Endo to Pay $193 Million for Illegal Marketing of Pain Patch

Endo to Pay $193 Million for Illegal Marketing of Pain Patch

Endo Health Solutions has agreed to pay nearly $193 million in civil and criminal penalties to settle claims with the federal government and several states over the illegal marketing of the pain patch Lidoderm.

lidodermpatchLidoderm is only approved by the Food and Drug Administration to treat post-herpetic neuralgia, a painful condition caused by shingles. Three whistleblower lawsuits were filed against Endo for its “off label” promotion of the patch to treat lower back pain, diabetic neuropathy and carpal tunnel syndrome between 1999 and 2007.

Under terms of the settlement, Endo (NASDAQ: ENDP) and its subsidiary Endo Pharmaceuticals Inc. will pay $172 million in penalties and a criminal fine of $20.8 million. The whistleblowers’ share of the settlement has not been determined.

“Endo Pharmaceutical enriched themselves at the expense of the public,” said Special Agent in Charge Andrew W. Vale of the Federal Bureau of Investigation.   “Patients will search for drug therapies to assist in pain management, and they deserve the right to drugs approved for such use.”

As a part of the settlement, Endo entered into a deferred prosecution agreement with the Department of Justice for a period of up to 2 ½ years and a corporate integrity agreement with the Department of Health and Human Services for a period of five years.

The Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome.   These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA.   The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.

“Illegally marketing drugs off-label puts patient lives at risk and rips off New York taxpayers and the state by defrauding Medicaid and other programs,” said New York Attorney General Eric T. Schneiderman, whose office led a team of states in the investigation and subsequent settlement with Endo.

“Pharmaceutical companies, no matter how large, are not above the law, and my office will continue to ensure that prescriptions are written based on sound medical judgment – and that drug manufacturers are held responsible for pushing their products for uses not approved by the FDA,” said Schneiderman.

A 30-day supply of Lidoderm patches can cost as much as $300. Endo’s off-label promotion caused healthcare providers to submit false reimbursement claims for non-covered uses to Medicare, Medicaid and other federal health care programs.

According to prosecutors, Endo sales managers instructed sales representatives to expand their Lidoderm sales conversations with doctors beyond just using the patch to treat post-herpetic neuralgia.  They were also encouraged to promote Lidoderm in workers’ compensation clinics.

The whistleblower lawsuits were filed by Peggy Ryan, a former Lidoderm sales representative, Max Weathersby, another former Lidoderm sales representative and Gursheel S. Dhillon, a physician.

“The company takes its responsibility to patients, healthcare providers and our shareholders very seriously,” said Endo’s president and CEO, Rajiv De Silva.

“We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements. We are committed to a company culture that supports the conduct of our business in a compliant and ethical manner.”

Authored by: Pat Anson, Editor

There are 6 comments for this article
  1. PainPeer at 7:07 am

    Off-label use is common practice, particularly with hard-to-treat conditions. As a person with chronic pain, including back pain, these patches are part of my treatment arsenal. I am not candidate for surgery due to multiple spinal issues. Unless you join the ranks of those in chronic pain, it’s very easy to think Western medicine has a “fix” for everything. It does not. I use a full complement of strategies to deal with intractable pain. But it still takes its toll every single day. What irks me about this situation is that “whistleblowers” have a monetary incentive bc Medicare (like GM) is run by bean counters not patient advocates. It’s hard enough to find decent chronic pain treatment – reducing available options does NOT help with that.

  2. dave at 4:43 pm

    Ms. Reynolds- people in pain should have a right to effective treatments and that doesn’t necessitate nor exclude the use of drugs for pain.
    Part of the Hippocratic oath is to not be deceived by a druggist. I am not opposed to freer use of lidocaine, by pain sufferers, but I am opposed to “false facts” for they are injurious not only to science but to people in pain who really don’t have the time to be as discerning as Cochrane Database authors to fully consider the evidence pyramid for a certain drug or treatment.
    Isn’t it bad enough that 50% of medical research goes unpublished and that NIH Director, recently has told us that efforts to ensure reproducibility of medical research are “hobbled”. The last people considered in all this are the greatest stakeholders- people in pain. They are always low man on the Totem pole as Professionals, government and companies promote their own self interests.
    Professionals, Pharmaceutical companies, and drug manufacturers shouldn’t try to deceive people in pain. In fact they should make evidence based medicine more easy to understand and use.
    People in pain usually have more than enough to deal with and especially now with Obamacare, the crackdown on opioids, without having to deal with overmarketed treatments for pain.

  3. Janice Reynolds RN, BC, OCN, CHPN at 8:08 am

    It may not have been “approved” by the FDA however there is sufficient research to support its use in back pain, broken ribs/pelvis, and other neuropathies. I have seen some amazing results with them. Using something off label should never be considered wrong unless it has the potential to be harmful. Many antipsychotics are not approved in the older adult with dementia in fact they are Black Boxed by the FDA for that use as they have caused deaths yet I have seen them prescribed many times for that population.
    I am sorry the patch did not work for you Denise however in the world of pain treatment, not everything works for everybody. Also many times we need combination of treatments for good effect. Your bigger problem seems to be your doctor.
    As one of the “safest” medications out there I am hopeful the Lidocaine patch will go over the counter at some point.
    Shame on this lawsuit .” Patients will search for drug therapies to assist in pain management, and they deserve the right to drugs approved for such use”-They have the right to use medication that research shows is effective. People with persistent (chronic) pain also have a right to have their pain treated and a pain plan which works for them-they don’t seem to be too worried about those rights as millions of people with persistent pain suffer daily unable to get a provider or treatment which works for them.

  4. Dennis Kinch at 5:55 pm

    There are 3 sides to every story, your side, my side, and the truth. In this case, as in others, we must accept the fact that Lidoderm works for some people in pain.Another drug, Neurontin, was an epileptic drug at the time they tried it on pain patients. In my pain class it was a miracle drug for half my class; the other half hated it.

    The truth here is probably in the way it is marketed i.e. reps telling docs false info to make more sales. If the lawsuit money goes back to any fed organization, then there is incentive for them to bring and judge lawsuits with huge fines and penalties; again, it’s about money.
    So maybe the truth is that someday the US will be on socialized medicine and when we are, it will be the fault of all the greedy, money grubbing officials who stand behind the dollar, not the patient. Isn’t this treason?

  5. Doc ForthePeople at 10:26 am

    And the war on chronic pain patients continues. I guess it is going to be a criminal act for a doctor to even schedule a chronic pain patient for an appointment, After all, there are no studies on anything for treatment for truly CHRONIC back pain!!!

    But then the DOJ is funded in good part by the money collected from this kind of investigation!

  6. Denise Knox-Beckman at 10:15 am

    So, what about the patients who were prescribed this exactly for lower back pain? It never did anything really to stop the pain and pretty much was a waste as the patch would slide around my backside! These things were not cheap! Insurance wise? I as a patient had to fork out 50 bucks a hit for one damn box. I kept using them, hoping and praying they would work. They didn’t. But a third back surgery finally gave me some relief! I wasn’t perfect, all things take time to work. And all the different drugs like cymbalta, Lyrica, anti-depressants in all flavors and sizes, did not do one positive thing for me! Unless you wish to count that I weighed in at 262lbs after all that crap, and never hungry, it elevated my blood pressure to seriously uncontrolled hypertension, as in five different pills a day. It took me 3 1/2 years to get the weight off, I wasn’t as active as I once was. But after the weight issue was gone, the blood pressure meds decreased, but one, which helps the nerve damaged leg, my cholesterol went away to a “non issue point now.” So all those damn drugs the pharmaceutical companies can shove it up their backsides because in truth, all they care about is the almighty dollar in a society that is no longer democratic, but capitalistic, and may the richest so companies win! This old woman here? Doctor was put on notice, “I refuse to be a walking, talking pharmaceutical lab rat as a human being, they can all get stuffed!” ( getting stuffed in Australia has a different meaning!)
    I now am going through another episode with my back. Each time I saw my doctor in the summer when it was getting worse and harder to sit, he would say, “get a donut to sit on.” Then I told him, “you know, besides my backside hurting, my upper portion feels off, and this brings back memories of the failed surgery. A couple good days, then down for the count, and just walking in a store if the pain intensifies, I break out in a dripping sweat, I mean my short hair drenched!” Again, ignored. I’ve been on pain management with him for years. In fact, so many years that all previous damn pain management scam artists doctors, where no two treatments are the same, have all been destroyed. He then gives me a “surprise, here is one month supply of pain medication, I can’t write for you, now I could take 8 a day, but didn’t. Not until it got severe enough and I might take six in one day, but taper back down. The thing is, a doctor should never cut a patient completely off their medications especially several I take. The risk of seizures, strokes and worse, death can create a major issue. So be forewarned. And don’t be a human lab rat for any new drug that comes out in the market! Give it a few years, because the FDA oversight is not doing their jobs!