SOLVING THE OPIOID EPIDEMIC IN OHIO.

• Author: Leduc, Lacy

1. INTRODUCTION 111 II. BACKGROUND 114 A. What Are Opioids? 115 1. Why Are They Harmful? 116 2. What Is Heroin, and Where Does it Come From? 116 3. Why This Issue is Important to the Government 118 4. The Role Of The Food And Drug Administration 119 B. What Role Are Drug Pharmaceutical Companies Playing? 120 1. Drug Representatives Provide Information to the Medical community 122 C. The Learned Intermediary Doctrine 124 III. ANALYSIS 127 A. The Solution: An Exception to the Learned Intermediary Doctrine 128 B. The United States Supreme Court has the Authority to Make this Exception 130 C. The Role of the FDA 130 D. The Ohio Supreme Court has the Authority to Make this Exception 131 1. Repealing The Learned Intermediary Doctrine 132 2. Punishment this Late would be Ineffective 132 IV. CONCLUSION 133 I. INTRODUCTION

   "Providers wrote nearly a quarter of a billion opioid prescriptions in 2013; enough for every American to have their own bottle of pills." (1) This high number of pills per American has started a tidal wave of problems that is sweeping across America. However, it is the drug manufacturers that are responsible for these growing problems. The opioid epidemic that is striking the nation is drawing serious attention and raising questions about what to do to solve it. While it is a nationwide problem, it has also hugely affected ohio. These drugs are no longer those that can be associated with the common image of a 'drug addict;' they are being found far more frequently in high schools, affluent neighborhoods, and families of all races, cultures, religions and income statuses alike. (2) The key to stopping this problem lies within the prescription drug community. Prescription drug manufacturers have a major influence on the number of pills being prescribed by doctors. In 2016, 631 million opioid pills, such as OxyContin, Percocet, Vicodin, Lortab, and Percodan were given out, and this number showed a 20.4% decrease since 2012. (3)

   These national problems target families and people all over the country, including Daniel, (4) who went to high school in a small affluent town right outside Cleveland, ohio. He was in high school the first time he began using pain pills. What started out as pain medication after an injury, quickly led Daniel to take illegal means to obtain more pain medication. Unbeknownst to his family and friends, this is how Daniel's problem began. He went off to college after graduating high school, and that is when it became very apparent to his family he was having problems. After plummeting grades and learning he had sold nearly everything he owned, his parents had no choice but to bring him home. It was not until Daniel got home that his family was really able to understand the severity of this problem. Not only was he selling his own belongings for pills, but he was stealing from his family and selling whatever he could get his hands on from the ones he loved just to get his next round of pills. (5) With the help of his family, Daniel agreed to go to a rehabilitation facility and get the help he so desperately needed.

   After completing his program, he stayed clean for a period of time, but eventually fell right back into his old habits, except this time, it became deadlier because the pills were no longer affordable. Daniel turned to heroin, a much cheaper and stronger option, and it was not until his first overdose that his family realized the true battle he had ahead of him. Daniel was denied rehabilitation treatment the next time around because health insurance refused to pay and the cost was far more than the family could afford out of pocket. (6)

   Unfortunately for Daniel, this was happening at a time when heroin was being mixed and cut with a new drug called fentanyl, a much stronger drug than heroin and usually kept quiet when it is mixed in with heroin. Shortly thereafter, when Daniel was only 24 years old, he was found dead in his apartment, and it was determined that this occurred from an accidental overdose of heroin. This is unfortunately the tragic yet common ending we are seeing in today's society. What started out as prescription pills for an injury, eventually lead to the untimely death because of addiction.

   The opioid epidemic that Ohio is faced with today is taking the lives of people across all age ranges. (7) Between 2014 and 2015, Ohio had the greatest number of opioid related deaths in the nation--with 1 in every 14 deaths from opioids in the United States occurring in the state. (8) With these alarming numbers, states like Ohio, that are being hit hardest with this problem, are looking for the best solutions to decrease these numbers. Ohio can be found at the top of that list, among other states, aggressively looking for ways to combat this terrible but growing problem.

   On May 31, 2017, Ohio Attorney General Mike DeWine decided to take a step in the right direction of fighting the epidemic. DeWine brought the first of many lawsuits against five top drug pharmaceutical companies. (9) The five companies are, Purdue Pharma, Teva Pharmaceutical Industries, Cephalon, Inc., Janssen Pharmaceuticals, and Endo Health Solutions Inc. (10) There are several counts being raised against the pharmaceutical companies, but only the counts for deceptive marketing practices are relevant for this Note. (11) This charge is particularly important here because Attorney General DeWine states that these deceptive marketing practices are one of the leading causes of this serious opioid epidemic. (12) This lawsuit has in turn prompted several other states to follow suit. (13) The trend of bringing these lawsuits shows the willingness of states to recognize the problem and the want of these states to hold the correct entities accountable. (14) New York Attorney General Eric Schneiderman stated, "For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe, they got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet." (15) With law suits becoming more prevalent, it is showing the willingness of states to accept and want to hold those who are responsible accountable: the big drug pharmaceutical companies. In doing so, any entity bringing a lawsuit will have to overcome an exception, that exists under Products Liability Law, the Learned Intermediary Doctrine.

   Under Federal and State law, there is an exception that exists, called the Learned Intermediary Doctrine. This exception is one which can absolve the drug manufacturers of liability from any misconduct that might be found and transfer that liability to any treating physician. (16) This exception is extremely relevant to this topic because it is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to the Learned Intermediary Doctrine should be introduced. This Note will begin with a discussion of opioids and how these drugs have become such an aggressive problem in a very short amount of time in Ohio. Part II will talk about the role the government can play and the role the drug manufacturers have played and continue to play in the availability of opioids. It will discuss the effect these drug pharmaceutical companies have had on this problem and have had in increasing this problem. Part II will also discuss why this is a problem and why this problem matters. Further, it will talk about the steps that have already been taken by the Ohio Legislature to combat the opioid problems. Finally, it will delve into a discussion of what this current lawsuit means for fighting and decreasing the opioid problem and how it will directly affect the heroin epidemic in Ohio.

2. BACKGROUND

   While this is a national problem, Ohio has been one of many states hit hard by this problem. (17) In 2010, Ohio declared a public health emergency due to rising overdose deaths. (18) "In 2016, unintentional drug overdoses caused the deaths of 4,050 Ohio residents, which was a 32.8% increase compared to 2015." (19) Although prescription opioid-related deaths have declined again, from 667 in 2015 to 564 in 2016, (20) the damage from the prescription pills has already been done and continues to ravage through the most unsuspecting homes and families. According to a study conducted by the Center for Behavioral Health Statistics and Quality, in August of 2013, three out of four new heroin users reported first abusing prescription opioids before beginning to use heroin. (21) While these unintentional drug overdoses include heroin, (22) the lawsuit brought by the state of Ohio relates the heroin epidemic directly to the misrepresentation of the effects of treating chronic pain with opioid pain killers. (23) The lawsuit intends to hold the drug manufacturing companies liable for these misrepresentations that were made, which in turn lead to the heroin epidemic that is faced by so many today.

   This section will begin with a brief discussion of opioids and what they are, the epidemic that is happening, and why it is important for the government to step in and take action. Next, there will be a discussion on the main role the drug manufacturers play in this epidemic. Also, this section will discuss the steps taken to try and hold these pharmaceutical companies liable. Finally, it will end with why the proposed solution is the best way to begin to get this epidemic under control.

   1. What Are Opioids?

      Opioids are a class of drugs that are usually taken for pain relief. (24) There are natural opioids and then there are manmade synthetic opioids. (25) Natural opioids come from the poppy plant, while synthetic opioids are created in a lab. (26) Heroin, fentanyl and OxyContin are the three most commonly known synthetic opioids because they are manmade as opposed to being natural. (27) "Prescription opioids are powerful pain-reducing medications...