All About The Januvia / Pancreatic Cancer Lawsuits

The federal court overseeing the nationwide Januvia pancreatic cancer litigation appointed Mr. Kennerly to the “Plaintiffs’ Steering Committee,” the group of plaintiffs’ lawyers responsible for building the case against Merck, the manufacturer of Januvia and Janumet.

I’ve written several posts going back to 2012 about the link between Januvia and pancreatic cancer, and below is an brief summary of the science behind the cases. In terms of the lawsuits, as of summer 2014, no jury trials have been held, and none will occur until mid-2015 at the earliest. Correspondingly, there have been no settlements: the drug companies still vehemently deny any responsibility, and the litigation is simply too new for any settlement discussions yet.

Right now, the federal court overseeing the litigation has put individual cases on hold, and has focused the litigation on the scientific evidence in the drug companies’ possession. The Plaintiffs’ Steering Committee is currently reviewing over 20 million pages of documents, conducting dozens of depositions, and investigating with scientific and regulatory experts.

I, along with Tor Hoerman Law (where I’m of counsel), already represent a wide variety of clients who developed pancreatic cancer after taking Januvia, clients on both sides of the country and everywhere in between, clients ranging in age from their forties to their eighties. We review cases free of charge, and we represent clients on a contingent fee. (That is, we pay all costs on the case, and only charge a fee if we recover compensation.)

The Causes Of Pancreatic Cancer, And The Cancer’s Relationship To Diabetes

If you’re reading this page, then likely you or someone you know was diagnosed with pancreatic cancer. You already know that the prognosis is typically poor, even with aggressive treatment.

Pancreatic cancer is typically asymptomatic for quite some time, showing up as nothing more than weight loss and vague abdominal pains. Typically screening isn’t performed unless a patient has two or more near relatives with pancreatic cancer, or a genetic condition — not least because there’s little agreement on whether non-cancerous lesions should be removed if they’re found. Many patients have generalized complaints until jaundice appears, when they seek treatment, and are given blood tests that reveal cancer somewhere in the body.

Surgery is usually the front-line treatment (e.g., the Whipple procedure, which is technically a “pancreaticoduodenectomy”), and it should be done as soon as possible after a diagnosis. If you or your family member hasn’t had surgery yet, then consider going to a facility with a higher volume, which tend to have better patient outcomes. You want a doctor who has done this many, many times before.

The causes of pancreatic cancer are complicated and multifaceted. On one level, cancer is “caused” by dangerous changes in DNA, and 90% of pancreatic ductal adenocarcinoma patients will show “oncogenic KRAS” gene signalling. But that’s not the whole story: we all have changes in the DNA of our cells all the time. Oncogenic KRAS is also found in many patients who do not develop pancreatic cancer, and so that gene alone has never worked for screening or diagnosis.

The problem is that the pancreas includes a variety of additional pathways, like the epithelial-mesenchymal transition (EMT), which can further contribute to the development of tumors, both benign and malignant. Compared to other organs, the pancreas is unusually active on the cellular level, and it performs a variety of different functions, including both producing hormones (the “endocrine” pancreas) and producing digestive enzymes (the “exocrine” pancreas). These metabolic pathways can cause the pancreas to accumulate lesions, called Pancreatic Intraepithelial Neoplasia (“PanINs”), which oncologists and endocrinologists grade on a scale from 1 to 3. These are sometimes called “precancerous” cells and lesions, because, the higher a “grade” they are, the more likely they are to give rise to invasive carcinoma of the pancreas. Most people develop PanINs to some extent during their lifetimes, to no ill effect, but, for people, the PanINs will become cancerous.

It is in those pathways, the pathways that affect cell proliferation and cell apoptosis and the development of precancerous lesions, that Januvia and Janumet use causes a problem.

How Does Januvia Work, And What Does That Have To Do With Pancreatic Cancer?

Diabetes is, of course, all about blood glucose levels. Glucagon, a natural hormone produced by the alpha cells in the pancreas, increases glucose levels. Incretins, which are natural hormones produced by the islets of Langerhans in the pancreas, decrease glucose levels. Januvia increases incretin levels (specifically, the incretin “GLP-1”) by inhibiting the protein dipeptidyl peptidase-4 (“DPP-4”), which breaks down GLP-1. Thus, Januvia increases GLP-1 levels, which in turn helps keep glucose levels lower and better regulated.

In short, Januvia alters the level of hormones in the body. It has long been recognized, however, that “hormones drive cell proliferation, and thus the opportunity for the accumulation of random genetic errors,” as discussed by this article on “hormonal carcinogenesis.” The scientific community has seen this again and again, including in cancers of the breast, endometrium, ovary, prostate, testis, and thyroid, and in osteosarcoma. (Here’s a PDF presentation explaining it in further depth.) We saw this with menopausal hormone replacement and breast cancer. The pancreas, unfortunately, cannot be excluded from that same process.

Several scientific studies have found evidence that Januvia and other incretin-related drugs can increase the extent of tumors in the pancreas (like this study), and that users of incretin-related drugs have a higher rate of pancreatitis and pancreatic cancer than users of other diabetes medications (like this study).

The additional scientific evidence relating to whether Januvia or Janumet can increase the risk of pancreatic cancer is at the core of the ongoing litigation.

How Do These Pancreatic Cancer Lawsuits Work?

Last year, the panel of federal judges that coordinates most of the major prescription drug and medical device litigation in the country ordered all of the pancreatic cancer lawsuits to be consolidated for discovery and pretrial purposes in the federal court in the Southern District of California. This process is typical in cases like this, and it was the same process used for the Vioxx cases years ago, and for the DePuy ASR hip recall cases that are currently in a settlement claims process.

That court, in turn, has appointed a group of lawyers – all of whom represent drug injury victims, and none of whom represent drug companies – to serve as the “Plaintiffs’ Steering Committee.” The Plaintiffs’ Steering Committee is responsible for putting together the main factual and scientific evidence that can be used by individual plaintiffs in their own lawsuits, and in overcoming the numerous legal hurdles that often preclude drug lawsuits from even reaching a jury, like the Daubert standard for scientific evidence. I am a member of the Plaintiffs’ Steering Committee, and a member of the “Law and Briefing” subcommittee that handles many of the court arguments and legal issues.

This is not the same thing as a class action. Unlike in a class action, where the injured consumers often don’t need to file a lawsuit and typically everyone receives roughly the same amount in the settlement, in this process, the claims still need to be individually filed, and the court does not approve a particular settlement amount that everyone receives. Thus, although most of the work in the case — like reviewing millions of documents and putting together a world-class group of expert witnesses — is done by the plaintiff steering committee, people who developed pancreatic cancer after taking Januvia still need to find their own lawyers to ensure their claims are preserved and presented properly, and, if a settlement is offered, negotiate the settlement.

In theory, a plaintiff could hire almost any personal injury lawyer to represent them, and then hope for the best if the settlement comes. I don’t think that’s a good strategy, though, and I think plaintiffs should hire firms that have the experience, resources, and understanding of the merits of the case to present a credible threat of trial to the defendants, because that’s the only thing that gets billion-dollar companies like Merck to offer reasonable settlement. You don’t have to hire a member of the Plaintiffs’ Steering Committee, but it typically helps.

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