You may have heard that the battle over insulin access and affordability has made its way into court, challenging status quo drug-pricing methods and actually accusing the three Big Insulin makers of illegal price-gouging that endangers people with diabetes.

This issue has been making lots of headlines over the past year, and we at the 'Mine have covered it from a variety of angles -- from the insulin makers' response to the historical context to the human cost, and how middle-men such as pharmacy benefit managers (PBMs) manipulate this process.

There have been some broad advocacy efforts to find solutions, including a meeting of national stakeholders, a grassroots initiative to provide insulin to those in need, lawmakers calling for Congressional hearings, and most recently, the American Diabetes Association itself launching a #MakeInsulinAffordable campaign.

Not surprisingly, news of several related federal lawsuits on this issue was met with cheers and virtual fist-pumps across the Diabetes Community, with many echoing sentiments like, "FINALLY!," "It's about time," and "Hopefully this results in change!" (See this CBS story on the litigation and responses.)

Today, we continue our own brand of coverage of #InsulinPrices and #PBMsExposed by examining this litigation, and how it may or may not make a difference among our D-Community:

 

The Insulin Pricing Litigation

Technically, a handful of different lawsuits against the Big Three insulin makers -- Lilly, Novo, and Sanofi -- have made their way into court.

  • A class-action lawsuit was filed on Jan. 30 in Massachusetts on behalf of 11 plaintiffs, a mix of people with both types of diabetes dependent on various brands of insulin and insurance plans. Days later, it was re-filed in the District of New Jersey and added one new PWD (person with diabetes) as a plaintiff. The 171-page lawsuit is captioned Chaires, et al. v. Novo Nordisk, et al, No. 3:17-cv-00699.
  • A second PWD-filed suit came on Feb. 13, mirroring much of the same allegations made in the earlier case against the Big Three. This case involves a father-son pair from Florida who are suing over 'insulin unaffordability' on the grounds that it endangers their lives. The 110-page lawsuit is Hector Valdes, et al v. Sanofi-Aventis U.S., et al., No. 3:17-cv-00939.
  • In the same NJ federal court, a federal securities lawsuit was filed in January against Novo Nordisk specifically, by the Lehigh County Employees' Retirement System in Pennsylvania -- accusing the insulin manufacturer of misleading stockholders and inflating business prospects for insulin. That 24-page lawsuit is Lehigh County Employees' Retirement System v. Novo Nordisk A/S, No. 17-cv-00209.
  • Another securities case against Novo appeared in January, alleging similar things relating to inflated, share-impacting insulin pricing practices. That 35-page lawsuit is captioned Don Zuk v. Novo Nordisk, et al, No. 3:17-cv-358.

The PWD-filed lawsuits are being combined into one over-arching case. One of the attorneys on the case, Steve Berman from the national class-action law firm Hagens Berman, says this about the first case in this line of litigation:

“The insulin makers have raised their prices so significantly just so that they can offer these other actors [pharmacy benefit managers] deeper discounts. The discounts serve as a quid pro quo for agreements to funnel patient business towards those drug makers. The aim of this lawsuit is to bring the insulin makers’ deceptive and unfair conduct to light and to force an end to such behavior. This lawsuit seeks to compensate people living with diabetes who have been deeply harmed by the drug companies’ price increases.”

Both lawsuits filed by PWDs against the insulin companies make similar claims against the insulin companies and PBMs involved in the pricing process. They outline not only the striking price-hikes seen in recent years, but how the drug-pricing system works to the advantage of manufacturers and PBMs without regard to the human lives dependent on these medications.

Some of the share-worthy excerpts from the lawsuits include:

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The lawsuits specifically note that recent moves by Lilly and Novo to lower price-hikes and offer discount programs are not adequate to offset the skyrocketing costs overall. Specifically:

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In these patient lawsuits, they're arguing the insulin companies have violated the federal racketeering law and are also making claims under all 50 states' consumer fraud statutes. Since they're being combined, the plaintiffs will have until mid-March to file a consolidated complaint and then the insulin companies have until mid-May to respond. While 15 PWDs are involved as plaintiffs at the moment, others in the D-Community can also join the litigation through the law firm's website.

As to the securities litigation against Novo, the shareholders in those lawsuits claim Novo colluded with Lilly and Sanofi to set the prices for insulin, thereby falsely inflating its share price.

Of course, the Big Three have all denied these claims and insist they follow the law -- and that you know, what the plaintiffs are experiencing is just a result of the overly complex, multi-faceted system of healthcare and drug pricing in the United States.

 

Tackling Drug Pricing at Large

But do those cases go far enough, and will they be successful in court?

Not everyone thinks so.

Beyond insulin and diabetes concerns, there are other cases pending across the country that target insurers and PBMs on this maddening issue of drug pricing. It's all part of a wave of litigation against PBMs that has arisen over the past 10 years.

In particular, the two most recent cases against PBMs are In Re Cigna PBM Litigation, No. 3:16-cv-1702 in Connecticut and in Fellgreen v. UnitedHealthGroup, No. 16-cv-03914. In both cases, insurers are accused of charging excessive co-pays and cheating customers in setting drug prices and with their overall business practices. Much of the detail provided in these cases is what some believe the insulin pricing litigation is missing.

A relatively new, obscure group called the T1 Diabetes Defense Foundation has emerged on Twitter, following the litigation using the hashtag #InsulinAction. Structured as a 501(c)3 non-profit and first formed in 2015, it's run by husband-wife pair Julia Boss and Charles Fournier in Eugene, OR, and has been critical of the lawsuit consolidation, and particularly of the lead counsel James Cecci, who this T1DF group claims has conflicts of interest in representing both patient-plaintiffs and the shareholders suing Novo.

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We reached out to the group's founders to learn their backstory and agenda, given that their website is quite scant, but the pair declined to share any personal details and noted that any "personal diabetes story" is protected medical information that may involve a child. Instead, they encouraged us to simply follow the hashtag and to focus on the lawsuit claims themselves.

We're left to assume that at least one of them has a personal connection to the issue (?)

 

Diabetes Advocates, Unite!

Meanwhile, we're thrilled to see the passionate T1International group playing a part in the above-mentioned litigation against insulin producers, specifically by working to connect PWDs with the law firm that filed the cases.

"We have always encouraged patients to stand up for their rights and to speak out against the injustice of outlandish insulin prices, so we are hopeful that the outcome of this case can change things in the long term for many patients with diabetes," T1International founder and fellow T1D Elizabeth Rowley writes to us from Europe.

The group has been using the #Insulin4All hashtag to highlight its efforts on global accessibility and affordability, and this lawsuit-related activity builds on its efforts to address the problem and give D-advocates tools to get involved.

Honestly, what T1International has done on this issue over the past year is pretty remarkable:

  • Access Charter: T1International created an Access Charter vowing access to insulin and diabetes items for all of those who need it, globally. More than 630 have signed the charter from 52 countries, and we're proud that the 'Mine is included in that.
  • Survey Says: In 2016, the group conducted an Insulin and Supply Survey that highlighted some harrowing information about affordability in the US and echoed a common theme that diabetes costs (insulin in particular) can drain a person’s monthly income and push them into poverty. The survey found that US-based PWDs on average pay $571.69 per month for diabetes necessities.
  • Advocacy Toolkit: The group launched an online advocacy resource in late 2016, comprised of five sections to guide the reader through various stages of the process -- from understanding a particular issue and goal, defining advocacy, planning action, ways to execute that action and put pressure on your target, and stepping back to evaluate advocacy efforts. This resource is free for anyone to download from T1I's website. It's also pretty cool that another grassroots advocacy group, Beyond Type 1, helped fund this toolkit, that's being printed and shared among 12 countries (Ghana, India, Sierra Leone, Austria, Brazil, Tanzania, Kenya, South Africa, Argentina, Saudi Arabia, Kuwait and the US).

"We continue to encourage the ADA and others to work in collaboration with those of us in the diabetes space who have been carrying out similar initiatives for some time," Rowley says. "Duplicating efforts can waste valuable time, considering these issues are truly life-or-death. It is also important ensure that everyone who wants to take action can do so with one powerful, united voice. Unification and open coordination is happening on some fronts, but we look forward to the opportunity to work with all organizations invested in this issue. After all, we are all working towards the same goal: to improve the lives of people with diabetes."

She adds: "I truly feel that, despite differing issues and focuses, we can all work better together by openly sharing and supporting one-another. Discussing best practice, talking strategy and learning from each other is the best way to create lasting change."

We at the 'Mine completely agree, Elizabeth! We're intrigued to see all of this advocacy happening, in line with the litigation that will hopefully shed more light on the insulin pricing problem and the bigger drug cost debacle.

While it will be some time before we see any end-result from these ongoing court cases, our D-Community will obviously be keeping tabs on the action and hopefully working together to move towards tangible improvements.

 

** UPDATE: On March 17, 2017, a new federal class-action lawsuit was filed in New Jersey on behalf of the T1 Diabetes Defense Foundation, accusing the Big Three Insulin Manufactures as well as PBMs of artificially inflating the price of insulin.