Be certain your liability insurance is paid in full and your assets are well-protected because as one perspicacious attorney put it, “people can sue for anything – the paper won’t reject the ink”. After years of experience as an expert witness (JF), just when you think you’ve seen it all, another crazy case surfaces. A few years ago a pharmacist was sued by a man missing a portion of his right forefinger; his spouse bit off her husband’s fingertip. How could a pharmacist possibly be held accountable? Because the pharmacist refused to fill a carisporidol prescription for the estranged wife after years of filling the prescription; and the presumed agitation from “withdrawal” sent her into a finger-biting frenzy. But since they were separated, it was difficult to obtain the prescription records without consent because of refusal for HIPAA consent by the wife. And, it just keeps getting crazier.
Here to present the recent turmoil on this topic is Guest Blogger Lisa Dragic, a Doctor of Pharmacy Candidate at Temple University School of Pharmacy with a true “passion for pain”. Working closely with yours truly, here’s what she had to say…
The nerve-wracking liability associated with filling prescriptions in a world fraught with substance abuse, opioid-induced respiratory depression, potential for associated morbidity and mortality, and now a corresponding responsibility for REMS and perhaps naloxone reversal training to caregivers, maybe it’s just easier to avoid opioid fills altogether.1,2 Or is it? Perhaps one can be sued for lying to a patient for not having the opioid in stock, which might subsequently lead to withdrawal, agitation, diminished focus and a motor vehicle accident.
Background: Turning attention to a broader issue, now various states have jumped on the bandwagon to sue major pharmaceutical companies for causing addiction within their state and surrounding communities. This begs the questions of whether it is an excuse for a political bully pulpit, a revenue-generating scheme, or an opportunity for more sensationalism by media and political propagandists.
True enough, after Oxycontin hit the market in 1996 it generated $45 million in sales its first year, and by 2000 the drug generated $1.1 billion.3 OxyContin and other opioid analgesics are labeled with warnings informing prescribers that, “abuse, misuse, or opioid addiction may occur: use cautiously in patients with history of substance abuse or mental illness; monitoring recommended.”4 Although prior to 1995, opioids were commonly prescribed for unremitting cancer pain, “the promotion and marketing of OxyContin” from 1997 to 2002 resulted in an almost tenfold increase in FDA sanctioned usage.3
Irrespective of your view on the Oxycontin story, from 1999 to 2010, the sale of opioids to pharmacies quadrupled.3 During that same timespan, the number of overdose deaths from prescription opioids also quadrupled, rising to almost 17,000.5 The US Centers for Disease Control and Prevention noted that nearly 2 million Americans either abused or were dependent on opioids in 2013. A CDC report also found that there were 43,982 drug overdose deaths in 2013. 51.8% of the deaths were related to prescription drugs and of that 71.3% involved opioid painkillers.6
States Turn to Lawsuits: There have been several lawsuits filed against Purdue and other companies for over-marketing and false claims regarding addiction to OxyContin. Kentucky alleges that Purdue Pharma led an aggressive and deceptive marketing campaign that misled doctors, consumers and the government about OxyContin’s addiction risk.3 Kentucky’s Attorney General Jack Conway states, “This is about holding them accountable. They played a role in the state’s drug problem. This started to explode in the mid-1990s when Purdue Pharma was marketing OxyContin. The resulting opiate epidemic … is a direct result.”3 But one can’t help wonder if it’s really about ”holding them accountable” or if its more about politics and media attention.
Chicago filed a similar lawsuit against Teva, Endo, Actavis, and J&J alleging the manufacturers using deceptive marketing to downplay the risks of opioids and encouraged physicians to prescribe the addicting opioids to unsuspecting physician- endorsed drug addicts.7 A federal Judge dismissed the case.
Many are ignoring the more sensible question of “are medical doctors and other prescribers so poorly educated, impressionable and naïve that the mere suggestion of inappropriate prescribing would guide their hand?” to order an opioid prescription. The medical community should be outraged at these presumptions!
Pharmacists and Medical Doctors Caught in the Crossfire: Nevertheless, the sensationalism has caused an avalanche of direct lawsuits against healthcare clinicians. On May 13th, 2015 a West Virginia Supreme Court ruling allowed drug addicts to sue doctors and pharmacists for their addiction disorder. The plaintiffs alleged three pharmacies and four physicians caused them to become addicted to controlled substances following car accidents or workplace injuries.8 In Bangor Maine, Charlene Whalen sued Dr. Weisberger for medical malpractice. Whalen suffered brain damage due to a high dosage of methadone, which caused her to stop breathing in her sleep. She was awarded $1.9 million dollars.9
Cases like this raise important questions. Do doctors and pharmacists play a role in the increasing addiction rate? What impact will these cases have on prescribing and dispensing opioids to legitimate patients? How should we treat chronic non-cancer pain, particularly in patients that either fail other medication therapies, or in whom they are contraindicated, less safe, or not indicated? Perhaps it is not the over-marketing by pharmaceutical companies but perhaps more precisely, lack of pain education in professional schools, including informed consent for long-term opioids, employing validated risk stratification tools, proper usage and interpretation of urine drug tests, counseling, and lack of payment by insurance companies for non-medical interventions (including diet, exercise, acupuncture, counseling, music therapy, tai chi, etc.).
Legitimate Patients Take the Bullets from Crossfire: As of 2011, at least 100 million Americans were estimated to have chronic pain which represents more than diabetes, heart disease, and cancer combined.10 Presumably legal cases will negatively impact appropriate and necessary treatment for these patients, most of whom don’t have the wherewithal to rise up against this complicated system. This is supported by Dr. Lynn Webster’s upcoming documentary, “The Painful Truth”, in this currently available trailer.
Even if proper evaluation by physicians and verification by pharmacists were consistently exercised, the snowball has already been discharged down a very long hill, and it continues to gain popular momentum by politicians, and media muckrakers starving for opportunity.
As Americans continue to crawl down this rabbit hole of sue-happy plaintiffs, perhaps defendants will need to dig more frantically in an effort to avoid the ground above, as the ground may be sued for death by a faulty parachute.
As always, comments are welcome!
This article was collaboratively written with Lisa Dragic, a 2016 Doctor of Pharmacy candidate at Temple University School of Pharmacy. Lisa is a fourth year student pharmacist with an interest in pain management, addiction, infectious disease, and palliative care. She hopes to complete a PGY-1 and PGY-2 pharmacy residency. Lisa aspires to be a leader in her chosen profession with focus on patient advocacy.
References
- Information by Drug Class – Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids. 2015. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
- Strang J, Manning V, Semmler C, et al. Overdose training and take-home naloxone for opiate users: prospective cohort study of impact on knowledge and attitudes and subsequent management of overdoses. Addiction [serial online]. October 2008;103(10):1648-1657. Available from: Academic Search Premier, Ipswich, MA.
- Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. American Journal of Public Health. 2009;99(2):221-227.
- Purdue Pharma L.P. OxyContin Package Insert. 2007. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020553s060lbl.pdf.
- National Institute. Although Relatively Few, ‘Doctor Shoppers’ Skew Opioid Prescribing | National Institute on Drug Abuse (NIDA). http://www.drugabuse.gov/news-events/nida-notes/2014/05/although-relatively-few-doctor-shoppers-skew-opioid-prescribing.
- Prescription Drug Overdose Data. 2015. http://www.cdc.gov/drugoverdose/data/overdose.html.
- Patton S. City of Chicago Vs. Purdue Pharma. 2014. http://freepdfhosting.com/3063aad0ee.pdf.
- Lowery M, Editor C. Should addicted patients be able to sue pharmacies? 2015. http://drugtopics.modernmedicine.com/drug-topics/news/should-addicted-patients-be-able-sue-pharmacies?page=full10
- Jury awards Corinth woman $1.9M in methadone malpractice suit. Bangor. http://bangordailynews.com/2012/04/12/news/bangor/jury-awards-corinth-woman-1-9m-in-methadone-malpractice-suit/.
- American Academy of Pain Medicine – Get the Facts on Pain. http://www.painmed.org/patientcenter/facts_on_pain.aspx.
I totally understand where you are coming from and it’s a great article but I was in the hospital for over a month and obviously became addicted to opiates. When I spoke to my Doctor about it his idea in 1998 was this “new” non addicting medication called OxyContin. Unfortunately I was young and just wanted to be free of this addiction so I took it. I realized that was not the answer and the next medication given to me was Methadone. I spent 14 years on it and basically my life was a mess. I go back and forth about what was my part in all this and what was the pharmaceutical companies and my doctors. I also lost a huge part of my life doe to this and feel very cheated. I live in Maine where it doesn’t matter because it’s a non-issue litigation wise. Possibly my part is much bigger than I’m seeing but it’s very frustrating! I’m off all opiates and will continue to be as I’ve found a 12 step program that does help.
Ms. Dragic, Your article makes many sad but valid points, the true sadness being that they are so very true. In this country, where a woman once won a lawsuit for spilling coffee in her lap because it was hot and she felt there should have been a warning to that effect, people will sue for every reason in which a lawyer will take up their case.
That being stated, I find the constant barrage of ammunition with which chronic pain patients can be denied adequate, if any, pain relief terrifying. It is a constant battle, as a chronic pain patient, to keep your prescription coming each month and secondly, to get a pharmacy to fill it. If you manage to find a wonderful, caring doctor such as Drs. Ibsen or Pat Murphy, there is still that nagging fear the rug will be ripped right out from under you for any number of reasons, and back to square one you will be.
Square one, for me, was in Kentucky when my PCP informed me the facility had changed their policies and were ceasing writing prescriptions for any controlled medications. It took me two full years to get anywhere close to some semblance of normalcy in my life having to seek out multiple specialists for my various malidies previously treated by one provider in a very opioid unfriendly atmosphere.
Thanks for keeping us informed, Ms Dragic, and thanks Dr. Fudin, as always for bringing a wonderful guest writer in for this piece. I give thanks on a daily basis for the pain care I am receiving at this time, however temporary it may feel, and who knows, it may truly be.
Kim, I couldn’t agree more with you. It is a very sad, but true. I am glad you are able to find some relief with great doctors. One should never have to live a life in pain or do the “pharmacy crawl” to get a prescription. Thanks for sharing.
Ditto Dr Webster.
Or: if car dealers should detect if their customer may speed, or cause a crash.
Car crashes have soared since 1905.
Plane crashes since 1920
Should we ban car and plane travel?
We are treating more patients in pain.
Pain causes 600 billion( with a B)
Impact on the economy. If we get people in pain moving, contributing, thriving, then we all win.
We just need to sort out those who benefit from those who don’t.
Isn’t taking more opiates/meds than medically necessary a NON-COMPLIANCE issue ? Why are doctors and Pharmacist not held responsible for pts being non-compliant – not taking their meds… if we are expected to be the “opiate nanny” … why aren’t we expected to be nanny to all pts ?
If you have noticed they are changing the nomenclature of opiate deaths from “accidental drug overdose” to “opiate related death”… really doesn’t matter if the pt had a MI.. if there was opiate in them or even a bottle of opiates on the nightstand… the death is opiate related… The DEA/Judicial system is losing MJ/MMJ and they have to find somehow to bump up the numbers of opiate related deaths.
Let’s not forget the 450 K – 500 K that die annually from Nicotine use/abuse..
and the 16 K – 18K that die from hospital acquired MRSA because staff won’t wash their hands and the 500 K that catch and 29 K that die from hospital/nursing home acquired C-DIF for the same reason… and the 40 K that commit suicide annually (22/day being veterans).. Lives matter… some appear to have a higher value than others… seems to depend on if the person’s life/death is supporting a bureaucracy…like the DEA and the entire judicial system
Steve, there is much to be said for that. And for example, medical examiners often assign opioids as cause of death based in large part on serum levels without regard to tolerance level because of lack of baseline blood levels. Moreover, opioids are assigned the cause without considering other agents such as benzos, other sedative-hypnotics, and alcohol.
Great article Lisa. I wonder if alcohol producers have been sued for creating alcoholism in an individual? There were more than 85,000 deaths from alcohol in 2012. This is a tragedy of colossal proportions. Why aren’t payers held accountable for not paying for safer alternatives. Medicare, Medicaid and WC among other payers deny ADFs, multidisciplinary care, cognitive therapy, etc for people in pain. Should the attorney generals be held accountable for not forcing them to provide the benefits? A lot of potential blame to go around. We need to focus on solutions but this will require an honest understanding the root causes to the problem not just finger pointing.
Thank you Dr. Webster. I think our author will have a lot to say here because her original proposed topic was on the very point you brought up. That is, specifically why is there is a double standard whereby alcohol manufacturers are not held accountable for alcohol addiction, associated motor vehicle accidents, and many other related issues.
Thank you Dr. Webster for your comments. It is especially encouraging and humbling to receive input from you on this forum! You raise important points that should be addressed. Other related queries could include the following:
Will obese patients be able to sue fast food chains?
Will people addicted to cigarettes be able to sue cigarette companies?
We live in a society where its easier to point fingers rather than comprehensively tackle the problem. I don’t think more lawsuits will fix this issue and perhaps it will create more problems. My hope is that eventually there will be close scrutiny with suggestions for some realistic solutions. That journey won’t likely be easy.