FDA Regulation of Potentially Dangerous Products
The Ohio products liability attorneys at Spangenberg Shibley & Liber have proven experience trying cases involving dangerous products. The Food and Drug Administration (FDA) is a United States government agency that is responsible for protecting the public health and welfare by ensuring that pharmaceutical drugs, medical devices and certain other products are safe and effective. This oversight applies to products prescribed and distributed in Ohio and throughout the U.S.
The FDA regulates and approves human drugs, vaccines, blood products and other biologics, and medical devices after appropriate testing is completed by the manufacturer. In addition, the FDA also regulates most foods other than meat and poultry products, including food additives, infant formulas, dietary supplements, electronic products that give off radiation, cosmetics, feed, drugs, and devices used on animals, and tobacco products. All of these products have the potential to be dangerous if they do not comply with FDA regulations, or if they are approved based upon false or incomplete information, which may constitute fraud. There are also some products that are offered for sale without FDA approval, such as dietary supplements, which may be dangerous or cause injury.
The FDA approves new drugs and medical devices based upon the scientific information provided to it by manufacturers, and does not conduct its own testing before approving a product. The FDA also does not guarantee the safety of drugs and medical devices. This means that the ultimate responsibility for the safety of a drug or medical device lies with the manufacturer. The drug or medical device manufacturer is responsible for ensuring that thorough testing is completed prior to selling a product, providing appropriate warnings, and making sure that any necessary changes are made if new information or risks are discovered. If the manufacturer is negligent in its testing or commits fraud in its application for FDA approval, you may be unknowingly exposed to a dangerous product.
Manufacturers and health care providers may voluntarily report problems with drugs and medical devices to the FDA. The FDA monitors the adverse effects that are reported, and these reports may lead to safety alerts and recalls. Not all adverse effects are reported, though, so FDA oversight is often not enough to protect the public from dangerous products.
When FDA Oversight Is Not Enough
Our attorneys know that just because a drug or medical device received FDA approval does not mean the product is safe. It may still be dangerous and can still cause serious injury, permanent physical harm or death. Pharmaceutical companies and medical device manufacturers may know of that risk and fail to warn you. We know that FDA regulation is not enough to guarantee the safety of pharmaceutical drugs, medical devices and other products.
If you or a loved one has suffered an injury that may be related to a pharmaceutical drug, medical device or other product regulated by the FDA, the responsible party should be held accountable. We know how to investigate injuries caused by FDA-regulated products, and our attorneys are here to help you seek compensation if you have been injured by an FDA-regulated product.
Some potentially dangerous drugs and medical devices that are regulated by the FDA include:
- Gadolinium
- Raptiva
- Morphine Sulfate
- YAZ/Yasmin
- Hip replacement devices
- Surgical patches
- Composix Kugel Mesh
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Should you file a lawsuit? You won't know until you talk to an experienced attorney. Contact us or call us at (888) 633-0360 to arrange a free, confidential consultation. You can get answers, find out what happened, and help prevent similar needless injuries from happening to other people, too.
We handle our cases on a contingency-fee basis: if we can't help you recover money damages, you won't pay attorneys' fees. When you meet with us to discuss your case, it will be with an attorney, not an investigator or paralegal. We also have Spanish and Ukrainian interpreters available. Contact us today to get us started on investigating your claim from our Cleveland headquarters.
Experienced, Sophisticated, Reputable.
For more than 65 years, the attorneys at Spangenberg Shibley & Liber have represented victims of dangerous drugs throughout Ohio and beyond. Our attorneys have access to the most sophisticated technical and medical resources available to investigate and prepare your case to win. When the insurance company lawyers see our name on the lawsuit, they know it is well researched, carefully investigated and thoroughly prepared. For you, that means insurance company lawyers come to the table prepared to discuss a full and fair settlement - or we'll see them in court.
Remember, if you have a claim, there is most likely a statute of limitations clock running, after which you won't have the right to file a lawsuit. Protect your rights by contacting us today or calling us at (888) 633-0360.
