By Meryl Kornfield, Scott Higham and Steven Rich.
May 10, 2022.
From left, Mallinckrodt national sales director Victor Borelli, CEO and President Mark C. Trudeau, compliance manager Karen Harper. (Opioid Industry Document Archive; iStock; María Alconada Brooks/The Washington Post)
From left, Mallinckrodt national sales director Victor Borelli, CEO and President Mark C. Trudeau, compliance manager Karen Harper. (Opioid Industry Document Archive; iStock; María Alconada Brooks/The Washington Post).
The largest manufacturer of opioids in the United States once cultivated a reliable stable of hundreds of doctors it could count on to write a steady stream of prescriptions for pain pills.
But one left the United States for Pakistan months before he was indicted on federal drug conspiracy and money laundering charges. Another was barred from practicing medicine after several of his patients died of drug overdoses. Another tried to leave the country in the face of charges that he was operating illegal pill dispensing operations, or pill mills, in two states. He was arrested and sent to prison for eight years.
These doctors were among 239 medical professionals ranked by Mallinckrodt Pharmaceuticals as its top prescribers of opioids during the height of the pain pill epidemic, in 2013. That year, more than 14,000 Americans died of prescription opioid overdoses.
More than a quarter of those prescribers — 65 — were later convicted of crimes related to their medical practices, had their medical licenses suspended or revoked, or paid state or federal fines after being accused of wrongdoing, according to a Washington Post analysis of previously confidential Mallinckrodt documents and emails, along with criminal and civil background checks of the doctors. Between April and September of that year, Mallinckrodt’s sales representatives contacted those 239 prescribers more than 7,000 times.
The documents, made public after years of litigation and bankruptcy proceedings, shed new light on how aggressively Mallinckrodt sought to increase its market share as the epidemic was raging.
The Mallinckrodt documents are part of a cache of 1.4 million records, emails, audio recordings, videotaped depositions and other materials the company turned over as part of its $1.7 billion bankruptcy settlement in 2020. Several state officials with claims against the company, led by Massachusetts Attorney General Maura Healey (D), urged that the documents be made public.
While most Americans may have never heard of Mallinckrodt, the Drug Enforcement Administration called the company in 2010 “the kingpin within the drug cartel” of legitimate companies driving the opioid epidemic. Between 2006 and 2014, Mallinckrodt accounted for 27 percent of the opioid market compared with 18 percent for Purdue Pharma, measured by the potency of the pills they produced, according to an analysis by The Post. While the Sackler family, which owned Purdue, attracted intense national attention and became a cynosure of criticism after the company’s introduction of its blockbuster pill OxyContin, the Mallinckrodt brand slipped under the radar.
“Everybody thinks of Purdue when they think about the opioid epidemic, but Mallinckrodt was far worse,” said Jim Geldhof, a DEA supervisor who investigated Mallinckrodt before retiring in 2016 after four decades with the agency and now works as a consultant to cities suing the opioid industry. “They were up to their eyeballs in oxycodone, and they knew exactly what they were doing. Their drugs had become the most popular on the street and they jumped in with both feet.”
Between 2000 and 2020, more than 270,000 people died of prescription opioid overdoses in the United States.
As the opioid epidemic took hold of the nation, Mallinckrodt’s 30 mg oxycodone tablet became the preferred drug on the street, according to the DEA. The baby-blue-colored pills, the equivalent to a hit of heroin, became so ubiquitous that the smuggling route from Florida to Appalachia became known as the “Blue Highway.”
In Massachusetts, Mallinckrodt’s pain pills were supplied to more than half of those who died of opioid-related overdoses during the past 12 years: 9,673 people, according to an analysis of prescription and overdose death data by the Massachusetts Attorney General’s Office. By comparison, Purdue and its affiliate Rhodes Pharmaceuticals supplied opioids to 2,967 people who died in the state.
“For the first time in a long time, industry secrets are going to be turned over to the public and millions of documents will live online in an archive forever,” Healey said. “Making this evidence available to the public will hopefully pave the way for important reforms that will stop dangerous conduct and save lives.”
Massachusetts resident Cheryl Juaire, who lost two of her three sons to opioid overdoses, 23-year-old Corey and 42-year-old Sean Merrill, applauded the release of the documents.
“It helps to heal the families to know what really happened and to know that their child had a disease and where it started and who caused it,” she said. “There is a healing in knowing.”
In videotaped depositions taken between 2018 and 2020 as part of a national lawsuit against Mallinckrodt, top company executives took little or no responsibility for the opioid epidemic. Several skirted questions about whether an opioid epidemic even existed.
The Mallinckrodt files are being made available through the Opioid Industry Documents Archive, a digital repository of material generated by state and federal lawsuits against drug companies and managed by Johns Hopkins University and the University of California at San Francisco. The Post was provided exclusive access to the files, the largest disclosure of its kind by an opioid company to date.
Among the documents was the company’s promotional material, including a reggae song with the chorus: “You can start at the middle, you can start at the top. You can start with very little but that’s not where you should stop. Your patient needs relief, mon, so please do what you should.”
Listen to the song
“You
can
start
at
the
middle,
you
can
start
at
the
top.
You
can
start
with
very
little
but
that’s
not
where
you
should
stop.
Your
patient
needs
relief,
mon,
so
please
do
what
you
should.”
For years, drug companies have argued they were simply filling orders written by medical professionals for legitimate patients. But the Mallinckrodt files show that the company had detailed knowledge of the prescribing patterns of doctors and bemoaned their loss when they fell into trouble with regulators.
Other key findings from the files:
Company managers pressured sales representatives to find doctors who would write large numbers of prescriptions and then targeted them for continued business. They rewarded top performers with bonuses and overseas vacations; and fired those failing to meet quarterly sales goals.
Three years after one sales rep cautioned that a dozen doctors in his region were running pill mills, illegal pain clinics that dispense large amounts of narcotics, five of them remained on the company’s preferred list of prescribers.
Mallinckrodt paid top prescribers thousands of dollars to extol the virtues of the company’s drugs to fellow doctors at “speaker programs” held at fine restaurants and resorts. All it took “was a speaker program to get them writing,” one sales rep wrote.
Mallinckrodt played a key role in an industry-wide effort to convince the health-care industry that addiction was rare among opioid users and marketed its drugs to specific segments of society. “With older adults, start dose low, go slow,” the company wrote in marketing material for drug industry trade shows. “But go!!”
“While Mallinckrodt does not agree with the allegations regarding decade-old issues, it has spent the past three years negotiating a comprehensive, complete and final settlement that resolves the opioid litigation against it, provides $1.725 billion to a trust serving affected communities, and allows Mallinckrodt to continue to serve patients with critical health needs under an independently monitored compliance program,” a company spokesperson said in a statement to The Post.
‘A lavish lifestyle’
Although generics made up the majority of Mallinckrodt’s business, the company also produced and marketed its own brand of time-release narcotics to remain relevant in the increasingly competitive opioid market. One of the drugs the company made and marketed directly to doctors was called Exalgo, a hydromorphone tablet and a close cousin of the pill manufactured and marketed by Purdue, OxyContin.
Mallinckrodt deployed a national sales team in an effort to turn Exalgo into a blockbuster of its own. Despite the company’s ambitions, Exalgo never caught on. It represented less than 1 percent of the company’s overall opioid sales. The Exalgo sales force was disbanded in 2015.
The internal documents show that the company’s sales managers grew deeply concerned about falling sales numbers when their top prescribers lost their medical licenses or went to prison.
The managers frequently checked in with their regional sales reps, asking them which prescribers had moved, died, lost their licenses or been arrested. The sales team also lamented the loss of doctors who were under investigation and tried to find a way to make up for those sales by recruiting physicians who could write prescriptions.
In April 2013, Mallinckrodt’s sales managers told one of their reps about a productive “target,” Fathalla Mashali, a pain management specialist who operated four busy clinics in Massachusetts and Rhode Island. Sales rep Dean Boissy reported back that Mashali pledged to start writing Exalgo prescriptions for his patients.
Mashali and his clinics were already under investigation by the FBI and the DEA. The previous year, four of his employees had complained to law enforcement about his “unprofessional, unethical, and unlawful behavior.”
Prosecutors would later find that “Mashali used the proceeds derived from his fraudulent billing to fund a lavish lifestyle, spending money on his extravagant Dover [Mass.] residence and a condominium in Florida. For example, he ordered the construction of a carriage house and outfitted his Dover home with a squash court and movie theater.”
A month before Boissy approached Mashali, federal agents had served search warrants on the doctor’s pain clinics, demanding patient and prescribing records. Mashali was arrested in 2014 while trying to board a flight bound for Egypt. He later pleaded guilty to health-care fraud, conspiracy to commit mail fraud and money laundering.
Fathalla Mashali departs federal court in Boston on March 15, 2017. He was convicted of health-care fraud, conspiracy to commit mail fraud and money laundering. (Steven Senne/AP)
“Losing Dr Mashali hurt to say the least. Not only did he literally produce half my Exalgo scripts but his opioid market output was incomparable to any other practice in my territory,” Boissy wrote to a manager. “A large portion of my time was spent w him so I’ve been trying to use that time to increase my number of writers even more to try to make up for his production.”
A company sales manager reviewing the prescribing patterns for the New England region agreed. The manager noted that the “absence of Dr. Mashali in the Worcester territory had a significant negative impact on this territory, the Boston District and likely the Northeast Region.”
Mashali did not respond to a letter sent to a federal prison in Massachusetts, where he is serving out his eight-year sentence. The attorney who represented him in the criminal case declined to comment.
Boissy did not return calls for comment.
‘Oops’
Another doctor favored by Mallinckrodt was George Griffin, an orthopedic surgeon who practiced in Cincinnati. The company placed him at the top of the list of doctors to recruit in the region, quarter after quarter.
George Griffin was convicted of unlawful distribution of controlled substances and sentenced to 40 months in prison. (Butler County, Ohio, Sheriff's Office)
“Griffin had 29 Exalgo [prescriptions] this week,” Ohio district sales manager Kevin Becker wrote to the rep handling Griffin, Matthew Hook, in March 2012. “Holy cow!”
In 2015, another sales manager wrote to Hook to highlight Griffin’s prescribing, suggesting that Hook had a shot at being included in the company’s President’s Club, a prestigious award for top-selling reps that came with free trips to destinations like Hawaii and Europe.
The company’s President’s Club was awarded to top-selling sales representatives and came with free trips to destinations like Hawaii and Europe. (Opioid Industry Documents Archive)
But Griffin was in trouble and the company knew it. Previously, the State Medical Board of Ohio had determined in 2010 that Griffin had overprescribed pain pills to more than a dozen patients. Griffin was able to appeal and continue to prescribe. For one patient, he prescribed 640 mg a day of OxyContin — despite warnings from a pharmacist that the patient was a drug dealer with a history of drug-related felonies, according to the board.
“It appears that as of November 22, 2011, Dr. Griffin lost his license,” Becker, the sales manager, wrote in an email to his supervisor three weeks later. “He is the districts 10th largest prescriber and Matt’s #2 writer of Exalgo.
“Crap.”
“Oops,” the supervisor responded. “We’ll figure something out.”
In 2019, Griffin was arrested along with 10 other doctors, charged with running suspected pill mills. A year later, he was convicted of unlawful distribution of controlled substances and sentenced to 40 months in prison.
Griffin, who has since been released from prison, did not respond to requests for comment. His attorney argued during his sentencing hearing that Griffin “broke the law with good intentions” to help people return to work after injuries.
Mallinckrodt sometimes kept working with doctors even though they were suspected of sending narcotics to the black market. In 2010, Michael Burgmeier, a sales rep assigned to the Pennsylvania region, flagged 11 local doctors among the company’s highest prescribers for running pill mills. Three years later, five of them remained on Mallinckrodt’s list of preferred doctors. No records in the trove indicated the company vetted the doctors on the list. Burgmeier did not respond to requests for comment.
Syed Jawed Akhtar-Zaidi was a popular pain doctor in Solon, Ohio, who Mallinckrodt ranked as one of their top prospects. While sales reps were bringing him Starbucks coffee and catered meals from Panera Bread in September 2013, according to expense records, three undercover DEA agents were posing as his patients. They left his office with opioid prescriptions, even though they were not diagnosed with pain problems, prosecutors later alleged.
Less than a year later, a federal grand jury indicted Akhtar-Zaidi, charging him with conspiracy to distribute controlled substances, health-care fraud, distribution of controlled substances and money laundering. The indictment accused the doctor of overprescribing opioids to people who didn’t need them, and directing his clinical staff not to report to law enforcement the patients suspected of selling their pills.
Syed Jawed Akhtar-Zaidi was charged with conspiracy to distribute controlled substances, health-care fraud, distribution of controlled substances and money laundering. (U.S. Department of Health and Human Services)
Before Akhtar-Zaidi was indicted, he left for Pakistan. Akhtar-Zaidi remains a fugitive. His former lawyer declined to comment.
‘BETTER MOUSETRAPS’
After identifying top prescribers, Mallinckrodt sales reps worked hard to expand the circle. Relying on a select group, one sales rep wrote, is like putting “a lot of eggs in just a few baskets.”
Mallinckrodt sales reps were delighted to sign up Eugene M. Gosy. It was hard to miss him in Buffalo. His pain clinic boasted as many as 40,000 patients and he drove around town in high-end sports cars, including a Ford GT Coupe and a Ferrari 360 Moderna F1. In 2010, he was targeted by Mallinckrodt as someone who could be a reliable writer of Exalgo prescriptions.
“How can we make a difference?” Mallinckrodt’s Eastern regional sales director Gavin J. McGowan wrote to his team on Nov. 18, 2010. “Doing the same thing day after day doesn’t seem to be cutting it.”
McGowan had some advice for his sales reps.
“BIG IDEAS. GAME CHANGERS. BETTER MOUSETRAPS if we want to be on a different plane,” he wrote. “As you all know I am a little competitive, and don’t think second place is an option. One area where I see immediate opportunity is with our top identified physicians.”
McGowan placed Gosy at the top of his list, according to the documents.
Within three years, Gosy’s prescription practices had also drawn the attention of federal investigators, who ultimately charged him in 2016 with running a criminal operation by issuing prescriptions for pain medications between 2006 and 2016 that were “without a legitimate medical purpose.” Federal prosecutors said he continued to write prescriptions “in flagrant disregard of warning signs of patient addiction and abuse and despite notice that patients of the practice had overdosed and/or died.”
On Oct. 15, 2020, Gosy was sentenced to 70 months in prison for conspiracy to distribute controlled substances and health-care fraud. Gosy’s defense lawyer said at the time that his client’s practice had become too overwhelming. The judge who oversaw the case agreed. “We’re not talking about a drug dealer here, but a doctor who lost control of his office,” Chief U.S. District Judge Frank P. Geraci Jr. said.
Gosy did not respond to a letter requesting an interview sent to FCI McKean, a medium-security prison in Pennsylvania where he is serving his sentence. Neither his attorney nor McGowan returned calls for comment.
Like other companies, Mallinckrodt touted its paid speakers’ program for doctors, hosting dinners and speeches at pharmaceutical conventions. The company advertised these get-togethers as an opportunity to provide educational resources for prescribers.
Steve Fanto, a Scottsdale, Ariz.-based pain management doctor, was on Mallinckrodt’s list of favorite prescribers. A company sales rep once described him in an email to a colleague as a “character” who drove a white Maserati with a license plate that read “PAINMD.” He and other doctors attended speaker’s programs at Dominick’s Steakhouse, a high-end, red-carpeted restaurant in Scottsdale, where a hand-cut New York strip costs $67, a la carte.
Sales rep Shelly Sheldahl called one of the events a success.
“I am confident that they will all give Exalgo some extra thought from here on out,” she wrote to her colleagues. “I used to call on these docs with a previous pharma company and all it ever took was a speaker program to get them writing, so I am hopeful to say the least.”
Fanto ran into trouble with regulators for accepting money from Insys Therapeutics, an opioid company that manufactured fentanyl products. Insys became infamous for sales videos that included rap songs urging doctors to prescribe high doses of the dangerous drug. Seven of its executives went to prison following their convictions on bribery and fraud.
In 2021, Arizona Attorney General Mark Brnovich (R) announced his office had settled a case it had brought against Fanto, accusing him of taking hundreds of thousands of dollars in “sham educational speaker fees” from Insys in exchange for prescribing the company’s fentanyl drug, Subsys. Fanto paid $400,000 to settle the case, Brnovich said.
Fanto said in a brief interview with The Post that he was targeted as a prescriber by drug companies because of his expertise in the pain management field.
“This is very typical in health care. It’s no different than being a mechanic, using a certain tool,” he said. “It’s like any other business. It’s not a negative thing.”
When asked about the speaker fees he was ordered to surrender and the status of his medical license, Fanto ended the interview. Fanto’s medical license was suspended in Arizona.
Mallinckrodt sales rep Shannon Cramer considered Frank Danger Li, a pain management specialist based in Seattle, to be one of her success stories. Li ran a chain of eight pain clinics and served thousands of patients in the 2000s and 2010s.
“Dr. Li is one of your high prescribing Exalgo targets and is also your largest prescriber of pain medications,” district manager Sean Wilmert wrote in Cramer’s 2011 evaluation.
But two years later, the state’s Labor Department refused to renew Li’s contract for worker compensation insurance after determining that two of his patients had overdosed, according to a memo from the state’s attorney general.
“Witness interviews indicate that Seattle Pain Center is well known amongst opioid addicts and other drug seekers as an easy place to get drugs,” investigators for the attorney general wrote in a memo. Between 2010 and 2015, 15 Medicaid patients died of opioid drug overdoses within three months of filling prescriptions obtained from Li’s clinics, the investigators said.
Li’s medical license was suspended in 2016. Four years later, he agreed to pay a $2.85 million fine to settle state and federal claims that his clinics ordered unnecessary medical tests. Li, who did not return calls for comment, did not admit any wrongdoing.
Some medical professionals pushed back against Mallinckrodt’s marketing. Dante Langston, a physician assistant in Colorado Springs, wrote an email to the Exalgo sales team in March 2011, urging the company to stop sending out opioid promotional material. He compared members of the company’s sales team to “the stereotypical used-car salesmen.”
The Mallinckrodt reps who small-talked their way into doctors’ offices were no different than those from Purdue Pharma, Langston wrote. He said they resorted to the same tactics of free food and “good ol’ boy kinds of talk,” he recalled in a recent interview.
“It just reminded me of the way that if you walk onto a car lot, it feels like you’re a piece of fruit that’s attracting a lot of flies,” he said.
Due diligence
Not long before Langston wrote to Mallinckrodt, DEA investigators had begun examining the drugmaker after a South Florida doctor was charged with drug trafficking and manslaughter because one of his patients had died of an overdose.
The doctor, Barry Schultz, who was later convicted, received most of his oxycodone through wholesale companies that worked directly with Mallinckrodt. In one year alone, Schultz received more than 20,000 tablets of Mallinckrodt-made oxycodone tablets through one of the company’s middlemen, Sunrise Wholesale of Broward County, Fla.
DEA investigators also noticed that another wholesale drug company, KeySource Medical, operating out of Cincinnati, was pouring massive amounts of oxycodone into Florida. In 2010, it sent 41 million tablets of Mallinckrodt-made oxycodone to the state — nearly 2.5 pills for every man, woman and child. The DEA eventually revoked the registrations of Sunrise and KeySource, barring them from distributing controlled substances.
In addition to the internal emails and documents, the Mallinckrodt files released Tuesday contain numerous videotaped depositions of the company’s top executives. The depositions were taken by plaintiffs’ attorneys as they prepared for a possible trial against Mallinckrodt.
Karen Harper held a variety of compliance positions during her 44-year career with the company. She was responsible for ensuring that Mallinckrodt complied with federal laws regulating narcotics. Drug companies are required to “maintain effective controls” over controlled substances to make sure they do not reach the black market. If companies receive suspicious or peculiar orders and they can’t determine why they are so large or frequent, they are supposed to halt those orders and notify the DEA.
“You did not always perform due diligence on peculiar orders before shipping them, correct?” plaintiffs’ attorney David Ko asked Harper during her deposition on Jan. 15, 2019.
“Correct,” she said.
In another deposition, a national sales account manager for the company, Steven Becker, was asked about the amount of oxycodone he sold to drug distributors while he was working for Mallinckrodt.
“You understand that a significant number of people died overdosing on oxycodone?” plaintiffs’ attorney Derek W. Loeser asked.
“I don’t know how many people passed away — or died from this epidemic,” Becker replied.
Loeser showed Becker a number of news articles documenting the rising death toll from oxycodone overdoses.
“But you know from the articles that we’ve gone over and you've read at the time that you were selling oxycodone that a significant number of people were, in fact, dying because of overdoses on oxycodone?”
“I believe so,” Becker said.
“Mr. Becker, can you please tell the jury if you have any regrets regarding your involvement in the sale and distribution of opioids during the time that you worked for Mallinckrodt?”
“No,” he said.
About this story
To conduct this examination, The Washington Post reviewed records contained in a cache of 1.4 million files that Mallinckrodt agreed to make public as part of its $1.7 billion bankruptcy settlement. Included in these files were the company’s rankings of its top prescribers nationwide during the second and third quarters of 2013.
Mallinckrodt ranked doctors across more than 100 regions based on prescribing patterns and volume. The Post compiled a list of 239 doctors named by the company as one of its top three prescribers in their region for both quarters.
The Post checked each of the 239 doctors by reviewing criminal records, medical board sanctions, DEA registration records and civil lawsuits. The Post found that 27 doctors had been convicted of criminal charges relating to their medical practices, 30 lost their medical licenses, 13 paid civil fines and other penalties, and 10 faced medical board sanctions such as license suspensions. Some doctors fell into multiple categories; in all, 65 individuals faced at least one of these penalties. In addition, The Post examined internal company reports that recorded the number of calls Mallinckrodt’s sales representatives made to each of these doctors.
The Mallinckrodt files were provided exclusively to The Post by Johns Hopkins University and the University of California at San Francisco, which oversee the Opioid Industry Document Archive. The files were added to the digital repository of records and made public Tuesday as part of national litigation involving nearly 4,000 cities, towns, counties and Indian tribes. The documents are available at industrydocuments.ucsf.edu/opioids/.
Video produced by Leila Barghouty, Jayne Orenstein and Luis Velarde. Illustrations by María Alconada Brooks and design and development by Yutao Chen. Social media by Angel Mendoza. Research by Monika Mathur, Alice Crites and Christopher Rowland. Story edited by Herman Wong, Jeff Leen and Meghan Hoyer. Copy editing by Karen Funfgeld.
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