DRUGS AND SUPPLEMENTS

States Are Fighting Opioid Sellers

By Temma Ehrenfeld @temmaehrenfeld
 | 
September 19, 2023
States Are Fighting Opioid Sellers

Who is responsible — and should pay — for the consequences of the painkiller crisis? States are fighting back, many of them together. Here's what you should know.

The opioid crisis has cost billions in tax dollars — and the fight isn’t over. But some money is coming from legal settlements with companies that profited from selling painkillers.

The precedent came with the lawsuits against tobacco companies, which linked smoking with lung cancer and other undisclosed risks. The cost of the opioid costs promises to be much higher in a shorter time than those related to deaths over decades from smoking.

 

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A deluge of lawsuits forced Purdue Pharma, the company that heavily marketed OxyContin as a safe pain medication, into bankruptcy. Looking for ways to cover costs, many states agreed to a settlement allowing the company to restructure and protect its owners, the Sackler family, which has not filed for personal bankruptcy.

But a handful of those hardest hit states challenged the protection for the Sacklers, which increased the offer from $4.5 to $6 billion.  

The hold-out states have now said they’ll take the deal. The Biden administration, however, continues to challenge the settlement, arguing that bankruptcy laws are intended to help entities in financial distress and noting that Sackler family members withdrew $11 billion from Purdue before agreeing to pay $6 billion in the settlement. The family admitted no wrongdoing and has kept much of its fortune.

The U.S. Supreme Court has agreed to hear the challenge in December.

The case against the painkiller industry

Under the U.S. legal system, it is unlawful to misrepresent your product, hiding known dangers. What exactly did manufacturers know about how easily opioids lead to addiction in chronic pain patients? Did their salespeople mislead doctors?

Distributors, on the other hand, operate under rules meant to keep their products out of the black market. Did they live up to that duty?

Thousands of lawsuits have raised those questions and others. In an early big success, a committee of state attorney generals banded together and negotiated with major industry players. In 2021, a coalition announced agreements with manufacturer Johnson & Johnson and the three major distributors — Amerisource Bergen, Cardinal Health, and McKesson.

In return for $26 billion over time, beginning in 2022, and a promise of changes in practices, most of the states agreed to settle all legal claims with the parties stemming from actions that fueled the epidemic. Most of the money will go towards opioid treatment and prevention, with distribution tilted towards the hardest-hit states.

The 10-year agreement means the distributors must establish a centralized independent clearinghouse with data available to state regulators, showing where drugs are going and how often. They must have new data-driven systems to detect suspicious opioid orders from pharmacies and report and terminate orders that suggest the drugs will be sold on the black market. Senior officials will be held responsible for the results.

Johnson & Johnson can no longer sell opioids or lobby or promote opioids and must share its clinical trial data.

In a separate action, the large business consultants, McKinsey & Company, agreed to pay $573 million to settle claims that it advised industry players to promote and profit from dangerous uses of their product.  

Other companies that have reached deals include Teva and the  pharmacy chains CVS, Walgreens, and Walmart

Are painkillers still the problem?

It’s important to understand that opioid deaths have come in three waves. The problem began in the 1990s, with doctors overprescribing painkillers. Deaths from the use of painkillers have increased since 1999.

The peak in prescriptions came in 2010, according to the Centers for Disease Control and Prevention (CDC). Under new federal restrictions, and a better understanding of the risks, doctors are writing fewer prescriptions and lowering the average dose. In 2016, when the CDC issued a guideline for primary care doctors, it stated that there was insufficient evidence to back the usefulness of opioids long-term for chronic conditions like unexplained back pain — rather than pain linked to cancer, or a recent injury or surgery.

But the damage remains. Some 3 million Americans have an opioid addiction. As many as one in four chronic pain patients who received opioids may have developed a problem.

At the same time, painkillers easily flowed into the black market, which made opioids easy to get illegally, for recreational use and for people who could no longer get prescriptions from their doctors.

In 2010, overdose deaths involving heroin began, as opioid users turned to that drug (also an opioid), to soar. Three years later, illegally manufactured fentanyl hit the black market as an additive to many drugs, bringing on more deaths. Fentanyl is cheap and deadly and can show up in heroin, cocaine, and even marijuana.

Today’s tragedy came in a cascade of effects. The settlements are making a dent in costs, but it’s not known how large those costs will be.

Has the industry sufficiently taken responsibility? Who pays the bill?

 

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Updated:  

September 19, 2023

Reviewed By:  

Christopher Nystuen, MD, MBA and Janet O'Dell, RN