Mylan Pharmaceuticals, Inc and Rite Aid named in class action lawsuit over sale of valsartan contaminated with a carcinogenic and liver-damaging impurity

This is a class action lawsuit pertaining to Mylan and Rite Aid’s manufacturing, distribution, and sale of valsartan-containing generic prescription medications contaminated with N-nitrosodiethylamine (NDEA), a carcinogenic and liver-damaging impurity.

NDEA is classified as a probable human carcinogen. Animal studies have revealed the carcinogenic nature of the compound. On July 13, 2018, the U.S. Food & Drug Administration (“FDA”) announced a voluntary recall of several brands of valsartan-containing generic medications. The recall traced back to a Chinese company, Zhejiang Huahai Pharmaceuticals, which supplied the active pharmaceutical ingredient, valsartan, to American subsidiaries, as well as other companies. The recall was due to the presence of N-nitrosodimethylamine (NDMA) in the recalled valsartan products. The FDA’s notice states that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Several subsequent recalls were made.

As alleged, Mylan failed to promptly recall its valsartan-containing medications for over four months after the initial recall was announced, and over three months after labs in India were implicated. The Mylan Defendants failed to do so despite knowing that their valsartan containing medication were also likely contaminated. It took the Mylan Defendants another two weeks to recall all non-expired lots of the medication due to the presence of NDEA.

Plaintiff and the Class were injured by the full purchase price of their valsartan containing medications. These medications are worthless, as they are contaminated with carcinogenic and harmful NDEA, and therefore and are not fit for human consumption. Indeed, Plaintiff has been instructed to immediately stop using the medication, and has been instructed to return the remaining medication for another, non-contaminated brand. Plaintiff and the Class are further entitled to statutory damages, damages for the injury sustained in consuming high levels of acutely-toxic NDEA, and for damages related to Defendants’ conduct.


Mylan Pharmaceuticals named in class action lawsuit over price gauging EpiPen



At the heart of this proposed class action is a pharmaceutical corporation seeking to boost profits at the expense of families who need the lifesaving product it sells. The product at issue is the EpiPen®, a lifesaving emergency auto-injector treatment for millions of people who suffer from severe allergies and are at risk for anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can occur quickly, sometimes within minutes, following exposure to an allergen including foods, medicines, latex, and insect bites or stings. EpiPen®s are sold in packs of two, expire, and must be replaced on an annual basis.

As alleged, the need for many families to have one or more EpiPen®s on hand is hard to overstate. According to Food Allergy Research & Education—an allergy advocacy and research group— approximately 15 million people have food allergies in the United States and allergic reactions account for about 200,000 emergency room visits per year.

When someone has a severe allergic reaction, he or she must promptly inject themselves or be injected with epinephrine to prevent anaphylactic shock. Anaphylactic shock can kill, so having handy, pre-measured, pre-loaded epinephrine in a portable EpiPen® can be lifesaving.

Mylan is the only company selling EpiPen®s, and it has increased the price of its product more than 500% since 2007 when it began selling the device, which originally cost just $94.00 for a two-pack. While the EpiPen® reportedly costs Mylan just $34.501 to produce, today it sells the EpiPen® for a staggering amount: $600 or more for a two-pack.

Plaintiffs bring this consumer class action individually and on behalf of a putative nationwide class, as defined below (hereinafter “the Class”). Plaintiffs seek declaratory and injunctive relief, and to recover drug payments and overpayments made from at least the year 2007 through the present (hereinafter the “relevant time period”), as a result of Defendants’ unlawful scheme involving unfair, exorbitant, and unconscionable price increases.

This case concerns all EpiPen® products manufactured and distributed by Defendants including the following:

  1. EpiPen®;
  2. EpiPen Jr.®;
  3. EpiPen 2-Pak®;
  4. EpiPen Jr. 2-Pak®;
  5. My EpiPen®;
  7. Be Pepared®;
  8. EpiPen4Schools®
  9. Never-See-Needle®.