Sunday, June 30, 2013

Hip implant lawsuits: DePuy moves to bar testimony of 2 experts from previous trial

Mass Device

June 27, 2013 by Arezu Sarvestani

Johnson & Johnson subsidiary DePuy asks an Ohio judge to bar the testimony of pair of expert witnesses who testified against DePuy in a patient injury lawsuit earlier this year.
hip x-ray illustration
Attorneys for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics moved this week to prevent a couple of expert witnesses from testifying during a metal-on-metal hip implant lawsuit taking place in Ohio. DePuy asked Judge David Katz to block witnesses J. Dennis Bobyn and George Samaras from testifying in court.

Bobyn is a professor of biomedical engineering and surgery at McGill University, currently listed as "on leave." He testified during another DePuy trial earlier this year that the rate of adverse events associated with DePuy's metal hip implants should have raised "red flags" as early as 2003, before the implants even hit the market, according to

In that lawsuit, brought by patient Loren Kransky, the jury in March ruled that DePuy's ASR XL metal-on-metal hip implant was defectively designed, charging the device maker with negligence, but dismissing additional claims that J&J failed to properly warn physicians about the risks of its metal hip implants. J&J was ordered to pay Kransky $8.3 million in damages, and the company later asked the court to stay the jury's decision while the company filed an appeal. The court in May refused to reverse the damages.

Samaras, a consultant, also testified in the Kransky lawsuit, according to a press release from patient injury law firm Parker Waichman LLP. Samaras told jurors that internal J&J documents showed that the AXR XL implant failed J&J's own safety tests, prompting the device maker to change the test protocols.

Samaras and Bobyn were retained by the plaintiffs in a multi-district lawsuit that is slated to begin in September. Lawsuits against DePuy began piling up in June 2010 when a a Florida woman accused the company of knowing about the devices' problems but failing to warn physicians. That suit was followed days later by 3 more from California residents who all had to have revision surgery after the implant partially detached from their hip sockets.

DePuy voluntarily recalled the ASR in August 2010 "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a company report. A report passed around internally in 2011, in the midst of the high-profile recall, concluded that 37% of DePuy's ASR hip implants would require revision or replacement in less than 4.6 years.

Thursday, June 27, 2013

Metal-on-Metal Hip Prostheses and Systemic Health: A Cross-Sectional Association Study 8 Years after Implantation


There is public concern over the long term systemic health effects of metal released from hip replacement prostheses that use large-diameter metal-on-metal bearings. However, to date there has been no systematic study to determine which organs may be at risk, or the magnitude of any effect. We undertook a detailed cross-sectional health screen at a mean of 8 years after surgery in 35 asymptomatic patients who had previously received a metal-on-metal hip resurfacing (MoMHR) versus 35 individually age and sex matched asymptomatic patients who had received a conventional hip replacement. Total body bone mineral density was 5% higher (mean difference 0.05 g/cm2, P = 0.02) and bone turnover was 14% lower (TRAP 5b, mean difference −0.56IU/L, P = 0.006; osteocalcin, mean difference −3.08 ng/mL, P = 0.03) in the hip resurfacing versus conventional hip replacement group. Cardiac ejection fraction was 7% lower (mean absolute difference −5%, P = 0.04) and left ventricular end-diastolic diameter was 6% larger (mean difference 2.7 mm, P = 0.007) in the hip resurfacing group versus those patients who received a conventional hip replacement. The urinary fractional excretion of metal was low (cobalt 5%, chromium 1.5%) in patients with MoMHR, but creatinine clearance was normal. Diuretic prescription was associated with a 40% increase in the fractional excretion of chromium (mean difference 0.5%, P = 0.03). There was no evidence of difference in neuropsychological, renal tubular, hepatic or endocrine function between groups (P>0.05). Our findings of differences in bone and cardiac function between patient groups suggest that chronic exposure to low elevated metal concentrations in patients with well-functioning MoMHR prostheses may have systemic effects. Long-term epidemiological studies in patients with well-functioning metal on metal hip prostheses should include musculoskeletal and cardiac endpoints to quantitate the risk of clinical disease.
  • Jennifer R. Prentice,
    Affiliation: Department of Human Metabolism, University of Sheffield, Sheffield, United Kingdom

  • Matthew J. Clark,
    Affiliation: Department of Human Metabolism, University of Sheffield, Sheffield, United Kingdom

  • Nigel Hoggard,
    Affiliation: Department of Human Metabolism, University of Sheffield, Sheffield, United Kingdom

  • Allison C. Morton,
    Affiliation: Department of Cardiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

  • Claire Tooth,
    Affiliation: Department of Neurology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

  • Martyn N. Paley,
    Affiliation: Department of Human Metabolism, University of Sheffield, Sheffield, United Kingdom

  • Ian Stockley,
    Affiliation: Department of Orthopaedics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

  • Marios Hadjivassiliou,
    Affiliation: Department of Neurology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom

  • J. Mark Wilkinson
  • Wednesday, June 26, 2013

    Biomet Hip Lawsuit News:

    Scheduling of Next Case Management Conference in Federal Biomet Hip Replacement Litigation

    Bernstein Liebhard LLP notes the scheduling of a Case Management Conference in the federal Biomet hip lawsuit litigation currently underway in the Northern District of Indiana.
    According to court documents, the proceeding’s next Case Management Conference has been scheduled for September 23rd, 2013 at 9:30 a.m.,* following a telephonic status conference slated for July 29th. At the federal Biomet hip lawsuit litigation’s most recent meeting, which took place on June 17th, the Court discussed the dismissal of duplicative cases and jurisdictional issues relevant to cases filed over the Biomet M2a Magnum metal-on-metal hip replacement, among other topics. (In re: Biomet M2a Magnum Hip Implant Products Liability Litigation – MDL No. 2391)

    Read more:

    Tuesday, June 25, 2013

    Hometown U: New measures aim to improve the state of hip surgeries (Steve Tower MD)

    When Anchorage orthopedic surgeon Stephen Tower needed an artificial hip in 2006 to maintain his passion for recreational bicycling, he decided on one marketed to active younger patients, the metal-on-metal A.S.R. fromDePuy Orthopedics, an arm of Johnson & Johnson.

    The results were disastrous. By 2007 he had hip pain, balance issues that led to bike crashes, and a blood cobalt level 100 times higher than normal. (A.S.R. hips have a ball and socket made from chrome cobalt.)

    Within 18 months, Tower developed ringing in his ears, sleep apnea, mild deafness and a mood disorder. By the end of 2009, his cobalt levels had peaked at 300 times normal and he began losing vision; the hip had to go. Once the A.S.R. was replaced with a ceramic-on-plastic model, his cobalt levels returned to normal and his neurologic symptoms disappeared.

    Tower's experience was not unique. By mid-2010, Johnson & Johnson recalled the A.S.R. they'd released to the market in 2003. Another manufacturer, Stryker, voluntarily recalled its Rejuvenate hip stems in July 2012 after corrosion developed at key metal junctures.

    In January, the Federal Drug Administration (FDA) ordered all five manufacturers of metal-on-metal hips to develop surveillance plans for patients with the devices, monitoring for soft tissue damage near the implant, blood cobalt levels and any new mood, cognitive, neurologic or cardiac problems.
    In March, a Los Angeles jury awarded a retired Montana prison guard $8.3 million in damages, the first of more than 10,000 lawsuits Johnson & Johnson faces over the devices. Barry Meier of The New York Times reported that internal documents released at trial reveal the company's own 2011 studies estimated 40 percent of the hips would fail within five years. This contrasts with the 15-year life span for more traditional artificial hips.

    The fix will be expensive. About 93,000 A.S.R. hips are in use around the world, one-third of them in the United States. An estimated 1 million metal-on-metal hips are in use globally. Now, even patients with the more common metal-on-plastic hips are reporting corrosion problems.
    What a disaster, right? But if good can come from bad, Tower is determined to make it happen.

    Toward solutions

    This spring, Tower reached out to UAA with several proposals in mind. He connected with the dean of the WWAMI medical program and two philosophy professors to suggest:
    • Creating an Alaska registry for all patients with artificial joints,

    • Launching an ethics discussion on how use of metal-on-metal hips spread so quickly and eluded scrutiny for so long.

    Australia and Great Britain have joint registries like the one Tower wants. The United States has trauma, tumor and heart registries, but not one for joints. Tower thinks a smaller registry of Alaskans with artificial hips installed and/or removed would be much faster to create than a national version, more nimble to operate and analyze, and a good predictor of universal experience.

    WWAMI dean Jane Shelby says she was immediately interested in Tower's registry idea. (WWAMI stands for Washington, Wyoming, Alaska, Montana Idaho regional medical education program.) She arrived at UAA in July 2012 with a deep background from WWAMI programs at the universities of Montana and Washington state. Before that, she was a professor of surgery at the University of Utah.
    "The registry would be a good collaboration between investigators at UAA and the medical community in the UMed District," Shelby said. "The registry, and other aspects of the failed hip implants, have the potential to provide research opportunities for UAA and WWAMI students."
    Tower's second idea for improving the state of hip replacements in the U.S. is to allow for easier exposure of the problems. Back in 2010 when he began trying to share his A.S.R. disaster at medical conferences and in medical journals, he says he was shut out.

    Ethical conflicts
    That experience is detailed and analyzed in a paper he co-authored with UAA philosophy professors Stephanie Bauer and Terrence Kelly, both members of UAA's Alaska Ethics Center. Their paper was titled "Will the Real Expert Please Stand Up! Power, Credibility and Expertise in Medical Discourse" and posted in May on the Philosophy of Science Archive at the University of Pittsburgh.

    The paper describes Tower's inability to find a professional audience for his hip replacement nightmare. The main reason, they argue? Because the orthopedic surgeons who are paid by companies to develop biomedical devices are also the journal editors and conference organizers who rejected his papers and panel suggestions. Even the FDA rejected his information because he'd never served as an industry consultant; they didn't consider him a qualified expert.

    The paper argues that medical science has been tainted, or "colonized" by medical industry, so that what is good for the industry overrides what is good for the patient.

    Tower's registry idea takes this conflict into account. He imagines a transparent database equally accessible for study and posting by surgeons, researchers, biomedical companies and even patients. If a doctor suggests a hip replacement and names a particular model, the patient could look it up on the database and find out what others report.

    "The opportunity for public health education is tremendous," WWAMI's Shelby said.

    Read more here:

    Federal Stryker Hip Lawsuits Consolidated for Multidistrict Litigation

    Injury Lawyer News

    Lawsuits filed in U.S. District Courts against hip implant maker Stryker Corporation over the recalled Rejuvenate and ABG II hip components have been centralized in Minnesota as multidistrict litigation, or MDL. In an order filed June 12, 2013, the federal Judicial Panel on Multidistrct Litigation ordered 41 Stryker hip lawsuits from 16 different federal districts to be consolidated under the purview of the Honorable Judge Donovan W. Frank. Judge Frank will preside over pretrial motions, discovery, and settlement negotiations for all federal claims alleging injury from the Rejuvenate or ABG II hip devices.

    Wright To Sell Hip Implant Division


    The maker of the Wright Conserve and Profemur Z metal hip implants announced on June 19 that it was selling its hips and knees division. RLG, which maintains Wright Conserve and Profemur Z lawsuit pages, notes that federal Conserve hip lawsuits were consolidated in court because of the device’s serious alleged side effects (In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, MDL-2329, U.S. District Court for the Northern District of Georgia).

    MicroPort Scientific Corporation will purchase Wright’s OrthoRecon division for $290 million, Wright announced on its website.

    “The sale of the division does not mean that metal-on-metal hip implant recipients may not file a lawsuit if they believe their Wright hip implants have harmed them,” said Rochelle Rottenstein, principal of RLG.

    Like other metal-on-metal hip implants, the Wright Conserve and Profemur Z have been the subject of research studies that found an alleged risk of metal poisoning (metallosis) and a high rate of revision surgery requirements.

    Saturday, June 22, 2013

    Time is running out in NY to file a suit: File or not? (Part Five of x) Testimony of Dr Schmalzried part Three

    I am reading the Kransky vs Depuy trial transcripts and making notes which are of interest to me in my quest to answer my questions and  thought they might also be interesting for you to review.  My objective is  to answer the question:  Should I file or not.

    Part one of x can be found here:  My questions are noted in that post.

    Part Two:

    Part Three: Questioning of Dr Schmalzried part One (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)

    Part Four:  Schmalzried (Dr S) part Two of his testimony

    Part Five :  Schamalzried (Dr S) part three of his testimony below -summary- (I am taking only snippets of the conversation that I find to be problematic in the examination.  This was a long trial and obviously, I can only summarize certain things which will answer questions I have about what transpired here.

    The first topic of the afternoon was  re a paper Dr. S co-authored in 2005.  The plaintiff's counsel asked about footnote 11 in that report which was paper by a tribologist, Dr Bobyn.  Dr. Bobyn's paper stated a few things:
    • "Little is known about the distribution of metal and ions."
    Is that true Dr S?  
    • Yes
    Was that statement true when the design team recommended the hip be released for humans?
    • Yes.
    The next sentence says: "the significance of the systemic distribution [of those ions] was not known[at the time].  Dr. Ss is  that a true statement?
    • Yes.
    And was that a true statement when the device was released to humans?
    • Yes
    Do you think patients had a right to know this?
    • They certainly do have a right to know.
    You were working with the marketing department [at depuy] right?
    • Yes
    Had you put these statements in a marketing brochure, these statements would have been true correct?
    •  Yes
    Had someone from Depuy wanted to put this in a brochure, would you have objected?
    • No
    What does systemic mean: 
    • Ions travel through the blood and particles travel through the lymph system or your immune system.
    And as a part of this metal degrades, it gives off ions right?
    • Yes
    Now you also write: "there is a also a concern about the potential for malignant generation secondary to prolonged exposure to these elements'?

    • yes
    Are these ions Cr and Co?
    • Yes but mostly Chromium
    [Then a discussion  ensued about whether you would use the word "these" to discuss only one element....  that is, did the reference to "these" include or exclude cobalt?  This line of questioning  didn't lead anywhere but raised a doubt about whether there are issues with Co as well as Cr.]

    [A discussion about edge ware came up and the lawyer wanted to know whether  the design team was aware of that at the time. ]
    •  No.  No one was talking about that on the design team.

    So no one on the design team mentioned that  Mr. John Fisher in Leeds England was working on edgeware in his paper in 2000?
    • Not that I recall
    Wasn't it your responsibility as a member of the design team to make sure you released a product that was at least as safe as what was on the market then?
    • That was  our  goal.
    It was your obligation wasn't it?
    •    No (he said he didn't understand the legal implication of this.)
    Weren't you obligated to put a bearing on the market that was as good as anything Depuy had on the market at the time?
    • I don't recall anyone telling me that
    Do you have a 23% revision rate with the Pinnacle hip?
    • No.
    Do you have a 23% revision rate with any hip in your practices?
    • No.
    [It was  stated that the goal of the surgical team to have the wear rate better than any other MoM device and they had some testing done to show it was low.  However, they only tested one head size at a perfect angle and the lawyer asked if that test was designed by the surgeons.  Dr S didn't recall.  The attorney then asked if Dr S was advised that the test conducted on the wear was not going to be done on the worst case scenario as would be customary in a situation like this.  Dr S didn't recall.  Dr S did concede that when releasing a product on the market, there would be a variability of use and placement.]

    It says in the 2004 paper that metals may react differently than poly, in  the normal immune response and that it is recognized that the Cr and Co particles have greater potential or cytotoxicity than poly particles and the cell may incapable of the same inflammatory response [microphages come and "eat" the offending particles]

    True when you wrote it? 
    • yes
    True when they released it to humans?
    • Yes.
    Did everyone on the design team understand that when you got too much debris in the local area, you can have cells dying?
    • yes.
    Low to moderate metal particles stimulate the  release cytokines right?
    • yes
    And then it says, cytotoxins such as Il1 and Il6  can lead to osteolysis and aseptic loosening correct?
    • Yes
    Then it says at higher concentrations however, Cr and Co particles have been found to be cytotoxic   and then there are many citation following  meaning many people were aware of this  right?
    • yes
    Altering the phagocytic activity of the macrophages leading to cell death right?
    • Yes.
    One of the citations goes back to 1975.  Does that sound right?
    • I'd have to check.
    Now if you go the end of the page under cancer risk, did you write Cr and Co metals have been known to induce cancer in animal models?
    • Yes.
    And you then stated you found no link between cancer and humans
    • yes
    Weren't you concerned that you should not be putting this in people until you could assure yourself that they were safe?
    • I wouldn't say it like that..

    end of  3 of 4 parts for Dr S's testimony.

    Well, as per my summary at the end of part two, I have not seen anything redeeming about this testimony either.  In fact, the comments seem to become more and more problematic as far as I am concerned.  The key take away from this testimony from my perspective is again, gets back to the "What did he know?"  When did he know it?"  "What did he do about what he knew?"

    He  clearly knew and  the whole design team knew the uncertainties surrounding both the ion levels and the systemic risks including  but not limited to  cancer.  Given that Depuy had the Pinnacle hip on the market at that time and it seemed to have a good track record at the time, I am not clearly seeing the reason the ASR was developed.

    I recall that the ASR might have been undertaken originally to address the competition in the market with the Birmingham resurfacing product in England  but the so called "Alpha project" was killed. Depuy never came to market with a resurfacing product.  There is some information gap here from my perspective.  Perhaps it's here but I missed it?  Maybe it will come up later.

    The  4th and final part of this testimony will be addressed next and then I will move on to other witnesses.

    Thursday, June 20, 2013

    Time is running out in NY to file a suit: File or not? (Part Four of x) Testimony of Dr Schmalzried part Two

    I am reading the Kransky vs Depuy trial transcripts and making notes which are of interest to me in my quest to answer my questions and  thought they might also be interesting for you to review.  My objective is  to answer the question:  Should I file or not.

    Part one of x can be found here:  My questions are noted in that post.

    Part Two:

    Part Three: Questioning of Dr Schmalzried part One (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)

    Part Four:  Schmarlzried (Dr S) part Two of his testimony (below)


    There were a number of discussions about various surgeons who were having problems with the ASR and Dr S was asked to talk to them as a member of the ASR design team to discuss the issues they were having.  The implication in the questioning was if Dr S was working with the marketing folks from Depuy, how could he objectively discuss other physician's problems with the product if Dr S were working on a commission/override basis?  Is there not a  in inherent conflict of interest?

    The ASR recall was in August of 2010.  When did you stop using the ASR?
    • A year before that
    • "I learned  they were going to discontinue it [The ASR] in September of 2009"
    • He learned that there was going to be a phase out. 
    Did you stop using the ASR once you were advised of this?
    • Yes
    • Because I wouldn't be able to get parts if something needed replaced.
    [From Connie:  I don't like all.  If I understand the comments correctly, Dr S knew in advance the hip was to be discontinued and when he was told, he personally  stopped using it but appeared to allowe other surgeons to continue using it?  This is what I mean when I say....what did he know and when did he know it and then what did he do  with the information.  Well, he did what was appeared to best for himself.  He apparently did not consider his surgeon colleagues in this news and seemed to clearly know that the parts inventory would be run down....meaning sold to other surgeons so that Depuy was not stuck was not stuck with  the parts inventory which is money of course. This is my understanding from reading this.  I am not saying it is right.  It is what I understand this testimony to imply....I wonder if he collected commission on the units sold in the inventory runoff?]

    [ From Connie: The questioning then turned to the  contacts whom Dr S used  at Depuy to communicate information.  Essentially, it was clear that Dr S's contacts were for the most part, marketing folks especially re the  revisions.  Is that unusual?  No.  Generally in most of the medical companies the chain of reporting is:
    • Dr has a problem
    • Problem goes to the sales rep
    • Sales rep reports the issue to marketing
    • Marketing goes to medical affairs
    • Question is answered or event reported and the response goes right back down the line in the same manner it went up.
    • If there is a big problem, medical affairs might contact the physician directly.  I did not find this to be out of the ordinary standard of practice but I suppose the question is:  Should the communication process  work in this manner?  Should a physician report to marketing re concerns from other surgeons when their remuneration is sales commissions?  Likely not but it is the way things are least when I was in this business.]
    In your practice, did you fill out a form each time you did a revision?
    • No [Connie:  but he did make the point earlier that this information did get communicated to marketing I believe.]
    [The  discussion then  turned to the number of revisions Dr S did which was estimated to be 15 of 66 or 23%.  So it was estimated that the minimum revision rate in his hands was 23%.  They then proceeded to establish the reason for the revision being  aseptic loosening due to adverse tissue reaction and metallosis.

    Oh, an answer to my question above:  Was he paid commissions on the runoff inventory?  The answer  appears to  yes given he was paid quarterly checks through  at least the Q1 2013.  So that means, he had to be  receiving commissions on that inventory run off so I surmise. ]

    Mid day break and I will pick this up tomorrow.

    Connie's comments:  Disappointing.  Dr S is a teacher and a researcher.  He has a moral and ethical  responsibility to inform his colleagues of information that he himself would want to know, notwithstanding the patient population who might have been subjected to this hip during that last year unnecessarily.  It appears to me that not only did he not step up to the  ethics required by the medical profession  but he received commissions on the devices sold before the market  and his colleagues knew of the recall ...

    So at this juncture/he failed my: "What did he know, when did he know it?"  He did not seem to use  the information known to him  to do the right  thing for the general  patient population and his colleagues.  He did do the right thing for his patients though in stopping the use of these devices.

    I hope I got all of this wrong.  Very disappointing indeed.  Perhaps there is redemption to come during the afternoon examination?  I hope so.  Could be that I misinterpreted all of this..... but it surely doesn't appear that way to me.

    I am no expert in court room law but I am sure there is a reason why questions like this didn't get asked:
    • Did you continue to receive commissions on inventory sold after the recall was announced?
    • How did you feel when you attended orthopedic meetings knowing that the recall was in process and the medical community was not yet informed?
    • Did you have any other physicians with whom you consulted during the time you were made aware of the recall and the actual market announced recall?
    • Did this advance knowledge cause you any concern?
    • If so why?
    • etc......
    I will attempt to find the exact date that the public was made aware of the recall if it was a date other than the actual recall date.

    Tuesday, June 18, 2013

    Time is running out in NY to file a suit: File or not? (Part Three of x) Questioning of Dr Schmalzried part One

    I am reading the Kransky vs Depuy trial transcripts and making notes which are of interest to me in my quest to answer my questions and  thought they might also be interesting for you to review.  My objective is  to answer the question:  Should I file or not.

    Part one of x can be found here:  My questions are noted in that post.

    Part Two:

    Part Three: Questioning of Dr Schmalzried part One (I shortened the questions and answers for expediency. So these are not quotes unless quotes are present.)

    Plaintiff's counsel went first and covered Dr. Schamlzreid's background:
    •  Co Inventor of the Depuy hip along with others on the "surgeon design team."
      • joined the ASR design team in 2001
    • Researcher
    • Publisher (160 or so peer reviewed  journal articles)
    • School:  UCLA, Harvard etc
    • Prominent joint surgeon primarily hips.
    • Compensation:  royalties on the sale of the hips
    What were the limitations of the hips in 2001?:
    • small diameter balls that limited the range of motion
    • wear resistance of the material (When you rub two materials together, materials can come off.  Wear turns into debris.)
    • sometimes balls came out of the sockets.  Smaller heads were used to minimize the volumetric wear debris
    Were you involved in the research of the cross linked poly?
    • In the late 80's and early 90's, he was involved in the research but not the development
    • He provided input to the engineers to what the wear resistance should be
    • Essentially, he was pretty familiar with all of the hips developed around that time.
    How did you test these devices you worked on at that time?
    • Monitored patients for wear and positioning over time with this microprocessor chip placed on the ankle of the patient and then we would  x-ray the joints.
    In the early 2000's, what kind of poly was available and with what type of ball?
    • cross linked poly which with a larger ball would become brittle and break
    • also, wear particles (tiny) would cause a tissue reaction called osteolysis
    • This was commonly known to surgeons like himself in the early 2000's
    Were you involved and aware of the metal on metal devices and when?
    • Outside of the US, MoM became available in the late 60's early 70's
    • In the US, they became available in the mid 70's
    What was your experience with the MoM hips in the late 80's?
    • Wear rates were lower than conventional poly and a larger diameter ball to increase range of motion
    What research had you done on the MoM hips prior to joining the ASR design team in 2001
    • He spent time researching a group of about 270 patients who had the hips in over a period of 10-20 years.
    Were you aware of the metal ions surrounding the MoM hips prior to joining the design team in 2001?
    • yes.
    What was your understanding of the metal ions in 2001?
    • Elevated levels of metal ions could occur
    How about the significance of metal ions in the early 2000's?
    • I don't think it was known or understood and continues to be studied to this day.
    Was reducing wear a goal of the design team?
    • yes.
    "What type of literature existed as of 2001" re MoM?
    • "The fundamental variables related to the bearing diameter, the lubrication, the radial clearance and the composition of the metal."
    "Did you have a toxicologist on the design team?"
    • "No"
    "Why not?"
    • There was a surgical design team and if we needed a toxicologist we could get one as a consult
    Have you been involved in looking at systemic effects of MoM products?
    • Yes.
    Have you published on that?
    • Yes
    Tell us about that
    • In the late 90's early 2000's one of the questions was,  was there a higher risk of cancer with MoM hips? So we looked at the world literature and found there was no difference between cancer rates in MoM vs a metal plastic total hip... there were only a few cases in the whole literature.
    What metal ion level causes you to follow your patients more closely?
    • greater than 2 parts per billion  (2ppb)...the ion level alone is not a trigger for me to take action
    What was the goal of the design team?
    • low wear
    Who was on the surgeon design team?
    • It was international
    • engineers
    • Surgeons
    How have you been compensated by Depuy over the various projects you have been involved with?
    • I have received about $20 Million some of it related to the Depuy ASR.
    Break.....I will resume on Schmarlzried's testimoney  tomorrow...

    My take away after reviewing 25% of his testimony:
    1. Competent guy
    2. Very familiar with the landscape of materials and implications thereof
    3. Understands the tradeoffs made in product  design
    4. So far, I find this fellow to be credible and conscientious.
    stay tuned....

    Time is running out in NY to file a suit: File or not? (Part Two of x)

    I am reading the Kransky vs Depuy trial transcripts and making notes which were interesting for you to review.  My objective is   to answer the question:  Should I file or not.

    Part one of x can be found here:  My questions are noted in that post.

    Topics that I found to be interesting in the pre- trial discussions between the judge and the attorneys follow.

    1. Punitive damage discussions
    The initial discussion  centered around the punitive damages and  the conflict of law issue.  That is:  Which state law should  govern the punitive damages in this case?  The defendants presented 5 states which were involved in this matter. The defendants suggested NJ and Indiana as the presiding or governing law.  Why:  LOW CAPS ON THE  punitive damages.

    You can find more information on the difference between punitive vs compensatory damages here:

    NJ (location of J and J, the parent co of Depuy)  NJ  punitive damage cap is $350K or  3xs the compensatory damages.

    Indiana, the location of Depuy  Indiana had  $50K or  3x compensatory damages.

    So, lets just examine this.  Had the judge ruled that either NJ or Indiana prevailed as the guideline for the punitive damages, Kransky inevitably would have gotten a cap of 3xs the base damage which if I recall correctly was the cost of the revision.  In my case, that cost a few hundred thousand or so.  So the cap would have been $600K vs that which was ultimately awarded:  $8M or so! (You get the drift. My numbers may be off but the concept is ok.)

    The plaintiffs, on the other hand argued that Montana  law should prevail because the plaintiff lives there. The injury occurred there  and the defendant had sales reps there.  Their  punitive damages are $10M or up to 3% of the defendants net worth.  Yikes!

    The wrong doing occurred in NJ and Indiana.  

    So, we know in retrospect  that plaintiffs won that motion. I suppose you can argue for anything as long as you can dig up a precedent someplace to support your argument.

    2. Other items of interest:

    There were 50 M documents gathered in discovery!  OMG.  Not sure that you can appreciate the amount of time involved and technology in culling down those documents.  It's quite a process and imperfect at that.  NO.  Generally speaking, no one reads all of the documents.  They use predictive modeling to find the relevant documents.   Essentially, someone has to pick some exemplar documents, categorize, or more likely, cluster the remaining  documents into bins and then run "more like this"  or related searches on the key or target documents to find what each party needs to make their case. 

    The objective of examining the documents is to have a "discovery" reach broadly  enough to identify the "smoking gun" docs  but  narrow enough to keep out the noise.  Typically, a preponderance of these documents are e-mails which under the best of circumstances are  what we in the search business call dirty documents.  They contain slang, abbreviations, irrelevant  headers and footers and spelling that all need to cleaned up.  Clean up is essential to being able to find the right documents.

    Amusing things of note:
    • Judge made it clear that he didn't want any shenanigans (my word not his) going on so  he was not going to issue decisions on  all of the pretrial motions presented.  I got the idea that both sides went off the runway into the cornfield filing motions that this judge found, not material or "silly" as he termed some of them.  Seemed like they submitted 25 or 30 pre trial motions one of which he did seem to read up front (which was the motion to guide  punitive damages) but hadn't gotten to the rest. 

    • The Judge also didn't want to be placed  into what he termed "an artificial state of narcolepsy" with boring laborious videos from depositions I think he was referring to.
    Good to have some 'color' as background to set the stage!

    They then had jury selection which was very  repetitive.  They ultimately ended up with people on the  jury such as computer programmers, cable technician, retired architect, traffic officer, hotel cook, legal assistant, an attorney etc.  Can't recall which ones actually got on the jury but it was a similar make up.

     In my next post , I will address the  Dr.  Schmalzride's testimony.  If you recall, he was one of the inventors of the hip.  I think you will find that discussion interesting .  I must have read that transcript out of order but I was interested in reading his comments first anyway.  So that post is out of sequence from the transcripts.

    Disclaimer:  These are my thoughts from the transcripts.  I am not an attorney.  Take the comments for what they are worth!

    Saturday, June 15, 2013

    Stryker Multi district litigation centered in Minneapolis MN

    Stryker Rejuvenate and ABGII products implanted during hip replacement surgery will begin with pretrial discussions through the MDL (multi district litigation proceedings.)

    Exactech Introduces Conservative Treatment Hip Replacement System

    Business Wire

    GAINESVILLE, Fla., Jun 11, 2013 (BUSINESS WIRE) -- Exactech, Inc. /quotes/zigman/60235/quotes/nls/exac EXAC -1.82% , a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today first implantations of a new hip replacement system designed to preserve a key portion of patients' bone in total hip arthroplasty procedures.(1,2)

    The Exactech LPI Prime hip system is a more conservative treatment option, designed for maintaining the maximum amount of proximal femoral bone while providing excellent initial stability, enabling biological fixation.(3) The geometry of the stem is designed to facilitate insertion through smaller incisions.

    The LPI Prime system includes specialized instrumentation contained within one tray, designed for efficiency in any surgical approach.

    "The materials and methods used in hip replacement have improved dramatically over the last two decades," said orthopaedic surgeon and Exactech CEO Bill Petty, MD. "The LPI Prime system is one of those engineering advances; it is designed to meet the growing demand for conservative treatments that make it possible for patients to stay active longer, since many patients are being treated at younger ages."

    Orthopaedic surgeons John Aldridge, MD, at Mary Immaculate Hospital (Newport News, VA) and Scott Dunitz, MD, at Tulsa Bone and Joint Associates (Tulsa, OK) recently performed the first surgeries using the new hip system and report excellent experiences with the implants and instrumentation.

    According to Dr. Dunitz, "The new implant saved more healthy bone compared to other implant designs I have used. The design allowed me to use a more minimally invasive approach, and I was impressed that it provided the stability of a traditional hip implant."

    Dr. Aldridge reported that he was able to restore his patient's natural anatomy, which can be a challenge in certain anatomies. "I am very pleased with the new hip implant geometry," he said. "The stem's size and design minimized disruption to soft tissue, and my patients are able to return to active mobility quickly - an important goal of hip replacement."

    The initial launch of the new system is underway in the United States, with full market release planned in 2014. The LPI Prime system joins Exactech's recently launched InteGrip(R) material as the company's latest innovations in hip arthroplasty.

    Orthopaedic surgeons who want to learn more about the new implants and the latest techniques in hip replacement can take advantage of Exactech's personalized medical education programs. Surgeons can design the workshop that best meets their individual preferences including live surgery observation, hands-on courses, hospital in-service programs or in-depth technical review with Exactech staff at the corporate headquarters.

    About Exactech

    Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech's orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 35 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at Copies of Exactech's press releases, SEC filings, current price quotes and other valuable information for investors may be found at and

    An investment profile on Exactech may be found at To receive future releases in e-mail alerts, sign up at

    This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company's expectations or beliefs concerning future events of the company's financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company's dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company's products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

    Thursday, June 13, 2013

    Time is running out in NY to file a suit: File or not? (Part one of x)

    Hello fellow patients,

    Seems as though the  news surrounding the Depuy hip has died down to say the least.  Traffic will pick up again when the next suit is litigated though.   Depuy won one case (Carol Strum), one was settled pre trial and one win by the patient (Kransky).(BTW/if you want to know details about that case, you can just type that into the search engine on the blog or open the litigation category for January of 2013.  You can follow the case from the press's perspective at least.)

    This blog has followed the  news surrounding this issue since December of 2010.  The news  consisted largely of  medical studies, legal perspectives on litigation  and some consumer news, in that order. 

    I have many conflicted thoughts  about this filing and  thought I would share my thoughts with you below.  So, in my case, reading the transcripts from the first case litigated (Kransky)  is my next step.

    My objective is to come to a decision one way or another (file or not.)  My fellow New Yorkers only have  a few more months  or so to make the decision.  There  is the statute of limitations of 3 years to file this suit from I believe[check with your attorney] the day you were made aware of your hip recall.   Most patients  were informed  via  snail mail from their physicians sometime between  August 2010 and mid to late October 2010. I was notified in mid October that my hip was affected but had read the story in the Wall Street Journal in August.

    So, what are the critical issues to me?  Well, I have worked  in the medical industry with two different companies over a period of 6 years or 7 years many years ago and I learned a lot about how companies in the medical business operate.  I had the opportunity to work on new product release teams (on the sales side) in my very early career for both medical products and pharma. There are two key issues to me:

    1. Tradeoffs:

    There are tradeoffs in the medical arena and in all areas where new products are released.  In the medical arena though, the tradeoffs perhaps are more pronounced  because there are effects on patients if there is a mistake made or something overlooked in the process of making those  trade offs. 

    There is no such thing as creating a device or medication that is perfect.  That is, you always must weigh the  patient benefits (efficacy)  against such things as  side effects, mortality* and morbidity*.  Generally, the manufacturer tries to balance these things.  I would never go into a medical procedure, take medicine or use a device without thinking about the potential downside of these things.

    In this case, I never could have imagined a revision.  But , my issue is not whether the device resulted in  a problem but rather:
    • What did the designers of the device know when they created it and
    • When did they become aware of the problem?   
    • What did they then do about the problem when they became aware?  

    Don't get me wrong.  I am not happy about this revision process. No patient would be. I wouldn't wish a revision on anyone but it occurred to me that I did not have enough information on the proverbial question from the Nixon, Watergate hearings//remember those? :  "What did they know and when did they know it?"  In my mind, that question has not been clarified,  at least not to my satisfaction but I can say, by reading the transcripts, that answer is becoming much clearer to me. 

    The video that I published over a year ago  (from the "Triumvirate"  including  Dr. Tony Nargol)  had a big impact on me but I never heard the other side of the story.   I am examining the other side of the story by reviewing the transcripts so I can make a more  informed decision. (See the Dr. Tony Nargol video here:  While many found these  videos  to be really graphic in nature, I was most interested in the timing of "what did Depuy know and when did they know it."

    My hip has given me mobility where I had none before  and I am grateful for that mobility  but as you know from my past blog posts, I encountered  real issues with this revision.

    2)  Is it possible that companies who release devices make errors, sometimes egregious errors  when releasing them to the market?  This, I can answer unequivocally yes, at least from my own experience inside the medical arena.

    My second encounter (I am skipping the first one because to this day, that case saddens me), I was selling devices that control the fluid of IVs entering the body.  I was on the sales team, and had just begun a trial in a hospital for monitoring the patients in the  ICU unit.

    When these devices were first introduced to the market, the business model was based on  the hospitals buying  the devices.....for each patient....but that business model didn't work well as funds in a hospital are limited  so we adopted a new business model.  That model was based on marking up the price of the IV tubing that went inside of the machines hence, the new model enabled a hospital to afford many more units and in effect, the machines were paid for over time.

    The problem with this model was twofold: 
    • We were experts in making IV equipment but NOT in making IV tubing.  We contracted the IV tubing out to a third party and  we had no experience with IV  tubing before release.
    • We  did not contemplate that when a unit like the ICU switched over to the IV equipment and IV tubing, that the IV tubing would be used without the equipment.
    Being the diligent salesperson I was, I  planned to work the three shifts to ensure that the nurses understood how to use the equipment.  The operations folks at the hospital pulled all of the old tubing because there was no need for it prior to the in-service training.  They didn't want any confusion as to what tubing should be used inside the machines.

     I was well trained to deal with an installation but no one foresaw the potential problem;  non essential IVs were hung with no instruments controlling the drips.  When the training was completed, I went home to bed.  Shortly after I got home, I got a call @ 2:00 AM,  that all of the IVS  which were not on machines ran away (ran quickly)....into the patients!  I was horrified and just so lucky none of the patients died on the unit.

    Little did I know that the most horrifying piece was yet to come.  I quickly got a type written letter (yes, this dates me doesn't it!) to the new CEO of the company and insisted that all of the salespeople be notified immediately and the IV tubing be pulled from the market. I described the problem in detail.

    Promptly upon receipt of the letter the following occurred: (I was maybe all of  27 or 28 years young and  na├»ve at that!)

    I was told that "The company comes first!"  I later learned that the letter was destroyed.  We are talking about something that happened almost 25 years ago or so.
    I will never forget that incident.  I just could not comprehend such a reaction especially in light of the fact that our start up  company was bought by a major Pharma company! Now this was quite some time ago but  I have never forgotten that event.  This incident  left an indelible mark on me. I left that company shortly thereafter.

    Conclusion to part one.

    I know there are tradeoffs in releasing products to the market.
    I know there are medical companies that don't put the patients first.

    I will post things that I find  in the transcripts which might help me come to a conclusion about filing.  This was not a closed trial as you all know.  Many have reported on the proceedings. Reading these transcripts is very time consuming so I won't be publishing each day but will post a few times per week on any findings that help me better understand:  What did they know and when did they know it.


    Morbidity refers to the state of being diseased or unhealthy.
    Mortality is the term used for the number of people who died within a population

    My next post will address Dr Schmalzride's testimony.  He was an inventor of the Depuy hip.  I found many things in that testimony interesting.  Stay tuned for part two.

    Wednesday, June 12, 2013

    Commentary and Perspective on the Stryker implants

    From the comments section of the Journal of Bone Surgery 2013.  This is a commentary on the two recent posts on this blog: and

    Stryker litigation Consolidated

    A federal panel of judges ordered on June 12 a consolidation of federal Stryker hip lawsuits in Minnesota, according to court documents. The order applies to lawsuits filed by those who have been injured by their Stryker Rejuvenate and ABG II hip implants.

    Excerpt from Rotenstein Law Group

    Tuesday, June 11, 2013

    Hip Implants: When Innovation Does Not Equate to Improvement


    Posted by Cal Warriner
    Monday, June 10, 2013 4:51 PM EST

    Legal Examiner (Palm Beach)

    [Nice review of the journal summary  I just published  on the hip revisions with 11 patients after 15 months.]

    Modular design hip replacements were first introduced about 30 years ago to allow surgeons intraoperative flexibility. They were marketed to younger patients who were presumably more active.
    Although there was little data regarding the viability of such designs, that did not stop the introduction of modular hips into the marketplace and the drive to “innovate,” as the medical industry likes to call it, when they readily adopt the latest, greatest and market it as a revolutionary improvement.

    Now we are finding this may not be true.

    A newly published study in the Journal of Bone and Joint Surgery found 11 patients underwent early revisions after undergoing a total hip arthoplasty with the Stryker modular femoral stem design. It now appears the additional modular junction creates new opportunities for corrosion between the neck and the body of the stem.

    Since most Stryker Rejuvenate implants used a ceramic ball and polyethylene socket (ceramic on plastic) both surgeons and patients felt secure in believing that the metal toxicity issues associated with metal-on-metal ball and socket designs were not present; however, the Stryker Rejuvenate did in fact have a significant metal on metal connection. The Rejuvenate design called for the neck and stem (typically one piece) to be two pieces. To assemble the device, the modular neck was inserted into the stem. Because both are made of metal, a significant metal on metal junction resulted.
    To increase complications, the dual taper stems, while allowing for increased options for movement, create new areas that can potentially corrode, specifically the neck/stem junction.

    The Rejuvenate combined a titanium-molybdenum-zirconium-iron (TMZF) alloy for the stem with a neck made from cobalt-chromium. In this study, it was just seven months after implant that most patients began experiencing pain. None of the patients suffered infections but serum cobalt levels were elevated in the patients’ blood. Fluids were beginning to collect in tissues and pseudotumors were seen in all but one patient.
    These failures mimicked those seen in previously recalled metal on metal hips even though the articular surfaces were not metal on metal. Instead of a 15-year life expectancy for a hip replacement, revision surgery took place at 15 months. And this was difficult surgery necessitating removal of the implant along with bone and necrotic tissue. Pale green chromium phosphate particles were observed. The cause of the failure was corrosion of the femoral neck-body junction. Also the femoral head-neck junction had corrosion though to a lesser degree. When the authors inspected the tissues surrounding the defective hips microscopically, the tissue showed dead cells and a high concentration of metal.
    What’s ahead for these patients, asks two very prominent New York-based surgeons? In a commentary that accompanies the published report, the doctors wonder if patient’s bodies are more susceptible to future corrosion since they have had complications.

    When will the next “innovation” subject patients to new dangerous “complications”?
    After all, these hips were introduced to the market using the FDA’s 510(k) notification process. To obtain clearance to sell the device, manufacturers notify the agency that the new product is “substantially equivalent” to another already on the market. But what if those already on the market are defective? That doesn’t matter it turns out- a defective and even recalled medical device can be named as a predicate device. Go figure.

    Rep. Edward Markey tried to stop that from happening with the Sound Devices Act he introduced into Congress last year. The bill would have given the FDA the authority to reject medical devices if their predecessors were subject to a recall or in the process of being recalled. It would also require medical device manufacturers to explain why their products are different from earlier versions, to explain the “innovation” as it’s called.

    That was defeated. In fact, the bill didn’t get even one vote in committee.
    Instead why not require clinical trials to be conducted before a new orthopedic implant can be sold to consumers? Sounds like a common sense idea that injured patients assumed was already happening. They assumed wrong.

    DePuy ASR Hip Recall: Bernstein Liebhard LLP Comments on DePuy’s Motion to Strike Costs in Wake of $8.25 Million DePuy ASR Lawsuit Judgment

    New York, New York (PRWEB) June 10, 2013
    The nationwide law firm of Bernstein Liebhard LLP notes that DePuy Orthopaedics has filed a motion seeking to strike nearly all of the $1.83 million in costs sought by attorneys representing the Plaintiff in the nation’s first trial stemming from the 2010 DePuy ASR recall. According to court documents, that DePuy ASR lawsuit trial ended in March, with a Los Angeles Superior Court jury awarding $8.26 million in damages to the Plaintiff, after finding that his metal-on-metal hip implant was defectively designed. (Kransky (Ellis) v. DePuy, et al., No. BC456086 (Los Angeles Super. Ct.))
    “Court records show that DePuy Orthopaedics has already motioned for a new trial and a judgment notwithstanding the verdict in this case, both of which were rejected by the Court. The Court has ordered the parties to meet and confer on this latest motion by defendants to strike costs,”

    Read more:

    All HIps implanted with titanium alloy stem and Co and Cr neck in recent study were revised in a mean of 15.2 Months!

    2013 May 15;95(10):865-72. doi: 10.2106/JBJS.L.01042.

    Adverse local tissue reaction arising from corrosion at the femoral neck-body junction in a dual-taper stem with a cobalt-chromium modular neck.


    Department of Orthopaedic Surgery, Rush University Medical Center, 1611 West Harrison Street, Suite 300, Chicago, IL 60612. E-mail address for J.J. Jacobs:



    Femoral stems with dual-taper modularity were introduced to allow additional options for hip-center restoration independent of femoral fixation in total hip arthroplasty. Despite the increasing availability and use of these femoral stems, concerns exist about potential complications arising from the modular neck-body junction.


    This was a multicenter retrospective case series of twelve hips (eleven patients) with adverse local tissue reactions secondary to corrosion at the modular neck-body junction. The cohort included eight women and three men who together had an average age of 60.1 years (range, forty-three to seventy-seven years); all hips were implanted with a titanium-alloy stem and cobalt-chromium-alloy neck. Patients presented with new-onset and increasing pain at a mean of 7.9 months (range, five to thirteen months) following total hip arthroplasty. After serum metal-ion studies and metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) revealed abnormal results, the patients underwent hip revision at a mean of 15.2 months (range, ten to twenty-three months). Tissue specimens were examined by a single histopathologist, and the retrieved implants were studied with use of light and scanning electron microscopy.


    Serum metal levels demonstrated greater elevation of cobalt (mean, 6.0 ng/mL) than chromium (mean, 0.6 ng/mL) or titanium (mean, 3.4 ng/mL). MRI with use of MARS demonstrated adverse tissue reactions in eight of nine patients in which it was performed. All hips showed large soft-tissue masses and surrounding tissue damage with visible corrosion at the modular femoral neck-body junction. Available histology demonstrated large areas of tissue necrosis in seven of ten cases, while remaining viable capsular tissue showed a dense lymphocytic infiltrate. Microscopic analysis was consistent with fretting and crevice corrosion at the modular neck-body interface.


    Corrosion at the modular neck-body junction in dual-tapered stems with a modular cobalt-chromium-alloy femoral neck can lead to release of metal ions and debris resulting in local soft-tissue destruction. Adverse local tissue reaction should be considered as a potential cause for new-onset pain in patients with these components, and early revision should be considered given the potentially destructive nature of these reactions. A workup including serologic studies (erythrocyte sedimentation rate and C-reactive protein), serum metal levels, and MARS MRI can be helpful in establishing this diagnosis.


    Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

    [Tomorrow, I will post a full review of this article.]

    Monday, June 10, 2013

    FDA analysis: 510(k) is here to stay, says medtech attorney

    Mass Device


    June 4, 2013 by Arezu Sarvestani

    The FDA's 510(k) "substantial equivalence" test for medical device review is strong, safe and here to stay, according to an analysis by medtech attorney Jeffrey Shapiro.
    FDA logo
    The FDA's less-stringent 510(k) medical device review pathway is no stranger to criticism, but it has at least 1 fan - Hyman, Phelps & McNamara attorney Jeffrey Shapiro.
    Shapiro defended the fast-track review pathway, which doesn't usually require that medical device companies submit to U.S. clinical trials in order to demonstrate safety and efficacy, and he expects that the 510(k) system will "be around for a long time."

    In a presentation prepared for last month's Petrie Flom conference at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Shapiro shared why he believes the 510(k) pathway is strong and getting stronger all the time.


    "Taken as a whole, the 510(k) program has proven adaptable to a wide variety of devices, and has allowed meaningful premarket review while fostering robust technological innovation," Shapiro wrote in an analysis published in April. "Under the 510(k) program, the device industry has flourished and allowed for increasingly safer and more beneficial device technology, thus providing a practical demonstration that the 510(k) program is working well."

    The 510(k) wasn't so favorably characterized by the Institute of Medicine, which in 2011 recommended that the FDA scrap the program altogether. The non-binding IOM analysis didn't make many waves at the FDA, which seemed to largely brush the report aside, but it certainly resounded with patient safety advocacy groups as well as with the editors of the New England Journal of Medicine.

    A ProPublica report issued earlier this year covered "4 medical implants that escaped FDA scrutiny," highlighting that certain medical implants, such as metal hip replacement systems and surgical mesh, have resulted in major recalls after having zipped through the 510(k) process as being "substantially equivalent" to other existing technologies.

    The process of using existing or "predicate" devices as the basis for evaluating the safety and effectiveness of a new device is "untenable," according to the NEJM editorial published in the wake of the IOM report. The authors recommend that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risks to patients.

    "As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness," wrote NEJM executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. "The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated."
    Shapiro maintained that the 510(k) program, although certainly flawed, is nonetheless

    "Certainly, there can be improvements," he wrote, noting that the program needs more transparency in particular, but the program remains a strong foundation for evaluating less-risky devices.
    Shapiro took issue with the IOM report, writing in his presentation that the call to kill the 510(k) program was "ill considered." The report failed to cite any problems with the program that aren't fixable, Shapiro said, admitting that the program has room for improvement. He further criticized the IOM's assessment as "a misplaced theoretical concern underpinned by a flawed legal analysis," rather than a practical assessment based on real-world outcomes of the 510(k) program. Indeed, the IOM admitted in its report that its recommendations weren't in response to any sort of "crisis" among medical devices wrongly admitted to the U.S. market, Shapiro noted.

    The IOM, and some of its sympathizers, argued that the more than 35-year-old 510(k) process is ill-equipped to manage the varied and vast medical device landscape of today, but Shapiro argued that the age of the program was among its hidden strengths.

    "The purpose of premarket review is to predict or characterize in advance the likely clinical performance of a device, in order to avoid unexpected adverse consequences," he wrote. "Now that 37 years have passed, the cohort of Class II devices have a long history of clinical use. They are generally well characterized as to their expected behavior. Further, their technology has been improved substantially over the years as would be expected. And regulations requiring reporting to FDA of adverse events, malfunctions and recalls have been in place for decades."

    Friday, June 7, 2013

    Medtech trends: The most talked about device makers in May 2013

    June 4, 2013 by Arezu Sarvestani  Mass Device looks at the internet chatter surrounding the medical device industry with some of most searched-for companies of the last month. looked at some of the most talked-about medical device companies, based on trends in Google searches for the last 30 days.
    During the last month the medtech titans were flush with news from conferences, court rooms and Wall Street.
    Minnesota giant Medtronic (NYSE:MDT) hit new highs after issuing its Q4 2013 earnings report, unveiled updates from trials of its renal denervation and TAVI devices and sparred with rivals over patents and batteries.


    Johnson & Johnson (NYSE:JNJ) jumped into a prominent seat on the list with stories driven largely by the ongoing metal-on-metal hip lawsuits (and a failure to appeal a $8.3M verdict) as well as by some legal battles over copyrights and spine patents.
    Covidien (NYSE:COV) slid to 3rd place in May with stolen merchandise and new financials ahead of a pharma spinout. Boston Scientific (NYSE:BSX) remained 4th with a dramatic overseas legal battle with OrbusNeich (which asked police to seize BoSci's stents) and a patent tussle with Medtronic that's headed for the Supreme Court.

     Johnson & Johnson

    Aspirin Post Hip Replacement OK for Extended Prophylaxis

    Last Updated: June 05, 2013.


    Aspirin for 28 days non-inferior and as safe as dalteparin for preventing venous thromboembolism

    Comments: (0)

    Twenty-eight days of aspirin is non-inferior to, and as safe as, dalteparin, a low-molecular-weight heparin, for the prevention of venous thromboembolism after total hip arthroplasty, according to research published in the June 4 issue of the Annals of Internal Medicine.
    WEDNESDAY, June 5 (HealthDay News) -- Twenty-eight days of aspirin is non-inferior to, and as safe as, dalteparin, a low-molecular-weight heparin, for the prevention of venous thromboembolism (VTE) after total hip arthroplasty (THA), according to research published in the June 4 issue of the Annals of Internal Medicine.

    David R. Anderson, M.D., of Capital Health in Halifax, Canada, and colleagues compared extended prophylaxis with aspirin or dalteparin for the prevention of symptomatic VTE after THA. In a multicenter study conducted between 2007 and 2010 in 12 tertiary care orthopedic referral centers in Canada, 786 patients who had elective unilateral THA followed by 10 days of dalteparin prophylaxis were randomly assigned to receive 28 days of extended prophylaxis with either dalteparin (400 patients) or aspirin (386 patients).

    The researchers observed VTE in 1.3 percent of patients receiving dalteparin and 0.3 percent of patients receiving aspirin. Aspirin therapy was non-inferior (P < 0.001), but not superior (P = 0.22), to dalteparin therapy for prophylaxis of VTE. There was no significant difference between the groups in bleeding episodes. Because of slow enrollment, the study was terminated prematurely.
    "In summary, our study suggests that aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after THA," the authors write.

    Pfizer contributed grant money and Bayer provided in-kind support for the study.