US law preempts state warning label liability, Monsanto argues

A Monsanto attorney argued federal law preempts liability in lawsuits over the safety of its Roundup weedkiller, drawing skepticism from a three-judge federal appeals panel on Friday.

The judges are weighing whether a 2019 letter from the Environmental Protection Agency declaring it will no longer approve cancer warnings on glyphosate-based products can be considered.

"It doesn't seem to have the binding force of law normally required," said Judge Ryan D. Nelson of the 9th U.S. Circuit Court of Appeals.

The case has divided federal and state regulators on whether product manufacturers can be held liable for California warning requirements the EPA has refused to impose. The U.S. Justice Department and state attorney general's office filed dueling friend-of-the-court briefs.

Circuit Judges N. Randy Smith and Michael D. Hawkins also sat on the panel considering the appeal of a $25 million verdict in favor of plaintiff Edwin Hardeman, who claimed exposure to Monsanto Co.'s weedkiller caused his Non-Hodgkin lymphoma. It was the first federal jury finding among thousands of cases in the sprawling multi-district litigation. Hardeman v. Monsanto Co., 19-16636 (9th Cir. Aug. 15, 2019).

During the Friday video hearing, Monsanto attorney Seth P. Waxman emphasized glyphosate's long-standing record of regulatory approvals and findings of noncarcinogenicity. He said Hardeman's claims are preempted under the Federal Insecticide, Fungicide and Rodenticide Act, which empowers the EPA to regulate the use, sale and labeling of pesticides.

"EPA's study of the cancerous potential of glyphosate has been nothing short of encyclopedic," he said. "A warning would be false and misleading and therefore, violate federal law."

Preemption exists not because Roundup was approved for sale by the EPA, Waxman continued, but rather because states may not impose requirements for labeling and packaging different from or in addition to those required under federal law.

Asked whether California has imposed requirements inconsistent with the government, the WilmerHale LLP partner responded that the EPA prohibited Monsanto from putting a cancer warning on its product.

The 2019 EPA letter has to be considered in the case since it's relevant to whether it would have been possible for Monsanto to change its label to include a cancer warning, Waxman noted. He called it a "capstone on the agency's prior determination on the noncancerous potential of glyphosate and its formulations."

Plaintiff's attorney David J. Wool, meanwhile, challenged the inclusion of the letter in the panel's analysis since the EPA did not follow proper protocol to exercise its misbranding authority. If it seeks to formally reject a label change, it must send the manufacturer notice and publish it in the Federal Register to allow for public comment, among other procedures. "It's merely an agency musing," he said.

Asked by Hawkins what course of action weedkiller manufacturers were supposed to take to comply with both federal and state labeling requirements, the Andrus Wagstaff partner disputed that Monsanto ever asked the EPA to include a cancer warning.

Regardless, the burden is always on the manufacturer to ensure its label is adequate, Wool said. There's no circumstance in which the mere rejection of a label has the force of law, he added.

The panel also examined whether the federal judge overseeing the trial erred in his role as a gatekeeper for expert testimony.

Monsanto has decried the allegedly relaxed standards in which U.S. District Judge Vince Chhabria allowed specific causation experts to testify, namely pathologist Dennis Weisenburger.

Waxman questioned the reliability of Weisenburger's testimony that exposure to Roundup caused Hardeman's cancer since more than 70% of Non-Hodgkin lymphoma cases are due to unknown causes. He cited Chhabria saying when he admitted the pathologist as an expert that "district courts in this circuit must be more tolerant of borderline expert opinions than in other circuits."

Nelson responded by noting that the 9th Circuit gets several cases in which the trial court excluded expert testimony and gets reversed.

"I'm sympathetic to the district court here who said that we learned our lesson," he said. "We like that the district court learned their lesson. [Chhabria] seems to have done the right thing here."

An appeal to the U.S. Supreme Court is likely no matter how the 9th Circuit rules. A more business-friendly high court might be more receptive to Monsanto's preemption defense.