LITIGATION IN THE PHARMACEUTICAL AND MEDICAL DEVICE SECTOR
CD: How would you characterise recent litigation activity involving companies operating in the pharmaceutical and medical device sector? What types of dispute are common and what factors are driving them?
Bell: In the US, we are seeing an upswing in litigation across multiple jurisdictions and involving multiple parties in the industry that is reminiscent in scope of the AWP cases of years past. A prominent example is the wide-ranging opioid litigation against drug manufacturers, distributors and retailers. In these cases, governments and other parties are accusing the defendants of contributing to the overuse of opioids by allegedly engaging in marketing that downplayed the risk of addiction and failing to report suspicious orders. Another significant case is the multidistrict generic price-fixing litigation, in which government entities and private parties allege that companies conspired to fix the prices of certain generic drugs. In essence, the plaintiffs are claiming that alleged price increases for the drugs in question result from a collusive agreement among the defendants as opposed to changes in market conditions that the defendants responded to unilaterally.
Greenblatt: Litigation remains frequent in this sector. Common litigation involving pharmaceutical and medical device companies includes everything from Hatch-Waxman patent infringement disputes between innovators and would-be generic entrants, to antitrust lawsuits based on brand manufacturer decisions that may alter the timing of generic competition, to mass tort product liability actions involving negligence or strict liability personal injury claims. Both the volume and diversity of cases is driven by the complexity of the business, as well as the specialised regulatory and doctrinal rules in place. Further, consolidated multidistrict litigations have expanded to make up nearly 40 percent of federal court civil actions, a large number of which involve pharmaceutical or medical device companies.
Apr-Jun 2018 issue
Charles River Associates
Goldman Ismail Tomaselli Brennan & Baum LLP