Big Pharma Under Fire Again

The opioid epidemic has caused much devastation throughout the country, shattering lives and ruining families. One of the more heartbreaking consequences of the epidemic is the effect that it has had on newborn children whose mothers took opioids during the course of their pregnancy. These children have experienced withdrawal symptoms after they have been born since they developed a dependence on opioids in the womb. Recently, large pharmaceutical companies have been sued on behalf of the class of infant children for their aggressive marketing of their opioid products and the damage that opioids have caused these babies.

Infants who have been exposed to opioids when in utero have, in some cases, developed neonatal abstinence syndrome (NAS). This occurs because drugs that are taken during pregnancy pass to the baby through the placenta. In some instances, they can cause serious problems for the baby. NAS can cause low birth-weight, jaundice or other types of intensive treatment after birth. These can all complicate the first month of a baby’s life. In certain rarer instances, NAS can have longer-term impacts on a baby’s health and wellbeing that can include developmental impacts. In the worst-case scenario, NAS can cause a newborn baby to suffer seizures.

The lawsuits have accused the big pharmaceutical companies of fueling the opioid crisis through their relentless marketing of their products notwithstanding the dangers. As a manufacturer, pharmaceutical companies have a duty to warn their customers of potential side effects of their medications. They also have a duty to warn customers of the potential for addiction and the risks of the medication. The lawsuits allege that they did not do so, and scores of patients took their medications without any knowledge that they can develop an addiction.

Both individual and class action complaints have been filed in multiple states. For example, there was a class action suit filed in 2017 in New York. This suit named all of the major manufacturers of opioids as defendants. The suit was brought on behalf of a child who suffered severe withdrawal symptoms and permanent and lasting physical and psychological damage from NAS. The child’s mother was prescribed opioids during the course of her pregnancy and became addicted. Ultimately, her addiction progressed to heroin, which is another opioid. By the time the baby was born, the baby had developed an addiction in utero.

The suit named the manufacturer of every opioid that the mother took while pregnant with the baby. In addition, the suit also named distributors of opioids as well, since they failed to act as a “check” on distribution. The compliant detailed how widespread the problem of babies with NAS has become. Up to 95 percent of babies that are born to opioid-dependent mothers will develop NAS.

This suit focused on the widespread marketing of opioids by the defendants. The complaint alleged that the defendants flooded New York with billions of opioid pills by means of negligent distribution. The FDA has cited big pharmaceutical companies before for their distribution practices. These companies have been required to change the way that they market their products as a result. Here, the sales representatives allegedly had a financial incentive to sell as many opioids as they could in New York. The defendants also gave doctors various inducement to prescribe opioids as they would for any other medication. This was despite the fact that opioids are highly addictive and differ in many ways from other medications. According to the lawsuit, the general promotion of opioids created an environment where opioid prescription and abuse became rampant.

This is part of a larger trend in which patients have been suing the manufacturers of opioids. In addition to NAS babies, adults have also been filing suits against opioid manufacturers. Babies have had some difficulties certifying as their own class to bring a lawsuit. In some instances, their lawsuits have become consolidated into larger class action suits.

Nonetheless, opioid addiction among babies is a growing and disturbing trend. It is estimated that every 25 minutes, there is a baby who is born with NAS. The numbers of mothers who deliver babies while addicted to opioids has gone up by a factor of five in the first decade of this century. These babies often require a long hospitalization which requires great expense. Much of this expense ends up being covered by state Medicaid programs.

Local and state jurisdictions have also brought suit against opioid manufacturers since they are often the ones bearing the brunt of the financial burden of babies born with NAS and other expenses of the opioid crisis. For example, over 50 counties in New York State have filed lawsuits against large pharmaceutical companies. These suits have been consolidated into one suit which is currently proceeding.

The potential legal liability for the pharmaceutical industry is staggering. If history is any guide, they made be required to pay for opioid associated costs for many years to come if these suits prevailed. One prior example that comes to mind is the litigation against Big Tobacco. This litigation resulted in a very large settlement that tobacco companies are still paying to this day. There, the tobacco companies admitted liability for the manner in which they manufactured and marketed their product. The marketing issues raise some parallels with the opioid NAS lawsuits.