People v. Johnson & Johnson

• Decision Date: 11 April 2022
• Docket Number: D077945
• Citation: 77 Cal.App.5th 295,292 Cal.Rptr.3d 424
• Parties: The PEOPLE, Plaintiff and Respondent, v. JOHNSON & JOHNSON et al., Defendants and Appellants.
• Court: California Court of Appeals

77 Cal.App.5th 295

292 Cal.Rptr.3d 424

The PEOPLE, Plaintiff and Respondent,

v.JOHNSON & JOHNSON et al., Defendants and Appellants.

D077945

Court of Appeal, Fourth District, Division 1, California.

Filed April 11, 2022

As Modified on Denial of Rehearing April 27, 2022

O'Melveny & Myers, Charles C. Lifland, Jason Zarrow, Lauren F. Kaplan, Los Angeles, Stephen D. Brody, and Martha F. Hutton, for Defendants and Appellants.

Horvitz & Levy, David M. Axelrad, Burbank, and Scott P. Dixler for the Advanced Medical Technology Association as Amicus Curiae on behalf of Defendants and Appellants.

Barnes & Thornburg and Kevin D. Rising, Los Angeles, for the American Urogynecological Society, the Society of Gynecologic Surgeons, the American Association of Gynecologic Laparoscopists, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction as Amicus Curiae on behalf of Defendants and Appellants.

California Appellate Law Group, Ben Feuer, San Francisco, and Julia Partridge for the U.S. Chamber of Commerce and American Tort Reform Association as Amicus Curiae on behalf of Defendants and Appellants.

Tucker Ellis, Mollie F. Benedict, and Peter L. Choate, Los Angeles, for the Washington Legal Foundation as Amicus Curiae on behalf of Defendants and Appellants.

Rob Bonta, Attorney General, Nicklas Akers, Assistant Attorney General, Jon Worm, Adelina Acuña, Tina Charoenpong, Monica J. Zi, Gabriel Shaeffer, and Daniel Osborn, Deputy Attorneys General, for Plaintiff and Respondent.

McCONNELL, P. J.

IINTRODUCTION

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon) appeal an adverse judgment following a bench trial. The trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon's surgically-implantable transvaginal pelvic mesh products. The court found Ethicon committed 153,351 violations of the Unfair Competition Law (UCL) ( Bus. & Prof. Code,¹ § 17200 et seq. ) and 121,844 violations of the False Advertising Law (FAL) (§ 17500 et seq.), and it imposed a $1,250 civil penalty for each violation.

Ethicon contends the judgment must be reversed because: (1) the trial court applied the wrong legal standards when determining that Ethicon violated the UCL and FAL; (2) substantial evidence did not support the court's findings that Ethicon's medical device instructions and marketing communications were likely to deceive doctors and patients; (3) the safe harbor doctrine precluded findings of liability; (4) the civil penalties violated Ethicon's rights under the free speech clauses of the state and federal constitutions; (5) the court abused its discretion by counting each deceptive communication as a separate violation and setting $1,250 as the civil penalty for each violation; and (6) the civil penalties violated Ethicon's due process rights and the excessive fines clauses of the state and federal constitutions.

We conclude the trial court erred in just one respect. In addition to penalizing Ethicon for its medical device instructions and printed marketing communications, the court penalized Ethicon for its oral marketing communications—specifically, for deceptive statements Ethicon purportedly made during one-on-one conversations with doctors, at Ethicon-sponsored lunch events, and at health fair events. However, there was no evidence of what Ethicon's employees and agents actually said in any—let alone all—of these oral marketing communications. Therefore, we conclude substantial evidence did not support the trial court's factual finding that Ethicon's oral marketing communications were likely to deceive doctors, and we amend the judgment to strike the nearly $42 million in civil penalties that were imposed for these communications.

We discern no other error and affirm the judgment as modified.

IIBACKGROUND

AStress Urinary Incontinence and Pelvic Organ Prolapse

Since the late 1990s, Ethicon has manufactured, marketed, and sold pelvic mesh products intended to treat two conditions that can affect women—stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

SUI is a chronic condition characterized by urine leakage during everyday activities such as laughing, coughing, sneezing, or exercising. Approximately one third of women experience SUI at some point in their lives. SUI is not life-threatening, but it can impair a patient's quality of life and limit the range of activities in which she can participate.

POP is a disorder whereby the muscles and tissue in the pelvis weaken and cause pelvic organs to prolapse (i.e., descend) into, and sometimes outside of, the vagina. Most patients who suffer from POP experience pressure in the pelvis or vagina. It is difficult for some patients with POP to urinate, have bowel movements, or engage in sexual intercourse.

SUI and POP can sometimes be treated through nonsurgical means. For example, patients can perform pelvic floor exercises known as kegel exercises to strengthen the muscles around the urethra. They can also insert a device called a pessary into the vagina to stop urine leakage. POP can be treated nonsurgically through the use of a pessary or a hormone estrogen cream.

Non-mesh surgical methods can sometimes be used to treat SUI and POP as well. SUI can be surgically treated through the Burch procedure, whereby an incision is made into the abdomen and sutures are placed to extend the neck of the bladder. POP can be surgically treated through a native tissue repair whereby sutures are inserted to support the top of the vagina.

BEthicon's Pelvic Mesh Products

Starting in the 1990s, Ethicon began to manufacture and sell surgically-implantable transvaginal pelvic mesh products for the treatment of SUI and POP. All of Ethicon's pelvic mesh products were (and are) composed, at least in part, of a synthetic polypropylene mesh. When the mesh functions as intended, it elicits an acute inflammatory response that causes scar tissue to grow through the mesh's pores and incorporates the mesh into the patient's body.

In 1998, Ethicon released TVT (tension-free vaginal tape ), Ethicon's first pelvic mesh product for the treatment of SUI. TVT is a precut strip of mesh that can be surgically inserted in the vagina and enclosed underneath the midurethra like a sling. A midurethral sling pushes the urethra closed when pressure is exerted (e.g., during a cough ) to stop urine leakage. After the release of TVT, Ethicon developed and sold additional iterations of midurethral slings including the TVT-Obturator, TVT-Abbrevo, TVT-Exact, and TVT-Secur. These products will be referred to as the SUI devices.

During the 2000s, Ethicon released pelvic mesh products to treat POP. In 2002, it released Gynemesh PS, a flat sheet of mesh that a surgeon can hand cut and implant in the pelvic floor to support the pelvic organs. After the release of Gynemesh PS, Ethicon developed and sold various iterations of pre-cut Gynemesh PS strips called Prolift, Prolift-M, and Prosima. These products will be referred to as the POP devices.

CFDA Regulation of Pelvic Mesh Implants

In 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification alerting health care providers about complications from pelvic mesh implants used to treat SUI and POP. It stated the most frequent complications were "erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence," as well as "bowel, bladder, and blood vessel perforation during insertion." The notification warned that, in some cases, "vaginal scarring and mesh erosion [could lead] to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia," i.e., pain during sexual intercourse. It advised that complications were "rare," but could have "serious consequences."

In 2011, the FDA issued an update to its public health notification, which focused specifically on complications relating to pelvic mesh implants used to treat POP. The update stated, "surgical mesh for transvaginal repair of POP [was] an area of continuing serious concern." It stated the FDA had determined that serious complications associated with surgical mesh for POP repair were not rare—a change from the FDA's earlier public health notification. The update stated the most frequent complications were "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia ), organ perforation, and urinary problems." The update identified "recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems" as other common complications. According to the update, many of the complications required intervention, some of them required repair surgeries, and some of them were incapable of being resolved. Additionally, the update stated mesh POP repairs introduced risks that were not present in non-mesh POP repairs, and mesh POP repairs did not improve systematic results or quality of life compared to non-mesh POP repairs.

In 2012, the FDA ordered Ethicon to conduct post-market surveillance studies for one of its SUI devices (TVT-Secur) and three of its POP devices (Prolift, Prolift-M, and Prosima). Instead of conducting these post-market surveillance studies, Ethicon stopped selling the products commercially.

Ethicon also changed the indication for its fourth POP device (Gynemesh PS) from a transvaginal indication to an abdominal-only indication. Ethicon continued selling its other SUI devices (TVT, TVT-Obturator, TVT-Abbrevo, and TVT-Exact) up to and throughout the present lawsuit.

Ethicon's competitors continued to sell pelvic mesh products for transvaginal repair of POP, even after Ethicon stopped selling most of its POP devices. However, in April 2019, the FDA concluded there was not a reasonable...