Tens of thousands of lawsuits have their origins in a man once arrested after firing a gun into the ceiling of his Yale University frat house and threatening a visitor, resulting in police discovering an illegal arsenal of weapons and explosives that earned him a one-year prison sentence.
ABC News called them "drunken shots" at the time, but more than a decade later David Light's laboratory Valisure has kickstarted mass torts over the heartburn medicine Zantac and other products with research submitted to the FDA, which hasn't always welcomed its efforts. The Department of Defense, on the other hand, recently picked the lab for a generic-drug testing contract.
His undergraduate career at Yale University was interrupted in 2008 by a stint in jail for possessing armor-piercing ammunition, assault and sniper rifles and what police determined were bomb-making supplies.
None of this was reported when New Haven, Conn.-based Valisure first made headlines in September 2019 over claims it found potentially deadly levels of the cancer-causing chemical NDMA in Zantac. Nor did Connecticut’s Democratic congresswoman Rosa DeLauro mention Light’s criminal past when she touted the lab’s new Pentagon contract in August, which was awarded despite previous criticisms from the FDA about Valisure's research methods.
The lab announced a cooperative research agreement, which typically doesn’t involve funding, to develop a test to score drugs used by the military for quality. The contract is just one more twist in the story of a tiny company, founded as an online pharmacy, that came to be at the center of multimillion-dollar litigation over commonly used products including Zantac, sunblock and shampoo.
Valisure's rise also illustrates how trial lawyers use supposedly independent labs, paid experts and sympathetic journalists and politicians to propel litigation based on scientific theories that don’t always stand up in court.
A federal judge in Florida last year dismissed thousands of lawsuits over Zantac after ruling that Valisure’s methods were unreliable, although state-court judges in Delaware and California have allowed the cases to proceed. A Delaware judge this fall will oversee the first trial of more than 75,000 claims over supposedly contaminated Zantac – generic name ranitidine – that have their roots in a “citizen petition” Valisure filed with the FDA in 2019.
Light didn’t respond to requests for comment on his past. He founded Valisure with fellow Yalie Adam Clark-Joseph in 2015 as an online pharmacy that would test drugs for impurities before shipping them to consumers. That business ran into trouble after the FDA inspected Valisure’s facilities in 2021 and found numerous violations including storing “illegitimate product” that “would be reasonably likely to result in serious adverse consequences or death to humans.”
In a December 2022 letter, the FDA also cited Valisure for “methodological deficiencies” in its testing, for using gas and liquid chromatography equipment in incorrect ways and failing to keep proper records. The agency warned Valisure against telling customers its testing could be used to validate good manufacturing processes.
Valisure’s response was that it complied with International Organization for Standardization procedures but its testing was not “used for any regulatory purpose.”’
This wasn’t Light’s first run-in with the government. In 2007, while an undergraduate biology major at Yale, a schoolmate reported him for shooting a pistol into the ceiling of his frat house. A Yale Daily News article says he threatened a visitor with a gun supposedly loaded with blanks, telling him, "Why don't I point it at your head to find out?"
Police later found 11 guns in Light’s room, including an AR-15 and a 50-caliber sniper rifle, as well as bombmaking equipment. Light pleaded guilty to charges of illegal weapons possession and reckless endangerment and was sentenced to a year in prison, according to Connecticut Department of Correction records. He was granted parole after six months.
Light earned his bachelor of science degree in 2011, although in his alumni profile, he identifies himself as a member of the class of 2008 - the year he went to prison.
The Valisure website says the company was founded after Clark-Joseph suffered severe complications from an anticonvulsant medicine and he and Light decided they should form a business to bring “quality and consistency to consumers and the overall healthcare industry.” It put that claim to the test in 2019, when it filed its first petition with the FDA, stating it had found dangerous levels of NDMA, also known as nitrites, in Zantac and called for a recall.
What Valisure didn’t disclose in its filing was that some of its work on other drugs had been paid for by plaintiff attorneys in search of targets to sue. It shared details of the Zantac case with at least one lawyer, Miami attorney Yitzhak Levin, who filed the first lawsuit over ranitidine the day the petition hit the FDA.
Levin happens to be Light’s brother-in-law. When asked in a deposition how Levin came to file a highly detailed, 30-page complaint based on Valisure’s petition before it was public, Light demurred, saying only that he had discussed some of the lab’s findings with Levin because Levin was considering giving Zantac to his daughter.
Light’s brother-in-law wasn’t the only person Valisure told about its findings in advance of the public filing. Also in that deposition, Light boasted of journalists that were “connections of ours,” including Bloomberg reporter Anna Edney. Edney reported on Valisure’s FDA petition the day it was filed and has since filed multiple flattering stories about Valisure, last year calling it “the lab protecting us from dangerous products.”
The FDA ordered a brief recall of Zantac products in 2019, only to later that year dismiss Valisure’s methods as unreliable. In its citizen petition, Valisure said it detected NDMA levels over 3 million nanograms, versus the FDA’s daily limit of 96.
The FDA criticized Valisure for heating Zantac in an “artificial stomach” to 260 degrees and subjecting it to lethal levels of salt to get those results. Valisure detected no NDMA in the drug when testing it under normal conditions for the human body, although it defended its methods as revealing the potential for contamination.
A Florida federal judge in 2022 dismissed around 50,000 Zantac lawsuits, saying Valisure’s methods were unreliable. Without causation evidence, the plaintiffs had no case. Judge Vivian Medinilla in Delaware came to a different conclusion on the science, however, and has allowed state-court cases to proceed, as has a judge in California.
Depositions and emails discovered in the Zantac litigation and other cases reveal a company that works closely with trial lawyers and sometimes receives money from them. Valisure has raised as much as $10 million since 2017, according to Securities and Exchange Commission records, but it declines to name its investors, customers or financial results.
One possible stream of income was revealed in a filing Unilever made in a lawsuit accusing it of selling benzene-tainted dry shampoo. It contains a letter from Valisure attorney Marty Sipple, before the litigation began, offering to test Unilever’s products for benzene for an up-front payment of $1.25 million and $250,000 a month, promising to keep results confidential. Unilever says it “declined this ‘offer.’”
Zantac defendants sought to probe Valisure’s financial connections with the lawyers suing it but a judge quashed the subpoena because Valisure wasn’t considered an expert witness in the litigation. The judge refused Valisure’s request for fees incurred fighting the subpoena, however, saying: “The record before me demonstrates that Valisure was on actual notice that its testing results were going to be used to support the plaintiffs’ claims in ranitidine litigation.”
Perhaps unusual for a research lab, Valisure hired plaintiff attorney Gregory Frank to help draft its first citizen petition to the FDA, as well as Connecticut law firm Robinson & Cole. Light also described arranging a series of dinners at the Yale Club in New York with Frank, Valisure investor Michael Bretholz and Lior Braunstein, a researcher at Memorial Sloan Kettering who did studies supporting Valisure’s conclusions.
One email described a June 25, 2019, meeting of the three “to strategize on the upcoming breaking of the ranitidine story.” Asked in a deposition what the strategizing was about, Light said “timing and form and all sorts of elements of how we would release the story, what we would say with the story.”
He also said Valisure‘s Zantac results “will be sent to journalists that are already connections of ours.” Bloomberg, the Wall Street Journal and other news outlets ran stories on Valisure’s petition almost simultaneously with its filing at the FDA.
Valisure also paid as much as $50,000 a quarter to the Washington lobbying firm of former Sen. Tom Daschle to talk up members of Congress and the press about its conclusions. Federal lobbying forms also show it hired the firm to push for legislation that would require drug and cosmetics makers to submit their products for testing by independent labs like Valisure.
Company emails reveal Valisure met with U.S. Rep. Anna Eshoo (D-Calif.), in September 2019 and a few days later, she sent a letter to the FDA about ranitidine.
A deposition taken in the Zantac litigation appears to refer to another part of Valisure’s strategy: Prompting state attorneys general. Defense lawyers obtained a document from the summer of 2019, before the Zantac petition was filed, saying “our first official action with the government was filed this past weekend and multiple offices of Attorneys General have already responded that they are taking it seriously and are investigating.”
In the deposition, attorney Brent Wisner, one of the lead lawyers in the Zantac litigation in Delaware, and Valisure’s attorney William Egan instructed Light not to answer any further questions about the subject, with Egan stating “this area of investigation is not subject to public disclosure, and I am directing the witness not to answer.” Plaintiff attorneys frequently work in close coordination with state AGs in lawsuits over opioids, climate change and other subjects that have generated billions of dollars in fees.
Valisure’s latest alliance may be with the Pentagon. The company announced a cooperative research agreement with the Defense Department in August – reported that same day by the Bloomberg reporter Edney called by Light one of the "connections of ours" – to test drugs purchased by the government for dangerous chemicals.
A Defense Department spokeswoman declined to comment on the agreement, or on Light’s criminal record. Rep. DeLauro’s office also didn’t respond to a request for comment.