In a recent publication, Newsweek explored whether pharmaceutical companies are, at least partially, to blame for the opioid crisis that has killed thousands of people in the United States. Since 1999, more than 183,000 people have died from opioid-related causes. Some say that pharmaceutical company executives have taken significant steps toward convincing the general public that these substances are safe—and that some of these steps may have been illegal.
Many officials, including President Donald Trump, have commented that the companies that manufacture these substances are responsible for the growing number of deaths attributed to opioids.
For example, Fentanyl has been infamously called one of the most dangerous opioids available. It is 50 times stronger than heroin. According to the United States Centers for Disease Control and Prevention, overdoses on Fentanyl have increased by a whopping 540 percent in just the last three years. Some have stated that Fentanyl is largely responsible for the opioid epidemic.
Insys Therapeutics, one of the companies that produce a type of fentanyl, is involved in a highly contested lawsuit over the drug. Several of the company’s executives, including John Kapoor, the company’s founder, was charged with conspiracy toward the end of October. The attorneys general in several states—Arizona, Illinois, Massachusetts, New Jersey, and Oregon—have filed claims, arguing that Insys Therapeutics made attempts to illegally bolster its sales. In each lawsuit, Insys is accused of lying to insurers, manufacturing patient data, and giving incentives to doctors who prescribed the drug.
In 2012, Subsys, a strong fentanyl-based liquid medication manufactured by Insys Therapeutics, was approved by the United States Food and Drug Administration. Specifically, Subsys was approved for cancer patients whose pain failed to respond to other types of painkillers. This type of pain is called “breakthrough cancer pain.”
Subsys acts quickly. It is administered by a spray under the tongue. The tongue has numerous capillaries and so the medication goes directly into the bloodstream without having to pass through the digestive system. Though this is an efficient method of delivery, it also makes it quite easy for a user to overdose on Subsys. In fact, just a few sprays may be all that is necessary for an overdose.
According to federal investigations, many of which are ongoing, Insys Therapeutics is accused of implementing a plan to market Subsys to patients who had not been diagnosed with cancer. According to the FDA, this is categorized as an “off-label use.” Insys Therapeutics never provided any clinical data to support the claims that Subsys would be safe—or even effective—for helping with pain unrelated to cancer. In Massachusetts, the United States Attorney claimed that Kapoor was “leading a nationwide conspiracy to profit by using bribes and fraud to cause the illegal distribution of a fentanyl spray.” Kapoor was charged with mail and wire fraud, racketeering, and violating federal anti-kickback laws, which forbid pharmaceutical companies from giving incentives to doctors to prescribe the drugs they manufacture.
Kapoor stepped down from the board of directors around the time the charges were filed. He entered a plea of not guilty at his arraignment and issued a statement that said, “I am confident that I have committed no crimes and believe I will be fully vindicated.”
A congressional investigation spearheaded by Senator Claire McCaskill (D-MO) provided additional insight into Insys Therapeutics’ actions. Senator McCaskill is a ranking member of the United States Senate Committee on Homeland Security and Governmental Affairs. Senator Ron Johnson (R-WI) is the chairman of the committee. In September, it published the first report on unethical marketing and sales mechanisms of pharmaceutical companies that sell opioid drugs. The report detailed how Insys Therapeutics created an entirely separate department to coax insurance companies into approving coverage of Subsys for patients who had not received authorization to take it. Insys Therapeutics employees allegedly pretended to be staff members from the medical offices of patients who were prescribed Subsys.
Subsequent reports are expected in the future. The committee has requested documents from the five pharmaceutical companies that produce most of the prescription opioid medications in the United States. These companies are Depomed, Insys Therapeutics, Janssen Pharmaceuticals, Mylan, and Purdue Pharma.
Insys Therapeutics was the first company to be investigated by the committee. According to Senator McCaskill, the company mimicked unethical sales and marketing techniques that were first implemented by Purdue in the 1990s. Purdue was accused of telling doctors that pain is undertreated in the United States and that opioids were most effective in treating it. Company representatives further argued that opioids were not addictive.
During a roundtable dialogue after the publication of the report, Senator McCaskill commented, “As it turns out, these messages were exaggerations at best and outright lies at worst.”
Each of the five companies listed above has settled claims regarding these unethical practices or is currently facing such claims. For example, Purdue Pharmaceuticals, which manufactures OxyContin, has settled numerous claims. One 2007 settlement finalized the claims of 26 states. Since that point, more and more lawsuits have been filed against pharmaceutical companies. These lawsuits have been filed by almost every state in the country. Many legal experts have remarked that the lawsuits stemming from the opioid epidemic mirror the Big Tobacco legal battles of the 1990s.
The Victims of Opioid Addiction
Sarah Fuller was 32 years old and had been battling fibromyalgia. She had been taking Lyrica for the condition. However, one of the negative side effects of Lyrica is that it can cause weight gain—Sarah gained 100 pounds while taking it. At just 5’3, such a weight gain was significant. Sarah often called her mother and complained that she “hurt all over.” Deborah, Sarah’s mother, recalled that Sarah was looking for a new doctor to find a way to manage her pain without medication. She hoped to try physical therapy, or perhaps surgery. However, Sarah’s new doctor prescribed opioids—including Percocet and OxyContin. The doctor eventually prescribed Subsys.
For the insurance companies, the prescriptions showed “step therapy”—that a patient had tried cheaper, less potent options, but that they did not work. According to investigations into Insys Therapeutics, this was a common practice. So that they could obtain a kickback from the company, doctors had to obtain approval from insurance companies for Subsys prescriptions. Medicare paid up to $24,000 per month for Sarah’s Subsys—significantly more than other painkillers, such as Oxycodone.
After taking Subsys, which at first seemed like a “miracle drug,” Sarah’s behavior changed. According to her fiancé, she was withdrawn and lethargic, and rarely got dressed. Sarah eventually died from a Subsys overdose. Just two weeks prior to her death, she told her mother, “I feel like I’m dying.”
Sarah’s toxicology reported showed that she might have been prescribed a dangerously high dose of Subsys. A settlement has been reached with her doctor.
Have You Been Injured by an Opioid drug?
If you or one of your loved ones were injured by an opioid medication, contact the experienced drug injury attorneys at Parker Waichman LLP today. Our opioid lawsuit attorneys will pursue all avenues of recovery on your behalf to obtain the compensation you deserve. Contact us for your free consultation, call 1-800-YOURLAWYER (1-800-968-7529).