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Product Liability and Malpractice Lawsuit Involving Fentanyl Drug

Buchalter v. Maryland Neurological Institute LLC

This is a prescription malpractice, fraud, a product liability case filed by a veteran in Anne Arundel County. This case was filed in Health Claims Arbitration on August 19, 2016. It is the 412th medical malpractice case filed in 2016 in Maryland. The court case number is C-02-CV-16-002718.

Summary of Plaintiff's Allegations

Plaintiff is a veteran who sustained injuries while in service. He has never been diagnosed with cancer. He begins treatment with defendants. Defendants prescribe Subsys to the plaintiff. This is essentially time release fentanyl. Patients spray it under their tongue for almost immediate pain relief.

The FDA approved Subsys solely for "management of breakthrough pain in cancer patients 18 years of age or older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain" in January of 2012. This is a transmucosal immediate-release fentanyl, and is a highly addictive narcotic drug administered using under the tongue spray, allowing rapid absorption into the bloodstream.

When the FDA approved the drug, they required a black box warning to call particular attention to its side effects. Per the required black-box warning, any prescriber of Subsys is required to be registered or enrolled in the TIRF-REMS program prior to prescribing the drug. Re-enrollment is required in this program every two years, with the goal of mitigating risks of abuse, addiction, and overdose of TIRF drugs, including Subsys. The requirements of this program include reviewing prescriber education materials, passing a knowledge assessment, and certifying that they understand Subsys is only for managing breakthrough pain in cancer patients who already receive and are tolerant to around-the-clock opioid therapy for underlying persistent pain. There is also a contract that the prescribing provider is required to enter into with a patient they prescribe the drug for, attesting to the same thing.

This drug has never been approved by the FDA to treat back or neck pain, myalgia, or non-cancer pains. It is typically prescribed at the lowest dose of 100 micrograms and only slowly increased if needed. Doctors do sometimes prescribe drugs off-label including this fentanyl drug.

Disregarding all of this, defendants write a prescription for plaintiff for 400 micrograms, accompanied by a prescription for 800 micrograms, each of which are a 30 day supply. One week later, a third prescription is written for Subsys, for 600 micrograms, another 30 day supply. All three prescriptions are written outside of the TIRF-REMS requirements. Plaintiff is kept on these prescriptions for about one year. He then takes a short break, and is restarted on Subsys. Over the course of two years, his dose is increased and maintained at 1600 micrograms every four hours.

Plaintiff alleges the prescriptions occurred during time periods when the defendants TIRF-REMS program enrollment was not active. Plaintiff is admitted to Ft. Belvoir for inpatient detoxification in the ICU, allegedly due to defendant's negligent prescription of medications including Subsys. The providers at Ft. Belvoir are shocked by the unprecedented prescription of Subsys.

Additionally, plaintiff alleges that during the course of his treatment with defendants, they negligently administered an injection containing Toradol, which they knew he was allergic to. In the doctor's notes, defendant admits that the plaintiff was inappropriately injected with Toradol. Finally, defendants prescribed plaintiff intramuscular Benadryl injections into his legs. Plaintiff alleges this was unwarranted and unnecessary, as the doctors should have known that prolonged use of these injections could lead to injury.

Plaintiff also alleges that defendant doctor was one of the compensated doctors listed in the drug manufacturer's "speakers program," which is used to funnel payments to prescribe in exchange for them prescribing Subsys for off-label inappropriate indications, at inappropriate doses, for inappropriate periods of time. Plaintiff alleges the drug manufacturer paid defendant doctor over $34,000 over the course of two years. Plaintiff claims these payments are just a sham, solely to induce defendant physician's prescribing of Subsys.

Additional Comments
  • This is a very atypical malpractice case. The question is whether this drug should have been prescribed for this patient should have been prescribed this medication. The drug company is also a defendant.
  • The defense to this case is that pain is not unique to cancer patients and this drug is effective in treating extreme pain. This guy is a veteran, and we should be doing everything we can to alleviate his pain.
  • Our law firm does not handle these cases
  • Anne Arundel County
Defendants Hospitals Where Patient was Treated
  • Ft. Belvoir
  • genesis lawsuits Prescribing Subsys to plaintiff when unwarranted and unnecessary, and in medically inappropriate doses for inappropriate periods of time
  • Skipped the titration process and prescribed multiple strengths of Subsys at one time
  • Prescribed Subsys to plaintiff inappropriately and outside of TIRF-REMS program requirements and at times when defendants TIRF-REM program enrollment had expired
  • Failed to appropriate manage, diagnose, and treat plaintiff's medical conditions
  • Failure to appropriate prescribe and manage plaintiff's medications
  • Prescribed an unsafe combination of drugs
  • Allowed physician assistants to prescribe medications
  • Failure to appropriately monitor plaintiff for abuse, misuse, and addiction
  • Improperly administered an injection containing Toradol despite knowing of plaintiff's allergy
  • Prescribed intramuscular Benadryl injections to plaintiff when unwarranted
  • Negligent misrepresentation that Subsys was medically indicated when it wasn't; negligently misrepresented that the prescribed doses of Subsys were appropriate when they weren't
  • Fraudulently misrepresenting safety and efficacy of using Subsys for indications other than non-breakthrough cancer pain
Specific Counts Pled
  • Negligence
  • Negligent Hiring, Training, Retention & Supervision
  • Negligent Misrepresentation
  • Fraud, Fraudulent Misrepresentation & Concealment
  • Civil Conspiracy
  • Unfair & Deceptive Trade Practices Under the Consumer Protection Act
  • Lack of Informed Consent
Plaintiff's Experts and Areas of Specialty
  • Joel L. Kent, M.D. - board certified in anesthesiology, with added certifications in palliative care & pain medicine
Case Progression
  • Pre-trial Conference scheduled for June 7, 2017
Getting a Lawyer for Your Malpractice Claim

If you have suffered as a result of the negligence of a doctor or nurse, our law firm can help you. You are entitled to compensation and justice for the harm that has been done to you. Miller & Zois has a history of getting results in medical malpractice cases in Maryland, earning large verdicts and settlements. Call us today to speak with a caring medical negligence attorney who can help you at 800-553-8082, or get an online case review.

More Malpractice Claim Information
  • New York Times article on this drug being prescribed off-label. The reality is that if doctors just prescribed Subsys for cancer, the Times article would not have this money quote: "…Subsys is, much as anything, a Wall Street story."
  • An article on a tragic death involving this drug being prescribed off-label for a woman with fibromyalgia.
  • A case filed against a nursing home in 2016, alleging a medication error leading to plaintiff's death
  • An overview of the value of medical malpractice cases in Maryland
  • Some information about medication errors
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