Thursday, January 31, 2013

J&J’s Ekdahl Says Hips Recalled Because of Clinical Needs

Bloomberg

Andrew Ekdahl, the president ofJohnson & Johnson (JNJ)’s DePuy unit, told jurors the company recalled 93,000 all-metal hip implants because they “did not meet the clinical needs for the product” and not because they were unsafe.

Ekdahl testified yesterday by videotape at the first of 10,000 cases to go to trial over patient claims that J&J defectively designed the implants and failed to warn of the risks before the recall of the ASR devices in August 2010. At the time, J&J said that 12 percent of the devices failed in the U.K. Analysts estimate the lawsuits could cost J&J billions of dollars.

Ekdahl, who became DePuy president in January 2012, had previously worked as a marketing executive. A lawyer for Loren Kransky, 65, a Montana man who is suing DePuy over his failed hip, repeatedly questioned Ekdahl about whether the company withdrew the hips because they were unsafe.

“It was taken off the market because it did not meet the clinical needs for the product in the marketplace,” Ekdahl said in a videotaped deposition taken in December 2012 and shown yesterday to state court jurors in Los Angeles.

J&J, the world’s largest seller of health-care products, denies that it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick, New Jersey.
Kransky attorney Michael Kelly asked Ekdahl a half-dozen ways whether DePuy considered ASR hips to be unsafe or harmful to patients. Each time, Ekdahl referred to clinical needs.

Acceptable Rate

Kelly has told jurors that an internal DePuy analysis in September 2011 showed 37 percent of ASR hips failed within 4.5 years, and that Australian national registry data showed in 2012 that 44 percent failed after seven years. Patients with failed hips need replacement surgery known as a revision.
In answering Kelly’s questions about the recall, Ekdahl said that the ASR didn’t have an acceptable revision rate.

“What was the acceptable revision rate?” Kelly asked.

“I don’t think we put a revision rate on paper and said this is a revision rate that was acceptable,” Ekdahl said in a deposition that may be played in many other lawsuits.
Kelly asked how many revisions DePuy forecasts for the U.S.
“We’re not forecasting a revision rate,” Ekdahl said.

Kelly asked why the U.S. rate of revision wouldn’t reach 40 percent, as in Australia. Ekdahl said he doesn’t know what the rate will be. About 32,000 patients had ASR devices implanted in the U.S., said Ekdahl, who said that “somewhere in the neighborhood of 15 to 20 percent” of those hips had failed.

Surgeon Complaints

Kelly questioned Ekdahl about DePuy’s handling of safety complaints that surgeons filed with the company about the device. Thousands of lawsuits claim the ASR device left them in pain or immobilized by joint dislocations, infections and bone fractures. Many also claim the devices shed chromium and cobalt into the bloodstream, raising those metals to harmful levels.

One surgeon, William Griffin, e-mailed Ekdahl and others on Dec. 18, 2008, to say he had “concerns about the design and have started to see failures consistent with my concerns.”Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. Griffin said the ASR didn’t stimulate enough bony ingrowth, the cup was too small, and the design created sharp edges.
“DePuy should at least de-emphasize the ASR cup while the clinical results are studied,” Griffin wrote. “I do not use the ASR. The ASR is not the only bad design out there but it certainly is not as good as some of the others.”

Clinical Team

Kelly asked if the e-mail went to DePuy’s clinical team.

“I believe this was reported to our clinical team,”Ekdahl said. “I just don’t recall who did it. We should have done it. I’m assuming that we did it. I don’t recall.”

Kelly asked about DePuy discussions in 2008 to redesign the ASR cup. A company engineer, Graham Isaac, e-mailed Ekdahl on April 30, 2008, to say the ASR is “susceptible to extreme metal ion levels,” which a competitor product didn’t face.

“We need to discuss that at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested,” Isaac wrote.
Ekdahl said that in response to the e-mail, he spoke to people on the marketing team.
Throughout the videotape yesterday, Kelly pursued various lines of questioning based on DePuy e-mails and internal documents that he contends show that company officials knew years before the 2010 recall that the ASR was failing.

‘Project Alpha’

Kelly showed documents related to DePuy’s deliberations in 2008 to redesign the ASR cup through “Project Alpha.” That project was never completed.

He asked Ekdahl about minutes of a May 2008 meeting in Las Vegas. Those minutes listed weaknesses of the ASR, including deformation and loosening of the cup.

At a September 2009 meeting of the company’s U.S. board overseeing joint devices, officials said the revision rate of the ASR XL device was two or three times that of another DePuy implant, the Pinnacle. It said that the impending publication of Australian registry data would be “very damaging to the ASR.”

DePuy ended Australian sales months before they halted in the U.S.
The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court at mauricepossley@gmail.com; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

Wednesday, January 30, 2013

DePuy ASR Hip Recall Lawsuit Update: Judge Brings Causes of Action From 14 to 10 In California Lawsuit

Bernstein Leibhard

The first DePuy ASR hip recall trial in the nation will proceed in Los Angeles Superior Court with ten causes of action on January 22nd, 2013. The parties submitted a statement notifying the judge that four of the 14 causes of action had been dismissed or withdrawn. The remaining causes of action include:
  • Negligence
  • Design defect
  • Failure to warn
  • Failure to adequately test
  • Breaches of warranties
  • Fraudulent concealment
  • Intentional misrepresentation
  • Negligent misrepresentation.
Judge Richard A. Karmer, who presides over the coordinated DePuy ASR litigation in San Francisco Superior Court, granted DePuy’s motion to dismiss causes of action for strict products liability, manufacturing defect, negligent recall and unlawful business practices. The plaintiff voluntarily dismissed a claim for loss of consortium. Judge Karmer also returned the case to its originating Los Angeles court for trial

J&J Failed Own Safety Test in Hip Design, Witness Says

By Maurice Possley, David Voreacos & Jef Feeley - Jan 29, 2013 12:01 AM ET

Johnson & Johnson (JNJ) failed its own safety test in designing an all-metal hip implant and then changed the protocol instead of fixing the flaw, a witness testified in the first of 10,000 lawsuits to go to trial.

George Samaras, a consultant, testified yesterday for Loren Kransky, who is suing J&J for defective design and failure to warn over an ASR XL hip he had replaced last year. J&J recalled 93,000 ASR hips in 2010 after saying 12 percent failed within five years. Another witness yesterday said Australian data last year showed the hip failed at a 44 percent rate after seven years. Analysts say the lawsuits could cost J&J billions of dollars.

Samaras told jurors in state court in Los Angeles that J&J’s DePuy unit failed the safety standard it set up for the ASR hip cup, in which a metal ball atop the femur rotates. He cited an internal document showing the ASR produced 16 times more chromium and cobalt debris in the body than another DePuy product. While DePuy’s review standards said the ASR should have failed, the company said it passed, Samaras said.

It’s horrible practice,” said Samaras, a biomedical engineer who runs a consulting firm near Pueblo, Colorado.“That’s not what good engineers do. You are playing games with what the requirements for the device are.”

The company denies Kransky’s claims, including failure to warn, defective design and negligent recall. In his opening statement, Alexander Calfo, a lawyer for J&J, said the ASR was properly designed. He said claims by Kransky, 65, of elevated metal levels in his body can be traced to his many other health problems, including diabetes, coronary artery disease, high blood pressure, kidney disease, strokes and cancer.

Design Criteria

Samaras said DePuy’s original design criteria said the ASR had to be at least as good as predecessor devices at the company. When that failed, DePuy found other devices for comparisons that put the ASR in a more favorable light, he said.

“They changed the test,” Samaras said. “They didn’t do what they were supposed to do, which is change the design.”

Samaras appeared before John Baron, an epidemiologist at Dartmouth Medical School testified that Australian national registry data showed that the ASR XL failed at a rate of 22 percent after five years and 44 percent after seven years.

The five-year rate, he said, “hits you between the eyes.”

He also reviewed data from England, Wales and Sweden, concluding that the failure rate is “extraordinarily high.”

‘Higher Rate’

“The ASR XL total hip replacement fails at a much higher rate than a typical hip replacement,” Baron said.

On cross-examination, J&J attorney Michael Zellers suggested that the rate of replacement surgeries rose after the negative publicity surrounding the recall.

“A surgeon would not remove a hip without a good reason,”Baron said. “It would be far-fetched to say that publicity regarding possible problems would lead a clinician to remove a hip.”

Jurors also saw the videotaped testimony of Magnus Flett, who led a DePuy design team and oversaw a group conducting a so-called failure mode and effect analysis, or FMEA, of the cup.
Flett said DePuy scrapped efforts to redesign the ASR cup because of financial and business reasons. He said that DePuy never told surgeons that the ASR failed and required follow-up surgeries known as revisions at a rate that was eight times that of another company hip device, the Pinnacle.
“I don’t believe that was clinically relevant,” he said.

Flett also discussed a proposal to study the performance of the ASR against the Pinnacle, another metal-on-metal device.

‘Like Suicide’

“This study seems like suicide to me,” he said in a 2005 e-mail. Flett testified that he likened such a study to suicide because “it will prove that one is better than the other and they are both our products and that means one will be worse.”

He said DePuy stopped selling the ASR in late 2009.

“We didn’t see the sales of the product continuing the way we wanted, so we took it off the market,” Flett said.

Kransky’s lawyers claim the implanted metal cups didn’t stimulate ingrowth of surrounding bone, making them unstable in the hip. They also claim the shallow design of the ASR cups, in which a metal ball atop the femur rotates, led to toxic debris of cobalt and chromium ions in the bloodstream.
J&J, based in New Brunswick, New Jersey, recalled the hip devices after saying U.K. data showed the ASR failed in more than 12 percent of patients after five years. A lawyer for Kransky, Michael Kelly, told jurors in his opening statement that internal J&J documents show 37 percent of ASR hips failed after 4.6 years.

Montana Physician

After Samaras testified, jurors heard by videotape from Daniel C. Brooke, a physician who practices in Kransky’s home state of Montana. He testified about examining Kransky and discussing a surgery to replace the ASR hip he had implanted in December 2007. Kransky, a retired prison guard, had a so-called revision surgery to remove the device in February 2012.

Brooke said that Kransky’s levels of chromium and cobalt debris were “very alarming.” Kransky’s multiple medical problems led the doctor to believe he might not survive the surgery.

“Kransky was always honest with me,” Brooke said. “He was an old man with a whole constellation of problems going on. He didn’t want to have surgery. I think he thought it was going to kill him.”

The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).
To contact the reporters on this story: David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Maurice Possley in Los Angeles at mauricepossley@gmail.com; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

Trial over metal hip replacements begins in LA

CBS News

LOS ANGELES A California jury heard opening statements Friday in a lawsuit that accuses Johnson & Johnson of knowingly marketing a faulty hip implant that lawyers say left thousands of people with crippling problems or in need of replacement surgeries.

The fraud and negligence suit is the first of thousands of similar cases to reach trial in the United States that involve an all-metal ball-and-socket hip joint that was pulled from the market two years ago.

A lawyer for plaintiff Loren Kransky showed jurors pictures from a surgery in which black material could be seen in the patient's hip socket. Attorney Michael Kelly said the material was from pieces of metal that had flaked off of the implant.

Kelly also played a segment of a doctor's audio deposition in which he said he feared that if the material wasn't removed, Kransky would have died. The pieces of metal were causing a form of metal poisoning, he said.

Kransky, a former North Dakota prison guard, sought hip replacement to relieve arthritic pain. He received the implant in 2007 and has since has had it replaced. He listened to opening statements Friday from a front row seat.

A lawyer for Johnson & Johnson's subsidiary, DePuy Orthopedics Inc., which manufactured the metal implant, said Friday that the 64-year-old Kransky had many pre-existing medical ailments. Attorney Alexander Calfo presented a list of 16 major diseases, including kidney cancer, diabetes, high blood pressure and vascular disease as well as exposure to Agent Orange during the Vietnam War.

"Mr. Kransky did not get worse because of the (implant) and did not get better when it was removed," he said.

He added: "Hip surgery is not perfect. No material to this very day has proven to be perfect."

Calfo said the metal implant had been designed to improve on plastic and ceramic implants.

The artificial hip socket was sold for eight years to some 35,000 people in the U.S. and more than 90,000 people worldwide. New Brunswick, N.J.-based Johnson & Johnson stopped making the product in 2009 and recalled it the next year.

However, documents unsealed in the court case last week indicated that Johnson & Johnson officials were aware of problems with the device at least as far back as 2008.

Also, according to a deposition from a DePuy official, a 2011 company review of a patient registry concluded that more than one-third of the implants were expected to fail within five years of their implantation.


Johnson & Johnson has put aside around $1 billion to deal with the costs of the recall and lawsuits.

Last year, British experts at the world's biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements after a study found that, after five years, about 6 percent of people who had used them needed surgery to fix or replace them.

That compares with just 1.7 to 2.3 percent of people who had ceramic or plastic joints.

Kelly said he will ask the jury to assess punitive damages at the end of the trial "to send a message to the defendants who failed to share with doctors what they knew."

He said that when DePuy Orthopedics learned the device they manufactured might be defective, "They acted in a manner that was indifferent."

Saturday, January 26, 2013

Maker Hid Data About Design Flaw in Hip Implant, Records Show

New York Times

                          
The company had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants, the documents show.
       
Still, executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so.
      
Plaintiffs’ lawyers introduced the documents on Friday in Los Angeles Superior Court during opening arguments in the first A.S.R.-related lawsuit to go to trial. The company faces more than 10,000 lawsuits in the United States in connection with the device. An estimated 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
      
DePuy executives insisted before the A.S.R.’s recall in mid-2010 that the implant was working well, despite years of complaints from doctors that it was failing early. In late 2009, the company announced plans to phase out the model but said it was doing so because of slowing sales, not safety concerns.
      
In opening arguments — followed remotely over the Courtroom View Network — a lawyer for DePuy, Alexander G. Calfo, reiterated those positions, telling jurors that DePuy had behaved ethically throughout the A.S.R. episode.
      
“The evidence will show that DePuy acted as an extremely responsible manufacturer,” Mr. Calfo said.
      
But a lawyer for Loren Kransky, the plaintiff in the case, painted a far different picture of DePuy’s behavior for jurors in his opening arguments.
      
The lawyer, Michael A. Kelly, also introduced a number of internal records that suggested that company executives’ concern for profits might have exceeded their worries about patients. For example, Mr. Kelly said, DePuy officials never told doctors that the A.S.R. had failed an internal performance test against another company hip.
      
“They did not report the data to American doctors,” Mr. Kelly said. “They changed the test and tested it against other things until they found one it could beat.”
      
The A.S.R. represents one of the biggest medical device failures in recent decades. According to DePuy’s internal estimates, it is projected to fail within five years in about 40 percent of patients who received one. That is eight times the failure rate of most orthopedic implants.
      
The A.S.R. belonged to a once-popular class of hip implants introduced about a decade ago in an attempt to address problems associated with hips made from traditional materials like metal and plastic. But surgeons have largely abandoned devices in that class because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.
      
DePuy sold two versions of the A.S.R., one used in an alternative hip replacement called resurfacing and one used in standard hip replacement. Only the version used in standard replacements was sold in the United States.
 
   In 2003, DePuy began selling the resurfacing version of the A.S.R. outside the United States in an effort to catch up with a competing device known as the Birmingham hip. But by 2005, some doctors had begun telling DePuy that the A.S.R. was failing quickly after implantation, and company consultants soon stopped using it, records show
 
  The problem, internal DePuy records indicate, was the design of the cup component that fit into a patient’s hip socket. The cup, which was used in both the resurfacing and the standard versions of the A.S.R., had an inside groove against which a surgeon pressed a tool to implant the component. 
 
    The design was flawed because the groove limited the surface area inside the cup in which the device’s ball could rotate as a patient moved. As a result, the ball was more likely to strike the cup’s edge, causing wear and generating metallic debris.
      
In 2007, DePuy engineers tested the A.S.R.’s rate of wear to see if it matched the wear rate of another all-metal hip implant made by the company. It did not.
      
“The current results for A.S.R. do not meet the set acceptance criteria for this test,” that report stated.
The same year, company officials began discussing ways to fix the problem, like redesigning the cup to eliminate the groove. But at the same time, it was actively marketing the A.S.R. to surgeons in the United States, who were implanting it into tens of thousands of patients.
      
“We will ultimately need a cup redesign, but the short-term action is manage perceptions,” one top DePuy sales official told a colleague in a 2008 e-mail. A DePuy executive, Andrew Ekdahl, who is now the unit’s president, was also told by a company consultant that the A.S.R. was flawed, according to another document.
      
In mid-2008, DePuy apparently abandoned the redesign project, an internal document indicates. A company spokeswoman, Mindy Tinsley, declined to comment on the document.
      
In the fall of 2009, the Food and Drug Administration rejected DePuy’s application to sell the resurfacing version of the A.S.R. in the United States, saying it was concerned about, among other things, “high concentration of metal ions” in the blood of patients who received it.
      
DePuy executives soon started making financial estimates of when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant, a document shows.
      
Before the Los Angeles trial began on Friday, DePuy had settled a few other A.S.R. lawsuits.
The plaintiff in the current case, Mr. Kransky, a former corrections official, is dying of cancer unrelated to his hip implant. He also has a number of unrelated illnesses.                  
 

Johnson & Johnson Hip Flop

The Economist

JOHNSON & JOHNSON is one of America’s best known companies and the world’s biggest seller of medical products. Every drug and device business has publicity problems from time to time. J&J is the market leader. Recent years brought recalls, and more recalls, of popular over-the-counter products. Some had too much active ingredient, others smelled odd, yet others had metal shavings. The worst news concerned its ASR hips. The metal implants had the unfortunate habit of shedding debris inside patients. In August 2010 DePuy, a J&J subsidiary, recalled 93,000 ASR hips. The company is now trying to move forward, but the news may grow worse.

J&J faces more than 10,000 lawsuits over its ASR hips, according to a quarterly filing in November. Lawsuits often bring settlements (Reuters reports that J&J’s may be particularly pricey), but they occasionally also bring trials. And trials often bring embarrassment, then bigger settlements or bigger awards. On January 25th an ASR suit will go to court in California. Already, court documents reveal worrying new details. In 2011 an internal study showed that 37% of ASR hips failed within five years. And in 2008, two years before the recall, there was already some evidence of problems with the hips.

These documents follow others, unearthed by the New York Times last year, which suggest safety concerns in 2009. In August of that year America’s Food and Drug Administration (FDA) wrote to DePuy about an application for a modified ASR product (a partial rather than complete hip replacement). The FDA said the indication was “not approvable”, in part because “there appear to be some publicly available data on the ASR that suggest somewhat poorer results for the device than results suggested by the data you submitted”. The letter also pointed to several analyses of patients with ASR hips, noting that the “high concentration of metal ions observed in some of these patients is concerning.”

For those wondering how the ASRs ever got on the American market in the first place—American regulators are supposed to be the world’s toughest—a recent paper in the New England Journal of Medicine provides a helpful history. For the most risky products, such as implanted defibrillators, companies must present clinical data. But many devices require only a so-called 510(k) application that shows them to be of “substantial equivalence” to a device already on the market. The FDA approved the ASR through this channel. (The later ASR product, which was never approved in America, had to meet the harder test.) On January 18th the FDA proposed regulations to require more stringent review for metal-on-metal hips. For those who have replaced their hip replacements, it may feel a bit late.

Evidence Supporting Ban of Metal-on-Metal Hips Grows, as FDA Issues New Guidelines

Public Health Watchdog

Overview: Metal-on-metal hip implants have been a growing health concern since 2010, when Johnson & Johnson recalled DePuy ASR hip implants due to a high failure rate. Since then, researchers have found that the high revision rate and the release of metals is a problem common to all metal-on-metal hip implants. The evidence against metal-on-metal is compelling, so much so in fact that some experts feel that the devices should no longer be sold. Recent information released by the U.S. Food and Drug Administration (FDA) only lends further support to this notion.
  • The FDA has issued new guidelines for patients with metal-on-metal hip implants
  • Metal-on-metal hip implants are known to release metal ions and cause complications such as soft tissue reactions
  • In March, the Lancet published a study showing that metal hip implants fail more often compared to other types of hip replacements; the authors call for an end to their use
Product & Manufacturer

Johnson & Johnson/ DePuy OrthopaedicsBiometSmith NephewZimmerWright Medical Technology
ASR (recalled)M2a MagnumOxiniumDuromCONSERVE Hip Systems
Pinnacle Birmingham BHR Profemur

Side Effects & Complications
  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

Some Calling for a Ban on Metal-on-Metal Hips
Recently, the FDA proposed stricter regulations for metal-on-metal hip implants that would force manufacturers to conduct safety test before selling them. Currently, the implants go through 510(k), a route that approves devices without safety tests so long as they are “substantially equivalent” to previous devices. Some experts, however, feel that metal-on-metal hip implants should be sold at all. In fact, these sentiments were expressed among experts last summer at an FDA advisory panel meeting convened to discuss the implants. In March 2012, the Lancet published a study showing that metal-on-metal hip implants fail at a rate of 6 percent in five years compared to 2 percent for ceramic and plastic devices

A call to prevent unsafe high-risk medical devices from reaching the marketplace

Commentary sheds light on approval process for implantable body parts

IMAGE:This is Rita F. Redberg, M.D., M.Sc., professor of medicine and director of the UCSF Women's Cardiovascular Services.
Click here for more information.

Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.

"This could be potentially very dangerous. Many Americans – patients and even physicians - are not aware of how many devices in this country are on the market without having clinical data of safety and effectiveness," said Rita F Redberg, MD, MSc, professor of medicine and director of the UCSF Women's Cardiovascular Services.

UCSF and the Australian Joint Registry published this month a perspective in the New England Journal of Medicine that reveals the complex history of how metal-on-metal hip implants reached the marketplace. The implants are categorized by the FDA as high-risk devices, yet have been allowed into the marketplace without first testing them. They failed at a dangerously high rate, often requiring reparative surgery at least four times as often as traditional hip replacement surgery.

The perspective's authors are calling for changes in how the FDA approves metal-on-metal hip replacement devices and other high-risk devices for the marketplace.

"If those hip implants are recalled, besides the problem of having to remove them because they're very painful, they can release chromium ions into the blood stream which pose an unknown risk," Redberg said. "Patients would also undergo significant disability having a second, third or fourth hip operation."

U.S. hospitals perform 48 million medical procedures each year, according to the U.S. Centers for Disease Control and Prevention. Of that number, roughly 676,000 patients undergo total knee replacement surgeries and 327,000 undergo total hip replacement surgeries.
"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that's just for the metal-on-metal implants."

An Obscure LoopholeThese high-risk metal-on-metal devices avoid going through clinical trials because of FDA loopholes in the 510(k) clearance, which allow them into the marketplace by claiming "substantial equivalence," which means they are similar to already approved devices or "predicate devices."
"All you have to do is show that your device is substantially similar to a number of other devices," Redberg said. "And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those 'predicate devices' that claimed 'substantial equivalence.'"

Even voluntarily recalled devices can serve as predicates under the 510(k) clearance as long as the FDA did not require their removal from the market or a court did not find they were misbranded or misrepresented in any way.

"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval (PMA) process doesn't always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."

Questions to AskFor patients who are in the process of undergoing a medical procedure, Redberg suggests they stay informed and ask many questions.

"Just like for any kind of procedure, I would ask, 'Are there scientific data that show this procedure or device is going to help me?'" Redberg said. "'Has it been studied in clinical trials? Has it been studied in patients like me? What are the risks? What are the alternatives?' Those are the questions patients should be asking before every procedure."

###

Redberg is the senior author of the paper; co-authors include Brent M. Ardaugh, MPH, MS, of the Framingham Heart Study; and Stephen E. Graves, MBBS, D.Phil, of the Australian Orthopaedic Association National Joint Replacement Registry in Adelaide, Australia.

The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

UPDATE 3-J&J profit tops forecast, mulls sale of diagnostic unit

CNBC

Q4 sales $17.56 billion vs Street view $17.7 billion
* Profit, excluding items, $1.19/shr vs Street view $1.17

* 2013 profit forecast $5.35-$5.45/shr, below Street view

* Shares down 1 pct in late-morning trading

Jan 22 (Reuters) - Johnson & Johnson reported better-than-expected fourth-quarter earnings on Tuesday, due in part to a favorable tax rate, and said it is considering selling a $2 billion-a-year diagnostics business.

The diversified healthcare company said it may sell its Ortho Clinical Diagnostics business, which makes everything from tests to determine blood type to laboratory equipment, or turn it into a stand-alone company.

The strategy comes as drugmakers are shedding businesses and cutting costs due to overseas price controls and pressure on payments from insurers and the government. Pfizer Inc., for instance, is spinning off its animal health products business, and Abbott Laboratories has split off its drugs unit.

Debbie Wang, an analyst with Morningstar, said the J&J diagnostics unit "is a slower grower, and if you're not one of the leaders, it's very difficult to compete in that area."

J&J said it earned $1.19 per share, excluding one-time items, in the fourth quarter, beating analysts' average estimate of $1.17.

A favorable tax rate and cost controls boosted results, according to Piper Jaffray analyst Matt Miksic. He also cited very strong growth in sales of J&J's traditional artificial hips and of artificial knees, whose combined U.S. sales rose 7 percent despite disruptions from Superstorm Sandy in the quarter.

CHARGES FOR HIP IMPLANTS

Including a charge of $800 million, related mostly to recalls of defective "metal-on-metal" hip replacement devices made by its DePuy Orthopedics unit, J&J earned $2.6 billion, or 91 cents per share. That compared with $218 million, or 8 cents per share, a year earlier, when the company took charges of more than $3 billion, including $800 million for medical costs related to the same recalls.

All-metal hip implants were developed to be more durable than traditional implants but have failed at a high rate. In some cases, they have shed metal fragments that have disabled patients. Traditional implants combine a ceramic or metal ball with a plastic socket.

As many as 500,000 Americans are estimated to have received metal-on-metal hip replacements in the last five years, with J&J the largest manufacturer of such products.

The company withdrew its ASR metal-on-metal hip system in 2010 and faces more than 2,000 lawsuits from patients claiming to have been harmed by it.

REVENUE UP BUT MISSES

J&J said global revenue rose 8 percent to $17.56 billion in the fourth quarter, below Wall Street expectations of $17.7 billion.

"The sales miss was driven by lower-than-expected medical device and consumer sales," RBC Capital Markets analyst Glenn Novarro said in a research note.

Navarro said selling the $2.1 billion Ortho diagnostics business made sense. The unit's products include equipment for laboratory diagnostics and blood transfusion screening. J&J's diagnostics sales fell 4 percent in the fourth quarter to $530 million.

Sales of prescription drugs jumped 7 percent to $6.52 billion, helped by strong sales of its treatments for arthritis, psoriasis and HIV.

"By any measure, we have transformed our pharmaceuticals business," Chief Executive Alex Gorsky told analysts on a conference call. The business is bouncing back after several years of anemic sales due to generic competition for some of its top medicines.

But J&J said it expects its blockbuster Concerta treatment for attention deficit disorder to face pressure from cheaper generics early this year.

Fourth-quarter sales of medical devices rose almost 14 percent to $7.38 billion, boosted by the company's recent acquisition of trauma-device maker Synthes.

Sales of J&J's array of consumer products fell almost 3 percent to $14.4 billion, hurt by the stronger dollar and recalls of Tylenol and other over-the-counter medicines that have curtailed availability of the brands.

The company forecast full-year 2013 earnings of $5.35 to $5.45 per share, excluding special items. Analysts, on average, expected $5.49, according to Thomson Reuters I/B/E/S. The company is known for making conservative forecasts at the beginning of the year.

J&J shares were down 74 cents, or 1 percent, at $72.49 in late-morning trading.

Maker Aware of 40 Percent Failure in Hip Implant

New York Times

An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device's early failure rate.

The company's analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.

The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson's DePuy Orthopaedics division knew about the device's problem before its recall and the actions they took or did not take.



The trial, which is expected to begin Friday in California Superior Court in Los Angeles, may also provide a guide to the consequences of the A.S.R. episode to Johnson & Johnson, both for the company's finances and its reputation. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the device. DePuy has offered to pay patient costs for replacement procedures.

The A.S.R. belonged to a once-popular class of hip implants in which a device's cup and ball component were both made of metal. While the A.S.R. was the most failure-prone of those implants, surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient's tissue and bone.
On Friday, Judge J. Stephen Czuleger, who is presiding over the Los Angeles case, unsealed a number of motions that contained portions of pretrial depositions of DePuy officials as well as related company records. Those disclosures, like the company's estimate of the A.S.R.'s failure rate, represent only a tiny fraction of the information that will become public if the trial proceeds.
Over the last two years, plaintiffs' lawyers working on A.S.R.-related lawsuits have reviewed tens of thousands of internal DePuy documents and taken depositions from dozens of company executives.
Executives of DePuy have long insisted that their handling of the A.S.R. was forthright and appropriate. In mid-2010, when DePuy recalled the implant, officials said they were doing so because data that year from the National Joint Registry of England and Wales showed for the first time that it was failing prematurely at a higher rate than competing implants. In 2011, the British implant registry updated its projected failure rates for A.S.R. patients who had had it the longest, saying it was failing in one-third of them. It was that estimate that was challenged by DePuy.

About 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio. An additional 2,000 cases have been consolidated in a California state court. The California case chosen to go to trial this week was selected because the plaintiff, a man named Loren Kransky, has cancer and may not live much longer, lawyers involved in the case said. DePuy has already settled a few A.S.R. cases before trial and it may choose to do so in Mr. Kransky's case as well.

About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design.

Asked for comment about the company's internal analysis, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that it "was based on a small, limited set of data that could not be used to generalize" the overall failure rate for the A.S.R.

Thursday, January 24, 2013

Summary of the data behind the FDA recomendations

Summary of Data

The 1982 Orthopedic Device Classification Panel (the 1982 Panel) recommended that while general controls alone were not sufficient, sufficient information existed to establish a performance standard to provide a reasonable assurance of safety and effectiveness for metal/metal hip systems. FDA disagreed with the 1982 Panel's recommendation and classified the devices as class III stating insufficient information existed to support the conclusion that performance standards or general controls will provide reasonable assurance of the safety and effectiveness of these devices.
On August 8, 2001, the Orthopaedic and Rehabilitation Devices Panel (the Panel) recommended five to two that the hip joint metal/metal semi-constrained prostheses (cemented and uncemented) not be reclassified from class III to class II. The Panel concluded the following:
  • There was insufficient clinical and preclinical testing information to establish special controls.
  • The length and rate of long-term patient followup data were inadequate to demonstrate that special controls would provide reasonable assurance of the safety and effectiveness of these devices.
  • In terms of preclinical testing, the Panel also concluded that validation of wear simulation, non-ideal preclinical wear testing, and biological evaluation of metallic wear debris generated by the device were not established. The particle size of the metallic wear debris generated by these devices is substantially smaller than the particle size of the metallic wear debris generated by other hip joint prostheses and the short-and long-term biological effects from human retrievals or preclinical evaluation of these smaller size metallic wear particles are unknown.
FDA agreed with the Panel and believes the Panel's concerns are still relevant today. Current wear testing methods for metal/metal bearings are limited, and importantly can underestimate bearing wear by an order of magnitude compared to clinical outcomes. There are also no standardized wear methods or consensus among researchers for investigating joint micro-separation, dislocation, cup deformation, demanding gait activities and third-body abrasion. In addition, there is a lack of wear measurements from retrieved metal/metal bearings, so it is a challenge to correlate wear rates from modern devices to adverse events demonstrated clinically like pseudotumors. To complicate matters further, metal/metal bearings have shown unpredictable wear trends in simulator testing, which have not been explained. Therefore, it is a challenge to introduce sufficient special controls to mitigate the risks of modern metal/metal hip devices. The summary of information provided in response to FDA's order issued under sections 515(i) and 519 of the FD Act (21 U.S.C. 360e(i) and 360i) (refer to docket FDA-2009-M-0101) is not adequate to identify special controls sufficient to ensure safety and effectiveness and therefore not adequate to support reclassification of metal/metal hip systems.
 
Recent reports and evaluations further support that reclassification of metal/metal hip systems is not appropriate. The United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) published several alerts in 2010 outlining concerns associated with metal/metal hip systems, including soft tissue reactions (Ref. 1). The final report, published in October 2010, outlines that acetabular cup angle, femoral head size, and metal ion levels are all risk factors that will affect the outcome of metal/metal hip systems. Moreover, a recent publication in the Journal of Bone and Joint Surgery outlines case reports of arthroprosthetic cobaltism in metal/metal hip patients (Ref. 2).
The Australian Orthopaedic Association National Joint Replacement Registry's Hip and Knee Arthroplasty Annual Report of 2010 states that the “metal/metal bearing surface has the highest risk of revision compared to all other bearing surfaces.” The report found the cumulative percent revision rate at 7 years is 6.3 percent for metal/metal, compared to 4.0 percent for ceramic/ceramic, 3.7 percent for ceramic/polyethylene and 4.2 percent for metal/polyethylene (Ref. 3).Show citation box
In December 2011, the American Academy of Orthopedic Surgeons (AAOS) published “Modern Metal-on-Metal Hip Implants: A Technology Overview” (Ref. 4). The AAOS overview provides a summary of clinical outcomes in patients with metal/metal hip systems in comparison to other bearing surface combinations, addresses patient, implant, and surgical factors that may predict successful and unsuccessful outcomes of metal/metal hip systems and discusses the prevalence of adverse clinical problems from metal/metal hip systems in comparison to other bearing surface combinations. The report concludes that “analyses conducted on objective patient-oriented outcomes by two joint registries indicate that, overall, patients who receive metal-on-metal total hip arthroplasty and hip resurfacing are at greater risk for revision than patients who receive total hip arthroplasty using a different bearing surface combination.” The report references the aforementioned Australian registry.
 
A recent article published in a scientific journal raised serious concerns about the failure rates of metal/metal hip systems for the UK population (Ref. 5). This peer-reviewed journal article presented the following findings regarding primary metal/metal total hip replacements: (1) Increased failure rate at 5 years for metal/metal total hip replacements related to larger head sizes; (2) significantly higher risk for revision in female patients (Note: In the United States, labeling includes warnings to discourage the use of metal/metal total hip replacements in females of child bearing age); and (3) revisions for dislocation in men with metal/metal hip replacements were slightly lower, showing some benefit to larger head sizes.
 
These reports, as well as recent recalls of devices from the U.S. market, have indicated that preclinical testing currently used to support marketing clearance of these devices has not been sufficient to mitigate the risks associated with these devices and identify potential clinically-relevant failure modes. These reports suggest that additional study is necessary before special controls can be identified and these devices can be reclassified.

Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

A Proposed Rule by the Food and Drug Administration on 01/18/2013

Action

Proposed Order.

Summary

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements
 
People  have 84 days to respond to this proposed order.

FDA Chief was arrested in prostitution sting operation

Yes, the very same physcian who is responsible for overseeing our hip issues!


Forbes (2011/ must have missed this)

Cardiologist William Maisel Arrested In Prostitution Sting Operation

Cardiologist William Maisel, the deputy director for science at the FDA Center of Devices and Radiological Health, was arrested on prostitution charges after being caught in an undercover sting operation in North Laurel, Maryland. Maisel was one of 10 men arrested on July 13.
The Savage-Guilford Patch reported that Maisel ”approached a plain-clothed female police officer and offered money for sex.” He is scheduled to appear in Howard County District Court on Sept. 20.
According to Pharmalot, the news ”was greeted with a mixture of shock and sadness inside the FDA, which is treating the incident as a personal matter, according to an FDA spokeswoman. The arrest, she tells us, ‘has nothing to do with the work he is doing here.’” Maisel did not respond to a request for comment from Pharmalot.

Prior to joining the FDA Maisel had been the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School. Maisel was a vocal advocate for better safety measures and FDA reform in the wake of the recall of the Sprint Fidelis ICD lead recall.

San Diego Chargers team doctor sues Smith & Nephew over botched hip implant

January 17, 2013 by MassDevice staff

Dr. David Chao, the team physician for the NFL's San Diego Chargers, sues Smith & Nephew over a botched hip implant that cost him $2.2 million in a malpractice settlement.
 
A doctor who blames a botched hip implantation on Smith & Nephew (FTSE:SN, NYSE:SNN) is suing the British medical device company to recoup his $2.2 million malpractice loss.
Dr. David Chao, the team physician for the NFL's San Diego Chargers franchise, sued Smith & Nephew in the U.S. District Court for Southern California, alleging that inadequate training and faulty surgical scissors for SNN's Birmingham Hip Resurfacing implant led to the botched surgery on Kathleen Adams in 2007.

Adams sued Chao for negligence, winning a $2.2 million settlement in 2008. Chao wants Smith & Nephew to cover the tab, accusing the company of training him and other doctors "to push the tips of the scissors into tissue in a manner such that the surgeon did not have a view of the tips of the scissor tines (i.e., 'blind' cuts)," according to court documents.

 

"Dr. Chao performed the BHR procedure on a patient who suffered significant complications and injuries caused by the BHR procedure, despite Dr. Chao precisely following the training provided by Smith & Nephew," according to the documents. "Smith & Nephew caused, in whole or at least substantial part, the loss and damage suffered by the patient and her husband, and in turn the losses suffered by plaintiffs in connection with the claim made against them arising from the BHR procedure performed on May 30, 2007. But for the defendants' failure to properly develop reasonably safe procedures and related surgical equipment, and to provide appropriate training and warnings, the plaintiffs would have suffered no claim against them and would have sustained no loss."

Wednesday, January 23, 2013

Maker Aware of 40% Failure in Hip Implant


Published: January 22, 2013 41 Comments


An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.
    
Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.
      
The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.
      
The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.
      
The trial, which is expected to begin Friday in California Superior Court in Los Angeles, may also provide a guide to the consequences of the A.S.R. episode to Johnson & Johnson, both for the company’s finances and its reputation. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the device. DePuy has offered to pay patient costs for replacement procedures.
       
The A.S.R. belonged to a once-popular class of hip implants in which a device’s cup and ball component were both made of metal. While the A.S.R. was the most failure-prone of those implants, surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.
On Friday, Judge J. Stephen Czuleger, who is presiding over the Los Angeles case, unsealed a number of motions that contained portions of pretrial depositions of DePuy officials as well as related company records. Those disclosures, like the company’s estimate of the A.S.R.’s failure rate, represent only a tiny fraction of the information that will become public if the trial proceeds. Over the last two years, plaintiffs’ lawyers working on A.S.R.-related lawsuits have reviewed tens of thousands of internal DePuy documents and taken depositions from dozens of company executives.
Executives of DePuy have long insisted that their handling of the A.S.R. was forthright and appropriate. In mid-2010, when DePuy recalled the implant, officials said they were doing so because data that year from the National Joint Registry of England and Wales showed for the first time that it was failing prematurely at a higher rate than competing implants. In 2011, the British implant registry updated its projected failure rates for A.S.R. patients who had had it the longest, saying it was failing in one-third of them. It was that estimate that was challenged by DePuy.
      
About 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio. An additional 2,000 cases have been consolidated in a California state court. The California case chosen to go to trial this week was selected because the plaintiff, a man named Loren Kransky, has cancer and may not live much longer, lawyers involved in the case said. DePuy has already settled a few A.S.R. cases before trial and it may choose to do so in Mr. Kransky’s case as well.
      
About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design.
      
Asked for comment about the company’s internal analysis, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that it “was based on a small, limited set of data that could not be used to generalize” the overall failure rate for the A.S.R.
      
In 2011, when DePuy challenged the British joint registry’s findings, the company made similar comments. Other medical organizations, however, have also projected very high failure rates for the A.S.R.
      
Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.
      
In pretrial testimony, Paul Voorhorst, DePuy’s director of biostatistics and data management, said that the company performed several reviews of A.S.R. failures in patients in fall 2011, a year after it recalled the model.
       
Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.
      
Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell off its inventories weeks after the Food and Drug Administration asked the company in a letter for additional safety data about the implant.
       
The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.
      
In other pretrial testimony released Friday, a DePuy engineer stated that company officials were aware in 2008 of reports by an English surgeon that the resurfacing version of the A.S.R. was releasing high levels of metallic ions, particularly in women. As a result of the reports, company officials felt they had to move quickly to redesign the implant.
  

Tuesday, January 22, 2013

J&J Said to Offer Implant Pact That May Reach $2 Billion

Bloomberg Businessweek

Johnson & Johnson (JNJ), which is fighting more than 10,000 lawsuits over its recalled hip implants, is negotiating a potential settlement with patients that may eventually total more than $2 billion, according to five people familiar with the matter.

J&J, the world’s biggest seller of health-care products, offered to pay more than $200,000 a case, according to the people, a deal which could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer as too low, the people said.
In 2010, J&J recalled 93,000 all-metal hips worldwide, including 37,000 in the U.S., saying more than 12 percent failed within five years. Patients who sued contend they suffer pain and are immobilized by joint dislocations, infections and bone fractures. They alleged metal debris from the hips causes tissue death around the joints.

The settlement talks probably won’t end until after the first trials of the lawsuits begin, starting next week, with more set for next month and May, according to the people, who asked not to be identified because they aren’t authorized to speak publicly about the talks.

“The company can’t afford to defend these lawsuits case by case,” said John M. Fitzpatrick, a defense lawyer at Wheeler Trigg O’Donnell LLP in Denver who isn’t involved in the matter.“J&J needs to shut this down. The only way they can do that is through a global settlement. Plaintiffs’ lawyers know that. That’s why everybody has to push to see what they can get.”

‘Litigation Strategy’

Lorie Gawreluk, a spokeswoman for J&J, declined to comment on the company’s “litigation strategy” or any settlement talks.

“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” Gawreluk said in an e-mailed statement about the JNJ unit which made the implants.
J&J, based in New Brunswick, New Jersey, said in a November filing with the U.S. Securities and Exchange Commission that it increased reserves “due to anticipated product liability litigation and costs associated with” the ASR hips. The company didn’t specify the amount of the increase.
JNJ rose 33 cents to $73.23 in New York Stock Exchange trading. The company said in January 2012 that it had spent about $800 million on hip recalls during the prior two years. J&J didn’t provide an estimate of its product-liability costs.

November Filing

J&J faced 10,100 suits over the hips through September, according to the November filing. Most pretrial collection of evidence has been consolidated in federal court in Toledo, Ohio, where 7,240 cases are pending, and California state court in San Francisco, where more than 2,000 cases are filed. Other cases have been filed in state courts around the U.S.

“At this time we have a significant number of trials set with the company and we are primarily focusing our efforts on trial preparation,” said Steven J. Skikos, co-lead counsel of a plaintiffs’ executive committee leading federal multidistrict litigation overseen by U.S. District Judge David A. Katz in Toledo.

“Any comment relating to settlement that does not come from leadership, the court, or from the company itself, is speculative and uninformed,” said Skikos, of Skikos Crawford Skikos & Joseph in San Francisco and Cleveland.

Attorneys involved in the litigation have reviewed more than 50 million pages of documents and have deposed more than 50 witnesses, according to Skikos.

Three Cases

The three cases going to trial in the next few months may offer lawyers guidance on potential liability and damages. The first proceeding starts Jan. 23 in state court in Los Angeles; the second begins next month in state court in Chicago; and a third is slated for May in federal court in Toledo, Ohio.
The negotiations will probably produce an accord that would compensate patients based on factors such as their age, the extent of their injuries and whether they had one or more surgeries to replace defective implants, according to the people.

In 2007, Merck & Co. set up a $4.85 billion settlement fund to resolve lawsuits over its Vioxx painkiller, which it pulled from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes. Under that accord, a court-appointed administrator analyzed each claim, weighing such factors as a user’s age, their length of use, and health risks such as obesity or hypertension.

The J&J hips were made from a cobalt and chromium alloy used in two related models of hips -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed to be replaced, and 12 percent of the ASR Hip Resurfacing System failed.

FDA topics on the MoM hips

All-metal hip implants can damage soft tissue: FDA
Reuters
(Reuters) - Metal-on-metal hip implants can cause soft-tissue damage and pain, which could lead to further surgery to replace the implant, the U.S. health regulator said, following several recalls of the artificial hip parts. All-metal hip implants ...
See all stories on this topic »
Metal-on-Metal Hip Implants: Use With Caution, FDA Says
Medscape
The US Food and Drug Administration (FDA) today issued an extensive set of cautionary guidelines for problematic metal-on-metal (MoM) hip implants that range from selecting the right surgical candidate to determining when to replace the hardware.
See all stories on this topic »
Skirting Regulations with Metal-on-Metal Hips
Illinois Nursing Home Abuse Blog (blog)
Over the last several years many seniors and their families were affected by problems with metal-on-metal hip implants that they received. From the Depuy hip recall to those affecting Stryker products, tens of thousands of residents faced the anxiety ...
See all stories on this topic »
FDA aims to clamp down on metal hip implants
Mass Device
The FDA prepares to issue new regulatory guidelines on metal-on-metal hip implants, potentially requiring companies with devices already on the market to submit new applications with clinical evidence of safety and effectiveness. hip implant x-ray ...
See all stories on this topic »
Rottenstein Law Group Encouraged by FDA's Plan to Tighten Metal-on-Metal ...
DigitalJournal.com (press release)
After more than 500,000 metal-on-metal hip replacements from companies such as DePuy have experienced early failure, becoming the subjects of hip replacement lawsuits and hip recalls, the U.S. Food and Drug Administration said on Jan. 17 that it would ...
See all stories on this topic »


Blogs2 new results for metal on metal hips
FDA: All-metal hip implants can hurt soft tissue, requiring ...
By Staff
Metal-on-metal hip implants can cause soft-tissue damage and pain, which could lead to further surgery to replace the implant, the U.S. health regulator said.
MedCity News
Hip Implant Update: The FDA Demands Proof That Metal-On-Metal ...
By M. Brandon Smith
For several years as metal on metal devices have failed at alarming rates and a question has been repeatedly asked but not yet answered Is there a lack of a clinical advantage with.
The Legal Examiner Regional Blogs


Web10 new results for metal on metal hips
FDA Seeks Stricter Regulation of Metal Hip Implants - WSJ.com
The FDA proposed that companies making metal-on-metal artificial hip joints produce medical evidence demonstrating their safety in order to stay on the market.
online.wsj.com/.../SB10001424127887324468104578248072...
Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews ...
Metal hip implants, the subject of thousands of consumer lawsuits, will have to navigate a longer U.S. review process and should only be offered to patients after ...
www.bloomberg.com/.../doctors-weigh-risks-of-metal-hips-as-...
Metal-on-Metal Hip Implants: FDA to Propose Strict ... - Benzinga
Bernstein Liebhard LLP is currently evaluating lawsuits on behalf of individuals who suffered metallosis, hip implant failure, revision surgery and other ...
www.benzinga.com/.../metal-on-metal-hip-implants-fda-to-pro...
FDA Proposes Tighter Regulations for All-Metal Hip Implants ...
The FDA proposes new regulations for metal-on-metal hip implants after 500000 devices failed prematurely. Lawsuits against J&J reach all-time high.
www.drugwatch.com/.../fda-proposes-tighter-regulations-for-a...
FDA plans to clamp down on all-metal hips - FierceMedicalDevices
The FDA is looking to rework its guidance on all-metal hip implants, proposing a rule change that would require devicemakers to demonstrate the safety and ...
www.fiercemedicaldevices.com/story/.../2013-01-17?...
Metal-on-Metal Hip Implants: FDA to Propose Strict Regulations for ...
We have been waiting for this news from the FDA for a long time. We continue to hear from metal-on-metal hip replacement patients who have suffered painful ...
features.rr.com/article/01343ql2qEa5d?q=Food+and+Drug...
FDA Issues Safety Alert For Metal on Metal Hips | Dangerous ...
Today the FDA has issued a safety alert for metal on metal hip implants. The alert went to orthopaedic surgeons, radiologists, risk managers and patients who ...
www.dangerous-medicines.com/.../fda-issues-safety-alert-for-...
Metal Hip Implants Draw Criticism for Painful Side Effects
Metal on metal hip implants like the DePuy ASR come under fire for causing more injuries than standard hip replacement devices.
www.topclassactions.com/.../3374-metal-hip-implants-draw-cri...
Metal-on-Metal Hip Implants: FDA to Propose Strict ... - PRWeb
Bernstein Liebhard LLP is currently evaluating lawsuits on behalf of individuals who suffered ...
www.prweb.com/releases/metal-on.../prweb10335191.htm
FDA Seeks Stricter Regulation of Metal Hip Implants
By Thomas M. Burton The Food and Drug Administration is studying whether several medical devices already on the market, such as electroconvulsive therapy ...
features.rr.com/article/05yCebueFi0ee?q=Food+and+Drug...