Drug Side Effects Explained
Although drug companies are required to report and depict all possible side effects associated with their products, they often do not do so clearly or comprehensively. Even where they directly inform patients of a product’s possible side effects, there is a tendency in the industry to downplay or diminish the significance of the risk. A patient taking an antidepressant or other mind-altering medication, for example, is not likely to be surprised at the prospect of drowsiness, but he or she may not find it reasonable to be at risk of uncontrolled seizures or permanent memory loss .
North America has one of the most heavily regulated drug industries in the world, and consumers are generally very well protected. This does not mean, however, that every protean or potentially life-threatening side effect is documented or disclosed. For this reason, patients should always contact a doctor about any unexpected or potentially serious side effects that are experienced while taking a drug.
Specific time limits apply to lawsuits alleging pharmaceutical side effects and patients need to be sure to obtain competent advice.
Grounds for Suing Pharmaceutical Companies for Side Effects
The legal grounds on which you may sue a pharmaceutical company typically involve product liability claims. These claims allege that the manufacturing process of a product caused it to be defective or that the product is otherwise inherently dangerous and unsuitable for consumption. In addition to product liability cases, there are also negligence and failure to warn claims against drug manufacturers. These claims allege that the manufacturer failed to properly warn consumers about the potential side effects associated with their products, which resulted in injury or illness.
In order to have grounds to file a lawsuit against a pharmaceutical company, you must be able to demonstrate that you are suffering from medical problems related to the drug and that you would not have been injured had you known about the risks of the medication.
In many cases, these firms handle product liability and other cases on contingency fees, meaning that you will not owe any money unless the case is won. It is important to consult with an experienced California pharmaceutical litigation attorney in order to explore your options.
Steps in Filing a Lawsuit for Drug Side Effects
When it comes to filing a lawsuit over an adverse effect of a medication, the first step is to decide whether the product is a prescription or over-the-counter (OTC) substance. If the substance is an over-the-counter drug, in which the company has provided warnings explaining uses, recommended dosages and precautions, the issue of negligence can be more difficult to prove. The reason is that OTC drugs are sold in pharmacies and supermarkets for safe self-dispensing. Unless FDA approved, there is no liability imposed upon the manufacturer in most cases. If the drug is prescription (Rx), there is a different set of prerequisites. Today, pharmaceutical companies provide detailed documentation to physicians and pharmacists that details all aspects of the drug, including warnings, dosage, as well as training in how to properly dispel the drug to consumers. As a result, when an adverse effect takes place, two considerations can be addressed when bringing a suit: Whether the company provided sufficient warnings, or Whether proper training was provided to the distributor or consumer.
Causation in a Drug Side Effect Lawsuit
The biggest challenge in a case involving adverse drug effects is proving that the side effect was indeed a result of a particular drug taken by a plaintiff. When a medication has multiple known side effects, a defendant may argue that the side effects suffered by a plaintiff were the result of something other than the medication in question. For example, a plaintiff that suffers liver damage may be accused of having suffered the injury as a result of excessive alcohol or drug use.
In order to prove causation, and that the drug in question caused the plaintiff’s injury, a plaintiff must provide medical records, testimony from the plaintiff’s doctor, and expert medical testimony. Medical records should include test results and diagnoses confirming that the plaintiff suffers from the claimed injury. Testimony from the plaintiff’s doctor is often used to confirm that, based on the doctor’s knowledge of all of a plaintiff’s health issues, the doctor cannot confirm another cause for the plaintiff’s injury.
However, expert medical testimony is often necessary to solidify a plaintiff’s case and provide evidence that a drug caused a side effect or injury. In cases involving a plaintiff that suffers from multiple health issues, it may be impossible to prove that one specific issue was the result of a particular medication without the help of an expert. An expert medical witness can provide an opinion regarding the cause of a plaintiff’s injuries that is based upon review of the plaintiff’s medical records and other medical literature.
In addition to testimony from an expert, pharmaceutical company defendants often present opposing experts. These experts will attempt to confirm that there are known causes for a plaintiff’s injuries other than the drug in question. Unfortunately for plaintiffs, despite the evidence that they can provide, frustration is often required and many cases are brought to or through trial before a settlement can be reached.
Possible Damages
If you are successful in your lawsuit against a pharmaceutical company, you may be entitled to the following forms of compensation:
Medical Expenses
This amount would be any of your medical bills up to that point. It would include the costs of treating your specific side effects from taking the medication in question, and would likely be a large part of any settlement or award received.
Lost Wages
Lost wages would be the income you would have received had you not experienced the side effects of the medications you took. This would include missed work days, lower pay as a result of medical leave , etc.
Pain and Suffering
Pain and suffering compensatory damages would be any compensation beyond the medical expenses. It would take into account pain and suffering related to the side effects you suffered, your emotional distress as a result of being injured by a medication you took, and compensation for any disfigurement or loss of enjoyment of life.
Punitive Damages
Punitive damages are awarded when the jury or judge decides that the defendant acted with recklessness, malice or deceit. They can be substantial and are generally meant to punish the negligent party for their behavior.
Examples of Cases and Precedents
There have been numerous individual lawsuits against pharmaceutical companies in the past that have ended in significant settlements and verdicts:
• In May 2017, a federal jury found Johnson & Johnson liable for $325 million in damages because of injuries suffered by a child who took Johnson & Johnson’s drug Risperdal. According to the plaintiff’s arguments in court, Johnson & Johnson did not properly label the drug, which was intended to be used by adult patients. The plaintiff also claimed that the drug caused him to suffer from gynecomastia, a condition that causes swelling of breast tissue on men.
• In November 2016, the husband of a plaintiff suffered injuries related to testosterone replacement therapy. The lawsuit claimed that pharmaceutical companies including AbbVie and AbbVie’s subsidiary tested, marketed and distributed AndroGel, failing in their duties to provide warning about the side effects of the drug. The plaintiff won $150 million in that case. Back in 2008, AbbVie also paid $1.6 million to settle a claim that AndroGel caused a plaintiff to suffer heart problems after taking the medication.
• In 2014, a Texas jury awarded $29.1 million in total to a plaintiff who suffered injuries because of Johnson & Johnson drug Risperdal. The plaintiff claimed that the drug caused gynecomastia. This case has become one of hundreds of cases plaintiff’s have allegedly won with suits against Johnson & Johnson regarding its drugs.
Hiring the Right Lawyer for Your Case
Finding an attorney with pharmaceutical litigation experience is essential when considering legal action against a manufacturer. It is best to select an attorney who regularly engages the defense of the pharmaceutical industry and understands the ins and outs of these rather complicated cases. There are several considerations when determining whether a particular attorney is a good fit. First, it is imperative that the client have confidence in the attorney’s ability. If you do not trust the attorney, you will not be able to follow the advice given, and again, confidence is key. Second, the attorney must be accessible and responsive. If you go days or weeks without hearing from the attorney, your level of frustration – and stress – will increase. Quick responses are therefore critical. Third, the attorney must be connected. We mean that the attorney you choose should have a reliable support system and trusted network. This is crucial to the success of your case. Other attorneys, law firms, legal teams, and supporting medical, scientific, and technical consulting are imperative to the efficient handling of large pharmaceutical litigation cases. So ask, who will be handling my case if you transfer firms or change jobs? Will there be anyone else working on the case? Do they have specialized assistant support? Fourth, the attorney you choose should not be afraid to go to trial. This may seem an obvious matter, but the realities of litigation are that you will be faced with a mountain of paper, experts who need to be deposed, attorneys who will do everything in their power to crush the case, obstacles at every turn, and plenty of difficult moments. Therefore it is important that the attorney you hire knows how to navigate these complexities, and remain calm while doing so. Choosing the right attorney is a very personal choice. Ultimately, you need to feel comfortable with the person who will be protecting your rights in the courtroom. As lawyers, we try to be informative, communicative, personal, and proactive in all cases we handle. But we cannot choose your attorney for you. It is up to you to research thoroughly, make an informed decision, and trust your instincts when choosing legal representation for your case.
Pitfalls and Risks
While the merits of suing large pharmaceutical companies for injuries sustained from medications are often compelling, the process of doing so is not without its challenges and critical risks. One of the largest hurdles is a powerful legal defense. Pharmaceutical companies tend to face lawsuits not as a matter of company policy, but as a matter of course because the claims against them are so numerous and so significant.
In situations where there is a verifiable and compelling link between the medication and the health outcome, this is often not an issue of law; it’s often more of an issue of economics. Settlements of claims are often very lucrative and, therefore, large pharmaceutical companies will invest significant resources in defending those claims simply to protect those assets. It is not uncommon for pharmaceutical companies to spend millions of dollars defending claims that only involve tens of thousands of dollars. This is a valuable lesson for anyone considering legal action against a pharmaceutical company. You must be willing to invest both the time and resources into a lawsuit.
The time commitment can be substantial. Lawsuits can often take three or four years, even once they’re filed. This can be even longer if cases are taken to trial , which means the time commitment is that much more substantial.
The economic commitment has significant ups and downs. There are many situations where pharmaceutical companies will make initial offers well below the value of the claims involved because their legal counsel can be very persuasive in dissuading a plaintiff from pursuing their case further. One of the virtues of a client-plaintiff relationship is that is can move forward with objectivity and not be swayed under the influence of these coercive offers.
On the other hand, once settlements have been reached (or judgments rendered), the equivalent value of that asset is often very high. Sometimes, as much as a portion of that value can be paid immediately after a settlement, but much more is earmarked under various types of agreements. For example, some settlements can include provisions requiring the plaintiff to make specific disclosures to healthcare providers about the case and the vaccine at issue. This is why it is very important to be realistic, honest, and forthcoming with your attorney to help them make the very best and most strategic decisions in these cases.
What remains absolutely critical, though, is for you to move forward with a good understanding of the various risks and benefits of suing pharmaceutical companies and to be open, and honest, with your legal counsel to help them mount the very best claim possible based on the circumstances.