Earl's View » FDA

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice

earlstevens58 — Sun, 24 Mar 2013 02:04:02 +0000

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice.

March 11, 2013 by Arezu Sarvestani FiDA hightlight

Veteran cardiologist and patient safety advocate Dr. Robert Hauser tells MassDevice.com about his new vision for healthcare surveillance, his long struggle to spur change at the FDA and what FDA regulators can learn from aviation regulation.

Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.

The patient safety advocate and vocal critic of the FDA announced at this year’s American College of Cardiology conference that he’s working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.

He’s looking to “recruit a couple people and go to Congress” with a proposal that would separate the FDA’s approval functions from its surveillance functions, he told MassDevice.com here in San Francisco yesterday.

In an in-depth interview, Hauser, a prominent cardiologist from the Minneapolis Heart Institute, told us about his drive to protect patients from faulty devices, his disappointment with the FDA and what healthcare regulators can learn from their counterparts in aviation.

Inspiration and disappointment

Hauser’s passion for healthcare safety was inspired in part by an experience he had in the mid-1970s, when a patient died when the pacemaker that he was dependent on short-circuited, he told us.

“A 40-year-old guy dropped dead on the doorstep of his home. His wife found him,” Hauser said sadly. “We then found out that it was due to moisture getting into the electronics through a defect in the circuit that the manufacturer knew about.”

At the time the FDA was considering what would become the Medical Device Amendments of 1976, which put into place the 3-tiered class system by which FDA assesses the potential risk and regulatory pathway for medical devices. Hauser “totally supported the amendment” at the time, he said, in part because of his experiences with faulty pacemakers. But in the intervening 40 years he’s grown pessimistic about the FDA’s ability to satisfy its duty to protect U.S. patients from potentially dangerous products.

He’s made it something of a life goal to promote changes at the FDA, but is growing increasingly discouraged, he told us.

“I’ve done everything I can to encourage the FDA to change. Nothing changes.”

Hauser has been instrumental in several discussions surrounding medical device risks and recalls, most recently in the January issue of the Journal of the American College of Cardiology, in which he warned physicians clamoring over Boston Scientific‘s (NYSE:BSX) “leadless” implantable defibrillator to curb their enthusiasm.

He was also at the center of an April 2012 scandal over St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator leads, in which the medical device maker called for the retraction of a Hauser study attributing 22 deaths to failures in the Riata or Riata ST leads.

Hauser was also 1 of the physicians who helped uncover problems with Guidant Corp.‘s pacemakers after a patient he was treating died. Boston Scientific, which acquired Guidant for about $26 billion in 2006, is still dealing with the legal fallout from those issues.

“I’ve done everything I can to encourage the FDA to change,” Hauser told us. “Nothing changes.”

His remaining alternative, as he sees it, is to change the fundamental structure of medical device and drug surveillance in the U.S.

Even as he prepares to advocate for a new regulatory agency to take some responsibility away from the FDA, Hauser is acutely aware of the hurdles that stand in his way, perhaps foremost among them “inertia” at the FDA.

“There’s 1 chance in 100, but it’s worth taking the chance,” he said. “It’s worth the effort, because maybe in the conversation something will happen that’ll change things.”

And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was “not bound to adopt IOM recommendations.”

The agency has since signed, and the White House approved, new deals with the medical device industry that raise the fees companies pay for agency review in exchange for the FDA meeting performance goals and getting applications out the door more efficiently.

What’s the hurry?

Medical device companies and lawmakers often chide the FDA for taking too long to get new, potentially life-saving products to the U.S. market. The agency frequently finds itself defendingits timelinesor promising to improve them.

The federal watchdog agency is regularly citedas the biggest hurdle delaying new products from reaching the market and industry advocates in Congress occasionally prod the FDAto speed the review process

“I don’t think we really help people by making drugs or products available more rapidly.”

Hauser fundamentally disagrees with those efforts, he told us, challenging the underlying assumption that faster is better.

“I don’t think we really help people by making drugs or products available more rapidly,” Hauser said. “There are occasional drugs and devices that really are game-changers, that deserve expedited study and review and approval. Many, many drugs and devices are incremental improvements – or they are in competition with other drugs or devices that are safe and effective.

“Thank God we’ve got pharma, thank God we’ve got the medical device companies. There have been revolutionary products, there will continue to be revolutionary products,” he added. “But there’s rarely great urgency to get something into the marketplace.”

The healthcare industry thrives, Hauser said, by pushing out new products and marketing incremental differences, no matter how small, in order to get a leg up on the competition.

Part of that is sustained by what he called “loopholes” in the FDA’s approval process, problems that Hauser said go beyond the scope of an independent monitoring authority.

The FDA’s unintended loopholes

“There are other issues that need to be addressed, separate from a National Drug & Device Safety Board,” Hauser told us. “We need to get rid of these loopholes that allow drugs or allow devices to get approved without adequate testing.”

He named the FDA’s premarket approval supplement system among the vulnerabilities in the agency’s review that allow potentially dangerous products to reach patients.

“Supplements to the original PMA allow manufacturers to make changes to medical devices that presumably improve design, manufacturing or labeling,” Hauser told an audience during a presentation at the ACC meeting on Saturday. “However, the PMA supplement has been employed – I should say abused – to introduce essentially new products that are significantly different than the original PMA devices.

“This is another pathway whereby high-risk Class III devices have been FDA-approved for widespread use without clinical trials or any human testing,” he added.

A classic example of how that process may fail, Hauser said, involved medical device giant Medtronic (NYSE:MDT) and its Sprint Fidelis ICD lead. The Sprint Fidelis, which was approved as a supplement to the Transvene lead, was the cause of a high-profile, precedent-setting recall after it had already been implanted in some 268,000 patients.Medtronic pulled the Sprint Fidelis in 2007, when it was announced that they were prone to fracture – meaning they could either fail to deliver life-saving therapy or else send unneeded shocks.

The defective leads were implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities listed the leads as a “possible or likely contributing factor.”

Hauser further targeted the FDA’s popular 510(k) medical device fast-track as an antiquated system that has outlived its usefulness. He agreed with a 2011 report released by the Institute of Medicine, the culmination of nearly 2 years and $1.3 million dollars, which recommended that the FDA scrub the 510(k) program completely.

The institute took issue withthe foundation of the 510(k) program, that devices which are “substantially equivalent” to already-approved products (so-called “predicate devices”) need not be subject to the more stringent pre-market approval process required for entirely new medical technologies.

The IOM report also found that 3 out of 4 devices recalled between 2005 and 2009 had been approved under 510(k) applications or had escaped review entirely.

The FDA’s failure to respond to recalls

The FDA has the authority to mandate recalls and investigate medical devices and drugs after they have been cleared for the U.S. market, but it rarely does so, Hauser explained.

“It’s a passive regulator,” he told us. “It tends to wait for manufacturers to voluntarily recall devices rather than pro-actively compelling manufacturers to take their products of the market or even, perhaps, to stop distributing while the potential problem is investigated.”

“How objective can a group be, inside the agency, when it’s discussing, potentially, the performance of another group inside the agency?”

Part of the problem is that the FDA is responsible for both approving devices and as well as monitoring them for problems, creating a fundamental conflict of interest within the agency, as Hauser sees it.

“Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug,” he said. “They’re all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it’s discussing, potentially, the performance of another group inside the agency?”

Hauser’s solution is to separate those responsibilities and task a new healthcare regulatory organization with monitoring and investigating healthcare products after the FDA has cleared them for the U.S. market. Lucky for Hauser, a model exists that exemplifies the segregation of approval and monitoring: the U.S. government’s regulatory oversight of the airline industry.

Learning from the FAA and the NTSB

The FAA and the National Transportation Safety Board are 2 sides of the same coin, regulating the aviation industry and monitoring it for issues, but the agencies are entirely separate. The NTSB has independent authority to investigate potential issues and reports only to Congress.

The pair of agencies were originally lumped into a single authoritative body that Congress later separated on the grounds that “no federal agency can properly perform investigatory functions unless it is totally separate and independent,” Hauser highlighted in his Saturday ACC presentation.

The NTSB has no regulatory authority and can’t induce airline companies to make changes or ground flights. It conducts investigations and makes recommendations, leaving it up to the FAA to take action.

That’s precisely what Hauser prescribed for U.S. healthcare regulation.

“We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings,” Hauser said. “The other thing NTSB does that we need on the medical side is they then share what they’ve learned about an accident with all the stakeholders. That doesn’t happen now with drugs and devices.”

He proposed that the NTSB participate in post-market studies, watch registries from around the world and make the data completely transparent and available to the public at large.

Hauser’s National Drug & Device Safety Board

Hauser aims to form the new healthcare regulatory agency by spinning out the FDA’s post-market surveillance efforts into an independent body modeled after the NTSB in purpose and structure.

“There would be a chairman appointed by the president and 4 board members, all of whom would have 3-5 year terms,” he told us. “The chairman would report to Congress, the board would report to Congress. They’d be an organization separate from any agency in the federal government, entirely independent.”

The new bureau would include engineers, scientists, statisticians and administrators to help monitor healthcare products on the market and collaborate with registries around the world to create a global network and public database of medical device and drug information.

The database might confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, Hauser noted, but the boon to industry is incidental to Hauser’s goal.

“It’s the end user that we’re really concerned about,” he said. “I’m not interested in helping the companies, necessarily. I’m interested in making a safer device or drug for a patient.”

FDA Proposes To Improve External Defibrillators (medicalnewstoday.com)
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
FDA and mobile health apps (mypersonalphone.wordpress.com)
FDA Issues Proposal To Improve The Safety Guidelines For Heart Defibrillators (medicaldaily.com)
Judges side with FDA in rejecting stem cell device (wfaa.com)
David Hauser, Co-Founder of Grasshopper Group, Shares his Entrepreneurial Journey, Lessons Learnt & More. (grasshopper.com)
Building a Company That Stands for Something: A Video Interview With David Hauser (grasshopper.com)
FDA Clarifies Plans for Mobile Health App Regulation (eweek.com)
FDA Proposes Tighter Regulation of Public Defibrillators (news.health.com)
Video: Medical devices: Video, statements and documents (pbs.org)

Filed under: FDA Approval of Hip and Knee Implants, FDA Review Tagged: Boston Scientific, FDA, Food and Drug Administration, Guidant, Health, Medicine, Medtronic, PMA, Premarket Approval, Robert Hauser, science

VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com

earlstevens58 — Sat, 09 Mar 2013 06:47:08 +0000

Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com.

VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.

The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.

In a statement, the company described the verdict as “mixed” and said that it planned to appeal the damage award. It disputed the finding by the jury that the A.S.R. was defectively designed.

It was impossible to say what the verdict, which came in a Los Angeles state court, would mean for other A.S.R.-related cases. A trial on a second lawsuit is scheduled to begin Monday in Chicago, with other cases expected to proceed later this year.

In its decision, the panel ordered Johnson & Johnson to pay the case’s plaintiff, a retired Montana prison guard, Loren Kransky, $338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.

Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve.

Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.

The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.

It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.

However, the A.S.R.’s design caused the cup and ball to strike against each other as a patient moved, resulting in the shedding of metallic debris. That debris inflamed and damaged tissue and bone, causing pain and, in some cases, permanent injuries to patients.

Today, all-metal hips like the A.S.R. are rarely used by surgeons because most models suffered from similar problems. But data from orthopedic registries suggests that the A.S.R. was far worse than many competing products.

An internal Johnson & Johnson document introduced at the Los Angeles trial estimated that close to 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced. In a recent filing with the Securities and Exchange Commission, Johnson & Johnson said that there are 10,750 A.S.R. lawsuits.

Traditional artificial hips, which are made of metal and plastic, are expected to last 15 years or more before needing to be replaced, and the normal replacement rate for early unexpected failures is about 5 percent after five years.

The lawsuit heard in Los Angeles was not originally scheduled to be the first over the A.S.R. but it was moved up because Mr. Kransky was found to have terminal cancer. Before the start of the Los Angeles trial, which began in late January, Mr. Kransky’s lawyers had not expected him to live through it.

Internal Johnson & Johnson documents that became public during the trial indicated that company executives were told by surgeons, who were also paid consultants to the device maker, that the design of A.S.R. was flawed. In addition, some surgeons also urged the device maker to slow sales of the implant or stop them completely, records show.

In the case, evidence was also presented that showed that Johnson & Johnson considered redesigning the A.S.R. to reduce its problems, but then abandoned the project because the implant’s sales did not justify the costs of the redesign. One of the DePuy executives involved in that decision was Andrew Ekdahl, who now heads Johnson & Johnson’s orthopedics division.

Johnson & Johnson executives like Mr. Ekdahl have said throughout the A.S.R. episode that they acted responsibly and moved to recall the device in 2010 when data from an orthopedic registry in Britain showed that its failure rate was higher than normal.

Before reaching its verdict Friday, the jury that heard Mr. Kransky’s case deliberated for more than five days. Mr. Kransky’s lawyers, citing what they described as the unethical behavior of DePuy executives in failing to warn doctors and patients of the device’s defects, asked jurors to punish Johnson & Johnson by awarding their client $36 million to $144 million. Jurors declined to do so.

Nonetheless, lawyers representing Mr. Kransky hailed the verdict.

“This is a victory for Mr. Kransky and thousands of other badly damaged A.S.R. patients who have yet to get their day in court,” Brian Panish, one of Mr. Kransky’s lawyers, said in a statement. “Jurors across the country will return similar verdicts until J.&J. takes full responsibility.”

A DePuy spokeswoman, Lorie Gawreluk, said in the company’s statement that it planned to appeal Friday’s verdict, contending that the A.S.R.’s design was not defective.

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
Damages awarded in J&J’s DePuy hip implant case (wfaa.com)
Parker Waichman LLP Weighs-In on $8.3 Million Verdict in DePuy ASR Hip Implant Trial (prweb.com)
Johnson & Johnson to award security guard $8.3m over faulty implant (guardian.co.uk)
Recalls-R-US… Johnson & Johnson Confirms Inquiry Into Hip Devices – NYTimes.com (earlsview.com)
DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
Johnson & Johnson Pays Out $8 Million In Lawsuit (huffingtonpost.com)
Jury awards damages in Johnson & Johnson hip case (kfwbam.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Chicago, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Kransky, lawsuit, Los Angeles, metal, Metal on metal hip, metal-on-metal hips, metallosis, New York TImes, science, Smith & Nephew, UNited States

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

earlstevens58 — Tue, 05 Mar 2013 10:07:33 +0000

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants.

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

Orthopaedic surgeons
Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

Traditional total hip replacement systems
Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers. This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal). Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
- Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated. Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years). If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Female patients
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity.
Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant. Please be aware of the FDA’s recommendations:

Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
Review the available device-specific labeling from manufacturers for MRI Conditions; and
Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream. Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results. Please be aware of the FDA’s recommendations:

The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention. The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

Consider the benefits and risks of all bearing surfaces for each patient.
Check the specific device labeling for compatibility of device components.
If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

	Symptomatic Patients	Asymptomatic Patients
Regular Clinical Evaluation	At least every six months	Typically at least once every 1 to 2 years
Soft Tissue Imaging	Consider the benefits and risks of MRI, CT and ultrasound for each patient.	Not necessary if you feel the hip is functioning properly.
Metal Ion Testing	Consider monitoring serial metal ion levels. Currently, the most reliable test results are available for cobalt in EDTA-anticoagulated blood*. In repeat tests, use same sample type, measurement method and preferably the same laboratory.	Not necessary if you feel the hip is functioning properly.

*For chromium testing, a validated method that resolves potential interferences must be used. Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

General hypersensitivity reaction (skin rash)
Cardiomyopathy
Neurological changes including sensory changes (auditory, or visual impairments)
Psychological status change (including depression)
Renal function impairment
Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

Be aware that every hip implant has benefits and risks.
Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices. Recent activities include:

On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices. Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans. Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

Date of implantation
Date of implant removal (if applicable)
Clinical cause for revision (if available)
System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Cobalt chrome, Cobalt poisoning, DePuy, FDA, Food & Drug Administration, Health, Hip implants, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson & Johnson, joint replacement, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, Patient, Radiology, Research, science, Smith & Nephew, soft tissue damage, Specialty, UNited States

DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

earlstevens58 — Tue, 05 Mar 2013 09:56:43 +0000

Trial plaintiff says J&J hips defective, company says not liable.

Trial plaintiff says J&J hips defective, company says not liable

3/1/2013

By Deena Beasley

(Reuters) – Johnson & Johnson‘s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.

The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.

Kransky attorney Brian Panish told Los Angeles Superior Court jurors that J&J should be ordered to pay around $5 million for Kransky’s pain and suffering, and as much as $179 million in punitive damages. The proceedings were monitored over the Courtroom View Network.

J&J recalled 93,000 of its ASR metal hips after determining that they were failing at a higher-than-expected rate.

Kransky’s attorneys argued that the design of the hip was defective, leading to the shedding of metal debris that caused tissue poisoning and pain as well as the need for the plaintiff to undergo hip revision surgery.

“Any compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person,” Panish said.

Both sides in the case agreed that Kransky’s medical problems, including diabetes, cancer, kidney disease, heart disease and vascular disease, were not related to the ASR hip implant.

J&J attorney Michael Zellers argued that Kransky’s ASR hip was implanted at an incline that was steeper than company guidelines advised. He also said the plaintiff’s need for revision surgery was caused by an infection.

Testimony in the trial included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

“We know there is no perfect hip design. There are always trade-offs,” Zellers said, adding that the company designed the all-metal device with the aim of developing a longer-lasting hip that would show less wear than existing devices.

The J&J attorney argued that there is no medical consensus on what levels of chromium and cobalt, the metals shed by ASR hips, could cause harm to patients.

“Ultimately the product did not perform as DePuy wanted it to perform or expected it to perform,” he said.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

Michael Kelly, another Kransky attorney, told jurors the evidence shows that J&J’s DePuy unit was primarily focused on making money from the all-metal ASR hips at the expense of patient safety.

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)
Parker Waichman LLP Reviews Closing Arguments of DePuy ASR Trial and Discusses Risks of Metal-on-Metal Hip Implant (prweb.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
DePuy ASR Hip Lawsuit News: Plaintiff’s Attorney Alleges J&J Pursued Profits Over Safety; Asks for as Much as $180 Million in Damages (prweb.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)

Filed under: 510k process, Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Courtroom View Network, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson, Johnson & Johnson, joint replacement, Kransky, Medicine, metal, Metal on metal hip, metal-on-metal hips, Plaintiff, Reuters, Smith & Nephew, Zellers

Oh Really … Why am I not believing you?…. Hip Replacement Device – NYTimes.com

earlstevens58 — Tue, 05 Mar 2013 09:35:01 +0000

Hip Replacement Device – NYTimes.com.

Oh Really Mr DePuy – are we as stupid as you look?

Published: March 4, 2013

Re “What a Company Knew About Its Metal Hips” (editorial, Feb. 11):

All of us at DePuy are united by the goal of improving patients’ lives, so we understand that the Articular Surface Replacement Hip System recall has been of concern for patients, their family members and surgeons. I disagree with how your editorial described company actions regarding ASR testing, data analysis and communications.

ASR was tested for years before receiving regulatory clearance around the world. Once on the market, we carefully considered all the data and investigated product complaints individually, while also looking for broader performance trends. We continued to share appropriate and validated data with regulators and surgeons.

When we received new registry data reporting that ASR patients were undergoing a second hip replacement surgery sooner than expected, we recalled the product and immediately supported patients with a reimbursement program for their medical costs.

Joint replacement surgery is one of the greatest medical advances of our time. We remain dedicated to serving patients who need this important treatment option.

ANDREW EKDAHL

President, DePuy Orthopaedics

Warsaw, Ind., Feb. 25, 2013

During Trial, New Details Emerge on DuPuy Hip – NYTimes.com (earlsview.com)
FDA cracks down on all-metal hip replacements (earlsview.com)
DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
RLG Responds to Report of Higher Metal-on-Metal Hip Replacement Failure Rates in Women (earlsview.com)
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
DePuy Hid Data About Failed Hip Implant, Documents Show – NYTimes.com (earlsview.com)
Biomet Hip Replacement Lawsuits: Bernstein Liebhard LLP Files Biomet Hip Implant Lawsuit on Behalf of Biomet M2a Magnum Hip Replacement Recipient (prweb.com)
Study shows cost-effectiveness and benefits to patients of early hip replacement (earlsview.com)
Patients victims of untested medical devices – SFGate (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: articular surface replacement, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Health, Hip Replacement, Johnson, Johnson & Johnson, joint replacement, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, New York TImes, Patient, surgery, UNited States

FDA cracks down on all-metal hip replacements

earlstevens58 — Sun, 03 Mar 2013 21:31:50 +0000

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html

FDA cracks down on all-metal hip replacements

Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration. Incredibly, for the past decade manufacturers have been aggressively marketing the devices as being better than conventional varieties without that evidence, to the great harm of patients.

Last year in our report on dangerous medical devices, we highlighted evidence that patients with all-metal artificial hip implants were suffering serious side effects, including pain, infections, muscle lesions, and neurological problems such as depression and deterioration of hearing and eyesight, as a result of reactions to metal debris wearing off their implants. At the end of this blog is a video highlighting one such victim, an Alaska orthopedic surgeon, Dr. Stephen S. Tower, whose research was cited in the the FDA’s announcement.

At the peak of the craze for all-metal hips in 2008, they accounted for about 40 percent of all hip replacements done in the U.S., according to new estimates by Steven M. Kurtz of Drexel University. He estimates about 755,000 Americans have been implanted with the hips. Their use has dropped dramatically in recent years as awareness of their dangers has spread.

The FDA regulations announced yesterday specify that once the new rules become final, likely to happen sometime later this year, manufacturers will have 90 days in which to file applications that include the results of clinical trials and other “valid scientific evidence” showing the hips are safe and effective. If they don’t, they’ll no longer be able to sell them in this country.

“I think it’s a good thing,” Tower told us, “but in a lot of ways it’s a formality, because the use of the devices has practically gone to zero anyway.”

Manufacturers we contacted yesterday said they were still studying the FDA’s proposal. Zimmer, once a major purveyor of the all-metal hips, has stopped selling them in the U.S. because “the demand is reduced so much they’re not commercially viable,” said media spokesman Garry R. Clark.

If you have an all-metal hip, here are symptoms to watch out for, according to the FDA:

Swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or a change in ability to walk.
General hypersensitivity reaction (skin rash)
Deterioration in your hearing or eyesight.
Psychological status change (including depression or cognitive impairment)
Kidney problems
Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)

Anyone who experiences these symptoms should seek medical attention and, in particular, consider tests that detect elevated levels of the toxic metals cobalt and/or chromium in the bloodstream.

Sources
FDA safety communication: metal-on-metal hip implants

Information for patients who have metal-on-metal implants (FDA)

FDA cracks down on all-metal hip replacements (earlsview.com)
Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
Stryker Encourages Monitoring of Australian Rejuvenate and ABG II Hip Recipients – February 25, 2013 (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications. (earlsview.com)
FDA Issues New Cautionary Guidelines for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports (prweb.com)
Metal-on-Metal Replacement Hip Implant Patients at Risk for Metallosis, Other Health Issues, Warns Wright & Schulte LLC (prweb.com)
F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)

Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

earlstevens58 — Sun, 03 Mar 2013 08:53:15 +0000

Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

By Stephen Tower,

Orthopedic SurgeonAffiliated Professor UAA WWAMI School of Medicine

Dear Dr. Jacobs,

Please consider this an open letter.

Your prompt reply to my concerns about Surgeon Industry Conflict of Interest (SICOI) and the Continuing Medical Education (CME) content at the upcoming annual meeting of the AAOS addressing the periprosthetic and systemic complications of chrome-cobalt metallosis is greatly appreciated.

I am aware of your many contributions over the past 25 years to the literature that supported the reintroduction of the metal-on-metal class of hips, the regulatory processes at the FDA that allowed for these devices to be implanted, and to the CME content of AAOS sponsored meetings and publications that persuaded American surgeons to select metal-metal hips over safer options in one-third of their patients over the course the past decade. You have consulted for Zimmer and Wright Medical; arthroprosthetic companies whose MoM liability exposure might exceed their gross capitalizations. You continue to hold stock options in Implant Protection, a company whose worth might soar with the awareness of the frequency and severity of the systemic complications of periprosthetic chrome-cobalt metallosis.

Your belief that a brief separation from industry derived income makes you an impartial authority on the complications for metal-metal hips now plaguing tens of thousands of American patients seems at best self deceptive. However, of the five surgeons selected by the hip program committee to address metal-metal hip complications in Chicago only Dr. Kwon is less conflicted that you are. Dr. Schmalzried, with whom you have collaborated, was paid by J&J 20 million dollars to design the ASR. The ASR was implanted in 92000 patients, has been withdraw from the market, and the ASR is likely to cost J&J of about 15 billion dollars. It would be unreasonable to expect that Dr. Schmalzried could reconcile the nature, severity, frequency, and impact of even the periprosthetic complications of chrome cobalt metallosis much less the systemic ones. When I last spoke with him he was still unaware of fifty years of case reports of cobalt poisoning from industrial exposure, the use of a cobalt beer additive, and the medicinal use of cobalt.

Dr. Lombardi and Dr. Fehring have likely been paid millions of dollars to promote Biomet’s arthroprosthetic products. Dr. Lombardi is the president of the Hip Society and is the chairman of the hip program committee that rejected my application for the Symposium, an Instructional Course Lecture, and three scientific papers addressing metal-metal hip complications. The majority of the members of the hip program committee are Biomet consultants and only several committee members have no declared SICOI. Biomet is another arthroprosthetic company whose metal-metal hip liabilities might exceed its capitalization.

Given that you have been a consultant to Zimmer for many years and that your focus of interest is metallurgic it is likely that you are, in part, are responsible for the design of the Durom. This case might interest you.

Thursday’s revision was a Durom implanted for 6 years, the patient had no symptoms at the hip. He was referred to me because his naturopathic leaning primary provider was aware of the potential for metal-metal hip related cobaltemia because my work is better recognized locally than nationally. His blood cobalt was in excess of 10 mcg/L on multiple occasions. His new neurologic and cardiac problems since his Durom implantation include impaired memory, weight loss, brain atrophy, urinary urgency, ataxia, progressive deafness, motor-sensory polyneuropathy, diastolic dysfunction and carditis. Although he had no symptoms at the hip he had a large mixed pseudo-tumor with moderate loss of hip capsule, severe proximal femoral lysis, and minor loss of hip abductors. Although the implants were optimally positioned the head shows a defined wear ellipsoid and multiple “hard stops” indicating material deformation from edge head contact. There was no bone ingrowth into the shell and most remarkably evidence of marked corrosion and fretting at the innermost taper junction of the head and neck.

Had this patient’s doctors followed present FDA recommendations for following patients implanted with metal-metal hips this gentleman’s cobaltemia, likely neurologic and cardiac cobaltism, and progressive periprosthetic tissue damage would likely have gone undiagnosed and might have progressed beyond remediation. I believe that you may have had a role in formulating the FDA’s rather tepid monitoring criteria.

This is just my most recent case. The number of metal-metal hips revised in our series is now at about 25, most have been notably cobaltemic, and about one-third appear to have been systemically toxic. In most instances we have metal levels, histopathology, and explant analysis. The case histories, the correlation of metal levels to systemic toxicity, the periprosthetic histopathology, and explant analysis were the subject of the three scientific papers that were rejected by Dr. Lombardi’s hip program committee. The detail and findings of the expanding Alaskan series is well beyond any I saw presented at last years annual meeting.

I appreciate your offer to present my research in Chicago. I would prefer to present it myself. Given that I am unlikely to be allowed near a podium I will forward the full updated series to you, piecemeal, one case report at a time followed by an analysis of the series as a whole. Since peer review of papers submitted for publication is done be the same industry entangled surgeons that determine what will be presented at meetings I will also web publish the information as I release it to you in “Blog” format. This appears to be my only means to limit the harm of neglected complications in hundreds of thousands of metal-metal hip implanted patients.

As you are aware I have been expressing concerns about the metal-metal hips to industry and to the Presidential Line of the AAOS since 2007 and to the FDA since early 2010. I now regret that I had not expressed my concerns more publicly. Given the barriers that I have experienced in presenting or publishing research counter to the interest of the arthroprosthetic industry it appears that the internet and the press might be the only means to convey relevant information to medical providers and patients.

Those that present CME content at meetings are allowed to influence the audience well beyond the merits of their research. That is how metal-metal hips were popularized. It would seem that the goal of the symposium on metal-metal hip complications in Chicago ought to be to educate the rank and file orthopedist not to further implant metal-metal hips and to recognize the early manifestations of chrome-cobalt metallosis so that the arthroplasty can be revised to one without chrome-cobalt components while the patient’s periprosthetic tissues are intact and before the patient experiences a decline in neurologic, cardiovascular, or endocrine function. If Dr. Schmalzried, Dr. Lombardi, and Dr. Fehring remain on the symposium panel those goals will not be optimally met and hundreds of thousands of patients might experience preventable harm. Surgeons that have promoted the metal-metal hips and been compensated millions for their efforts have every reason to be in a state of denial about the frequency and severity of the periprosthetic and systemic complications of chrome-cobalt metallosis.

Freeing three spots on the panel would allow for the addition of faculty that would further the idealized goals of having the symposium. Dr. Kevin Bozic could address epidemiology and moderate the panel, Dr. Michael Mayor or John Currier could cover what explant analysis has taught us about metal-metal tribology, and I am still willing to cover cobaltism and what we have learned from the Alaskan series of failed metal-metal arthroplasties.

Sincerely,

Stephen S. Tower, MD

On Feb 28, 2013, at 6:23 PM, Joshua Jacobs

wrote:

Dr. Tower,

Thank you for your communications expressing your concerns about the systemic effects of metal degradation products from joint replacement components. To study this issue, the orthopaedic device manufacturing industry needs to collaborate with researchers and laboratories that have expertise and clinicians who have access to patients with the devices. That is where I fit in – I oversee the metal ion analysis facility at Rush which is currently CLIA approved.

This is a topic that has been of great interest to me since 1980, when as a medical student I joined a team of researchers at Rush University Medical Center who had started pioneering research to characterize the systemic distribution of Ti, Al and V from porous titanium implants in subhuman primates. That study was one of the first papers I published (Woodman. J.L., Jacobs, J.J., Galante, J.O., and Urban, R.M. Metal Ion Release from Titanium‑Based Prosthetic Segmental Replacements of Long Bones in Baboons: A Long‑Term Study. J. Orthop. Res. 1: 421‑430, 1984).

I have continued to study the systemic distribution of metal following joint replacement. In the March 2013 issue of the JBJS the 10 year longitudinal results from our NIH-funded study on metal release from primary metal on polyethylene total hip replacements will be published: (Levine, B.R., Hsu, A.R., Skipor, A.K., Hallab, N.J., Paprosky, W.G., Galante, J.O. and Jacobs, J.J. Ten-Year Outcome of Serum Metal Ion Levels after Primary Total Hip Arthroplasty. A Concise Follow-up of a Previous Report. J Bone Jt Surg Am: 95 March, 2013).

Over the years, NIH, OREF and the orthopaedic implant industry have funded our laboratory to conduct systemic metal distribution studies. I have had industry funding from Wright Medical, Zimmer, Medtronic, Spinal Motion, Advanced Spine Technologies and Nuvasive to measure metal levels in patients with permanent metallic implants including hip and intervertebral disc replacement devices. It is important that the aforementioned companies collaborate with clinician investigators and provide support for research to study this issue.

During my service on the presidential line of the AAOS, I have not held any consulting relationships with the orthopaedic device industry. That was a requirement of the AAOS prior to my election to the presidential line. Despite the fact that my consulting stopped when I became second VP, ACCME rules required that I list financial relationships for the preceding 12 months. I realize this may cause some confusion when trying to interpret existing conflicts.

My current relationships with industry involve ongoing studies by our facility, to measure metal ion levels in the serum of patients with hip replacements and intervertebral disc replacements. This is important information in the characterization of the clinical performance of these devices. I personally receive no money from these research studies – the funding is used to pay for the labor and material costs of metal ion analysis and patient tracking.

As you know, I also list the fact that I have stock options in a company called Implant Protection. This company was the brainchild of Israeli scientists who were seeking a method of preventing metal and other debris from circulating into the synovial fluid and beyond. This is a laudable goal. These scientists reached out to me for background information on matters related to tribocorrosion of metal implants, an area of my research activity over the years. Since this company is a start up, they could not compensate me for time; rather stock options were offered. Currently the activities of this company are dormant and it is not clear that this situation will change.

Systemic effects of metal degradation products are an important consideration when evaluating patients with metal on metal bearings. I have consistently advocated that clinicians be aware of these effects and query their patients about their general health with particular emphasis on symptoms of cardiomyopathy, hypothyroidism, skin rash, neuropathy, and changes in hearing and vision. I have made this statement in many CME venues, including the Annual Meeting of the AAOS. For the March 2013 meeting, I intend to again make this point. I always try to present this information in the context of the best available evidence, which as you know is limited in this area. I know you have personally experienced systemic manifestations of elevated metal levels from your failed ASR and I always cite your published report in JBJS during my presentations. If you have additional scientific information from your own investigations of systemic effects that have not yet been published, please let me know so that I can update my presentations accordingly. I will be in Anchorage for the 2013 Alaska State Orthopaedic Society meeting on April 6^th. If you are in attendance, I would be happy to meet with you for a more in-depth discussion.

We are always very concerned about the outcome of the procedures we do, including total hip replacement. It is our commitment to present the best scientific evidence available to inform our members and the public.

Thank you for your time and consideration.

Sincerely,

Joshua Jacobs, MD

1^st VP AAOS

Professor and Chair

Department of Orthopaedic Surgery

Rush University Medical Center

On Sat, Feb 23, 2013 at 2:46 PM, Stephen S Tower wrote:

Stephen Tower

Orthopedic Surgeon

Affiliated Professor UAA WWAMI School of Medicine

Dear Dr. DeHaven,

I understand that President Tongue has deferred consideration of my concerns about surgeon-industry COI influencing the annual meeting CME content addressing the complications of Metal-Metal hip arthroplasty to you.

I believe that the topic of surgeon-industry COI is critical and timely given the upcoming annual meeting of the AAOS. The attached PDF is a work in progress about surgeon-industry COI in the genesis of the metal-metal hip troubles. I do not believe that the degree to which a small group of industry consultant surgeons have controlled the literature, meeting content, and governance of the AAOS is well appreciated. Until this is appreciated I fear that there will be an avoidable continuance of the metal-metal troubles.

The AAOS annual meeting has great influence among rank and file orthopedic surgeons and the upcoming one will be the third in which the complications of the metal-metal hips will likely be understated, to the potential determent of about a million patients.

I made a concerted effort to assemble a symposium and an instructional course lecture on the local and systemic complications of chrome-cobalt metallosis for the 2013 annual meeting. I also submitted three papers for presentation at the scientific program. The faculty that I had recruited for the symposium and the ICL included:

Bernie Morrey- Professor Mayo Clinic.

Michael Mayor- Professor Dartmouth, founder Dartmouth Biomedical Engineering Center.

Kevin Bozic – Professor UCSF, expert on the epidemiology of hip replacement.

John Currier- research engineer at DBEC, he described that in vivo shortcomings of the metal-metal bearing couple.¹

Stephen Graves – Head of the Aussie total joint registry that sounded the alarm about the high early revision rate of the ASR.^2 3·

Simona Catalani – Italian neuro-physiologist that has done recent experimental work on neuro-cobaltism.

Kristy Weber – John Hopkins Orthopedic oncologist, as a “neutral” moderator.

Stephen Tower – Arthroprosthetic Cobaltism.^4 5

The commercial conflicts of the hip program committee that rejected my five applications are delineated in the PDF, as are those of the five panelists chosen instead for the symposium the complications of the metal-metal hips. It is notable that 4 of 5 are consultants to arthroprosthetic companies with a stake in the fate of the metal-metal hips. Two are Biomet, one Zimmer, and one DePuy (the design surgeon of the ASR no less). The inclusion of Dr. Schmalzried to the panel seems equivalent to recruiting the captain of the Costa Concordia to give the seminar on safe cruise ship navigation.

I understand that given my personnel experience that I have a biased perspective but I think I made a creditable effort to recruit a respected and relatively un-conflicted panel. As delineated in the PDF I have also made a concerted effort to express my concerns about surgeon-industry COI to the leadership of the AAOS. It is notable that at the time I started these efforts that two of the four were DePuy consultants, and one was a Zimmer consultant.

Given my experience I am in an uncomfortable catbird seat of knowing the ways of the cat but being unable to communicate my knowledge to the other birds at risk. Because of my publications I am contacted frequently by patients likely in trouble with their metal-metal hips that have been dismissed by their surgeons. These surgeons have been reassured through the orthopedic literature and through the content at AAOS sponsored CME events that the local and systemic complications of chrome-cobalt metallosis are rare. We do know that if the complications chrome-cobalt metallosis are ignored eventual salvage surgery is more difficult and outcomes are compromised. The continued control of industry over the CME content at the AAOS annual meeting is likely to harm thousands.

Given the degree to which industry influence dominates that leadership of the AAOS it seems unlikely the organization can correct this problem from within. The AAOS leadership has stated to me that such surgeon-industry relationships are “Kosher” because faculty must disclose potential COI, it is left to the audience to evaluate whether these commercial associations might influence presented educational content. However, the full disclosure forms are not readily available to the audience. The presenters flash up a crowded slide of their potential commercial conflicts and then state that these relationships are unrelated to the content of the presentation. I spent about 12 hours on the AAOS web site and on “Google Scholar” to unearth the potential commercial conflicts of the hip program committee and the panelists chosen for the metal-metal hip symposium. This is an effort not likely to be repeated by other AAOS member surgeons attending the meeting in Chicago.

I am hopeful that you might review my concerns in an expedited fashion such that the symposium faculty addressing metal-metal hip complications might be changed to a balanced panel. Failure to do so has potential adverse impact on thousands of patients implanted with metal-metal hips.

Could you kindly inform me as to the temporal plan to review my concerns? Dr. Upsur Spencer is Alaska’s delegate to the board of councilors. I am hopeful that he might address these concerns at the Chicago meeting.

Sincerely,

Stephen S. Tower

1. Currier JH, McHugh DJ, Tower DR, Kennedy FE, Van Citters DW. Gouge features on metal-on-metal hip bearings can result from high stresses during rim contact. Tribology International 2012.

2. Graves SE. What is happening with hip replacement? Med J Aust 2011;194(12):620-1.

3. Graves SE, Rothwell A, Tucker K, Jacobs JJ, Sedrakyan A. A multinational assessment of metal-on-metal bearings in hip replacement. J Bone Joint Surg Am 2011;93 Suppl 3:43-7.

4. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.

5. Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am 2010;92(17):2847-51.

Stephen Tower

Orthopedic Surgeon

Affiliated Professor UAA WWAMI School of Medicine

Dear Dr. Jacobs,

Please consider this an open letter.

Your prompt reply to my concerns about Surgeon Industry Conflict of Interest(SICOI) and the Continuing Medical Education (CME) content at the upcoming annual meeting of the AAOS addressing the periprosthetic and systemic complications of chrome-cobalt metallosis is greatly appreciated.

Sincerely,

Stephen S. Tower, MD

On Feb 28, 2013, at 6:23 PM, Joshua Jacobs

wrote:

Dr. Tower,

Thank you for your time and consideration.

Sincerely,

Joshua Jacobs, MD

1^st VP AAOS

Professor and Chair

Department of Orthopaedic Surgery

Rush University Medical Center

On Sat, Feb 23, 2013 at 2:46 PM, Stephen S Tower wrote:

Stephen Tower

Orthopedic Surgeon

Affiliated Professor UAA WWAMI School of Medicine

Dear Dr. DeHaven,

Bernie Morrey- Professor Mayo Clinic.

Michael Mayor- Professor Dartmouth, founder Dartmouth Biomedical Engineering Center.

Kevin Bozic – Professor UCSF, expert on the epidemiology of hip replacement.

John Currier- research engineer at DBEC, he described that in vivo shortcomings of the metal-metal bearing couple.¹

Stephen Graves – Head of the Aussie total joint registry that sounded the alarm about the high early revision rate of the ASR.^2 3·

Simona Catalani – Italian neuro-physiologist that has done recent experimental work on neuro-cobaltism.

Kristy Weber – John Hopkins Orthopedic oncologist, as a “neutral” moderator.

Stephen Tower – Arthroprosthetic Cobaltism.^4 5

Sincerely,

Stephen S. Tower

1. Currier JH, McHugh DJ, Tower DR, Kennedy FE, Van Citters DW. Gouge features on metal-on-metal hip bearings can result from high stresses during rim contact. Tribology International 2012.

2. Graves SE. What is happening with hip replacement? Med J Aust 2011;194(12):620-1.

3. Graves SE, Rothwell A, Tucker K, Jacobs JJ, Sedrakyan A. A multinational assessment of metal-on-metal bearings in hip replacement. J Bone Joint Surg Am 2011;93 Suppl 3:43-7.

4. Tower S. Arthroprosthetic cobaltism: identification of the at-risk patient. Alaska Med 2010;52:28-32.

5. Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am 2010;92(17):2847-51.

–

Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
Some Surgeons Do Speak & Shout – but Those that Should Listen Don’t Hear… (earlsview.com)
DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
Severe Metallosis Leading to Femoral Head Perforation | Orthopedics (earlsview.com)
What Patients Should Know About Silicone Breast Implants (aboutplasticsurgery.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Biomet, Chicago, chrome cobalt, cme content, Continuing Medical Education, FDA, Food & Drug Administration, Health, Medicine, metallosis, Orthopedic surgery, science, UNited States

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg

earlstevens58 — Fri, 01 Mar 2013 23:51:32 +0000

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg.

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues

By Maurice Possley & David Voreacos - Mar 1, 2013 12:17 PM ET

Johnson & Johnson (JNJ)’s pursuit of profit led it to sell a defective metal-on-metal hip that failed faster than any similar device, a lawyer argued at the first of 10,750 lawsuits over the recalled implant to go to trial.

Jurors in Los Angeles heard closing arguments today on claims by Loren Kranksy, 65, that J&J’s DePuy unit defectively designed its ASR hip and failed to warn of the risks. Kransky attorney Brian Panish asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million.

J&J, the world’s largest seller of health-care products, failed patients before recalling 93,000 ASR hips in August 2010, Panish said. At the time, J&J’s DePuy unit said 12 percent failed within in five years, requiring follow-up revision surgeries. The Australian rate hit 44 percent in 2012, he said.

“That design was defective from the first day they put it out,” Panish argued to the state court jury at a trial that began Jan. 25. “It was beyond what any hip had ever done to anyone in the history of the world. It’s not even close.”

J&J, based in New Brunswick, New Jersey, denies that it defectively designed the device or failed to warn of the risks associated with it. Analysts say resolving the lawsuits could cost the company billions of dollars.

After the summations, Judge J. Stephen Czuleger instructed jurors on the law. Deliberations are expected to begin tomorrow.

Kransky, a retired prison guard from Montana, had his hip implanted in December 2007 and removed in February 2012. His “diabetes, cancer, kidney disease, heart disease, vascular disease and his many other health problems are unrelated” to his hip, J&J attorney Michael Zellers said in his summation.

Injury Causation

“This case is about what caused Mr. Kransky’s injuries,” Zellers said. “The evidence is clear that Mr. Kransky’s injuries were not caused by a defect in the ASR hip. It’s not a case about a recall. It’s not about revision rates of the ASR today.”

Zellers denied claims by Kransky and his attorneys that the tissue around his hip was damaged because the device, made of chromium and cobalt, shed metal ions.

Kransky testified that he believed the debris was poisoning him, and he feared the revision because he thought it would kill him. Records show his metals level was eight times higher than the level DePuy considered acceptable.

“There is no scientific support that Mr. Kransky’s metal ions were toxic,” Zellers said. “The evidence in this case was that Mr. Kransky was not being poisoned and that the cobalt and chromium levels in his system were not toxic.”

Hip Infection

Zellers said Kransky’s revision came after his hip grew infected, not because of problems with the ASR.

“Mr. Kransky had an infected hip,” Zellers said. “That caused him pain. That pain caused the revision.”

Panish asked jurors to award Kransky $338,000 for his medical expenses and $5 million for his pain and suffering. Jurors also should impose punitive damages of $72 million to $179 million on DePuy, or 2 percent to 5 percent of the company’s value, Panish argued.

“This is a company that needs a solid message sent to them,” Panish said. “Nobody has ever accepted responsibility from DePuy. For a company in today’s world to do this to patients — unfortunately, it happens because the money corrupts. They don’t have a soul.”

J&J failed to test the ASR adequately before it was sold in the U.S. in 2005, and ignored reports by leading surgeons of mounting patient complaints, Panish said.

Metal Cup

Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. Panish said DePuy failed to test the cup at any angle other than the optimum one of 45 degrees. Witnesses said that the steeper the angle, the greater the amount of metal debris that was shed.

Panish said the ASR was “unsafe at any angle.”

Zellers responded to Panish’s criticism of DePuy for failing to conduct a clinical study before selling the ASR.

“This was the mostly extensively tested device in DePuy history at the time,” he said. “They worked hard to develop a product that had low wear and would last a long time.”

He denied that DePuy hid its testing data.

“DePuy shared its information with everyone,” he said. “This was not something DePuy hid and kept in its laboratory.”

Implant Angle

He said the evidence showed that Kransky’s hip was implanted at an angle greater than 55 degrees.

“If you are going to put a cup in at that angle, you are going to get more wear,” he said.

Zellers told jurors that complaints about the hip jumped after the recall, and not because it was defective.

“When the recall occurred,” he said, “there were many, many, many complaints related to the ASR. That’s understandable. There was a lot of publicity. There was worry by patients.”

Kransky’s lawyers “have tried to make you angry at DePuy,” Zellers said. “They have tried to convince you that DePuy acted maliciously. DePuy set out to make the very best hip device they could make. DePuy is a good company. It has a superb reputation. DePuy is an open and honest company.”

In a rebuttal argument, Kransky attorney Michael Kelly derided Zellers for suggesting that revisions rose after the recall because of lawyers, like it was a “global conspiracy.”

He said revisions came two to four years after the implant, with the biggest year of U.S. sales in 2007, at 10,581.

“Surprise, surprise, these are the ones that are hurting people right on schedule,” Kelly said.

He said for DePuy to say Kransky had an infected hip was “complete, total, utter bunk.”

Kelly also told the jury that Zellers said there’s “no perfect hip.”

“Ladies and gentlemen, this is not an imperfect hip,” he said. “This is a public health disaster.”

The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court atmauricepossley@gmail.com; David Voreacos in Newark at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues (bloomberg.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
Johnson & Johnson Plaintiff: Profit Motive Led to Defective Hip Implant (counselheal.com)
J&J Expert Says Infection, Not Defect, Led to Hip Failure – Bloomberg (bloomberg.com)
J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told – Bloomberg (earlsview.com)
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
DePuy ASR Hip Lawsuit News: Plaintiff’s Attorney Alleges J&J Pursued Profits Over Safety; Asks for as Much as $180 Million in Damages (prweb.com)
DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, California Superior Court, Cobalt chrome, Cobalt poisoning, David Voreacos, Defective Hip, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Los Angeles, maurice possley, metal-on-metal hips, metallosis

J&J gambled on hip implant safety, lawyer alleges – latimes.com

earlstevens58 — Fri, 01 Mar 2013 23:27:35 +0000

J&J gambled on hip implant safety, lawyer alleges – latimes.com.

J&J gambled on hip implant safety, lawyer alleges

Johnson & Johnson ‘knew this hip was defective’ but failed to warn patients, a plaintiff‘s attorney says. The company said it acted properly and ‘put patients above money.’

Loren Kransky, shown in court with his wife, Sheryl, alleges he suffered metal poisoning and other health problems from Johnson & Johnson’s ASR XL hip implant. (Al Seib, Los Angeles Times / February 28, 2013)

By Chad Terhune, Los Angeles TimesFebruary 28, 2013, 5:59 p.m.

Healthcare giant Johnson & Johnson played “Russian roulette” with patient safety by ignoring high failure rates and surgeons’ complaints about its once-popular artificial hip, a Los Angeles jury was told during closing arguments at a high-stakes medical trial for the company.

Jurors heard arguments from both sides Thursday in a case that pits the world’s biggest seller of medical products against Loren Kransky, a 65-year-old former prison guard in Montana who claims he suffered metal poisoning and other health problems from the company’s ASR XL hip implant he received in 2007.

The company “knew this hip was defective long before Mr. Kransky got it,” Brian Panish, one of Kransky’s attorneys, told the 12 jurors and one alternate. “They wanted to play Russian roulette with patients. This defendant didn’t care about patient safety.”

J&J has denied Kransky’s claims that it designed a defective hip implant and failed to warn patients about the risks. Attorneys for J&J have said that Kransky’s ailing health was due to his diabetes, kidney cancer and other long-standing medical problems.

Based in New Brunswick, N.J., the company recalled about 93,000 ASR artificial hips in 2010 after they were tied to higher-than-expected failure rates. Last week, the company disclosed that federal officials are investigating the marketing of these hip replacements, a lucrative business as baby boomers age and their joints give out. The company said it is cooperating fully with the government inquiry.

The closely watched trial began Jan. 25, and it’s the first of several thousand suits to reach trial nationwide about this all-metal hip, introduced in 2005 by DePuy, the orthopedic division of J&J. The outcome of this case could portend what the financial fallout will be for J&J. Last year, the company took a $3-billion charge to cover costs related to the ASR hip recall, legal expenses and other related items.

The case went to the jury Thursday and deliberations are expected to begin Friday.

In closing arguments, Kransky’s attorneys portrayed J&J’s DePuy business as a “ruthless competitor” that repeatedly put profit ahead of patients.

Panish implored jurors to send a message to the company’s top executives that they couldn’t easily dismiss. He suggested that jurors award Kransky $5 million for his pain and suffering and up to $179 million in punitive damages against the company.

“All they care about is the money,” Panish said. “They aren’t looking at patients. They’re looking at balance sheets.”

The plaintiff’s attorneys showed jurors photos of Kransky smiling with his children and grandchildren before his hip surgery and then subsequent photos of him in drab hospital gowns while he battled severe medical problems.

Panish then displayed charts showing a 44% ASR hip failure rate among Australian patients who had the implant seven years. He also cited an internal DePuy analysis from 2011, a year after the recall, that estimated that 37% of patients who received the ASR hip implant may need to have it replaced within five years.

At trial, Kransky testified he was in constant pain, had difficulty walking and thought debris from the metal device was poisoning him. In the courtroom Thursday, Kransky sat just behind a row of attorneys in a charcoal gray suit and silver tie. He was surrounded by his wife, Sheryl, and other family members.

A few steps away, Michael Zellers, an attorney for J&J’s DePuy unit, urged jurors to focus solely on what caused Kransky’s injuries.

“The evidence is clear,” he told the jury. “Mr. Kransky’s injuries were not caused by a defect in the ASR XL hip or any conduct of DePuy.”

Zellers said the company had done extensive testing of the product before its launch and while it was on the market. Even with that, he said, debris from normal wear and tear on an implant is expected, as are a certain number of revisions, or replacement surgeries, to fix the original device. “There is no perfect hip design,” Zellers said.

Zellers told jurors that the company initiated the voluntary hip recall in 2010 because the product wasn’t meeting its performance standards. He said that action showed it “put patients above money.”

In Kransky’s case, Zellers said that the Montana retiree had an infected hip unrelated to his implant and that pain caused him to need a second surgery. “Mr. Kransky was not being poisoned,” Zellers said.

All-metal hips accounted for an estimated 40% of all U.S. hip replacements in 2008. But since then, they have fallen out of favor as concerns grew about their effectiveness and safety.

In an interview, Lisa McGiffert, director of Consumers Union‘s Safe Patient Project, said the ASR device and other metal hips have been used in an estimated 750,000 patients nationwide and many of those people have suffered serious medical problems as a result.

“These metal-on-metal hips are the poster child for what’s wrong with the way medical devices are brought onto the market,” McGiffert said. “The failure and complication rate from these hips was significantly higher than other hip replacements.”

Overall, product safety issues have become a major headache in recent years for J&J, long admired by consumers as a trusted medical name. The company has issued more than 30 product recalls since 2009.

Many of the recalls have involved common medications such as children’s Tylenol. The U.S. Food and Drug Administration put the company’s manufacturing practices under tighter scrutiny as a result.

These miscues haven’t damped investor enthusiasm for the company. Shares of J&J are trading near a 52-week high and were down just 21 cents Thursday at $76.11.

Jeff Jonas, a portfolio manager at Gamco Investors in New York and a J&J shareholder, said there was some concern about the amount of litigation against the company and the potential damage awards from juries. But he said investors remained confident J&J could weather the legal storm.

“It’s something that the company can easily afford,” Jonas said. “They appeal these cases and drag them out for years and years.”

Superior Court Judge J. Stephen Czuleger ruled against a defense motion for a mistrial Thursday after Kransky’s attorney mentioned the thousands of other patients who are suing J&J’s DePuy unit when asking jurors to award punitive damages.

chad.terhune@latimes.com

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues (bloomberg.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
Johnson & Johnson Plaintiff: Profit Motive Led to Defective Hip Implant (counselheal.com)
J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, Johnson, Johnson & Johnson, latimes.com, Lawyer, Medicine, Metal on metal hip, Plaintiff, Smith & Nephew, UNited States

Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say

Allison — Wed, 27 Feb 2013 15:36:04 +0000

The metal debris Johnson & Johnson (J&J)’s DePuy ASR hip implant shed into a man’s bloodstream and tissue is harmless, a toxicologist claimed in the first of 10,000 lawsuits that allege J&J defectively designed the device. Dennis J. Paustenbach – a researcher paid by J&J – told jurors on J&J’s behalf that the cobalt and chromium from the implant did not cause or worsen plaintiff Loren Kransky’s health problems, and that his chromium levels were “basically of no health risk.”

J&J’s lawyers claim Kransky already has diseased blood vessels in his body, and that the elevated metal levels in Kransky’s body can be traced to diabetes, high blood pressure and cholesterol, stroke and kidney cancer instead of hip replacement failure, a Bloomberg article reported.

J&J recalled the ASR hip in August 2010 after 12 percent of the devices had failed. That number has since climbed to 40 percent in Australia.

Paustenbach was part of a team of researchers who claim they were unable to find previously published medical literature on the effects of cobalt on the body. The research conducted by the firm ChemRisk Inc. – which been retained in the past by companies accused of being responsible for chromium pollution – has cost J&J’s DePuy unit at least $5 million over the past 18 months. Paustenbach also claimed they found no evidence of an increased cancer risk associated with the device, and that cobalt is “not an issue to be concerned about at concentrations observed in patients with implants.”

Paustenbach cited several different studies to support his claims, including 1950s research of anemia patients given cobalt doses. “In the blood, we found that there were virtually no adverse effects in the people who had levels up to 300 parts per billion,” while Kransky’s highest cobalt reading was 57 parts per billion. He also cited an unpublished study of ten people who received cobalt doses for 30 days with no adverse effects (although the men’s blood levels reached 32 parts per billion and the women reached 91 parts per billion).

Kransky’s attorney read a list of dozens of corporations by which Paustenbach was paid to conduct research; his work has been used on numerous occasions to undermine carcinogen exposure concerns involving materials such as asbestos. When asked if he was referred to as the “go-to guy for industry,” Paustenbach reacted angrily and then acknowledged he had been described that way.

Paustenbach was also questioned extensively about ChemRisk’s Journal of Occupational and Environmental Medicine article that reversed a study that found a significant association between chromium in drinking water and high rates of cancer in certain regions of China. The journal retracted the article in 2006 for failing to disclose that it was written by his company.

Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (bloomberg.com)
DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance (earlsview.com)
DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)

Filed under: DePuy ASR Hip, DePuy Hip Litigation, DePuy Hip Recall, DePuy Hip Replacement Recall, DePuy Lawsuit, Hip Replacement, Johnson & Johnson, Johnson & Johnson lawsuit, Metal ions Tagged: Australia, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Journal of Occupational and Environmental Medicine, Kransky, Loren Kransky, metal-on-metal hips, metallosis, Paustenbach

Earl's View » FDA

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice.

Inspiration and disappointment

What’s the hurry?

The FDA’s unintended loopholes

The FDA’s failure to respond to recalls

Learning from the FAA and the NTSB

Hauser’s National Drug & Device Safety Board

Related articles

VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com

VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

Related articles

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

FDA Safety Communication: Metal-on-Metal Hip Implants

Audience:

Device:

Summary of Problem and Scope:

Recommendations for Orthopaedic Surgeons:

Before Surgery

Patient Follow-Up

Imaging

Assessing Metal Ion Levels

Device Revision

Recommendations for Health Care Providers:

Recommendations for Patients Considering Hip Implants:

Recommendations for Patients with Metal-on-Metal Hip Implants:

FDA Activities:

Other Resources:

Reporting Problems to the FDA:

Contact Information:

Related articles

DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

Trial plaintiff says J&J hips defective, company says not liable

Related articles

Oh Really … Why am I not believing you?…. Hip Replacement Device – NYTimes.com

Oh Really Mr DePuy – are we as stupid as you look?

Re “What a Company Knew About Its Metal Hips” (editorial, Feb. 11):

Related articles

FDA cracks down on all-metal hip replacements

FDA cracks down on all-metal hip replacements

Related articles

Open Letter – Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

Surgeon-industry COI and the CME content of AAOS 2013 addressing MoM hip complications.

Related articles

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg

J&J Profit Pursuit Led to Defective Hip, Lawyer Argues

Injury Causation

Hip Infection

Metal Cup

Panish said the ASR was “unsafe at any angle.”

Implant Angle

Related articles

J&J gambled on hip implant safety, lawyer alleges – latimes.com

J&J gambled on hip implant safety, lawyer alleges

Johnson & Johnson ‘knew this hip was defective’ but failed to warn patients, a plaintiff‘s attorney says. The company said it acted properly and ‘put patients above money.’

Related articles

Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say

Related articles