Company Sued by DOJ for Continuing to Manufacture Unapproved Drugs
On June 20th, the US Department of Justice issued a lawsuit against a Shreveport-based pharmaceutical company for making and distributing unapproved drugs.
Reportedly, this is the second time that Sage Pharmaceuticals has faced federal problems for selling drugs without FDA approval.
The US Food and Drug Administration said that, during an inspection of Sage’s plant in February 2012, they found evidence that the pharmaceutical manufacturer was making and selling unapproved drugs including pain killers, over the counter cold remedies, and wound cleansers. They did not have FDA approval to make or sell these drugs.
Over the past 13 years, says the FDA, they warned Sage Pharmaceuticals that they had to stop making and distributing misbranded and unapproved drugs. In 2000, the government obtained an injunction that barred the company from selling two unapproved drugs.
The lawsuit filed in Thursday seeks a permanent injunction against the medical manufacturer until it complies with FDA regulations.
“Today’s action furthers the FDA’s mission of ensuring that all drugs sold to the public are safe and effective, and those companies that undermine this mission will be held accountable,” Justice Department official Stuart Delery says in a statement.
Unapproved Drugs Could Cause Personal Injury
According to the FDA, part of the reason that unapproved drugs continue to be prescribed and used is because many health care providers hear about the drug, and assume it is a generic version of a name brand drug. “Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.”
Every year, thousands of consumers sustain serious injuries from defective products. Many of these injuries could be avoided if the manufacturers or distributors of these products took additional steps to ensure consumer safety. If a pharmaceutical manufacturer does not receive FDA approval for a drug or medical device before marketing it, whether or not they have done enough studies, they are putting consumers at serious risk for personal injury.
There are a number of reasons that unapproved and defective products make it to our shelves:
- Defective manufacturing
- Inadequate testing
- Design defects
- Marketing Misrepresentation
To protect yourself and your family, it’s important to know what products have been recalled because they are defective or unsafe. Federal agencies such as the FDA (Food and Drug Administration) and the CPSC (U.S. Consumer Product Safety Commission) frequently issue recalls for medical devices, drugs, and products that may be harmful to consumers.
The Strom Law Firm Can Help with Personal Injury Cases Against Unappoved Drugs
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, including unapproved drugs. We represent individuals who have been killed or injured by unapproved, dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using an unapproved drugs or medical products, contact our drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800
