Industry giant Johnson & Johnson is facing the potential of a $1 billion verdict in damages in a California state court trial that began the week of July 14, 2019. The state’s attorney general brought the lawsuit due to the alleged defectiveness of pelvic mesh implants that were manufactured by Ethicon, a unit of Johnson & Johnson.

Deceptive Marketing & False Advertising

In the first case of its kind to go to trial, the lawsuit alleges that Ethicon practiced deceptive marketing tactics to induce approximately 50,000 women and their physicians to use pelvic mesh implants as a treatment for conditions like pelvic organ prolapse and stress urinary incontinence. All previous pelvic mesh trials were filed by individual plaintiffs and centered around personal injury and product liability claims.

California alleges that Ethicon violated false advertising and unfair competition laws when it withheld information regarding the risks associated with mesh implants. Thousands of female patients claim that the implants left them with infections, chronic severe pain, and the need for multiple additional surgeries later in attempts to remove the mesh, sometimes proving futile. For each violation the state alleges, there is a $2,500 fine, so the company (valued currently at more than $70 billion) could potentially be looking at damages of nearly $1 billion. Ethicon maintains that it did inform patients and doctors adequately about the risks associated with such implants, and insists that the devices provide a safer alternative than invasive surgeries.

Opening Statements From Both Parties

The full trial, being heard without a jury, is occurring before Judge Eddie Sturgeon of the San Diego County Superior Court. Entire proceedings are being webcast via the Courtroom View Network.

Deputy Attorney General Jinsook Ohta attested in her opening statement that treatment for ailments she termed as “lifestyle conditions that are not life-threatening” should not leave a woman in a worse medical condition with more serious complications than she had before receiving the device. She further contended that Ethicon “chose to deceive doctors and patients” about the possibility that a chemical in the mesh, polypropylene, could cause an adverse reaction to a patient’s body fluids and tissue resulting in chronic inflammation and scarring.

Ohta pronounced, “[They] blamed the doctors, blamed the women, blamed the surgery: they blamed everything they could think of besides the mesh itself.” She further contended that many women treat incontinence issues with simple sanitary pads and over-the-counter options. She suggests that many women only resorted to choosing mesh implantation because the marketing approach that was used to promote the surgery described it as a “quick, easy, minimally invasive” procedure done as an outpatient. She admonished, “Truthful advertising under California law means you have to give the good with the bad.”

During opposing opening statements, the attorney for Ethicon, Carolyn Kubota of Covington & Burling, argued that mesh implantation risks are well known to the medical community, and that Ethicon already provides sufficient warnings in the instructions included with the devices. She suggested that doctors should learn about the risks of a procedure from hands-on training. “You can’t fit a whole medical education on a document that comes in a box,” she added.

She further contended that incontinence and organ prolapse are not merely “lifestyle conditions,” and they seriously impact a woman’s quality of life.

Mesh products for incontinence and organ prolapse have been withdrawn from the U.S. market. Earlier in 2019, a lawsuit brought by Washington State was settled by Ethicon for nearly $9.9 million but did not require the company to admit wrongdoing. The current California trial is expected to take possibly two months.

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