Taking Legal Action Against Big Pharma

Defective Drugs
Opioid Epidemic

By Sean Lally, Staff Writer

The National Center for Health Statistics recently released numbers pertaining to the opioid epidemic, revealing that the crisis has only gotten worse since 2015, when nearly 33,000 people died of opioid-related overdoses. According to the recent report, there were nearly 64,000 fatalities related to drug overdoses in 2016 – a big jump from 52,000 in 2015. Of those, 14,400 were linked to opioid pain relievers (OPRs), 20,100 were related to synthetic opioids such as fentanyl, and 15,400 were tied to heroin. This is significant, especially because, according to a JAMA Network study, 75 percent of heroin abusers started with pain medications.

The Campaign

Big Pharma may be one of the most obvious sources of this ever-growing crisis. In the late 90s, companies like Purdue marketed OPRs as the ultimate remedy for chronic pain, an ailment affecting nearly 100 million people at the time. Between 1996 and 2002, Purdue (a company owned by the Sackler Family) commenced an immense campaign to push OPRs onto the market. The company started nearly 20,000 “pain-related educational programs,” and poured funding into organizations like the American Pain Society who pressured physicians to prescribe OPRs for the treatment of non-cancer chronic pain and who severely downplayed the risk of addiction.

Legal Action

The concerted effort by Big Pharma to saturate the market with OPRs has been the source of recent litigation against those companies. Victims, municipalities and states, from all over the country, argue, broadly, that major pharmaceutical corporations aggressively marketed highly addictive drugs knowing full well that those medications came with great risks – namely, that OPRs are highly addictive and would create drug dependencies for many users. It isn’t difficult to believe these allegations, as, in 2012, 793 million doses were prescribed in Ohio alone. Additionally, according to an LA Times report, Purdue marketed OxyContin as a 12-hour pain reliever, even though it knew that that duration was bogus. Nonetheless, plaintiffs in OPR-related lawsuits will have many hurdles to jump.

Difficulties with Legal Action

Ken Feinberg, a seasoned attorney who handled cases ranging from the BP Oil Spill to the Boston Marathon, told Fortune that opioid-related lawsuits face a lot of obstacles because, technically, Big Pharma never violated the law – the medications are FDA-approved, after all – and these companies aren’t directly selling the drug to the consumer, as there are a lot links in the supply chain dividing the manufacturer from the patient.

Growing Number of Lawsuits

Despite Feinberg’s warnings, many lawsuits have been filed in a number of different contexts. The Cherokee Nation filed claims earlier this year in a tribal court, targeting both Big Pharma companies and distributors. Everett, a city in Washington, filed a suit against Purdue in January. In that suit, plaintiffs claim that the company knew that OPRs were being sold on the black market and let it happen anyway. And more recently, Washington Attorney General Bob Ferguson filed claims against Purdue, asking for civil penalties and damages, and requesting that Purdue forfeit all profits gained (in Washington) by way of its allegedly illegal activity.

Sam Quinones, who wrote Dreamland: The True Tale of America’s Opiate Epidemic, told The Atlantic, “What you’re getting now is a lot more legal minds across the country focusing on this, and figuring out how to pay these huge bills,” continuing, “Everyone is groping for a legal theory that will work in court.”

Which Theory?

Litigators recognize that they face steep odds as they attempt to take on pharmaceutical behemoths who have their hands in the pockets of regulators and politicians nationwide. Plaintiffs need to overcome more than just a disparity of resources. The case history tells a pro-pharma story that will be difficult to overcome. Appeals to negligence, product liability (including defective product and insufficient warning label claims), and negligent marketing (among other theories) have yielded mostly negative results for plaintiffs, according to a West Virginia Law Review paper.

There may be some hope in the lawsuit filed in Mississippi, where plaintiffs argue that Purdue robbed Medicaid of millions of dollars by concealing the “true status of their respective drugs from the state’s Medicaid agency.” Attorneys representing the state of Mississippi and other states and governmental agencies appear to have valid legal theories, it is just a question of whether juries and judges will see it that way.

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