The Latest Weight Loss Craze Litigation

In the last three years, the diabetic drug now widely known as “Ozempic” has become a new phenomenon as an alternative route for weight loss.

Following its approval for chronic weight management by the US Food and Drug Administration (“FDA”) in June 2021, Ozempic has since gained worldwide traction with celebrities and public figures advocating for its use. However, in tandem with the increased use of the drug and other competitor products subsequently entering the market, a wave of litigation has arisen focusing on the side effects arising from these particular types of drugs. As litigation continues to grow in the US, manufacturers are becoming increasingly subject to claims of personal injury and whether manufacturers were aware of the side effects of such drugs and failed to warn consumers.

It is interesting that whilst the US litigation landscape with respect to weight loss drugs begins to gain traction, the UK government has announced that it is collaborating with the world’s largest pharmaceutical company Eli Lilly and Company (“Eli Lilly”) through a five-year clinical trial to test the efficacy of weight loss drugs Mounjaro and Zepbound on preventing diabetes and obesity-related complications.[1]

Background

The brand name “Ozempic” refers to a type of semaglutide produced by manufacturer Novo Nordisk (“Novo”) that was approved for the treatment of Type 2 diabetes by the FDA in 2017. Semaglutides are injected by a user and work by activating glucagon-like peptide-1 (“GLP-1”) receptors, which act by convincing your brain it is full, thus reducing your appetite. Whilst this type of drug has been used to treat Type 2 diabetes for many years, upon clinical trials observing weight loss as a key side effect, Novo released a higher dosage of the drug in 2021 called “Wegovy” which it specifically marketed for treating obesity. Novo referred to clinical trials that found Wegovy would help users lose 15% of body weight over 68 weeks and the drug rapidly grew in popularity and has since become so effective that Novo has reached market capitalisation of more than $600 billion.

In light of Novo’s success, other manufacturers have entered the market introducing similar GLP-1 receptor against drugs (“GLP-1 RA”) that work in the same manner. Eli Lilly, for example, entered the market in 2022 with the now commonly known alternative “Mounjaro” containing tirzepatide which activates GLP-1 receptors in a similar way to semaglutide. The use of such drugs have also been popularised by reality TV star Kourtney Kardashian. Her “Lemme” brand recently released an Ozempic alternative called “GLP-1 Daily” which has been branded an “Ozempic-style” supplement intended to boost the GLP-1 hormone that Ozempic replicates to make us feel fuller for longer.

Following the rise in publicity and perceived success of these GLP-1 drugs in achieving effective weight loss, demand has reached such a level that Novo has been hit with critical supply issues. However, the increased usage has also caused a spotlight on their purported side effects. These side effects are understood to include gastroparesis, ileus (intestinal blockage), vision loss and suicidal thoughts. Given the scale of use of the drug, this has brought litigation to the door of Novo and others, with US plaintiffs claiming personal injury caused by their use of the drugs.

US Litigation

In August 2023, the first lawsuit was filed against Novo and Eli Lilly in relation to products Ozempic and Mounjaro respectively. The plaintiff, Jaclyn Bjorklund, alleged that she had suffered severe side effects from the using the drugs, including gastroparesis. She argued that the manufacturers had knowledge of the association between the use of GLP-1 RAs and the risk of developing severe gastrointestinal issues, thus should have explicitly warned users of such risks.

Subsequently, further lawsuits of a similar nature were brought against Novo and Eli Lilly and in February 2024 an initial 55 claims were consolidated into a federal Multi District Litigation (“MDL”) in Pennsylvania covering the medications Ozempic, Wegovy, and Rybelsus, manufactured by Novo, and Trulicity and Mounjaro, manufactured by Eli Lilly. Notably, prior to the MDL, the FDA added a new warning label to Ozempic in September 2023 to include the risk of ileus. To date, in October 2024, the MDL has reached 1,090 cases and continues to grow fairly rapidly in size.

The commonalities amongst the cases justifying its consolidation into an MDL include (i) the allegation about GLP-1 RAs and their alleged propensity to cause gastrointestinal injuries; (ii) issues of fact as to whether defendants knew or should have known that their GLP-1 RA products can cause gastroparesis and other gastrointestinal injuries; (iii) whether defendants adequately warned plaintiffs or their prescribing physicians about the alleged dangers of these products; and (iv) whether defendants made false, misleading, or incomplete representations regarding the safety of these products. Both Novo and Eli Lilly deny all of these allegations.

The MDL remains in its preliminary stages, however in August 2024 the MDL court granted the Defendants’ request for early discovery and motion practice on two pivotal issues being (i) the reliability of gastroparesis diagnostic testing; and (ii) the adequacy of the warning labels provided by the manufacturers. Defendants have since urged the MDL court to have the judge not only grant this early discovery but also rule on these issues at a preliminary stage, which the Plaintiffs vehemently oppose. The Plaintiffs equally consider that this “early discovery” should include the Defendants’ marketing discovery in circumstances where they allege the drug’s promotional materials were misleading and the manufacturers engaged in aggressive marketing and promotion of the products which led to their widespread use. These issues remain ongoing in the MDL.

Wider implications

It remains to be seen whether the MDL court will make any preliminary ruling on the adequacy of the warning labels for the manufacturers’ products, however such a decision could prove pivotal to the landscape of Ozempic and GLP-RA litigation going forwards.

As the claims evolve, it will be interesting to see if liability will be allocated differently given the intended use of the drug. Ozempic was approved for use for the treatment of Type 2 diabetes, and not weight loss. In contrast, Wegovy was released by Novo as a weight loss drug. Can a manufacturer be held responsible for side effects when a drug is used for different purpose, or can such side effects be reasonably expected in any event which manufacturers knew about?

In the event the US courts find that the manufacturers did know of the dangers of the products, failed to adequately warn users, but nevertheless continued to market the products without effective warnings, it is clear this will raise interesting coverage arguments for insurers should the manufacturers seek to recover any amounts paid in light of settlement or awards on its insurance.

Furthermore, as trials are still in progress to understand the full extent of side effects associated with taking GLP-1 RA drugs, it is likely that the scope of personal injury allegations, and thus the scope of potential plaintiffs, will continue to increase. As recently as 2 September 2024 there was a study which scrutinised the potential for there being a relationship between the drugs and suicidal thoughts.

On the other hand, the clinical trials taking place in the UK in collaboration with Eli Lilly with respect to the effectiveness of Mounjaro and Zepbound to tackle obesity as a public health issue suggests that the concerns over the drugs’ side effects is not (yet) a major issue on this side of the Atlantic as it is in the US.

Nevertheless, as others attempt to capitalise off this booming market, this further broadens the scope of potential litigation and insurers should be cognisant not only of Ozempic related litigation but also this next wave of individuals using similar type drugs and supplements that shows no signs of slowing down.

Insurers will be most interested in whether plaintiffs are successful in the key assertion that manufacturers had prior knowledge of the dangers of gastroparesis and ileus, and other gastrointestinal issues despite continuing to market Ozempic, Wegovy, Mounjaro and Zepbound. Should that be the case, applicable exclusions in policies may prevent coverage leaving Novo and Eli Lilly to foot a significant bill.