Products Liability
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.
Buchalter v. Maryland Neurological Institute LLC Summary
Plaintiff is a veteran who sustained injuries while in service. He has never been diagnosed with cancer. He begins treatment with the defendants. Defendants prescribe Subsys to the plaintiff. This is essentially time-release fentanyl. Patients spray it under their tongues for almost immediate pain relief.
The FDA approved Subsys solely for the “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.” 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 before prescribing the drug. Re-enrollment is required in this program every two years, to mitigate 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, the defendants prescribe the plaintiff 400 micrograms, accompanied by a prescription for 800 micrograms, each of which is 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 restarted Subsys. Over two years, his dose is increased and maintained at 1600 micrograms every four hours.
Plaintiff alleges the prescriptions occurred during periods when the defendant’s TIRF-REMS program enrollment was not active. Plaintiff is admitted to Ft. Belvoir for inpatient detoxification in the ICU, allegedly due to the defendant’s negligent prescription of medications including Subsys. The providers at Ft. Belvoir are shocked by the unprecedented prescription of Subsys.
Additionally, the plaintiff alleges that during his treatment with the defendants, they negligently administered an injection containing Toradol, which they knew he was allergic to. In the doctor’s notes, the defendant admits that the plaintiff was inappropriately injected with Toradol. Finally, the defendants prescribed the 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 the 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. Plaintiff alleges the drug manufacturer paid the defendant doctor over $34,000 over two years. Plaintiff claims these payments are just a sham, solely to induce the 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.
- Fentanyl is a highly toxic substance. The mindblowing statistic is that weight is approximately 80-100 times more potent than morphine. Fentanyl is a medication that can cause death if more than the intended amount of medication is administered so there are a number of fentanyl overdose medical malpractice lawsuits.
- Fentanyl has a very narrow therapeutic index. This means the difference between a therapeutic dose and a fatal dose of fentanyl is razor thin. So if more than the designed dose of fentanyl is administered by a transdermal patch, fentanyl can be delivered in an amount that can cause death.
Jurisdiction
- Anne Arundel County
Defendants
- A pain management doctor
- Physical Medicine & Pain Management Associates
- Maryland Neurological Institute, LLC
- Five certified physician assistants
- Insys Therapeutics Inc.
Hospitals Where Patient was Treated
- Ft. Belvoir
Negligence
- Prescribing Subsys to the plaintiff when unwarranted and unnecessary, and in medically inappropriate doses for inappropriate periods
- Skipped the titration process and prescribed multiple strengths of Subsys at one time
- Prescribed Subsys to the plaintiff inappropriately and outside of TIRF-REMS program requirements and at times when the defendants TIRF-REM program enrollment had expired
- Failed to appropriately manage, diagnose, and treat the plaintiff’s medical conditions
- Failure to appropriately prescribe and manage the plaintiff’s medications
- Prescribed an unsafe combination of drugs
- Allowed physician assistants to prescribe medications
- Failure to appropriately monitor the plaintiff for abuse, misuse, and addiction
- Improperly administered an injection containing Toradol despite knowing of the plaintiff’s allergy
- Prescribed intramuscular Benadryl injections to the 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 the 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.
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