Insys faces more lawsuits over illegal marketing of Subsys fentanyl spray despite Oregon settlement

by Jim Orr

Specialty pharmaceutical company Insys Therapeutics is facing questions from federal and state attorneys general about the company’s marketing of the fentanyl sublingual spray Subsys. Insys is currently under investigation by several federal and state attorneys general for illegally promoting Subsys to doctors in violation of FDA rules.

Subsys—an oral spray designed to deliver the powerful opioid painkiller fentanyl to patients with late stage cancer pain—was first placed on the market by Insys in 2012. Since then, the drug has earned record profits for the company. Over the first six months of 2015, Insys earned $147.2 million in sales from Subsys—more than 99% of the company’s revenue during that period.

However, these record profits have also come with questions from state and federal authorities about the marketing of Subsys. Officials in California, Massachusetts, Oregon, Connecticut, Arizona, and Illinois have all launched investigations over concerns that Insys has illegally marketed the Subsys fentanyl spray to doctors. Although Subsys has only been approved by the FDA to treat patients with late stage cancer pain, Insys has allegedly marketed the drug directly to doctors as a treatment for neck pain, migraines, and other conditions. Federal law allows doctors and other licensed medical staff members to prescribe drugs legally for conditions that have not been authorized by the FDA; however, it is illegal for companies to market their products for these so-called “off label” uses.

Former employees of Insys say that the company told them to target family doctors, internists, and general practitioners in their marketing of Subsys, even though these doctors flatly told them that they never treat the kind of patient with severe, chronic pain for which the drug is intended. A report by the Oregon attorney general’s office also said that the company used “flirtation” and other questionable methods in order to get doctors to prescribe Subsys more often.

Insys has also been accused of paying doctors, nurse practitioners, and other medical professionals to prescribe Subsys. In 2015, a nurse practitioner in Connecticut pleaded guilty to accepting $83,000 in kickbacks from Insys to prescribe the fentanyl spray to patients. Investigations have revealed that many of the top prescribers of Subsys across the U.S. received payments from the company.

Insys has used a number of other techniques in order to fuel prescription of the drug, including working with doctors and insurance companies to obtain “prior approval” for the drug and offering to cover patients’ out-of-pocket co-pay for up to $500 for each Subsys prescription. A class action lawsuit filed against Insys by investors has alleged that the company knew that only about 10% of these prior approval prescriptions were for cancer patients.

In August 2015, Insys agreed to pay $1.1 million to settle charges against the drugmaker by officials in Oregon—more than twice the company’s sales of Subsys in Oregon. Insys has also offered to pay a $6.125 million settlement to end the investor’s class action lawsuit over the company’s marketing of the fentanyl spray.

Despite the record profits earned by Insys in recent years, legal experts say that more settlements like the one in Oregon could be disastrous for the company. “If other states followed suit with similar conduct and obtained similar results, that would be a severe sanction for the company,” says Oregon Assistant Attorney General David Hart. “Clearly, having to disgorge two times their income would be a deterrent and frankly perhaps a death sentence.”

Lawsuits Filed By HO&P on behalf of Fentanyl Overdose Victims

If your loved one has been a victim of an accidental overdose caused by fentanyl products such as Subsys, you may be eligible to file a lawsuit against the manufacturer, as well as the doctor or hospital that prescribed the drug. The first step in filing a fentanyl lawsuit is to speak to a law firm whose attorneys have the training and experience to handle your case and help you to attain the best possible result for your loved one.

Heygood, Orr & Pearson has filed more lawsuits on behalf of victims of fentanyl overdose than all other law firms in the country combined. In the very first jury trial filed by our attorneys against a fentanyl pain patch manufacturer, a jury awarded a $5.5 million verdict to the family of a Florida man who died while wearing a fentanyl pain patch sold under the brand name Duragesic. More recently, our firm obtained a $16,560,000 judgment against two subsidiaries of Johnson & Johnson on behalf of the family of an Illinois woman who died while wearing a fentanyl pain patch.

Hundreds of lawsuits have been filed against manufacturers of the fentanyl pain patch and other fentanyl products on behalf of patients who died as a result of an overdose. Many lawsuits have also been filed against doctors, hospitals, or medical staff who improperly administered fentanyl products to their patients, including fentanyl prescriptions that were administered in combinations with other CNS-depressant medications.

If you or a loved one has suffered an overdose involving fentanyl products, contact the lawyers at Heygood, Orr & Pearson to learn more about whether you may qualify to file a lawsuit. For more information and a free consultation about your case, call toll-free at 1-877-446-9001, or follow the link to our free case evaluation form and answer a few simple questions to get started.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.