FDA Announces Recall of EpiPen Products
There are countless allergy sufferers in the United States. For many of these people, having an allergy to certain foods or insects is a relatively minor health aspect. But for others, being exposed to an allergen can result in death. Some common examples of severe allergies include bee stings, seafood, and peanuts. Recently, the manufacturer of the anti-allergy medicinal medication EpiPen initiated a recall after learning that some of the units may not work as intended, placing patients and other individuals who rely on the device in serious jeopardy. The device contains epinephrine, a chemical that counteracts the effects of a severe allergic reaction in the body.
Meridian Medical Technologies, the manufacturer of EpiPen and EpiPen Jr, recently expanded this recall to include South America, Europe, and Asia. The recall covers 13 lots of the devices, which are auto-injector pens that are used to help treat severe allergic reactions in emergency situations. The recall notice states that the covered lots may suffer from a defect that prevents the pen from activating.
To date, the number of adverse event reports is small, but according to the FDA, the recall was initiated because the products contain a potentially defective component that could result in death for some users. Meridian Medical urges individuals who have an EpiPen or a related product to seek a replacement device by calling a hotline or emailing an email contact address provided in the recall notice. Health care professionals have also been advised to report any adverse events, reactions, or device failures to the FDA immediately.
In general, medical device manufacturers have a duty to design and manufacture devices with reasonable care. This also includes providing sufficient warnings to alert users to the potential side effects and risks associated with the devices. Almost every state also recognizes a strict liability cause of action, which allows a plaintiff to recover compensation if the plaintiff can show that the device was designed in an unreasonably dangerous manner, suffered from a defect during the manufacturing process, or failed to include appropriate warnings. There are a number of different approaches to proving that a product was designed in an unreasonably dangerous manner, and the requirements can differ from state to state. And, unlike in a negligence claim, in a strict product liability claim, the plaintiff is not required to show that the defendant breached a standard of care.
If you have suffered injuries as a result of a defective medical device, the experienced dangerous medical device lawyers at Moll Law Group are ready to assist you in seeking the compensation that you deserve. We have counseled numerous victims regarding a wide variety of products and devices, including clients located in Florida, Illinois, California, and New York. As a result of this experience, we understand how stressful this event is for you and your family, and we will ensure that your legal rights are protected throughout each step of the process. To schedule your free consultation, call us now at 312-462-1700 or contact us online.
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