This case involves a twenty-seven-year-old patient that presented to the emergency department complaining of nausea, diarrhea, and vomiting associated with a severe cough. He was treated with Promethazine, Dilaudid, Zofran, Ultram, Pantoprazole, Fentanyl, and Phenergan. Additionally, he was given a prescription for Phenergan upon discharge from the emergency room. The patient returned to the emergency room two days later with the same complaints. He was treated with Hydromorphone, Prochlorperazine, and Pantoprazole. Once again, he was discharged without an extensive workup to rule out life-threatening cardiac or respiratory disease. Three days after the final discharge, the patient was found dead in his home. Contributing factors to his death included the lethal combination of Phenergan, Hydrocodone, and Diphenhydramine.

This patient was inappropriately managed on several accounts: 1) A thorough work up for abdominal pain, assumed to have been an issue given initial treatment with Dilaudud, Ultram, and Fentanyl, should have been done at the initial admission, including cardiovascular imaging studies and a gastroenterology consult. If this was not done on initial admission it should have absolutely been done on the subsequent admission within one day from previous discharge. 2) The medication management for this patient was not reflective of the standard of care. I cannot understand how all of these medications could be prescribed for a patient given the presenting symptoms and multiple admissions without an appropriate and relevant diagnosis 3) The multiple discharges for this patient are not reasonable without a diagnosis and final treatment plan. The patient should have been kept longer and evaluated further.

1. What can be done to avoid drug-drug interactions and overdoses in cases like this one?

Location: Maryland B.S., Duke University M.D., University of Medicine and Dentistry of New Jersey Residency, Internal Medicine, Pediatrics, University of Chicago Hospitals Fellowship, Hospitalist Scholars Training Program, University of Chicago Hospitals. Board Certification: Internal Medicine Member, Society of Hospital Medicine Member, Society of General Medicine Member, American Medical Association Member, American College of Physicians Reviewer, 3 major medical journals Published, 15 peer-reviewed medical publications Research, 7 clinical research projects Former I********* M******* U********* o* C****** Former D******* A******* H***** Current A******** P******** o* s****** a* a m**** m****** u********* Current H********** I******* M******* a* 4 m**** h********* n*******

This extremely qualified, pediatrics focused board-certified hospitalist has acquired numerous clinical as well as administrative positions throughout her career, including an assistant professorship at a major medical institution. In addition to her vast body of publications and research experience, she is also affiliated faculty at some of the most prestigious healthcare centers in the nation.

Phenergan Toxicity Allegedly Causes Cardiac Arrest and Death

This case involves a fifty-five-year-old female cancer patient who suffered from numerous complications. She remained in good spirits, however, and had the energy to resume near normal activities with sufficient pain medication. She presented to the ER with complaints of severe leg pain and was treated by various physicians who were managing her acute pain. The patient died during the overnight hospital stay. It appears that the cause of death was an overdose of Fentanyl that was ordered and issued at several orders of magnitude above the accepted adult loading dose.

A number of fatal Fentanyl overdoses have been directly tied to the drug over the past few years. In particular, manufacturers of time-release Fentanyl patches have come under scrutiny for defective products. While the Fentanyl contained in the patches was safe, a malfunction of the patches caused an excessive amount of Fentanyl to leak and become absorbed by patients, resulting in life-threatening side effects and death. Regardless, Fentanyl is considered the safest opioid medication on the market, as well as the least physically harmful to the body, especially with long-term or life-term use. In this case, it would be considered a breach in care if the patient was prescribed a lethal dose that was not picked up by the pharmacy or nursing staff before being administered.

1. What are your initial thoughts on the case?

Located: New York B.A., summa cum laude, Biology, State University of New York at Geneseo M.D., State University of New York at Buffalo Residency, Emergency Medicine,Thomas Jefferson University Hospital Board Certification, Emergency Medicine Certification, Advanced Cardiac Life Support (ACLS) Certification, Pediatric Advanced Life Support (PALS) Diplomat, the American College of Emergency Physicians Fellow, American College of Emergency Physicians Former F*** T**** P******** M******** H******* Former E******** M******* P******** M**** M****** C***** R******** C***** Former E******** M******* P******** R**** a* R***** Current M****** D******* o* U***** C*** C***** a* a m**** m****** c***** i* N** Y*** Current E******** M******* P******** a* a m**** h******* i* N** J***** Current D******* o* C******* C*** i* t** E******** D********* o* a m**** h******* i* N** Y***

This expert has been practicing for nearly a decade. He assists with the management and leadership of the Emergency Department providing emergency medical care to low-high acuity patients at a 38,000/year visit emergency department in a suburban setting. He also has his certification in hyperbaric treatments for wound care patients, and performs quality assurance reviews. He has been published, has significant research experience, and serves in both clinical and administrative roles. He has also won numerous awards, honors, and grants.

Fentanyl Overdose Due to Medical Documentation Error

This case involves a fifty-five-year-old male patient with a past medical history significant for hepatic cirrhosis and liver dysfunction. The patient was admitted to a local hospital for confusion and slurred speech that was attributed to evolving encephalopathy, ascites, and multiple metabolic derangements. The patient received a therapeutic paracentesis to remove excess fluid and was given large doses of Dilaudid for abdominal pain. The patient was found to be unresponsive with minimal spontaneous respirations at which point Narcan was administered; at which time immediate improvement in mental status was noted. The medical records from the hospital note that the patient’s acute change in mental status during the hospitalization was likely due to excess narcotic administration. The patient’s condition worsened after he experienced a severe episode of aspiration of gastric contents that required intubation and a transfer to an ICU setting. After several rounds of hypotensive episodes, chronic hemodialysis and critical care trials the family decided to withdraw pressor support and terminally extubate under palliative care protocol. The endotracheal tube was removed and the patient passed away comfortable within a few hours.

The management of pain in patients with cirrhosis is a clinical challenge for medical professionals as there are not a lot of prospective clinical studies that have offered an evidence-based approach. The reason why patients with cirrhosis experience these complications is because they do not have a functioning liver to metabolize the drug. Thus, the drug accumulates in the blood or in the fat which can add up to lethal doses in the patient. A complication from analgesia in these types of patients include respiratory depression, which can result in even death. In general, acetaminophen at decreased dosages is a better and often safer option. Other options include administering fentanyl or even topical lidocaine patches.

1. Should high doses of opioids have been used in this patient and did this potentially hasten the patient's clinical decline?

Excessive Pain Medication Administered to Patient With Advanced Liver Disease Results in Death

This case involves a female patient who was a long-time patient of a local pain clinic and was prescribed Fentanyl patches for a host of complaints, primarily complex regional pain syndrome. On one occasion, while the patient was under the influence of the medication, she was involved in a serious workplace accident. The patient was working as a forklift operator in a large warehouse when she struck a support strut for a shelf, causing the entire shelving unit to collapse on her forklift. It is alleged that the patient should not have been operating the forklift while under the influence of the drugs, and that the medication she was prescribed was not appropriate for her condition.

I frequently treat patients with CRPS as well as a variety of other complex pain disorders and can speak to their proper monitoring and treatment. Classically, CRPS does not respond to high dose opiates. The treatments of choice typically entail neuropathic pain agents, sympathetic blockade and neuromodulation. The particular medication regimen described here is typically reserved for cancer patients and palliative care. Patients on such high dose medications are advised to abstain from driving or operating heavy machinery. One should periodically do urine testing to make sure there are no other medications being taken in addition to Fentanyl. I have served as expert witness for another CRPS case regarding a patient injured and improperly treated causing the CRPS to worsen. I am board certified in pain medicine. I have published on Chronic Pain Disorders in several textbooks and peer-reviewed journals and have lecture around the country on treatments for complex pain disorders, including CRPS.

1. Do you routinely treat patients similar to the one described in the case? 2. What measures could have been taken to monitor the patient and determine the proper prescription of Fentanyl?

Location: New York B.A., University of Rochester M.D., Drexel University College of Medicine Residency, Physical Medicine and Rehabilitation, New York University Medical Center at Rusk Fellowship, Pain Medicine, Tri-Institute Pain Medicine Fellowship of Cornell University Board Certification: Physical Medicine and Rehabilitation, Pain Medicine Member, American Academy of Pain Medicine Member, American Board of Physical Medicine & Rehabilitation Member, American Pain Society Member, New York Society of Interventional Pain Physicians Published, 6 peer reviewed pain medicine publications Former D******* T***** C***** G*** S******* H******* Former A******** P*** P******** N** Y*** P*** M********* G**** Current P******** a** C** p****** p*** m********* c*****

This board certified expert has a BA from University of Rochester and an MD from Drexel University College of Medicine. He is a member of American Academy of Pain Medicine, American Board of Physical Medicine & Rehabilitation and American Pain Society. Previously, he was Attending Pain Physician with New York Pain Management Group. Currently, he is President and CEO at a private pain management center.

Pain Management Expert Opines on Fentanyl Prescription for Complex Regional Pain Patient

This case involves a middle-aged female who was diagnosed with cervical cancer. After undergoing a tumor cryoablation treatment for her cervical cancer for some time, she reported the onset of neurological symptoms. At this point, doctors discovered that her cancer had metastasized to several other organs. The patient was kept in the hospital for several days, after which time she was released to the care of a skilled nursing facility. While at hospital, the patient was receiving medication to treat high blood pressure. However, when the patient was discharged from the hospital, the discharge paperwork incorrectly indicated that the patient should receive more than double the dosage she had been receiving in the hospital. Once admitted into the skilled nursing facility, the jump in dosage caused severe beta blocker toxicity in the patient almost immediately. The patient was taken by ambulance back to the hospital, where she died several days later. Doctors claimed that the software system should have prevented this fatal miscommunication of dosage.

I work in a hospital setting and I am on-staff at multiple hospitals. There are required classes all doctors need to take and certification is offered by the hospital before doctors "go live" with the system discussed above. Also, there are "superusers" whose job is to guide and work in groups to help doctors get quality work done with the system in question. I have been trained to use this system, and was the very first doctor to "go live" the first day as I admitted the very first patient to the hospital on the system. It is not easy to blame the software for human input error. The system has multiple checks to prevent the wrong dose from being accepted. Ultimately, the ordering physician needs to take responsibility for re-reading the final discharge reconciliations or for creating new discharge reconciliation, otherwise it will be incorrect for many patients. This software has preventative programs in place and has safety as its first mission. Unfortunately, if the physicians wish to circumvent the safe method built into the system, they can do that. Discharge reconciliation is required especially for the inter-facility transfer. In case of any questions, the receiving facility is to call the sending facility to verify the nature of orders. The discharge process standard of care is no different using this particular system versus any other electronic record.

1. Can you speak to the training physicians are required to receive prior to using the software system in question? 2. Can you speak to complications that can occur with the program, specifically implementing prescription dosages? 3. Does this system have preventative programs in place to help prevent human input error?

Location: NJ BS, University of Wisconsin, Milwaukee MD, Medical College of Wisconsin, Milwaukee Residency, Internal Medicine, Loyola University Medical Center Board Certified, Internal Medicine Member, American Medical Association Member, American College of Physicians Member, American Society of lnternal Medicine Award, America's Top Doctor - 2006, 2008 & 2009, Research Council for American Healthcare Award, AMA Physician Recognition Award Former C******* I********* o* M******* L***** U********* Former A******** P******** - I******* M******* a** U***** C*** C****** D***** H******* Former H********** a** C********* I******** T** I****** H******** Former A******** P******** - I******* M******* a** E******** M******* B************ H******* Former C******* I********* o* M******* A***** E******* C****** o* M******* Current I******* M******* P******************** T**** N** J***** H********

This highly qualified hospital physician has over two decades of clinical experience. He completed his undergraduate education at the University of Wisconsin and earned his MD degree from the Medical College of Wisconsin. He completed a Residency in Internal Medicine at Loyola University Medical Center. He is a member of the American Medical Association, the American College of Physicians and the American Society of Internal medicine. He has won multiple awards throughout his career including America's Top Doctor for three consecutive years. He is currently a physician in private practice as well as an attending internal medicine physician at three New Jersey hospitals.

Cancer Patient is Killed by Drug Overdose Caused by Alleged Software Error

This case involves a child with a history of low blood sugar who began feeling extremely nauseated and was taken to the hospital. The attending physician ordered the patient normal saline. Soon after starting on the saline, the child began vomiting frequently. Within the hour, the child turned gray and stopped breathing. A response team was able to get the child breathing again and she was transferred to the ICU. For the next few hours, the child had several seizures. After being given insulin and Ativan, the patient’s sugar levels went back down into the 500 range. Several hours later, the child began to have difficulty breathing and her sugar levels went back up to 1,200. The child was intubated and put on a ventilator. She remained in this state for over 2 weeks before passing away. It was eventually discovered that the pharmacy technician had mixed D70 rather than D10 1/2 normal saline for the child’s IV bags.

I am an assistant professor of pharmacology with 10+ years of professional experience in the areas of pharmacokinetics, drug transport mechanisms, drug delivery, neuropharmacology, molecular pharmacology, and drug-drug interactions. I have published over 25 peer-reviewed papers and 6 book chapters in the areas listed above. I operate a federally funded research laboratory that is currently studying novel therapeutic approaches for the treatment of ischemic stroke, traumatic brain injury, and acute/chronic pain. I teach in both the MD and PhD programs at a prestigious college of medicine. My specific lecture topics include pharmacokinetic principles (i.e., drug absorption, distribution, metabolism, and elimination), systems pharmacology of cardiovascular, gastrointestinal, and neurological drugs, blood-brain barrier, and drug transport mechanisms. As part of my teaching duties, I teach medical students on the physiology and pharmacology of fluid administration including adverse events that may occur from incorrect fluid administration. I am also an active member of several pharmaceutical associations and have experience as an expert witness and have provided both trial testimony and deposition testimony. Based upon the initial information, this case involves a serious medication error that caused undue harm to the patient. The fluid that was ordered was appropriate in this particular situation, as the patient required an increase in total fluid volume and nutritional supplementation to accommodate for hypoglycemia. In error, the patient was given a solution that contains 70 g dextrose per 100 ml fluid. This is clearly the cause of the patient's persistent hyperglycemia (i.e., consistent blood-glucose levels above 1,000), vomiting, difficulty breathing, and seizure activity, symptoms that may indicate the presence of hyperosmolar hyperglycemic syndrome. The preparation protocols for D10 1/2 normal saline solution and D70 solution are vastly different and highly unlikely to be confused with one another. This points towards negligence by the hospital pharmacy that placed the patient at a foreseeable risk for undue harm.

1. Please describe your background in pharmacology. 2. What is the protocol for ensuring the patient receives the proper dosage in these types of cases?

Hospital Pharmacist Administers Fatal Saline Dosage To Child

Dani Alexis Ryskamp, J.D.

Purdue Pharma, makers of opioid painkiller OxyContin, recently reached an agreement with the U.S. Department of Justice (DOJ), pending the approval of the bankruptcy court. The agreement is an important step towards resolving a long legal battle over the drugmaker’s role in the nation’s opioid epidemic. Details of the $8.3 Billion Settlement Under the terms


Purdue Pharma, makers of opioid painkiller OxyContin, recently reached an 

 with the U.S. Department of Justice (DOJ), pending the approval of the bankruptcy court. The agreement is an important step towards resolving a long legal battle over the drugmaker’s role in the nation’s opioid epidemic.

Under the terms of the agreement, Purdue Pharma will pay $8.34 billion in damages and will plead guilty to a three-count felony information in New Jersey. The charges against the company include one count of conspiracy to defraud the United States and violate the 

, and two counts of conspiracy to violate the 

In order to resolve the case, Purdue Pharma will pay a $3.54 billion criminal fine, $2 billion in criminal forfeiture, and a civil settlement of $2.8 billion for civil liability under the 

. Pursuant to its guilty plea, Purdue Pharma is expected to admit that between May 2007 and March 2017, the company conspired to defraud the United States by falsely claiming it was working to prevent opioid painkillers from getting into the hands of people who did not medically need them. In fact, according to the U.S. Department of Justice, Purdue Pharma was marketing those opioids directly to doctors it knew—or had good reason to suspect—were providing them to non-pain patients.

By helping to dispense OxyContin and other opioids outside the legal channels for treating medical conditions with a valid prescription, the DOJ states, Purdue Pharma engaged in a conspiracy to aid and abet violations of the federal Food, Drug, and Cosmetic Act. Purdue will also admit to paying two doctors through its speaker program incentive to write more OxyContin prescriptions. This, according to the DOJ, constitutes a conspiracy to violate the Federal Anti-Kickback statute.

In addition to the guilty plea, Purdue Pharma reached a civil 

 resolving federal claims against both Purdue and its individual shareholders—including the Sackler family, who founded and own the company. The civil settlement includes a bankruptcy claim against the company by the United States for $2.8 billion, resolving claims that Purdue Pharma was involved in defrauding various federal healthcare programs, that it paid kickbacks to certain parties, and that it contracted with specialty pharmacies to fill opioid prescriptions after other pharmacies had refused, describing the prescriptions as not medically necessary.

The terms of a separate civil settlement require five members of the Sackler family to pay a collective $225 million. This settlement resolves claims that the five Sacklers pushed for increased sales of OxyContin starting in 2012, endorsing a program that marketed the drug specifically to doctors who wrote large numbers of OxyContin prescriptions. It also addresses claims that in 2018 and 2019, Purdue Pharma transferred assets to the five Sackler family members for improper or fraudulent reasons. The Sackler family will also no longer be in charge of Purdue Pharma, which will become a public benefit company.

What to Expect in Future Opioid Litigation

While the settlement addresses a number of federal claims against Purdue Pharma and its owners, it does not address any state-level claims against the parties. States may continue to pursue their claims against Purdue Pharma and any members of the Sackler family. The deal also does not address criminal charges against any members of the Sackler family as individuals. Criminal investigations against individual Sacklers are still 

 and could yield additional charges in the future.

Purdue Pharma has proposed to settle outstanding claims with a deal that could be worth $8 billion to $12 billion dollars, once all claims are paid. Some state attorneys and others, however, are pushing for a larger settlement, pointing to evidence that the Sackler family 

 over $10 billion out of the company between 2008 and 2017.

The $3.54 billion criminal fine is part of Purdue Pharma’s bankruptcy proceeding. As a result, it remains to be seen whether and to what extent that fine will be paid. The federal government has indicated that money collected from the fine will be used to fund opioid treatment programs. This plan, however, has received some pushback from state governments.

The complex nature of the claims against Purdue Pharma means that settlements will continue to be complicated as well. Many states will likely continue to pursue state-level claims against the company. Its bankruptcy and status as a public benefit company could continue to complicate the process of obtaining settlements and resolving claims.

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