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Whistleblower Wants Prison Time for Convicted J&J Med Device Execs

Melayna Lokosky

Melayna Lokosky

Mesh Medical Device News Desk, July 25, 2016 ~ Whistleblower Wants J&J Subsidiary Execs To Be Imprisoned Following $18 Million Fine and Federal Conviction

 

Melayna Lokosky is not shy.

The former Acclarent Inc. medical device sales rep worked for a Johnson & Johnson subsidiary until 2011 when she filed a whistleblower lawsuit against the company. Lokosky alleged Acclarent executives were aggressively marketing a medical device for uses not approved by the U.S. Food and Drug Administration (FDA).

When she didn’t play ball, she lost her job and created the appropriately named Facebook page, Killing My Career.

Last week, after a six-week trial, the two executives were convicted of 10 misdemeanor counts and the misdeeds cost Acclarent $18 million. Lokosky, the whistleblower, will receive $3.5 million for her role in bringing the actions to light.

But she wants more. She believes prison time is more fitting for these two.

From change.org

From change.org

 

BACKGROUND 

Last Friday, the seal was lifted on the case and now Lokosky can speak about it.

The Department of Justice revealed Acclarent will pay the government $18 million to settle the whistleblower lawsuit also known as a False Claims Act.

“The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “We will not permit companies to circumvent that process and put profits over patient safety.” 

 

Executives William Facteau, 47, Acclarent’s former CEO, and VP of Sales, Pat Fabian, were convicted by a federal jury in Boston July 20th of distributing adulterated and misbranded medical devices into interstate commerce.

The company made the RElieva Stratus Microflow Spacer, also known as Stratus to be used with saline solution to maintain sinus openings after surgery.

Instead, Acclarent marketed Stratus as a drug delivery device for corticosteroids even after the FDA in 2007 rejected the company’s request to include that in approved uses.  Acclarent even made a video demonstrating Stratus being used with the drug Kenalog-40, a corticosteroid.

Health care providers who submitted claims to Medicare and other federal health programs for that use, then did so falsely.

The jury agreed the two men marketed the Stratus for use as a steroid delivery device.

The 10 misdemeanors are a violation of the Food, Drug and Cosmetic Act carry a year in prison for each count.

Lokosky believes the executives held responsible should be held accountable and has started a Change.org petition calling for the stiffest penalties allowed under law.

“If you were injured by a medical device then you’ll want to pay attention to this story. Don’t miss your opportunity to weigh in on sending convicted white collar medical device executives to jail. Especially if your injury stems from a company first funded by NEA – New Enterprise Associates (like Gynecare or Essure because they also funded Acclarent.”

 

“We cannot allow the courts to encourage, replicate and reward unethical and illegal behavior that a jury of peers already CONVICTED on, by going soft on medical device executives during their sentencing.”

 

ACCOUNTABILITY 

The case is unusual for holding accountable executives of a major corporation rather than just imposing civil fines.

Last fall, U.S. Deputy Attorney General Sally Yates issued a memo published by Stat. It states the trend toward charging based on individual accountability for corporate wrongdoing.

“One of the most effective ways to combat corporate misconduct is by seeking accountability from the individuals who perpetrated the wrongdoing. Such accountability is important for several reasons: it deters future illegal activity, it incentivizes changes in corporate behavior, it ensures that the proper parties are held responsible for their actions, and it promotes the public’s confidence in our justice system.”

The lawsuit was filed under the Health Care Fraud Prevention and Enforcement Action Team, created by Health and Human Services in May 2009 to reduce and prevent financial fraud in Medicare and Medicaid.  The False Claims Act allows whistleblowers to alert lawmakers to financial crimes. The DOJ has reportedly recovered more than $30 billion since January 2009.

Lokosky filed her whistleblower suit under the False Claims Act which allows private parties to sue for false claims on behalf of the government and share in a portion of the recovery. The civil lawsuit was filed in the District of Massachusetts United States ex rel. Melayna Lokosky v. Acclarent, Inc.

Stratus was taken off the market in May 2013 and marketing for the device was discontinued. It is no longer commercial available in the U.S., according to a DOJ statement.

Johnson & Johnson acquired Acclarent in 2010. The company says the alleged misconduct took place before the J&J purchase.  Attorneys for Facteau & Fabian plan to appeal the misdemeanor convictions.  ##

 

 

12 Comments

  1. Mary Pat says:

    So the DOJ actually investigates????? Why have they ignored the mesh problem? I filed a complaint with the DOJ several years ago and I didn ‘t even reveive a response! Not a word! I met a DOJ investigator assigned to my region. I asked him about my complaint. It was not even referred to him. He was unaware of the mesh issues. So DOJ if you are reading this, get to work on investigating the mesh problem!

  2. D g says:

    I have concern in situations like this where companies get fines, paid to whistle blower or government entities, but they haven’t settled with the injured with life changing injuries .?

  3. Lordhelpus says:

    Ok it’s a start. This will open doors for everything else, because “what’s done in the dark….”

  4. Tammy S Jackson says:

    Wonderful article Jane, I signed and shared for Change.org. These Big Pharm needs jail time. They place money over Lives. With Greed and Corruption, they don’t care about injuring humans. Shame,Shame

  5. Jan Mc says:

    Prison sentence is appropriate for knowingly selling a product to any citizen beforemail being appropriately tested and proven harmless.

  6. Dorothy G says:

    THIS SHOULD TELL THE OTHER COMPANIES TO SETTLE UP. I. STILL WONDER HOW C.R.BARD WON AN AWARD IN 2016 FOR MEDICAL SAFETY

  7. Dorothy G says:

    GREAT ARTICLE THANK YOU FOR YOUR HARD WORK AND STAYING ON TOP OF IT ALL

  8. K says:

    I have no problem with whistle blower getting paid for what was done. She was harmed by what they did to her for blowing the whistle and it helps us all! Thank God for her and her bravery!

  9. Mary Pat says:

    This will encourage more whistle blowers! Watch out big pharma! The truth will get you!

  10. Suri says:

    I went to a new GYN in March 1997 for a pap smear –and he said he had a new partner who– just learned a new bladder procedure, “A simple Procedure” that wouldn’t leave any scars and he would tighten me like a virgin to strengthen my pelvic walls, too. And when I got old, my bladder wouldn’t fall out through my VJJ. I was freaking out after he showed me a picture of someone’s actually falling out and decided to have it done since I stood for a living cutting hair for over 10 years…expecting to be doing it another twenty years.Two weeks later, April 7th, 1997 my life changed forever. Pain and suffering, non stop. Every day was like waking up from surgery. They wouldn’t give me any prescriptions for pain meds and I went crazy and lost my new home, my three businesses, my marriage, and had to pawn all my jewelry to buy a used car. I went through multiple surgeries and tried to sue the doctors. I even wrote the FDA a letter telling them women were getting mutilated from laporscopic bladder suspension surgeries….went through my VJJ to implant the mesh. I have a lawsuit filed with Nations Law Firm but I don’t feel like they are really trying to help us women and they have never settled one case out of around 2,000. Come April 7th, 2017—I will have lost 20 years of my life to pain and suffering…cut down in the middle of my working career. I slept in my car for three winters plugged into my friend’s house. Moved so many times because I couldn’t pay the rent. Slept a year on m sister’s sofa and I can only sleep on my right side due to my bladder pain and now my right shoulder needs an operation. I need a lawyer who I can trust not to sell out my case under the table. I need money now. Im 60 yrs old and depressed and all I do is write about my pain in my journals. Helps some. Im so sick, I missed four Dr appointments last month. I need medical care help but will not move into a place with no privacy. I lived at a shelter for 20 days last year because summer is not a place for a disabled person to be living in a car. Couldn’t straighten my legs out…Had to pee in a tea pitcher. Showered at the Gym but never worked out. Was thinking about living in a storage unit…but never did…but still might. I am a victim of J&J mesh. I have a case that is 100% proved through medical records. What have I done so badly in my life to deserve this? I ask God everyday why this is happening to me. I pray I find new legal team that I can trust that has already won a case for other women. I read Judge Goodwin said to bring the oldest 2,000 cases to court this year, but Nations Law Firm never contacted me and said if I moved my case, I would have to start all over, and that would delay my settlement. I need my settlement while I am alive not dead…. What should I do? Please pray for me. Thank you.

    • Jane Akre says:

      I’m so sorry Suri. Please share the name of that doctor who made those false promises to you. You must have been the unfortunate recipient of one of the early experimental meshes, though they were all experimental…. ProteGen? TVT was not yet approved in the US in 1997 but perhaps that is what you received since you mention J&J. Please let us know. Have you any reliable doctor who can help you with your pain? Please let us know because it is painful to hear of our suffering over these last 20 years. There may be someone in your area who can help… Pls advise… thank you and again, I’m so sorry.

  11. Samuel says:

    A hero is a better title for you.

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