NEW YORK--(BUSINESS WIRE)--Marie Napoli, a partner of national plaintiff litigation firm Napoli Shkolnik PLLC, has released the new consumer brief, Protecting Yourself from Defective Drug Risks During the Age of COVID-19.
The report is free to the public. It details how and why the United States Food & Drug Administration (FDA) recalls some previously approved products and issues warning letters about possible serious side effects linked to other products, including dangerous drugs. In 2016, this entailed more than 8,000 defective products and 14,000 warning letters about possible serious side effects.
The report provides guidance for how consumers can report side effects and other harm to the FDA and gives several examples of drugs that were recalled after being shown to cause injury and death.
In addressing the COVID-19 vaccines now available, Ms. Napoli says:
“Vaccines are largely safe. During normal times, the testing and quality control measures in place by the FDA provide an extra layer of protection against possible problems that may arise. With that said, I am concerned over the safety and well-being of millions of Americans as vaccines for COVID-19 are made available. It is vital that such a preventive cure become approved and adapted by Americans. But the urgent need for having one cannot disrupt or alter the safe scientific methods of clinical trials for continuing to ensure vaccines are safe.”
Marie Napoli draws on her 25 years of experience as a pharmaceutical litigator to prepare this report. She has been involved in many high-level negotiations that resulted in favorable settlements for her clients including the Cuyahoga Opioid Settlement, World Trade Center Litigation, and the pending court approval $641.2M Flint Water Crisis agreement, among many others.
Napoli Shkolnik PLLC has settled several billions of dollars in pharmaceutical litigation and medical malpractice cases for their clients, including the $2.4 Billion Actos® Pharmaceutical Settlement; the $650 Million Pradaxa® Settlement; the $100 Million NuvaRing® Settlement and many others.