EpiPen is a product known to many to be a lifesaver and necessity. Recently, EpiPen’s manufacturer has been slammed by the FDA for fatal device malfunctions that turned this lifesaver into a life-taker. With hundreds of complaints filed, the FDA (U.S. Food and Drug Administration) is taking action and urging EpiPen’s manufacturers to account for their failure to protect users. Read on to learn more about this developing situation and how you can protect yourself if you rely on EpiPen.
EpiPen Device Malfunctions Risking Lives
EpiPen, an auto-injector that injects epinephrine into the body, is widely accepted as the “go-to” for allergic reactions. Manufactured by Meridian Medical Technologies, Inc., which is owned by Pfizer, EpiPen is for many people a household staple. EpiPens are then distributed to Mylan, who holds ownership of the devices. In recent years, Mylan has been the subject of scrutiny over significant price increases of EpiPens, making it difficult for patients to obtain.
Most commonly used in life-threatening emergencies, allergy sufferers rely on EpiPen for safety, confidence, and life-saving medication administration. If the EpiPen malfunctions, the individual suffering an allergic reaction could suffer serious consequences, or in many cases, can die. The FDA says that is exactly what happened to hundreds of people who relied on EpiPen.
If you or someone you love relies on EpiPen, but has suffered harm due to a device malfunction, contact Brown & Brothers today to speak with our medical malpractice attorneys.
FDA Shines Light on Fatal Device Malfunctions and Failed Responses
On September 5, 2017, the FDA sent a letter to Meridian slamming them for their failure to address hundreds of complaints about malfunctioning EpiPen devices. The FDA stated:
“Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.”
The FDA continues throughout the letter to detail complaints that have been filed about EpiPen failing. For example, on multiple occasions, complaints of device malfunctions have led to Meridian disassembling EpiPen’s only to find defects. Even so, no recalls were issued and no further investigations were pursued. Meridian’s only response was that the defect was “infrequent”, but never provided proof that they examined other batches.
Between 2014 and 2017, Meridian received more than 170 “complaint samples” – defective products returned to the company upon consumer complaint. Meridian has previously stated that the only way to determine what caused a malfunction is to disassemble the device for inspection. An FDA inspection of Meridian early in 2017 indicated, however, that the majority of complaint samples had not been disassembled for inspection. In fact, Meridian employees stated during the inspection that most samples sent back from consumers were not disassembled.
In the days following the inspection earlier this year, Mylan issued a recall of tens of thousands of EpiPens. Together with Pfizer, Meridian continues to stand behind their brand, quality, and efficacy. They have since stated that they will cooperate with the FDA to resolve the issues identified in their letter.
FDA Standards to Keep Consumers Safe
The FDA has strict protocols for medical devices that are found to be defective. These protocols help regulate how manufacturers make, market, and distribute products. FDA protocols, rules, and laws also help to ensure that you (consumers and patients) are protected from unnecessary risks. As a consumer or patient, you have certain legal rights that protect you when negligence leads to a defective product.
Manufacturers who discover that one of their products is defective are tasked with proposing a correction or removal. These processes are identified as:
- Correction: Addressing the problematic device in the location where it is used or sold.
- Removal: Addressing the problematic device by completely removing it from where it is used or sold.
When a manufacturer proposes a correction or removal based on a product that does not meet FDA rules and laws, then a recall is issued. Recalls consist of various actions and processes, and do not always mean that the product is immediately pulled from consumer reach. According to the FDA, recalls may include the following:
- Inspecting the device
- Repairing the device
- Re-labeling the device
- Adjusting settings on the device
- Destruction of the device
- Notifying patients of known or potential problems
- Monitoring patients for device-related health issues
In the case of EpiPens, Meridian eventually recalled 13 lots of the EpiPen and EpiPen Jr, advising patients to keep the recalled product in case of emergency and until a replacement product arrived. The recall affected products distributed throughout the U.S., as well as Asia, Europe, and South America.
Device Malfunctions and Your Legal Rights
The FDA’s slamming of Meridian certainly suggests that the company was negligent in their handling of the complaints and samples consumers sent back. It is reasonable to wonder if Meridian had issued a recall when complaints initially were made, if less people would have been harmed by the malfunctioning device. Unfortunately, speculation cannot take away the pain and grief when a necessary, life-saving device causes more harm than good.
If you have been injured by a medical device malfunction, it is important that you understand your legal rights. Don’t let manufacturers or large corporations dismiss your complaints and concerns. Take action to defend your legal rights and get the justice you deserve.
Contact Brown & Brothers to schedule your free case evaluation. We are passionate about helping our clients hold negligent manufacturers accountable when their acts or omissions cause needless harm. Fill out our online form to get started today.