FDA Warns EpiPen Makers Over Manufacturing Faults
The U.S. Food and Drug Administration sent a warning letter to Meridian Medical Technologies, a unit of Pfizer, charging that it failed to investigate multiple complaints that some EpiPen auto-injectors, distributed by Mylan N.V., had failed during emergencies, including some that involved fatalities.
September 08, 2017 at 03:49 PM
4 minute read
Makers of the EpiPen failed to investigate multiple complaints that the product malfunctioned during life-threatening emergencies, including some instances in which patients died, the U.S. Food and Drug Administration charged Thursday.
In a warning letter the FDA sent Meridian Medical Technologies Inc. on Tuesday and publicly announced Thursday, the agency told the company that it also failed to adequately respond after the manufacturer identified faults in some of its life-saving allergy auto-injectors. These faults included a failure to activate 171 times between 2014-17, according to user complaints, and the device's failure to deliver the epinephrine in it when needed, the letter said.
The FDA letter advised the company to “correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.” The letter further stated that unresolved violations could prevent other federal agencies from awarding the company contracts.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View All
FTC Sues Cash-Advance Fintech Dave, Says It Deceives the 'Financially Vulnerable'
Policy Wonks' Obsession: What Will Tuesday's Election Mean for FTC Firebrand Khan?
6 minute read
Old Laws, New Tricks: Lawyers Using Patchwork of Creative Legal Theories to Target New Tech
The FTC's Rebecca Slaughter Wants Fair Competition, and a Good Night's Sleep
Trending Stories
- 1Judge Denies Sean Combs Third Bail Bid, Citing Community Safety
- 2Republican FTC Commissioner: 'The Time for Rulemaking by the Biden-Harris FTC Is Over'
- 3NY Appellate Panel Cites Student's Disciplinary History While Sending Negligence Claim Against School District to Trial
- 4A Meta DIG and Its Nvidia Implications
- 5Deception or Coercion? California Supreme Court Grants Review in Jailhouse Confession Case
Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250
