BRAIN INJURY FROM OXYCONTIN/DRUG OVERDOSE
Goza & Honnold represented a woman who suffered brain damage from an OxyContin overdose. The case, pending in Lafayette County Circuit Court, recently settled for $750,000.
Our client had received a prescription for OxyContin from her psychiatrist for chronic low-back pain. The next day she overdosed on the medication and suffered respiratory distress, anoxic brain damage and permanent neurological deficits. Today, she is functional but requires near-constant supervision by her husband, who is her primary caretaker.
We claimed our client should never have been prescribed OxyContin. She had experienced addiction issues in the past with narcotics. A required thorough psychological assessment would have revealed that history. Further, plaintiff had a chronic history of asthma- at least a relative contra-indication to taking OxyContin. Finally, our client had just switched both her family doctor and her psychiatrist. Her prior physicians had refused to prescribe her narcotic medications. We alleged that the defendant should have contacted these prior physicians or at least obtained her medical records which should have served as a red light preventing prescription of the drug. .
Although plaintiff had a history of narcotics use, she had not been on painkillers as powerful as OxyContin before. Until adequate tolerance is developed, people exposed to powerful opioids are at risk for confusion, which can result in a loss of sense of time and over-ingestion of the medication.
We presented a life-care plan with substantial costs. The parties ultimately settled for $750,000. This case was brought in a rural county often considered difficult venues for plaintiffs.
PRESCRIPTION OPIOID OVERDOSE/KANSAS WRONGFUL DEATH
Goza & Honnold recently concluded a case involving the sale and mismanagement of a Fentanyl based opioid. The health care providers and pharmacy involved paid $1.6 million and the pharmaceutical company settled for a confidential amount.
This case involved the tragic and preventable death of a 34 year old married woman with two young children. The decedent had a history of migraine headaches for which she would be treated in the emergency room with diazepam and phenergan. Her physician decided to prescribe an opioid to her for management of her headache pain. Decedent filled the prescription that afternoon and took the medication at various points during the evening. The next day she stayed home because she was still not feeling well. A family member found her dead later that morning. An autopsy revealed she had died from an accidental overdose of Fentanyl.
Because of it’s risks, the FDA had approved this drug with strict limitations for use only in the treatment of breakthrough cancer pain in those patients that were opioid tolerant. Decedent did not have cancer, nor was she opioid tolerant as that term is defined by the FDA and as set out in the drug’s label.
Our experts were critical of the use of this drug because narcotics are not generally useful for treating migraine headache pain and, more importantly because decedent was not” opioid tolerant.” There was simply “no safe” dose for patients that were not opioid tolerant.
Opioid tolerance is not related to the amount of drug it takes to relieve pain. Because opioids do not work well on migraine headaches, patients with true migraine headache pain seemingly need higher doses of narcotics for any effect. It is important therefore not to confuse the concept of resistance with tolerance. Opioids are drugs that work by binding to receptors found primarily in the central nervous system. Tolerance in this setting is the process whereby neuro-adaptation occurs through receptor desensitization resulting in significantly decreased respiratory risk from the drug. This desensitization only occurs while the patient is actually taking opioids, i.e. when the patient is on around- the- clock opioids. Death from an opioid is most often the result of respiratory depression with the acute administration of the drug in a patient that is not opioid tolerant.
In sum, our experts believed decedent was placed at life-threatening risk with a drug that has never been shown by any scientifically supported data to relieve migraine headache pain. The prescription was in direct contravention of the drug’s Black Box warning, without adequate instructions, in a patient who was on other medications that significantly increased the risk of respiratory depression and death
The Pharmacy Negligently Filled The Prescription
The prescription in this case specifically stated take “for breakthrough pain episode. May be repeated once if pain is not relieved after 30 minutes. ” However, the actual label the pharmacy placed on the bottle stated that “take one tablet for breakthrough pain- may repeat thirty minutes.” The label left out the word once.
Relevant Kansas regulations governing pharmacists are summarized below:
1. KSA 65-1636-All prescriptions shall be filled in strict conformity with any directions of the prescriber….
2. KSA 65-1642- Upon receipt of a prescription, the pharmacist shall examine the patients medication profile record before dispensing the medication to determine the possibility of harmful drug interaction or reaction to medication. Upon recognizing the a potential harmful drug interaction or reaction to medication, the pharmacist shall take appropriate action to avoid or minimize the problem which shall, if necessary include consultation with the prescriber with documentation of actions taken on the prescription record.
3. KSA 65-1663- the supervising pharmacist shall be responsible for the acts or omissions of the pharmacy technician.
4. KSA 68-2-19- The pharmacist shall “interpret and verify patient medication records and perform drug reviews.”
5. The pharmacist shall “encourage proper drug utilization and medication administration….. including advising a patient about common side effects, interactions or contraindications….
Our experts believed the label was missing an important word which was significant omission. It appeared from this label you could take the drug for breakthrough pain and then repeat every 30 minutes which was certainly not the physician’s intent. Kansas law makes clear that a pharmacist is to fill a prescription in strict conformity with the directions of the prescriber. If there is any question or the prescription is vague it is the responsibility of the pharmacist to call the physician
Separate and apart from the labeling error, our experts believed that the pharmacy should not have filled this prescription without confirming decedent was opioid tolerant. Our experts felt that the pharmacist was obligated to look at potential contraindications or medications taken together that might create potential problems for the patient. The Drug Company materials also seemed to indicate that pharmacists would be educated on the need to check confirming patients were opioid tolerant. The prescription box had a specific checklist “To the Pharmacist” which stated:
[ ]Patients receiving this drug must be opioid tolerant to around-the-clock opioid therapy.
Our experts believed that the pharmacist had an obligation to review the patient’s medication profile which would have established decedent was not “opioid tolerant” and should not be receiving the drug.
The Manufacturer Failed to Adequately Warn
Our claim against the manufacturer was that they had engaged in “off-label marketing” which diminished the warnings about the appropriate use of the drug thereby making the written warnings inadequate. This contention was at least in part supported by the treating physician who testified company representatives knew he was using the drug on non-cancer patients for the treatment of headache pain.
It Is Illegal For A Pharmaceutical Company To Promote Off-label Use Of A Drug
A. FDA Regulations
The Food, Drug, and Cosmetics Act, 21 U.S.C. §§ 301 et seq., authorizes the FDA to strictly regulate the content of consumer and physician based marketing. While physicians are allowed to prescribe medication for “off-label” use, it can be especially dangerous with powerful narcotics. Further, the FDA prohibits pharmaceutical companies from marketing their drugs for “off-label” use. This prohibition is to ensure that the pharmaceutical company’s promotional activities are limited to indications for which the FDA has found the drug safe and effective based on substantial evidence. Under 21 C.F.R. § 202.1(k)(2), any brochures, handouts, or other such promotional materials are deemed “product labeling” and 21 C.F.R. §201 requires all “product labeling” to be pre-approved by the FDA and to conform to exact requirements.
The “off-label” use of this particular drug at times approached 90%. We believed that the company was not only aware, but actually encouraged this “off-label” when it marketed to physicians who did not treat cancer pain, and we believe included revenue from “off-label” sales as counting towards sales quotas, developed key opinion leaders who would talk to other physicians about off-label use, and helped physicians get reimbursement for “off-label” use.
Significantly, in 2004 the AMA revised their ethical code relating to interactions between physicians and pharmaceutical companies. The broad language calls for caregivers to “place the health and welfare of the patient ahead [of their own] economic self-interest. Further, common-law places the physician in a fiduciary relationship to their patients. Numerous authorities have argued that duty encompasses “an obligation to avoid placing themselves in situations where pharmaceutical marketing has the potential to compromise their medical judgment.” Beware Those Bearing Gifts: Physicians’ Fiduciary Duty To Avoid Pharmaceutical Marketing, KU Law Review (3/7/2009). “Physicians have a fiduciary duty to avoid pharmaceutical marketing when their patients interests may be compromised.”
Most physician practices have no policies or procedures relating to “off-label” use of drugs, the requirement of warnings for unapproved FDA use, or access between their physicians and pharmaceutical representatives. Given the number of pharmaceutical companies which have been fined in recent years for “off-label” marketing , physicians would do well to consider creating guidelines for such interactions.