In 2007, Thomas & Company, the maker of Painout, received approval from the U.S. Food and Drug Administration (FDA) to market Painout for the treatment of acute pain in adults. Thomas spent millions of dollars persuading physicians and consumers to use Painout for pain, especially arthritis pain, instead of less expensive alternatives. Many people who used Painout found that it provided more effective short term relief for pain, particularly from athletic injuries, than any other painkiller on the market at the time. At its peak, Painout had over 20 million users.
However, in March 2010, a study was published indicating that patients taking Painout for 8 months or longer had two to four times as many heart attacks and strokes as patients using another drug. Thomas claimed that one study was not conclusive, and kept Painout on the market. Later in 2010, a cardiologist proposed to Thomas that a study be initiated to determine the effect of Painout on patients with severe chest pain. Thomas refused. Thomas continued to say publicly that it had confidence in the safety of Painout.
In early 2011, the FDA criticized Thomas for minimizing the drug’s serious side effects. Thereafter, three independent studies of Painout were conducted. All the results showed correlations between Painout and the increased risk of heart attacks. Thomas did its own study in 2012, only to have the results show that, after several months of daily use, Painout increased cardiovascular risks. At this point, Thomas voluntarily removed the drug from the market. Nonetheless, Thomas continued to maintain that Painout was safe until it was proven otherwise. Numerous lawsuits followed. Plaintiffs blamed Painout for various patients’ injuries and deaths. In 2013, Thomas lost its first Painout lawsuit, and the jury awarded $100 million to the plaintiff.
Please answer the following questions. Be sure to incorporate the readings into your paper. You should reach conclusions for each question, and not simply leave them unanswered.
1. Was Thomas’ stated position in 2010 and 2011 (that it still had confidence in Painout’s safety), a proper defense of the company during a difficult time, or improper and unethical conduct?
2. Did Thomas do anything wrong by waiting for conclusive evidence of harm before recalling Painout?
3. When Thomas’ own study showed increased cardiovascular risks after several months of daily use, Thomas voluntarily removed Painout from the worldwide market. Was that the right thing to do, or was it too little and too late?
