The pharmaceutical company Insys has been sued in a class action lawsuit filed on behalf of stock investors. Insys is the company behind Subsys, sublingual fentanyl spray that has been approved by the FDA for breakthrough cancer pain in opioid-tolerant patients. Subsys is highly addictive and can pose life-threatening risks if patients overdose from fentanyl, a powerful opioid pain killer that is considered 100 times more powerful than morphine.
The recent lawsuit alleges that the drug company issued false or misleading statements and/or failed to disclose: (1) the company’s illegal and/or improper marketing of Subsys; (2) that improper marketing of Subsys could lead to regulatory scrutiny; (3) that such regulatory scrutiny could expose the company to potential fines and other disciplinary actions; and (4) as a result of the foregoing, that the company’s financial statements were materially false and misleading.
Subsys was approved only for cancer patients suffering from severe pain. However, sales for Subsys have soared since FDA approval was granted in 2012. The sales volume has raised concerns about potential illegal marketing of the drug for “off-label” uses beyond what was originally determined to be safe and effective. There have been reports that only 1% of Subsys prescriptions are by oncologists, half are from pain specialists, and the rest are issued by doctors, dentists and even podiatrists apparently prescribing the drug off-label. It is illegal for pharmaceutical companies to promote their drugs for applications that have not been approved by the FDA.
On December 12, 2013, Insys disclosed that it had received a subpoena from the Office of Inspector General of the Department of Health and Human Services. The subpoena is part of an investigation of potential violations involving HHS programs and requesting documents regarding Subsys, including Insys’ sales and marketing practices relating to Subsys. The stock price fell on this news.
Then, on May 8, 2014, news broke that a Michigan neurologist was under federal Medicare fraud investigation for his Subsys prescription practices. It was reported that Medicaid had paid Dr. Gavin Awerbuch about $6.9 million from Jan. 1, 2009 through Feb. 6, 2014 for Subsys he prescribed. Awerbuch wrote 1,283 prescriptions for the drug in five years, while the next closest prescriber wrote 203 prescriptions. Reports indicated that Awerbuch was responsible for approximately 20.3 percent of the Subsys prescribed to Medicare beneficiaries nationwide during the time period. Again, the Insys stock fell.
The class action lawsuit is brought on behalf of purchasers of Insys stock between May 2, 2013 and May 8, 2014. The suit seeks to recover damages caused by misleading financial statements.
Off-Label Prescribing Practices Contribute to Fatal Fentanyl Overdoses
Despite the efforts of federal investigators to limit the off-label promotion of fentanyl products such as Subsys, thousands of patients have died because of an overdose caused by this dangerous drug. Many of these deadly fentanyl overdoses occurred because patients were given too much fentanyl by their doctors or because they were given the drug despite the fact that they were not eligible to use fentanyl under FDA guidelines.
Fentanyl products can also be deadly when they are prescribed in combination with other drugs that suppress the central nervous system. The interaction between fentanyl and other CNS depressant medications can lead to a combined drug overdose, which can cause respiratory depression and death.
If you or a loved one have been the victim of a fentanyl overdose, you may be eligible to file a lawsuit and seek compensation for your injuries. The lawyers at Heygood, Orr & Pearson will work hard to ensure that your legal rights are fully protected so that you or your loved one receive the outcome in your case that you deserve.
The lawyers at our firm have successfully resolved more fentanyl lawsuits than all other law firms in the United States—combined. These cases include a verdict of $5.5 million in a Florida case involving the death of a man who died while wearing a fentanyl patch, and a verdict resulting in payment of more than $21 million for the death of another fentanyl patient in Illinois.
To receive a free legal consultation about your case and find out whether you may be eligible to file a fentanyl lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and submitting some brief information about your case.