A Department of Veterans Affairs medical center director misled Sen. Kelly Ayotte, denying that agency officials prescribed a contaminated drug for a New Hampshire veteran and then refused for five years to give him key information about his treatment, documents obtained by the Washington Examiner show.
Records show that the department did both, and that Deborah Amdur, director of the White River Junction Veterans Affairs hospital, would have known that when she told the New Hampshire Republican the contrary last month.
Soon after Marine veteran Ted Stachulski took a bupropion pill given to him by officials with the Veterans Affairs facility at White River Junction, Vt., in August 2009, he had a seizure that left him repeatedly smashing his head into a toilet.
The drug may have been contaminated with glass, insects, “black particles,” and other brain medications due to product quality control problems at the manufacturing facility, according to State Department, Food and Drug Administration and court documents. Veterans Affairs officials were aware of those problems when he was given the drug.
But the prescription bottle was taken from him after his seizure, and that began Stachulski’s five-year quest to obtain from the government his own medical records. When he did finally get the documents, they showed that the pills he was given came from a batch that was among those recalled.
At one point during the ensuing odyssey, the Veterans Affairs’ Office of Inspector General sent a team of armed agents to search his house for weapons — as he attempted to take his daughter to soccer — after a department employee claimed that she felt threatened by Stachulski’s requests. He later learned that employee retracted her complaint, he said.
The recall resulted from a December 2008 inspection by the U.S. Food and Drug Administration of a facility of the Canadian company Apotex in response to complaints from pharmacists. The inspectors found that the facility’s drugs were “adulterated” and could be banned from the U.S., according to State Department records.
In August 2009, another FDA inspection found similar problems. The agency then issued an “Import Alert” and Apotex “recalled adulterated drug products from the U.S. market.”
A July 22, 2009, letter from Veterans Affairs showed that that agency was aware of problems before giving Stachulski the pills, with a Veterans Affairs contracting officer writing that, “Due to Food and Drug Administration current good manufacturing practices (CGMP) deficiencies that were revealed in the FDA Warning Letter dated June 25, 2009, for Apotex’s manufacturing facility … the government may reject and return any products that were manufactured during a period of CGMP deficiencies and shipped without written authorization from the contracting officer.”
A Sept. 2, 2009, letter from Apotex, the manufacturer, told distributors: “If you possess any bottles of the affected lots, please discontinue their sale immediately.”
The month after he was prescribed the pills, Stachulski requested his records, which the government was obligated to provide within 20 days. He also requested that his files be marked “sensitive,” causing the computer to begin creating a log of every time Veterans Affairs staff accessed them, but that didn’t happen until 2011.
Though Veterans Affairs has the technical capability to keep tabs on who is doing what with electronic medical records, it does not do so unless patients request a “Sensitive Patient Access Report” to be enabled.
The fact that the records had not been flagged as sensitive made it nearly impossible to see what Veterans Affairs officials were doing with his records. Once the files were flagged, however, the computer records showed that the documents had been accessed hundreds of times, even as agency officials were telling Stachulski that there were no such records because they were routinely destroyed after three years.
At another point, Veterans Affairs officials appear to have created a new record to attempt to placate him. Stachulski told a records specialist that he recalled the word “gold” having something to do with the recalled medication. Not long afterward, a Veterans Affairs specialist sent him a official-looking piece of paper that said he had been given medicine manufactured by “Gold Brand.” But there is no such manufacturer.
Stachulski filed a legal action against the department before the statute of limitations ran out, but it was tossed out of court after he was unable to provide evidence without having access to his records.
In a Dec. 3, 2014 letter, Andrea Wilson, a privacy officer at the department’s Washington headquarters, admitted that it blew the 20-day deadline by five years, explaining that “it was just very untimely.”
“We consider this a privacy policy violation and appropriate action will be taken,” she wrote.
She added that “you requested your record to be marked sensitive in 2009 but that did not happen until 2011. This was an oversight.”
Stachulski, a New Hampshire resident, took his concerns to Ayotte, who also serves on the Homeland Security and Governmental Affairs Committee. Ayotte’s staff inquired about Stachulski’s case with the department.
Deborah Amdur, the White River medical center’s director, told Ayotte that “after completing several reviews related to this issue, we continue to be unable to validate Mr. Stachulski’s concerns. On Dec. 14, 2014, the Chief of Pharmacy completed a search of the national drug recall database and confirmed the medication prescribed to Mr. Stachulski is not listed as a recall action to date.”
The first two entries, however, in the results from a March 31 Google search by the Examiner of the pills’ “lot number” — JD9958 — were the recall notices from the Food and Drug Administration and from the manufacturer.
“We were able to identify that all requests for release of medical records received by the Mr. Stachulksi [sic] or on his behalf were handled appropriately, with the exception of one. There was a four-day delay in processing that request,” Amdur told Ayotte.
She also said “facility records” indicated his record was promptly marked sensitive.
Wilson’s review three months prior — based on statements to her by the White River Junction staff — and other correspondence contradict both of Amdur’s claims to Ayotte.
A Feb. 17 email indicated that Amdur would have seen the documents proving those assertions to be false shortly before writing to Ayotte.
Clarence Hallmartel, a White River Junction privacy officer, wrote to another department employee that the latest delay was because Amdur wanted to review information pertaining to Stachulksi before it was released to him.
“As a result of his complaint to our director, she wanted to review the records and request prior to my release of the document,” he wrote.
Sue Hopkins, a regional Veterans Affairs public affairs officer, said “privacy issues” preclude the department from commenting.
“We can say that Director Debra Amdur’s response to Sen. Kelly Ayotte was prepared after a thorough assessment of the case and was accurate based on VA records,” she said.
“We regret the length of time it took for the veteran to receive a copy of his records, and have reviewed that process to ensure such requests are completed in a timely manner.”
The White River Junction Medical Center did not respond to an Examiner request for comment.
Stachulski’s experiences add another entry in a steadily growing list of scandals in which top officials at Veterans Affairs facilities manipulated official records to make it appear healthcare and benefits were being delivered in a timely fashion.
Dozens of veterans died while waiting for delayed care and thousands of them were forced to wait months and years before being approved for benefits they earned while serving in combat.
