For 17 years, Johnson & Johnson (J&J) lied to doctors and patients about the safety of their transvaginal mesh products. As more and more women came forward with horrific injuries, and federal regulators started to take notice, the company doubled-down and deliberately misled the public about the risks of pelvic mesh.
This is not the story J&J tells, but it’s clearly apparent in internal company memos that came to light during the pelvic mesh lawsuit brought by the State of California.
Prosecutors, led by California Attorney General Xavier Becerra, uncovered evidence that J&J withheld risks associated with its pelvic mesh products in order to convince thousands of women to implant the dangerous device. Becerra said in a press release:
“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies.
Johnson & Johnson knew the danger of its mesh products but put profits ahead of the health of millions of women.”
Now, a California judge has ordered J&J to pay $344 Million in damages for their deceptive marketing of pelvic mesh. This is more than twice the amount of a $117 Million settlement J&J reached last year to resolve similar allegations with 41 states and the District of Columbia.
“Today we achieved justice for the women and families forever scarred by Johnson & Johnson’s dishonesty,” said Becerra.
What Did J&J Lie About?
In the ruling, Judge Eddie Sturgeon of San Diego Superior Court wrote that evidence presented at the trial showed that J&J had “taken active, willful measures for nearly 20 years to suppress information and conceal serious risk and complication information from physicians and patients [about their pelvic mesh].”
Companies have to be honest about the risks associated with their products. When it comes to medical devices, especially those that are implanted inside living bodies, manufacturers have a legal obligation to be truthful. When they lie or tell half-truths, people get hurt.
Ethicon, the J&J subsidiary responsible for selling pelvic mesh, advertised the implant as a “safe and effective” and “minimally invasive” outpatient procedure.
But according to internal documents and depositions from their own medical experts, at the time they launched the product in 1998, Ethicon was already aware of the following complications associated with its pelvic mesh products:
- Lifelong and recurring risk of vaginal exposure
- Lifelong and recurring risk of erosion into organs
- Excessive contraction or shrinkage of the tissue surrounding the mesh, which can cause acute and chronic pain and dyspareunia (pain or difficulty during intercourse)
- Debilitating/life-changing/chronic pain
- Chronic groin pain
- Pain to sexual partner
- Chronic or lifelong dyspareunia
- Neuromuscular problems, including acute and/or chronic pain in the groin, pelvic, and/or abdominal area
- Urge incontinence
- Urinary frequency, retention, and/or obstruction
- Voiding dysfunction
- Need for mesh removal for serious complications
- Removal can take multiple surgeries and require significant dissection, and even after additional surgeries are performed, adverse reactions and their symptoms
Far from the “minimally invasive” procedure described by Ethicon, pelvic mesh implants caused a host of severe, often irreversible health effects. Some of these effects could be so painful or debilitating as to require multiple revision surgeries.
Despite knowledge of these risks, Sturgeon wrote that the evidence showed “J&J marketing personnel made the decision not to publicize or share information” with patients or doctors about mesh removal because “they believed it would be bad for business.”
Had women been made aware of the severe and potentially irreversible risks of a pelvic mesh implant, many would have likely selected another option. Had their physicians been given accurate information, they never would have advised women to use the device in the first place.
J&J Allegedly Lied to Create ‘Rosy Picture’ for Doctors and Patients
Of the 2 million women who have pelvic mesh implanted, many were treating pelvic organ prolapse (POP) or stress urinary incontinence (SUI). These are known as lifestyle conditions because they are not life-threatening or debilitating, even though they may significantly impact a person’s way of life.
In order to push their dangerous product for POP and SUI, J&J had to downplay the severity of the side-effects. Otherwise, pelvic mesh would be an unthinkably risky option for people dealing with a lifestyle condition.
Sturgeon referenced company emails in his ruling, including one from Ethicon’s marketing director that argued for keeping the risks hidden from patients. “Frankly, I do not want to dig my own grave,” the director wrote, by publishing the truth and giving patients “reason to believe” that their implant might have to be removed.
The same director also instructed one of her employees to remove data that showed clinical trial participants suffered from dyspareunia, which is pain or difficulty during intercourse. Her reason for concealing this complication was a fear that including the real risks of the device “IS GOING TO KILL US.”
It’s a telling choice of words, and it underscores the fact that corporate wellbeing was more important to J&J than the safety of the people who used their products. As Sturgeon wrote, “J&J intentionally concealed and misrepresented risk information that would undermine the rosy picture it was selling to physicians and patients in its marketing materials.”
Ultimately, more than 2 million women around the world implanted pelvic mesh into their bodies. Most were never warned about the risks.
And, when the public was alerted, J&J did everything they could to undercut the truthful medical advice in order to prop up mesh sales.
J&J Downplayed FDA and Internal Warnings
In 2008, the Food and Drug Administration (FDA) issued a warning about pelvic mesh because so many women had been hurt. Instead of sharing the true scope of the dangers with doctors and patients, Ethicon’s president instructed sales reps not to initiate discussion about the warning and to lie about the accuracy of their labeling.
Around that time, one of Ethicon’s own scientists told the company to update the incorrect information it was providing. Post-operative evidence showed that thousands of women were getting hurt in similar ways. Though Ethicon’s leadership was advised of the risks in clear terms, they refused to update the risk information they provided to women and their physicians.
Then, in 2011, the FDA updated its warning about pelvic mesh to reflect that complications “were not rare.” The agency once again asked manufacturers to ensure that patients and doctors would be advised of the risks before choosing to undergo this potentially risky procedure.
Instead of coming clean about the risks they knew all too well, J&J paid consultants more than $2 Million to draft an article that contested the FDA’s warning. Their salespeople were instructed to use this article to convince doctors that the agency’s fears were overblown.
To this day, some of the known risks associated with J&J pelvic mesh are still not included on the product information.
J&J Defends ‘Patently False and Misleading Representations’
In April of last year, the FDA banned pelvic mesh in the United States, but it was too late for many women. Currently, J&J faces nearly 20,000 pelvic mesh lawsuits. The company has denied any wrongdoing and continues to stand by its marketing practices.
This complete lack of recognition figured into the stiff penalty imposed by Sturgeon. Rather than accept responsibility for their clearly illegal actions, J&J has defended them. “At trial,” wrote Sturgeon:
“J&J’s current medical director defended the company’s inclusion of patently false and misleading representations in patient-facing brochures on the basis that patients could obtain accurate information elsewhere and would not understand the information disclosed to them in brochures anyway.”
This outlook is completely unacceptable and flies in the face of the “caring” portrait J&J has tried to cut for the public. Doctors and patients deserve to be treated with respect, not told to read the fine print. And in this case, even the fine print was a lie.
In other litigation, J&J faces lawsuits over its role in the opioid epidemic and its handling of the asbestos risks associated with its talc-based products. In both of those high-profile cases, internal J&J documents have also come to light that implicate the company in deceptive dealings.
Only transparency will rehabilitate the embattled company image. As the company considers the price of such honesty, hopefully, they will consider their patients with equal regard as they do their shareholders.