The U.S. Justice Department on Monday is expected to make its opening arguments in a weeks-long bench trial that will shine light on whether Bayer Corp. made unfounded claims that a probiotic supplement helps defend against certain symptoms including bloating, constipation and diarrhea.
The government estimated last year that consumers have spent hundreds of millions of dollars on the colon supplement, “luring consumers away from available alternatives."
In a Newark, New Jersey courtroom, government lawyers will strive to convince federal judge Jose Linares that the healthcare conglomerate violated a 2007 consent decree because it failed to substantiate its statements with “competent and reliable scientific evidence."
The Justice Department must establish a violation of the consent decree by “clear and convincing evidence." That is a tougher standard of proof than in a typical civil lawsuit but more relaxed than the “beyond a reasonable doubt" burden of proof in a criminal prosecution.
The dietary supplement industry has been closely monitoring the spat between Bayer and the FTC, the government agency responsible for cracking down on deceptive business practices. The FTC is aiming to set a precedent that would require human clinical trials before supplement marketers can tout a product’s benefits, which would be dangerous, according to supplement industry representatives.
The government’s demand for randomized controlled trials (RTCs), supplement advocates maintain, is unnecessary and would undermine the 1994 Dietary Supplement Health and Education Act (DSHEA). The industry has credited the 21-year-old law with empowering the industry to flourish, catering to more than 150 million Americans and yielding annual sales north of US$30 billion.
In federal court last September, FTC requested an order to show why Bayer should not be held in contempt for violating the 2007 order or so-called consent decree. The consent decree related to claims Bayer made in support of a different supplement, its WeightSmart line of One-A-Day vitamins.
According to a gastroenterologist retained by the government, Bayer should have produced human, randomized clinical trials in support of its claims for the particular strains of bacteria that are contained in the supplement. Phillips’ Colon Health contains three types of bacteria that are supposedly beneficial to the gut.
Bayer’s failure to conduct the proper RCT violated the consent decree’s requirement that the company possess “competent and reliable scientific evidence" in order to make the representations about the supplement, according to the Justice Department.
“The evidence is clear that competent and reliable scientific evidence for the specific claims at issue requires an RCT of a daily dose of the actual, three-bacteria strain formula of PCH in the population to which Bayer asserts its claims are addressed: healthy people," government lawyers wrote in a June 5 trial brief.
Bayer has countered since last year that its probiotic claims are backed by several clinical trials on the species of bacteria in the product, in vitro and animal studies on the bacteria strains, and genomic tests that confirm the strains help protect against constipation, gas, bloating and diarrhea. In court papers last October, Bayer said the consent decree does not require human clinical trials on the specific product. Bayer also argued the government is seeking to hold the company to a standard that conflicts with the FTC’s own guidance and is incompatible with DSHEA.
The government and its expert, Loren Laine, M.D., of the Yale School of Medicine, are arguing for a standard that “would subject dietary supplements and prescription drugs to the same standard," Bayer’s lawyers wrote in their trial brief. “This standard, which no one in the dietary supplement industry meets, conflicts with Congress’s enactment. The whole point of … DSHEA was to lower the substantiation standard for supplements."
As the case has progressed, the government is said to have raised fresh arguments. In the June 5 trial brief, government lawyers said Bayer has failed to establish that it possessed materials, such as studies, when it made its probiotic claims. Consequently, the 10-page brief reasoned, the company has violated a provision in the consent decree that required Bayer maintain business records demonstrating compliance with the order.
“While Bayer’s counsel produced to the FTC approximately 100 papers and several cover letters as purported substantiation," government lawyers wrote, “it did not produce any evidence establishing that Bayer possessed and relied upon those papers at the time it made the specific claims at issue."
Bayer shot back with a derisive rebuttal in its own trial brief, characterizing the record-keeping argument as “a completely new theory of contempt."
“If the Court allows the government to proceed with its last-second change in game plan, it should reject the government’s new position, which is premised on a plain misrepresentation of the record," Bayer’s outside legal team wrote. “Bayer complied with the record-keeping provision and produced documents showing it possessed and relied upon volumes of scientific studies in the public domain."
The trial is largely expected to feature competing testimony from experts, such as Laine and Bayer’s potential witnesses, including the doctors Brian Fennerty, a gastroenterology expert, and Daniel Merenstein, a probiotics guru.
The Justice Department will have four days beginning Monday, June 15, to bring its case-in-chief. Bayer will present its defense the following week, led by Sidley Austin’s trial lawyers Jonathan Cohn and Mark Hopson.
Linares, the federal judge who will decide the case, also has set aside June 30 for genetics experts to weigh in, which may include testimony on whether different strains of the probiotic species have meaningfully different effects on digestive health.
The stakes are high for Bayer. The Justice Department has asked that Linares impose a fine of $25,000 per day to coerce compliance with the consent decree, require the removal of advertising and packaging claims, and award compensatory damages reflecting consumers’ alleged losses.
Finally, Bayer has argued a ruling in favor of the government would have broad implications for the supplement space.
“If Dr. Laine’s tests were required for probiotics and supplements, it would likely require nearly all supplement advertising to be eliminated, greatly impacting public health," warned Merenstein, an associate professor with tenure at Georgetown University, in a signed statement on Dec. 22, 2014. “As far as I can tell, no probiotic supplement could be sold as they are currently marketed. I am unaware of any probiotic that meets Dr. Laine’s standard."