The U.S. Drug Watchdog has a goal of identifying every single one of the more than 130,000 Americans who received the DePuy Pinnacle hip implant constructed of a metal ball and joint, between the years of 2005 and 2010. In an effort to ensure no recipient of the implant who suffered harm is left behind, the initiative to reach all of those exposed to the potential dangers is considered extremely important. Thus far, less than a thousand people have come forward, although the Drug Watchdog believes those numbers should reach well over a hundred thousand—the underlying reason for this very aggressive victim’s initiative. Once victims have been found, they will be provided access to the highest quality personal injury attorneys who possess a thorough knowledge of the deficiencies of the metal ball and joint hip implants.  The ultimate goal for victims of the DePuy Pinnacle hip implant is to ensure they receive appropriate compensation if their hip implant has failed or is in the failure process.

Potential Hazards of Metal-on-Metal Hip Implants

On December 27, 2011, the New York Times reported on the extremely high failure rate of this particular type of hip implant. Although these devices, constructed of a metal ball and joint, should last a minimum of fifteen years, high numbers of the implants are failing within months of the initial surgery. The ball and joint are constructed of cobalt and chromium; during physical activity the two surfaces rub against one another causing tiny metal particles to flake off. In some cases these toxic metal ions find their way to the recipient’s bloodstream causing metallosis or kidney or liver disease, while in others the surrounding tissue is damaged and necrosis takes place. The metal ion shavings can lead to joint immobility in some patients as well as swelling in the groin and back, severe and chronic pain and elevated levels of toxic metals in the blood.

Questions from the U.S. Drug Watchdog

The U.S. Drug Watchdog questions the necessity of the FDA in light of the hundreds of thousands of American citizens currently implanted with a dangerous metal-on-metal hip implant with a high likelihood of failure. When innocent people are faced with toxic levels of potentially harmful metals as well as an entire litany of other potentially serious health issues due to a medical device which appears to have slid right under the FDA’s radar, the question is a valid one.  The Watchdog group wants to help every potential victim of the metal-on-metal hip in whatever ways they can.

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The global medical crises of dangerous metal-on-metal hip implants and other defective medical devices has prompted the European Union to push for patient and implant registries.

A European Parliament committee unanimously passed a resolution at the end of April that would create registries to track patients who receive implants and methods to trace the devices themselves, Fierce Medical Devices reports.

“It is essential to … strengthen surveillance and safety controls and placing on the market requirements,” the committee stated.

Researchers in United Kingdom have been at the forefront of discovering and reporting the frightening and long-term complications from the all-metal artificial hips.

In January, The Telegraphreported that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) was investigating the safety of the implants because a British Hip Society study found that 49 percent of such devices require revision surgery within six years.

By the end of February, the MHRA was recommending that patients with all-metal hip implants — especially those with a head diameter of 36 millimeters or larger — have their devices monitored on an annual basis for the life of the device.

The larger components of the hip replacement system were found to suffer more wear as they rubbed against each other, producing metal shavings.

The Telegraph reported that a new study in the British Medical Journal linked faulty metal-on-metal hip replacement systems to an increased risk of kidney cancer and bladder cancer.

The findings suggest that the metal shavings cause changes to cells that could be precursors to cancer in 20 percent of patients with all-metal hip-replacement systems.

In addition, the metal particles have been blamed for tissue damage, tumors, high metal ion blood counts and metal blood poisoning.

Then came the MHRA warning that yet another hip implant combination—Mitch TRH cups made by Finsbury Orthopaedics used with Accolade femoral stems made by Stryker Orthopaedics — caused high failure rates and the need for early corrective surgeries.

This news was yet another blow to consumers worldwide, who are already grappling with DePuy Orthopaedics’ recall of 93,000 ASR metal hip implants, which included its ASR XL Acetabular System total hip replacement and ASR Hip Resurfacing System, in August 2010. Previously, in 2008, Zimmer Holdings recalled its Durom Cup for similar problems.

Almost 50,000 patients in the U.K. are affected by the metal-on-metal hip implant warnings and recalls, the Daily Mail reports. It’s clear their government intends to act in its citizens’ best interest by pursuing the truth about the dangerous hip implants and taking steps to track medical devices in the future.

Certainly, the sluggish U.S. Food and Drug Administration (FDA) could learn a lesson from its British counterpart.

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May 10, 2012 by Arezu Sarvestani

The quarrel between hip implant maker DePuy and researcher Deborah Cohen may be more than an academic altercation playing out in the pages of the esteemed British Medical Journal – it may be a preview of things to come.

Troubled Johnson & Johnson (NYSE:JNJ) subsidiary DePuy submitted a formal response this week in the form of a letter to the Journal, highlighting the “factual errors and omissions in Deborah Cohen’s article on the safety of metal-on-metal (MoM) hip implants.”

The arguments laid out by DePuy spokesmen Graham Isaac and Simon Sinclair may represent the company testing the water for its upcoming defense of its metal-on-metal hip implants.

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“This response serves as a preview of the defenses J&J will raise in the DePuy Pinnacle lawsuits and reiterates points they have already raised in the DePuy ASR lawsuits,” Felecia Stern, partner at the law firm of Bernstein Liebhard LLP, told MassDevice.com.

DePuy has been the subject of class action and multi-district lawsuits, public outcry and FDA scrutiny since the company launched a recall of a pair of metal-on-metal ASR hip implants in August 2010.

A multi-district lawsuit combining more than 1,100 hip replacement lawsuit for DePuy’s Pinnacle is underway in the U.S. District Court for the Northern District of Texas. The 1st of the ASR implant lawsuits should begin jury trials later this year.

“What I found most interesting was the fact that the authors claim that Depuy ‘monitors closely data related to Ultamet MoM implants’ (used with the Pinnacle system) yet they were silent on whether DePuy had monitored data concerning the ASR,” Stern noted. Her law firm has filed lawsuits on behalf of patients claiming injury against both the Pinnacle and ASR hip implants.

The Pinnacle implant, a predecessor to the ASR, is a metal-on-metal was dragged into the fray after DePuy recalled 2 MoM ASR implants over concerns about higher-than-normal failure rates and the potential for the devices to shed minute particles into a patient’s bloodstream as the implant’s components rubbed against each other

“DePuy monitors closely data related to Ultamet MoM implants from many sources, including published and unpublished data from national joint registries, published papers, company sponsored clinical trials, and internal complaint data,” the company wrote.

A study published in February, led by Deborah Cohen, argued that “hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices.” The report spurred a contentious back-and-forth, in print, between a pair of DePuy spokesmen and the study’s main author – a rare move for a company with pending litigation on the matter.

Cohen was particularly vehement about a perceived lack of clinical testing for the devices, given that both sets of writers agreed that the issue of potentially toxic compounds making their way into patients bodies had been researched for decades.

“It begs the question why no clinical studies were carried out before the metal-on -metal Pinnacle hip system (called Ultamet in your letter) was put onto the market,” she wrote. “Given this, one would have thought DePuy would carefully follow up a cohort of patients once the implant was on the market measuring ion data and monitoring both local and systemic effects.”

In a response published this week, mostly reiterating comments submitted on the original study, the DePuy writers rebuffed the notion that DePuy had concealed MoM erosion risks – an allegation Cohen later denied making.

The company added that all hip implants wear, and that the latest generation of MoM hips were a response to erosion concerned raise about polyethylene hips.

“All hip implants, irrespective of the materials used, are known to wear,” DePuy’s authors wrote. “Cohen suggests that the current generation of MoM hip implants was introduced despite known risks and without a clear clinical need. This is not true. Early failures in the first generation of MoM implants were reported, but subsequent reviews showed that many of them were successful long term, with much lower wear than polyethylene systems.”

The response followed Cohen’s fiery rebuttal to DePuy’s original comments on the study. Cohen shot back early this month, stating that DePuy’s report “sidesteps the substantive concerns described in the BMJ feature.”

DePuy had called Cohen’s study “unnecessarily alarmist,” to which Cohen replied, “We do think it is necessarily alarming rather than ‘unnecessarily alarmist’ that design changes to implants that were already known to release potentially toxic metal ions passed through the regulators without any need for clinical studies.”

DePuy did not respond to requests for comment.

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US Drug Watchdog Now Offers To Help All Recalled DePuy ASR Hip Implant Recipients Get Identified To The Best Attorneys Out Of Fear These Recipients Won’t Be Compensated

The US Drug Watchdog says, “The DePuy ASR metal-on-metal hip implant was recalled in August of 2010, because of a high failure rate.” According to court records there are about 40,000 DePuy ASR recipients in the United States, and only about 3400 individual DePuy ASR hip implant recipients have been identified by the federal court in Ohio, that is handling the litigation for this recalled hip implant. At this point the US Drug Watchdog does not care if a recipient’s DePuy ASR hip implant has failed, or not. They think it is vital to get every recipient identified by the federal court in Ohio, and they can suggest national caliber attorneys, for every recipient. Their biggest fear is once the federal litigation involving the DePuy ASR is over, and the individuals signed up get their settlement, it gets much more difficult for new victims of a DePuy ASR failure to get anything. The US Drug Watchdog says, “If you received a recalled ASR DePuy hip implant, even if it has not yet failed, don’t get left behind, we will try to help you find the best possible law firm to help you. Please call us anytime at 866-714-6466.” http://USDrugWatchdog.Com

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The past couple of years have seen a steady drumbeat of concerns by some lawmakers that health regulators are doing too little to protect consumers from hastily approved devices that can cause injury or even death.

“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to 1 million Americans earlier this year. “The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.

“This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market,” he wrote.

For decades, certain devices have been cleared by the FDA without the manufacturers ever having to test them in human beings in clinical trials, which take time and money.

The fast-track approval process is known in the industry as Pre-market Notification, or 510(k), named for the numbered section of the Food, Drug and Cosmetic Act.

Intended for low- and moderate-risk medical devices, such as blood pressure cuffs and hypodermic needles, too many high-risk devices, such as hip implants and heart valves, were cleared through the 510(k) process and later found to cause life-threatening incidents, according to Guest.

Consumer Reports, an independent nonprofit, publishes a monthly magazine, as well as newsletters focusing on health, money, travel, home and garden, weddings and other topics.

It has a total of 8 million subscribers to all of its publications and 800,000 for its On Health monthly newsletter, which was established in 1989. On Health maintains its own medical experts, but sometimes taps outside physicians.

Consumer Reports’ advocacy arm, Consumers Union, would not disclose how much money it is spending on efforts to change the medical device approval process, but says its campaign is a top priority. The campaign was launched late last year at its annual Patient Safety Summit.

The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as “fatally flawed” and said it should be scrapped.

The FDA, for its part, believes that the current device-approval process could stand some improvement. Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said 510(k) should not be eliminated, but thought changes to the process were in order.

Lawmakers have the authority to change the way devices are approved. FDA cannot change the process, but it can change the way it classifies devices. Hip implants and heart valves, for example, are categorized as “moderate risk,” which allows them to go through the 510(k) process.

The medical device industry has argued for either leaving the 510(k) process as it is or further streamlining the approval process. Most new medical devices – about 4,000 in 2009 – are cleared through the accelerated program.

AdvaMed, the trade group representing medical device makers, warns that more regulation would stifle innovation and that streamlining the process is necessary to move the large volume of products awaiting approval through the system.

HIGH-PROFILE CASE

In one of the highest-profile cases, Johnson & Johnson in August 2010 recalled its ASR hip implants after they failed at a higher-than-expected rate, with some patients experiencing pain, joint dislocation and sometimes systemic damage to the central nervous system, thyroid and heart. Many patients have cobalt and chromium poisoning from the implant.

Surgical mesh – used to repair or reinforce soft tissue where there is weakness, for such procedures as pelvic organ prolapses – has also been a subject of major recalls, including products by Boston Scientific Corp and J&J. Almost every synthetic mesh device on the market today cleared through the 510(k) process was based on the ProteGen mesh, manufactured by Boston Scientific, even though it was recalled in 1999.

Jaye Nevarez, of Lakewood, Colorado, said she never would have had J&J’s Gynecare surgical mesh implanted in her body four years ago had she known how easy it was for products to gain approval and how severe the complications could be.

At age 50, Nevarez cannot walk because of nerve damage that she believes is a consequence of mesh erosion.

“I’m alive. I function, but I don’t function well. I’m in pain every day, all day long, day after day, and it doesn’t go away. It’s not worth it,” said Nevarez, who is suing J&J.

A J&J spokesman declined to comment.

BASIS FOR REJECTION

Possible changes to medical device regulations are especially relevant this year, as Congress is reviewing the fees the industry pays to the FDA in exchange for speedier review times. Since fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, the bill often serves as a vehicle for broader FDA-related changes.

Last month, U.S. congressmen Edward Markey (D-Massachusetts), Henry Waxman (D-California) and Jan Schakowsky (D-Illinois), introduced legislation – the Safety Of Untested and New Devices Act of 2012, dubbed SOUND Devices Act – that would give the FDA more authority to reject a manufacturer’s application for a new device if it was based on a similar product that was recalled.

Guest said any new law should also require rigorous testing of the devices upfront and a national registry that would track device performance over time. Raising manufacturers’ user fees that fund FDA could help fund a registry, he said.

Some 93,000 people have been implanted with DePuy‘s ASR hip system worldwide and J&J faces more than 2,000 lawsuits in state and federal court.

“When clients call, they are livid when they find out how (the device) was approved. They say ‘I don’t understand how this was able to get on the market in the first place,’” said attorney Felecia Stern of Bernstein Liebhard LLP, a New York law firm handling more than 200 cases against J&J over the ASR hip. However, these patients, she said, are usually too overwhelmed by medical problems to get involved in activism.

Carol Kochhar-Bryant, a 62-year-old professor and senior associate dean at the Graduate School of Education and Human Development at George Washington University, was one recipient of the Consumer Reports’ email blast.

She had the ASR implanted in 2009. The joint failed after a couple of years and she said it left her with high chromium and cobalt levels in her bloodstream, a condition known as metallosis that some experts fear could cause cancer and other serious problems. She continued to have pain and recently underwent a second, more extensive surgery to scrape out metal shavings embedded in the surrounding tissues of her hip and replace the entire ball and socket with a new device.

“I was assuming there was a much more rigorous process,” she said, referring to the approval process of her hip replacement. “I did not quiz my doctors on how these things come to the market. They gave me a lot of pamphlets on it. I went back to look to see what adverse events were listed, but there’s nothing in there.”

Katie Ayers, 42, also had the ASR hip implanted when she was 36 years old. Blood tests revealed that she also had elevated levels of cobalt and chromium, and she decided to have the device replaced with a J&J ceramic implant.

Ayers is suing J&J and testified before Congress last year. Kochhar-Bryant said she has not yet decided on legal action.

TWO STUDIES, DIFFERENT CONCLUSIONS

AdvaMed cites a September 2010 study by Battalle, a research organization it commissioned to look at the issue, that found that Class 1 recalls, the most serious kind, accounted for only 77 out of 46,690 (0.16 percent) of the medical devices – including low risk devices – that were cleared through the 510(k) process between January 1, 2005 and May 1, 2010.

But a more recent study of the same data had a far different result. The study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen, the high-profile cardiovascular medicine chair at Cleveland Clinic, was published in the peer-reviewed medical journal, Archives of Internal Medicine, in February 2011.

Zuckerman said Battalle understates the problem because many products are often recalled after they have been on the market for five years or more. In addition, she noted that the Battalle study only looked at raw numbers of device approvals and did not consider how many people were affected by recalls.

“If you care about public health, you look at how many devices were recalled and how many lives were put at risk,” said Zuckerman.

She said her study concluded that more than 70 percent of the high-risk recalls were for medical devices that the FDA categorized as “moderate risk” and therefore went through the 510(k) process for approval.

AdvaMed, however, said the real problem at FDA is growing delays and inconsistency in product reviews. AdvaMed Senior Vice President David Nexon said consumer groups often do not have a realistic understanding of risk.

“Consumer groups, which typically represent primarily people who are healthy, often have a very heavy emphasis on avoiding any risks,” Nexon said.

“Patient groups … have an equally strong interest in the development of new treatment and cures, and they understand that there is always a balance between risk and benefit,” he added.

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I have spent a great deal of time contemplating this weekend as you may have seen from my most recent comment! I was asked to sit down and consider my compensation claim to be put to Johnson and Johnson De Puy and I found it not quite the liberating experience I thought it might be. Mainly because I like many others would be doing so and thinking: “This is my life, my damaged body and my uncertain future!”

This process did however prompt me to go back over the last 18 months or so and consider all that has happened, the amazing people I have had the honour to meet, I have realised what is was for so long that many of my patients used to describe to me as the ‘medical merry-go-round”, and above all else, I have realised just how dangerous a faulty device, that was blindly approved for use, installed by surgeons who were either ill-informed or ignorant to it’s risks, is to the poor patients who have been unfortunate enough to receive these devices.

To those who are unaware, the 2 biggest class actions here in Australia have combined (Shine Law Firm and Maurice Blackburn Legal Firm) and now we all just have to wait and see what Johnson & Johnson De Puy decide to do! I also feel for those who have received a Birmingham or any other metal on metal implant as I believe that more and more evidence is coming to the surface about just how risky this technology is to those who have had it installed in their bodies. I hope that all of you have been given some opportunity to seek re-course if you have had your health adversely effected in any way. I would implore all of you to keep seeking advice, keep asking questions and please don’t be afraid to have it removed if you are concerned in any way.

I have had the pleasure of meeting people like Bob Lugton and others who all continue to suffer each and every day from either the after effects of their original implant or the supposed correction surgery that has either failed or was so complex that their bodies will never be the same. It is because of people like Bob and others that I will continue to speak up and let as many people as I can know about the damage and distress that these devices have caused.

We have now had the results of the Senate inquiry handed down, a handy amount of media interest in it and the issues that were behind its formation and of course the class actions continue. We need to keep this issue in front of the public, if you are asked about it don’t be afraid to speak up, if you are not sure or worried, you can always refer any one interested to those of us who have been a part of the process and the media for a while. Please be assured that this is not going to go away, everyone should realise that the health issues related to these implants are only going to get worse until the medical fraternity realise that desperate research and medical funding is going to need to be poured into looking after the health of those of us effected sooner rather than later.

I hope that all of you have a good week, that the pain is bearable, any little wins you have are celebrated and above all else, don’t give up!!

Stuart Cain

By BARRY MEIER

Published: February 14, 2012

Andrew Testa for The New York Times

Dr. Antoni Nargol, right, shown at the University Hospital of Hartlepool in England. Dr. Nargol, an orthopedic surgeon, worked on the study that DePuy submitted to the F.D.A. and later became a critic of the device.

I

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Every thing I thought was fine.  Got full mobility back.  No pain.  Loved it.

In fact, in October 2010, I went to my DR in regards to getting my Right hip done. I wanted another BHR.

Sent me for X-Rays etc.  Nothing about having ion blood test.  Did get asked if I ever had one?  My reply was no.  My surgeon last words were, only come back if you get a problem.  Nothing about getting tested.

So, by now I have left the UK and now living in Australia.

My husband and I took out private health care, because of my hip problem.  I have mild hip Dysplasia.

Confirming that I would need to go through another surgery, I put off having the surgery until I thought it was the right time to get it done.

August 2011 I looked into surgeons who do do BHR.  As my Left hip was still not causing any pain.

It was only when I booked in to see a surgeon, did he ask questions, and showed concerns of a cyst over my Left Acetabulum implant.

Here I was asked if I ever had a test done for ions?

First thing first, he sent me for a blood test and a MRI and more X-rays.

I got called back to the surgeons office.

My ion levels were

1220 *nmol/L  (Chromium 63.5 *ug)
1849 *nmol/L (Cobalt 109.0 *ug/L)

That put paid to me having my Right hip done with a BHR.

My Left hip got revised in November 2011.

I am hoping to get my Right hip done early this year some time.

I knew there had been a recall on Depuy and J&J.  But not much on S&N?

Looking back over the past 2009/2010, I was experiencing head ache, not like the normal head ache, but pressure building inside my head.  Forgetfulness.  Menopause symptoms which my test came back normal for.

Prior to my revision hip on November 2011, its all a bit of a blur.  Nose bleeds, hormones up the poll, fatigue was the biggest over all factor.  Really having to listen to people hard and concentrate on tasks.  There were times where my body hurt and I had no energy.

Over my revised Left hip op, nose bleeds are far less.  Menopause symptoms have gone, no fatigue, and no ringing in the ears and having to concentrate on everything one at a time.  Multi tasking is back on the agenda.

I so happen to be reading the Telegraph on 31 January, when I saw the article about S&N implant recall.

Found this blog, and I am adding my story.

Ions in the blood, interest me?  Having a group fitness background, keeping fit is part of my job and helping other gain fitness.

So this is why I am looking into BHR and people who have experienced similar to myself.

I am waiting on my Bio-mechanics report on my BHR implant.  Apparently makes interesting reading.

My consultant is doing a paper on his findings.

I look forward to seeing him again in March to talk about these findings.

If they get reported or forward to some where.

Information needs to be logged.

Still in the process of retrieving my operation medical notes from 2/2006.  Both my Consultant and myself have requested them, and any prior x-rays etc.  So far heard nothing back.

Harder again as I am out the country.

One positive thing has come from this, I have not been a burden on the NHS system this time.  Not sure how long I would of had to waited.

Would love information and updates on this matter.

Your sincerely

Tracy

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All-Metal Hip Replacements: Not All Patients Informed of Recall

British orthopedics officials have written surgeons, fearing not all patients who got “metal-on-metal” hip replacements know they were recalled.

The British Orthopaedic Association has notified surgeons because they are concerned some of the 40,000 patients who got “metal-on-metal” hip replacements never got the recall notice.

Professor Joe Dias, the association’s president, told The Sunday Telegraph the letters said the records held by DePuy — a subsidiary of Johnson & Johnson — show that just over one-third of the patients with the devices were recorded as having participated in the recall.

Dias said it was possible other patients had been contracted by hospitals and undergone checks, without their details being centrally logged but that he was concerned some patients were never contacted.

The surgeon said private hospitals and large National Health Service units seemed to have been thorough in contacting patients, it was less clear if small NHS units had.

“My worry would be about cases where surgeons have retired, and no-one is following up on the patients they treated,” Dias told the Telegraph.

The implants’ manufacturers cannot contact patients directly, because they do not have access to their records.

The metal-on-metal implants were considered stronger and were often given to younger patients, but friction between the metal ball and cup causes minuscule metal filings to chip off and seep into the blood causing inflammation, destroying muscle and bone, Dias said.

There are concerns fragments containing cobalt and chromium could put the kidneys and other organs at risk. In 2010, patients were told to be checked annually for at least five years.

Copyright 2012 United Press International, Inc. (UPI). Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI’s prior written consent.

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Johnson Takes $3 Billion Hit on Hip Recall

By REUTERS

Published: January 24, 2012

The company’s DePuy Orthopaedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.

The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.

“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.

The company forecast 2012 earnings of $5.05 to $5.15 a share, compared with the consensus Wall Street view of $5.21.

William Price, a company spokesman, said most analysts had not factored in damage from the stronger dollar.

Johnson & Johnson reported better-than-expected fourth-quarter earnings, helped by favorable taxes and sales of new prescription drugs. The company earned $218 million, or 8 cents a share, in the quarter. That compares with $1.9 billion, or 70 cents a share, a year earlier, when it also took charges for recalls of hip replacement devices.

Excluding special charges, Johnson & Johnson earned $1.13 a share. Analysts had expected $1.09, Thomson Reuters said.

Johnson & Johnson, which is based in New Brunswick, N.J., said global sales rose 3.9 percent in the quarter, to $16.26 billion, slightly below analysts’ target.

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