No More Tears: The Dark Secrets of Johnson & Johnson

Content Warning: This section of the guide includes discussion of physical illness, mental illness, description of surgical procedures, and death.

For many decades, the FDA did not regulate medical devices like those J&J manufactures. This changed after the Dalkon Shield, an intrauterine contraceptive device, caused severe side effects. In 1976, Congress gave the FDA the power to regulate medical devices. However, they also created a loophole called the 510(k) process that stated companies would not need to seek approval for “small modifications” to already-existing devices. 

As a result, most complex medical devices are never tested in human trials before going to market: Companies simply claim the new devices are not substantially different from those already on the market before 1976. Further, the FDA is reluctant to aggressively regulate manufacturers because they rely on companies like J&J for their funding. In 2011, CEO of J&J Alex Gorsky agreed to expand FDA funding. In 2012, the FDA agreed not to issue recalls or bans of two J&J medical devices then under scrutiny, the Pinnacle metal-on-metal hip implant and Prolift vaginal mesh.