Three years ago I wrote this column: My Challenge to Medical Device and Drug Companies: Put Me Out of Business! The point was straightforward: if companies would do the right thing, and properly test their medical devices, and carefully monitor the drugs they sell, and try to help patients instead of merely chasing profits, then I will stop being a product liability lawyer. Well, turns out my line of work may be safe for a long time. This week several executives from Insys Therapeutics were found guilty of racketeering. The jury found that these executives conspired to push sales of a deadly fentanyl drug, by increasing dosages and prescriptions. These guys are going to jail. And they should. The story that emerged from the two-month trial was hideous, and it proves yet again that without careful oversight companies will often harm public health in their pursuit of massive profits.

Before I bullet point some of the evidence developed at trial, start with this: the Centers for Disease Control estimates that well over 200,000 people have died from prescription opioids since 1996. Sit with that for a moment. More than 200,000 people have died from opioid overdoses. It is heart-wrenching. Now, add to this tragic statistic the narrative that several opioid companies, and not just Insys Therapeutics, pushed for more prescriptions and higher doses for decades, solely to increase sales and profits and employee bonuses.

Let’s take a look at the evidence from the Insys criminal trial:

• Insys pushed an aggressive marketing scheme for its sales representatives.
• Insys paid doctors for speeches they never gave; instead these doctors were getting paid for prescribing Insys’ fentanyl-spray, “Subsys.”
• Doctors were also enticed to prescribe more opioids with other perks, like lap dances. (Classy.)
• Insys hired a stripper, Sunrise Lee, to serve as a sales rep for the company. One witness testified that Ms. Lee gave a doctor a lap dance as part of her sales work for Insys. (Ms. Lee was eventually promoted to regional sales director.)
• Insys executives pushed doctors to prescribe opioids to patients for whom the fentanyl-spray was not intended.
• Sales representatives testified that their bonuses were tied directly to the dosages the doctors in their sales territory prescribed. The higher the dose, the more money the sales rep would make. (Why? Because a higher dose would almost ensure addiction and thus more sales.)
• Sales reps had to report to their bosses within twenty-four hours if one of their doctors prescribed a low dose.
• Insys purposely directed its marketing efforts to doctors with a history of prescribing large amounts of opioids.
• Insys pursued doctors and medical providers who were considered “pill mills.”
• Insys also pushed insurance companies to cover the cost of the drug for the patients they insured. These costs often reached thousands of dollars per month for a single patient.
• In 2015, two jackasses who worked for Insys produced a rap video cheerleading for increased sales of the fentanyl product. (The US Department of Health and Human Services estimated that in 2015, 12.5 million people abused prescription opioids, causing over 33,000 deaths.)
• Insys generated annual sales of $300,000,000.00.

Insys is not the only bad actor. Not even close. Investigations are underway against the Sackler family, founders of Purdue Pharma, makers of Oxycontin, and private doctors have been criminally charged with taking kickbacks from opioid manufacturers. There is no doubt that more criminal prosecutions and thousands of civil lawsuits will occur in the coming months and years. The opioid epidemic has been a massive failure of the American people, and corporate greed is at the center of it all.

Opioids are synthetic forms of opiates. Opioids are manufactured chemicals that operate in a similar way to opiates like morphine. Opioid products include OxyContin, Vicodin (hydrocodone), and Fentanyl. While temporarily effective at relieving pain, opioids can be extremely addictive and often lead to overdoses and deaths.

If you or a family member has been a victim of opioids, you are welcome to call me to discuss: (919) 830-5602. Either way, good luck.

Note: Information in this post came from several news sources, including NPR, The New York Times, other newspapers, and my previous posts.

Despite the addictions, injuries, and deaths, and despite reports of awful business practices by the makers of these prescription painkillers, defense lawyers have developed certain legal defenses to help these drug companies avoid liability. Let’s look at a few:

The FDA Approved the Drug, So It’s the Government’s Fault

This is a tough one. Essentially, the drug companies proclaim: the FDA approved the opioid product for manufacture and sale, so we can’t be liable for claims such as defective design. If opioids were a problem, they argue, the FDA should not have approved the drug for sale in the first place.

I have struggled with this defense for years. For one, the FDA is one government agency, and it is tasked with overseeing the review and approval of all new drugs, as well as monitoring practices among drug companies after approval. Plus, and although it shouldn’t be, the FDA inevitably becomes political, and depending on the administration, the policing efforts can range from effective to cozy with drug companies. In political climates with relaxed enforcement, problem drugs can reach the market.

The solution: the FDA must remain independent, and protected from political influence, and serious and competent people must run the operation. If that can happen, this defense would hold more weight.

The Learned Intermediary Doctrine, So It’s the Doctor’s Fault

A drug maker has a duty to warn patients about the risks of its drug. If the drug label is inadequate, leaving out vital information, the person injured by the drug can bring a claim for failure to warn. However, if the label lists all the risks (even if a key risk is buried deep in the package insert) the drug company can often rely on a defense known as the learned intermediary doctrine. This means a manufacturer is not liable for a high-risk prescription drug if the risk was placed on the label and technically made available to the patient’s doctor (the “learned intermediary”). In these cases, the duty to warn shifts away from the drug company and to the physician, who is supposed to give the patient a full explanation of the benefits and risks of the medication he prescribes.

The problem is this: in many cases general practitioners don’t know all the risks of a certain drug. And really, how could they? Doctors must stay current on all kinds of illnesses and conditions, and they can’t be expected to know granular detail of every drug on the market.

I’ve never liked this defense. Of course, I represent individuals injured by defective medical devices and drugs, so I guess it is predictable that I wouldn’t like it, as it can cause me and my clients certain difficulties. But aside from my potential professional bias, the learned intermediary doctrine is a flawed defense, mainly because it occasionally allows drug companies to escape truly negligent and harmful behavior.

The Patient Misused Opioids, So It’s the Victim’s Fault

This defense can be very effective, and in many ways it is galling. A drug company puts a highly addictive drug on the market, pushes the drug in marketing campaigns and in aggressive one-on-one meetings with doctors to push prescriptions, and then, when the patient becomes addicted and misuses the product, the drug company points to the bad behavior as an affirmative defense. And it often works. The alleged misuse can take many forms: taking the drug after recovery from the underlying injury is complete, or, after addiction has set in, attempting to procure opioids from different doctors or for made-up health reasons. Now granted, many people can and have abused these drugs. I get it. But it is a complicated matter when you are dealing with an addictive prescription medication like opioids.

The Statute of Limitations Has Run, So It’s the Calendar’s Fault

I have written about the statutes of limitations many times on this site. As a plaintiff’s lawyer, the statute of limitations haunts my dreams like The Lone Biker of the Apocalypse in Raising Arizona. The statute of limitations is a law limiting the time you may bring a lawsuit for personal injury. In each state you have a certain number of years from the injury, or the date of discovery of the injury, to file a complaint in court. In opioid cases, plaintiffs argue that the court should use the “discovery rule,” which states that the limitations period cannot begin to run until the plaintiff knows or should have known about the specific injury. As you can imagine, however, vicious fights occur in court about the start date for many statutes of limitation.

Now you be the lawyer: what arguments can you make to overcome these defenses? What weaknesses do you see in these defenses? Feel free to email me your thoughts. Or call me to discuss further.

Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses. In response to this tragic loss of life and the economic strain placed on many state and local governments, several lawsuits have begun.

What Exactly Are Opioids?

Opioids are synthetic or semi-synthetic forms of opiates (like morphine). Opiates are derived directly from the poppy plant while opioids are manufactured chemicals that are very similar to opiates.

Opioids are used as painkillers and prescribed to patients to treat a variety of medical conditions where moderate to severe pain is a concern. Commonly prescribed opioids include:

• Oxycodone (OxyContin)
• Hydrocodone (Vicodin)
• Fentanyl

Opioids are effective at relieving pain, but unfortunately, they are extremely addictive and often lead to overdoses and the use of stronger (and more dangerous) illicit drugs. The causes of the opioid epidemic are complex, but one approach to combating it is to seek relief in the courts by going directly after the opioid makers.

The Basis for Opioid Lawsuits

Both individuals and local governments have sued the pharmaceutical companies under a variety of legal theories, although they are often based on the idea that the makers of opioids downplayed the risks of opioids while exaggerating their benefits.

These lawsuits are in new legal territory, but parallel some of the earlier lawsuits where states sued Big Tobacco and firearms manufacturers for the number of deaths and the financial toll their products were taking on the general population and state budgets.

If the opioid lawsuits have the same ending as the lawsuits against cigarette companies, states and municipalities may be able to help pay for fighting and treating the opioid crisis. For example, when the lawsuit against Big Tobacco settled, it resulted in the largest civil settlement in history, amounting to tens of billions of dollars. Continued payments are made by cigarette companies forever to help states treat their sick citizens suffering from tobacco-related illness and disease.

However, the opioid lawsuits face potential challenges that may not guarantee victory. For example, the opioid crisis has many causes, not just the pharmaceutical companies allegedly marketing their opioid products incorrectly.

For example, opioid abuse is the result of doctors who are overprescribing opioids and (questionable) scientific studies incorrectly concluding opioids were non-addictive. In addition, many of the abused opioids are obtained illegally by users and prescription medication distributors often don’t halt suspicious orders for opioids. Despite these challenges, there have been early successes in the opioid litigation.

For example, in 2004, the state of West Virginia settled its lawsuit against Purdue Pharma, the makers of OxyContin, for $10 million. And in 2007, Purdue Pharma agreed to pay $130 million for future civil lawsuit settlements brought by private parties, such as patients who were prescribed OxyContin.

Current Status of Opioid Lawsuits

Recently, many of the opioid lawsuits have been brought by government plaintiffs, such as states, counties and cities. Several of these plaintiffs include:

• The state of Ohio
• Cherokee Nation
• The city of Everett, Washington
• Santa Clara and Orange counties in California
• Orange, Nassau, Broome, Erie and Suffolk counties in New York
• The city of Chicago, Illinois

Most of these lawsuits have been brought within the past few months, so we need more time to see the direction they will take. Regardless of the outcome of these cases, the mounting pressures from the opioid crisis is starting to make a difference in other ways.

For example, in June 2017, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to voluntarily pull one of its opioids, Opana ER (oxymorphone hydrochloride) from the market. The FDA made this recommendation on the basis that Opana ER was being abused in ways where the benefits from having the drug available in the market were outweighed by its risks. For example, Opana ER was being manipulated so that it could be injected. Besides the obvious addiction and overdose risks, this new method of abusing the drug created outbreaks of diseases, such as HIV and hepatitis C.

I suspect opioid lawsuits will increase dramatically over the next few years. With opioid litigation having only just begun, stay tuned to this blog for any additional updates.