GSK, Pfizer and several other pharmaceutical companies are taking aim at the credibility of a small independent lab in Connecticut as they defend themselves against thousands of lawsuits claiming a popular heartburn medication can cause cancer.

Valisure, a 20-person operation based in New Haven, caused shockwaves when it said in 2019 that it had found Zantac and generic versions of the drug, which have been sold in the US for more than three decades, contained N-Nitrosodimethylamine, better known as NDMA, which regulators classify as a “probable human carcinogen”.

Since then more than 2,000 personal injury lawsuits have been filed and a further 70,000 claims registered by users of the medication in litigation, which analysts forecast could cost the companies tens of billions of dollars in damages.

As the lawsuits move towards trial, companies who sold branded versions of Zantac over the past 35 years — including GSK, Sanofi, Pfizer and Boehringer Ingelheim Pharmaceuticals — have denied that using Zantac, the brand name for the drug ranitidine, leads to an increased cancer risk.

In mounting their defence they have singled out Valisure, claiming its testing methodology was flawed, biased and undertaken in co-ordination with plaintiffs’ lawyers.

“Valisure’s testing, lobbying, and publicity campaign is the ground zero of this entire litigation,” the pharma groups alleged in court documents filed in litigation overseen by US District Court Judge Robin Rosenberg.

Next month Judge Rosenberg will hold hearings to determine what scientific expert testimony will be admissible in the cases, focusing on testing methods and what levels of NDMA may pose a cancer risk.

Valisure’s research on Zantac has divided scientific experts. US regulators agree that NDMA is not expected to lead to an increase in cancer risk at very low levels, noting it is present in most food and water. However, sustained higher levels of exposure may increase the risk of cancer in humans, they said.

The US Food and Drug Administration previously concluded Valisure’s testing methodology was “inappropriate” and “contributed to or caused the levels of NDMA to be artificially high”. Documents released in response to Freedom of Information Act inquiries, which were first reported by Consumer Reports, also reveal the agency is investigating the lab to ensure its work for companies that seek FDA approval for products complies with the law.

Nevertheless, seven months after Valisure published its own research on Zantac’s NDMA risk, the FDA requested manufacturers to withdraw all their ranitidine drugs from the market, concluding that NDMA levels increase over time even under normal storage conditions.

“This shows the critical importance and impact of independent testing being part of the supply chain.” David Light, co-founder and chief executive of Valisure, told the Financial Times.

The pharma groups have alleged the lab used a testing method that was never validated to test for NDMA in ranitidine, which they said involved “superheating” samples of the drug to produce “artificially high” levels of NDMA.

The companies have also argued that Valisure worked with the plaintiff’s bar to pave the way for the litigation. One of the first lawsuits detailing Zantac’s alleged link with NDMA and cancer was filed by Yitzhak Levin, a lawyer who is a brother-in-law of Light, according to the pharma groups.

Another plaintiff’s lawyer in the Zantac litigation, Gregory Frank, was a “key player in co-ordinating Valisure’s ranitidine testing and citizen petition”, claimed the companies in the court documents.

Neither lawyer responded to a request for comment.

Light said the lab stood by its research methodology and accused pharma groups of attempting to paint Valisure as being behind a “conspiracy”.

“That is absolutely not true at all . . . We are about the science which has been proven right many times and this [screening] is impactful and needs to be better utilised within the industry,” said Light.

He said Valisure was sometimes contracted for consultancy work on behalf of plaintiffs’ lawyers and other groups in relation to its research, but the laboratory was not hired as experts in the Zantac case. Light said a relative of his brother-in-law was prescribed ranitidine, and said he had evidence that it was a problematic drug.

“I think it appropriate that I told him don’t do that [continue to allow his relative to take ranitidine] . . . He’s a litigation lawyer and he filed some of these lawsuits and, you know, that’s his business,” said Light.

Big Pharma’s criticism of the New Haven lab stands in stark contrast to the praise the lab has received from consumer advocates and members of congress for its efforts in highlighting safety concerns about Zantac and other drugs and consumer products.

Valisure is one of only a handful of independent labs in the US, which screen products to ensure they do not contain dangerous substances. Last year it published research showing the presence of benzene, a known human carcinogen, in sunscreen and body sprays leading to numerous product recalls by manufacturers, including Johnson & Johnson.

“There is kind of this big misconception that the FDA is testing everything when the reality is that, you know, the manufacturers self-report the data and the FDA is reviewing the paperwork essentially,” Light said. “There are cracks in the system that are not being well addressed.”

Women have been accusing investment banks of sexual discrimination and harassment for years. Almost none have done anything quite like Jamie Fiore Higgins.

Last week, Higgins published Bully Market, a 320-page account of her 17 years at Wall Street powerhouse, Goldman Sachs, where she had a coveted managing director job until she quit in 2016.

Here’s a taste of what she says happened to her in that time:

She passed out at work, having gone back earlier than her doctor advised after a miscarriage because a manager said the office was short staffed and when his wife had a miscarriage “she was fine after a few days”.

She felt as if she would pass out after confronting a subordinate having an affair with a client who wrapped his hand under her jaw, pinned her against a wall and screamed, “If I could, I’d rip your fucking face off.”

She sat near a man who asked his friend to do a “fuckability” ranking of female analysts on Excel.

She stopped using the bank’s lactation rooms after a boss said she would never make managing director if she was pumping milk instead of working. When she went ahead anyway after having another baby, male colleagues moaned “Moooo” and pretended to squeeze their breasts as she headed to the lactation centre. One day she got back to find a toy cow on her desk.

Higgins does not spare herself. Coming from a modest background, she says she was seduced by the bank’s lavish bonuses and kept her mouth shut to get ahead.

She finally quit when her career started tanking after she complained about a colleague who went unpunished after he drunkenly hurled racial epithets at a karaoke bar worker on a night out with clients.

I found my eyes popping as I read the book, despite an author’s note at the start warning that some names are changed, the dialogue is not verbatim and several Goldman people are “composite characters”.

Goldman said last week it strongly disagreed with Higgins’s characterisation of its culture and her “anonymised allegations”. “Had Ms Higgins raised these allegations with our Human Resources department at the time we would have investigated them thoroughly and addressed them seriously,” the bank said.

“We have a zero-tolerance policy for discrimination or retaliation against employees reporting misconduct.”

The question is, five years after the #MeToo movement took off, has this behaviour endured, in banking or anywhere else?

“I think probably it’s not as bad as it once was,” says Higgins, who was being driven from her New Jersey home to Manhattan for a round of TV network interviews when I spoke to her last week.

She is confident the physical assault she suffered would no longer be tolerated, though she says the man who assaulted her is still working in financial markets in New York.

And since her book started being publicised, she has had “probably over 100” messages from women with similar experiences who are either still in the banking industry, or recently left, or are in private equity, law, medicine and other male-dominated fields.

A lot stay quiet because of non-disclosure agreements.

“I’ve gotten so many messages on my various social accounts from people saying, ‘Oh my gosh, this is my book, I can’t write it because of my NDA’.” 

Higgins thought of suing but after a lawyer explained the risks, she instead drew up a “spreadsheet of freedom” to calculate the moment she would have enough financial security to quit. As she says, “it’s kind of rare for people to just walk away with the intention of never working on Wall Street again”.

She started writing classes after she left, and got a writing coach to help shape what has become Bully Market.

Now 46, she is also an executive coach with a couple of dozen clients. She has a lot to say, starting with the advice she offers at the end of her book to any powerful organisation.

Three ideas stand out: Make HR independent. Ensure ideals and principles drawn up in the executive office permeate all ranks. And don’t pay or promote managers just because of their financial contribution. Instead, hold them accountable for their character and the culture of their teams. Otherwise, everyone in the firm might one day wake up to read something about themselves that they never expected to see.

pilita.clark@ft.com

France’s Sanofi plans to name outgoing Société Générale boss Frédéric Oudéa as chair to replace veteran private equity executive Serge Weinberg in 2023, as the pharmaceutical group pursues a turnround.

Oudéa, who has been chief executive of SocGen for nearly 15 years, will become a non-voting member of Sanofi’s board as a first step with immediate effect, Sanofi said. Shareholders will then have a say on his nomination as non-executive chair.

Oudéa’s term at SocGen is due to end in May 2023 and his successor is expected to be chosen in the coming weeks. Weinberg has been Sanofi’s chair since 2010.

The change comes as Sanofi chief executive Paul Hudson enters his fourth year in the role, amid questions about the strength of the group’s pipeline of experimental drugs.

Hudson is making strategic changes at the group that include exiting commodity categories such as heart disease and diabetes and pouring money into research into immunology and cancer. But several promising drugs have failed recently and Sanofi’s efforts to develop a Covid-19 vaccine have not yet borne fruit, a notable failure for one of the world’s biggest vaccine makers.

Analysts have questioned whether the company may need to consider more acquisitions to boost its pipeline.

There are bright spots, however, such as the blockbuster eczema treatment Dupixent, sales of which are growing much faster than predicted and are a big contributor to profitability. The group raised its annual profit target in July on Dupixent sales.

Weinberg said he was confident of Oudéa’s success and cited his experience of “managing and leading the digital transformation of a large global company in a highly regulated sector”. 

Oudéa took over SocGen in the wake of a rogue trading scandal, and has been credited with stabilising the bank and navigating it through several other crises. His most recent strategic changes have begun to pay off with improved earnings.

But its share price has yet to return to pre-2008 levels and has lagged some rivals.

SocGen has been searching internally and externally for a successor to Oudéa. Sébastien Proto, a former Rothschild banker who is in charge of merging SocGen’s French bank networks, is seen as a strong internal contender, people close to the situation have said. Investment bank head Slawomir Krupa is also a candidate, the people said.