EpiPen Suit Update: Where It Stands and What It Means for Consumers

in Food Allergy, Food Allergy News
Published: July 29, 2021
Photo: Getty

Updated Oct. 28: In late July, a U.S. District Court judge granted preliminary approval of a $345 million settlement agreement with Pfizer Inc. and its subsidiaries in the class action lawsuit involving the lifesaving EpiPen. It’s an important step in the suit, which claims EpiPen’s makers and marketers engaged in anticompetitive strategies.

So where does this leave as many as seven million consumers who are included in the antitrust lawsuit, and what are the next steps that will unfold in the litigation that’s been running since 2017?

First, attorney Elizabeth Pritzker, the co-lead counsel for the consumer plaintiffs’ side tells Allergic Living that, presuming the Pfizer settlement gets final approval, eligible class members will be able to file a claim starting in August. Claims are toward amounts paid for EpiPens or their generic equivalent auto-injectors.

Pritzker explains that the amount an individual consumer can receive will be decided soon. In mid-November, the U.S. District Court in Kansas will consider the final decision on whether the proposed settlement is “fair, reasonable and adequate.”

While Pfizer is prepared to settle, the device manufacturer denies any wrongdoing. A company spokesperson wrote in an email to Allergic Living: “This resolution reflects a desire by the company to avoid the distraction of continued litigation and focus on breakthroughs that change patients’ lives.”

Speaking for the plaintiffs, Pritzker notes that U.S. District Court Judge Daniel Crabtree was “pleased” there was a proposed resolution to the Pfizer portion of the case.

How to Make a Claim

The website EpiPenClassAction.com offers consumers detailed information about who is eligible to file a compensation claim. Starting in August, eligible consumers will be able to do so electronically or by mail. (See also, the website’s FAQ.)

Anyone who “paid or provided reimbursement for some or all of the purchase price of branded or authorized generic EpiPens for the purpose of consumption” during August 24, 2011 to November 1, 2020 is eligible to file a claim for settlement benefits, according to court documents. The final deadline to submit a claim is November 12.

Pritzker says that while it’s “very difficult to get a handle on what the class size may be,” she estimates that about seven million people are involved in the lawsuit.

Latest on Mylan Lawsuit

Back in 2016, Pfizer along with Mylan (now Viatris), which markets the EpiPen and its generic equivalent, faced consumer and political backlash over the fast-rising price of branded EpiPen auto-injectors. The list price for a set of two of the devices grew to over $600, an increase of more than 500 percent from 2008. Controversy also arose over whether Mylan had strategically deterred competition as the epinephrine auto-injector market grew alongside the rise in food allergies.

Mylan defended its pricing and marketing strategies, and quickly introduced an enhanced consumer discount card on EpiPen sets. But critics weren’t placated, and in 2017, the class action lawsuit was filed. It alleged that Mylan and Pfizer and its subsidiaries had engaged in anticompetitive conduct that violated federal and state antitrust laws.

After years of litigation, the summer of 2021 is the beginning of resolution in this lawsuit – both for and against the consumer plaintiffs.

On June 23, Judge Crabtree ruled substantially in favor of Mylan/Viatris, accepting the company’s call for a summary judgment that dismissed most antitrust claims, including those related to the federal Racketeer Influenced and Corrupt Organizations Act (RICO). In a press release, Viatris said it was “pleased with the court’s decision to dismiss all of the plaintiffs’ claims under the federal RICO statute, which includes claims asserted against Mylan’s former CEO Heather Bresch.”

Headed to Trial in Generic’s Delay

However, Mylan/Viatris will still face a jury trial in January 2022 over the plaintiffs’ allegations that the company and its competitor Teva Pharmaceuticals reached agreement to delay the launch of Teva’s generic epinephrine auto-injector. The plaintiffs’ lawyers contend this was part of an agreement to resolve patent litigation disputes between the two companies over EpiPen’s patent and that of Teva’s Nuvigil sleep disorder pills. The plaintiffs claim the agreement was that the two companies decided they would both profit by limiting competition by a few years in their respective drug monopoly marketplaces. The Mylan/Viatris team counters that the two patent agreements were coincidental, and that Teva encountered issues developing its auto-injector device, which led to delays with FDA approval.

Judge Crabtree is sending this to trial to resolve. In his June 23 order, he notes that plaintiffs’ pharmaceutical expert cited an unusually long delay for Teva to respond to issues the FDA raised about its injector. That expert’s analysis says it took “nine years and nine months” for Teva to get FDA approval (in 2018) for its generic auto-injector. By comparison, other Teva injectables were approved in under 30 months. The judge said that a jury may or may not find this analysis credible and pertinent – but it should be considered at trial. 

On the topic of the RICO claims, Judge Crabtree wrote in his June order that “the plaintiffs allege that defendants “joined together in an association-in-fact enterprise and used the interstate mails and wires in furtherance of’ their scheme to raise EpiPen prices.” The plaintiffs say the scheme involved moving to only selling two-device sets of EpiPens, removing single pen auto-injectors from the market, plus moves to stifle competition. The latter were alleged to include higher rebates to pharmacy benefit managers (PBMs) to hurt the Auvi-Q auto-injector’s entry to the marketplace. 

Judge Daniel Crabtree

Referencing other RICO rulings, the judge accepted Mylan/Viatris’s request for summary judgment, agreeing that the issues would not hold up at trial as racketeering claims. For example, he wrote that under RICO, the plaintiffs’ attorneys would have needed to establish that the consumer “injuries” (paying inflated prices for EpiPens) would not have occurred – unless there had been use of the mail and wires to further the EpiPen pricing scheme. (The term ‘wires’ includes the Internet.)             

However, the lawyers representing the plaintiffs have submitted a motion for the court to reconsider its summary judgment on the RICO claims. “We think the judge made some fundamental legal errors in granting that summary judgment,” said Pritzker. She says it is possible to have those claims revived in time for the January trial date. However, she adds: “We’ve got good evidence against Mylan, even if we just go to trial on our remaining claims.”

The plaintiffs’ side has had another setback. On July 27, Judge Crabtree also sided with Mylan/Viatris and Pfizer in accepting summary judgment to dismiss antitrust claims by KPH Healthcare Services, a pharmacy group that was part of the consumer lawsuit. Mylan said it was pleased with the decision, “as it has always maintained that its actions were completely lawful and pro-competitive.”

It is hard to say the impact this well-known lawsuit and the likely Pfizer settlement will ultimately have on auto-injector and other drug pricing. But Pritzker concludes: “It’s important for people to know that there is a dedicated group of representatives and lawyers who are really trying to do the right thing in the U.S. by keeping drug pricing in line with these types of lawsuits.”

Related Reading
Pfizer Agrees to Pay $345M to Settle EpiPen Price Hike Case
Allergic Living’s All About Epinephrine Guide
Lawmakers in 2016 Grilled Mylan CEO Over EpiPen Prices