The FDA announced that on October 2, 2014, a complaint was filed in the U.S. District Court for the District of New Jersey, seeking a permanent injunction to stop Pharmaceutical Innovations Inc., a New Jersey pharmaceutical that manufactures and distributes ultrasound, mammography, and electrocardiogram gels as well as scanning pads that are used for diagnostic purposes in health care settings, from manufacturing, marketing, selling, and distributing medical products until it comes into compliance with all applicable FDA requirements.
The FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. That’s why the timing of the filing of the complaint that alleges that the New Jersey pharmaceutical company did not manufacture its devices in conformity with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act, and that it distributed its products nationwide without required premarket approval or clearance, is disturbing.
The FDA contends that it requested in April 2012 (two-and-a-half years ago) for U.S. marshals to seize certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the New Jersey company, after FDA laboratories found significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca in those lots, which are bacteria that pose serious risks of infection, such as pneumonia, to people exposed to the product. The FDA was aware at that time of people who were infected with Pseudomonas aeruginosa after having undergone a surgical procedure at a Michigan hospital involving the company’s Other-Sonic Generic Ultrasound Transmission Gel. The FDA issued a safety alert to health care professionals and facilities to stop using the contaminated product, on April 18, 2012.
If the New Jersey pharmaceutical company’s products had allegedly caused serious injuries to people in Michigan in April 2012, and may have posed an ongoing threat to the health of people using its products, was the FDA too slow in seeking a permanent injunction against the company? Were more people harmed by the allegedly defective products before the FDA took appropriate action to protect people?
The FDA’s statement referencing the delay is discomforting: “Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law. This presents serious health risks to patients who used and continue to use the company’s products. By taking this action, the FDA is demonstrating its commitment to protecting the public from the dangers of adulterated and misbranded medical products.”
If you or a loved one may have suffered injuries or other harms as a result of a pharmaceutical product, you should promptly consult with a local pharmaceutical claim attorney in your state who may investigate your defective product claim for you and represent you in a case against a pharmaceutical company, if appropriate.
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