Dangerous Drugs Basics

Dangerous Drug Law Basics 101

     As a consumer, it is important to know what drugs may impact your health. We trust our doctors, the Food and Drug Administration (a government agency), and various pharmaceutical companies with our healthcare needs. When it comes to people taking prescription medication in the United States, around 70% of consumers take at least one prescription medication. It is hard to believe that drugs designed to make us better could end up killing us. Accordingly, when a consumer is harmed by a drug deemed dangerous, there may be an opportunity to be compensated depending on the circumstances.

Prescriptions versus Over-the-Counter Medications and the FDA Approval Process

     Dangerous drug cases can be brought with respect to both prescription and over-the-counter medications. Although prescription drug cases are more common than OTC cases, they are not unheard of. As you likely already know, prescription medications are those authorized by a medical doctor, received, and paid for at a pharmacy, used to treat one person. To be legally sold in the U.S, the prescription medication must be approved by the FDA, which is done by submitting a New Drug Application to the FDA. The application must include important data concerning animal and human testing, the process by which it is created, and details about how it works within a person’s body to treat the condition it is intended to treat.

     Certainly, the approval process with respect to OTC medications is much less complex and doesn’t involve the rigor that is required with prescription medications. An OTC medication is approved by the FDA by comparing its labeling, acceptable ingredients, and dosing to already-approved OTC medications. To date, there are 700 or more OTC medications on the shelves today.

The Food and Drug Administration

     The Food and Drug Administration (FDA) plays an important role in dangerous drug law, as the FDA is the government entity approving certain drugs to be sold on the open market. Every year, the FDA approves hundreds of drugs. However, this neither guarantees that all approved drugs will work, nor that they won’t harm consumers using the drug. While the FDA cannot allow dangerous drugs to be sold on the market, many times, it won’t be discovered that the drug is dangerous until it’s already in circulation. Many times, a drug can be on the market decades prior to concerns being raised about its safety or the drug being formally recalled. Accordingly, many people consuming dangerous drugs can take these drugs over a several year period prior to experiencing any harmful side effects.

While the FDA used to be a government entity that consumers could count on, the FDA is not as consumer centered as it used to be, and there is significant evidence indicating that the FDA does not engage in the policing and regulation that it should. The FDA is undeniably influenced by big pharma, policy makers, and pharmaceutical lobbyists promoting drug related legislation, such as the Prescription Drug User Fee Act.

Dangerous Drug Warnings

     You may be wondering why pharmaceutical companies do not place more robust warnings on the inserts that come packaged with almost every drug available. The answer is obvious: money. When big pharmaceutical companies place warnings encompassing every potential harm that could result by taking a particular drug, doctors are less likely to prescribe those drugs to their patients. Generally, several drugs may be available to treat the same condition, creating competition amongst pharmaceutical companies, and making it less likely that any given pharmaceutical company will be motivated to disclose potentially dangerous side effects. However, when adequate warnings aren’t provided, consumers aren’t able to appreciate the risks associated with the various drugs they are taking and are ostensibly robbed of the opportunity to make informed decisions when it comes to their healthcare needs.  

     At times, the FDA requires certain warnings be disclosed when serious and/or deadly conditions and side effects can result by taking a particular drug. These warnings are called “black box warnings” and are considered the most serious warning available. To have a black box warning, medications must undergo extensive observations, studies, and testing to reveal the drug’s impact. Although black box warnings would reduce dangerous drug cases and the number of consumers damaged, black box warnings often aren’t placed on drugs until it’s too late. Generally, black box warnings are only given once a drug has been placed in the open market and its dangerous properties can be realized. Accordingly, when it comes to these warnings, consumers are often pharmaceutical companies’ guinea pigs.

     These warnings, although having some positive impact on risk reduction to consumers, are not guaranteed to be adequate and protect against all potential risks. There have been strong concerns surrounding whether medical doctors properly understand black box warnings themselves and can adequately warn their patients about potential consequences in taking drugs with black box warnings. Conversely, black box warnings can also discourage consumers who need the medication to treat an otherwise incurable disease. Many drugs with black box warnings are used to treat specific conditions that no other drug or treatment can cure.

     It is important to understand that black box warnings can also be removed, many times without good cause or evidence to suggest that the warning should be removed. This calls the FDA’s transparency into question. There are two notable instances where the FDA considered removing, and did remove, a black box warning despite weak evidence to prove that the warning was unwarranted. For example, consider Chantix, a commonly known and controversial smoking cessation drug, which was shown to cause severe psychiatric occurrences. Although the FDA ultimately opted to keep the black box warning, it appeared to consider removing it based on one short-term study.

     GlaxoSmithKline (GSK), a major pharmaceutical company who is responsible for a predominant portion of drugs sold on the market today, petitioned the FDA to remove the black box warning on its prescription Avandia, which is used to treat Type 2 Diabetes. Although Avandia was proven to cause severe heart problems, GSK successfully had the black box warning removed by presenting evidence based on one randomized trial.

     While black box warnings probably minimize the risk to consumers, and are ostensibly better than no warnings at all, there are deep, lingering questions about how adequate warnings such as these are and whether we can depend on pharmaceutical companies and the FDA to warn and protect consumers taking potentially dangerous drugs.

Drug Recalls 

     Surprisingly, the FDA does not have the legal authority to recall a drug, they can make a recommendation and/or order that the drug be recalled, but the FDA has no actual authority to remove drugs off the shelves or the open market. The responsibility to recall a drug lies with the pharmaceutical company that designed and manufactured the drug. However, a pharmaceutical company won’t initiate a recall on a product until the FDA raises concerns about its effects. The FDA may garner details about the concerns based on health reports, studies, observations, etc. indicating that the drug is causing problems in its consumers.

Doctors, Drug Promotion, and the FDA

     There are also more nuanced issues concerning the FDA and their regulations. Although pharmaceutical companies are not permitted to market their drugs for any purpose or condition that is not approved by the FDA (which would be illegal), there is no way to effectuate this regulation. Many doctors have been found to prescribe FDA-approved prescription drugs to treat any medical condition, without consideration as to whether the drug was designed to treat the medical condition at issue. This creates a huge and dangerous gap between FDA standards and the medical practice.

     Although the FDA dictates that consumers must be presented with all available treatment options, including potential risks and complications in taking prescription drugs, there is no way to carry out this regulation other than holding the physician legally liable via a malpractice suit, where the regulation against prescribing medications to treat unapproved conditions. Many big pharma companies and doctors with malpractice suits brought against them will attempt to negate consumers’ claims by arguing that the FDA’s broad approval—merely permitting the drug to be sold on the market—is enough.

     For example, consider the drug Topamax, an anti-seizure medication. Topamax was the only FDA approved treat for epilepsy. However, Ortho-McNeil Pharmaceutical, a Johnson & Johnson subsidiary who was responsible for Topamax, widely promoted the drug as an antipsychotic. Naturally, Ortho-McNeil was hit with a heavy lawsuit resulting in an $81 million dollar settlement when it was discovered that Topamax was being used to treat other psychiatric conditions unrelated to epilepsy. However, Ortho-McNeil has remained undeterred, and Topamax is still sold to treat conditions it hasn’t been approved to treat, including weight loss. We’ll discuss a similar situation concerning the previously well-known weight loss drug, Fen-Phen, below.

Common Dangerous Drugs and Famous Dangerous Drug Cases

     Not all drugs are considered dangerous, although some drugs treating certain conditions have been discovered to create more risks than others. Some conditions and prescriptions that may have inherently adverse side effects include Prozac, Celexa, and Lexapro, which are all considered selective serotonin reuptake inhibitors (SSRIs) and used to treat depression, but could ironically lead to suicidal thoughts and behaviors. Other drugs include Fluoroquinolone antibiotics, which contain black box warnings (discussed above), such as Cipro, Avelox, and Levaquin.


     In July 1997, the Mayo Clinic released a report showing that 24 patients taking the popular weight loss drug known as Fen-Phen developed serious heart valve problems. That same day, the FDA issued a public health advisory describing the potential risks in taking the drug. A little over a month later, the FDA announced that Fen-Phen would no longer be sold on the market and recommended that consumers immediately stop taking it. This decision came upon discovering that many doctors’ reports showed that Fen-Phen users with no previous heart disease systems had suddenly developed severe heart valve conditions.

     What made the Phen-Fen cases particularly interesting is that the FDA had not improved the two active ingredients used in Fen-Phen—Pondimin (the “Fen” in Fen-Phen) and Phentermine (the “Phen”)—to be used together. The two drugs were not combined until 1988, when an American doctor suggested combining them. Pondimin had already been approved to be sold in both European and U.S. Markets. Pondimin worked by signaling the brain to produce serotonin, which was known to decrease appetite. However, it was not widely prescribed because it was shown to cause drowsiness. This is where Phentermine came in; known to be a mild stimulant, Phentermine counteracts the drowsiness caused by the Pondimin.

     Despite not being approved by the FDA, like the Topamax situation discussed above, many doctors nonetheless prescribed Fen-Phen to their patients, advertising it as a safe and practical weight loss tool. By the time Fen-Phen became popular, its patent was set to expire, prompting Fen-Phen’s creators to create a similar product known as Redux. By that time, Europe had discovered that drugs like Fen-Phen and Redux could have a dangerous impact on heart health. However, despite this enlightening discovery, Redux was also approved by the FDA in 1996 and Fen-Phen and Redux sales skyrocketed.

     About six million people had taken Fen-Phen by the time it was recalled. Several thousand lawsuits ensued against American Home Products, the pharmaceutical company responsible for Fen-Phen and Redux, to recover damages related to various cardiovascular conditions. Nearly three years later, in August 2000, the Court approved a settlement with American Home Products amounting to a whopping $4.75 billion dollars, covering both medical monitoring costs and damages to compensate those who had been harmed by taking the drug. Lawsuits continued to increase, eventually reaching 600,000 consumers who claimed to have been adversely affected by Fen-Phen. To date, the total settlement is valued at around $7.65 billion. At the time, the Fen-Phen settlement was the second largest in American products-liability history.

     Many consumers who took Fen-Phen 20 to 30 years ago may still have a chance at bringing a lawsuit, as many harmful side effects caused by Phen-Fen can take many years to develop. The delayed side effects include valve leaks, valve regurgitation, Primary Pulmonary Hypertension (PPH), among others.

     For individuals living with morbid obesity, the chance that heart problems could arise is already a likely consequence. At the time, a doctor, and their patient with significant weight to lose could have reasonably concluded that the short-term use of Fen-Phen and similar weight loss drugs presented minimal risk in comparison to the long-term consequences of obesity. However, in healthy people, who had little to no weight to lose, the consequences were severe, and should have been deemed too risky to chance. The Fen-Phen cases provoked questions about whether the FDA, with rising obesity rates around the county, should have recognized that Fen-Phen could easily be abused given the correlation between diet pills and cosmetic weight loss.

Paxil, Welbutrin, and Avandia

     GSK, the pharmaceutical company who produced Paxil, Welbutrin, and Avandia (discussed above) is recognized as the most dubious pharmaceutical in American products liability history, shelling out a $3 billion settlement. In addition, the GSK scandal involved an extensive wide-scale investigation involving numerous government agencies, including the FBI, FDA, and HHS-OIG.

     The penalties imposed on GSK included $956,814,400 in criminal penalties and $2 billion to resolve civil claims under the False Claims Act. The penalties were imposed on the ground that GlaxoSmithKline had engaged in deceptive marketing practices, promoted drugs such as Paxil, Welbutrin, Advair, and Lamictal to treat unapproved uses, and giving kickbacks to doctors willing to promote the drug. There was also extensive evidence showing that GSK was underreporting its drug prices, resulting in lower rebates to under the Medicaid Drug Rebate Program.

     The GSK scandal involved several authoritative persons: CEOs, salespeople, doctors, and more, all people we count on to act in consumers’ best interest. Although there are still deceptive practices used by GSK and other pharmaceutical companies, this scandal drew attention to unethical business practices and used GSK as an example.

     Novel, non-monetary penalties were also extended to GSK, including Corporate Integrity Agreement (CIA), by which it agreed with the Justice Department to make substantial changes to the way it conducted business. Prior to the settlement, GSK had implemented compensation-based incentives when sales goals were met in various territories, encouraging GSK employees to make sales, however necessary. The CIA, in an attempt to redress this incentive-based sales program, required GSK to change its executive compensation program, and directed GSK to recover any bonuses and long-term incentives obtained by misconduct. The CIA, among other things, also required that GSK engage in more transparent research, reporting, and publication practices. 

     What made the GSK scandal so extortionary, notwithstanding the extreme penalties imposed and the multi-agency investigation conducted, is the acknowledgment that consumers need transparency to make informed healthcare decisions and that consumers count on every person or entity in drug manufacturing and approval process. You can read more about the various claims brought against GSK and the eventual settlement here.

Dangerous Drug Cases

     The Supreme Court has recognized that torts based on inadequate drug design have a positive societal impact, as they did in Brusewitz v. Wyeth, because they provide an avenue to compensation to those harmed by vaccines (and potentially other dangerous drugs), as well as place legal, economic, and moral incentives on pharmaceutical companies to ensure that their products are adequately designed and won’t detrimentally harm unsuspecting consumers.

     Dangerous drug cases come in various forms and can be based on a variety of issues, including defective design, defective warnings, and harmful, unintended side effects. In addition, dangerous drug cases are applicable to all types of drugs, including topical medications, oral medications, over-the-counter medications, prescription medications, and even vaccines. There are also claims that can be brought based on medical devices, such as hearing aids. Medical devices are really a whole realm on their own and won’t be covered here. 

     Dangerous drug cases usually involve some complexity and are much more sophisticated than a typical torts case. This is because a consumer generally needs an expert to show whether the drug was dangerous and whether it directly caused harm to the consumer. To complicate this matter, massive pharmaceutical companies, making billions of dollars in sales each year and endless resources to rebut the consumer’s claim, will tote their own experts to disprove the consumer’s expert’s theories and conclusions.

Mass Torts and MDLs

     All consumers have likely seen a late-night television advertisement asking whether they’ve been harmed by “XYZ” drug and directing the consumer to call a 1-800 number to be compensated. Generally, these advertisements relate to a class action type lawsuit. Usually, when a consumer is harmed by a drug, it is not a singular occurrence, and many other consumers are likely to have experienced the same harm. When multiple consumers are harmed by the product, this is known as a “mass tort.” The consumers who have been harmed will generally have an option to bring a lawsuit against one or more responsible parties, either individually or together, along with other harmed consumers.

     However, when multiple people have been harmed by the same drug and many individuals sue the same pharmaceutical company, the lawsuits will usually be consolidated into a single action in one federal court. Although this may appear to be a class action, rarely are these class actions brought based on the harm sustained or deaths that have occurred. The cases are temporarily consolidated in a single action because it is convenient to do so. It makes more sense to have a court preside over all the cases simultaneously rather than one at a time. Indeed, many cases will involve common questions and issues. The consolidation of multiple cases involving the same issue in one federal court is known as “multidistrict litigation,” abbreviated as MDL.

     Once the claims have been consolidated in an MDL, the various attorneys representing their client-consumers that were harmed will engage in discovery to resolve issues that are common to all the consumers in the action, which is likely to involve depositions, interrogatories, and document production. Once discovery is complete, a bellwether trial may be held. A bellwether is ostensibly a “sample” trial that will give all remaining parties involved a taste at what their case’s value is and potential outcomes that may result.

     Usually, once the consumers’ attorneys and the pharmaceutical company’s attorneys have an idea about how their claim is likely to play out, a settlement can be reached. Few MDL cases ever make it to trial. Generally, global settlements are reached, or the case(s) are dismissed altogether. Ultimately, there is no real way to determine the amount a particular consumer will receive in an MDL. While some consumers can receive over a million dollars in damages, many consumers will receive much less than they had expected. For this reason, many attorneys may advise their clients not to take the MDL route.

     Though most claims settle once a bellwether trial is conducted, some do not. The remaining claims will be sent back to state court and a trial on the merits will take place. However, this approach can be risky. It is not necessarily good news when you can’t settle your claim through an MDL and are forced to return to state court. With any trial, you run the risk that the jury will not view things your way, resulting in a loss. Depending on how severe the harm is, receiving some compensation may be better than taking the risk of receiving nothing at all. However, once a case that is not settled is sent back to state court, an individualized examination can take place concerning the single consumer at issue, so any damages awarded, should the consumer win, will be personalized and based on the consumer’s damages.

MDLs Don’t Apply to Every Potential Consumer

     You should know that, just because you’ve been harmed by a dangerous drug and a class action-type suit is on the rise, you aren’t necessarily guaranteed to be compensated or even obtain the opportunity to join in on a lawsuit. Many attorneys representing consumers place limitations on who they’re willing to represent based on the harm the consumer has endured, often setting minimal criteria a consumer must meet to be permitted to join an MDL. Let’s use consumers who have been prescribed Zantac as an example.

     You have likely seen many TV commercials in the past advertising Zantac, used to treat heartburn. Semi-recent quality control testing conducted by an independent pharmaceutical company known as Valisure discovered that the active ingredient in Zantac (and its generic equivalents) known as ranitidine contained a toxic byproduct, and cancer-causing chemical, called NDMA (n-nitrosodimethylamine), as recognized by the World Health Organization and the Environmental Protection Agency.

     While Zantac can increase the risk that all cancers will eventually develop, studies have shown that Zantac is particularly linked to liver, colon, stomach, and other gastrointestinal cancers, as well as breast cancer, lung cancer, esophageal cancer, and prostate cancer. Because Zantac is linked to these cancers, consumers with other cancers are unlikely to be able to bring an action alleging that Zantac was the cause of their eventual cancer diagnosis. In these circumstances, it would be challenging at best to prove any direct correlation between the drug and the resulting cancer, particularly when there are studies linking Zantac to only some cancers and extensive expert testimony to rebut any claim otherwise.  

     In addition to limiting lawsuits based on the kind of harm endured, there are also restrictions concerning the period in which the consumer took the medication. For example, with respect to Zantac, a consumer likely needs to have taken Zantac over a six-month period to be able to bring an action. Again, to prevail, the consumer must show a direct correlation between taking Zantac and the cancer diagnosis. Those consumers who only took the medication once or twice over a period of several years will be unlikely to prove Zantac as a direct cause.

The Takeaway

     There are many pending lawsuits concerning various drugs that have now been deemed “dangerous.”  Dangerous drug law is a complex area that involves many issues not easily understood by the average consumer. In this sense, we heavily rely on pharmaceutical companies and government agencies, such as the FDA, to protect us. However, it appears that this trust can often be misplaced given the money and competition amongst pharmaceutical companies and legislation aimed at making certain drugs more accessible, despite overwhelming risks that could result. The chances are that you’re not alone if you’ve experienced harmful side effects when taking certain medications. If you’ve been harmed by a drug, you should seek an experienced attorney working in dangerous drug law to assess your claim.

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