In August, Johnson & Johnson was hit with a $417 million verdict after a California jury sided with plaintiff Eva Echeverria, who charged that her daily application of the company's talcum powder had caused her to develop ovarian cancer in 2007.
While a judge threw out that record-breaking verdict on October 20 and granted the company a new trial, the court case leading to the initial decision tells yet another dramatic story about a pharmaceutical behemoth's betrayal of its female customer base. It's a story that is all too familiar to Johnson & Johnson.
Women who got laparoscopic hysterectomies
The popular trend in medicine of "minimally invasive surgery" was bolstered in part by pharmaceutical companies selling devices that made certain new surgical techniques possible. A fast-track process called 510(k) allows companies to quickly get approval from the Food and Drug Administration (FDA) to market new surgical tools, implants, and other medical devices. The ease of this process has led critics and researchers to charge that devices do not get enough scrutiny from the FDA before landing in doctor's hands.
Power morcellators would become a prime illustration for this concern. For gynecologists, the benefits seemed clear. Doctors treating women afflicted with uterine fibroids—benign but painful growths on the uterus—used to cut their patients open to remove the growths and the uterus. But using the power morcellator, doctors could remove fibroids laparoscopically. The morcellator works by literally morcellating—mincing, slicing, and dicing—the fibroids and the uterus into minuscule pieces inside the patient's body. This allows doctors to remove the organ through a much smaller incision.
It took pushback from an anesthesiologist-turned-activist and her outspoken husband, a heart surgeon, to question the wisdom of grinding up an unknown mass before it's removed.
"From a surgical perspective, it's clear that indiscriminate morcellation of any tumor with malignant potential inside a patient's body poses a prohibitive danger," wrote Hooman Noorchashm, the surgeon married to Amy Reed.
Reed underwent what she was told would be a low-risk surgery to treat her uterine fibroids in 2013. Doctors did not discover until after they performed the procedure that Reed was not suffering from fibroids but from uterine cancer. The morcellation device had likely caused her cancer to spread and metastasize.
As she grappled with a devastating Stage 4 cancer diagnosis, Reed and her husband lobbied medical authorities, politicians, and journalists to scrutinize the use of morcellators in uterine surgery. The FDA finally relented and agreed to study the safety of morcellators. The agency reported that the morcellators were spreading undiagnosed cancer in an estimated 1 in 350 women, a figure that was "much higher than previously suspected rates of 1 in 10,000," the FDA acknowledged.
Johnson & Johnson subsidiary Ethicon was the largest manufacturer of laparoscopic power morcellators, and the FDA's warnings about the device put the corporation under pressure. The FDA subsequently issued a "black box" warning on power morcellators in November 2014. The Federal Bureau of Investigation (FBI) launched its own an investigation into Johnson & Johnson after the discrepancies in safety data came to light. About 100 patients filed lawsuits against Ethicon claiming that the parent company's researchers were aware of the risk that uterine tumors could be misdiagnosed as fibroids.
Ethicon ultimately decided to pull its morcellator out of hospitals in 2014, explaining in a letter to doctors that "Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk." Johnson & Johnson began settling the morcellator lawsuits last year; the Wall Street Journal reported in March 2016 that there were about 100 suits and they'd settled about 70.
But for Noorchashm, more work is yet to be done. The American College of Obstetricians and Gynecologists (ACOG), the nation's largest group representing gynecologists, has cautiously continued endorsing the morcellation procedure, writing in a 2014 statement that "we continue to believe that power morcellation has a role in gynecologic surgery."
The morcellator used on Amy Reed was not developed by Johnson & Johnson but by competitor Karl Storz Endoscopy, whose morcellators have not been recalled to date. The couple battled the German device-maker in civil court and, in an unusual strategy, announced that they would refuse to settle until Karl Storz takes its product off the market. Since the products haven't been recalled, the settlement still hasn't happened.
Reed died from cancer in May 2017 at age 44. Noorchashm, frustrated with a lack of a response from ACOG, wrote an open letter to the American Society of Anesthesiologists on July 26, asking them to consider the death of their former colleague and to intervene in surgeries when gynecologists try to use morcellators, power or manual. "It takes no amount of effort for any reasonable physician to understand that mincing up tumors with malignant potential inside a human body cavity is a prohibitively dangerous practice—because it risks spreading or upstaging a deadly process," he told the anesthesiology society.
ASA spokesperson Theresa Hill says that evaluating the safety of morcellation is outside their scope of operations, but that their ethics committee may consider the general question of whether anesthesiologists "have an ethical duty to intervene regarding medical procedural decisions made by surgeons."
Meanwhile, another device-maker last year won FDA approval to market its own version of the power morcellator. Olympus said in a release that its new tool is equipped with a "containment device" that will supposedly stop "the escape of fluids, cells, and tissue fragments."
Even though the new Olympus morcellator is already on the market, researchers point out that there is limited data proving that the containment bags actually work at preventing the spread of cancer cells. Researchers used morcellators equipped with containment bags to perform surgery on 76 women last year and found that the bags leaked in seven of those patients.
It is perhaps for that reason that Olympus is continuing to test its morcellators, despite already having FDA approval. The company is currently planning to test its power morcellators on 140 women, in a study conducted by doctors at the University of North Carolina. Noorchashm has tried to put a stop to this research, arguing that it is "critically flawed" and unethical to test the morcellator on people.
Olympus responds that they simply want to improve on their products and keep their "commitment to continuing innovation." The practice of testing a device for safety after it has already been granted FDA approval "is common in the medical device industry," Olympus spokesman Stephanie Sherry says.
Gynecologists have wrestled with the benefits and drawbacks of morcellation. Generally, they say that undergoing a minimally invasive hysterectomy is much safer than it is to have open abdominal surgery. For women diagnosed with benign uterine fibroids, ACOG says that morcellation is still the best option available, as vaginal hysterectomies—the association's preferred method to perform hysterectomies—are not possible to do when a patient has fibroids. But ACOG urges its members to approach the procedure with nuance.
ACOG acknowledges that there is no foolproof way to confirm ahead of time that a fibroid is, in fact, benign. "The inability to preoperatively identify leiomyosarcomas with certainty illustrates and confirms the need for further research to develop reliable diagnostic tools," ACOG says in a 2014 special report on morcellation.
The doctors' group advises doctors to consider each patient's individual risk of cancer before using a morcellator. "Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue," the association said unequivocally in 2015. "However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives."
Women who got surgery for pelvic prolapse
The story behind the plastic netted implant marketed as pelvic mesh or transvaginal tape (TVT) mesh has some striking similarities to the morcellator. Both were cleared under the 510(K) process, and both were supposed to allow for faster operations on women's reproductive organs, the difference with mesh being that the device itself was supposed to stay implanted in the patient permanently.
Treating women who had suffered from a common condition called pelvic organ prolapse used to require somewhat complicated gynecological surgery. Johnson & Johnson's TVT mesh was supposed to make that surgery easier when it was introduced in 2002. Johnson & Johnson subsidiary Ethicon sold gynecologists on the mesh implant with the pitch that, once again, it allowed for minimally invasive surgery. Doctors could place the implant in the patient's pelvis with minimal cutting and a short recovery time.
Women who underwent the procedure said they were never informed of the specifics of what was actually being done to them. They said that doctors described the implant as a hammock of sorts that would gently hold their organs in place.
In reality, as patients would later learn, mesh is a plastic implant made of rough netted material and is attached to the pelvis with trocar hooks; pelvic tissue grows into the mesh to create a wall of support. Ethicon documents revealed in courtrooms around the world described ways in which the plastic netting could cause severe pain and complications including painful sex, bleeding, organ perforation, and pelvic, back, and leg pain. And should patients suffer from those complications, there is little recourse, as most doctors do not know how to remove the implant or can't remove all of it.
It took the complaints of thousands of patients describing unbearable pain, destroyed sex lives and other issues to get the FDA to reevaluate. Finally, in 2011, the FDA released a warning that complications from mesh used to treat pelvic organ prolapse were "not rare" after all, and they re-classified the device as high-risk.
Ethicon opted to stop selling mesh for pelvic organ prolapse in 2012, though it never recalled the product, and Johnson & Johnson and others still sell mesh to treat other gynecological or urological conditions, such as incontinence caused by giving birth. For many patients, the new federal warnings were too little, too late. Doctors had been treating pelvic organ prolapse with Johnson & Johnson's mesh for nearly a decade before the FDA revised its stance on the device.
The regulators' about-face opened the floodgates to personal injury attorneys, who put out aggressive advertising campaigns to find the mesh patients who had suffered complications. An estimated 54,000 women have filed lawsuits against Johnson & Johnson in the United States, and lawsuits against other mesh manufacturers brings the total to an estimated 100,000 suits, making mesh lawsuits the largest type of personal injury litigation since the asbestos lawsuits, according to Reuters.
So many women have filed lawsuits and have sought surgeries to have the mesh removed that a new cottage industry has developed in which medical lenders pay for plaintiffs' mesh removal surgery upfront. The lenders then demand a stake of the financial reward should the patient secure a financial settlement. Patients who won mesh settlements describe being shocked to find their money gutted by medical liens, as Reuters reported in 2015. Attorneys have also reportedly been pressuring their clients to accept low settlement offers.
Litigation against Johnson & Johnson isn't limited to the United States. In Australia, where approximately 700 women have joined a class action lawsuit against Johnson & Johnson, public officials and news media have given much more attention to complaints about the product. One lawmaker in Australia said pelvic mesh is "the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs."
According to testimony against Johnson & Johnson in the Australian courts, one of the company's implanting physicians admitted that he would never perform the mesh procedure on his own wife. Salespeople reportedly incentivized doctors to perform the procedure by giving them Lamborghinis and ski trips to the Swiss Alps. Surgeons were also told, according to the court testimony, that they could insert four mesh devices "before lunch," which would earn them $10,000 in a single morning.
Johnson & Johnson responded to the Australian news media in an August statement that though it could not comment on documents used in litigation, "we have confidence in the safety and efficacy of these mesh products, they are backed by scientific research."
Women who used talcum powder
For decades, smooth, absorbent talcum powder has been marketed as an all-purpose hygiene product for both men and women of every age. Talc is present not just in baby powder but in makeup, medicine tablets, and even food. But consumers in recent years have raised concerns that some cosmetic-grade talc may be contaminated with asbestos. Regulators banned the use of asbestos in cosmetic-grade talc in 1973, but cosmetics companies are not required to have their products independently tested by the FDA.
The FDA finally tested a selection of talc-based cosmetic products and in 2012 reported finding no traces of asbestos. Even then, the FDA warned, "the results were limited" because only four talc suppliers agreed to submit samples for testing.
Independent of asbestos concerns, questions of whether talc itself could cause ovarian tumors have been around since the 1980s, when Harvard researcher Daniel Cramer began reporting a link between talc use for feminine hygiene and ovarian cancer. The FDA maintains that research about the dangers of daily use is inconclusive.
Nonetheless, an estimated 5,000 people have sued Johnson & Johnson over its marketing of talcum powder. The women suing say they developed ovarian cancer after using talc daily for feminine hygiene and argue that the company knew of a link between ovarian cancer and talc use for decades. Johnson & Johnson has already had to pay out a total of $307.6 million in damages to plaintiffs who won their cases. On August 21, jurors shattered that record with their $417 million judgement to Eve Echeverria.
Johnson & Johnson pledged to appeal the verdict, as it has previous cases, and on October 20, a California judge reversed the decision citing insufficient evidence on both sides and granted the company's request for a new trial. Three days prior, the Missouri Court of Appeals reversed a $72 million verdict awarded to the family of an Alabama woman who claims her ovarian cancer stemmed from use of the company's baby powder. The court ruled that the lawsuit shouldn't have been filed in Missouri since the woman wasn't injured there nor is the company based there. Johnson & Johnson has not yet returned inquiries about whether it is reevaluating its overall approach to gynecological health.
In response to the lawsuits, the company launched its own website to defend the safety of talcum powder. "Multiple scientific and regulatory reviews have determined that talc is safe for use in cosmetic products and the labeling on Johnson's Baby Powder is appropriate," Johnson & Johnson said in a statement.
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A version of this story originally appeared on Consumer Affairs.