Part II: Something Stinks at Johnson & Johnson’s DePuy Synthes

Part II: Something Stinks at Johnson & Johnson’s DePuy Synthes

October 26, 2015

(Note to media: Please use the full name or the parent name to attribute accountability-correctly. ex: Johnson & Johnson DePuy Synthes)

(Note to any Johnson & Johnson patient, consumer or employee victims: Please support each other publically through social media as a means to gain media attention to forced accountability back on Johnson & Johnson.  One person is not & will never be Johnson & Johnson’s worst nightmare, it’s victims (Risperdal, Ethicon Gynecare Mesh, Morcellators, Acclarent & DePuy Synthes) banning together in a unified front getting media attention exposing the negative truth Johnson & Johnson would rather remain hidden, that’s their worst nightmare).

  You all have lost sleep due to your Johnson & Johnson caused injuries,  isn’t it time they do too?

Part I: Johnson & Johnson DePuy Synthes ASR & Pinnacle Hips: The Unwalking Almost Dead

In Part I, we met the executive players either currently working for or who recently “decided” to leave Johnson & Johnson DePuy Synthes the company who knowingly and willfully implanted over a 100,000 faulty ASR & Pinnacle metal on metal (MoM) cobalt & chromium hip implants worldwide.  You’ll have noticed a pathological pattern within Johnson & Johnson where executive’s unethical & illegal behavior is not only encouraged, it’s replicated and rewarded.

Metallosis,  is when a body has too high of levels of cobalt in the system,  often a by-product for 100,000’s of patients with (MoM) implants, that can result in death to healthy bone & tissue around the implant site which also can affect the nervous system, cardiovascular system, and even organ failure which ultimately leads to death.  The purpose of surgery is to fix or make a problem better, not make it worse and create additional problems for patients. If you’re reading this and think it doesn’t affect you because you aren’t planning on surgery or know anyone who is, you’re wrong, dead wrong. Preventable revisions, removals, and other medical related fraud by medical device companies not only costs their patients turned victims additional  money which include everything from pharmaceuticals to hospitals stays, it also drives up the cost of private insurance deductibles, co-payments for office visits & pharmaceuticals for everyone.  And make no mistake it is fraud if a company is aware of problems, doesn’t report or under-reports implant complications for profit at the expense of patients.

Sadly, it’s very difficult to expose this problem in part for two reasons: companies like Johnson & Johnson spends over $2 billion annually on corporate advertising and the media doesn’t want to bite the hand that feeds them.  The second reason is that these patients don’t fit the made-for-the-evening-news formula: patient talks about their medical problem, the patient has surgery, patient happily sings the praises of the surgeon and surgery. For most of these patients, there isn’t a happy or even a marginally better outcome so, these patient victims, who need the news coverage more than Lamar Odam needs a Kardashian intervention are ignored by mainstream media. Or worse (if you can imagine worse) those in media like unethical journalist/ Editor of  Reuters On The Case, Alison Frankel,  who exploited a Johnson & Johnson Ethicon Gynecare injured mesh victim to find out what her competition Bloomberg was writing about for an upcoming mesh & FDA story only demonstrates further victimization this time by media. Then Frankel manipulates the facts without shame, remorse, guilt or accountability while blaming the editors and glibly tosses in a transparent, insulting & demeaning  compliment at the end of her email.

One article for roughly 80,000 victims in U.S. federal court across all the mesh device makers, including AMS, Boston Scientific,  Coloplast, Johnson & Johnson but Frankel gave at the office, she’s done, but oh by the way ladies would you mind helping her with her job?

Harsh? Yes. Accurate? Yes. And while it’s recognized that the subject matter is often dense filled with complex medical jargon it’s the media’s job to break down complex stories so the general population can understand the problem and explain why it’s relevant to them; but, that’s not happening because too many journalists just want to cut and paste from a press release opposed to actually doing some research.

Where is the Wall St. Journal, Reuters (we know Alison you already did your victim story of the year), Bloomberg?

Bought media, lazy journalism and a corrupt company like Johnson & Johnson’s desire to “manage perception,” around the worldwide failure of their MoM hip implants is exactly why people in the United States and a greater part of the world don’t know that of their 500,000 devices implanted in just the United States there was a roughly a 25% (125,000) failure rate.  For those outside the industry, it’s a HUGE RED FLAG when the failure rate of a device hits between 2-5%.     

In the United States companies are FDA  required to fill out a MAUDE report (Manufacturer User Facility Device Experience) to alert the FDA of potential problems when one of the company’s medical devices malfunctions; however, this site refers to MAUDE reports as FRAUD reports.  Company regulatory and compliance during new hire rep training will explain (explain again, and in case you missed it explain a third time) the importance of collecting the medical device in question directly from the OR if possible or as soon as possible after the case, wrap in a biohazard bag, include the device lot number, surgeon’s name and a description of what or how the device failed, if the patient was injured (degree of injury) and send it to the home office where the engineers will determine the problem and fill out then MAUDE report.

There should be two MAUDE reports (on sent directly to the government from the rep – the one encounters 99% of the malfunctions) and a second sent after the engineer finds the problem to be “user error.” You see it’s never, and I mean never the device that failed from the company perspective,  it’s either the rep’s fault for not training the surgeon properly or the surgeon’s fault for breaking the device or somehow even the patient’s fault but never the company’s fault. Thirteen years in the industry taught me that regulatory & compliance usually wants to do their job properly as do the reps; but, there’s tremendous unethical & even illegal pressure from managers & executives to manipulate the facts at the expense of reps, surgeons and patients all for company profit when it relates to MAUDE reports.

That’s not to say it can’t ever be poor training,  user error or the device was used in the improper patient population but reps, in my experience, are often threatened if they fill out too many MAUDE reports, especially in Venture Captial backed startups that are either looking to IPO or sell to a large conglomerate.  It would be like trying to sell a house with all the doors missing.  People will start to ask questions.

Johnson & Johnson DePuy Synthes ASR hips hit the market in 2005 and were recalled in August 2010, sold 500,000 units in the U.S. alone where at least 125,000 units failed, the MAUDE database should have flagged this around 5,000 cases which means two things: Our government is failing us, and the companies aren’t filling out MAUDE reports.  

Johnson & Johnson DePuy Synthes Part I taught us who the executive player are that encourage, replicate and reward unethical & illegal behavior Part II taught us about how MoM problem with the hip implants created problems for at the very least 125,000+ patients in the U.S. alone and in the coming weeks Part III will discuss what to do when a company knowingly & willfully injure hundreds of thousands of patients.