Company concealed risks that can result in devastating health impacts to women
SEATTLE — Attorney General Bob Ferguson today asked a court to rule that Johnson & Johnson misrepresented, and in some cases failed to disclose entirely, serious risks associated with its surgical mesh devices.
Ferguson asserts that Johnson & Johnson and its subsidiaries knowingly omitted serious, debilitating, life-altering complications associated with its mesh devices from the instructions included with every device sold from 1999 to late 2015. The missing information included risks such as chronic pain, pain with sexual intercourse, numerous urinary issues and the difficulty of removal. Johnson & Johnson still has not amended some of its instruction packets to warn about other risks associated with its devices, such as the risk of mesh contracture.
In addition to omitting serious risks in its instruction packets, Ferguson asserts that Johnson & Johnson downplayed some of the serious complications caused by some products before 2015.
“Washington women will suffer for the rest of their lives because a powerful special interest put profits over patients,” said Ferguson. “I’m asking the court to hold Johnson & Johnson accountable for its actions.”
The Attorney General filed motions for partial summary judgment in King County Superior Court, asking the court to rule that Johnson & Johnson’s omissions and misrepresentations in the devices’ instruction packets violated the state Consumer Protection Act. These motions are part of a lawsuit filed by Ferguson against Johnson & Johnson in 2016. In the lawsuit, Ferguson seeks to ensure that Johnson & Johnson does not engage in unfair or deceptive marketing of mesh products and is not asking the court to ban Johnson & Johnson from selling them.
If the court rules that Johnson & Johnson violated the law, the Attorney General’s Office will seek the maximum penalties of $2,000 per violation, as well as costs, fees, restitution and other relief. The Attorney General’s Office asserts that Johnson & Johnson violated the law for each omission and misrepresentation of the potential risks of its products.
Johnson & Johnson and its subsidiaries manufacture and sell surgically inserted mesh devices used to treat two common pelvic floor conditions in women – pelvic organ prolapse and stress urinary incontinence. The devices are designed to hold up organs that have shifted from their normal positions, causing these conditions. Both pelvic organ prolapse and stress urinary incontinence are non-life-threatening conditions that can be treated via multiple, surgical and non-surgical methods.
Johnson & Johnson is one of the largest manufacturers and sellers of surgical mesh devices in the U.S. The devices sold by Johnson & Johnson are permanently implanted into a woman’s body. Removing the mesh is extremely difficult, and in some instances, impossible.
One Washington state woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her entire leg from mesh devices for the past eight years. She now cannot empty her bladder without a catheter. The woman is largely homebound and suffers from depression and loneliness.
Two years after receiving a mesh implant, another patient in Washington state experienced incontinence and pain during urination, bowel movements, lifting and sexual intercourse. She endured three separate surgeries to partially remove the mesh and treat her incontinence.
Johnson & Johnson sold over 12,000 surgical mesh devices in Washington state between 2002 and September 2015. It continues to sell four of its devices in Washington state.
Outside of the U.S., Johnson & Johnson’s devices faced scrutiny as early as 2007. The company stopped distribution of one of its mesh devices in Australia due to its poor safety and efficacy outcomes, and to protect Australian consumers. It continued to distribute the same device in the U.S. until 2012, without informing doctors that it had stopped distribution in Australia due to safety concerns.
The company and its subsidiaries knowingly omitted life-altering risks associated with its mesh devices from the devices’ “Instructions for Use” from 1999 to late 2015, including many of the devastating health impacts experienced by the aforementioned Washington women. Instructions for Use inserts provide doctors with important information about a medical device. The instructions should include any risks or adverse reactions associated with the device or its use.
Johnson & Johnson knew that some of the most serious risks it failed to include — chronic pain, pain with sexual intercourse and more — were associated with the use of its mesh. It also knew that the impact of these reactions would exponentially increase due to the difficulty of removing the mesh once implanted.
Despite knowing that women who received these devices could experience life-altering complications, Johnson & Johnson did not add or update the instruction packets for its devices until late 2015.
The devices’ current instruction packets include more than 20 separate statements regarding adverse reactions, most of which were not included before 2015. The company still has not included the risk of mesh contracture and shrinkage, which among other things, can lead to persistent, lifelong pain.
Johnson & Johnson included a small portion of the number of risks associated with its mesh devices in some devices’ instruction packets; however, it still failed to disclose all of the risks. In some instances, Johnson & Johnson informed doctors that its mesh would cause short-term reactions, such as leg pain and inflammation, even though Johnson & Johnson knew that these conditions could be persistent.
Ferguson asserts that the omissions and misrepresentations in the instruction packets were part of Johnson & Johnson’s larger strategy that included doctor-oriented marketing materials, patient brochures and other patient marketing. Today’s motions pertain only to the instruction packets.
Assistant Attorneys General Daniel Allen and Breena Roos are lead attorneys on the case.
If the court grants Ferguson’s motions, it will only partially resolve the case. Other allegations made by the Attorney General’s Office still need to be resolved.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact the Consumer Resource Center at 1-800-551-4636 or file a complaint online.
The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Visit www.atg.wa.gov to learn more.
Dan Jackson, Acting Communications Director, (360) 753-2716; DanJ1@atg.wa.gov