Cleveland Defective Drug Attorneys
We Can Help You Recover Compensation
Defective drugs have caused devastating physical injuries to thousands of people — even death. Consumers rely on Food and Drug Administration (FDA) investigations to help protect them from drugs that do more harm than good, without realizing that the understaffed, underfunded, and overworked FDA relies largely on pharmaceutical manufacturers' own information before approving a drug and its warning labels. When dangerous drugs are released to the public, they end up causing serious side effects and other injuries.
Not all side effects mean the product was "dangerous" in the legal sense of being defective. Pharmaceutical drugs are inherently dangerous, but when the manufacturer knew or should have known about harmful side effects that it did not convey to the FDA or doctors, there may be liability.
Contact the legal team at Spangenberg Shibley & Liber LLP to discuss the circumstances of your potential drug injury claim, or a loved one's injury or death that may be linked to a prescription drug.
Types of Drug Cases We Have Handled
FDA Regulation of Consumer Products
The Food and Drug Administration (FDA) is a United States government agency that is responsible for protecting 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.
What Products Are the Regulated by the FDA?
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, and 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 Responsibility of Manufacturers
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 supervision is often not enough to protect the public from dangerous products.
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Spangenberg Shibley & Liber LLP’s groundbreaking litigation helped define this area of the law by challenging dishonest or careless drug makers on products such as:
- The morning sickness drug Thalidomide
- The miscarriage prevention drug DES
- The diet drug Fen-Phen
- Albuterol asthma medication, which was recalled due to contamination
History of Excellence
Our firm has been helping individuals since 1946 and has secured billions of dollars on behalf of our clients.
We go the distance for you and your future fight to obtain maximum compensation on your behalf.
Our trial attorneys have tried hundreds of cases and are not afraid to take your case to trial.
We offer one-on-one attention and detailed counsel. To us you are not just another case number.