Everything You Need to Know About the Dangerous Drug Lyrica (Pregabalin)
Lyrica (generic name Pregabalin) is a pain medication and anti-convulsant. It is prescribed for people who suffer from seizures, such as epilepsy. Unfortunately, it has also been the subject of countless lawsuits across the United States. The problem with Lyrica is that its marketing wasn’t limited to anticonvulsant purposes (after all, the market for people suffering from epilepsy is thin). Instead, it was marketed to doctors in favor of its side-effects (i.e. effects which were not tested nor approved by the Food and Drug Agency (“FDA”). If you were prescribed Lyrica and believe you suffered significant harm from taking it, then you may be entitled to recover damages.
What Is Lyrica? What Does It Do?
Lyrica is an anticonvulsant and painkiller medication manufactured and distributed by Pfizer. It was approved for use by the FDA in 2005. Lyrica was originally approved to treat epilepsy, post-herpetic neuralgia, and diabetic neuropathic pain. In 2007, its approved uses were expanded to treat fibromyalgia. While the true mechanism of Lyrica (i.e. Pregabalin) has never been fully understood, it is known that it reduces the production of some neurotransmitters.
What Gave Rise to The Lawsuits?
Two issues gave rise to the class actions. First, Pfizer marketed Lyrica in two deceptive ways: (1) it didn’t inform patients of the side-effects and (2) the drug was marketed to treat conditions for which it never received approval by the FDA. Lyrica was used to treat patients suffering from chronic pain, perioperative pain (pain you suffer after an operation), and migraines without fully explaining the risks associated with taking the drug. Lyrica was never approved for these uses, nor should it have been marketed for such uses. Lyrica was reserved for patients suffering from extreme pain and seizures, not for garden-variety pain that could be managed with other medications or techniques. Second, many patients who were prescribed Lyrica were not informed of the side-effects, including but not limited to, suicidal thoughts, angioedema, birth defects, and withdrawals.
From 2005 to 2009, Pfizer marketed Lyrica for off-book uses, including diabetic nerve pain. However, in 2009, Pfizer was fined (for Lyrica and three other drugs) a record $2.3 billion by the Department of Justice for fraudulent or misleading marketing. Pfizer also engaged in illegal marketing techniques including inviting doctors to resorts for consultant meetings and paying doctors to stay at the resorts. However, if you think that $2.3 billion is a lot, last year, Pfizer made $34.7 billion on Lyrica sales.
The problem with marketing is that it works. According to a 2011 Congressional Budget Office report, drugs that engaged in direct marketing to patients were prescribed nine times more than drugs that were not. These are powerful market incentives that encourage pharmaceutical companies to risk misleading or false advertising if they can reap the reward of becoming a blockbuster drug. One study found that 40 percent of Americans make an appointment with their doctor after seeing a drug on T.V. they think it relates to one of their conditions. The advertising is designed to get people to think that newer is better – which isn’t necessarily true.
Severe Side Effects
According to the FDA, Lyrica increases the risk of suicidal thoughts in patients taking it and also causes mood changes or shifts. For example, some patients might become more aggressive, depressed or manic. Also, these suicidal thoughts were found to be serious and significantly raised the risk that patients would suffer fatal harm due to intentional ingestion. Lyrica is believed to cause suicidal thoughts in about 1 in every 500 people. Its effects are known to include: (1) anger, irritability, aggression, and agitation, (2) violence, (3) dangerous impulses, (4) worsened depression, (5) panic attacks, (6) anxiety, (7) insomnia and restlessness, and (8) extreme increases in talking or activity.
Furthermore, Lyrica resulted in significant withdrawal symptoms in many patients. For example, patients reported feeling panic, extreme anxiety, and nausea when they tried to taper off or stop taking Lyrica. Other patients also report suicidal thoughts, mood swings, muscle aches, insomnia, and depression. Lyrica withdrawal has also been known to cause increased sweating, headaches, and diarrhea.
Angioedema refers to swelling in the lower layer of the skin and tissue which is just beneath the skin or mucous membranes. The swelling can occur in a broad range of places including the larynx, arms, legs, face, tongue, lips, throat, gums, and abdomen.
A 2016 study found that women who took Lyrica while pregnant were more likely to have babies with major birth defects as against women who did not take Lyrica. The study found that the babies born to women who took Lyrica were six percent more likely to develop major birth defects. Furthermore, women who took Lyrica had a lower live-birth rate (71.9 percent versus 85.2 percent).
Lyrica, like many anticonvulsants, interferes with the way the brain stores memories. Lyrica works for dampening down the central nervous system which also has the effect of clamping down on the storage of new memories.
Finally, the issues described above may not end once you stop taking the drug. Lyrica prevents certain brain functions which impede memory formation but also alters your brain by preventing the formation of new brain synapses. Several studies have found that impeding the development of brain synapses can result in dementia or Alzheimer’s.
Lyrica also has other, more benign, side-effects. For example, Lyrica has been known to cause:
- Weight gain;
- Dry mouth;
- Blurred vision;
- Swelling in feet or hands; and
- Lack of coordination.
Lyrica is also known to cause improved happiness, calmness, euphoria, and excitement which resulted in it being classified as a Schedule V controlled substance.
Should You Take Lyrica?
That isn’t a question this piece can answer; it’s up to you and your doctor to decide it Lyrica is a good fit for your treatment. Lyrica does do what it was designed to do, prevent seizures and reduce pain. However, you should take Lyrica with both eyes wide-open; understand the side-effects and weigh the pros and cons.
State of the Legal Proceedings
There are thousands of Lyrica lawsuits being filed all over the country. However, at this point, no Multidistrict Litigation has been consolidated yet (to be discussed more fully below). But, if the pace of the lawsuits continues, it is highly likely a federal judge will order consolidation at some point.
Lyrica Lawsuit: The Basics
Suits over Lyrica are products liability actions. Products liability is a type of tort lawsuit (a tort is a lawsuit over injuries caused to a person due to another person’s failure to act reasonably). Products liability requires manufacturers, distributors, and retailers to sell products that are safe for the public to use. These rules put the burden on the companies to test their products – rather than on consumers to test them – for safe uses.
Drug companies are routinely the subject of products liability actions. Pfizer, and other drug companies, is required to test medications before releasing them to the market and to market them reasonably. Moreover, just because a drug is licensed by the FDA, does not relieve the company of ongoing duties to test and ensure the product remains safe to use. Essentially, the company must continually work to ensure the product is free from defects.
In this case, there are three potential entities you can sue: (1) Pfizer, (2) the distributor, and (3) the seller. Pfizer is liable because it is the manufacturer and designer of Lyrica. The distributor could be liable if it did not properly store and transport the Lyrica, resulting in damage to the medication and harm to you. Finally, you can sue the seller. The seller could be:
- The pharmacist/pharmacy who prepared your prescription;
- The doctor who recommended it;
- The nurse who administered it; or,
- The hospital who provided it;
Often, who is liable is a combination of many of these groups. An experienced litigator can help you work out who you should sue and not.
Duty to Warn
You probably noticed that Lyrica has unavoidable side-effects due to this operation, therefore how could anyone sue Pfizer if they benefited from the drug but did not like the side effects? Good catch, some products are unavoidably dangerous and thus cannot be made safe. Therefore, you cannot base your lawsuit alone on the side-effects (unless it was unreported or there was an issue with the manufacture of your particular pills). Rather, you can sue if there was inadequate warning. Here, Pfizer fell flat. Pfizer failed in its duty to warn patients of the potential side effects when it began aggressively marketing Lyrica to the public. As stated above, the public relies on Pfizer to inform it of the drugs it manufactures therefore Pfizer has a duty to warn the public.
There are three theories under which you can recover for products liability: (1) strict liability; (2) negligence; and (3) breach of warranty. Under strict liability, you can recover against the manufacturer or seller of Lyrica if you can show that it had a unreasonably dangerous defect that injured you, you took Lyrica in the way it was intended, and the product wasn’t substantially changed from the condition in which you bought it. So, basically, to recover under strict liability you need to prove:
- That Lyrica has a dangerous condition (check, see above);
- You took Lyrica in the way it was intended (if you took it as prescribed by your doctor, check); and
- The Lyrica you took wasn’t substantially changed from when you bought it (so, you can’t put rat poison in your Lyrica and sue Pfizer for the harm you suffer).
Recovering under strict liability is easy because the law purposefully shifts the burden of making products safe from the consumer to the manufacturer/seller. The theory is that the manufacturers are better positioned to test for and remove dangerous conditions from products.
The one exception to recovering under strict liability is if you knew Lyrica had a dangerous condition but continued to use it anyway. However, if Pfizer didn’t adequately warn you or your doctor about the side-effects, then it is unlikely you would be aware of the dangers. Here, a doctor stands between you and Lyrica therefore the burden on you to know the risks is substantially lowered because you rely on the expertise of your doctor and of the truthfulness of Lyrica.
Under negligence, you can recover against Pfizer if you prove that Pfizer was careless in the design or manufacture of Lyrica. Again, you could likely recover because Pfizer engaged in significant marketing strategies that downplayed the risk of the side-effects and marketed Lyrica for off-label uses, such as for migraines.
Finally, you can also recover for breach of warranty. A warranty is a promise that a product will perform as expected for a certain period (years, months, or weeks). The warranties can be implied by law (which will depend on the law of the state in which you reside) or by contract. However, most retail contracts specifically exclude any warranties.
Timeline of a Lawsuit
The exact timelines will depend on your particular state’s laws. However, in general, you can expect to follow these steps. First, you need to hire an attorney. The attorney will investigate your case and prepare the filings. Second, starting the case. The case is started when you file initial papers with the courts. These initial papers inform the defendant(s) that you intend to file a claim. Once the case is filed, you start the third phase – discovery. Discovery can take anywhere from six months to a year or even longer. Discovery is the process by which you request documents, ask questions, and gather evidence to prove your claims (or uncover evidence of new claims). Discovery can often be the longest step in the process if the parties don’t cooperate.
Finally, you go to trial and get a verdict. You can expect the trial to last a few days at least. The verdict is usually issued a month or so after the trial. You can expect the verdict about one to two years after filing your suit. The last step is collection. If the defendant refuses to pay the judgment, you will have to initiate collection procedures which can take an extra year. The duration of the case depends on the complexity of the matters and the amount of money at stake. Also, keep in mind, that at any time you can settle the case – from the moment you file to the moment trial starts.
Class Action vs. Mass Tort
Depending on your injuries, it may not be worth it to pursue a claim, even if you have merit. To solve these issues, many people suffering minor injuries, the class action and mass tort were invented. Both of these actions consolidate many smaller claims into either one big case or coordinated smaller cases to ensure that these claims are not overlooked or ignored by large corporations.
Class actions and mass torts share similar characteristics. They both involve large groups of people who were hurt; the same defendant(s); and the lawsuit is consolidated into one action. Here, suits against Pfizer over Lyrica share the same people (those who took Lyrica); the same Defendant (Lyrica); and are therefore ripe for consolidation as a class action or mass tort.
Class actions are typically used when a diverse group of plaintiffs are injured in the same way by the same defendant. Class actions often, but not always, span multiple states. In class action, the Representative stands for the entire class therefore the entire class is treated as one plaintiff. The class need only prove the specific facts for that one plaintiff for everyone to recover.
The benefits of class actions is that it brings together a large group of people at one time that would otherwise be impractical to bring individually. So, a class action Lyrica suit for people who suffered the minor side-effects and weren’t informed of those side-effects, could be feasible because the injuries suffered are likely too minor to warrant an individual suit but a collected suit it becomes more economical. Class actions are also easier on the class. The class representatives are the only ones intimately involved in the case; the rest of the class will simply receive a check when the case is settled or won.
Conversely, in a mass tort each plaintiff must prove the facts that give rise to their claims. Each plaintiff must prove their own case, however, in the context of a consolidated action. Mass torts are often used when a large number of plaintiffs are affected in the same way in the same geographic area (like a fire or earthquake). In a mass tort, each plaintiff gets a trial on their issue and must prove their claim. However, this isn’t as difficult as it sounds.
Each trial will be personalized to your injuries but the facts learned in one case can often be applied to many other trials, greatly reducing litigation costs.
The downside to class actions is that it greatly reduces the amount each person can recover. Conversely, in a mass tort, you are required to prove your right to recover – including damages. In a mass tort, you can recover more money for your injuries, but you are also required to be more involved in the lawsuit. Mass torts are often used in large accidents, like airplane crashes, and against pharmaceutical and medical supply companies for products liabilities due to defects or other issues.
Class Action vs. Mass Tort
Whether you file suit as a class action or mass tort depends on the situation. Often, mass torts are used because one factor to form the class action is not met. For example, the class must suffer the same common injuries. If the injuries are related but diverse, a mass tort might be the more effective option.
As regarding Lyrica, it is hard to say which action is best because, on the one hand, everyone suffers the same side-effects from the same drug and same company. However, the expression of each side-effect is different for each patient. Furthermore, patients took Lyrica for a broad range of reasons; some more reasonable than others which could also affect recoverability. Finally, patients were deceived to varying degrees; also affecting recovery. A class action might be the best way to go but a mass tort is also feasible. If you have questions, you should consult with your attorney. It is possible, your attorney is already involved in a Lyrica lawsuit and may be able to tell you the best way to get involved.
What Should You Do?
It is important that you balance the side-effects with your lawsuit. Many of the side-effects, such as blurred vision, headaches, and nausea are expected from medications, like Lyrica, that interact with the brain in this manner. You can’t recover for experiencing anticipated side-effects to treat your condition.
However, what isn’t acceptable is Pfizer marketing Lyrica to treat conditions it wasn’t approved for and for failing to inform patients for the extensive side-effects to treat comparatively benign conditions, like migraines. Pfizer is most informed about what its drugs can and can’t do, so it is up to them to keep patients informed of everything they need to know. To a certain extent, you and every other patient relies on Pfizer and other drug companies to market their medications honestly. In this case, Pfizer tried to market Lyrica for uses that it wasn’t approved for – and people suffered for it.
Help Finding a Lyrica (Pregabalin) Lawsuit Near Me
If you need help finding a professional to assist you with a potential Lyrica (Pregabalin) lawsuit near you, contact Consumer Alert Now at (800) 511-0747 for assistance. Consumer Alert Now can help inform callers of ongoing, major lawsuits involving medications, treatments and other complex multi-jurisdiction litigation matters and help guide you to a trusted attorney or law firm for assistance. The Consumer Alert Now website is here to inform you on everything you need to know about the dangerous side-effects of Lyrica (Pregabalin) and what to do if you suffered harm anywhere in the United States.