Category: Pharmaceutical

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Kentucky AG files lawsuit against opioid distributor McKesson

As I mentioned in our blog post on November 6, 2017, we would be covering the US “opioid crisis” as the lawsuits against manufacturers and distributors heated up. Today, we found out Kentucky Attorney General, Andy Beshear, filed a complaint against McKesson Corp. According to this story by Reuters, Mr. Beshear “accused drug distributor McKesson Corp of helping fuel the opioid epidemic by failing to halt shipments of suspiciously large or frequent orders by pharmacies of prescription painkillers.”

Mr. Beshear’s office filed suit in Kentucky state court. The complaint further alleges McKesson filled suspicious orders and shipped tremendous quantities of prescription opioid pharmaceuticals to Kentucky pharmacies, without reporting them to authorities or preventing the shipments. According to the AG’s own press release, “Federal and state law requires pharmaceutical distributors to monitor and report to law enforcement when it ships large or suspicious supplies of opioids to a state or region.

There’s a wide array of state and local governments pursuing lawsuits against pharmaceutical companies, including McKesson, for deceptive marketing and failures to report suspicious activity which are resulting in opioid addiction and deaths within their cities and towns.

Let’s take a look at causes of action and potential experts:

Based on the complaint, we see that the Kentucky AG is attacking McKesson on some interesting causes of action, including: Consumer Protection Act Violation; Public Nuisance; Negligence per se; Negligence; Unjust Enrichment; Fraud by Omission; and Medicaid Fraud. Mr. Beshear is seeking punitive damages for the State of Kentucky. The complaint further provides the Kentucky Consumer Protection Act protects citizens from “predatory or inappropriate acts by sellers of goods.” The Act states “unfair, false, misleading, or deceptive acts or practices in the conduct of any trade or commerce are hereby declared unlawful.”

With this information it appears deceptive marketing practices will be an issue in this lawsuit. Both Kentucky and McKesson are likely to employ marketing expert witnesses to address which practices may or may not be false and misleading.

Within this cause of action, Mr. Beshear further alleges violations of the Kentucky Controlled Substances Act. This Act creates a “broad duty on the part of wholesalers to monitor, detect, investigate, refuse to fill, and report suspicious orders of prescription opioids.”

One can only imagine there will be an argument over what constitutes a “suspicious order of prescription opioids.” As such, we expect both parties will be retaining pharmaceutical and pharmacy industry experts. The parties are likely to argue about the existence of indicators used to alert a distributor when a suspect order is placed. I anticipate the parties will be looking to pharmaceutical supply chain or logistics expert witnesses to provide background about notification and indicator systems for identifying suspicious orders.

What relief is the Kentucky AG seeking?

By reviewing the complaint and articles mentioned above, Kentucky is arguing McKesson’s activity has resulted in overdoses which put a drain on emergency services and hospitals. I’m certain Mr. Beshear will argue the costs of medical services have increased significantly as the state has had to deal with opioid overdose.

I further envision an argument will be made about the increase in law enforcement and first responder costs associated with fighting the illegal sales of heroin and other opiates stemming from addiction.

The complaint makes it pretty clear Mr. Beshear is seeking punitive damages on behalf of Kentucky. That being said, both parties are going to employ damages experts. This may involve the use of economists and forensic accountants to determine the amount of financial damage inflicted on Kentucky by McKesson’s actions.

Final Thoughts:

As I’m sitting here in California, I do not understand the true ramifications of the opioid crisis on the State of Kentucky. I am interested to see what individual civil litigation options may be available to the citizens of Kentucky. As such, I invite my friend Daryl Dixon of Daryl T. Dixon Law, in Paducah, Kentucky, to provide us with his thoughts on this subject on his own blog! Ball is in your court, Daryl. Let’s see what the Wildcats have for me…

UPDATED 02/07/2018:

Here is the response from Daryl T. Dixon – Examining the Opioid Crisis: What are my options?

 

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Opioid Crisis – An increase in addiction medicine and pain management expert witnesses.

In the nearly 8 years that I’ve been with Experts.com, I have noticed a massive increase in the number of addiction medicine and pain management expert witnesses marketing their services with our company. Between 2010, when I joined Experts.com, and today, the increase has been nearly five-fold.

Is this increase a surprise? Based on what we’re seeing in the news, the answer is no. The United States is experiencing an opioid epidemic. According to CNN’s Opioid Crisis Fast Facts, “more than two million of Americans have become dependent on or abused prescription pain pills and street drugs.” CNN further explains, “during 2015, there were 52,404 overdose deaths in the United States, including 33,091 (63.1%) that involved an opioid. That’s an average of 91 opioid overdose deaths each day.”

Just last week, I spoke to one expert witness who experienced an opioid-related death in his family.  The same day, hours apart, another expert began promoting his pain management and addiction medicine services on our site. This epidemic is impacting millions of families throughout our country. As a result of this epidemic, and much of the overdoses stemming from prescription medication, we are beginning to see significant litigation in the area of opioid-based pharmaceuticals.

Our Opioid Litigation Experiences:

Experts.com has processed more than a handful of expert witness referrals related to opioids. The cases have ranged from prescription abuse in family law settings to overdose issues resulting in wrongful death actions. Probably the most interesting opioid-related matter was as follows: general counsel for a mining company in a small town discovered the townspeople were using methadone at a rate approximately 5 times higher than the national average. Many citizens of the town were also employees of the mining company. They grew concerned about the potential liabilities of employees operating heavy equipment while ingesting powerful pain killers. The company decided to do some testing which triggered some privacy concerns and potential litigation. We have delivered toxicologists, addiction medicine specialists, and pain management professionals in dozens of different opioid-related cases.

Recent Litigation:

In the last few years, we have seen stories of both civil and criminal litigation related to the opioid epidemic, even before it was claimed to be a crisis. Here are a few of the cases you may want to follow:

Civil Litigation:

There have been many lawsuits against Purdue Pharma (maker of OxyContin) since the early 2000’s. As one article explains, more and more state and local governments are launching lawsuits against the manufacturers and distributors of heavy-duty pain medications. The frequency of these lawsuits is almost weekly.  In addition to Purdue Pharma, Cardinal Health, Teva Pharmaceuticals, Janssen, and others are targeted.

In July of this year, one of the lawyers, Michael Moore, who targeted tobacco companies in the 1990’s, began urging state lawsuits against the drug makers. By August, an Oregon County sued pharmaceutical companies for $250 million for allegedly persuading physicians to over prescribe opioids. As of September, Attorneys General in 37 states were urging insurance companies to do more to curb the opioid epidemic.

What can we deduce from the high-profile coverage of civil suits against the makers of pain killers? In my assessment, the worst is yet to come for the drug makers. This does not mean the drug makers are defenseless against the lawsuits. After all, there are others in the supply chain to be blamed: doctors, pharmacies, and the patients themselves. Over the long-term, the pain medication lawsuits are likely to be very costly for manufacturers and distributors.

Criminal Litigation:

For the sake of brevity, I’m going to ask you to assume that there is significant drug related crime and we’re going to skip the standard (possession and distribution) opioid cases. Where I have noticed a substantial increase, both in the news and in requests for expert witnesses, is in criminal prosecutions of prescribing physicians and pharmacists.

As CNN described, “doctors are increasingly being held accountable — some even facing murder charges — when their patients overdose on opioid painkillers they prescribed.” The article further explains that the DEA took action against 88 doctors in 2011 and 479 doctors in 2016. One of the doctors described has been convicted of murder. I see at least one new story a week where a doctor, or pharmacist, is being held responsible for the excessive amounts of pain killers prescribed.

The numbers described in the article above, combined with a more aware public, lead me to believe we’ll see even larger numbers of DEA actions against doctors when the 2017 statistics are available.

Other Legal Issues:

As you can tell, I focused on the two areas that I’ve noticed the largest increase in visible litigation. We have processed many other expert witness referrals associated with opioid issues. Many overdose cases are resulting in medical malpractice actions as well as actions brought by medical boards for ethical violations by doctors.  We often see the requests for expert witnesses relating to emergency medicine physicians, toxicologists, pharmacy and pharmacology experts, and more.

Opioid litigation may very well be the “tobacco” litigation of our time.  As such, we are confident that we’ll have more to write about and discuss in the future.

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PHARMACEUTICAL PRODUCT LIABILITY

With the onslaught of legal drugs on the market, pharmaceutical product liability cases have become mainstream in the court system.  It boggles the mind how many possible harmful side effects there are for one medication alone.  Just listen to any commercial for depression medicine – and you’d better listen carefully.  They have to speak quickly to get them all in.

If a pharmaceutical company lists all possible harmful effects, does that relieve them from liability?  Do a certain number of people have to die or have a stroke in order for the drug to be pulled from the market?  Conversely, did the patient do something to exacerbate the problem?  Take too much of the medicine?  Not enough?  Is the pharmacy liable for miscalculating the dosage?

This is when Pharmaceutical, Pharmacology and Toxicology Experts and Consultants come into play.  The variables are so complex and many that a case cannot be thoroughly adjudicated without the scientific and practical experience that these particular Experts hold.  They use their skills to review medical and pharmacy records, evaluate drug delivery standards of care, toxicity, adverse drug events and even FDA regulations.  These Experts and Consultants are retained to determine the period of time a drug was used and a patient’s average compliance or adherence to taking a drug, among so many other things.

The bottom line is that Pharmaceutical, Pharmacology and Toxicology Experts and Consultants are essential to resolving complex medical issues involving pharmaceuticals and drugs.  That they play a major role in helping to regulate the industry, compensate the injured and defend the innocent cannot be denied.