A California Court has ordered Monsanto to pay $2.055 billion in damages to two individuals diagnosed with non-Hodgkin lymphoma (NHL) over allegations that the company failed to warn consumers that exposure to glyphosate in Roundup weed killer could cause the disease.

This is the third consecutive trial where Monsanto has been ordered to compensate NHL victims with the total compensation amount arising from the three proceedings currently standing at $2.424 billion, subject to further appeals. There are over 13,000 Roundup related cases pending in US Courts.

This alert looks at the most recent US litigation, the emerging regulatory treatment of glyphosate in other jurisdictions, and the implications these events may pose for the development of regulation in Australia.

What is glyphosate and what does the science say?

At the outset, it is important to consider the chemical nature of glyphosate and contrast this with emerging contaminants such as per- and poly-fluroalkyl substances (PFAS), which have been the focus of recent Australian litigation and regulatory reforms, as reported in our previous updates (from October 2017 and March 2018). PFAS has been in the spotlight because of its strong carbon-fluorine bonds which has raised concerns as to its persistence in the environment. In contrast, glyphosate has a weaker carbon-nitrogen-phosphonate chemical chain, is able to be broken down by microbes, and only has a half-life in soil of between 1 to 174 days.

Glyphosate is the most commonly used herbicide globally and is the active ingredient in Roundup and other popular weedkillers. Many crops are genetically engineered to be tolerant to glyphosate, which has led to its widespread use in agriculture. The substance is strongly attracted to organic content within soil, such that little is expected to leach from the applied area or be transferred to adjoining land by rain or irrigation water. Metabolism studies conducted in the late 1990s indicated that glyphosate residues have minimal tissue retention and are rapidly eliminated from various animal species including mammals, birds and fish.

The UN’s Food and Agriculture Organisation and the World Health Organisation have approved the chemical, concluding that it is “unlikely to pose a carcinogenic risk to humans from exposure through the diet”. However, the International Agency for Research on Cancer suggested in 2015 that glyphosate was “probably carcinogenic to humans” based on experimental animal studies indicating that chronic exposure to the chemical could contribute to DNA damage.

Recent US jury trials

There have now been a number of cases run in the US against Monsanto relating to its failure to warn consumers about cancer risks associated with Roundup exposure. The trials have raised various allegations of corporate misconduct, including manipulation and corruption of scientific records, and in the most recent case, influence on regulatory agencies.

On 14 May 2019, a Californian jury ordered Monsanto to pay $2 billion in punitive damages to an elderly couple who had been using Roundup on residential properties since the 1970s, plus another $55 million in damages for hospital bills and pain and suffering (Pilliod Trial).

The jury determined that exposure to Roundup was the underlying factor which caused the Pilliod couple to develop NHL, finding that:

  • Roundup was defectively designed;
  • Monsanto had failed to warn consumers of the cancer risk; and
  • the company acted negligently in doing so.

It is likely that the damages in the Pilliod Trial will be reduced on appeal, as the ratio of punitive to compensatory damages awarded exceeds maximum limits set by previous US Supreme Court rulings.

It should be noted that the Pilliod Trial was a jury trial, and there was no judicial consideration of the merits of the evidence or the persuasiveness of the causation case linking glyphosate to cancer.

The experts appearing on behalf of the claimants presented the opinion that while studies conducted to date had been limited in terms of scope and sample sizes, a causal link between Roundup and NHL could be credibly inferred based on:

  • epidemiologic studies linking glyphosate exposure, especially exposure more than 10 years prior to a cancer diagnosis, with an increased risk of contracting NHL;
  • studies suggesting that exposure to glyphosate could trigger kidney tumours and lymphomas in certain species of mice and rats; and
  • data demonstrating glyphosate could be absorbed through human skin after direct exposure.

The claimants’ experts were also highly critical of the US Environmental Protection Authority’s (US EPA) May 2019 findings that glyphosate was not a carcinogen and that there were no public health risks when glyphosate was used in accordance with labelled instructions. The experts claimed that the US EPA had ignored and/or failed to give sufficient weight to animal studies.

No studies were presented as to the distribution of glyphosate in systemic tissues other than blood after direct ingestion, and environmental exposure more broadly was not an element of the trial.

The Pilliod Trial followed two other similar Californian cases in which there were initial awards of $289 million to a groundskeeper and $80 million to another man who used Roundup on his property. Bayer, Monsanto’s parent company, has announced its intention to appeal both of these cases along with the Pilliod decision.

To date, all the US cases have been brought by individuals against Roundup’s manufacturers. No cases have been brought against suppliers or land owners in relation to downstream impacts (i.e. land contamination).

What trends are emerging overseas?

Glyphosate has been subject to differing regulatory reactions overseas. A number of jurisdictions have imposed complete or partial bans on the use of glyphosate due to the perceived risk it poses, while others have taken a more measured approach and are awaiting definitive scientific findings. However, a key challenge to regulating against glyphosate use is the lack of an equally effective alternative. A ban on glyphosate could subject farmers to a significant increase in production costs and may lead to less effective, and possibly more harmful, products being used in larger quantities.

In late 2017 the European Union (EU) voted to renew glyphosate’s licence for 5 years, despite widespread calls for a ban. While the European Chemicals Agency concluded that glyphosate was not a carcinogen, EU countries such as Germany, France and Belgium have commenced legislating against the use of the product.

All non-commercial glyphosate use is banned in the Netherlands and France’s Ministry of Agriculture has developed an action plan to put an end to the main uses of the herbicide, “where alternatives exist”, by the end of 2020 and for all uses by 2022.

Outside the EU, reactions remain varied. Sri Lanka initiated a complete glyphosate ban in 2014, however this ban was lifted in mid-2018. Recently, Vietnam has declared a ban on imported herbicides containing glyphosate.

On the back of the litigation in the US, the New Zealand Environmental Protection Agency (NZEPA) was asked to consider adding glyphosate to its hazardous substance reassessment list in August 2018. The NZEPA chose not to add glyphosate to the list, maintaining that the chemical was safe to use in accordance with labelled instructions.

Implications for Australia

Over $400 million of glyphosate based products are sold in the Australian market each year.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) considers glyphosate to be safe in accordance with labelled instructions and a recent Senate inquiry[4] found no issues with the assessment methodology used to reach this determination.

However, the APVMA’s approval of the substance is not a bar to litigation and there is a possibility of claims, including possible class actions, based on similar premises to the ongoing US litigation being brought in Australian courts, with test cases possible either relating to direct use or downstream impacts. Nevertheless, it is highly unlikely that an Australian court would award damages of the magnitude seen in the US cases, as punitive or exemplary damages to punish a defendant are not routinely awarded in Australia. Further, satisfying the legal tests for negligence and causation before a judge is likely to be more difficult than convincing a lay jury. Failure to warn cases are also relatively uncommon in Australia.

At the same time, some local government authorities have moved to reduce reliance on glyphosate herbicides following the US litigation, and Cancer Council Australia has called for a formal independent review of glyphosate’s carcinogenicity. Continued publicity around the risks associated with glyphosate and adverse findings made in the course of US litigation may compel Australian regulators to reconsider their position.

Given these trends, users of glyphosate based products need to be aware of potential risks and actively monitor the emerging regulatory landscape. Close attention should also be paid to company insurance policies, in particular exclusion clauses that may potentially exclude or limit liability relating to glyphosate use.

To date, all US cases have been brought against manufacturers and not users. If actions are brought in Australia, corporate users may be able to limit their exposure to claims for concurrent or contributory liability by:

  • ensuring they strictly follow manufacturers’ instructions for use;
  • complying with protocols in Material Safety Data Sheets; and
  • developing appropriate risk management plans for employees who apply glyphosate including requirements for the use of proper protective equipment.

Australian users of glyphosate should carefully monitor regulatory developments both here and abroad and re-evaluate risk positions at regular intervals.