Two days after the twins’ birth in 2002, her son Andreas started to have seizures. He was transferred to the neonatal intensive care unit for the next five weeks and a year later was diagnosed with cerebral palsy, a neurological disorder that impairs muscle coordination. Twins are more than four times as likely to have it as single children.
Her other son, Zachary, is healthy. While it’s impossible to know what caused Andreas’ disability, what bothers Leontiou is that no one raised the concern about the increased risk of complications from multiples. Had she been informed of the risks, she insists she would have taken her chances with a single-embryo transfer.
“It’s hard to wrap your head around why fertility doctors are doing it this way,” said Leontiou, a professor of communication and author of the book, “What Do the Doctors Say?” “They’re supposed to do no harm. Yet they are adding tremendously to the number of disabled people in this country who will need care for years and years and years. I know because I’m affected.”
Credit: Emily Harger and Olivia Merrion/Reveal
When things go wrong, the costs add up. On crowdfunding sites, dozens of IVF patients seek help with their medical bills. Some of these costs are picked up by insurance companies.
More widely adopting single-embryo transfers in the U.S. could save about $1 billion a year in health care costs, according to a 2011 analysis by leading researchers.
Dr. Rifaat Salem rarely transfers one embryo at a time. In women under 35, he performed a single-embryo transfer 5.7 percent of the time. In 2014, 4 of every 10 babies born from Salem’s clinics were twins, triplets or more.
In Malissa Pineda’s case, Salem inserted three embryos. He says it’s what the couple wanted. The Pinedas say Salem never gave them any other option.
The Pinedas will never know what might have happened with those three mistakenly transferred embryos if Salem had not removed them. The couple’s spiritual beliefs never would have led them to terminate a pregnancy, Malissa said. The thought of what could have been still drives Malissa to tears and leaves David seething.
“We would have kept them, all of them,” Malissa said.
After leaving the Pacific Reproductive Center, they took their business elsewhere. Malissa Pineda got pregnant twice more through IVF, but both ended in miscarriage.
For her, the stress of what happened took a toll. She experienced dizzy spells and nausea. She would lose her balance and fall. At work, she was taken off rigorous assignments.
Then came severe anxiety and memory lapses. One day while Pineda was shopping at Costco, she had a panic attack in the store. Piper Joy, who was 6 at the time, had to find her mother’s phone to call her dad so he could pick them up.
Pineda was diagnosed with depression and anxiety, which her therapist believes was related to her experience at the Pacific Reproductive Center. She took antidepressants for awhile, but she didn’t like the way they made her feel. She has found some respite in meditation.
The couple still think about their experience with Salem almost every day. And they still haven’t found an answer to the riddle of infertility, which leaves them swinging between finding acceptance and a persistent hope that they’ll still be able to have a baby one day.
“I still have so much more love in my heart,” Malissa said.
But the Pinedas have given up on the fertility industry. They’ve become cynical about the doctors who, to them, seemed more interested in making money than helping patients.
“Nobody cared,” David said. “They wanted to start another cycle because they knew they were getting paid again.”
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