When you go to the doctor and are prescribed medication, you have the inherent trust that the prescription you receive is going to help fix you, not make you worse. Since nearly 50% of the United States’ population is on a prescribed medicine and many of these people take more than one, it is essential that they trust the manufacturer to do their job and the doctor to know and make them aware of all of the side effects.
But over the past decade, recalls from defective drug and medical devices have increased significantly. Dangerous medical devices have injured thousands of users due to their defects and many drugs have been recalled because of their potential to cause high-risk or even fatal injuries.
Many of these prescriptions were intended to regulate important bodily functions like blood pressure, testosterone, and sugar. Instead, the recalls send users panicking to their doctors and the physicians scrambling to soothe the patients’ fears. They then have to try to replace the recalled drug with a suitable substitute when possible – and it’s not always possible.
One would think that with a global pharmaceuticals market worth an estimated $934.8 billion recently and projected to reach $1170 billion by 2021, the checks and balances to ensure that each drug was safe and effective before it reached the market would be accurate. But it seems that getting that next big drug to the shelves before the competition has become a priority over patient safety, and patients are paying the price in more ways than one.
The Good and Bad Side of Medical Device and Drug Recalls
A recall of a drug or device happens when it is deemed to be defective or can cause harm to the public that is using it. As defined by the FDA, recalls are “a method of removing or correcting products that are in violation of laws administered by the U.S. Food and Drug Administration,” and they take their jobs seriously.
The FDA regulates drugs, medical devices, vaccines, blood and blood products, radiation-emitting products, and transplantable human tissue. All these products may be recalled at any time, but the manufacturer must be the one to initiate the recall. The FDA can’t force it; they can only recommend one. Because of this missing link in the chain of events for drug recalls, a company can choose to leave a dangerous drug or device on the market for use for as long as it wants to and the patient taking it is none the wiser.
Social media and ease of access of news mean that headlines can spread like wildfire, even when they are not quite as bad as they are made to seem. That means that many of the medical device or drug recalls that are seen on the news are blown out of proportion. Sometimes the drug recalls are due to a simple bad batch and the patient can call the pharmacy to see if theirs was part of the recall. Then they can get a new batch.
In other cases, the recall was due to an error in the labeling process or another small problem. These are not likely to cause any harm to the patient, but rules and guidelines require that a recall be issued. The words “medical drug recall” often set off hotbeds of inaccurate conversation and fear so that a minor recall can be a major scare for many users.
In still other recalls, though, that fear is justified. Many medical product recalls are due to dangerous products that could cause or already have caused serious bodily injury or death. The FDA has an adverse-warning campaign called MedWatch specifically for the consumer to take control of their medication use and ensure it is not on the list of potentially hazardous medications.
This site is updated monthly and gives the reader safety alerts for human medical products. Any recall that has been recently announced can be found on the MedWatch site. As a preventative measure, it works great. You can avoid taking anything that is listed as recalled. But what if you are already taking it or are using the device?
Drug recalls are quite common and are listed by the FDA as voluntary. If you hear of your medication being recalled, talk to your pharmacist and your doctor before you decide to stop taking it. It may be a minor recall and to stop taking your medicine could cause you more harm than to continue taking the recalled drug.
Choosing what to do after you find out your prescription has been recalled largely depends on the reason for the recall. Just because a medication is FDA approved or cleared does not necessarily mean that that drug is completely safe. As more people use the drug or device, the side effects become more evident. Those side effects may be significant enough to result in a recall or safety alert.
Why are Medical Drugs and Device Recalls Skyrocketing?
Recent studies have shown that the death toll in the United States from adverse effects to prescription medications has climbed to over 100,000 people per year. These medications were almost always prescribed correctly. They were medications that were approved by the FDA. Yet they still killed the user.
Beyond these deaths, over two million people annually were injured by adverse reactions to their prescriptions. That’s over two million individuals who trusted their doctor, who trusted the pharmacy, who dropped the ball somewhere between making a profit and patient safety and efficacy.
Medical devices fall in the same category, with thousands of defective devices recalled every year. These medical devices have included sterile drug products, breast implants, baby product warmers, endotracheal tubes, and ventilators, to name a few. Adverse reactions to these products can result in terrifying, tragic consequences.
So why are these recalls skyrocketing recently? The general consensus seems to be that since so many people want a large part of the pharmaceutical pie, the competition is fierce. This drug competition results in the first company to the market being the winner, but safety is often compromised in the name of speed. Quality control practices are often cut out in exchange for profit.
Most medications require a thorough process to be completed before they are FDA approved. This process includes:
- An FDA reviewed analysis of the intended use of the drug. The FDA will determine the context of the drug’s use and any risks and benefits associated with it.
- An FDA reviewed assessment of those risks and benefits as per clinical data. The drug maker submits data that supports the use of the medication. These results are supposed to come from at least two clinical trials. The potential to help treat the targeted condition should outweigh any possible risks.
- A strategy for managing risks. Since there is a potential risk involved with taking any drug, risk management strategies must be created before the drug will be approved.
The assessments and decisions are not always clear-cut. When they are uncertain and are approved anyway, for whatever reason, there may be unexpected side effects that result in recalls.
Personal Injury Claims on the Rise Due to Drug Recalls
According to the FDA, medical device defects or potentially dangerous drugs that are recalled can be corrected by the company while the device or drug stays on the market or they can be removed completely, returned to the manufacturer to be corrected, or removed completely and not returned to the market at all.
The solution to the recall may depend on the class of the device or pharmaceutical recall itself.
- Class I recalls are considered to pose a reasonable chance of serious health problems and possibly fatal injuries.
- Class II recalls may cause temporary health problems or conditions that can be reversed. There may be a small risk of serious health conditions or death.
- Class III recalls occur when the device or drug is not likely to cause any injuries or health problems.
It is common for a class action lawsuit to follow a recall of a drug or medical device. These lawsuits occur when many plaintiffs with common injuries that stemmed from the recalled product come together to file a claim against the defendant. But in these lawsuits, your story is not shared, and your injuries are not considered. You will receive a general compensation based on the average injury, regardless of your suffering.
It is possible to opt out of the class action lawsuit and file an individual claim. When you retain the knowledgeable attorneys at Hershey Law to represent you against the manufacturer, your story will be heard and your injuries will be made clear to the accountable party. Your damages and compensation will be specific to your unique set of circumstances.
If you were injured by a medical drug or device that was recalled, call Hershey Law for your free consultation before you opt in with any class action lawsuit. Learn your rights and legal options from the experts before you follow the crowd.