1. The Pierce majority announces a new “cause of action in New Jersey for wrongful discharge when the discharge is contrary to a clear mandate of public policy.” Such a mandate, it goes on to say, could be found in a professional code of ethics, yet Dr. Pierce had failed to identify one in her complaint with enough specificity. How does the dissenting judge respond to this point?
2. What is the procedure for obtaining FDA approval of a new drug? Do you agree with the majority that when Dr. Pierce stopped working on the loperamide project, the risk to human test subjects was not “imminent”?
3. Surveying the interests at stake in the case, the Pierce majority states:
[W]e must balance the interests of the employee, the employer, and the public. Employees have an interest in knowing they will not be discharged for exercising their legal rights. Employers have an interest in knowing they can run their businesses as they see fit as long as their conduct is consistent with public policy. The public has an interest in employment stability and in discouraging frivolous lawsuits by dissatisfied employees.
Are there any important stakeholder interests not mentioned here?
4. The dissent mentions “past failures of official regulation to safeguard against pharmaceutical horrors.” There have been more recent failures. Since 2000, the cholesterol lowering Baycol caused muscle tissue breakdown, the diet drug Fen-Phen led to lung and heart disorders, antidepressants like Zoloft and Prozac caused some children to commit suicide, and the painkiller Vioxx was found to double the risk of heart attack. In each instance, there was evidence that the pharmaceutical firms had evidence suggesting serious problems with drugs that were in development or had already been brought to market. By the time Merck recalled Vioxx in late 2004, there were congressional hearings underway. A doctor in the FDA’s Office of Drug Safety, David Graham, told Congress that Vioxx may have caused as many as 55,000 deaths. Graham charged his agency with being “incapable of protecting America” against dangerous drugs. A study led by Dr. Graham that looked at the cardiovascular risks of taking Vioxx was supposed to be published in a prestigious medical journal but was pulled at the last minute after Dr. Graham received a warning from his supervisor. FDA management then began a smear campaign, with anonymous claims that his study could reflect scientific misconduct, and that Graham “bullied” his staff.
5. The regulatory apparatus of our government depends on ethical behavior on the part of corporations. It depends on corporations to generate accurate data for agencies such as the FDA, the FAA, and the EPA to use in analyzing safety risks. The government’s resources are limited; it cannot perform all the necessary tests itself, but must rely on companies to do their own tests, and to share all relevant results—particularly when those results point to safety problems. Business decisions to hold back adverse information from regulators can be both fatal and expensive. Consider the Bridgestone/Ford debacle of 2000. In the 1970s, the National Highway Traffic Safety Administration (NHTSA) collected safety data directly from a network of repair shops, but after the budget cuts of the 1980s, this agency began relying on data generated by industry. NHTSA also made reports of foreign car recalls voluntary. In 1999, both Bridgestone and Ford knew the Wilderness tire/Ford Explorer combo was dangerous; there had been dozens of tread separations and SUV rollover deaths abroad, particularly in hot climates. The two companies planned a recall in Saudi Arabia but then made a joint decision not to alert NHTSA, fearing this would lead to a recall in the United States. By late 2000, after SUV rollovers caused more than 100 fatalities in the United States, Bridgestone was forced to recall more than 6 million tires, and both companies faced countless lawsuits.
The dissent in Pierce mentions the need to protect “professional autonomy.” What does this phrase mean? What connection might professional autonomy have with the U.S. safety regulatory scheme?
6. In 1986, responding to the Pierce decision of its supreme court, the New Jersey legislature adopted The Conscientious Employee Protection Act, 16 shielding from retaliation employees who object to, or refuse to participate in, “any activity, policy or practice which the employee reasonably believes to be incompatible with a clear mandate of public policy concerning the public health, safety or welfare.” What would have been the likely outcome had Dr. Pierce sued under this new law?