FDA Recalled Drugs
Dangerous Drug Lawyer Helping Victims of Defective Medication
The U.S. Food and Drug Administration (FDA) usually approves between 20 and 30 new drugs every year. Sometimes, after the FDA approves a drug, side effects begin to present themselves. While some side effects can be minor, like headaches and nausea, some can be life altering and permanent, like an increased risk of cancer, stroke, blood clots and death. If you have suffered unwanted side effects from an FDA recalled drug, contact the Dudek Law Firm APC today for a free consultation.
San Diego dangerous drug lawyer Frederick M. Dudek has years of experience dealing with the FDA and drug injury law. He has served on several pharmaceutical litigation committees and acted as chairman of the FDA Litigation Sub Committee. He was also involved in many high-profile cases that involved FDA drug recalls, including Vioxx, Baycol and Fen-Phen. This knowledge and experience is crucial when going up against powerful pharmaceutical companies with seemingly unlimited legal funds; you need someone who knows how the system works.
The FDA Recall Process: How it Works
Reports of defective drugs reach the FDA in a few different ways. The FDA might:
- Discover abnormalities during one of its own investigations
- Receive a report from an agency
- Receive a notice from the Centers for Disease Control
Contrary to a popular misconception, the FDA does not recall the drug itself. Instead, it tells the company that it found a problem with its drug. Most companies then voluntarily issue a recall of their products. If the company fails to do so, the FDA has the power to step in and force a recall. This method usually involves lots of forms and red tape, so the company usually issues the recall itself.
Once the company decides to issue a recall (or the FDA decides to force a recall), the FDA will use media outlets and/or its own website to spread awareness of the recall.
Types of FDA Recalls and Drug Recall Classifications
There are three types of FDA drug recalls: Class I, Class II and Class III.
- Class I: Could cause serious health concerns. The most serious drugs that can cause potentially life-threatening side effects require a Class I recall.
- Class II: Class II recalls pose a less severe risk than drugs classified under Class I. Usually these drugs do not work as well as advertised, or they may cause mild side effects like headaches or nausea.
- Class III: Packaging/manufacturing defects. Class III is the least severe type of FDA recall. These recalls usually involve missing information on the product label, or packaging/manufacturing flaws.
Bad Medication Cause Drug Injuries? Find a Dangerous Drug Lawyer Near You
Have you or a loved one suffered serious side effects because of a drug recalled by the FDA, or even a drug that has not been recalled? Dudek Law Firm APC can help. Our personal injury attorney will take the time to listen to your story, collect all the documents and do everything he can to provide you with some peace of mind after a horrific and unexpected encounter with a dangerous drug. Contact us today for a free consultation – Fred normally provides legal services on a contingency fee basis, so you do not pay anything unless he wins your case.