High Court Refuses to Hear J&J Mesh Case
The U.S. Supreme Court has declined to hear a Johnson & Johnson case that sought the high court’s review and reversal of a California Court of Appeal decision imposing $300 million in civil penalties on the company’s Ethicon unit for marketing its pelvic mesh product in the state.
In its petition to the Supreme Court, Johnson & Johnson said the state claimed that statements made by the company about mesh used in pelvic surgery were “likely to deceive” consumers and physicians. “The California court counted up more than 200,000 statutory violations — based in significant part on communications not proven to have reached consumers at all,” the petition said. “Ethicon lacked fair notice of the severity of this penalty,” it said, adding that California statutes do not define what constitutes a separate violation when counting penalties.
In a brief submitted by Washington Legal Foundation, the group said the case “details how a series of statutory and prosecutorial overreaches have radically transformed California’s well-intentioned consumer protection laws into a trap for the wary and unwary alike. As applied today, California law fails to put the public on fair notice of what kind of conduct constitutes a violation. With no definition of a ‘violation’ for purposes of assessing penalties, courts are left to interpret and apply amorphous, elastic, and imprecise language, such as whether a practice is ‘unlawful,’ ‘unfair,’ or ‘fraudulent,’ on a case-by-case basis. This deprives businesses of the benefit of fair notice and due process.”
WLF further said the state laws’ vagueness has resulted in an increasingly standardless and often arbitrary application of the laws by California state courts and, at times, their federal counterparts. “The chaos has snowballed over time, providing even greater opportunities and incentives for abuse of the judicial process by government entities and others who seek to enforce one or both statutes (Unfair Competition Law and False Advertising Law),” it said.
A Johnson & Johnson statement says the decision “leaves unresolved significant legal questions that courts across the country will continue to face. Without clarity from the Supreme Court, the patchwork of vague state statutes will continue to result in uneven, unclear, and unfair enforcement that harms both consumers and businesses.”
In 2008, FDA warned of complications experienced by women who were prescribed the product to help with stress urinary incontinence and pelvic organ prolapse. Thousands of personal injury lawsuits have been filed alleging pain, urinary problems, and bowel, bladder, and blood vessel perforation. In 2019, the agency ordered mesh manufacturers to stop selling devices for transvaginal repair of pelvic organ prolapse in the U.S.