Drug Recalls – What You Need To Know
Thousands of drugs are voluntarily recalled every year. Some recalls are issued by pharmaceutical companies, while others are issued by the FDA. The purpose of a drug recall is to protect the public from possible risks associated with a prescription drug. While this can prevent future harm, recalls do little to help victims who have already been injured.
State and federal laws offer protections to patients who are injured by dangerous drugs in the United States. If you have been harmed because of a defective drug you have the right to assert those protections by filing a product liability lawsuit. The company responsible for putting that defective drug in your hands can be held strictly liable for your injuries.
- 1 How Do Defective Drugs Get FDA Approval?
- 2 When Are Drugs Recalled in the United States?
- 3 Are Drug Companies Automatically Liable When They Issue a Recall?
- 4 Can Issuing a Drug Recall Shield Companies From Liability?
- 5 What Are the Grounds For Filing a Drug Recall Lawsuit?
- 6 Should I Join a Class Action or File My Own Claim?
How Do Defective Drugs Get FDA Approval?
Before a drug can be sold or prescribed in the United States, it must be approved for use by the FDA. Applications for approval must include information about the drug’s intended use and evidence that it is effective. Companies pitching new medications have an obligation to make sure that drugs are thoroughly vetted through clinical testing procedures.
The FDA receives thousands of applications for new drugs every year. While the agency demands compliance with a 5-step process, it really lacks the ability to review each application with the attention it deserves. As a result, the FDA puts a lot of trust into pharmaceutical companies and relies on them to do their due diligence and make sure that drugs are safe for consumer use.
Drug companies are notorious for taking advantage of the stressed FDA approval process. Many cut corners and fail to put medications through extensive clinical tests. As a result, companies aren’t really fully aware of all potential side effects or the long-term consequences of using the new medication. Patients end up being the real test subjects. Dangerous side effects and risks may only become evident once the drug has been widely used for many years.
When Are Drugs Recalled in the United States?
Recalls are voluntary and can be issued by private companies or the FDA. Recalls may be disclosed publicly or issued privately to healthcare providers and pharmacists. Recalls can be issued when one or more person reports a previously unknown or undisclosed risk associated with a specific drug. The likelihood of a recall increases with each additional report.
Drug recalls are classified into one of three categories. Alerts to the public about drug recalls will often depend on which classification has been chosen for a specific drug.
- Class I Recalls: Issued for drugs that “could cause serious health problems or death.”
- Class I Recalls: Issued for drugs that “might cause a temporary health problem” or “pose a slight threat of a serious nature.
- Class III Recalls: Issued for drugs that violate FDA labeling or manufacturing laws but that are “unlikely to cause adverse health reactions.”
Class I recalls are reserved the most serious health risks, while Class III recalls are more of a warning that a drug could potentially be dangerous because of legal violations.
Are Drug Companies Automatically Liable When They Issue a Recall?
No. Drug companies are encouraged to issue a voluntary recall whenever a possibility exists that a drug could pose a threat to patient health. If issuing a recall automatically caused a company to be liable, few would take this important step. However, the fact that a company issued a safety recall can be helpful if you decide to file a personal injury lawsuit. You could use the recall to help establish essential elements in your case.
Can Issuing a Drug Recall Shield Companies From Liability?
No. Again, drug recalls are issued for the sole purpose of protecting patients from possible health risks. The fact that a company voluntarily issued a drug recall will not shield them from liability if they are sued for damage caused by that drug. These companies can be held strictly liable for injuries caused by the medications they design and sell. This means that patients do not have to prove that a company was negligent or knew about the defect.
Instead, strict liability forces companies to make sure that they take all steps necessary to ensure that products are safe for consumer use. If a company misses something or cuts corners to save time and money, they can be liable for harm in the future. The fact that they later issued a recall for a danger they should have caught earlier is irrelevant.
What Are the Grounds For Filing a Drug Recall Lawsuit?
Product liability laws can be used to hold companies responsible for the products they design, manufacture, and/or sell. Injured patients typically approach these cases using one of three arguments: manufacturing defect, design defect, or failure to warn.
Manufacturing Defect: The drug contains a defect that exists because of how the product was manufactured. It was not manufactured according to its design specifications.
Design Defect: The drug contains a defect that is inherent in its design. This defect makes the product unreasonably dangerous.
Failure to Warn: Companies have an obligation to disclose any risks or hazards that it knows or should know about.
Should I Join a Class Action or File My Own Claim?
Class action lawsuits aren’t uncommon when a recalled drug has caused a lot of damage. In a class action suit, victims who have very similar cases band together and pursue compensation as one. This can be beneficial when multiple victims have few resources. Class actions can draw attention and make it more difficult for a drug company to escape liability. When a class action is successful, each victim in the class receives a portion of the financial award.
You’re not required to join a class action lawsuit if you’ve been injured because of a recalled drug. Filing a lawsuit on your own gives you more flexibility and control over your case. You’ll also be able to enjoy the entirety of your settlement or award without sharing with other victims. However, it can be more expens
ive and time-consuming to pursue a case on your own.
The best thing to do is consult with an experienced personal injury lawyer. Your attorney will review your case and help you understand all of the legal options available to you. With this information in hand, you can make an informed decision about the path you’d like to take. Your attorney can help to answer any questions you may have.
Sagi Shaked is the founding attorney at Shaked Law Personal Injury Lawyers, an injury law firm in Miami, FL. As an experienced personal injury lawyer, attorney Sagi has handled thousands of successful cases including product liability cases.