Mylan EpiPen, EpiPen Jr. Are Being Recalled. Mylan EpiPen Life-Threatening Allergic Reactions. Parker Waichman LLP is investigating potential lawsuits involving Mylan’s EpiPen and EpiPen Jr. These epinephrine auto-injector products are used to treat severe, life-threatening allergic reactions in emergency situations. Certain lots of the EpiPen and EpiPen Jr were recalled in the United States due to a defect that may prevent the devices from working effectively. Mylan also recalled the EpiPen in other countries, after receiving two reports that the auto-injector failed to work during allergic reactions. The EpiPen recall reached Europe, Asia, North America and South America.
Because the EpiPen and EpiPen Jr are used for emergency treatment, a product defect can mean the difference between life and death. These epinephrine auto-injector products are crucial for individuals with severe allergies to foods, drugs, insect bites or stings, and other allergens. If you or someone you know is interested in filing an EpiPen recall lawsuit, contact one of our experienced product defect lawyers today.
How Does EpiPen Work?
EpiPen is used to treat individuals suffering from a life-threatening allergic reaction called anaphylaxis. When someone with a severe allergy encounters the allergen, whether it be a food, insect bite or sting, drugs, or other substance, they can experience symptoms of an allergic reaction. Anaphylaxis is the most severe type of allergic reaction, in which the patient develops hives, swelling, difficulty breathing and narrowing of the airways. Since the body is releasing histamines the blood pressure also drops substantially, leading to shock.
EpiPens inject epinephrine into patients during anaphylaxis. This helps combat the reaction by narrowing blood vessels and opening airways in the respiratory system. In addition to common allergens, EpiPen can also be used to treat anaphylaxis caused by exercise.
Patients should use EpiPen exactly as instructed on the label. The epinephrine is injected into the muscle of the outer thigh; it can penetrate clothing. The effects of EpiPen may only last 10 or 20 minutes, so patients should immediately seek emergency medical treatment after using the device.
EpiPen and EpiPen Jr Recalled Due to Defective Part, Failure to Activate
In March 2017, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of Mylan’s EpiPen and EpiPen Jr Auto-Injector products. According to the agency press release, the affected products may fail to activate due to a defective component. Meridian Medical Technologies manufactures EpiPen, which is distributed by Mylan Specialty.
According to the FDA press release, the recall affects 13 lots of EpiPen and EpiPen Jr Auto-Injectors distributed between Dec. 17, 2015 and Jul.1, 2016 in the United States. Regulators reiterated EpiPen label instructions, which urge consumers to seek emergency medical help right away after using their EpiPens. This is especially crucial if the EpiPen fails to activate.
Since EpiPens are used in life-threatening situations, a product defect can have severe consequences. The release comments that “While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement.”
According to a Mylan press release issued on Mar. 31, 2017, the company received two reports where the device failed to activate due to a potentially faulty component. “The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled,” the company states in the press release.
The generic version of the EpiPen Auto-Injector, which is also distributed by Mylan, is not affected by the recall. The affected devices contain 0.3 mg and 0.15 mg doses.
The week prior, roughly 80,000 EpiPens were recalled in Australia. The country’s Therapeutic Goods Administration (TGA) and Alphapharm reported that four batches were affected by the recall due to a defective part.
According to the Mylan press release, the recall is expanded to include locations in Europe, Asia, and North and South America.
EpiPen Price Scandal: Mylan Criticized and Sued Over Rising Prices of Life-Saving Product
In the summer of 2016, Mylan faced a wave of public and Congressional outrage for hiking up the price of EpiPen. The company has been heavily criticized for allegedly taking advantage of consumers who have no choice but to get the life-saving auto-injector. According to a Fortune article in August 2016, the price of EpiPen went up 500 percent since the product was acquired by Mylan in 2007. Reportedly, the full list price for EpiPen is $608 for a package of two.
In April 2017, a class action racketeering lawsuit was filed against Mylan over the increased cost of EpiPen. The suit alleges that Mylan unlawfully plotted to hike up the price of EpiPen over the past decade. The suit alleges that Mylan’s payments of rebates to pharmacy benefit managers (PBMs) has resulted in “skyrocketing” list prices for EpiPen. PBMs handle prescription drug benefit programs for insurance plans; they include CVS Caremark, Express Scripts and Optum Rx.
According to the lawsuit, Mylan only disclosed that the increased cost of EpiPens were related to rebate payments to the PBMs after facing public outrage in the summer of 2016, CNBC reports.
Although the lawsuit only names Mylan as a defendant, it also asserts that PBMs are partly to blame because they “knowingly made material misstatements to health care payers, plan members, and the general public” regarding the true price of EpiPen. The complaint alleges that the PBMs and Mylan “negotiated the rebates discounting the list price of EpiPen for a purpose other than the PBMs’ own enrichment.”
The lawsuit was filed in the U.S. District Court in Seattle. Plaintiffs allege that Mylan violated consumer protection laws in all states and the Racketeer Influenced and Corrupt Organizations Act.
Mylan has also faced allegations from government agencies regarding EpiPen. Specifically, lawmakers alleged that Mylan underpaid Medicaid rebates by misclassifying the product as a generic as opposed to brand-name. Drug makers must pay 23.1 percent with a branded drug for Medicaid rebates, compared to just 13 percent for a generic.
According to the Centers for Medicare and Medicaid Services, Medicaid paid $797 million for EpiPens between 2011 and 2015. The amount includes rebates. The program paid $960 million before rebates are applied. CMS issued these figures in response to a request from U.S. Senator Amy Klobuchar of Minnesota, Fortune reports.
In October 2016, Mylan agreed to pay $465 million to settle the allegations.
“I am glad the Department of Justice pursued this so quickly,” said Klobuchar. “If other drugs are misclassified, and surely EpiPen isn’t the only one … the taxpayers need to get their money back.”
Meanwhile other lawmakers said the company should have paid more for their alleged actions. “This settlement is a shadow of what it should be – lacking real accountability for Mylan ‘s apparent lawbreaking,” said Senator Richard Blumenthal of Connecticut.