Class Actions in the United Kingdom
In the 1980s and 1990s, benzodiazepines were the subject of the largest-ever class-action lawsuit against drug manufacturers in the United Kingdom. This lawsuit involved 14,000 patients, 1,800 law firms, and over £50 million spent on legal aid and by the drug companies. The suit alleged that the drug manufacturers were aware of the potential of benzodiazepines to cause physical dependence, but intentionally withheld this information from doctors and other medical prescribers.
Patients simultaneously sued 117 general practitioners and 50 health authorities in an attempt to recover damages for suffering and loss caused by the harmful effects of benzodiazepine dependence and withdrawal syndromes.
Unfortunately, the suit never reached a settlement or verdict. While the United Kingdom provides government funding for legal assistance to those who cannot afford to pay a lawyer, the funding for this suit was withdrawn in 1993-1994. In addition, there were many allegations that the pharmaceutical company’s consulting psychiatrists and expert witnesses had conflicts of interest.
What was notable about this suit is that it led some prescribers to require that patients sign an informed consent form before being prescribed benzodiazepines, and to recommend that all patients be warned, prior to the initiation of benzodiazepine drug “treatment,” of the potential for this class of drug to cause dependence and withdrawal issues. On the other hand, actual changes in British law that resulted from this landmark trial would end up making future class action lawsuits more difficult.
Following the collapse of the litigation, the benzodiazepine harm problem became even more insidious. In just three years, between 1994 and 1997, the number of prescriptions for sedatives / hypnotics increased, with prescriptions for Valium alone escalating by 15 percent. In addition, by 1999, prescriptions for the new sedative / hypnotic drugs—Z-drugs such as Zolpidem (Ambien) and Zopiclone (Zimovane / Imovane)—climbed to about 2 million per year, even though the number of adverse events associated with these drugs was much greater (x 100) than for any of the benzodiazepines.
Class Actions in the United States
There have been no American class action lawsuits related to benzodiazepines. Most benzodiazepines prescribed today are generics, and according to a 2011 Supreme Court decision, generic manufacturers cannot be sued for failure to warn. The Court’s reasoning was that the FDA requires generic and brand-name manufacturers to use the same warning label, which can only be updated by the brand-name manufacturer, making it unfair to hold the generic manufacturer responsible for something it could not legally address.
The Supreme Court decision failed to set a precedent as to what harmed patients could or should do instead. While it would be intuitive in such cases to file a lawsuit against the patent holder—usually the brand-name manufacturer—not every state allows such an action. Some states have decided that if a patient has never taken the brand-name equivalent of a drug, the brand-name manufacturer should not be held responsible for any harm. This leaves many patients in a situation where there is no recourse for filing suit in the case of legitimate harm.
Medical Malpractice Lawsuits
When it comes to individual patients or their families who have been harmed by benzodiazepines, there has been some successful litigation and monetary compensation. Whereas sixty years of appeals to ethics, evidence, guideline recommendations, and accounts of devastating harm and loss have seemed to fall on closed ears, legal action has in some cases been an important way to address the benzodiazepine crisis.
In the United States it may be difficult to find an attorney knowledgeable enough about benzodiazepine harm to successfully file and win a lawsuit. In addition, the payouts, like all medical malpractice payouts, may be capped at a very low amount, depending on state rules. Additionally there are statutes of limitations in effect that require initiating a suit within a certain amount of time. Benzodiazepine Information Coalition has compiled a list of benzodiazepine aware attorneys, but the list is very short, and the attorneys are quite selective in choosing cases.
Despite these restrictions, many patients in both the United States and abroad whose situations fit the necessary criteria and who are able to meet the legal deadlines have been successful in suing their prescribers for benzodiazepine-induced harm. Most of these lawsuits result in settlements—meaning they do not go to trial—and often the terms of the settlement are confidential. One public U.K. settlement is that of Luke Montagu, founder of the Council for Evidence-based Psychiatry (CEPUK).
Filing a Medical Board Complaint
In the hope of preventing future harm to others, and in an attempt to force benzodiazepine education on the prescriber that harmed them, some patients take a medical complaint route. Filing a complaint about negligent medical providers with your State Medical Board (or another prescriber regulatory agency, depending on where you live) may be an appropriate way to bring to your doctor’s attention the harm you have experienced from benzodiazepine prescribing or irresponsible cessation. Doctors prefer to avoid formal complaints, so such a complaint could be a significant motivator.
On the other hand, legal and regulatory approaches come with their own problems, as they often don’t encourage learning, but instead teach avoidance behaviors. Lawyers knowledgeable about benzodiazepine harm are rare, and state medical boards typically do not understand the full nature of the harm. Even if such actions are successful, they can potentially harm other patients, as doctors who fail to understand why the actions were taken against them may learn only not to prescribe benzodiazepines, and they may stop prescriptions abruptly. Existing patients would then be forced to find a new prescriber or face a potentially deadly and disabling cessation.
Reporting Harm to the FDA
Beyond lawsuits and medical boards, one important place to anonymously report all harm without any risk to the patient or provider is the FDA. Benzodiazepine Information Coalition, along with other patient organizations such as Benzo Buddies, have joined together to participate in the FDA reporting program Medwatch. To learn more and report your own harm from benzodiazepines, click here.