Johnson & Johnson last week 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.
The court case leading to the record-breaking verdict 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.
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 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 Food and Drug Administration 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. But using the power morcellator, doctors could remove fibroids laparoscopically. The morcellator works by literally morcellating -- or mincing, slicing and dicing -- the fibroids and the uterus into minuscule pieces inside the patient’s body. This allows doctors to then 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 is removed from a patient.
“From a surgical perspective, it’s clear that indiscriminant morcellation of any tumor with malignant potential inside a patient’s body poses a prohibitive danger,” wrote Dr. Hooman Noorchashm, the heart surgeon married to activist Dr. 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.
Caused the cancer to spread
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 Food and Drug Administration 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 most high-profile manufacturer of laparoscopic power morcellators, and the FDA’s warnings about the device put the corporation under pressure. The FBI launched an investigation into Johnson & Johnson after the discrepancies in safety data came to light, and the FDA subsequently issued a “black box” warning on power morcellators. About 100 patients filed lawsuits claiming that the 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 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.
But for Hooman Noorchashm, more work is yet to be done. The nation’s largest group representing gynecologists has cautiously continued endorsing the morcellation procedure, writing in a public 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. 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. That still hasn’t happened.
Frustrated after Reed's death
Reed passed away from cancer in May 2017. Noorchashm, frustrated with a lack of a response from gynecologists, 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. "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.
Society of Anesthesiologists spokesman Theresa Hill writes to ConsumerAffairs 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 advertises that its new morcellator 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 on patients, 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 writes to ConsumerAffairs via email.
The story behind the plastic netted implant marketed as pelvic mesh or TVT mesh has some striking similarities to the morcellator. Both were cleared under the 510(K) process, and both were supposed to allow for fast 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 the 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. Ethicon sold gynecologists the mesh implant with the pitch, once again, that it allowed for minimally invasive surgery. Doctors could place the implant in the patient's organs without any 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. Company documents revealed in courtrooms described ways in which the plastic netting could cause severe pain and complications. And should patients suffer from those complications, there is little recourse, as most doctors do not know how to remove the implant.
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 the following year, 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 from giving birth. For many patients, the new federal warnings were too little and 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 that total to over 127,000, 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 that 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 Austrian news media in a statement this month 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."
Smooth, absorbent talcum powder has for decades 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.
Independently of asbestos concerns, questions of whether talc itself could cause ovarian tumors have been around since the 1980s, when Harvard researcher Dr. 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.
Regardless, an estimated 5,000 people have sued Johnson & Johnson over its marketing of talcum powder. The women suing say that they developed ovarian cancer after using talc daily 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.
“Ms. Echeverria is dying from this ovarian cancer," her attorney told CNBC, "and she said to me all she wanted to do was to help the other women throughout the whole country who have ovarian cancer for using Johnson & Johnson for 20 and 30 years."
Johnson & Johnson has pledged to appeal the verdict, as it has previous cases. The company has not yet returned inquiries from ConsumerAffairs about whether it is reevaluating its overall approach to gynecological health.
In response to the litigation, 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 says in a statement.