Monday, July 30, 2012

Vast F.D.A. Effort Tracked E-Mails of Its Scientists

WASHINGTON — A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.
A list names three of the 21 people said to be collaborating in criticism of the F.D.A., including employees and outside contacts.

 


A memo reports that monitoring software had been placed on the laptop of an agency medical officer.

 

What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.
      
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
      
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
      
While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.
The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.
      
The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.
      
A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”
The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications.
       
With the documents from the surveillance cataloged in 66 huge directories, many Congressional staff members regarded as sympathetic to the scientists each got their own files containing all their e-mails to or from the whistle-blowers. Drafts and final copies of letters the scientists sent to Mr. Obama about their safety concerns were also included.
       
Last year, the scientists found that a few dozen of their e-mails had been intercepted by the agency. They filed a lawsuit over the issue in September, after four of the scientists had been let go, and The Washington Post first disclosed the monitoring in January. But the wide scope of the F.D.A. surveillance operation, its broad range of targets across Washington, and the huge volume of computer information that it generated were not previously known, even to some of the targets.
F.D.A. officials said that in monitoring the communication of the five scientists, their e-mails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.” While the F.D.A. memo described the Congressional officials and other “actors” as collaborating in the scientists’ effort to attract negative publicity, the F.D.A. said that those outside the agency were never targets of the surveillance operation, but were suspected of receiving confidential information.
      
While federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government.
      
Other administration officials were so concerned to learn of the F.D.A. operation that the White House Office of Management and Budget sent a governmentwide memo last month emphasizing that while the internal monitoring of employee communications was allowed, it could not be used under the law to intimidate whistle-blowers. Any monitoring must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing,” the memo said.
Although some senior F.D.A. officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation.
      
But Stephen Kohn, a lawyer who represents six scientists who are suing the agency, said he planned to go to federal court this month seeking an injunction to stop any surveillance that may be continuing against the two medical researchers among the group who are still employed there.
The scientists who have been let go say in a lawsuit that their treatment was retaliation for reporting their claims of mismanagement and safety abuses in the F.D.A.’s medical reviews.
      
Members of Congress from both parties were irate to learn that correspondence between the scientists and their own staff had been gathered and analyzed.
      
Representative Chris Van Hollen, a Maryland Democrat who has examined the agency’s medical review procedures, was listed as No. 14 on the surveillance operation’s list of targets — an “ancillary actor” in the efforts to put out negative information on the agency. (An aide to Mr. Van Hollen was No. 13.)
      
Mr. Van Hollen said on Friday after learning of his status on the list that “it is absolutely unacceptable for the F.D.A. to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies.”
       
Senator Charles E. Grassley, an Iowa Republican whose former staff member’s e-mails were cataloged in the surveillance database, said that “the F.D.A. is discouraging whistle-blowers.” He added that agency officials “have absolutely no business reading the private e-mails of their employees. They think they can be the Gestapo and do anything they want.”
      
While national security agencies have become more aggressive in monitoring employee communications, such tactics are unusual at domestic agencies that do not handle classified information.
      
Much of the material the F.D.A. was eager to protect centered on trade secrets submitted by drug and medical device manufacturers seeking approval for products. Particular issues were raised by a March 2010 article in The New York Times that examined the safety concerns about imaging devices and quoted two agency scientists who would come under surveillance, Dr. Robert C. Smith and Dr. Julian Nicholas.
      
Agency officials saw Dr. Smith as the ringleader, or “point man” as one memo from the agency put it, for the complaining scientists, and the surveillance documents included hundreds of e-mails that he wrote on ways to make their concerns heard. (Dr. Smith and the other scientists would not comment for this article because of their pending litigation.)
      
Lawyers for GE Healthcare charged that the 2010 article in The Times — written by Gardiner Harris, who would be placed first on the surveillance program’s list of “media outlet actors” — included proprietary information about their imaging devices that may have been improperly leaked by F.D.A. employees.
      
F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that “matters of public safety” can legally be released to the news media.
       
Undeterred, agency officials began the electronic monitoring operation on their own.
The software used to track the F.D.A. scientists, sold by SpectorSoft of Vero Beach, Fla., costs as little as $99.95 for individual use, or $2,875 to place the program on 25 computers. It is marketed mainly to employers to monitor their workers and to parents to keep tabs on their children’s computer activities.
      
“Monitor everything they do,” says SpectorSoft’s Web site. “Catch them red-handed by receiving instant alerts when keywords or phrases are typed or are contained in an e-mail, chat, instant message or Web site.”
      
The F.D.A. program did all of that and more, as its operators analyzed the results from their early e-mail interceptions and used them to search for new “actors,” develop new keywords to search and map out future areas of concern.
      
The intercepted e-mails revealed, for instance, that a few of the scientists under surveillance were drafting a complaint in 2010 that they planned to take to the Office of Special Counsel. A short time later, before the complaint was filed, Dr. Smith and another complaining scientist were let go and a third was suspended.
      
In another case, the intercepted e-mails indicated that Paul T. Hardy, another of the dissident employees, had reapplied for an F.D.A. job “and is being considered for a position.” (He did not get it.)
      
F.D.A. officials were eager to track future media stories too. When they learned from Mr. Hardy’s e-mails that he was considering talking to PBS’s “Frontline” for a documentary, they ordered a search for anything else on the same topic.
      
While the surveillance was intended to protect trade secrets for companies like G.E., it may have done just the opposite. The data posted publicly by the F.D.A. contractor — and taken down late Friday after inquiries by The Times — includes hundreds of confidential documents on the design of imaging devices and other detailed, proprietary information.
      
The posting of the documents was discovered inadvertently by one of the researchers whose e-mails were monitored. The researcher did Google searches for scientists involved in the case to check for negative publicity that might hinder chances of finding work. Within a few minutes, the researcher stumbled upon the database.

FDA shouldn't be spying on whistle-blowers!

Reprinted from the Tampa Bay Times

Federal employees should not have to tolerate Big Brother as part of the job. But that's what happened at the Food and Drug Administration when five of the agency's scientists became the focus of intensive surveillance after they criticized the FDA's approval of certain medical devices. The spying program is an inexcusable overreach, reflecting a culture of retribution where whistle-blowers are harassed and retaliated against. An investigation is needed to determine which FDA officials and managers participated, whether their actions violated federal employee protections and whistle-blowing laws, and how the agency's culture can be changed.

The scientists, some of whom have since lost their jobs, had been part of a yearslong dispute with their bosses about the agency's review process for medical devices. They were concerned about the safety of medical imaging equipment used for mammograms and colonoscopies that they claimed exposed patients to unsafe levels of radiation. The Office of Special Counsel, the office that handles federal employee grievances, found a "significant likelihood" that what the scientists warned of was true. But higher-ups in the agency didn't like it that these federal employees were raising concerns with congressional offices and the media, exposing the office to outside scrutiny.

A trove of more than 80,000 documents accidentally posted online shows that starting in mid 2010, the agency used spy software to monitor what these scientists were doing on their government laptops used at work and home. The software tracked personal email communications, documents on their personal thumb drives and every keystroke they entered. The FDA operation also put together an enemies list that included 21 congressional officials and journalists, among others, with whom the scientists communicated.

The FDA says the spy program was not intended to interfere with any communications but to determine whether the scientists were inappropriately sharing proprietary information and trade secrets. That's a poor excuse. By gathering up protected communications, such as attorney-client conversations and whistle-blower complaints made to Congress, the FDA itself may have violated federal law. The program is sure to dissuade government employees from coming forward with insider knowledge of government waste, fraud and wrongdoing.

In response to the scandal, the White House has already sent a memo throughout the federal bureaucracy stressing that agencies may not monitor their employees to discourage whistle-blowing. But that is not enough. Some members of Congress are calling for a full investigation, which is what should happen, holding those who participated responsible. It's the only way the oppressive culture of the agency will change.

Sunday, July 29, 2012

Is the MDL ever going to lead to a settlement?

Exerpts from a Bernstein Liebhard release

On July 26, 2012, the Honorable David A. Katz, who is overseeing the consolidated DePuy ASR hip litigation, issued a Case Management Order setting forth deadlines for bellwether trial selection and related discovery.* The federal DePuy ASR hip litigation is currently underway in the U.S. District Court for the Northern District of Ohio. According to the order, the first federal ASR hip recall lawsuit trial is scheduled to begin on May 6, 2013 with the second trial set for July 8, 2013.

Lawyers for plaintiffs and defendants must select the potential trial cases by August 8, 2012. For these first ASR hip recall lawsuits, the court will only consider cases involving plaintiffs who needed revision surgery.

Discovery Rulings Ordered To Ensure The ASR Hip Recall Lawsuits Move Towards Trial

In order to ensure that these first ASR hip trials go forward as scheduled, Judge Katz also issued certain discovery deadlines. For example, depositions of the plaintiff, the implanting surgeon, the explanting surgeon, and one fact witness for each side must be conducted by November 1, 2012.

xxx

[From Connie:  Boy this MDL litigation seems to be moving at a snail's pace.  This started in october of 2010.  The first case won't be tried until May of 2013.  That case is just a sample case to see how quikly everyone can settle.  If the award is high, I suppose deupy will try and settle quickly.  I don't know exactly but it would seem to be the case.  This is a 3 year time line before a trial starts!  Yikes!  The only thing that seems slower is the congress. Maybe they are all this way?]

Saturday, July 28, 2012

$5.5 Million Awarded to Transvaginal Mesh Victim

You might wonder why I am publishing the court award for a transvaginal mesh victim.  Recall that there are 4 big product issues surrounding 4 medical devices that classified as dangerous medical devices (see this link for more information http://www.mydepuyhiprecall.com/2012/03/consumer-reports-investigates-dangerous.html):
  • MoM hips
  • Transvaginal mesh
  • Lap bands for people who have had surgery on there stomach for weight loss
  • Implantable Cardiac Defibulators
Perhaps this is an indicator of what happens with court trials involving all of these devices including the hips.

xxxxx

 excerpts  from Virtual Strategy Magazine.

A jury awarded a woman $5.5 million against C.R. Bard for serious injuries sustained by a transvaginal mesh device. This was the first transvaginal mesh claim to go to trial, however there are currently hundreds of other similar cases currently pending just within the four federal vaginal mesh MDLs against multiple manufacturers, including C.R. Bard (MDL 2187), American Medical Systems (MDL 2325), Johnson & Johnson’s Ethicon (MDL 2327 ) and Boston Scientific (MDL 2326), which are pending in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin, involving polypropylene mesh used to treat pelvic organ prolapse and stress urinary incontinence. “This verdict gives validity and merit to women’s transvaginal mesh claims and illustrates the gravity of some of the injuries sustained,” commented Attorney Holly Ennis of Ennis & Ennis, P.A.

Christine Scott, 53, of Bakersfield, CA had two of Bard’s mesh devices implanted in 2008 to treat occasional urinary incontinence, but has since undergone eight additional surgeries and nine other procedures due to the mesh device cutting her colon and tissue that continues to grow through the tiny holes of the mesh, according to court documents. Yet, it wasn’t until July 1, 2012 that the defendant Bard suspended sales of Scott’s mesh device in the United States. Meanwhile, in July 2011, the FDA issued a Safety Alert for all transvaginal mesh devices stating it was unclear if the “mesh is more effective than traditional non-mesh repair” and may expose patients to greater risk.
Like Ms. Scott, hundreds of women suffer as a result of transvaginal mesh devices. The FDA's Safety Alert warns that complete removal of the mesh device may not be possible and may not result in complete resolution of complications, including pain. The FDA further warns that injuries include vaginal mesh erosion, pain, painful sexual intercourse (dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.

More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ) (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of studies on the devices’ safety and effectiveness, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.

xxx

I wonder if this was a bell weather trial to indicate the propensity of a jury to issue large awards?







Thursday, July 26, 2012

Metal-on-Metal Total Hip Arthroplasty: Causes and High Incidence of Early Failure

David Fabi, MD; Brett Levine, MD; Wayne Paprosky, MD; Craig Della Valle, MD; Scott Sporer, MD; Gregg Klein, MD; Harlan Levine, MD; Mark Hartzband, MD
  • Orthopedics
  • July 2012 - Volume 35 · Issue 7: e1009-e1016

Abstract

Early failures of metal-on-metal total hip arthroplasty (THA) occur due to aseptic loosening, metal hypersensitivity reactions, pseudotumor formation, and component seizing. The purpose of this study was to investigate the timing, common modes of failure, clinical outcomes, and incidence of metal-on-metal THA revisions.

A review was performed of 80 patients who underwent revision of a failed metal-on-metal THA for any reason. The most common reason for metal-on-metal failure was aseptic acetabular loosening, with a rate of 56.25% (45/80 patients). Early failure of metal-on-metal THAs was noted, with 78% of these revisions being performed within 2 years of the index operation and 92.5% within 3 years. Furthermore, 13% of patients experienced significant localized soft tissue reactions. Mean preoperative Harris Hip Score was 42.35±14.24 and mean postoperative Harris Hip Score was 66.5±23.2 (range, 9.55–95.4), with an average follow-up of 438±492 days (range, 40–2141), or 1.2 years.

It is imperative that clinicians be cognizant of the fact that the proposed advantages of metal-on-metal THA are not without potential detrimental sequelae. This article proposes an algorithm to aid in diagnosing the etiology of a painful metal-on-metal THA, as well as 2 classification schemes regarding metal-on-metal THA complications to help direct treatment.

Wednesday, July 25, 2012

Timing of Acute Myocardial Infarction in Patients Undergoing Total Hip or Knee ReplacementA Nationwide Cohort Study

Arief Lalmohamed, PharmD; Peter Vestergaard, MD, PhD, DMSc; Corinne Klop, PharmD; Erik Lerkevang Grove, MD, PhD; Anthonius de Boer, MD, PhD; Hubertus G. M. Leufkens, PhD; Tjeerd P. van Staa, MD, PhD; Frank de Vries, PharmD, PhD

Arch Intern Med. 2012;():1-7. doi:10.1001/archinternmed.2012.2713

Background Limited evidence suggests that the risk of acute myocardial infarction (AMI) may be increased shortly after total hip replacement (THR) and total knee replacement (TKR) surgery. However, risk of AMI in these patients has not been compared against matched controls who have not undergone surgery. The objective of this study was to evaluate the timing of AMI in patients undergoing THR or TKR surgery compared with matched controls.

Methods Retrospective, nationwide cohort study within the Danish national registries. All patients who underwent a primary THR or TKR (n = 95 227) surgery from January 1, 1998, through December 31, 2007, were selected and matched to 3 controls (no THR or TKR) by age, sex, and geographic region. All study participants were followed up for AMI, and disease- and medication history–adjusted hazard ratios (HRs) were calculated.

Results During the first 2 postoperative weeks, the risk of AMI was substantially increased in THR patients compared with controls (adjusted HR, 25.5; 95% CI, 17.1-37.9). The risk remained elevated for 2 to 6 weeks after surgery (adjusted HR, 5.05; 95% CI, 3.58-7.13) and then decreased to baseline levels. For TKR patients, AMI risk was also increased during the first 2 weeks (adjusted HR, 30.9; 95% CI, 11.1-85.5) but did not differ from controls after the first 2 weeks. The absolute 6-week risk of AMI was 0.51% in THR patients and 0.21% in TKR patients.

Conclusions Risk of AMI is substantially increased in the first 2 weeks after THR (25-fold) and TKR (31-fold) surgery compared with controls. Risk assessment of AMI should be considered during the first 6 weeks after THR surgery and during the first 2 weeks after TKR surgery.

Tuesday, July 24, 2012

Federal DePuy ASR Hip Litigation Status Conference Set For July 25, 2012

Bernstein Liebhard LLP, a nationwide law firm representing clients in the DePuy ASR hip recall hip litigation, reports that a status conference is scheduled to take place on Wednesday, July 25, 2012 in the consolidated action, In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio.* All of the metal-on-metal hip lawsuits filed in federal court by plaintiffs who received recalled DePuy ASR hip implants are pending before the Honorable David A. Katz. On Wednesday, the Court will conduct a status conference at 9:30 a.m. with members of the Executive Committee. An open court conference will commence at 11:30 a.m. that same day.

Our DePuy ASR hip recall lawyers are hopeful that one of the issues to be addressed at this week’s conference will be the confirmation of dates for the initial bellwether trials of the metal-on-metal hip lawsuits. As discussed during the last hearing, lawyers leading the DePuy ASR hip litigation are actively working towards this goal. As of that time, the first federal bellwether trial was expected to take place in Spring 2013.** Depositions of DePuy executives continue to be noticed, including:

  • a company representative who can testify about DePuy’s postmarket surveillance procedures;
  • DePuy’s Group Market/Product Manager; and
  • DePuy’s Staff/Senior Bioengineer.***
xxxx

What is a bellwether trial?

By definition Bellwether is an indicator of future trends. Courts utilize a bellwether approach when large numbers of plaintiffs are proceeding on the same theory or claim and there is no other feasible way for the courts to handle the enormous caseload. This approach has been used in many cases including asbestos litigation. A group of plaintiffs are chosen to represent all the plaintiffs. The issues for trial should concern common claims or theories among all the plaintiffs. These representative cases go for trial and the results act as the bellwether for the other plaintiffs’ trials. The verdict from this grouping is extrapolated to the remaining plaintiffs’ cases. The actual results may be utilized for valuing groups of claims in settlements. The plaintiffs can also choose to continue with their own individual trial.

Monday, July 23, 2012

Neat Infographics of the Depuy time line for people who are just getting up to speed!

Depuy ASR™ Recall | Infographic |

Infographic: Depuy ASR™ Hip System Recall

The DePuy hip implant infographic by DefectiveHip.org is designed to assist individuals in learning about some of the complications associated with the DePuy ASR™ XL Acetabular System, the DePuy ASR™ Hip Resurfacing System and the DePuy Pinnacle® Acetabular Cup System. These hip implants have been associated with problems such as a loosening of the hip implant, infection and injuries from metal particles that were shed from the metal on metal designs.
++Click to Enlarge Image++

Sunday, July 22, 2012

Henry Miller: FDA has device makers looking outside U.S.

Regulatory disincentives have consequences, and device companies are voting with their feet.

By HENRY I. MILLER

Miller, a physician and fellow at Stanford University's Hoover Institution, was founding director of the FDA's Office of Biotechnology.
Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine: pacemakers, artificial joints, cardiac stents, scanners and radiotherapy machines. The United States currently is the global leader in medical device innovation, and it is one of the few major industries that both boasts a net trade surplus and is a job-creator. The sector employs 400,000 Americans directly and is indirectly responsible for almost 2 million more that supply and support the highly skilled workforce.

But the medical device industry is being ravaged by unwise and excessive public policy. Regulatory disincentives have consequences, and device companies are voting with their feet. They have begun to move R&D and manufacturing offshore and even to write off the U.S. market for certain products that are so over-regulated that financing for their testing is unobtainable.
An example of the Food and Drug Administration's misuse of its discretion concerns the Fisher Wallace Stimulator, a portable device used to treat depression, anxiety and insomnia – common symptoms of Post-Traumatic Stress Disorder. It causes no serious side effects and has been on the market without incident since 1991. Because it gained clearance through antiquated "grandfathering" laws, the FDA must now either reclassify the device from Class 3 (usually support or sustain human life, or may pose a high risk of illness or injury) to Class 2 (low-medium risk) or relegate it to an approval process that requires clinical trials on par with hugely expensive drug trials – impossible for a device company that generates under $10 million annually in revenue

The company's reclassification hearing took place in February. Although the FDA's panel of outside experts agreed that device is safe, they were strongly divided over whether to reclassify the device based on effectiveness data that lacked the robustness of full-blown drug trials.

Such disagreements are not unusual, but what is noteworthy is that FDA seems actually to have engineered the impasse by manipulating the composition of the panel for this particular meeting. One of the most prominent members of the panel, Dr. Alvaro Pascual-Leone, professor of Neurology and Director of the Berenson-Allen Center for Noninvasive Brain Stimulation at Harvard Medical School, was absent. FDA said at the hearing that Dr. Pascual-Leone was "unable to attend" but thereafter, he informed Fisher Wallace via email that the agency had instructed him not to show up.

Given Dr. Pascual-Leone's well-known support of brain stimulation technology, his removal from the panel seems to have been intended to influence its recommendations. If that is so, it indicates the extent to which the FDA will go to manipulate the supposedly disinterested expert advice it receives. (What makes the regulators' actions to bias the panel discussion particularly problematic is that advisory groups' recommendations are only advisory, and need not be accepted by FDA.)

New York City-based Fisher Wallace Laboratories currently manufactures its products in New Jersey and sells them to American veterans of the Vietnam, Iraq and Afghanistan wars. If the FDA decides not to reclassify the company's device, Fisher Wallace has said it will likely shift its focus abroad, which would leave American veterans and active-duty military personnel without this safe treatment at a time when PTSD is at record levels, and the suicide rate among active-duty troops has overtaken the number dying in battle in Iraq and Afghanistan.

An interesting aspect of medical devices is that many of them originate not from industry behemoths but from individual tinkerers. Perhaps the epitome of the phenomenon is the Fogarty catheter, which has been used for almost half a century to remove blood clots from blood vessels relatively noninvasively. It was invented during the late 1950s by medical student Thomas Fogarty, who went on to become a renowned cardiac surgeon, inventor and entrepreneur. (He is still at it, and has become a noted California winemaker as well.)

More than 23 million of the Fogarty catheters have been manufactured. But consistent with the observation of a former head of the FDA that "dogs bark, cows moo, and regulators regulate," regulators seem to be trying to squelch this kind of garage-inventor innovation.

Consider the sorry saga of Connecticut psychologist and educator Robert Reynolds, who invented a low-tech gizmo for teachers to use in the classroom for children with attention and behavior problems – a simple radio-frequency device that allows a teacher to send two different pager-like vibrations to a student's watch. One kind of vibration reminds him when he is off-task, and a slightly different one is sent if he self-corrects and is on-task. The watch tracks the points the student earns, for which he can receive prearranged awards.

Sounds like an update of the way the gold stars in my copy-book and a few words from the teacher were used when I was a kid, but FDA apparently saw this as an opportunity to flex their bureaucratic muscles – and they threw the book at this guy, burying him in a hugely expensive, terrifying, Kafkaesque experience.

According to Reynolds, when FDA found out about his invention, they investigated him and concluded that the off-task vibration could "become a noxious stimulus for some child and he or she might develop some psychiatric syndrome as a result." Therefore, they charged him with using and selling an "adulterated and misbranded medical device," a federal crime. This is a classic example of bureaucrat-think because, as Reynolds observed, "Common sense would tell you that these children are already dealing with noxious events – their teacher constantly yelling at them."

These examples epitomize an agency that seems lately to use its power in ways that contravene decency and compassion toward patients. American taxpayers, ill or healthy, deserve better.

xxxx

[ from Connie: We have to reach a compromise between regulation an innovation.  Too much regulation stifles innovation an too little regulation results in mishaps such as the recall with Depuy hips and other devices which enabled invasive  devices with no real testing to be released into the market with catastrophic results.  I don't know the answer.  It is a complex balancing act.]

Saturday, July 21, 2012

Report calls for changes in medical device sector

 


By Mike Verespej | PLASTICS NEWS STAFF
Posted July 18, 2012

WHITE PLAINS, N.Y. (July 18, 2:50 p.m. ET) -- A new analysis says the U.S. medical device industry is facing unprecedented challenges that could prove catastrophic not only to the industry itself and to the livelihoods of its employees, but to the health of the patients who benefit from its technologies.

“For decades now, the United States has fostered an ideal environment for medical innovation, allowing it to become a world leader in the field, and resulting in significant advances in healthcare technology,” said Yair Holzman, author of the report and the director of the global life sciences practices for the global tax advisory firm WTP Advisors.

“But mounting threats to the industry from within the U.S., coupled with a flourishing medical technology industry abroad, are putting these advances at serious risk,” he said. “If we don’t do something now, we will see the U.S. market wither, along with our health and our economy.”

In the report, Holzman said that “the U.S. medical device industry faces the confluence of many internal challenges. Four significant weaknesses [are] a growing talent and development gap, a slow and cumbersome regulatory system, an excise tax on medical devices, and a lack of a permanent R&D tax credit.”

There are also other reasons why the U.S. leadership in the $350 billion medical device market is being challenged, said Holzman who interviewed 28 CEOs from medical devices companies in the U.S., China, United Kingdom, Germany, France, Brazil, Israel, Japan and India for the report, which was published July 17 by White Plains, N.Y.-based WTP.

“Gross domestic product and unemployment numbers remain weak in much of the developed world [and] Western governments are faced with unprecedented levels of debt and are taking extreme measures to slash budgets,” he said. “Developed nations like the United States are slipping in their capacity and capability for innovation, while emerging markets are rapidly gaining ground.”

To help ensure that the U.S. does not lose ground in medical market, Holzman said that the 2.3 percent excise tax on medical devices that is scheduled to go into effect in January must be repealed, that the approval process at the Food and Drug Administration must be reformed, and that the United States must make the R&D tax credit permanent and develop a tax policy that stimulates innovation and discovery.

“Not repealing the medical devices tax ... could be devastating to innovation, patient care and job creation,” Holzman said. “The result will be devastating to innovation, patient care, and job creation.”

He pointed to a study conducted for AdvaMed that claims the tax could ultimately cost more than 45,000 jobs.

To compete with faster regulatory approval processes in Europe, “the [FDA] approval process must be more predictable, consistent, and timely, while continuing to assure that products are safe and effective,” he said.

“The U.S. medical device industry is a highly regulated sector of the economy plagued with bureaucracy and complex regulations,” said Holzman’s report. “The FDA review process is almost twice as long as that of its European counterpart, the European Medicines Agency, for devices not requiring clinical data, and almost three times as long for devices that do.”

“Across the developed world, medical device developers face multiple challenges,” Holzman said. “Emerging companies must ensure that they can survive and sustain innovation through the challenging funding climate. Companies of all sizes will need to continue exploring ways to leverage foreign markets to offset domestic challenges from emerging markets.

Finally, U.S. companies will need to demonstrate to worldwide markets that a particular intervention improves patient outcomes and enhances the efficiency of the healthcare system,” Holzman said. “The need [exists] to offer a complete product, including the addition of services and data as part of the complete offering and solution.”

“Real-time patient diagnostic data could prove as valuable as the newly developed medical device for some product categories,” said the report. “In tandem, a new device, with rich patient diagnostic data and a full array of supportive services might prove essential as the key for the future success of the medical device industry.”

“The medical device industry will be fueled by scientific progress in this new century of the life sciences, as fundamental discoveries and advances in computing, materials, engineering, and physics create the knowledge base for an explosive growth in the creation of new treatments and cures,” said the report. “Mobile health, value-based purchasing, and personalized medicine will also drive more cost-effective, outcome-based initiatives and greater collaboration among payers, providers, and the medical technology industry to develop and deliver complete patient-centered solutions.”

More than half of the leading global medical device companies today—including 32 of the 46 companies with $1 billion or more in revenue—are based in the United States and those companies employ 400,000 people and indirectly provide 2 million more jobs in the U.S., said the WTP report.

“Between 2005 and 2007, the industry created 80,000 new jobs [and] from 2007-2009, R&D investment in medical devices increased by 9 percent,” said the report. “Not only is the industry a source of life-enhancing and life-sustaining treatments and cures, but it is also an important manufacturing industry and a driver of current and future U.S. economic growth. It is one of the few American manufacturing industries that consistently export more than it imports,” said the report, which pointed out that medical exports doubled between 1998 and 2008, to $33 billion annually.

Holzman said U.S. medical device manufacturers will continue to benefit “from the aging U.S. population [and that] the influx of newly insured people due to the healthcare reform bill will drive up demand for devices.”

The United States spends a larger percentage of its GDP and more per capita on healthcare than any other country. It is the largest healthcare market and should remain so during the next decade,” he said.

As a result, the report called the “future potential for U.S. economic growth driven by the medical technology industry ... tremendous.”

“Worldwide markets for medical technology will expand dramatically as populations’ age in countries across the globe,” said the report. “Additionally, hundreds of millions of people in countries like India and China will enter the middle class and demand modern, quality healthcare.”

However, the regulatory environment is growing more stringent, which will decrease profits and force some companies to shift functions overseas,” he said. “Revenue in the device industry will not grow as quickly over the next five years, and the increasingly strict regulatory environment will remain a significant hindrance.”

“The Patient Protection and Affordable Care Act of 2010 will place an excise tax on medical devices, eating into revenue and reducing profit,” he said. “Also, potential reform to the approval process for new devices will likely hamper innovation and encourage more companies to shift functions overseas.”

The report by Holzman also said the outsourcing of manufacturing, R&D, and other operations from the U.S. to other countries, in combination with the ongoing industry consolidation, will decrease the number of medical manufacturers in the U.S

“During the past five years, consolidation has swept the industry, with the number of companies decreasing at an average annual rate of 5.5 percent to total 828,” said the report. “Meanwhile, emerging markets like China and Brazil will attract medical device manufacturers, as U.S. customers face more stringent Medicare reimbursement requirements and other cost-cutting pressures.”

Stryker Recall Harms its Key Argument About its Hip Implants

Attorneys say the recall of Stryker Corp.’s Rejuvenate and ABG II metal hip replacement components may undermine a key defense argument made by the manufacturers that the metal-on-metal hip replacements are not intrinsically faulty.

Stryker’s device differentiates from other metal-on-metal hip implants because it has a metal neck inside the metal stem rather than a metal ball rubbing against a metal socket, according to Law360 (subscription required). Nevertheless, the tissue injury risks linked with the Stryker hips are identical to the ones linked to other metal hips such as DePuy’s ASR, say attorneys.

Last month some of the medical device makers tried to argue to the Food and Drug Administration that their hip replacement products were too different to be lumped together in a class but should be considered on a case-by-case basis, writes Law360.

xxxx

Amazing the extent to which metal  device makers will go in order to avoid being lumped into the the MoM litigation.

Thursday, July 19, 2012

Causes and High Incidence of Early Hip Replacement Failure

    2012 Jul 1;35(7):e1009-16. doi: 10.3928/01477447-20120621-12.

    Metal-on-Metal Total Hip Arthroplasty: Causes and High Incidence of Early Failure.

    Abstract

    Early failures of metal-on-metal total hip arthroplasty (THA) occur due to aseptic loosening, metal hypersensitivity reactions, pseudotumor formation, and component seizing. The purpose of this study was to investigate the timing, common modes of failure, clinical outcomes, and incidence of metal-on-metal THA revisions.A review was performed of 80 patients who underwent revision of a failed metal-on-metal THA for any reason. The most common reason for metal-on-metal failure was aseptic acetabular loosening, with a rate of 56.25% (45/80 patients). Early failure of metal-on-metal THAs was noted, with 78% of these revisions being performed within 2 years of the index operation and 92.5% within 3 years. Furthermore, 13% of patients experienced significant localized soft tissue reactions. Mean preoperative Harris Hip Score was 42.35±14.24 and mean postoperative Harris Hip Score was 66.5±23.2 (range, 9.55-95.4), with an average follow-up of 438±492 days (range, 40-2141), or 1.2 years.It is imperative that clinicians be cognizant of the fact that the proposed advantages of metal-on-metal THA are not without potential detrimental sequelae. This article proposes an algorithm to aid in diagnosing the etiology of a painful metal-on-metal THA, as well as 2 classification schemes regarding metal-on-metal THA complications to help direct treatment.

    Tuesday, July 17, 2012

    Johnson & Johnson 2Q net income falls by half on sales dip, litigation and other charges

    By Associated Press, Updated: Tuesday, July 17, 3:01 PM


    Health care giant Johnson & Johnson, struggling with tough market conditions, ongoing manufacturing problems and other issues, lowered its profit forecast for the year after posting second-quarter net income that dropped by half due to a slew of litigation and acquisition-related charges.
    The maker of Band-Aids, medical devices and prescription drugs, its iconic image tarnished by legal and manufacturing lapses, on Tuesday noted some positive signs. They include small increases in hospital admissions and surgical procedures in the U.S. Despite that, revenue dipped by 0.7 percent due to lower sales in the U.S. and for consumer health products worldwide.

    The results beat analysts’ expectations for adjusted profit by a penny, but fell short of the revenue forecast by nearly $250 million.

    Many J&J nonprescription products remain off the market due to about three dozen recalls since September 2009. The company said Tuesday that they won’t all be back in stores until sometime next year. Two of its consumer health product factories are operating at reduced capacity due to increased government scrutiny and the third is being rebuilt from the ground up. J&J noted remediation costs this year have been higher than expected.

    “We remain committed to and optimistic about the future of our (over-the-counter) business,” new CEO Alex Gorsky told analysts on a conference call Tuesday, adding that there’s strong consumer demand for products that are back in stores, such as some versions of Tylenol.

    Gorsky gave what amounted to a long pep talk about the company’s great opportunities, despite continuing pressure from government and other health plans to reduce prices. His priorities include resolving the manufacturing problems, building on recent approvals and other success in the prescription drug business, and integrating Swiss orthopedics device maker Synthes. The company bought Synthes in June for $19.7 billion, its largest acquisition ever, and Synthes product sales in the quarter’s last couple of weeks boosted revenue by 1.2 percent.

    “I am resolute to keep our credo as the foundation of Johnson & Johnson,” Gorsky said, referring to J&J’s longtime guiding principle to put patients, doctors and employees before profits.

    Many critics have questioned whether J&J still follows the credo. The government is prosecuting J&J for alleged kickbacks to boost medicine sales and improper marketing of a few prescription drugs. And J&J has had to recall medicines containing the wrong amount of active ingredient or glass or metal shards.

    The company, based in New Brunswick N.J., said net income was $1.41 billion, or 50 cents per share, down from $2.78 billion, or $1 per share, a year earlier. Revenue fell by 0.7 percent to $16.48 billion.

    Excluding a total of $2.2 billion in after-tax charges, income was $3.63 billion, or $1.30 per share. Analysts expected earnings per share of $1.29 on revenue of $16.71 billion, according to FactSet.
    The charges included include asset write-downs, costs from the Synthes purchase, more recall costs for its DePuy hip replacements and another $611 million added to J&J’s legal reserve for a potential civil settlement with the Justice Department its marketing practices. That case is expected to be finalized soon, with J&J paying a penalty in the $2 billion range.

    A case of an infected total hip arthroplasty following a dental procedure.

    Hematogenous Infection of Total Hip Arthroplasty With Actinomyces Following a Noninvasive Dental Procedure

    Matthew L. Brown, BA; Christopher J. Drinkwater, MD, FRACS

    • Orthopedics
    • July 2012 - Volume 35 · Issue 7: e1086-e1089
    • DOI: 10.3928/01477447-20120621-27

    Abstract

    This article describes a case of an infected total hip arthroplasty following a dental procedure. A 59-year-old man underwent total hip arthroplasty for osteoarthritis and had a routine recovery. Approximately 9 months postoperatively, he underwent a dental cleaning without antibiotic prophylaxis. One month later, he reported gradually worsening right hip pain and a purulent discharge. After several unsuccessful interventions, the patient was referred to the authors’ facility. The patient’s history, draining sinus tract, and radiographic changes were considered diagnostic of a late chronic infection, and the patient underwent 2-stage revision. Intraoperatively, the sinus tract extended directly to the acetabular component. Actinomyces spp were isolated from 3 of 7 intraoperative anaerobic cultures, and the patient received penicillin G for 8 weeks. Two weeks after discontinuing antibiotics, with no clinical manifestation of recurrent infection and a negative hip aspiration, a new hip prosthesis was implanted. The patient was prescribed penicillin for 12 months postoperatively. Harris Hip Score was 100 at 52-month follow-up.

    The American Dental Association and the American Academy of Orthopaedic Surgeons issued consensus guidelines for chemoprophylaxis in orthopedic patients undergoing dental procedures in 1997 and 2003. Although the American Academy of Orthopaedic Surgeons issued a revised guideline in 2009 recommending more robust antibiotic prophylaxis, significant controversy exists because at least one professional organization representing dentists has repudiated the 2009 American Academy of Orthopaedic Surgeons guideline. The authors describe the implications from their experience and similar cases in the literature with regard to such guidelines.

    Mr Brown is from the University of Rochester School of Medicine & Dentistry, and Dr Drinkwater is from the Department of Orthopaedics and Rehabilitation, University of Rochester School of Medicine & Dentistry, Rochester, New York.
     
    Mr Brown and Dr Drinkwater have no relevant financial relationships to disclose.
    The authors thank Steven M. Fine, MD, PhD, from the Infectious Disease Division for his contribution to this patient’s care and his interpretation of this patient’s microbiology.
    Correspondence should be addressed to: Christopher J. Drinkwater, MD, FRACS, Department of Orthopaedics and Rehabilitation, University of Rochester School of Medicine & Dentistry, 601 Elmwood Ave, Box 665, Rochester, NY 14642 (christopher_drinkwater@urmc.rochester.edu

    xxx

    Interesting because I have been told my my orthopedic surgeon that I must take antibiotics prior to any dental proceedure for the rest of my life. 

    Sunday, July 15, 2012

    Synovial Sarcoma with a metal on poly hip replacement

    2011 Jul-Aug;25(4):242-5.

    Synovial sarcoma in a patient with metal-on-polyethylene total hip replacement. A case report.

    [Article in Spanish]

    Source

    Centro Médico ABC, México D.F. lucas876@prodigy.net.mx

    Abstract

    We present the case of a synovial sarcoma five years after primary total hip arthroplasty in a male 65 year-old patient who was surgically treated for left hip pain due to coxarthrosis. A 32 mm uncemented prosthesis with metal-on-polyethylene tribology was placed in the patient. The latter developed synovial sarcoma that caused lung metastasis. The association between total hip arthroplasty and malignancy is discussed, as well as its frequency worldwide.

    xxx

    What is a synovial sarcoma?
    A synovial sarcoma (also known as: malignant synovioma[1]) is a rare form of cancer which usually occurs near to the joints of the arm, neck or leg. It is one of the soft tissue sarcomas.
    Synovial sarcoma was originally coined early in the 20th century as some thought that the microscopic similarity of some tumors to synovium and its propensity to arise adjacent to joints indicated a synovial origin; however, the actual cells from which the tumour develops are unknown and not necessarily synovial.

    If you have had a hip revision, it is likely that during the revision the surgeon had to debride (clean out) the snynovial fluid of metal particles.

    Joint.png

    Friday, July 13, 2012

    ASR failure rate expected to rise to 80 percent at eight years says Dr. David Langton

    RPT-INSIGHT-As lawsuits climb, J&J may have new hip trauma


    Thu Jul 12, 2012 4:29pm IST  (Reuters)

    * J&J's Pinnacle all-metal hips shows same problems as recalled device

    * J&J refusing to recognize claims -legal experts

    * Lawsuits could cost J&J nearly $5 bln if court agrees

    By Debra Sherman

    CHICAGO, July 12 (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.

    A successor to ASR, the Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending in U.S. courts. Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years.

    Metal-on-metal hip implants were sold on being more durable than those made of other materials, such as polyethylene or ceramic. They are meant to last up to 15 years, but as controversy over all metal-on-metal implants heats up, fewer surgeons are using them.

    A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal implants before the U.S. Food and Drug Administration warned of potential problems. That number dropped to 10 percent since the FDA warning, and doctors say the number probably has dwindled further.

    Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.

    "We're simply seeing the tip of the iceberg with metal-on-metal failures," Dr Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, said of the entire class of metal-on-metal devices. O'Connor said she does not use metal-on-metal hip implants because she has been concerned about metal poisoning for years.

    The new round of complaints represents a significant threat for J&J's DePuy Orthopedics unit, whose Pinnacle line includes non-metal models and covers a much wider range of products than ASR. The diversified healthcare giant, under new Chief Executive Alex Gorsky, has also just raised its bet on orthopedic products with the $20 billion purchase of device maker Synthes.

    "Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance" than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. "We recalled it because it was not performing as it should."

    She said DePuy is closely monitoring the performance of the Pinnacle metal-on-metal system, but is "very confident" in the product and will vigorously defend itself against lawsuits. DePuy did not make other executives available for comment.

    DePuy and FDA officials said there is not sufficient evidence linking metal ions in the blood to health risks.

    A total of 500,000 patients in the United States have received metal-on-metal hips, according to government data. Of those patients, an estimated 150,000 received the Pinnacle device, and 37,000 got the ASR implant. But while J&J has set aside $3 billion to settle the 3,000 ASR lawsuits, it is fighting complaints related to the Pinnacle device -- meaning that patients with virtually identical problems are facing different financial burdens.

    Frances Grisham, 50, from Jackson, Tennessee, recently had surgery to repair a fracture to her left hip caused by the ASR implant. She was reimbursed for most of her out-of-pocket expenses and could be eligible for some of the settlement funds.

    Harriett Bowen, 64, from Salisbury, Maryland, received the Pinnacle all-metal hip in 2008. She soon developed the same symptoms as Grisham: pain, limited mobility and elevated levels of cobalt and chromium in her blood. In July 2011, Bowen's left hip fractured at the implant site, requiring more surgery.

    Bowen's doctor determined she had a cobalt and chromium count of 7 micrograms per liter (mcg/L), a level flagged by UK health authorities as worrying. "He said, 'Look, we've got to get this thing out of you.' It nearly scared me to death."

    Unlike Grisham, she has received no compensation for the repair from J&J. Bowen is suing J&J.

    "I have never done anything like this before, but considering what I went through for three years, I feel like I should be compensated," said Bowen.



    PROBLEMS WITH ALL-METAL CITED ACROSS INDUSTRY

    While other makers of total hip replacement systems -- including Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc -- face similar complaints, the numbers of devices involved is much smaller. The next most widely used product belongs to Biomet, which is defending itself against lawsuits over its metal-on-metal M2a Magnum Hip System.

    Legal experts say J&J is taking a harder line defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices - known as revision surgery. It maintains the device performs better than other all-metal hip implants.

    Paul Voorhorst, director of biostatistics and data management at DePuy, told an FDA advisory panel last month that the Pinnacle metal-on-metal device "is performing consistent with or better than other metal-on-metal products."

    Should the Pinnacle lawsuits be found to have merit, J&J could end up paying nearly $5 billion to cover revision surgeries alone, according to plaintiff attorneys. DePuy revenue last year was $5.81 billion, or 9 percent of J&J's total.

    Legal experts not involved in the cases say J&J probably is just taking its chances to see how the first few lawsuits play out - a common strategy for Big Pharma in major drug litigation cases. They say J&J may be aided in its defense by the lack of any U.S. program to track the performance of medical devices once they are implanted in people's bodies.

    "The last thing plaintiff lawyers want is to go one by one (for each case). With so much unknown, proving cause and effect may be difficult," said Carl Tobias, Williams professor of law at the University of Richmond School of Law.

    Cindy Schipani, professor of business law at the University of Michigan, said J&J could be playing with fire if the Pinnacle metal-on-metal devices are shown to be defective.

    "They lose credibility if they keep saying they're not responsible and then it turns out the product is the problem," she said. "I question this strategy."



    NO HARD DATA

    While doctors can report problems about the Pinnacle to an FDA database, products with that name also include artificial hips that are not exclusively made of metal. One product is metal-on-polyethylene, the most popular of the Pinnacle devices, and another is metal-on-ceramic. A Reuters search of the database could not isolate adverse events reported for the all-metal Pinnacle, which is the least used of the Pinnacle products.

    There is also no hard data yet on the Pinnacle's failure rate, partly because DePuy does not publicly disclose how many were implanted. DePuy's Voorhorst told the FDA advisory panel that 4 percent to 4.5 percent of these Pinnacle implants require a second surgery to fix the devices within five years after implantation, which is in line with other hip devices.

    Felecia Stern, an attorney with Bernstein Liebhard LLP, represents Bowen, Grisham and many other patients who received the ASR and Pinnacle all-metal devices. She noted that the recall of 93,000 ASR implants in 2010 led doctors to notify patients and monitor for high metal levels. But problems with the Pinnacle are being reported less systematically since the devices weren't pulled from the market.

    "At the end of the day we will see a similar occurrence of high metal levels in Pinnacle metal-on-metal recipients as more and more of them get their blood tested. That is certainly what we are seeing in our client population," she said.

    Her firm also serves on the Plaintiffs Steering Committee for the federal Pinnacle lawsuits, which have been consolidated into a multi-district litigation in Texas.

    The FDA has been monitoring problems with all-metal hip implants and convened the panel of outside advisers last month to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

    In May 2011, the agency ordered device makers to conduct follow-up studies in cases in which an implant's failure could have serious consequences. Companies would be expected to take blood samples from patients to measure metal ion levels. But more than a year later, the FDA and device manufacturers agreed on study protocols for less than one quarter of the devices. Most of the study plans, including DePuy's, have not been finalized.

    "We need more data to better understand how these devices perform," FDA spokeswoman Michelle Bolek said. "We are open to a more collaborative effort, if it helps us get the data we need."

    MINIMIZING RISK

    The final failure rate for the ASR device has not yet been established, but a study released last March by the British Orthopaedic Association and the British Hip Society indicated a failure rate of up to 49 percent after six years - nearly four times the rate cited by DePuy when it recalled the device.

    Dr David Langton is an orthopedist who has studied all-metal implants for years and supplied the two British organizations with data. He said he expects the ASR failure rate to rise to 80 percent at eight years. Based on a cohort of about 1,000 patients he is tracking at North Tees Hospital in the UK, the Pinnacle metal-on-metal hip has a failure rate of 8 percent at five years. He said that rate climbs to 16 percent after 6-1/2 years.

    About 150,000 Pinnacle metal-on-metal devices are estimated to be implanted in patients outside the United States.

    Several differences between the ASR and Pinnacle metal-on-metal could explain a lower failure rate.

    One main reason is that the Pinnacle has a smaller head; larger heads are associated with higher failure rates because there is more friction.

    Langton believes it is just be a matter of time before Pinnacle all-metal device failure rates climb, as more metal debris from the implant are released into the bloodstream and tissue. And while the failure rate might be lower than ASR, the absolute number of patients is higher.

    "We believe the (Pinnacle) failure rate will be far above 10 percent," said attorney Brian Devine of Seeger Salvas LLP, which is handling both ASR and Pinnacle cases.

    That would translate into second replacement surgery for 15,000 patients, he said. In 2002, Sulzer Medica AG paid an average of $250,000 per revision on its 2001 recall of its InterOp hip. Adjusting for inflation, an average J&J settlement could be $319,000 per revision, or $4.785 billion in total, he said.

    Mayo Clinic's O'Connor is worried that the entry of metal ions into the bloodstream will damage internal organs, not just the surrounding tissues in the hip socket. There are also concerns high ion levels cause cancer, though that has not been proven.

    "Autopsy studies of patients with metal-on-metal implants showed metal ions were everywhere the body - in the liver, the spleen, all over the place," O'Connor said.

    Wednesday, July 11, 2012

    Stryker recalls certain hip implant products


    (Reuters) - Orthopedic implant maker Stryker Corp said it has begun to recall certain modular-neck stems used to correct hip biomechanics, due to potential risks associated with fretting and corrosion.

    The company, which has terminated the global distribution of Rejuvenate and ABG II stems, said it would continue to evaluate the data related to these products.

    xxx From Stryker web site:

    Q: Why are these products being voluntarily withdrawn from the market?
    A: While modular neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, we decided to voluntarily recall these modular-neck stem hip systems because there is a potential for fretting and corrosion at the modular-neck junction which may lead to adverse local tissue reactions.

    Q: How would I know if my hip implant is experiencing fretting and corrosion?
    A: The incidence of complications associated with modular-neck stems is extremely low. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.

    Q: What should I do if I have one of these hips but don’t have any pain or swelling?
    A: If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).

    Q: I have pain and/or swelling around my hip now. What should I do?
    A: If you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon to discuss your symptoms. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).

    Q: Is there a chance this issue will affect me in the future if I don't have any symptoms now?
    A: The incidence of complications associated with modular-neck stems is extremely low. If in the future you experience pain and/or swelling of the hip, you should schedule an office visit with your surgeon to discuss your symptoms.

    Q: I have a Rejuvenate Modular or ABG II Modular implant. Do I need revision surgery?
    A: The incidence of complications associated with modular neck stems is extremely low. Affected patients may present with symptoms of pain and swelling at the local joint site not attributable to other conditions such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.

    Q: I don't know if I have Rejuvenate or ABG II, how can I find out?
    A: For privacy reasons patients should speak with their surgeons and/or review their medical records for implant identification information.

    Q: I don't have Rejuvenate or ABG II, but I do have a Stryker hip. Should I be concerned?
    A: This voluntary recall is specific to Rejuvenate Modular and ABG II modular-neck stems only.