Of the five largest mass lawsuits either underway or scheduled for trial in 2018, three are about prescription drugs, with a fourth one listing a defective medical device as the cause of action. These cases involve not only negligence, failure to warn; and product defects; but in at least one of the cases the defendant is alleged to have engaged in criminal acts.
At the top of the list are opioid manufacturers and distributors. Opioid use and addiction have reached crisis proportions in the U.S. over the past several years. This has been due in no small part to deceptive advertising and marketing by pharmaceutical companies, misleading consumers as to the dangers of addiction. In addition to allegations of negligence, breach of duty and failure to warn, these companies also face accusations of violating federal anti-racketeering laws under the RICO Act.
What also makes this mass tort action unusual is the number of defendants. Most multi-district litigation of this nature involves a single defendant. If there are multiple defendants, such lawsuits focus on one event for which they share liability, as was the case of the massive 2010 oil spill in the Gulf of Mexico following the explosion of the Deepwater Horizon. Named defendants in current opioid litigation includes drug manufacturers Activais, Endo, Janssen, Mallinckrodt, Purdue, and Teva, in addition to major wholesale distributors AmerisourceBergen, Cardinal Health, and McKesson.
Second on the list of top cases for this year is hernia mesh litigation. Named defendants Ethicon and parent company Johnson & Johnson allegedly designed, manufactured, and sold a product they knew to be defective. The device in question is the Physiomesh, which was used for hernia repair.
According to the complaint, the coating “prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications.” Furthermore, the polypropylene material from which the Physiomesh was made was “insufficient to withstand normal abdominal forces,” and prone to breakage and disintegration. Physiomesh lawsuits were consolidated in June of 2017. Pre-trial proceedings continue as additional plaintiffs file claims. Currently, there are over 300 plaintiffs who have filed complaints against Ethicon.
Risperdal (risperidone) is a “second generation,” or atypical antipsychotic medication used primarily to treat schizophrenia and other forms of psychosis. Manufactured and marketed by Johnson & Johnson subsidiary Janssen Pharmaceuticals, Risperdal has been associated with a serious movement disorder known as tardive dyskinesia, neuroleptic malignant syndrome, hyperglycemia, and suicidal tendencies. Johnson & Johnson has also promoted the drug for “off-label” indications in violation of FDA regulations. Seven bellwether trials have been held since 2015, resulting in four judgments against the defendants. Johnson & Johnson has also reached out-of-court settlements with two other plaintiffs.
Invokana, another Janssen product, was hailed as a “miracle drug” when it was first approved by the FDA, despite serious concerns raised by prominent physicians. Used to manage Type 2 diabetes, Invokana is an SGLT-2 inhibitor that allows excess glucose to be eliminated through the urine. This drug has been implicated in cases of diabetic ketoacidosis, severe kidney damage, and lower limb amputations. All Invokana cases were consolidated into multidistrict litigation in December 2016. The first bellwether trials are scheduled to begin sometime in the fall of 2018.
All of these products were approved through the “fast-track” procedure known as 510(k) Premarket Notification, which allows drug and medical device manufacturers to bypass normal clinical studies and testing. New healthcare products continue to win FDA approval through this process. If history is any indication, these companies will not be the last to be targeted in mass tort litigation in coming years.