Texas Attorney General Sues Pfizer Over Dangerous ADHD Medication

Updated

Texas Attorney General Ken Paxton has filed a new lawsuit against Pfizer and Tris Pharma. The lawsuit alleges that the two pharmaceutical companies defrauded Texas Medicaid and provided adulterated pharma drugs to children. Quillivant is an ADHD drug that was originally developed by NextWave Pharmaceuticals. Tris Pharma owned a 5% share in NextWave, which Pfizer acquired in May 2012. 

After the acquisition, Pfizer agreed to pay Tris Pharma for product approval as well as a 25% royalty on all sales from the drug. In September 2012, the drug was approved by the FDA. 

Quillivant is “an extended-release oral suspension methylphenidate” for the treatment of children with ADHD. Quillivant is a Schedule II Controlled Substance and carries a black box warning for abuse and dependence. Pharmacists combine the provided powder with water to reconstitute the drug, while caregivers are expected to shake the reconstituted drug before providing it to the child. 

Quillivant commonly causes reactions, even when taken as directed, including insomnia, nausea, vomiting, anxiety, and tachycardia. Severe side effects can also occur when used as instructed. These side effects include cardiovascular reactions that can cause sudden death, psychiatric reactions, and long-term suppression of growth. If Quillivant is not taken at the proper dose, it can cause an overdose that would require emergency medical treatment. 

The complaint further states, “Under the FDCA, it is illegal to adulterate a drug or to introduce into interstate commerce any drug that is adulterated. A drug becomes adulterated if ‘the methods used in, or the facilities or controls used for, its manufacture…do not conform to or are not operated or administered in conformity with current good manufacturing practice (CGMP).” CGMP is a minimum set of standards and “courts have broadly interpreted adulteration requirements, noting that ‘drugs produced in violation of CGMP regulations are deemed to be adulterated without the FDA having to show they are actually contaminated.” 

According to the filing, Tris Pharma could not achieve consistency in manufacturing and failed mandatory quality control tests. The FDA issued a citation, and Tris agreed to correct the testing deficiencies. Tris Pharma later “concealed subsequent quality control test failures by manipulating the test process itself, in violation of federal and state laws and regulations.”  

Pfizer knew that the sales of this drug depended on getting approval into the Texas Medicaid program. They lobbied and successfully got Quillivant added to a list of drugs reimbursable under Texas Medicaid in 2013. Pfizer was also able to obtain preferred placement for the drug in 2014. This enabled the Pfizer sales force to market Quillivant to Medicaid providers in Texas actively. All of this occurred despite their failure to update Texas Medicaid regarding the quality control measure failures. This is a direct violation of Texas law. 

Dissolution testing is important to ensure the drug will be released into the patient’s body as expected. During this testing phase, Quillivant samples contained lumps after water was added to reconstitute the drug. Tris Pharma did not try to resolve this issue but instead retrained analysts to shake the mixture longer and only to test when “foaming is absent from the suspension.” Despite the new testing protocol, the testing still failed. 

Tris Pharma CEO Mehta ordered that analysts stop testing with this method, which was producing failed results. They created a new, insufficient test that did not accurately represent real-world usage by patients. The method was also in direct opposition to the instructions provided to pharmacies to reconstitute the drug. 

The new method required using a sonicator at maximum power for three minutes. A sonicator retails for over $1,000 and generates 40,000 pulses per second. Despite this new requirement to pass dissolution testing, the instructions for pharmacies were to “vigorously shake bottle for at least 10 seconds.” Ten seconds of vigorous handshaking is drastically different than 40,000 pulses per second for 180 seconds. 

The FDA requires a submission for any change in substance, product, production, quality control, equipment, or facilities that “has a moderate potential to have an adverse effect on the identity, strength, quality, or potency of the drug.” This submission must be made at least 30 days before they can distribute any drugs that are produced with these changes.

The senior VP of quality objected to the CEO and stated that the testing method was not scientifically sound. At the same time, Pfizer was aware of the quality control issues and that the manufacturer had developed a new testing method. Texas Medicaid was not notified of the testing changes or difficulties. The complaint continues on for several pages detailing how the methods continued to adapt while Tris Pharma and Pfizer explained the problem as a “laboratory error” and that the analyst “erroneously sonicated samples” later in the testing process. 

Several more methods were used to try to obtain more favorable test results. Pfizer indicated that the drug would need to be tested and re-released or recalled. However, Pfizer simply accepted that the problem was solved when the method 7 dissolution test was implemented. The lawsuit goes on to say that Tris Pharma failed to investigate or determine the root cause of the dissolution failures and instead changed the testing method multiple times in an attempt to pass the test. 

This, says Texas, is the evidence that the ADHD drug Quillivant was adulterated, which is against federal and state law. The plaintiffs of the lawsuit are seeking monetary relief in excess of $1 million. That includes “two times the amount of any payments” provided under the Medicaid program and civil penalties between $5,500 and $11,000 for “each unlawful act committed by the defendants.”

Attorney General Paxton made the following comments in a press release about the investigation. “I am horrified by the dishonesty we uncovered in this investigation. Pfizer and Tris intentionally concealed and failed to disclose the issues with Quillivant receiving taxpayer-funded benefits through Texas Medicaid, defrauding the state, and endangering children. Our Civil Medicaid Fraud Division has done an outstanding job holding these pharmaceutical companies accountable.” 

 

Steven Middendorp

Steven Middendorp is an investigative journalist, musician, and teacher. He has been a freelance writer and journalist for over 20 years. More recently, he has focused on issues dealing with corruption and negligence in the judicial system. He is a homesteading hobby farmer who encourages people to grow their own food, eat locally, and care for the land that provides sustenance to the community.

Other Headlines

Coronavirus

Vaccine Causes Autism in Rats, Per New Study

A new study finds autism-like behaviors in male offspring when pregnant rats are given BNT162b2, the Pfizer mRNA COVID-19 vaccine. This single study clearly refutes the mantra of Big Pharma that “vaccines do not, and cannot, cause autism.” The study found significant alterations in WNT gene expressions in male and female rats. The researchers mention the limitations of animalContinue reading Vaccine Causes Autism in Rats, Per New Study

More news about Coronavirus

Health & Nutrition

Fenway Community Health Claims Government Immunity in De-Transitioner Case

Fenway Community Health has claimed Federal protection and immunity from litigation for the misdiagnosis and injury caused to the de-transitioner July Carlan, known as “Shape-Shifter.” The Federal Tort Claims Act (FTCA) provides nationwide malpractice insurance for qualified health centers. Health center employees are considered government employees, and any malpractice lawsuit must be filed against the United StatesContinue reading Fenway Community Health Claims Government Immunity in De-Transitioner Case

More news about Health & Nutrition

Vaccines

Entries Within V-Safe Data Release Raise Eyebrows

The first batch of free-text V-safe data was released on February 15th, after a court victory. With 390,000 free text entries, it is time-consuming to browse and find the most revealing details. There was one comment that said “death,” and another said, “died.” There were several results for “miscarriage,” while a few more comments mentionedContinue reading Entries Within V-Safe Data Release Raise Eyebrows

More news about Vaccines

Science & Tech

USDA Reopens Comment Period for Deregulation of Gene-Edited Plants

The deregulation of gene-edited plants is on the USDA agenda, and the public comment period has been extended by 21 days. The comment page has yet to be posted on the Federal Register. CRISPR is a new technology that is being used in agriculture to modify plants. “New Gene Technologies” or NGTs are how big agricultural companies like Bayer areContinue reading USDA Reopens Comment Period for Deregulation of Gene-Edited Plants

More news about Science & Tech

Environment

Biden Faces Massive Opposition to Electric Vehicle Mandate

The Biden administration’s push for an electric vehicle (EV) mandate has received massive opposition from a wide range of stakeholders, including 26 states and the energy, agriculture, and automotive industries. Critics say that the new fuel standards would increase consumer costs and put an unfair burden on U.S. businesses.  On November 24, the Department of Transportation’s NationalContinue reading Biden Faces Massive Opposition to Electric Vehicle Mandate

More news about Environment

Policy

Look Into My Eyes, Rishi Sunak!

Nobody could escape the pain, anger, and feeling of betrayal in John Watt’s eyes and voice as he testified at the recent COVID-19 town hall with British Prime Minister Rishi Sunak on February 12 in County Durham, England. Watt, like other audience members, ended up harmed by the COVID-19 vaccines. Watt, of Glasgow, Scotland, now has PosturalContinue reading Look Into My Eyes, Rishi Sunak!

More news about Policy