Hundreds of lawyers are involved in the opioid crisis. Scores represent addicts-turned-plaintiffs. Dozens and dozens defend the drug makers. A plethora of attorneys has been hired by public hospital districts, municipalities and states to recover the costs of treating indigents who have abused the painkiller.
All of them expected to pocket millions of dollars or even more for their efforts.
Then there is Kerstin Arnold of Austin, who may be the single most important lawyer in Texas in the opioid crisis.
Arnold is the general counsel of the Texas State Board of Pharmacy and arguably the most influential and knowledgeable attorney on issues of public health and the pharmaceutical industry in the U.S.
Earlier this month, the Texas General Counsel Forum honored Arnold with its prestigious Magna Stella Award for General Counsel of a Non-Profit/Governmental Agency.
During her nearly two decades as the Pharmacy Board’s chief legal officer, Arnold has helped rewrite regulations for pharmacies and pharmacists, guided cutting-edge reforms through the Texas Legislature, presided over thousands of investigations and enforcement actions and took over control of the state’s prescription drug databases and monitoring programs.
“Kerstin does the work of 10 lawyers,” said Clark Hill Strasburger partner Corinne Smith, who nominated Arnold for the award. “Kerstin lives and breathes public health and pharmacy law. It is great that she is finally being recognized for the great work she does.”
Legal industry analysts say that Arnold has become such a leading and respected national expert on pharmaceutical issues that the private sector would likely pay her 20 times her current salary.
“I’m happy where I am,” Arnold told The Texas Lawbook in an exclusive interview. “It is extremely rewarding to do what I am doing, trying to change the world for the better.”
GC Forum leaders cited exactly that commitment in honoring Arnold.
“Kerstin is passionate about protecting the public health and safety of the citizens of Texas,” former Bazaarvoice Chief Ethics and Compliance Counsel Gracie Renbarger said in recognizing Arnold for the award.
“Over the past decade, she has spearheaded the agency’s regulatory response to the ever-changing landscape involving the proliferation of non-therapeutic dispensing of controlled substances and has worked to implement a robust enforcement program to face the ongoing challenges associated with the regulation of pharmacy practice,” said Renbarger, who is president of the Austin/San Antonio Chapter of the GC Forum.
Born in Munich, Germany, Arnold came to the U.S. with her parents on an H1 Visa – her father was an immunologist – in 1970 when she was four-years-old and spoke almost no English.
Arnold grew up in San Antonio, where she received a bachelor’s degree in computer science from the University of Texas at San Antonio in 1985. Four years later, she became a U.S. citizen.
After working seven years as a computer programmer, Arnold took the LSAT and scored high.
“My desire was to get a graduate degree of some sort and I wanted a job with more people contact because computer science is very isolating,” she said. “Law school seemed like a good idea.”
Arnold wanted to stay in the state, so she went to law school at the University of Texas, where she graduated in 1995. After doing an internship at the Texas Supreme Court, she decided to take a staff attorney’s position at the Texas Medical Board instead of joining a law firm.
“I worked a lot of overtime as a computer programmer and I didn’t necessarily want to bill hourly,” she laughs.
For four years, Arnold handled licensing issues and other matters for the state’s medical board.
Then came 1999 – the year that changed her life. She gave birth to her only child – a son who is now a sophomore at the University of Texas with a 4.0 GPA. It also was when the Texas State Board of Pharmacy offered her its general counsel job. While the physical move was not significant – from the seventh floor of the William P. Hobby Building in Austin to the fifth floor – the breadth and depth of the new position was considerable.
Arnold oversees a staff of six lawyers and 10 legal assistants. She has guided the agency through two sunset provisions and she has been with the board longer than any of its members. She is constantly working to update and improve regulations and enforcement.
Arnold’s office receives more than 6,000 complaints annually and handles more than 500 disciplinary cases a year against pharmacies, pharmacists and technicians. About half of the disputes involve pharmacists or their technicians engaging in illegal activity, such as stealing drugs or falsifying records. Another 25 percent of the cases deal with various forms of malpractice, including dispensing errors or failing to provide proper counseling.
A growing problem, she said, is impairment – drug use or alcoholism – by pharmacists or their technicians.
With the Texas legislative session just a couple months away, she will be a frequent witness testifying before various committees.
“There have been laws that the legislature wanted to pass and I had to tell them that the proposal was contrary to federal law,” she said.
One of Arnold’s first challenges came in 2002, when the Internet turned the pharmaceutical world upside down. Hundreds of websites started popping up selling prescription drugs.
“Most of the pharmacy websites first focused on selling Viagra and hydrocodone,” she said. “It seemed like the crooks were ahead of us every step of the way. As soon as we figured out what they were doing and shut them down, they would change their method of operation.
“We started conducting a lot of undercover investigations by ordering drugs from these websites to see if they arrived from a Texas pharmacist or a pharmacist licensed in Texas,” she said.
In September 2012, Arnold started getting reports of an outbreak of fungal meningitis in Texas after receiving steroid injections.
“People started dying,” she said. “We discovered that the steroid injections from one specific pharmacy, the New England Compounding Center, were contaminated and mislabeled. I had to learn everything I could as quickly as I could about sterile compounding.”
Arnold became one of the nation’s leading experts on the legal issues and regulations regarding sterile compounding.
“For six to nine months, it was huge – one of the worst public health tragedies in U.S. history,” she said. “A lot of people in Texas were affected. It was such a horrible situation.”
Seventy-six people died. More than 800 others were severely sick. NECC was shutdown and paid a $200 million settlement to the victims. Fourteen of the company’s employees, including its president and chief pharmacist, went to federal prison.
Today, Arnold is deeply involved in yet another serious public health matter.
“The opioid crisis is bad – it causes me to lose a lot of sleep,” she said. “Between 170 and 190 people are dying daily [in the U.S.]. That’s the equivalent to a 737 jetliner crashing every day.”
In 2015 and 2016, Arnold worked with the Texas Legislature to move the state’s Prescription Monitoring Program from the Texas Department of Safety to the Texas Board of Pharmacy.
“The difference is that we look at the monitoring program as a clinical tool and approach the problem as a healthcare focus instead of a law enforcement focus,” she said.
“It was a big challenge to get the program working as we needed it, but we have improved the program dramatically,” she said. “Doctors, dentists, veterinarians and others are able to more easily review electronically the substances prescribed to the patients.”
Arnold also helped Texas implement the NarX Score, which provides pharmacists a quick summary of patient histories of drug prescriptions and evaluates potential abuses or even a likelihood of overdose.
“NarX is simply designed to provide analytics or a score to pharmacists indicating whether the patient may have a problem,” she said.
“The opioid crisis is a huge crisis beyond comprehension,” she said. “We have seen people hurting their pets so that their vets would give them the drugs.”
Asked again, Arnold insists she has no interest in considering a more lucrative job at a law firm or an in-house position within Big Pharma.
“This agency has given me tremendous flexibility to be a single mom,” she said. “I’ve gotten to go on field trips, be a Cub Scout leader, spend a lot of time at his school and be at his football and lacrosse games.
“Besides, it is extremely rewarding to do what I’m doing,” she said. “I really am able to help change the world for the better.”