US opioid ruling redraws the lines for Big Pharma

Turn on a TV set or YouTube video in America today and it won’t take long before you’ll encounter a drug company’s ad telling you how their product can help you live a better life.

There's a turkey stirring a pot in the ad for Chantix, a prescription medicine for those who want to quit smoking. You'll hear the 1975 hit Magic play over an ad for Ozempic, a diabetics drug. Then there's Truvada, which claims to reduce the risk of contracting the HIV-1 virus.

Like cars and fast food, pharmaceutical drugs are front and centre in public life in the US, a country that consumes prescription opioids at a greater rate than any other. Spending in drugs and medicines in the US reached $485 billion (€438 billion) in 2018, accounting for more than 40 per cent of the global market, according to the IQVIA's Institute for Human Data Science.

So this week's ruling at a court in Oklahoma that Johnson & Johnson must pay the state $572 million (€517 million) to fight the opioid epidemic has rightly been described as a landmark case for states, counties and local municipalities in the throes of legal action around the country.

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The lawsuit, taken by Oklahoma's attorney general Mike Hunter, claimed that over-aggressive marketing by J&J and its subsidiary, Janssen Pharmaceuticals, helped create an opioid crisis that has taken around 6,000 lives in the state. Hunter initially sought compensation of $17 billion (€15.3 billion), and J&J's share price rose when the judge announced his ruling, such was the expectation among investors that the pay-out would be considerably more. The fine covers the cost of providing services for opioid addicts for only one year, a point criticised by many activists.

J&J’s lawyers say the company intends to appeal the ruling.

"This is the first opioid lawsuit to go to trial. [In the past] there have been lots of settlements, but no trials," said Prof Elizabeth Burch of the University of Georgia Law School. "It was televised and transparent – both of which are good things overall."

The public had access to an “astounding amount” of evidence on both sides, she said – 33 days of trial testimony, 874 exhibits and 42 witnesses. “So much of the litigation [unitl now] has remained under seal in the MDL (multidistrict litigation) or has been redacted, that this was the public’s first glimpse under the hood.”

Big Pharma

The precedent has sent ripples through the world of Big Pharma. A day after the Oklahoma ruling, Purdue Pharma, the producers of the painkiller OxyContin and MS Contin, and which is owned and controlled by the Sackler family, offered to settle myriad claims it faces for between $10 billion and $12 billion (€9 billion – €10.8 billion). It would still leave the Sacklers, who made their fortune through the sale of the opioid painkillers, with billions in the bank. In March, Purdue settled with Oklahoma for $270 million (€244 million).

When abused, OxyContin, a narcotic painkiller that contains the opioid analgesic oxycodone, produces highs similar to heroin when crushed and snorted or injected.

The lengths pharmaceuticals have gone to get their product in front of pain-weary Americans has only come to light in recent years. In 2017, CBS News reported how Insys Therapeutics, the makers of a potent fentanyl painkiller for cancer patients called Subsys, made payments of more than $2 million (€1.8 million) to 18,000 doctors, recruited physicians with dinners at lavish restaurants and paid them for fake speaking engagements. In June, Insys filed for bankruptcy following a $225 million (€203 million) settlement with the US justice department.

Several Ireland-domiciled pharmaceuticals have found themselves caught up in the ongoing legal battles.

Mallinckrodt Pharmaceuticals, which in recent years invested €95 million at its facility in Blanchardstown, saw half a billion of its oxycodone pills distributed in Florida between 2008 and 2012. A US Drug Enforcement Agency (DEA) investigation found that Mallinckrodt should have flagged the huge rate of orders as suspicious, but didn't. But when the DEA handed over its findings to the US justice department, the latter settled with the company for a $35 million (€31.6 million) fine – about a week's income for Mallinckrodt, according to CBS News.

With revenue of almost €3.16 billion, Endo International plc has also found itself in the spotlight this month. On August 20th, the Ballsbridge-headquartered pharma giant announced it would pay $10 million (€9.04 million) to two counties in northern Ohio and provide up to $1 million (€904,000) more worth of drug products (all the while avoiding any admittance of wrong-doing). In June 2017, the US Food and Drug Administration (FDA) requested the removal of Endo's reformulated Opana ER drug, an opioid painkiller, from the US market.

The FDA acted “based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation [in 2012].” The Irish company became the first to see its product removed from sale by the FDA explicitly due to fears of abuse by the public.

Both Mallinckrodt and Endo remain in the firing line as 2,000 opioid cases are consolidated into the first federal legal action on the issue in Cleveland, Ohio in October, along with another Irish-domiciled pharma company, Allergan.

Particularly prevalent

US communities have experienced high over-prescription rates since as far back as the 1990s. Opioid use and addiction is particularly prevalent in industrial regions such as the Midwest, where factory workers often find themselves facing chronic pain after years of physical, repetitive work.

For years, doctors running pain clinics or “pill mills” as they were called, distributed enormous amounts of painkillers. It was a particular feature of the system in Florida, before the majority were shut down in the past five or so years. But their closing failed to solve the problem. Some, in fact, believe that’s when things got much worse.

Denied prescriptions, users quickly turned to illegal ways to feed their addiction largely through highly addictive Mexican fentanyl often cut with heroin. As tolerance levels among users increased, powerful carfentanyl, most commonly used as an elephant tranquilliser, began entering rural and urban communities across the region, leading to a spike in the death toll.

If the Midwest is the part of America worst-afflicted by the opioid crisis, Dayton is arguably its weary capital. Ohio's fourth-largest city saw fatalities from accidental overdoses quadruple between 2010 and 2017 when deaths reached 577 people. For a time, the overwhelmed city morgue had to store bodies in refrigerated trucks.

At the height of the crisis in the summer of 2017, pharmacies in the city were forced to store controlled substances in time-delayed safes to prevent robberies. One Dayton doctor has been accused of writing prescriptions for 1.75 million pills in a two-year period. Dayton has since managed to almost halve the number of opioid-related deaths and overdoses.

Lacklustre response

Federal government has been criticised for its initial response to the crisis, particularly during the Obama years, with it being compared to the lacklustre response from Washington to the AIDS epidemic in the 1980s. For years, and as recently as 2016, there was almost no funding set aside for opioid treatment in the federal budget.

Efforts to change that surfaced in December 2016 when the 21st Century Cures Act designated $1 billion (€904 million) in grants for states to fight the opioid epidemic over a two-year period. Last October, as the nationwide death toll from opioid use rocketed to one fatality every 11 minutes, US President Donald Trump signed the Support for Patients and Communities Act to make more funding available for opioid addiction treatment.

Around 400,000 people are thought to have died in the epidemic.

Aside from becoming the first opioid case involving a major pharmaceutical to be settled in court, the Oklahoma suit was the first to deploy the public nuisance law, a century-old statute that allows states to take claims against individuals or entities deemed to threaten the public’s health.

Using the public nuisance provision is a tactic that current and future opioid-related lawsuits across the country are now likely to pursue, including the consolidated case involving 2,000 cities, local municipalities and Native American tribes set for trial in Cleveland in October. However, even if the Oklahoma ruling withstands appeal, public nuisance laws in other states are more tightly worded and may not prove applicable to pursuing drug companies over alleged opioid marketing abuses.

For their part, the pharmaceutical companies are unlikely to take the ruling lying down. "No Oklahoma court has ever done what this court has done today in applying public nuisance law to any commercial activity, let alone the highly regulated area of prescription medicines," warned Johnson & Johnson attorney Sabrina Strong immediately after the Oklahoma ruling.

Experts warn that as much of a breakthrough the J&J ruling is for Oklahoma, outside the state some may afford it more weight than it actually merits.

"Going forward, of course, plaintiffs and defendants will argue that their case is/isn't analogous to what happened in Oklahoma," says Prof Burch of the University of Georgia. "But it's important to keep the limits of that case in mind … This is one defendant (J&J), who has only two products (Duragesic and Nucynta), one state attorney general (Oklahoma), and one claim (public nuisance). It will be appealed, and that appeal will go before judges who, like judge Thad Balkman who heard the Oklahoma case, are elected."

Defendants, Prof Burch suggests, will likely attempt to point their fingers at one another and suggest blame lies elsewhere.

From the legal perspective, there’s still plenty of muddied water to wade through. “Sure, we’ll see analogies, particularly to the public nuisance law, but nothing about the Oklahoma decision will be controlling,” says Prof Burch. “Appeals are likely to play an important role here, too. And I suspect J&J’s appeal will centre on the public nuisance law’s scope given that this is a bench trial and not a jury trial.”