No More Tears: The Dark Secrets of Johnson & Johnson

In 1998, J&J purchased DePuy Orthopaedics, a company that was pursuing a metal-on-metal hip implant. Previous attempts at metal-on-metal implants had failed because the rubbing between the metal cup and ball components caused metal shards to grind off and migrate through the body, causing infection and implant failure. Hip implant makers typically use plastic liners to prevent these kinds of problems. However, in the 1990s, surgeons theorized that a metal-on-metal implant with a narrow gap between cup and ball could prevent the failure of previous devices because “bodily fluids would work themselves into the divide and never allow the two sides to touch” (272).

On November 10th, 2000, J&J was planning on submitting its metal-on-metal hip implant Pinnacle to the FDA for approval in three days when a research engineer raised concerns that one of the implants being tested “was falling apart in the simulator” (270). The engineer suggested they increase the gap between the cup and the ball in the metal joint to avoid this failure. J&J widened the gap in its device, but it submitted the narrow-gapped design to the FDA for approval. 

In 2004, J&J submitted a wide-gapped implant design to the FDA for approval called the ASR XL. In 2005, the FDA responded with concerns about the wide-gapped design because it was believed that was what had caused failure in previous metal-on-mental implants. In response, J&J pointed out that its Pinnacle design had the same wide gap as its ASR XL—admitting it had lied on its initial proposal in 2000. 

Although the FDA was concerned, they approved the ASR XL wide-gapped design because it believed the Pinnacle already on the market was safe. However, J&J had illegally not disclosed “dozens” of adverse events related to Pinnacle to the FDA. Further, it considered directing its sales team not to report “every revision” or corrective surgery related to its Pinnacle implants.

In September 2007, J&J/DePuy and “every major orthopedic device company” agreed to pay a fine for “brib[ing] orthopedic surgeons to use their contracts” (277). Prior to this, the practice of providing financial incentives was rampant in the industry.

In December 2000, the FDA approved Pinnacle for the market. J&J created incentive schemes to encourage use of its Pinnacle implants, notably “seeding trials,” a process whereby J&J sponsored “trials” of its implants. However, unlike scientific trials where the company pays for patient care, in seeding trials, the patients pay for their own care. These so-called PIN studies often skirted the Internal Review Board (IRB) requirements typical for scientific studies. For instance, PIN studies did not collect patient consent forms until 2003. The purpose of these studies was not scientific study, but rather to provide financial kickbacks to surgeons to encourage them to use Pinnacle implants. Three IRBs refused to provide clearance for PIN studies. One PIN orthopedic surgeon at Baptist Medical Center continued his PIN study even after IRB refused to clear the work and he was directed to stop the study by the hospital IRB chairperson.

In 2007, J&J used the “data” from its PIN studies in marketing materials at the annual meeting of the American Academy of Orthopaedic Surgeons to emphasize the quality of its Pinnacle implants. However, internal studies showed that Pinnacle implants had a failure rate 10 times higher than typical metal-on-plastic implants. A subsequent trial revealed that J&J PIN surgeons hid failures from regulators, and that J&J claims they were unaware of these failures were untrue.

In 2008, J&J launched a massive marketing campaign for Pinnacle implants featuring basketball coach Mike “Coach K” Krzyzewski. However, accounts of “revisions” or subsequent surgical interventions to repair or replace Pinnacle implants were growing. The company capitalized on these problems by selling replacement parts, thus profiting from its failures. 

The company also launched a modified version of the ASR XL implant called the aSphere to address surgeons’ growing concerns. To further head off complaints, J&J focused on convincing surgeons that the failures were due to the surgeons’ techniques rather than product failure. Meanwhile, the implants were “ruin[ing]” the lives of patients. One testified to the FDA that she was left in constant pain after metal debris from the implant caused muscle weakness. Many surgeons paid by J&J/DePuy stopped using the implants in 2009 or 2010.

In 2009, Australian authorities halted sales of the ASR metal implant. In 2010, the ASR was recalled in the US. In 2013, J&J/DePuy pulled Pinnacle metal-on-metal implants from the market in the US following stricter FDA hip implant regulations and declining sales.

Harris describes how J&J brought a vaginal mesh product to market without FDA approval. Vaginal mesh was inserted “to address urinary problems caused by sagging bladders pressing against the vagina” (293). However, the product had terrible side effects, including incontinence and painful sex, leading to a mass tort litigation against J&J and manufacturers of similar products.

Typically, doctors used “women’s own tissue to strap organs down within their abdomens” (294). However, this tissue could dissolve, requiring further surgeries. In the 1990s, surgeons began experimenting with plastic mesh for pelvic organ prolapse (POP) and urinary incontinence surgeries (SUI). In 1996, the FDA approved the first mesh. However, these products, like J&J’s Gynemesh, had problems because the plastic mesh could erode thin vagina walls, causing infection, pain, and even damage to a penis inserted into the vagina. 

A J&J abdominal surgeon in Germany, Dr. Klinge, discovered that the body “inevitably” attacked the plastic meshes as “invaders,” resulting in an inflammatory response and scarring. Klinge reported his findings to J&J and published them. He argued J&J’s UltraPro, a mesh with larger pores than the Gynemesh, was a safer product. However, the company deemphasized UltraPro because it was cheaper than the Gynemesh and made J&J less money.

In 2002, J&J got FDA approval for Gynemesh to be used in prolapse repair. With a French team, J&J developed a kit for OB-GYNs to insert Gynemesh called Prolift. However, before it went to market, European doctors raised concerns about Gynemesh’s side effects. Nevertheless, in 2005, J&J brought the Prolift to market without FDA approval. That same year, the French team released findings showing that upwards of 25% of women who had Gynemesh had to have surgery for repairs or removals.

In 2007, the American College of Obstetricians and Gynecologists (ACOG) issued a warning about vaginal mesh. In response, J&J lobbied the group to reverse its warning. In 2008, at an ACOG meeting, doctors and surgeons raised concerns about vaginal mesh. One surgeon, Peggy Norton, reported her practice was “flooded with women [who] needed to have their mesh removed” (303). Despite studies and accounts pointing to the dangers, sales of Prolift “surged.”

In 2011, a clinical study found 15% of people with Prolift “had seen the plastic erode through their vaginal walls” (305) and that the cohort had no better outcomes than those who did not use Prolift. In July 2011, the FDA issued a warning that vaginal mesh could result in “serious adverse events” (305). However, J&J insisted to the FDA that it was safe by pointing to a study that suggested it was beneficial, although it was later revealed that J&J had overseen and funded the study. 

In January 2012, the FDA ordered J&J to undertake a formal study of vaginal mesh. In June 2012, J&J pulled Prolift and other vaginal meshes from the market. In 2019, the FDA banned all vaginal meshes for prolapse repair.

J&J and other vaginal mesh manufacturers were sued for the pain and suffering caused by the product. They settled most of those cases, but others are still pending.