Pharma Opioid Suits Casting a Wider Net
Under both federal and state law, it is unlawful to advertise if the advertisement tends to mislead or deceive. States have enacted consumer protection laws to enforce and regulate such deceptive practices. In New York, under General Business Law §349, deceptive acts or practices in the conduct of any business, trade, or commerce, or in the furnishing of any service in the state, is declared unlawful. Over the years, the Federal Trade Commission has prosecuted many businesses accused of engaging in false and deceptive advertising. While the FTC has jurisdiction over the prosecution of businesses accused of engaging in false and deceptive advertising, consumers have the right to sue advertisers under state consumer protection laws as well. Consumers have sought to employ this right in a vast number of cases against pharmaceutical companies that marketed opioids as pain killers.
Now, laws against deceptive marketing have taken on an even wider span, as states, counties, and cities are seeking to join in the growing number of deceptive marketing lawsuits involving prescription opioids.
For example, the Mississippi Attorney General and a host of private plaintiffs’ attorneys brought suit against opioid manufacturers, accusing them of promoting the drugs by consistently understating the health risks associated with their use while exaggerating the benefits, thereby violating state law. The City of Chicago filed a lawsuit against five major pharmaceutical companies, alleging that they contributed to the country’s epidemic of prescription drug abuse through their deceptive marketing strategies. And multiple counties in New York, including Nassau, Suffolk, Orange, Schenectady, Broome, and Erie, joined the growing number of local governments filing opioid-related lawsuits alleging that manufacturers of prescription opioids are responsible for the ongoing drug epidemic.
These cases are generally based on deceptive marketing laws and seek to establish that the manufacturers knew of the devastating consequences of their drug. The suit in Mississippi, for instance, seeks to compel the defendant drug companies to produce their internal records, which could include records that the plaintiffs hope will show discrepancies between what the defendants told doctors, regulators, and the public about opioids and what they knew or may have suspected privately.
These cases brought by states, counties, cities, and individuals are also driven in large measure by the statistics showing the nationwide increases in opioid prescriptions and opioid-related deaths. Plaintiffs pursuing these claims argue that, since 1999, the number of prescription opioids sold in America has almost quadrupled, while over the same period, prescription opioid deaths have more than quadrupled. Using attention-grabbing assertions such as nearly 19,000 people having lost their lives to opioid overdoses in 2014, these lawsuits allege that despite knowing the addictive and debilitating nature of these drugs, the manufacturers wanted to expand the market to maximize profits.
But these opioid cases are not without significant legal hurdles. Because prescription opioids are regulated by the FDA, defendants argue that the courts should defer to the FDA’s approval of prescription opioids as safe and effective for treating chronic pain and the FDA-approved drug labeling that disclosed addiction-related risks. This defense worked in an action brought in California state court, where the judge threw out the lawsuit against various opioid makers on the grounds that it would have usurped the function of the Federal Food and Drug Administration. In a conflicting decision in Chicago, however, a federal judge rejected the “primary jurisdiction” argument and allowed the city to go ahead with a similar case.
Another hurdle, of course, is the “learned intermediary” defense, and the role that doctors play in prescribing these medications is an important point that must not be ignored as a way to insulate pharmaceutical companies from potential liability for failing to warn of a drug’s risks.
Some have analogized these cases involving prescription opioids to the $206 billion settlement that tobacco companies reached in 1998. Certainly, the growing number of such cases presents significant risks to not only to manufacturers, but also to prescribers and insurers. We will continue to follow this area as these cases unfold.