Tuesday, April 30, 2013

DePuy wins FDA supplemental approval for ceramic hip implant

Mass Device

April 26, 2013 by Arezu Sarvestani

Johnson & Johnson subsidiary DePuy Orthopaedics won supplemental FDA approval for a new size of its Ceramax ceramic-on-ceramic artificial hip replacement system.
 
DePuy's Ceramax hip implant
The FDA this month granted supplemental approval to Johnson & Johnson (NYSE:JNJ) and its DePuy Orthopaedics subsidiary for a new size of the Ceramax ceramic-on-ceramic hip implant.
Originally approved in December 2010, Ceramax is indicated for non-cemented use in adult patients undergoing total hip replacement. The implant contains some metal components, but is a break from the metal-on-metal hip implants that have mired the company in lawsuits and headlines since a recall in 2010.

The Ceramax implant features a metal hip stem, a ceramic femoral head, a metal acetabular shell and a ceramic insert that fits into the acetabular shell, according to the FDA approval notice. "The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move," the notice reads.

The latest supplemental PMA was submitted to include a new 36 mm ceramic femoral head and related components, according to the FDA safety & effectiveness summary.
 
"The clinical data in this application support the reasonable assurance of safety and effectiveness of the 36mm DePuy Ceramax Ceramic Total Hip System when used in accordance with the indications for use and indicated population," the FDA reported. "Therefore, CDRH believes that it is reasonable to conclude that the benefits of the use of the 36mm DePuy Ceramax Ceramic Total Hip System for the target population outweighs the risk of surgery when used in accordance with the directions for use."

In a patient guide published alongside the approval summary DePuy describes the Ceramax implant and its potential benefit over hips made of other materials, including the metal-on-metal, or MoM, implants that have been the focus of thousands of lawsuits nationwide and around the world.
"While there is no conclusive evidence that supports the benefits to patients of the DePuy Ceramax Ceramic Total Hip System over other artificial hips," according to the patient guide. "There are concerns with reports of serious adverse reactions in patients having Metal-on-Metal artificial hips. These adverse reactions are believed to be caused by the metal particles and/or metal ions coming from the metal bearing components."

In connection with the FDA's premarket approval order, DePuy agreed to a 10-year follow-up post-approval study of 80 patients implanted with the 36 mm Ceramax device. DePuy further agreed to perform a single-arm post-approval study of 170 patients with follow-up at 6 weeks and every year for 5 years. The medical device maker lastly agreed to gather short, medium, and long-term data on Ceramax patients from the U.K. National Joint Registry and the Australia Orthopaedic Assn. NJRR, with 10-year post-op follow-up for all patients, according to the FDA approval letter.

DePuy and J&J are currently battling a slew of MoM hip implant personal injury lawsuits as well as a highly subscribed multi-district lawsuit proceeding in Ohio. The 1st bellwether trials in th DePuy MDL are slated to begin in June, having been postponed from their previous May 13 date.

Earlier this month DePuy filed for appeal of a jury decision charging the company with negligence in designing the ASR XL MoM implant, awarding the plaintiff in that case $8.3 million in damages.
Lawsuits against DePuy began piling up in June 2010 when a a Florida woman accused the company of knowing about the devices' problems but failing to warn physicians. That suit was followed days later by 3 more from California residents who all had to have revision surgery after the implant partially detached from their hip sockets.

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

Ten-Year Outcome of Serum Metal Ion Levels After Primary Total Hip Arthroplasty: A Concise Follow-up of a Previous Report*.

2013 Mar 20;95(6):512-8. doi: 10.2106/JBJS.L.00471.

 

Source

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

Abstract

We previously reported on the metal ion concentrations of cobalt, chromium, and titanium that were found in the serum of patients three years after they had undergone primary total hip arthroplasty as compared with the concentrations found in the serum of control patients who did not have an implant. This study is a concise update on the serum metal levels found in a cohort of these patients ten years after the time of hip implantation. Of the original seventy-five subjects, metal ion levels were available for forty patients (53%). Ten patients (hybrid group) had received a hybrid total hip replacement that consisted of a modular cobalt-alloy femoral stem with a cobalt-alloy femoral head that had been inserted with cement and a titanium acetabular socket that had been inserted without cement. Nine patients (cobalt-chromium [CoCr] group) had received an implant with an extensively porous-coated modular cobalt-alloy femoral stem and femoral head along with a titanium acetabular socket; the femoral and acetabular components had each been inserted without cement. Eight patients (titanium group) had undergone insertion of a proximally porous-coated modular titanium-alloy femoral stem with a cobalt-alloy femoral head and a titanium acetabular socket; the femoral and acetabular components had each been inserted without cement. Thirteen patients (control group) from the original control group of patients who had not received an implant served as control subjects. Serum metal levels were measured with use of high-resolution sector field inductively coupled plasma mass spectrometry. The hybrid total hip arthroplasty group had mean cobalt levels that were 3.2 times higher at 120 months than they were at baseline, and the cobalt levels in that group were significantly higher than those in the titanium total hip arthroplasty group at thirty-six, sixty, eighty-four, ninety-six, and 120 months (p < 0.01). The hybrid group had mean chromium levels that were 3.9 times higher at 120 months than they were at baseline, and the CoCr total hip arthroplasty group had chromium levels that were 3.6 times higher at 120 months than they were at baseline. The serum titanium levels were higher in the titanium group at all follow-up time intervals as compared with the levels in all other groups, and the level in the titanium group at 120 months was eighteen times higher than it was at baseline (p < 0.01). Patients with well-functioning primary metal-on-polyethylene total hip replacements had elevated serum metal levels for as many as ten years postoperatively. Furthermore, metal release at the modular femoral head-neck junctions, rather than passive dissolution from porous ingrowth surfaces, was likely the dominant source of serum cobalt and chromium. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Sunday, April 28, 2013

Metal-on-metal pseudotumour

Radiopaedia

metal-on-metal pseudotumour is a mass-forming tissue reaction around a metal-on-metal hip (or knee) replacement.

Clinical presenation

Metal-on-metal pseudotumours are large focal solid or semiliquid masses around the hip (or knee) prostheses. The pseudotumours mimick local effects of neoplasia or infection in the absence of either of these. The principal symptom is pain. There may be restricted range of movement with large pseudotumours.

Epidemiology

Incidence of symptomatic pseudotumours following metal-on-metal hip arthroplasty is in the region of 5%.
Patients with bilateral resurfacing THR who develop a pseudotumour in one hip have a 1 in 3 chance of having a lesion on the contralateral side.
Pseudotumours are more common in females.

Pathology

The pathophysiology is poorly understood. Metal-on-meta; pseudtumours are sterile inflammatory lesions, also termed ‘aseptic lymphocyte-dominated vascular-associated lesions’
Excessive wear is considered the initiating process, leading to the release of particles (nanometer sized). These are cytotoxic to macrophages once phagozytised, therefore leading to necrosis within the lesions.
Reactive masses are related to high serum and joint fluid ion levels, and a delayed typoe IV hypersensitivity reaction has been implied.

Radiographic features

Ultrasound
Sonographic features are non specific but may show
  • mass of heterogenous echogenicity 
  • without internal power or colour Doppler signal 
  • fluid components
MRI
Posterolateral lesions
  • located at posterolateral aspect of the joint, often in continuity with the greater trochanter
  • typically cystic in nature
  • frequently with layering of contents, and a low signal intensity wall
  • foci of susceptibility artifact due to metal content 
  • representing extension through posterior capsular defects (typical surgical approach in hip arthroplasty)
 Anterior lesions 
  • less common
  • typically involving the iliopsoas bursa
  • solid components are more likely
  • typical: Contiguous with the joint capsule (representing distension of the iliopsoas bursa)

Differential diagnosis

Imaging differential diagnosis in MRI
There are two important diagnostic alternatives
 Infection
  • less well defined than pseudotumours
  • lack of a low signal intensity rim
Soft-tissue oedema can be seen with both infection or pseudotumor. Extensive perifascial fluid is more suggestive of infection
Abductor tendon avulsion-associated fluid collections
  • pure fluid signal
  • lack of a low signal intensity rim
  • typical: location at the site of abductor avulsion
Pseudotumours can coexist with abductor tendon avulsion following hip arthroplasty

Saturday, April 27, 2013

DePuy ASR Hip Replacement Lawsuit Update: Bernstein Liebhard LLP Notes Rescheduling of First Trial in Federal DePuy ASR Hip Recall Litigation

Bernstein Liebhard LLP notes that the first trial of thousands of DePuy ASR hip replacement lawsuits in Ohio federal court has been rescheduled for June 3, 2013. According to an Order dated April 19th, a final pretrial meeting will be held on May 14th, and jury selection is to begin on May 30th. Court documents indicate that some 10,750 lawsuits stemming from the DePuy ASR hip recall have been filed in courts throughout the country. Three-quarters of those claims are pending in the multidistrict litigation underway in U.S. District Court, Northern District of Ohio. (In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197)

Friday, April 26, 2013

Legal: DePuy aims to reverse $8.3M metal hip implant loss

Mass Device

April 22, 2013 by Arezu Sarvestani

Johnson & Johnson subsidiary DePuy Orthopaedics asks a California judge to stay an $8.3 million jury decision against the company while attorneys file an appeal.

Orthopaedics subsidiary are hoping to dodge an $8.3 million judgment stemming from the company's 1st metal-on-metal hip implant complaint to go to trial.
DePuy last week asked the Los Angeles Superior Court to put a hold on the jury's decision in a trial brought by patient Loren Kransky, who claimed his ASR hip failed less than 5 years after he received it.
In March the California jury ruled against J&J and DePuy, finding that the company's ASR XL metal-on-metal hip implant was defectively designed. The jury ruled that the companies were negligent and ordered J&J to pay $8.3 million in damages.

 

DePuy asked the court for a stay on the final judgment to allow the company to file an appeal without bond. The company had issued a statement following the March jury decision, promising to file the appeal.

Wednesday, April 24, 2013

Legal Rights in Question with FDA Action on Metal Hips

Take Justice Back


Taxpayers and patients could pay the price for faulty metal-on-metal hips when the U.S. Food and Drug Administration (FDA) reclassifies several metal-on-metal hips, requiring manufacturers to complete a premarket approval application (PMA) or product development protocol (PDP) in order to receive the agency’s approval.  The reclassification may put patients’ legal rights in question.

In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that patients harmed by medical devices approved by the FDA’s PMA process cannot sue the manufacturer for injuries because the FDA gave the product the agency’s stamp of approval.  Since then, thousands of medical device product liability cases have been dismissed or never brought before a court (Smith and Nephew and Stryker hips, St. Jude cardiac defibrillators, Boston Scientific spinal cord stimulators, Essure birth control), simply because the FDA used the PMA process to approve a device.  The Riegel rationale applies even when a product has been withdrawn from the market for safety, as in Medtronic’s Sprint Fidelis leads.

Metal-on-metal hips have cost thousands of consumers’ needless pain and suffering. The FDA’s goal should be to protect the consumer from unsafe medical devices, not further harm those who have suffered.  We know when an injured patient cannot hold the manufacturer responsible for harm, it is insurance, Medicare, Medicaid, and patients who pay the financial price for an unsafe device and the necessary medical care.  Reclassifying metal hips for added safety cannot be allowed to result in negative financial consequences just because the government determined the device needed additional testing.

Monday, April 22, 2013

Trial News: DePuy Hip Implant Patient Likely Hypersensitive, Jury Hears [Normal wear on the explant was claimed)

Depuy argued it was Carol Strum's individual biology not its product that made her revision  surgery necessary.

This post is interesting because it reviews the reason the jury came to  the conclusion it did.  I was curious as to what happened in the first trial that was missing in the second one.  This review by a Chicago law firm provides that information. 


DePuy Hip Implant Patient Likely Hypersensitive, Jury Hears

by Peter J. Flowers who is  a partner in the Chicago law firm of Meyers & Flowers

 Chicago (April 11, 2013, 5:38 PM ET) -- An orthopedic surgeon testified Thursday at a trial over Johnson& Johnson subsidiary DePuy Inc.'s ASR XL metal hip that he believed the plaintiff had developed a hypersensitivity to a normal amount of debris from the device, and that he found no evidence in her implant of excessive wear.




 
   
DePuy has argued, meanwhile, that it was Strum's individual biology and health issues, not its product, that made her revisionary surgery necessary.

Cuckler told jurors Thursday that he had found no evidence of excessive or abnormal wear on Strum's implant, and that during his review of that device and Strum's own medical information, he had also not found any evidence that excessive wear had caused Strum to need a revision surgery.

He testified that he believed Strum had developed a hypersensitivity that caused her body to overreact to a normal amount of wear debris from device, and that Strum's reports that she has experienced a slower recovery and continuous pain since her ASR XL was replaced with another metal-on-meta hip were typical of a hypersensitivity reaction.

Strum is likely someone who just does not react well to a normal amount of metal wear debris, Cuckler testified, telling jurors, "The design has nothing to do with this."


 
 Cuckler also said that younger, more active patients who receive hip implants are more likely to need revision surgeries later.

Strum received her implant before age 50, which placed her in a higher-risk group for needing a revision surgery, Cuckler confirmed when questioned by DePuy attorney Richard Sarver of Barrasso Usdin Kupperman Freeman & Sarver LLC.

On cross-examination by Peter Flowers of Meyers & Flowers LLC, Cuckler said he did not believe that the ASR hip replacement system, which DePuy recalled in 2010, was defective and said it should still be implanted in human beings today.

The trial began in mid-March and is steadily heading toward closing arguments.

On March 8, a Los Angeles jury hit DePuy with an $8.3 million verdict at the first trial over the ASR devices but declined to award punitive damages, which Strum is seeking in her case.

DePuy voluntarily recalled its ASR hip system in August 2010 after receiving data from a registry for England and Wales that indicated a jump in revision rates for the devices.

Strum is represented by Denman Heard of Heard Robins Cloud & Black LLP, Herbert Orlandah Phillips IV of Phillips Law Office PLLC, Douglass A. Kreiss of Aylstock Witkin Kreis & Overholtz PLLC, and Peter J. Flowers of Meyers & Flowers LLC.

DePuy is represented by Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver LLC, Michael Conner of Barnes & Thornburg LLP, David Sudzus of Drinker Biddle & Reath LLP and Sanford Watson of Tucker Ellis LLP.

The case is Carol Strum v. DePuy Orthopaedics Inc. et al., case number 2011-L-009352, in the Circuit Court of Cook County in Illinois.

xxxx

Gee, if all of this is factual, I think a few points should be emphasized:

1) Make sure you document everything about that revision.
2) Make sure you surgeon saves the debris!!!  Mine didn't and he said he didn't because I didn't ask him to prior to the surgery.
3) Make sure the company who reviews your explant has done many of these  exams before and has the right equipment to testify on the wear issues of your explant. (Shocking to me that someone would go to court with a hip that has no evidence of wear!  Yikes!)
4) Get a consulting surgeon to reaffirm the specific  need for the surgery.  
5) Get all of the right MRI protocols to document the tissue damage/bone damage etc  which can't really be done properly by most MRIs (you need the MAVRIK protocol used especially for the tissue damage.)  
6) If you are going to sue someone, best to have evidence for  the need for the revision and it better be iron clad with world class experts verifying the need for the revision.

Given there are no standards that would lead a surgeon to say..."this fits the revision rule", you as a patient better darn well do your homework to ensure that the revision must be done, especially if you are asymptomatic (from outwardly visible symptoms.  Examples of evidence:  very high Cr and Co levels, MRIs that document tissue damage, etc... and post explant, get that explant viewed by expert labs in looking at hip explants.  Ask them how many of these they have done over what period of time.)

I am flabbergasted that she lost this case based on the defense testifying that the plaintiff had no excessive wear from the device and that in fact, she was just hypersensitive to a normal amount of debris shedding.  It sounds to me as though the plaintiff group was ..................ill prepared perhaps?

hey/what do I know?

Connie

Sunday, April 21, 2013

An ebay for medical devices?

Mass Device

 

April 18, 2013 by Brian Johnson

Novation spinout Aptitude launches an online medical device marketplace for hospitals, aiming to streamline the sales process and amass data on medtech sales trends and market shares.
 
Novation aptitude

Is it a game-changer, or "game over" for the medical device industry's business model?
Aptitude LLC, an online marketplace aimed at streamlining the hospital purchasing process by connecting medical device suppliers with their counterparts in the hospital industry, is set to launch early next week at the IDN Summit in Orlando.

The web portal, created as a wholly owned subsidiary of Irving, TX.-based group purchasing organization Novation, is billed as the "industry's first online direct contracting market."

"The way I would describe it is that Aptitude is very much like ebay, which provides a marketplace where buyers and sellers can come together," Aptitude general manager Troy Kirchenbauer told MassDevice.com. "You have pre-defined buyer and seller entities in the market and the market is infused with data that's provided by the participating hospitals."

 

Kirchenbauer, who's held executive positions at Novation since 2001, said Aptitude is the result of a substantial investment the GPO made 2 years ago to re-engineer the way hospitals and medical device suppliers do business. The goal is to lower the cost and time associated with purchasing medical equipment.

"We've really spent the last couple of years looking at market models and trying to find alternative ways to bring buyers and sellers together in healthcare, which would reduce the cost of brokering those relationships and create incremental benefit for both the buyer and the seller, to help alleviate the challenges they experience today in the market," Kirchenbauer explained.

Unlike a typical e-sourcing application, Aptitude is built on a foundation of data that Kirchenbauer said will make the contracting process more transparent.

"Hospitals are providing monthly feeds of all of their purchasing information at the invoice level to Aptitude. That serves as the basis for the market, not only to facilitate brokering between the buyers and the sellers but to manage the performance of those agreements on behalf of buyer and seller," he explained.

Here's how it works: Hospital sourcing and purchasing managers put out requests for bids on specific product categories, such as blood pressure cuffs or endotrachial tubes and other devices.

"They can see who the players are in the market. They can see how they already work with those players, what the current spend is and, in a couple of seconds, submit an RFP that would likely take a month for them to build today on their own," Kirchenbauer told us.

Medical device companies that sign up with the service will receive the information and then be able to respond quickly to those RFPs directly. And participating medtech makers will receive "unparalleled transparency on that buyer's profile," Kirchenbauer added.

"[Medical device companies] can understand their current market share position, the total category potential of the buyer and see line-item information and use automation to respond to cross-reference request," he said. "From there, the seller provides a fairly structured pricing response, with many potential options for the buyer to consider, and they can do that in a way where they can visualize how the buyer will compete with current pricing today."

Medical device companies will have to pay a subscription fee to be a part of the service, plus transaction fees paid to Aptitude. But Kirchenbauer said the business model differs from the GPO model because Aptitude does not actively negotiate on behalf of the purchasing hospital.
Aptitude's senior director of marketing & research, Justin Hibbs, said the portal isn't designed to eliminate medical device sales reps or remove physician's influence in purchasing decisions.
"We don't want to eliminate the human aspect of [selling medical devices]. We want to facilitate the process to make it more efficient and make it a more logical approach," Hibbs told us.

Medical device companies involved in the recently concluded pilot project have been excited by a new level of access to data on their potential clients, he said. In particular, device companies will be able to see market share data on a hospital-to-hospital basis, hospital purchasing patterns and the total spend on particular device categories.

Aptitude is slated to launch April 21 with 20 product categories and 20 suppliers, with a goal of 75 product categories and 70 suppliers by the end of the year, Hibbs said.

Friday, April 19, 2013

Which Factors Determine the Wear Rate of Large-Diameter Metal-on-Metal Hip Replacements?: Multivariate Analysis of Two Hundred and Seventy-six Components



A.J. Hart, MA, MD, FRCSG(Orth)1; S. Muirhead-Allwood, FRCS(Orth)2; M. Porter, FRCS(Orth)3; A. Matthies, BSc, MBBS1; K. Ilo, BSc, MBBS1; P. Maggiore, BSc, MBBS1; R. Underwood, PhD4; P. Cann, PhD4; J. Cobb, FRCS(Orth)1; J.A. Skinner, FRCS(Orth)2
1 Department of Musculoskeletal Surgery, Imperial College (Charing Cross Hospital Campus), Fulham Palace Road, London SW7 2AZ, UK. E-mail address for A.J. Hart: a.hart@imperial.ac.uk
2 Royal National Orthopaedic Hospital, Brockley Hill, Stanmore, Middlesex HA7 4LP, UK
3 Wrightington Hospital, Hall Lane, Wigan, Lancashire WN6 9EP, UK
4 Department of Mechanical Engineering, Imperial College London, South Kensington Campus, London SW7 2AZ, UK
 

Abstract

Background:  Determining the relationship between clinical factors and engineering analysis of retrieved hip implants can help our understanding of the mechanism of device failure. This is particularly important for metal-on-metal hip arthroplasties because the most common cause of failure is unexplained. We sought to understand the variation in wear rates in a large series of retrieved metal-on-metal hip arthroplasty components.
Methods:  We prospectively recorded preoperative, intraoperative, and postoperative data to study the effect on both head and cup wear rates of the following variables: patient sex, cause of failure, manufacturer type, resurfacing or modular design, blood cobalt and chromium levels, edge-loading, femoral head size, and cup inclination angle. We analyzed 276 components (138 femoral head and acetabular cup couples) retrieved from failed metal-on-metal hip replacements.
Results:  We found a high rate of edge-loading (64%), but only forty-three (31%) of 138 hips had a cup inclination angle of >55°. Multivariate analysis showed that the most important factor responsible for the variation in wear rate was the presence or absence of edge-loading, even when adjusted for cup inclination angle. Strong positive correlations were found between acetabular cup and femoral head wear rates and between wear rates and both blood cobalt and chromium ion levels.
Conclusions:  Multivariate analysis of nine factors found that edge-loading was the most important predictor of wear rate and occurred in two-thirds of failed metal-on-metal hip replacements. The majority did not have excessive cup inclination angles: 68% had an inclination angle of ≤55°. This finding, together with the relatively low median wear rate of the components in our study, suggests that cup position and/or wear rate may not be the only outcome related to failure of metal-on-metal hip replacements.

Businessman, 59, ordered to drop his pants by airport staff to prove he had a hip replacement that set off metal detec

UK
Mail OnLine

  • Nigel Lloyd-Jones was asked to lower his underwear in front of two guards
  • Security workers wanted proof of hip replacement surgery scars
  • He warned staff his metal hip might set off detectors but was still taken aside
By Emily Davies
|
A businessman who was forced to remove his underwear by airport staff to prove he had hip replacement surgery has described the treatment as 'prehistoric'.
Nigel Lloyd-Jones informed security officers at Birmingham Airport that his metal replacement hip was likely to set off metal detectors as he prepared to board a flight to Germany.
But despite this Mr Lloyd, who was flying to visit a client on April 9, was taken to a room with two officers and asked to lower his trousers and his underpants so they could see the scar.
Nigel Lloyd-Jones from Cheltenham described security measures at Birmingham Airport as 'prehistoric' when he was asked to drop his pants to show a surgery scar
Nigel Lloyd-Jones from Cheltenham described security measures at Birmingham Airport as 'prehistoric' when he was asked to drop his pants to show a surgery scar
 
The 59-year-old, who runs a live events company, has taken 64 flights since his hip operation in November 2011 after a motorbike accident.
This was the first time he had been asked to show his surgery scar.
 
‘It was clearly very uncomfortable for the security guards and very uncomfortable for me,’ said Mr Lloyd, who moved to Cheltenham five years ago.
‘The thought of my 86-year-old mother or my 76-year-old aunt to be put through such an indignity beggars belief.
'No-one seems to be able to tell me why this now has to be a requirement when we have bodyscanners and other state-of-the-art screening technology.
‘It's clearly come from a very senior level. What does it say about their faith in the technology?
Mr Lloyd-Jones said Birmingham Airport told him their security policy which involved him having to reveal surgery scars had been implemented in recent weeks
Mr Lloyd-Jones said Birmingham Airport told him their security policy which involved him having to reveal surgery scars had been implemented in recent weeks
 
He added: ‘According to Birmingham Airport security this has only been implemented in the last three to four weeks and has been imposed after an external security review by representatives of the Department of Transport.

‘I would like to see these new surgery scar procedures published, so those who have gone through such operations can make up their own minds on whether they wish to travel via Birmingham.’

A spokesman for Birmingham Airport said: ‘Security is paramount at Birmingham Airport and all necessary security measures are implemented as and when required.
‘On occasion it can become necessary for security officers to conduct additional search procedures.

‘This can include a private search or a body scanner search.
‘Private searches are conducted by two security officers, of the same gender as the passenger, and every effort is made to undertake this procedure as sensitively as possible


Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants

Wall Street Journal
April 18th 2013

WASHINGTON, April 18, 2013 /PRNewswire-USNewswire/ -- Consumers Union urged the U.S. Food and Drug Administration today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency's premarket approval (PMA) process to prove that the devices are safe and effective.

In a comment letter to the FDA signed by more than 11,000 consumers, Consumers Union called on the agency to re-classify all high risk implantable medical devices under the PMA process so clinical evidence will be required to show their effectiveness and safety before the devices can be sold.

"Thousands of patients have been seriously injured by faulty metal on metal hip implants and other medical devices that were never properly tested before being cleared for sale," said Lisa McGiffert, Director of Consumers Union's Safe Patient Project (www.safePatientProject.org). "It's time to stop experimenting on patients and require more rigorous safety testing of all high risk implants to prevent flawed medical devices from reaching the market."

A copy of Consumers Union's letter to the FDA follows:

April 18, 2013

Food and Drug Administration

Docket No. FDA-2011-N-0661

To Whom It May Concern:

Consumers Union and the more than 11,000 people signing this letter due to their concern about high-risk implants are in full support of the FDA proposal (Docket No. FDA-2011-N-0661) to require all metal on metal (MoM) hips to be reviewed through the agency's premarket approval (PMA) process. It is too late for thousands of people who have been harmed by these implants that were cleared for market through a loophole in the law that allowed them to be sold without thorough review by the FDA to assure safety, even though they were classified as "high risk."

We also strongly support the proposal's requirement for makers of hip implants in this category that are already on the market to provide critical safety information to the agency within 90 days. However, it is troublesome that MoM hips can continue to be commercially distributed up to 90 days after the FDA order.

This order will finally require manufacturers to demonstrate clinical testing for safety and effectiveness before approval of new metal on metal hips. But at this time we are skeptical that any metal on metal hip implant could be safe for patients. Because of that, we urge the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market, because of the high failure rates and high numbers of adverse events, especially experienced by women.

While the FDA has issued an alert about possible adverse events to the public, this does not guarantee that all affected patients have been given advice on monitoring their metal hips for problems. As was done in the UK, all patients with these implants should be notified about their risks and advised to get yearly tests for cobalt poisoning. Unless the FDA confirms that each manufacturer has done due diligence to notify every patient with these MoM hips, the problem has not been properly addressed.

The New York Times recently reported that a MoM hip sold by Johnson and Johnson had a 40% failure rate but the company continued to sell the remainder of their inventory, despite the knowledge of the failure rate. This kind of irresponsible behavior must stop. Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market.

In addition, we strongly encourage the FDA to review and re-classify to PMA status all Class III implantable medical devices. Other high risk implanted medical devices like surgical mesh should also be put into the PMA approval track, requiring more clinical information. Patients suffering from harm due to surgical mesh implants have reported debilitating side effects from punctured organs to autoimmune disorders. Many have undergone multiple surgeries to remove the mesh, which has broken apart and traveled to other parts of the body.

Please move quickly to bring metal on metal hips and all other high risk implants under the PMA process so clinical evidence will be required to show their effectiveness and safety.

Sincerely,

Lisa McGiffert

Consumers Union Safe Patient Project

506 West 14th Street Suite A

Austin TX 78701

lmcgiffert@consumer.org

SOURCE Consumers Union

Wednesday, April 17, 2013

J.&J. Prevails in Defending Its Marketing of Hip Device

New York Times

By BARRY MEIER Published: April 16, 2013

A jury in Chicago rejected claims on Tuesday that the orthopedics unit of Johnson & Johnson inappropriately marketed an artificial hip, which the company recalled in 2010.
The verdict came in the second trial of some 10,000 pending lawsuits involving the all-metal device, which was known as the Articular Surface Replacement, or A.S.R. In March, a jury in Los Angeles awarded $8.3 million in the first trial of an A.S.R.-related case.
The DePuy Orthopaedics unit of Johnson & Johnson said in a statement that all its actions related to the sale, marketing and recall of the device had been appropriate.
Internal DePuy documents introduced at the trials indicated that company officials knew that the design of the A.S.R. was flawed long before they recalled the device and even considered redesigning the implant. They never shared that information with doctors and patients, those documents show.
It was not immediately clear why the two juries returned such differing verdicts.
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.

DePuy Settlement News: J&J Wins Major Verdict In Illinois Trial

Wall Street Journal

CHICAGO, April 17, 2013 /PRNewswire/ -- Legal-Bay LLC, The Lawsuit Settlement Funding Company, is reporting that Johnson & Johnson's DePuy Hip Unit scored a major verdict yesterday by not being found liable for any damages involving the much anticipated second ASR Hip case to go to trial. In the first case in Los Angeles, CA the jury awarded over $8MM to the plaintiffs. However, the jury in Illinois saw it a different way.


Legal-Bay is a plaintiff advocate firm for clients of the DePuy litigation, by providing plaintiffs with lawsuit cash advances today, prior to their cases even being settled. However, now that DePuy has won a major verdict many of the lawsuit funding firms may stop funding on DePuy, says Legal-Bay. However, Legal-Bay believes that the win for DePuy is only temporary, and they will remain funding these cases.

Patty Kirby, Head of Client Relations at Legal-Bay, commented, "We remain committed to our clients of the DePuy litigation in spite of the recent verdict in DePuy's favor. Although this may slow the litigation down a little bit, we firmly believe that these DePuy settlement values are still worth as high as $500K in some cases. We will continue to fund our ASR clients as needed; as well as assist the DePuy Pinnacle clients with funding and other services; including referring them to a national DePuy law firm if they haven't already retained counsel."

The verdicts are now evened up: one for the plaintiffs and one for the defendants in the "Bellwether Trials". The Bellwether Trials are designed to gauge the settlement ranges on the remaining 11K cases still in the system. Since each side already has a victory under its belt, there is sure to be more cases brought in front of juries to see exactly where the public's perception is as to DePuy's liability in the timing of the recall.

Legal-Bay's pre-settlement lawsuit funding program on DePuy cases offers clients a no risk transaction, where they only need to repay the advance if their case was successful. "Here is a perfect example of the risk that our industry takes on these cases. If Ms. Strum were to have taken a $50K advance with us last week, at least she would have had something to show for her lawsuit, as she would not have been obliged to repay our firm," explained Chris Janish, CEO of Legal-Bay. "We expect DePuy funding applications to rise now that many of the plaintiffs are in fear of walking away with absolutely nothing like Ms. Strum -- although we do not have this same sentiment and will continue funding DePuy cases as we have been from the beginning of the litigation."

Tuesday, April 16, 2013

The newly unveiled Health & Human Services budget proposal allocates $4.7 billion to the FDA, with more than half of that to be dedicated to medical product safety.

Mass Device
Aril 11, 2013

The 2014 budget proposal for the Dept. of Health & Human Services contains some important boosts in the FDA's coffers, including a $59 million increase the agency's medical device review arm compared with 2012.

The new budget would provide the Dept. of Health & Human Services a total of $967.3 billion in outlays and $80.1 billion in discretionary spending, and it includes initiatives that aim to save $361.1 billion over a decade.

The budget sets aside $4.7 billion for FDA's medical device, drug and biologic oversight, an increase of 21%, or $821 million, over 2012, according to the report.

Of that total, $2.6 billion is dedicated to medical product safety, including authority over medical devices, drugs and biologics.

Broken down further, the proposal allocates a total of $435 million for the FDA's medical device program, $1.29 billion for human drugs and $338 million for biologics. Those budgets are meant to be supplemented by the FDA's user fee programs through which the agency collects payment for reviewing new products.

The budget further recommends a $15 million "medical products reinspection" user fee that would put the full cost of a reinspection and associated follow-up squarely on a manufacturer should the review turn up health and safety violations.

J&J Jury Urged to Award $5 Million for Failed Metal Hip

Bloomberg
April 15th, 2013

Johnson & Johnson (JNJ)’s DePuy unit defectively designed a metal-on-metal hip implant and should award an Illinois nurse at least $5 million for harm caused by her device’s failure, her lawyer argued to a Chicago jury.

DePuy knowingly sold defective ASR hips before J&J, the world’s largest seller of health-care products, recalled all 93,000 of the metal-on-metal implants in August 2010, said Denman Heard, an attorney for Carol Strum, the plaintiff. Heard also urged jurors to award extra damages to punish the company.

“Shame on DePuy for allowing this to happen,” Heard said in his two-hour closing argument at a trial that began on March 11. “They could have saved and prevented so much harm.”

The Strum lawsuit is the second of almost 11,000 around the U.S. to go to trial. On March 8, J&J was ordered to pay $8.3 million in compensatory damages by a Los Angeles jury that found the design was defective and DePuy failed to warn of the risks.

Analysts have said the cases could cost J&J billions of dollars.

Jurors began deliberating this afternoon after being told how to apply the law to the evidence by Cook County Circuit Judge Deborah Mary Dooling.

‘Premeditated Attempt’

As in the first trial, DePuy’s lawyers today denied that the device, made of chromium and cobalt, was defective. Heard’s arguments were a “deliberate, conscious and premeditated attempt to play on your sympathy,” DePuy attorney Richard Sarver said in his closing argument.

The design of Strum’s ASR XL, which was implanted in January 2008 and replaced with a different device three years later, “had nothing to do with her bad outcome,” Sarver said. Rather, he pointed to her biology and health problems, including allergies, migraine headaches, chest and back pains, a family history of Crohn’s disease and apparent autoimmune problems.

While Strum, 54, sat at a table in the well of the courtroom beside her attorneys, her husband, Mike, watched the proceedings with the couple’s son and daughter. Addressing them directly, Heard called his client, “a courageous woman.”

“I believe that Carol Strum has earned her damages,” heard said. “And she will most assuredly earn her damages in the future with every waking moment, with every sleepless night,” he said.

Bloodstream Metals

Evidence of blackened tissue and a spike in the presence of metal ions in her bloodstream were proof that the DePuy device implanted in Strum was shedding metallic debris into her body and proof of a bad design.

“This does not just happen,” Heard said. At least one study showed 47 percent of the ASR implants failed after seven years, while another report showed a 37 percent failure rate after four years, he said.

“From the summer of 2007, they knew that this was a doomed product,” Heard said.
Still Sarver said the plaintiffs had failed to connect any problem with the ASR to the problems Strum had with it.

“The ASR XL didn’t cause Mrs. Strum’s revision,” Sarver said, using the clinical term for replacing one hip implant with another. “It just didn’t.

Strum’s natural hip failed due to arthritis while she was still in her 40s, the defense attorney said. She still suffers pain with the implant that replaced the ASR.

State Lawsuits

J&J faces more than 10,750 ASR lawsuits. About 500 are in state court in Illinois, according to another attorney for Strum, Peter J. Flowers.

About three-quarters of the total were consolidated in federal court in Toledo, Ohio. More than 2,000 are in state court in California. Others are in state courts around the U.S. The next trial is scheduled in federal court in Ohio in May.

Heard called the ASR XL, “the biggest public catastrophe of any hip implant ever put on the market” in the U.S., and “a public health disaster.”

Defending DePuy’s design efforts, Sarver’s co-counsel, Michael Conner, asked the jury to judge their product on what was known between 2001 and 2003 when it was being designed, not in 2011 after it was recalled.

“This is not a product that was developed on the back of a napkin and sold,” the attorney said.

The case is Strum v. DePuy, 2011-L-9352, Circuit Court of Cook County (Chicago).
To contact the reporters on this story: Andrew Harris in the Cook County Circuit Court in Chicago at
aharris16@bloomberg.net; David Voreacos in Newark at dvoreacos@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

THA increases physical activity level in men, women regardless of age

Healio Orthopeidics
Orthopedics Today

April 15, 2013
CHICAGO — Swiss researchers found that total hip arthroplasty increases physical activity in patients and that physical activity persists 5 years and 10 years postoperatively.
“Primary total hip arthroplasty substantially and durably improves physical activity in men and women in all age categories,” Anne Lübbeke-Wolff, MD, DSc, lead study author, stated in a presentation at the American Academy of Orthopaedic Surgeons Annual Meeting, here. “In patients less than 55 years, postoperative activity levels remained level just before [osteoarthritis] OA symptom onset.”

In her prospective cohort of THA patients recorded since 1996 from the Geneva Hip Arthroplasty Registry, Lübbeke-Wolff and colleagues found that before the onset of OA symptoms, the mean UCLA score was 6.9. The score significantly decreased preoperatively to 3.5. At 5-year follow-up, the score significantly increased to 5.7 and to 5.5 at 10 years. Obese patients’ activity levels tended to be lower over time compared to nonobese patients, she said.

Regarding active lifestyle, Lübbeke-Wolff noted that during the past decade, the proportion of people with a perceived active lifestyle who underwent total hip arthroplasty (THA) increased by 10%. She and colleagues followed the prevalence of active lifestyles in patients with a total of 2,995 THAs studied both before and after surgery. While 33% of patients were active from 2000-2003, she said in 2008-2012, that percentage increased to 47%.

Reference:
Lübbeke-Wolff A. Paper #44. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 19-23, 2013; Chicago.

Monday, April 15, 2013

DePuy ASR Recall Lawsuit Update: Rottenstein Law Group Anticipates Verdict in 2nd DePuy Hip Trial

(PRWEB) April 12, 2013
 
The jury in the nation’s second DePuy ASR trial is expected to deliberate next week in Chicago to determine if Johnson & Johnson and its subsidiary DePuy must pay plaintiff Carol Strum damages for injuries she allegedly suffered from her DePuy ASR metal-on-metal hip implant, according to court documents (In Re DePuy ASR Hip Litigation, No. 2011-L-009352, Cook County [Ill.] Circuit Court).


The Rottenstein Law Group represents clients in metal-on-metal hip lawsuits and maintains a website at http://www.depuyrecallnewscenter.com, which provides news and information on hip lawsuits and the DePuy hip implant recall.

Sunday, April 14, 2013

Poor Short Term Outcome with a Metal-On-Metal Total Hip Arthroplasty.

Destroy user interface control
    2013 Mar 25. pii: S0883-5403(13)00064-8. doi: 10.1016/j.arth.2012.10.005. [Epub ahead of print]

     

    Source

    Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla, California; Department of Molecular and Experimental Medicine, The Scripps Research Institute, La Jolla, California.

    Abstract

    Metal-on-metal (MoM) bearings for total hip arthroplasty (THA) have come under scrutiny with reports of high failure rates. Clinical outcome studies with several commercially available MoM THA bearings remain unreported. We evaluated 78 consecutive MoM THAs from a single manufacturer in 68 patients. Sixty-six received cobalt-chrome (CoCr) monoblock and 12 received modular titanium acetabular cups with internal CoCr liners. Femoral components were titanium with modular necks. At average 2.1years postoperatively, 12 THAs (15.4%) demonstrated aseptic failure (10 revisions, 2 revision recommended). All revised hips demonstrated capsular necrosis with positive histology reaction for aseptic lymphocytic vasculitis-associated lesions/adverse local tissue reactions. Prosthetic instability following revision surgery was relatively common. Female gender was a strong risk factor for failure, though smaller cups were not. Both monoblock and modular components fared poorly. Corrosion was frequently observed around the proximal and distal end of the modular femoral necks.

    Dilemmas about the toxicological consequences of metal-on-metal hip prostheses - What we do and do not know, and what we should do?

    [For those of you who have access to the direct articles, might want to have a look at this.  No Abstract in pub med for reprint.]
      2013 Apr 5. [Epub ahead of print]

       

      Source

      Department of Medicine, University of Colorado, School of Medicine and Colorado School of Public Health , Denver, CO , USA.

      Metal allergy in patients with total hip replacement: A review.

      2013 Feb 22. [Epub ahead of print]

       

      Source

      Third Department of Orthopaedics, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, Guangdong Province, China.

      Abstract

      Metal-on-metal prostheses are increasingly and widely used in total hip arthroplasty, and offer particular benefit to patients with osteoarthritis. Adverse effects related to the release of metal ions (such as cytotoxicity, genotoxicity, carcinogenicity and metal allergy) are common, however. The aims of this review article were to explore the relationship between corrosion products and implant-related hypersensitivity, define normal and toxic metal ion concentrations, and differentiate between allergy and infection in painful total hip replacement. The simultaneous presence of corrosion products and hypersensitivity-related tissue reactions indicates a relationship between the development of corrosion and implant-related hypersensitivity. There are no clear boundaries between normal and toxic metal ion concentrations. Several methods exist for the differential diagnosis of metal allergy and infection, including ultrasound-guided aspiration, patch testing and arthroscopic biopsy. More research is required to elucidate fully the relationship between metal articulations and allergy, and to determine the concentrations of metal ions that lead to harmful effects.

      Do Ion Levels in Metal-on-metal Hip Resurfacing Differ From Those in Metal-on-metal THA at Long-term Followup?

      2013 Apr 10. [Epub ahead of print]
       

       

      Source

      Laboratory for Orthopaedic Pathophysiology and Regenerative Medicine, Rizzoli Orthopaedic Institute, Via di Barbiano 1/10, 40136, Bologna, Italy, luciamaria.savarino@ior.it.

      Abstract

      BACKGROUND:

      Metal-on-metal hip resurfacing arthroplasty (MOM HR) has become an established alternative to traditional metal-on-metal total hip arthroplasty (MOM THA) for younger, more active patients. Nevertheless, concerns remain regarding wear and corrosion of the bearing surfaces and the resulting systemic metal ion distribution.

      QUESTIONS/PURPOSES:

      We therefore asked whether (1) serum ion concentrations in patients with MOM HR at the time of long-term followup were higher than concentrations in a control population with no hip implants; (2) the ion concentrations in patients with MOM HR were different from those in patients with MOM THA; and (3) sex would influence ion levels with regard to implant type.

      METHODS:

      The MOM HR and MOM THA groups consisted of 25 patients (evaluated at a minimum of 96 months) and 16 patients (evaluated at a minimum of 106 months), respectively. Forty-eight healthy donors were recruited for reference values. Cobalt, chromium, nickel, and molybdenum were measured by furnace graphite atomic absorption spectrophotometry.

      RESULTS:

      Ion concentrations of cobalt, chromium, and molybdenum in MOM HR were higher than in controls. Chromium and cobalt release were higher in MOM HR than in MOM THA. The sex-based analysis showed the difference was because women had higher concentrations in the MOM HR group than in the MOM THA group, whereas there was no difference between the men in the two groups.

      CONCLUSIONS:

      In MOM HR, high metal ion release persists for the long term. Consequently, it is important to implement strict biomonitoring for patients who have received these implants. The sustained high levels of chromium in females within the MOM HR group are concerning and merits strong consideration when choosing implants in this patient group.

      Patent activity for medical device technologies surged from 2010 to 2012, according to a Thompson Reuters report.

      Mass Device


      The medical device sector posted the strongest growth in patent activity among 12 leading sectors, making it 1 of the most innovative industries in the world, according to a Thompson Reuters report.
      The medtech sector was assigned 60,300 patents from 2010-2012, making it the 6th-most active industry of the 12 considered in Thompson Reuters' "2012 State of Innovation" report, with 8% of total patents awarded (the computer & peripherals category logged 30% of the total patent activity, according to the report, making it top dog).

      But medical devices grew the most, at a 15.7% clip, according to Thompson Reuters.

       

      The analysis also listed the top 10 U.S. assignees among medical device companies:
      Thompson Reuters State of Innovation report


      1. Covidien (NYSE:COV) [Tyco Healthcare Group]: 354
      2. GE (NYSE:GE): 334
      3. Medtronic (NYSE:MDT): 214
      4. Johnson & Johnson (NYSE:JNJ) [Ethicon Endo-Surgery]: 212
      5. Boston Scientific (NYSE:BSX): 144
      6. St. Jude Medical (NYSE:STJ): 72
      7. Johnson & Johnson (NYSE:JNJ) [Synthes]: 69
      8. Covidien (NYSE:COV) [Nellcor Puritan Bennett]: 67
      9. Abbott (NYSE:ABT) [Abbott Diabetes Care]: 59
      10. Cook Medical: 55
      And here's a look at the breakdown by device type:
      Thompson Reuters State of Innovation report

      • Diagnosis/Surgery: 34% (+21.3%)
      • Sterilizing/Syringes/Electrotherapy: 30% (+13.8%)
      • Dentistry/Bandages/Prosthesis: 19% (+15.9%)
      • Medical Aids/Oral Administration: 17% (+18.5%)

      U.S. healthcare groups taking a closer look at medical implants