A review of an internal Darden Pharmaceuticals investigation suggests that errors may have been made by a Darden employee tasked with oversight of Xytek, an antiseizure medication now the subject of a potentially billion-dollar multidistrict litigation. According to the company’s own investigation, in his capacity as vice president of Risk Assessment, Doug Sinclair, now deceased, ignored physicians’ warnings about unexpected and adverse side effects in pregnant patients and failed to file the required Adverse Event Report with the FDA. These findings are yet to be confirmed by an independent investigative body, though the matter has been referred to the FDA. A company spokesman says that Darden is prepared to cooperate fully. According to fellow employees, who spoke on condition of anonymity, Doug Sinclair was generally respected, but there were recent reports of performance issues. The matter has also been referred to the FBI for investigation.
Katrina
ONE DAY BEFORE
A search of the Blair, Stevenson database revealed that Tim Lyall wasn’t just any corporate partner at the firm. It appeared he handled special projects, too. It’s not the kind of thing that would have been obvious to anybodybutme—I knew the telltale signs, the cryptic matter names, the expense billing to “general office.” But it seemed that, unlike me, Tim Lyall was a true corporate fixer—acting on behalf of the companies themselves, not their rogue employees. Mark had never mentioned there being more than one of us, but I’m not sure I would have wanted to know. My Uber was pulling off the FDR at Sixty-first Street, only a few blocks from Tim Lyall’s apartment, when I got a text from Mark.
A heads-up that theJournalwent live with a story for tomorrow’s paper about Sinclair and Darden.
He followed it with a link.
It was bound to come out. Anonymous sources are definitely other employees doing a CYA. Doesn’t change the work that remains to be done.
Bound to come out? Darden had clearly gone to theJournalthemselves. Mark could try to act blind, but he wasn’t an idiot. I began to type something to that effect, then deleted it. I wanted to see these documents Tim Lyall had before I did anythingelse. And maybe I was a little afraid of how Mark was going to respond. I had a bad feeling about all of it.
Okay,I wrote back instead.Thanks for letting me know.
“I work for Tim Lyall,” I said to the doorman crouched behind the small reception desk in the clearly pricey but also very generic Upper East Side apartment building. I flashed my work ID.
“He’s not—”
“Here. I know. He’s on his way to Zurich. He left some client documents in his apartment. He needs me to take them to him at the airport.”
“Residents have to leave permission in writing and their keys if they want to let somebody in,” he said, taking a step back. “Those are the rules.”
“Well, my boss needs the documents. We can call him if you want. But he was yelling at everybody before he left the office.” I dug out my phone and extended it to him. “Maybe if you want to be the one to tell him …”
Tim Lyall’s apartment was a postmodern box with parquet floors and neutral mid-century furniture, utterly devoid of not only personality but any trace of a person. Like a corporate Airbnb. There was not a single photograph or birthday card or piece of evidence that a Tim Lyall existed.
It took me only a couple minutes to find the file cabinet tucked away in a mostly empty closet. It turned out what Tim Lyall lacked in knickknacks, he made up for in client files kept at home—way more than even the most conscientious partner should ever have. His own little insurance policy, perhaps. The documents touched on a whole range of matters, but all of them had to do with some kind of corporate hiccup: an agency violation, expedited approvalneeded, an accounting error excused. Tim had retained only a few documents in each case, probably enough to use as leverage in a cover-your-ass fashion. But at the back of the cabinet there was a thicker hanging folder labeledDarden.
Inside were dozens of folders containing a range of documents—studies, data, FDA correspondence, and internal documents related to the FDA approval process for Xytek years ago. There were research results and test studies, internal memos and emails.
At the back I spotted a sealed envelope, unmarked.
Inside the envelope were printouts of more recent emails, sent from Doug to Phil Beaumont, Darden in-house counsel, six months ago. And they made Doug’s position crystal clear in very formal, on-the-record fashion:
Phil,
To reiterate what I stated in our discussion earlier today: We need to discuss this phone call. Dr. D’Angelo is the head of obstetrics and gynecology at Vanderbilt University Hospital. He’s highly respected. He claims he spoke with people at DardenYEARS ago.An adverse event report was never made, Phil. I’m sure that whatever happened was an oversight. But we need to at least look into it.
Sincerely,
Doug Sinclair
Phil,
I understand the company’s position that D’Angelo was being sued for malpractice and maybe he was indeed trying to put theblame on Xytek. Regardless, these claims need to be reported now. An adverse event report needs to be made to the FDA that reflects when Dr. D’Angelo made his first call to Darden, which was long before the lawsuit. There was an oversight. It happens. The only path forward is transparency.
Sincerely,
Doug Sinclair
And then one from only a month or so ago. After the filing of the multidistrict litigation complaint.
Phil,
I’m not going to stay quiet about this. I’ll come forward myself if need be. I’ll go to the press and I’m going to tell the truth.
