A landmark ruling by a judge in Oklahoma, USA, awarded the state record damages of $572m (£468m) from the manufacturer of synthetic opioids like oxycodone and fentanyl patches, Johnson & Johnson (J&J). With an estimated half a million Britons now hooked on synthetic opioids too, Weightmans' Richard Burrows explores the potential for litigation in the UK.
Opioids
Synthetic opioids are now widely regarded to be the root cause of an epidemic of painkiller addiction in the USA. It has cost thousands lives, at an increasing rate since recent attempts to tighten prescription policies has pushed addicts onto illegal narcotics, like heroin, and had a hugely detrimental impact on families and entire communities.
The attorney generals of states, local governments and Native American tribes are concentrating their efforts on pursuing manufacturers, distributors and even retailers like Walmart as the targets of litigation. The Oklahoma ruling will have emboldened many others across the US and has sparked speculation this side of the Atlantic that a wave of litigation may come crashing over the pharmaceutical industry here.
Differences between the UK and US healthcare systems, let alone legal systems, could not be starker. But litigation here is not just conceivable but likely, especially as we find ourselves in the grip of an addiction crisis too.
Legalised heroin
The benefits of opioids have been known for centuries. The ancient Greeks and Romans were the first to discover their powerful pain-relieving qualities. Later, in 1803, the first extraction of morphine from opioids took place and the synthesis of heroin followed in 1874. It was initially used for medicinal purposes in 1898, and only five years later, heroin abuse became recognised as a problem in the USA. It was outlawed in 1914, and much of the rest of the world, shortly after.
While morphine has continued to be used as a painkiller, drugs companies began to develop new synthetic alternatives. Just like heroin and morphine, these were highly effective painkillers. But the difference, their makers claimed - though in decreasing degrees since their launch - was that they were not meant to be as addictive and so, in theory, could be prescribed more freely.
Except they weren't. People rapidly developed addictions to synthetic opioids and, because of the lower threshold of ailments doctors prescribed them for, an epidemic in the US, and now the UK, ensued.
Trouble in America
The scale of the opioid addiction problem in the US and the recent ruling against J&J has fuelled speculation that the scale of litigation against so-called 'Opioid Inc' could reach the heights of those pursued against Big Tobacco.
There's a reason why people draw this comparison. In America, its private healthcare system creates an environment where pharma businesses deliver multi-million dollar above the line advertising campaigns for drugs targeting everyday consumers. At the heart of the claims against manufacturers involving opioids are allegations that the adverts misled users, and doctors, over the safe consumption of the same, leading to addiction.
More than this, it is alleged Big Pharma paid for experts and physicians to publish papers and speak at conferences extolling the virtues of synthetic opioids as effective painkillers, without disclosing how they were funded and in fact making it appear as if they were independent.
America's legal system awards significantly higher damages sums than its UK counterpart. Unlike in the UK, trials are held by jury - making the emotive nature of cases like addiction arguably more compelling. The sums payable can be astronomical.
But the Oklahoma case isn't new. Back in 2004, Purdue, manufacturer of the now notorious OxyContin, settled a case alleging inappropriate marketing for $10m. The difference then, as in many similar cases that followed since, is that they were settled before trial. In Oklahoma, the state made its case against J&J on grounds of public nuisance, a law typically enforced against people such as the owners of brothels, which J&J decided to fight. But by losing its battle in the courtroom, there is a view that the floodgates could now open.
Over in the UK, I've no doubt that claimants' solicitors will have sat up and taken notice.
Meanwhile, in Britain
A Public Health England enquiry revealed the scale of opioid consumption in the UK in September, with prescriptions now being handed out to one in eight of the adult population.
Even before this latest estimate, we knew in 2017 that the number of people with prescriptions had increased by 10 million since 2007.
Behind only Israel and Slovakia, the UK has seen the fastest growth of people across the world seeking professional help for opioid addiction.
There's also a worrying regional disparity in prescription rates. Socioeconomic factors appear to influence the prescription rates of opioid-based medication, with Blackpool and Teesside, as well as Swansea in Wales, boasting the highest prescription rates in the country. These prescription and addiction rates far outstrip those per capita in London and the Home Counties. This suggests the prescription system is not functioning as it should. There is also a correlation between prescription rate and deaths from opioid overdose in these areas too.
These worrying trends, official investigations in the UK, like The Gosport Inquiry in 2018, and allegations made against British pharma business, Indivior, create fertile ground for potential litigation on these shores.
UK pharma (and others): brace for action
The UK's claimant solicitor sector has made an industry from whiplash, noise induced hearing loss (NIHL), PPI and package holiday claims. Its major players will likely be active in looking at the data on UK addiction and prescription rates and we would anticipate them marketing for claimants soon, as with the VW emissions scandal.
While the kind of mass class action common in the US is less common in our system, as well as the huge sums paid out, group litigation is still possible such as the group litigation order (GLO) for silicone breast implants.
What would their line of attack be? And who exactly will they target?
The differences between our healthcare system and the American one is as wide as the ocean the separates us. In the UK, claims would be brought under the law of tort, specifically manufacturing negligence around product liability. Any product-based litigation relating to the 'safety' of opioid-containing medication would probably be under the Consumer Protection Act 1987.
Synthetic opioids' addiction risks have been known for a long time now. But did UK-based pharmaceutical manufacturers, or distributors, warn GPs, or patients, through clear labelling and product information? What guidance was given on how much to prescribe and for how long, given what was known? Could things like blister packaging have been introduced sooner? These are the key considerations that manufacturers need to reconcile.
It is a situation analogous with the far-reaching use and reliance upon asbestos - something promoted as a wonder material and marketed as such even after its manufacturers allegedly knew of the risks.
There's some evidence to suggest similar transgressions in the UK with opioids. Examples reported in UK media include patients being given repeat prescriptions for two years without needing to revisit their GP. Even the commonly prescribed contraceptive pill requires more contact than this. In another case, a single GP had 10 patients addicted to synthetic opioids.
The Royal College of GPs is now very clear on its guidance that doctors should give the lowest possible dose for the shortest period. It's what manufacturers now say that matters.
What comes next
The crisis has claimed its first corporate casualty in the US. Purdue declared itself bankrupt in September after agreeing compensation packages totalling $10 billion. Some US states have challenged this as they believe it's undervalued. Bankruptcy protection effectively prevents further litigation, in the same way companies that are in compulsory liquidation in the UK cannot face claims without permission from the High Court.
If manufacturers, distributors and even GPs haven't acted now they need to. Ensuring clear instruction, guidance, labelling and information is essential to showing that they're alive to the risks of opioid addiction. Anything they can do to show they're helping counter the UK's rising epidemic might also help in the court of public opinion.
Richard Burrows is a solicitor at Weightmans LLP, a national law firm and defendant solicitors.