Prescription drugs in the U.S. can be very expensive. It is not uncommon for some drugs to cost tens of thousands of dollars for a single prescription. Some of these drugs may be necessary to treat patients and not all insurance companies will be willing to pay.
Prescription drugs are also highly regulated and need to meet strict requirements to pass Food and Drug Administration (FDA) approval. This includes providing the proper warnings, clinical trial approval, and the drugs have to be manufactured in a facility that meets strict requirements.
Unfortunately, some doctors may put profit ahead of care and purchase counterfeit, off-label, or unapproved drugs to use on their patients, knowingly putting the patient at risk of injury. A St. Louis County doctor was indicted by federal law enforcement for conspiring to buy, ship, and conceal chemotherapy drugs for use in patients.
Misbranded and Unapproved Chemo Drugs
According to the St. Louis Post-Dispatch, a doctor in St. Louis was indicted on federal criminal charges in connection with a scheme to import and use misbranded and unapproved chemotherapy drugs. Dr. Abid Nisar conspired with a man and woman in California to buy drugs from a packager in the United Kingdom, who obtained the drugs from manufacturers in countries like Turkey and Sierra Leone.
These chemotherapy drugs had unapproved labels, were printed in other languages, or did not have the dosing or potency information. The drugs were also manufactured in facilities that were not certified by the FDA. The contents were also shipped in a way that concealed they contained drugs.
According to the indictment, one of the co-conspirators did not want to monitor the temperature of the drugs because it may risk throwing out an entire batch of drugs if a thermometer showed the proper temperature had not been ensured.
The Illinois Department of Financial and Professional Regulation suspended Nisar's medical license. Nisar pleaded guilty to misdemeanor charges of introducing and misbranding “illegal and unapproved” cancer drugs, purchased for more than $350,000.
Nisar used the drugs on patients without warning them or notifying the insurance companies paying for the drugs that these drugs were unapproved and purchased from non-FDA-regulated labs.
Nisar was sentenced to 2 years probation, fined $25,000, and agreed to pay Medicare and others over $1 million as part of a settlement agreement.
Criminal Conspiracy to Export Adulterated Cancer Drugs
In connection with the case, a Turkish man was sentenced to 30 months of imprisonment and fined $150,000 for smuggling misbranded and adulterated cancer treatment drugs, including being one of the sources of the UK drug wholesaler who later sold drugs to Nisar.
According to the Special Agent in Charge, Catherine Hermsen, “patients receiving cancer treatment drugs should be assured that the medications meet FDA's standards for safety and quality.”
Injuries Caused by Defective Drugs
It can be a serious problem when there are defects in the way a drug was created, manufactured, packaged, sold, or prescribed. Injuries caused by defective drugs can lead to serious complications, organ damage, or death. Victims of defective pharmaceuticals may not even be aware that the drug was harmful or defective.
If you or a loved one suffered an injury or illness caused by a defective medicine or doctor altering drug information, talk to experienced medical malpractice lawyers at Gilman & Bedigian. Contact our law office online or by calling (800) 529-6162.