Medical Devices for Unapproved Uses For several decades, Parker Waichman LLP has successfully represented clients in product liability lawsuits for injuries related to defective drugs and medical devices. Our personal injury attorneys have a vast knowledge of drug and medical device injury litigation issues, including off-label marketing, which means that a product is promoted for an unapproved use.
If you or someone you know suffered a drug or medical device injury related to off-label use, contact our attorneys today. We are here to answer any questions you may have about filing a lawsuit.
What is Off-label Marketing?
When the U.S. Food and Drug Administration (FDA) approves or clears a drug or medical device for sale in the United States, it does so under specific conditions. A drug or medical device is approved to treat a certain condition in certain patients. The agency also specifies that the product is used a certain way.
Prescribing a product in any manner not approved by the FDA is considered “off-label.” It is not illegal or unethical for physicians to prescribe or use products off-label; they have the right to do so when they believe that the off-label use will benefit the patient. It is illegal and unethical for pharmaceutical companies to engage in off-label promotion or off-label marketing. Companies may face criminal charges and penalties under the False Claims Act for promoting their products for unapproved uses. The government has penalized various drug makers for engaging in alleged off-label promotion; this type of marketing is unlawful and may harm patients.
J&J Executives Convicted of Crimes Related to Off-label Promotion
In July 2016, two former Johnson & Johnson executives were convicted of off-label marketing charges related to the Relieva Stratus Microflow Spacer. The device was originally manufactured by Acclarent, acquired by Johnson & Johnson’s Ethicon unit in 2010.
The FDA approved the Stratus to keep a patient’s sinus open. According to a July 20, 2016 press release issued by the Department of Justice (DOJ), U.S. Attorney’s Office for the District of Massachusetts, the former Chief Executive Officer and Vice President of Sales of Acclarent, Inc. launched on off-label marketing campaign to promote the product as a steroid delivery device. The DOJ release notes that regulators specifically refused to approve the Stratus for steroid delivery without additional evidence to support this indication.
Following six weeks of trial, a federal jury in Boston found William Facteau, 47, of Atherton, California, and Patrick Fabian, 49, of Lake Elmo, Minnesotta, guilty of 10 misdemeanor violations of the Food, Drug and Cosmetic Act. Each violation might result in up to one year in prison. Jurors acquitted the executives of 14 felony counts of fraud.
“The evidence at trial demonstrated that Facteau and Fabian sought to quickly develop and market products, including the Stratus as a drug delivery device, to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition,” the release states.
According to Fierce Pharma, the convictions may help pave the way for future off-label promotion cases.
Federal Government Pursues Off-label Marketing Claims, Obtains Large Settlements
The federal government has pursued various off-label marketing cases in the past several years, some of which produced sizable penalties.
In July 2012, GlaxoSmithKline pleaded guilty to charges of healthcare fraud and agreed to pay $3 billion to resolve criminal and civil liability for various activities, including off-label promotion. According the DOJ’s press release, it was the largest health care fraud settlement in the nation’s history at the time.
The government alleged that GlaxoSmithKline (GSK) promoted Paxil, the antidepressant, off-label in patients under the age of 18. The FDA only approved Paxil to treat depression in adult patients. Among other things, GSK allegedly “participated in preparing, publishing, and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” Simultaneously, the company did not present data from other studies showing that Paxil is not effective in patients under 18 years of age.
The settlement also resolves off-label marketing allegations involving Wellbutrin, which the FDA only approved for Major Depressive Disorder (MDD). GSK allegedly promoted the drug off-label to treat sexual dysfunction, substance addictions, and Attention Deficit Hyperactivity Disorder (ADHD). GSK allegedly paid illegal kickbacks to physicians to attend events where the drug was promoted for off-label use.
“Patients rely on their physicians to prescribe the drugs they need,” said John Walsh, U.S. Attorney for Colorado, according to the release. “The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs. This case will help to ensure that your physician will make prescribing decisions based on good science and not on misinformation, money or favors provided by the pharmaceutical industry.”
The federal government has also pursued off-label marketing charges against J&J, leading to a $2.2 billion penalty in 2013. Among other things, J&J allegedly promoted Risperdal (risperidone) and other medications for unapproved uses.
According to the DOJ’s press release, the government alleged that J&J promoted Risperdal for children even though the company was aware that the drug “posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.”
Additionally, the government alleged that J&J promoted Risperdal to treat elderly patients with dementia, even though the FDA only approved the drug to treat schizophrenia at the time. J&J admitted to promoting Risperdal off-label, including offering incentives to sales representatives.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society-children, the elderly, and those with developmental disabilities,” said Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania according to the release. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said the Director of the FDA’s Office of Criminal Investigations, John Roth, according to the DOJ release. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”
Filing a Lawsuit for Drug or Medical Device Injuries
Parker Waichman is a national personal injury law firm that represents clients in drug and medical device injury lawsuits. Our goal is to ensure patient safety and hold manufacturers liable in situations where they failed to warn patients and physicians about the risks associated with a drug or medical device. Misrepresenting the safety of a medical product puts patients at risk. If you or someone you know suffered a drug or medical device injury and want to learn more about filing a personal injury lawsuit, contact our firm today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).