When it comes to medicine, who should make decisions about safety and efficacy – and on what evidence should those choices be made? At present, the Food & Drug Administration has the responsibility to determine approvals and labeling language based on a scientific review of the evidence. Should this authority be ceded to the tort bar?
Consider the recent spate of litigation against the manufacturers of opioid pain medications. One example is the City of Chicago’s lawsuit against multiple manufacturers of opioid pain treatments. In the United States District Court for the Northern District of Illinois (Eastern Division), the City of Chicago’s First Amended Complaint (“FAC”) seeks to limit the ability of Chicago doctors to treat the chronic, non-cancer pain of patients in the manner doctors deem most appropriate. Although the Food and Drug Administration has approved certain opioid pain medications for the treatment of chronic non-cancer pain, the FAC seeks to deprive patients and doctors of that treatment choice by having six lay jurors determine that “the use of opioids to treat chronic pain is not ‘medically necessary’ or ‘reasonably required’ in that their risks do not exceed their benefits.”
The FDA has determined that opioids serve an important public health role: “When prescribed and used properly, opioids can effectively manage pain and alleviate suffering—clearly a public health priority. Chronic pain is a serious and growing health problem: it affects millions of Americans; contributes greatly to national rates of morbidity, mortality, and disability; and is rising in prevalence. At the same time, there is no dispute that opioids pose significant public health risks: Opioids also have grave risks, the most well-known of which include addiction, overdose, even death. The labeling for these products contains prominent warnings about these risks. Moreover, the boxed warning states that all patients should be routinely monitored for signs of misuse, abuse, and addiction.
In September 2013, the FDA ruled on a citizen’s petition filed by a group of clinicians, researchers, and health officials called Physicians for Responsible Opioid Prescribing (“PROP”). Like the Chicago FAC, the Petition directly challenged the use of opioids for “chronic non-cancer pain.” PROP contended that the “long-term safety and effectiveness of managing [chronic non-cancer pain] with opioids has not been established,” and requested that the FDA, inter alia, impose a “maximum duration of 90-days for continuous (daily) use for non-cancer pain.” The FDA carefully reviewed the Petition and more than 1900 related comments. The agency assessed the relevant literature. It held a two-day public hearing at which it received “over 600 comments” and dozens of experts and concerned citizens testified. The FDA noted that “the majority of comments” “opposed PROP’s requests” and that “many professional societies,” including the American Medical Association, “did not support the Petition and stated that the data cited by PROP did not support PROP’s requests.” After completing a 14-month review, the FDA determined that opioids should continue to be available for the treatment of chronic pain, while also directing further study and certain labeling changes for some opioid drugs. Significantly, after being presented with the same assertions as those now alleged in the Amended Complaint, the FDA made two findings directly at odds with the underlying premises that form the cornerstones of the FAC.
But the lawsuits keep coming. The FDA has the authority, the ability, the means, the mission, and the mandate to manage the health care risks and benefits inherent in the products it regulates on behalf of the American public.
A more balanced legal system will occur only when elected officials determine the time has come for real tort reform, as it affects pharmaceutical companies. But that day is likely very far off. Healthcare leaders must devote their most aggressive efforts toward reform.
Maybe when our elected officials understand that it's the health of their constituents versus the pocketbooks of lawyers, our public servants will finally get serious on tort reform.
Consider the recent spate of litigation against the manufacturers of opioid pain medications. One example is the City of Chicago’s lawsuit against multiple manufacturers of opioid pain treatments. In the United States District Court for the Northern District of Illinois (Eastern Division), the City of Chicago’s First Amended Complaint (“FAC”) seeks to limit the ability of Chicago doctors to treat the chronic, non-cancer pain of patients in the manner doctors deem most appropriate. Although the Food and Drug Administration has approved certain opioid pain medications for the treatment of chronic non-cancer pain, the FAC seeks to deprive patients and doctors of that treatment choice by having six lay jurors determine that “the use of opioids to treat chronic pain is not ‘medically necessary’ or ‘reasonably required’ in that their risks do not exceed their benefits.”
The FDA has determined that opioids serve an important public health role: “When prescribed and used properly, opioids can effectively manage pain and alleviate suffering—clearly a public health priority. Chronic pain is a serious and growing health problem: it affects millions of Americans; contributes greatly to national rates of morbidity, mortality, and disability; and is rising in prevalence. At the same time, there is no dispute that opioids pose significant public health risks: Opioids also have grave risks, the most well-known of which include addiction, overdose, even death. The labeling for these products contains prominent warnings about these risks. Moreover, the boxed warning states that all patients should be routinely monitored for signs of misuse, abuse, and addiction.
In September 2013, the FDA ruled on a citizen’s petition filed by a group of clinicians, researchers, and health officials called Physicians for Responsible Opioid Prescribing (“PROP”). Like the Chicago FAC, the Petition directly challenged the use of opioids for “chronic non-cancer pain.” PROP contended that the “long-term safety and effectiveness of managing [chronic non-cancer pain] with opioids has not been established,” and requested that the FDA, inter alia, impose a “maximum duration of 90-days for continuous (daily) use for non-cancer pain.” The FDA carefully reviewed the Petition and more than 1900 related comments. The agency assessed the relevant literature. It held a two-day public hearing at which it received “over 600 comments” and dozens of experts and concerned citizens testified. The FDA noted that “the majority of comments” “opposed PROP’s requests” and that “many professional societies,” including the American Medical Association, “did not support the Petition and stated that the data cited by PROP did not support PROP’s requests.” After completing a 14-month review, the FDA determined that opioids should continue to be available for the treatment of chronic pain, while also directing further study and certain labeling changes for some opioid drugs. Significantly, after being presented with the same assertions as those now alleged in the Amended Complaint, the FDA made two findings directly at odds with the underlying premises that form the cornerstones of the FAC.
But the lawsuits keep coming. The FDA has the authority, the ability, the means, the mission, and the mandate to manage the health care risks and benefits inherent in the products it regulates on behalf of the American public.
A more balanced legal system will occur only when elected officials determine the time has come for real tort reform, as it affects pharmaceutical companies. But that day is likely very far off. Healthcare leaders must devote their most aggressive efforts toward reform.
Maybe when our elected officials understand that it's the health of their constituents versus the pocketbooks of lawyers, our public servants will finally get serious on tort reform.
