When you take a prescription or an over-the-counter drug, there are warnings regarding side effects or contraindications included in the packaging. However, these medications often have hidden problems that do not come to light until a recall is issued. Such issues include serious, even deadly, side effects due to drug interactions or defective drugs.
An experienced Pennsylvania drug recall lawyer at The Rothenberg Law Firm can help you receive compensation for injuries suffered from taking defective drugs. Schedule a free consultation so we can answer your questions and assess your case.
When are Drugs Recalled?
The U.S. Food and Drug Administration (FDA) defines a recall as “a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.”
A recall is an alternative to the FDA initiating court action for removing or correcting products distributed to the public. Companies can recall drugs on their own after receiving evidence that the medication is causing side effects that are not addressed in the packaging. Most drug recalls fall into this voluntary capacity.
The FDA asks that the manufacturer recall drugs after determining the product is in violation of its regulations after finding problems during drug manufacturing inspections or reports from patients or healthcare providers. Should the manufacturer refuse to recall the drug, the FDA will pursue legal action to get the product off the market.
As per the FDA, a recall action is the most effective way to protect the public from a defective or potentially harmful product. Top recall issues include:
- Rare side effects missed in clinical trials
- Incorrect labeling
- Improper storage
What are the Different Types of FDA Recalls?
The FDA has three types of drug recall classifications based on levels of severity.
- Class I–A dangerous drug or product that can cause serious health problems or prove fatal. These recalls are nearly always publicized via the media as the FDA wants the public to know about the danger. In 2022, just 6 percent of recalls fell into Class I.
- Class II– A drug or product that could cause a less serious or temporary health issue. This type of recall is less likely to be publicized widely, although it makes up the overwhelming majority of recalls. The FDA lists all recalls in its weekly enforcement report.
- Class III–A drug or product that may not cause adverse reactions but violates FDA manufacturing or labeling laws. This type of recall is the least likely to receive media attention.
Drug Recall Lawsuits We Handle
At The Rothenberg Law Firm, we have won and collected billions of dollars for our injured clients over the past 50 years.
Examples of recent dangerous drugs are:
- Nexium and other proton pump inhibitors
- Xeljanz and Xeljanz XR
Who is Liable for a Drug Recall?
Liability for a drug recall depends on factors surrounding the drug’s deficiency. While pharmaceutical companies generally hold the greatest liability for drug recalls–if the product is defective in its design–it is often during the manufacturing process that problems arise. Drug manufacturers may not make the medication correctly, or the product may become contaminated or adulterated. Mislabeling may also occur.
Marketing is another area of liability. A drug may not have inherent defects but is marketed for medical conditions for which it is not the appropriate treatment. It is not unusual for a drug to prove safe and effective for the purpose for which it received FDA approval. However, side effects happen when the drug is taken for a different issue.
What is the Statute of Limitations for Filing a Defective Drug Lawsuit?
In Pennsylvania, the statute of limitations for filing a personal injury lawsuit is two years from the date of the injury. There are exceptions to this deadline. When it comes to defective drugs, the victim may not realize their injuries resulted from taking the recalled medication. Under such circumstances, the statute of limitations kicks in when the injured person discovers that a defective drug caused their illness or medical condition.
If a person succumbed to the effects of a defective drug, their family members have two years from the death date in which to file a wrongful death lawsuit.
Finally, compensation, or damages, in defective drug lawsuits may include medical expenses, present and future, lost wages, loss of earning potential, disability, and pain and suffering.
How Our Pennsylvania Drug Recall Lawyers Can Help You
If you or someone you know has been injured from defective drugs, you need the services of a Pennsylvania personal injury attorney at The Rothenberg Law Firm. We leverage our considerable resources and experience to fight for your right to fair compensation for your damages. In addition, we work on a contingency basis, so there are no upfront fees. We look forward to hearing from you.