EpiPen Auto-Injector Lawsuit
Meridian Medical Technologies, Inc., a Pfizer Company, was sent a letter by the U.S. Food & Drug Administration (FDA) in September 2017 warning the company that it failed to safely manufacture multiple epinephrine auto-injectors, the Mylan EpiPen and EpiPen, Jr., at its facility. These products are designed to deliver epinephrine, a life-saving drug used in emergency treatments for debilitating allergic reactions, such as anaphylaxis.
If you or a loved one uses EpiPen or EpiPen, Jr. and has been a victim of serious injury or death due to using the device, please be aware that consumer protection lawsuits may be filed because of negligence on behalf of Meridian and Mylan. Pittman, Dutton & Hellums is a consumer protection law firm serving EpiPen and EpiPen, Jr. victims throughout the United States.
Latest Known Facts:
- Before the FDA sent a warning letter, hundreds of complaints had been made to Meridian that the EpiPen devices failed to activate properly and were linked to severe injuries and patient deaths
- The FDA claims the Meridian facility never investigated the cause of the complaints and failed to thoroughly determine which lots of the EpiPen products were faulty
- In 2016, Meridian identified a failing unit sampled from an incoming lot, which was rejected, but other units from the associated lot were not examined to identify similar defects, while new products using other lots of the same component continued to be manufactured
- Between 2014 and 2017, Meridian received more than 170 complaint samples for EpiPen products that failed to activate after patients followed the proper sequence
- In 2015, reports surfaced that serious EpiPen injuries had been found in child users, who lack the cognitive ability to sit still, which complicates the defective devices even further
- Hundreds of thousands of EpiPen products may be defective
Even though Meridian received so many complaints about faulty EpiPen products, the manufacturer only sought to identify the cause of the malfunctioning product and implement corrective measures after the FDA began an investigation. The company knowingly continued to put hundreds of thousands of patients at risk, despite having warnings that should have been taken seriously.
Earlier in 2017, Mylan recalled more than 20 lots of EpiPens, but only after its factory had been inspected and government officials had talked with the company many times.
This isn’t the first time that EpiPen has come under fire. The pharmaceutical companies Mylan Specialty L.P. and Mylan Inc. agreed in August 2017 to pay a settlement of $465 million with the United States Department of Justice for violating the False Claims Act. The pharmaceutical companies were accused of knowingly labeling EpiPen as a generic drug and misclassifying the product, so they could avert paying rebates owed primarily to Medicaid.
The company was accused of doing this in order to profit at the expense of the Medicaid program, after which it raised the price of EpiPen by about 400 percent between 2010 and 2016. The drug was not a generic drug, even though Mylan claimed it was and continued to pay only a fixed 13 percent Medicaid rebate.
In 2017, French drugmaker Sanofi filed a lawsuit against Mylan alleging that the company inflated the price of EpiPen in order to create a drug monopoly, thus preventing Sanofi’s competing Auvi-Q allergy treatment from making an impact on the market.
Do You or Someone You Know Use EpiPen Products?
Because Mylan and Meridian have received numerous complaints but have a track record of misleading patients, doctors and the government and of not looking into warnings of dangers that could cause serious injuries or death in EpiPen users, it is vital that anyone who uses EpiPen or EpiPen, Jr. check the lot number on the product and consult with a physician about potential dangers. It is also important to be aware of potential future harm these products may cause, due to lack of inspection or errors in manufacturing.
EpiPen and EpiPen, Jr. can cause serious injury or death. The Pittman, Dutton & Hellums consumer protection law firm is currently pursuing lawsuits because of negligence on behalf of Meridian and Mylan. Our firm is dedicated to providing caring and focused service to each of our clients, to help them obtain the justice and compensation they deserve.
If you or a loved one has been seriously hurt or died after using an EpiPen or EpiPen, Jr. product, please contact us as soon as possible at (866) 722-0250 for a free consultation. The statute of limitations prevents lawsuits from being filed after a certain amount of time, which is why it’s so vital to contact us as soon as possible to learn your rights and potential compensation you may be entitled to. You can also contact us online here.
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