On March 31, 2017, Mylan, the distributor of the EpiPen, expanded its voluntary recall of specific lots of the product in the USA, after a separate recall of about 80,000 of the devices in other areas of the world. The initial recall came about through two reports of the lifesaving allergy shot device failing to activate in emergency situations.
The recalled lots of the epinephrine (adrenaline) delivery devices were manufactured by Mylan’s manufacturing partner, Meridian Medical Technologies, a Pfizer company, and distributed to consumers between December 2015 and July 2016. The recall is for the 0.3 mg and 0.15 mg EpiPen Auto-Injector (EpiPen and EpiPen Jr). The generic versions of the EpiPen are not part of the recent recall.
EpiPen Update – FDA issues warning letters to Meridian Medical Technologies
On September 5, 2017, the U.S. Food and Drug Administration (FDA) issued the second of two warning letters to Meridian Medical Technologies, the manufacturer of two epinephrine auto-injectors known as EpiPen and EpiPen Jr. The warning letter outlines significant violations of the current good manufacturing practice (cGMP) requirements for the epinephrine auto-injectors devices.
During an FDA inspection earlier this year, the agency’s inspectors found Meridian Medical had failed to investigate thoroughly auto-injector component failures. The manufacturer failed to sample from an incoming lot of an auto-injector components and investigate customer complaints about EpiPens failing to activate or devices that spontaneously dispensed prior to use.
According to the FDA: “Your response is inadequate. You did not explain why your own investigations failed to identify the scope and frequency of the (b)(4) component defect, or why you had previously concluded that this component defect occurred too infrequently to warrant a market action. You also failed to review all of your investigations to determine whether you had assessed all lots of components and finished products potentially affected by this manufacturing defect. Finally, you did not determine a root cause for any failure-to-activate complaint samples that you determined had functioning (b)(4) and were thus not attributable to the same (b)(4) defect.” FDA called for the company to conduct a comprehensive review.
Meridian also was cited for the following issues: insufficient complaint handling procedures, Quality System regulation violations concerning statistical methodology used to detect recurring quality problems, as well as inadequate validation of the device design. The FDA said Meridian Medical’s responses were inadequate and the company has requested further clarification.
Meridian Medical Technologies has a quality agreement to manufacture the EpiPen products for Mylan Specialty. However, ultimately Meridian Medical Technologies is accountable and responsible for the quality of the epinephrine auto-injectors products it manufactures.
In the warning letter, the FDA stated: “FDA understands the importance of epinephrine auto-injectors and will work to ensure that the company’s corrections are adequate so that patients can be assured of the safety and efficacy of the products,” said FDA in a statement.
The warning letter comes on the heels of a March 31, 2017 of the EpiPen products by Mylan, the distributor of the EpiPen. This expanded voluntary recall of specific lots of the product in the U.S, after a separate recall of approximately 80,000 EpiPen devices in other areas of the world. The initial recall came about through two reports of the lifesaving allergy shot device failing to activate in emergency situations.
The recalled lots of the epinephrine were manufactured by Mylan’s manufacturing partner, Meridian Medical Technologies, a Pfizer company, and distributed to consumers between December 2015 and July 2016. The recall is for the 0.3 mg and 0.15 mg EpiPen Auto-Injector (EpiPen and EpiPen Jr). The generic versions of the EpiPen are not part of the recent recall.
If you or a family member have been injured or affected due to an EpiPen product, Meyers & Flowers is ready to help you explore your legal recourse options. We have successfully litigated on behalf of hundreds of thousands of patients against pharmaceutical companies and medical device manufacturers, such as Mylan. Contact us today at email@example.com, by phone at 877-221-2511 or request a free case evaluation online.
Severe allergies, such as nut, bee sting, soy, reactions to medications and many others, can lead to an anaphylactic reaction that can involve the following life-threatening symptoms:
- Constricted breathing
- Coughing or wheezing
- Tightness in lungs
- Fast, weak pulse
- Low blood pressure
- Dizziness or fainting
- Swelling of throat, face, lips, tongue
- Hives, welts
The symptoms of anaphylactic shock present very quickly after exposure to the allergen, typically within three to thirty minutes. Children who have severe allergies are required to carry an EpiPen with them at all times, and if old enough, be taught to inject themselves. Some severe reactions require more than one injection of the medication. The injection of epinephrine can reverse symptoms within a few minutes. It is imperative that the EpiPen performs as it should. A device that fails to inject the needed medication could lead to death or severe health complications.
Allergens that Trigger Anaphylaxis
Children most commonly have a severe allergic reaction to certain foods, while adults more commonly have an allergic reaction to a medication, but either can occur in any age person. The most common food to trigger anaphylactic reaction include:
Adult triggers are more commonly associated with the following foods:
- All tree nuts
Medications, can also trigger an allergic reaction, most commonly:
- Non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen
- Anti-seizure medications
EpiPen: Potentially Faulty or Defective Products Sold to Patients
With approximately 3.6 million Americans prescribed the EpiPen in 2015, and more than 300,000 doctor visits for severe allergic reactions in children under 18 each year, parents rely upon the EpiPen to provide the needed injection of epinephrine in a health crisis. The recall has many people up-in-arms, concerned that they or their children are unprotected should a severe allergic reaction occur. Although Mylan has promised to replace the recalled devices, patients are warned to continue to carry the current device with them until the replacement arrives.
The devices recalled may have a defect in which the device is difficult to activate, requiring increased force, or fail to activate at all – posing an extreme risk to the health of children and adults who rely on the product to treat a severe allergic reaction.
Will Your EpiPen Work?
Although Mylan reports that the defective products are extremely rare, those who are in possession of EpiPens from the recalled lots are nervous – and for good reason. If on that rare occasion, the device fails to inject the needed medication, the person could be at high risk. Patients are urged to quickly take steps to replace any EpiPen from the recently recalled lots that are in circulation in the USA. Thirteen specific lots of the EpiPen and EpiPen Jr. are subject to the recall, with expiration dates of April 2017, September 2017, and October 2017.
Mylan: A Disturbing History
Mylan came under scrutiny, accused of price gouging, with the cost of the EpiPen increasing from less than $100 to over $600 for a two-pack of the device – an increase of 548% since 2007. Mylan CEO Heather Bresch was forced to testify to the U.S. House Committee on Oversight and Government Reform regarding the outrageous price increase, and Mylan was subsequently fined $465 million after being accused of a false reclassification of the device to allow the company to overcharge Medicaid. Currently, several lawsuits against the company related to the price gouging accusation are moving forward.
Meyers & Flowers: Defective Medical Device Lawyers
Meyers & Flowers represents people injured by defective medical devices, and has garnered a reputation for being one of the premier firms for these cases. The attorneys at the firm are each named in the prestigious 2017 Illinois SuperLawyers® list. If you or a member of your family has suffered severe health complications due to the use of a recalled EpiPen that failed, we can help. Our firm has an extensive track record of favorable outcomes in cases against pharmaceutical companies and medical device manufacturers. Contact us directly at 877-221-2511 or fill in our free online case evaluation form.