ASR

Discussion in 'DePuy Ortho' started by Anonymous, Oct 16, 2012 at 7:42 PM.

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  1. Anonymous

    Anonymous Guest

    Thousands of hip replacement surgeries take place every year—and thousands may have to be repeated, thanks to a defective hip implant. Cityview investigates.

    photography By Jimmy Chiarella
    Researched by Halie Christ


    It’s the simple things of life that keep us moving, from the flowers that bloom at the first sign of spring to the gentle breathing of a sleeping baby. For many of these simple things we hardly spare a second’s thought—like the inter-workings of our own bodies. With countless cells constantly at work, 206 bones piecing us together, and 600 muscles and 360 joints enabling activity, there is plenty of room for failure. It can be easy to take our bodies for granted, not often considering the possibility of joint failure until it happens.

    When it happened to Teresa Adams, a single, working mother of two, she understood the devastation of hip failure. Adams, like most people, wanted nothing more than a normal, pain free life. Her face lights up as she talks about her 35 years in the floral business. The joy in her eyes is as profound as the despair of her having to give up her work. Adams recalls the severe pain in her hips she lived with for years, despite the countless steroid injections and other temporary fixes. “In both my hips I had sharp pains from arthritis,” she says. Teresa says her pain became so bad that she could no longer endure the movement needed for floral design. With trepidation she began the process of considering a hip replacement. “My joints were just worn out,” she says. “They had told me for years I was going to have something done or I’d be in a wheelchair.” Despite her concern, she decided to move ahead with the surgery.

    When it comes to the simple things, you don’t notice the spring’s flowers until they don’t bloom, and you don’t notice the blessing in a baby sleeping until it starts to cry. With your body, you may start to realize something isn’t right when you begin to hurt, or, in Adams’ case, when unbearable hip pain forced her to give up her livelihood. It can be a difficult process for a person to realize that their body has failed them, sometimes waiting until there is no other choice before admitting defeat. Choosing to have the surgery is often one of the biggest decisions a person can make. For many, so is the surgeon you choose.

    Dr. Matthew Nadaud, an orthopedic surgeon at Knoxville Orthopedic Clinic in his tenth year of practice, was Adams’ surgeon of choice. A true veteran of hip and knee replacements, he has preformed close to 6,000 hip and knee replacement surgeries. His diagnosis of Adams was no different than what she’d heard for years: “There wasn’t anything else they could do,” Adams says. Surgery was imminent. Nadaud says he does not go by what implant companies want you to believe about their product, nor what patients choose to believe about certain implants. “I’ll use the product that I know how to use well,” he says. Teresa says she was happy she chose Nadaud; Nadaud however did not seem to feel fortunate placing his trust in DePuy.

    DePuy Orthopedics is the oldest orthopedic company, as well as one of the largest. Now they are a subsidiary of Johnson and Johnson, a worldwide company with $61.6 billion in sales 2010, and DePuy itself grossing $5.6 billion. DePuy is responsible for many innovations in orthopedics, such as the first low-friction hip implant, however, their metal-on-metal ASR hip system-ASR XL Acetabular System and DePuy ASR Hip Resurfacing System- led to recall. DePuy set off to create a hip joint for the physically active person. In order to get increased mobility from the joint, the design required a shallower cup giving less coverage of the femoral ball to allow greater motion within the socket. Unfortunately this did not prove to be true for many people who received the implant. The lack of coverage concentrated the forces of the ball against the cup in a way that caused it to wear quickly. According to DePuy, there were other potential issues. There were concerns of loosening when the implant does not stay attached to bone in correct position, fracture around the implant, and the possibility of dislocation, where the two parts are no longer aligned. In other words, a multitude of patients having this hip implant could face immense pain if theirs fails.

    Avoiding significant crisis until this hip recall in August 2010, DePuy is now facing the repercussions of notifying 93,000 patients that their hip implant may fail.

    This hip system first became available in July 2003, and remained on the market for just over seven years before problems with the device were officially announced. Naudad says they were aware there were problems with their product for a period of almost two years. “Instead they had their spokespeople blaming the doctors. And that’s the part that’s hardest for me to stomach,” he says. “I understand they thought they had a good product initially, but when they realized the product was problematic, they weren’t very forthcoming.” DePuy decided to end production of it in 2009, but didn’t recall it until mid 2010. They now could potentially face millions of dollars in lawsuits. “It’s a hard thing to do to tell one of your patients they need another operation,” Nadaud says. “And it severed my relationship with DePuy.”
     

  2. Anonymous

    Anonymous Guest

    UPDATE! 730PM ET DePuy Hid Data About Failed Hip Implants

    New York Times
    7:30 PM ET

    DePuy Hid Data About Failed Hip Implants

    --If you want to see something even more disturbing look at the court records for today's proceedings.

    It shows the actual DePuy internal documents and Emails with everyone at DePuy acknowledging problems with ASR, keeping it under wraps, then strategizing about a quick fix to the product before everyone figures it out. There are emails about potential fallout from surgeons and the short window of opportunity to convert these surgeons to another product. This all at least a year before recall.

    I'm surprised no one has made the connection yet about Depuys acquisition of Finsbury's MOM Resurfacing during this whole process as a way to replace with a better implant after abandonment of Project Alpha (ASRII).

    http://www.nytimes.com/2013/01/26/business/johnson-johnson-hid-flaw-in-artificial-hip-documents-show.html?ref=business&_r=0
     
  3. Anonymous

    Anonymous Guest

    And who is surprised by this? There are men making a lot of money who made those decisions. In my humble opinion the company should be forced to fire them. But no they just continue to be rewarded. For what? Who the hell knows. This management style has destroyed the DePuy reputation. The solution? Change the name and with it goes the crap. I believe the strategy is to eventually eliminate the DePuy name all together. Patients simply won't know that Synthes Orthopedics was once DePuy Orthopedics. Instead of spending $$$$$$$ on a new name why not show the bozos the door. That would make too much sense. Instead leave them in power so they can continue to make decisions and groom more people to be just like them. It's a disgrace to be honest. A disgrace to all the lives that have suffered because of bad decisions.
     
  4. Anonymous

    Anonymous Guest

    Re: UPDATE! 730PM ET DePuy Hid Data About Failed Hip Implants

    There are names attached to these emails. Names of sales and marketing and manufacturing and research personnel. Kilburn. Eckdahl. They knew what was going on and walked the halls of Warsaw looking for ways to cover their own asses. It's the DePuy way. It is a corrupt organization built on self promotion, intimidation and short term gain.

    There are people who tried to do the right things and were put in a corner and those who tried to cover it up.

    After we finish paying the $$$billions in fines, how about an investigation of the internal politics and a board exposé' to the entire organization letting people know that doing the right thing is allowed and won't get you fired or marginalized?
     
  5. Anonymous

    Anonymous Guest

    Whistle blower hotline should have been on fire. Don't forget, you can make a lot of money by making a phone call. Unless of course your full of shit, like 99% of this site.
     
  6. Anonymous

    Anonymous Guest

    What makes you so sure the hotline hasn't been on fire dumb f$&k? I doubt that the article that was posted was 99% incorrect. I doubt that high level names would be called out in a news article unless they were positive of their facts. I wonder how you would feel if it were your mother or father with and ASR poisoning their body. Would you draw your sword and defend the decisions to sell this product regardless of the warnings?
     
  7. Anonymous

    Anonymous Guest

    The ASR disaster is just beginning.
     
  8. Anonymous

    Anonymous Guest

    ASR won't of be a thought in 2 years. 2 billion loss isnt shit for JnJ and only means less % for the overpaid reps pushing faulty shit. Bite the dog and dogs gonna bite back.
     
  9. Anonymous

    Anonymous Guest

    Absolutely true. Most will not remember ASR in time. Do you remember Hylamer? Why not? Because DePuy cut the DuPont collaboration as fast as possible after that debacle.

    The point I'm making is that changes will be made to ENSURE that no one can remember it. Any guesses as to what the changes will be?
     
  10. Anonymous

    Anonymous Guest

    Watching Mr. President testifying on ASR. Quite interesting. Is the projected cost of the recall still $2B?
     
  11. Anonymous

    Anonymous Guest

    What is he saying about the emails?
     
  12. Anonymous

    Anonymous Guest

    Just Googe it and hear for yourself...
     
  13. Anonymous

    Anonymous Guest

    That was brutal to watch!
     
  14. Anonymous

    Anonymous Guest

    No shit! All that beverage drinking made me want to pee!
     
  15. Anonymous

    Anonymous Guest

    Kilburn shat the bed today. So far, he and Eckdahl have been awesome witnesses for the plaintiff. Geez, this is going to be a mess. After today's performance, Kilburn is going to have a lot of free time to spend at Stonehenge again this summer. He came across as sleazy and manipulative.
     
  16. Anonymous

    Anonymous Guest

    Was Kilburns testimony recorded? If so where can I find it?
     
  17. Anonymous

    Anonymous Guest

    I didn't think Berman had it in him. No wonder he left. He was trying to do the right thing but was being blocked. Kilburn probably didn't read the emails. Not sure the reception is very good on the golf course.

    "J&J’s Marketer E-Mailed Hip Safety Concerns Before Recall
    Bloomberg

    A top marketing executive at Johnson& Johnson’s DePuy unit said the company should consider a recall of a hip implant almost a year before 93,000 of the devices were recalled, according to an internal e-mail shown to jurors.

    Paul Berman, DePuy’s director of hip marketing, wrote Sept. 18, 2009, that he wanted to “reiterate my concern” over safety of the ASR device, given mounting failures. Jurors, at the first of 10,000 lawsuits to go to trial, saw several e-mails yesterday from marketers before the recall on Aug. 24, 2010.

    Berman discussed a recommendation to “discontinue the product from all but 10 surgeons because of failure rates with the broader universe,” according to the e-mail shown to state court jurors in Los Angeles.

    “If the company feels the safety profile of the platform is not acceptable among the majority of surgeons it seems we should consider recalling it altogether,” Berman wrote.

    Jurors are weighing the lawsuit of Loren Kransky, 65, a retired prison guard who claims that DePuy defectively designed the device. Kransky’s lawyers claim that surgeons who implanted the ASR complained for years before the recall about device failures, and DePuy failed to warn properly of the risks.
    HEALTH PROBLEMS

    J&J, the world’s largest seller of health-care products, denies it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick, New Jersey. In an opening statement on Jan. 25, J&J lawyer Alexander Calfo said Kransky’s lawyers took e-mails out of context to“paint a picture about a company that simply isn’t true.”

    In a videotaped deposition shown yesterday of Michael Rhee, a hip marketing manager, Kransky’s lawyers asked about e-mails starting in 2008. A San Francisco surgeon, Thomas Sampson, e-mailed Thomas Vail, a surgeon who helped design the ASR.

    Sampson wrote that he saw an ad on the cover of Orthopedics Today claiming 99.2 percent survivorship for ASR patients.

    “It was difficult to read the ad considering my failure rate is in double digits,” Sampson wrote on July 28, 2008. He said another doctor’s “are worse and other orthos I have talked with stopped using it all together because of pain and fibrous ingrowth.” Sampson added “I don’t believe the failures are due solely to technique.”

    Vail forwarded the e-mail to another surgeon who also helped design the ASR, Thomas Schmalzried, who responded,“Using ‘surgical technique’ to explain failures to a surgeon is an uphill fight.”
    ASR STUDY

    Jurors also saw an e-mail chain involving Tom Fehring, a North Carolina surgeon who had advocated studying ASR patients. Berman sent marketing materials to Fehring about another J&J hip, the Pinnacle, according to an e-mail. Fehring complimented Berman on the materials.

    Berman e-mailed Rhee in January 2009 stating he had “sent all Pinn design surgeons the new Pinn brochure with a letter telling them we plan to continue promoting it. Should make them back off asr a bit.” Rhee replied, “Why r u getting in my s---.”

    Berman wrote, “Keeping fehring from recalling your product. You’re welcome.”
    On March 14, 2010, Berman wrote an e-mail to a colleague, according to testimony.
    “I want to reiterate my concerns with the safety of the ASR platform,” he wrote. “With growing chatter in the market and commentary” from a British surgeon and others, “I still remain concerned with the safety of this product,” he said.
    ‘AN OBLIGATION’

    “As a marketing professional, I do not make product safety decisions, but I do have an obligation as an employee of J&J and DePuy to make it known when I do not feel comfortable,” he wrote.
    He referred to four earlier e-mails he sent, including the one in September 2009 suggesting a possible recall.

    Kransky’s hip was implanted in December 2007 and removed in February 2012 through a so-called revision surgery. His lawyers said that he suffered from high levels of chromium and cobalt released from the ASR device. Kransky also suffers from diabetes, coronary artery disease, high blood pressure, kidney cancer, and other health problems.

    His physician, Thomas Trotsky, said he was concerned that Kransky wouldn’t be healthy enough to survive the revision.

    “What was driving this was everyone’s conviction that unless the hip was replaced, Bill was dying,” Trotsky said in videotaped testimony shown yesterday. “We felt we were dealing with a man who was slowly dying from being poisoned.”

    “I was convinced that Mr. Kransky would die from toxicity if the hip weren’t removed,” he said. “Mr. Kransky was convinced it was his last and only chance to survive.”
    COBALT MEASUREMENT

    In his opening statement, Calfo said “the evidence will show the amount of cobalt measured in Mr. Kransky was not enough to cause any adverse systemic health effects.”

    Asked by J&J attorney Michael Zellers what caused him to conclude that Kransky was threatened with metal toxicity, Trotsky said: “There’s no research evidence that would cause me to come to that conclusion.”

    Kransky’s daughter, Jennifer Flynn, wept as she testified yesterday about her father’s suffering before his revision surgery. She said her father fell several times, including once when he came out of the shower and landed with his head in the cat litter box.

    “He’s a prideful man and to have your daughter pick you up because your head is in the catbox is not the way it’s supposed to be,” she said. "
     
  18. Anonymous

    Anonymous Guest

    J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told
    Bloomberg


    Three years before Johnson & Johnson’s DePuy unit recalled its chromium and cobalt hip implants, company marketers feared the backlash over metal ion debris in patients, a jury in Los Angeles was told.

    A DePuy marketing executive, Randall Kilburn, testified today in California state court at the first of 10,000 lawsuits to go to trial over the ASR hips, which J&J withdrew in August 2010 when their failure rate reached 12 percent. Kilburn was asked about a meeting in July 2007 in Chicago, where the marketing team discussed several hip devices.

    At that meeting, the sales force saw a PowerPoint presentation titled: “What scares us the most in the year ahead?” Of the nine items listed, the first was: “Metal ion backlash.” Others included industry consolidation, price pressure and Japan.

    Jurors are weighing the lawsuit of Loren Kransky, 65, who claims the ASR hip was defectively designed and the company failed to warn of risks. Kransky’s lawsuit and many others claim that the shallow design of the hip cup, in which a metal ball sitting atop the femur rotates, led to the shedding of metal ions in surrounding tissue and bloodstream.

    J&J, the world’s largest seller of health-care products, denies it designed the ASR defectively or that it led to dangerous levels of metal ions. J&J, based in New Brunswick, New Jersey, says it properly warned of the risks. Analysts say the lawsuits could cost the company billions of dollars to resolve.
    Kransky attorney Brian Panish asked Kilburn whether he considered metal ion backlash a threat.
    ‘MANY THREATS’

    “Yes, it’s one of many threats,” Kilburn said.
    Panish asked Kilburn about complaints from surgeons who claimed the ASR was failing. In 2008, DePuy also weighed a redesign of the ASR cup, which is slightly less than a half-circle, and included a groove to help a surgeon place the device in the hip. Kransky’s lawyers and experts say that design led to metal ions entering the bloodstream.

    “Weren’t you aware that surgeons complained that the ASR shed excessive debris?” Panish asked.
    “When it was malpositioned, yes,” Kilburn said.
    “That would be a red flag, wouldn’t it?” Panish asked.
    “Yes, when it was malpositioned,” the witness said.
    ‘GAME ON!’

    Jurors saw a video of a 2008 sales meeting in New Orleans where Kilburn announced that the ASR hip division had increased sales in 2007 by $62 million over the previous year. At one point he said to the audience, “Game on!”

    “This was after you had received many pieces of information raising red flags?,” Panish asked. Kilburn agreed.

    “You were still out there - game on - selling as much as you could,” Panish said. Kilburn agreed.
    Panish showed e-mails from March 2008 discussing public ridicule by Derek McMinn, a British orthopedic surgeon, of the ASR and its designers. In 1997, London-based Smith & Nephew Plc introduced McMinn’s Birmingham Hip Replacement.

    That device advanced metal-on-metal designs of the 1960s and 1970s that had fallen out of favor as metal-on-polyethylene grew popular. DePuy began selling a similar device, the ASR Hip Resurfacing System, outside the U.S. in 2003. Both devices used an alloy of cobalt and chromium.
    DePuy engineer Graham Isaac wrote in an e-mail that McMinn gave a speech to the British Hip Society and attacked competitors, while “his main vitriol was reserved for ASR.”McMinn, Isaac wrote, “implied that the testing of ASR was both incompetent and biased.”
    ‘SHAKING WITH RAGE’

    Isaac said that the lead surgeon designer of the ASR,Thomas Schmalzried, “was almost shaking with rage.”

    “We should be flattered as we are obviously seen as the main threat,” Isaac wrote.
    Marketing executive Paul Berman wrote four days later to Schmalzried and another surgeon designer, Thomas Vail.

    “Good to know the Society generally didn’t give credence to what McMinn was saying,” Berman wrote. “It certainly is baffling that they continue to give him air time. I suppose it is somewhat like Brittany Spears…nobody really respects her, but there is a lot of morbid curiosity,” an apparent reference to pop singer Britney Spears. “I am confident that McMinn will continue to dig his own grave here in the U.S.,” Berman wrote.

    Berman wrote to Schmalzried that he got 10 calls after“McMinn’s little performance at Hip Society.”
    “We now have some surgeons asking what is wrong with ASR,” he wrote. “While McMinn may not have come across as credible, some surgeons certainly listened to him. A position statement will really help our sales force deflect the mess he created.”
    AVOID REBUTTAL

    Schmalzried wrote that the ASR board preferred to avoid publicly rebutting McMinn.
    Jurors saw an Isaac e-mail from April 30, 2008. He said clinical data comparing the ASR and BHR showed the DePuy device in some conditions was subject to “extreme metal ion levels.”
    After the data appeared in medical journals, it had “the potential to seriously affect our business,” Isaac wrote.

    “We need to discuss this at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested,” he said.

    No upgrade was done. Jurors heard testimony this week about a 2011 internal DePuy study showing 35.8 percent of ASR hips failed within 4.57 years, requiring replacement or revision surgeries.
     
  19. Anonymous

    Anonymous Guest

    GAME ON! Or is it Bang On? I'll bet all the patients that are teed up are thinking the exact same thing today! Feels like justice will be served. Do you think they'll get promotions out of this one? Just curious since its been said that J&J promotes the competent ones. One would think J&J would be cutting bait!
     
  20. Anonymous

    Anonymous Guest

    What is great is that we( the competition) now have a printed document to show the Depuy docs how the company really feels about them and patients. They dont give a shit! Good luck Depuy reps you cant hide this one. Just give youselves a month and you will have another recall to deal with.