In a letter of warning to VPR Brands, Food and Drug Administration Commissioner Dr. Robert Califf said the company’s nicotine gummies are “a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year.”
According to the manufacturer, the tobacco-free products were meant to “empower adult smokers with the tools to use nicotine on their own terms.” But the gummies’ bright colors and fruit flavors like blueraz, cherry bomb, and pineapple could also appeal to kids. VPR Brands bowed to regulatory pressure and withdrew the gummies, but observers fear other similar products may be in the pipeline.
“The FDA oversight of these products is not going as fast as it needs to be,” opined American Lung Association Assistant Vice President Erika Sward. “I think until the FDA shows that they’re serious about cracking down on these companies that are coming out with these products, it’s going to continue to be a problem,” she added.
FDA’s Regulatory Power
Public pressure is a very common FDA tactic. That’s primarily because, in most cases, it’s the only available tactic. The FDA does have the power to suspend marketing activities and statutory authority to take defective medical devices off store shelves.
A recall may be an inadequate remedy. The FDA only applies public pressure or other adverse action based on concrete evidence of serious injuries. Hundreds or thousands of people have been hurt by the time this agency decides to do something.
Furthermore, a recall does nothing to compensate the victims of nicotine gummies or other hazardous products. Only a New York dangerous drug lawyer can do that.
Failure to Warn Claims
When a new product hits store shelves, these manufacturers must sell as many pills and/or gadgets as quickly as possible, to recoup staggering development. To keep demand high, companies may fail to warn consumers about known risks.
Frequently, manufacturers suppress negative information. That’s especially true regarding serious side-effects, like cancer and heart failure, which are all too common.
Usually, such data only comes to light after a New York dangerous drug lawyer files a legal action. During a lawsuit’s discovery process, each side has a legal duty to turn over all information in their possession regarding the claims and defenses in such action.
Other times, companies hide potentially dangerous side-effects on a long list of side-effects.
Usually, attorneys use failure to warn claims to obtain compensation if the drug or device was properly made yet is still dangerous. If the victim had a pre-existing medical condition that enhanced the danger, maximum compensation is usually still available, thanks to the eggshell skull rule.
Since failure to warn is a negligence claim, various negligence defenses, such as comparative fault, are available.
Defective Drug Claims
Other drug injury claims hinge on product defects. Generally, companies are strictly liable for injuries their defective products cause. Common product defects include:
- Manufacturing Defect: Cost-conscious companies often take cost-saving shortcuts during the manufacturing and shipping process. Common shortcuts include cheap materials and lack of oversight. A slight manufacturing defect could cause a serious injury.
- Design Defect: Recently, Congress reduced the medical drug and device exclusivity period. Once cheaper generic products appear, companies make less money. In the rush to get their products approved, companies often take shortcuts during the design process.
Damages in a negligence or strict liability claim usually include compensation for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages are often available in these cases as well, if there’s clear and convincing evidence that the company intentionally disregarded a known risk.
Consumers are often at the mercy of unsafe drugs. For a free consultation with an experienced dangerous drug lawyer in New York, contact Napoli Shkolnik, PLLC. We do not charge upfront legal fees and only recover a fee when we win your case.