MDL Update: Mylan EpiPen and Proton-Pump Inhibitor Litigation

Bruce Burk

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— Updated on June 23, 2020

MDL Update: Mylan EpiPen and Proton-Pump Inhibitor Litigation

MDL Update

EpiPen Price Hiking by Mylan (2:17-md-2785)

Mylan NV, a large pharmaceutical company is now dealing with a class action lawsuit regarding the price of EpiPen allergy medication that went up from $100 to $600 in recent years. The EpiPen assists patients that have problems with allergic reactions by providing an injection of epinephrine. Many times, the treatment can save the patient’s life.

The lawsuit claims that the company acted in coercion with pharmacy benefit managers to overcharge customers. They did this by paying rebates to these pharmacy benefit managers to use the EpiPen over other products.

This pay-to-play behavior helped Mylan achieve 95% control of the EpiPen market. Once they had a nearly complete monopoly, they allegedly jacked up the prices of the EpiPen, while customers had no choice but to purchase them.

Recently, the company paid a $465 million settlement to the Justice Department related to their EpiPen product. This lawsuit was brought under the Racketeer Influenced and Corrupt Organizations Act (RICO). This settlement came as the result of the US government accusing the company of falsely labeling the EpiPen as generic instead of a branded product in order to allegedly short-change medicare.

However, Mylan’s issues don’t stop there. The company was just forced to recall massive quantities of their EpiPens due to reports that the injectors have failed to activate.

In response to some of these issues, Mylan has offered a generic version of the EpiPen for $300. However, to most of middle-class Americans, that will not cure the feeling of being taken advantage of by a big drug company.

“Mylan has tried to pass the buck and excuse itself from any responsibility, attempting to wash its hands of the dubious scheme that has plagued allergy sufferers with unbearably high prices,” said Steve Berman, an attorney for the Plaintiffs said in a press release.

Some patients who cannot afford the EpiPen’s have gone so far as to use expired EpiPens or to use syringes to manually inject epinephrine into themselves.

This case was brought in Kansas Federal District Court and involves lawsuits in Illinois, Kansas, New Jersey, and Washington. The parties are currently proceeding under a August 8, 2017 Trial Order directing discovery and setting deadlines for the litigation. The case is currently sealed and not accessible on PACER.

The case is currently still in the discovery stages and we will likely hear more about the case as the trial date gets closer.

Proton-Pump Inhibitor Products Liability Litigation (2:17-md-2789)

Another multi jurisdictional lawsuit involves Prilosec, a proton pump inhibitor that helps treat heartburn and serious gastrointestinal diseases.

This lawsuit involves a woman named Penny who went in for an eye exam and found out that her kidneys were not functioning properly, allegedly due to her use of proton-pump inhibitors. She claims the company failed to warn her about the risks involved in using Priolsec.

Part of the litigation has to do with the fact that protein pump inhibitors have been overprescribed by doctors to treat other diseases like gastroesophageal reflux disease (GERD). Some research has shown that the majority of patients using the drugs do not need them.

With the rise in use of PPIs, many patients started demonstrating signs of kidney failure. A study of 10,000 patients who had used the drug revealed a correlation between chronic kidney disease and the medication.

Thankfully, Penny was able to get a kidney transplant from a friend. However, she does not have faith that Proctor and Gamble, the company that distributes the drug, will make adequate changes to their warnings to help protect other patients from the problems she experienced.

The company responded to the allegations by saying, “AS with any OTC medication, it is important to read and follow all label directions to ensure proper dosing and avoid drug interactions. Prilosec OTC is to be used once a day, every day for 14 days as a course of treatment. DO not take for more than 14 days or more often than every 4 months unless directed by a doctor.”

There are 15 other lawsuits in different federal courts with similar claims of kidney failure from the use of PPIs. Many of these plaintiffs attempted to combine the litigation in to the multi-jurisdictional panel, and were sucessful.

With such widespread use of this drug, it would not be shocking to see many more patients come forward to join these lawsuits. It is obvious that the company objects to the use of this drug labeling because it would likely devastate their sales numbers. One can imagine that most people would think twice about using a drug that had a good chance of causing their kidneys to fail.

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