<figure>
 <img src="https://media.eaglewebservices.com/public/2020/2/1582842150507.jpeg" alt=" Mylan CEO Heather Bresch takes her seat on Capitol Hill on Sept. 21, 2016, prior to testifying before a House Oversight Committee on EpiPen price increases. She defended the cost of the life-saving devices, despite a public outcry. Pablo Martinez Monsivais / Associated Press" />
 <figcaption> Mylan CEO Heather Bresch takes her seat on Capitol Hill on Sept. 21, 2016, prior to testifying before a House Oversight Committee on EpiPen price increases. She defended the cost of the life-saving devices, despite a public outcry. Pablo Martinez Monsivais / Associated Press</figcaption>
 </figure>BY DAN MARGOLIES, <a href="https://www.kcur.org/post/kansas-city-kansas-ruling-allows-millions-join-lawsuit-over-high-cost-epipens#stream/0">Kansas News Service</a>In
 a major victory for consumers, a federal judge in Kansas City, Kansas, 
is allowing a lawsuit over EpiPen price hikes to move ahead as a 
nationwide class action under the federal racketeering statute.U.S. District Judge Daniel Crabtree also is allowing consumers to sue for damages under state antitrust laws.The
 ruling was a setback for the main defendants in the case, Mylan NV and 
Pfizer Inc., which respectively sell and make the potentially 
life-saving auto-injector device.“On behalf of the nationwide 
class of consumers and third-party payers, we’re grateful that Judge 
Crabtree ruled in favor of holding Big Pharma accountable for illegally 
raising the price on lifesaving drugs like EpiPen,” said Prairie Village
 lawyer Ryan Hudson, whose firm, Sharp Law, represents dozens of 
consumers who purchased EpiPens.“We look forward to pursuing 
these claims at trial and holding the defendants responsible for their 
conduct in Kansas and nationwide.”Lawyers said the classes certified by Crabtree could number in the millions of individuals.Although
 Crabtree issued his ruling in two separate sealed filings, he also 
issued a publicly available order summarizing it. He said he plans to 
unseal the filings after the parties have reviewed them for confidential
 information.Crabtree’s ruling allows “all persons and entities”
 in the United States who paid or provided reimbursement for EpiPens as 
of Aug. 24, 2011, to sue for damages under the federal Racketeer 
Influenced and Corrupt Organization Act. The law allows plaintiffs to 
recover triple damages.The ruling also allows “all persons and 
entities” who paid or provided reimbursement for EpiPens as of Jan. 28, 
2013, to sue under the antitrust laws of 17 different states, including 
Kansas, that allow indirect purchasers to pursue antitrust claims.“It’s
 a great day for the class and consumers everywhere,” said Overland Park
 lawyer Chuck Schimmel, who represents an EpiPen purchaser.“A 
big hurdle in any class action is obtaining an order from the court 
deeming it appropriate to proceed as a class action and certifying the 
class or classes,” Schimmel said. “And that’s exactly what Judge 
Crabtree has done.”Elizabeth Pritzker, an attorney in Oakland, 
California, who serves as chair of the plaintiffs' steering committee in
 the massive litigation, said the ruling was cause for celebration by 
consumers.&nbsp;“It was a nice order to see,”&nbsp;she said.&nbsp;None of the defendants or their attorneys could immediately be reached for comment.The
 litigation has been playing out here since 2017, when a judicial panel 
consolidated five separate consumer cases filed in Kansas, New Jersey, 
Illinois and Washington in federal court in Kansas City, Kansas, plus 
another case filed by drugmaker Sanofi-Aventis. The panel ruled that the
 court presented a “geographically central forum for this nationwide 
litigation.”&nbsp;The consolidated cases allege that Mylan, Pfizer 
and their affiliates engaged in an illegal scheme to monopolize the 
EpiPen market by hiking its price more than 500% and offering rebates 
and discounts to pharmacy benefits managers and insurers in return for 
their pledge not to reimburse competing products.The consumer 
cases also allege the companies secured overlapping patents on minor 
changes to the EpiPen and then engaged in sham patent litigation to 
forestall competition from generic products.In addition, they 
charge that Mylan offered public schools free or discounted EpiPens 
conditioned on the schools entering into exclusive contracts with the 
company. Mylan reportedly spent $4 million lobbying Congress to pass the
 School Access to Emergency Epinephrine Act, which was enacted in 2013 
and gives federal funding priority to schools that stockpile EpiPens.EpiPens
 are auto-injector devices containing epinephrine, otherwise known as 
adrenaline, used to counter the effects of severe allergies and 
indicated for people at risk of going into life-threatening anaphylactic
 shock. Anaphylaxis is most commonly caused by food allergens but can 
also be caused by insect bites, medications and other substances.Mylan
 acquired the right to market and distribute the EpiPen in 2007. Pfizer,
 through two of its subsidiaries, is Mylan’s exclusive supplier.Since
 the Mylan purchase, the price of EpiPens has shot up, from about $100 
in 2007 to more than $600 in 2016, accounting for more than $1 billion 
in annual sales for the company. Meanwhile the cost of the EpiPen’s dose
 of epinephrine has remained at about $1.At a hearing in 
September 2016, the late Rep. Elijah Cummings, the ranking Democrat on 
the House Oversight Committee, accused Mylan CEO Heather Bresch, who is 
also a defendant in the litigation, of exploiting an “old cheap drug 
that has virtually no competition” and raising “the price over and over 
and over again as high as you can.”Bresch, the daughter of 
Democratic Sen. Joe Manchin of West Virginia, saw her pay rise during 
the period of 2007 to 2015, when Mylan hiked the price of EpiPens, from 
about $2.5 million to nearly $19 million, a more than seven-fold 
increase. That triggered fury among EpiPen users, many of whom said they
 could no longer afford the device.&nbsp;In 2017, <a href="https://www.justice.gov/opa/pr/mylan-agrees-pay-465-million-resolve-false-claims-act-liability-underpaying-epipen-rebates">Mylan paid the federal government $465 million</a> for misclassifying the EpiPen as a generic drug, allowing it to overcharge Medicaid by $1.27 billion.And last year, <a href="https://www.sec.gov/news/press-release/2019-194">it paid $30 million to settle a case brought by the Securities and Exchange Commission</a>. The SEC alleged Mylan failed to disclose to investors the government’s probe into whether it overcharged Medicaid.Other deals entered into by Mylan have come under congressional scrutiny as “pay-for-delay” agreements.When
 drugmaker Teva Pharmaceutical Industries sought FDA approval in 2008 to
 market a generic EpiPen, Pfizer sued it for infringing its patents. <a href="http://newsroom.mylan.com/press-releases?item=123144">They settled the case in 2012</a>.
 The consumer cases in Kansas City, Kansas, allege that settlement was 
unlawful because it required Teva to delay launching its product for 
three years in return for Pfizer’s agreement to provide significant 
benefits and compensation to Teva.Crabtree’s decision today is 
the first major ruling he’s issued in the fiercely fought case since 
August 2018, when he largely denied Mylan and Pfizer’s motion to dismiss
 it. His 128-page ruling found that the plaintiffs “plausibly” alleged 
that “Mylan’s anticompetitive conduct harmed the competition.”He
 also declined to dismiss Sanofi-Aventis’ lawsuit, which charges that 
Mylan used its monopoly power to block the inclusion of Sanofi-Adventis’
 auto-injector device in drug formularies – the list of prescription 
benefits covered by health plans.Dan Margolies is a senior reporter and editor at KCUR. You can reach him on Twitter <a href="https://twitter.com/DanMargolies">@DanMargolies</a>.

KCK ruling allows millions to join suit over high cost of EpiPens