Atlanta Personal Injury Lawyer

Will Broadspire Pay My DePuy ASR Hip Claim After My Statute of Limitations Expires?

M. Brandon Smith — Wed, 16 May 2012 14:20:37 GMT

Based on our experiences and conversations, the average client is usually unaware of the level of sophistication a risk management firm such as Broadspire, who has been hired by DePuy Orthopaedics and Johnson & Johnson to help control and downplay their massive DePuy ASR hip implant recall dating back to August of 2010, and the levels to which it will operate in favor of its clients: DePuy and J&J. Broadspire, in its role as a risk management firm, uses the data and documents sent in by claimants (related to their medical bill reimbursement requests) in order to garner as much information about the patients as possible.

A brief look at Broadspire’s website is illustrative of the context in which the company utilizes medical records of the claimant for the benefit of its client, DePuy and J&J. Broadspire even claims to have a panel of medical professionals at their disposal as represented on their website.

Many clients have come to rely on the reimbursement benefit that affords only out of pocket expenses such as co-pays and deductibles. So the next two key questions become:

Will this benefit continue into the future for the client that needs it?
Will Broadspire continue to pay a patient’s out of pocket medical expenses after their statute of limitations (“SOL”) runs in August of 2012 (for most 2 year SOL states)

In seeking to look at these questions it is important to remember that this “reimbursement process” is not a contracted or promised benefit of funds being administered by DePuy and J&J. This benefit can therefore be changed at anytime without recourse by DePuy and J&J. Some have suggested the purpose of the Broadspire process is really to influence the hip implant victim to not pursue a legal claim or lawsuit for the harms associated with the defective hip implant device. If this underlying theory and goal of Broadspire is fulfilled: Will DePuy and J&J continue to pay reimbursements when the claimant can no longer pursue a civil claim barred by their respective statute of limitations?

In trying to answer this important question, it is also important to know that the harms associated with cobaltism and metallosis are very significant. Many of the known harms associated with the DePuy ASR device are latent and do not manifest for 3-6 years after implantation of the device. Many claimants therefore will only recognize the full extent of their harms after statute of limitation has expired in their given state and many may be left without any recourse for their medical bills, injuries and suffering after that SOL time period lapses. Because DePuy and J&J are not required by law to pay, or even consider, claims that are beyond the statute of limitation, it is very possible, and even likely, that they will tell Broadspire to stop making reimbursement payments on its behalf to patients that are beyond their SOL. Is this a risk consumers, with absolutely no contractual guarantees or promises being made in writing, should be willing to take?

In the estimation of Childers Schlueter and Smith, LLC, we strong suggest the answer should be No as the harms and value of each timely filed and prosecuted claim will include future considerations and medical expenses that may not be accounted for unless the responsible companies are held legally accountable. Given the hundreds of millions of dollars that could potentially be saved from such a course of action, the risk is too great for a claimant to rely and trust a company like DePuy and J&J to do the right thing when there is no legal mechanism to force them to do so. The average claimant will have been exposed to high levels of Chromium and Cobalt that will require ongoing monitoring and treatment. Questions will persist into the future: Will there be long term affects from exposure, such as impaired renal function, hearing, neurologic effects, or conditions that affect the heart, or perhaps effects that will impact to the thyroid gland or cause other forms of cancer like lymphoma?

If you are faced with these same questions and concerns regarding the DePuy ASR hip implant device, the firm of Childers Schlueter and Smith LLC is available to answer your questions and explain your legal options.

Individual considerations of particular circumstances are evaluated including the possible uncertainty of the longstanding effects of metallosis, cobalt, chromium and other known complications. Each represented client has claims that are different in many respects and therefore should be treated as such.

After revision many patients find impairment to their vigor and health. It is not uncommon to have tissue damage and destruction of the joint by the time they were diagnosed. Substantial impairment of range of motion could be a real concern and not just related to an awful complication from revision surgery. The body can only take so much insult to it from repetitive procedures and loss of bone may be a real problem that limits you from the enjoyment of activities and hobbies from physical limitations caused by the failure of the device. Despite these findings, we have already seen that Broadspire routinely denies reimbursements for collateral injuries to the body that, in their sole opinion and discretion, is not directly related to the defective hip implant. Even when other patients’ medical doctors disagreed with Broadspire’s assessment, they still have refused to change or re-evaluate their self-serving opinions and findings in an effort to avoid responsibility and accountably.

Further, routinely, Broadspire has disallowed reimbursements that it deems “chronic”. For the claimant that has substantial bone loss and joint destruction caused by the failed device, it calls into question long term concerns for mobility and whether those patients deserve to be properly treated and be compensated for the harms the DePuy devices have caused, rather than simply labeling these conditions “chronic” and refusing to cover the same. We commonly refer to such tactics and actions as “Putting Profits Over People”.

By our evaluation 28 states have statutes of limitation that are two years or less for product liability claims like the 6,000 other claims already filed by other victims of the DePuy ASR hip implant device all over the Country. For those clients unrepresented we encourage them to speak to a lawyer immediately and consider formally filing a claim/lawsuit before their statute of limitation expires in order to avoid this potential pitfall.

In short the concerns of future problems regarding this device are potentially daunting and will ultimately leave many harmed victims of this device without real options or recourse. The attorneys at Childers Schlueter and Smith, LLC are experienced and understand the methodology employed by DePuy and J&J in their Mass tort strategy to limit and minimize client claims either through the process employed by its agent Broadspire or via the national law firms it hires and employs to limit a client’s potential claim in litigation. Based on our experience, the DePuy defendants will not voluntarily consider or pay a reasonable hip implant settlement that takes into account many of the above considerations without the assistance of an experienced lawyer or firm.

If you want help or just the ability to become more informed about the overall process, please call us at 1-800-641-0098 and ask to speak to one of DePuy hip implant attorneys. You can also contact us on the internet at www.cssfirm.com

Originally posted at InjuryBoard by M. Brandon Smith

Balding Medication May Do Much More Than Just Stop Hair Loss

Darren Tobin — Thu, 19 Apr 2012 10:26:00 GMT

Are you currently taking Merck & Co.’s prostate drug Proscar or Propecia, the company’s drug that treats male pattern baldness or any generics to this prescription drug? New information relating the side effects of this drig that are important for you to know.

The Food and Drug Administration expanded the warning label on finasteride, a drug that Proscar, Propecia, and the generic brands use. Finasteride is used to treat male pattern baldness and an enlarged prostate. The new warning came out this past April 12, 2012.

According to the Associated Press, finasteride has been linked to sexual side affects. The expanded warning states that side effects continued after patients stopped taking the drug.

The newly expanded warning label for Propecia will say that some men who took the drug experienced libido disorders, orgasm disorders, and ejaculation disorders after they stopped taking the drug.

Proscar’s label now has included decreased libido. Both drugs now include a description of the difficulties experienced by men including cases of male infertility and poor semen quality. In these particular cases, it changed for the better or normalized after the men stopped taking the drug.

The drug Proscar was first approved in 1992 in order to treat symptoms in men who had an enlarged prostate and to reduce the chance of urinary retention. The drug Propecia was first approved in 1997 for the treatment of male pattern hair loss.

It took many years for the FDA to expand the drugs’ warning labels. However, with these new warnings both present and future patients will recognize that there are serious side effects related to taking finasteride.

Originally posted at InjuryBoard by Darren Tobin

Proscar and Propecia Not Helping Men

Darren Tobin — Tue, 17 Apr 2012 09:41:51 GMT

The Food and Drug Administration recently added and expanded the warning label on the drug called finasteride. The expansion occurred this past Thursday, April 12^th. Finasteride is a drug used to treat male pattern baldness and treating an enlarged prostate.

The Associated Press published an article saying that the expanded warning label comes after some patients took the drug experienced sexual side effects even after the patients stopped taking it. In Merck & Co.’s prostate drug Proscar, Propecia, used to treat baldness, and the generics to these two drugs use finasteride as the main ingredient.

Finasteride has been linked to sexual side effects, even before this expanded warning came out. Since some particular men who took finasteride and experienced side affects even after they stopped taking the drug continued to experience these side effects. The FDA needed to warn others who may take these dangerous drugs.

Proscar was approved in 1992 for treating symptoms in men who had an enlarged prostate and also used to reduce the chance of urinary retention or the need for surgery. Propecia was approved for the treatment of male pattern hair loss.

The newest warning says that some men who took the drug experienced libido disorders, ejaculation disorders, and orgasm disorders after they stopped taking the drug. Proscar’s label now has included decreased libido. Both drugs now include a description of the difficulties experienced by men including cases of male infertility and poor semen quality. With those particular cases, it changed for the better or normalized after the men stopped taking the drug.

With this new warning, patients will be warned of these serious side affects related to finasteride.

Originally posted at InjuryBoard by Darren Tobin

Cancer and The DePuy ASR Hip Systems: Is There A Link And Should Patients Be Concerned?

M. Brandon Smith — Sat, 17 Mar 2012 04:20:00 GMT

The evidence against metal-on-metal hip implants continues to grow. Late last month, a joint report from the BBC and the British Medical Journal indicated that recipients of large metal-on-metal hip replacements may be at an increased risk of cancer in addition to early hip failure, toxicity and other complications.

As a result, the main regulatory agency in Britain—the Medicines and Healthcare products Regulatory Agency—said that these patients were considered to be in a “high-risk” category that will necessitate annual monitoring indefinitely. That monitoring affects nearly 50,000 patients who received large-head metal-on-metal hip implant devices. Another 15,000 patients aren’t considered high risk even though they have a metal-on-metal device, because of the smaller size of that device.

Ever since DePuy Orthopaedics issued a recall of nearly 100,000 metal-on-metal hip implant devices in 2010, the risks of these products have become relatively well-known. A primary concern with the devices is that the friction created between the two metal components in the device will cause metal shards to enter the bloodstream. That metal is toxic to the body and can cause metallosis or cobalt poisoning, in addition to destroying muscle and bone tissue in the area of the implant. Nearly 5,000 lawsuits have been filed against DePuy already and the company has set aside $3 billion in anticipation of possibly having to compensate patients.

This issue is, of course, not limited to Britain. It is estimated that in the United States a huge proportion of the 500,000 patients who had hip replacement surgery in the last decade received one of the faulty all-metal devices. That means those patients will possibly face the risks that these devices pose and should be alert to the early signs of implant failure. These include:

Pain in the groin, hip or leg
Swelling at or near the hip joint
A limp or a change in walking ability
Chest pain
Shortness of breath
Numbness
Weakness
Changes in vision or hearing
Fatigue
Feeling cold
Weight gain
Change in urination habits

As more information is learned it will be the subject of many updates and new articles in the weeks ahead.

Originally posted at InjuryBoard by M. Brandon Smith

Should Metal on Metal Hip Implant Devices Be Completely Banned In United States

M. Brandon Smith — Fri, 16 Mar 2012 14:19:28 GMT

Ever since DePuy Orthopaedics, a division of Johnson & Johnson, recalled nearly 93,000 of their ASR metal-on-metal hip implant devices in August of 2010 there has been a near constant stream of news about the risks of these metal-on-metal devices and the horror stories of patient suffering.

The issues with these hip implant devices seem to be endless: the risk of metallosis or cobalt poisoning (more here, here, and here), the extremely and unacceptably high failure rate of the devices, how doctors and surgeons downplayed these risks (and here), and questions about the FDA approval process, among others.

Now, surgeons and physicians are starting to take a stand and call for the complete end to the use of metal-on-metal hip replacements. The BBC News reports that the British Hip Society is saying that patients should no longer receive all-metal hip replacements because of the life-long risks that the devices pose. That same report indicates that the problems with all-metal devices don’t actually come as a surprise—but that the problems have been known for decades.

While regulators—such as the Medicines and Healthcare products Regulatory Agency—claim that the implants can still be used, those agencies also recommend that patients will need lifelong monitoring on an annual basis. That monitoring includes blood tests to check for metal debris and scans to detect raised metal levels and adverse symptoms.

The British Hip Society backs its position with some fairly strong evidence. As reported on Zeenews.com, concerns are particularly high for individuals with large-diameter total hip replacements. The Society points to countless patients who have suffered pain, swelling of the joints and damaged tissue around the implant. Some physician members of the British Orthopaedic Association are joining in the call to cease use of the metal-on-metal devices. But their concern isn’t just about the risk of metal debris. Their concern is that these devices promised to be more durable, yet the rate for revision surgeries is over double compared to traditional hip replacement implants.

As more and more information comes out about these metal-on-metal devices, ceasing their use completely starts to make sense. The risks are great and there doesn’t appear to be any increased benefit.. Only time will surely tell but I think everyone, including orthopaedic surgeons, sees the writing on the wall that MoM devices may be a thing of the past in terms of the medical commumnity and their patients.

Originally posted at InjuryBoard by M. Brandon Smith

Distracted Driving-We All Need To Help Stop It

M. Brandon Smith — Thu, 08 Mar 2012 18:13:14 GMT

Distracted driving is a dangerous epidemic on America's roadways. In 2010 alone, over 3,000 people were killed in distracted driving crashes. [Distraction.gov]

Distracted driving is becoming increasingly more common and contributing to far too many crashes. Several actions can be considered a driving distraction – such as adjusting the radio / GPS device or talking on a cell phone – when operating a vehicle.

An estimated 15 people are killed and some 1,200 injured each year in crashes that were reported to involve a distracted driver, according to the U.S. Centers for Disease Control and Prevention (CDC).

Studies have repeatedly concluded that using a cellular device while driving – hand-held or hands-free- delays the drivers’ reaction time similarly to be legally drunk.

Distracted Driving Safety Tips

When operating a vehicle don’t talk and/or text on your cellphone

Program your GPS device before venturing out so that you aren’t trying to figure it out on the highway, thereby distracted.

Avoid any activity that takes your eyes off the road – shaving, applying makeup, eating, looking for something and even talking to the other occupants.

Adults can be just as guilty as kids when it comes to using their phone behind the wheel. Parents need to set an example and turn off their cell phones before driving. Parents should watch this video about distracted-driving (YouTube) with their teens. It’s graphic and upsetting but that is the very point of the video.

The single most important way to end distracted driving is through education. Read the statistics, think about them and most importantly share them with your family, friends and teens. Together we can make a difference.

Visit Distraction.gov to learn about specific state laws governing the use of cell phones and hand-held devices while driving.

End Distracted Driving (EndDD)

In April 2012, hundreds of amazing trial lawyers will be educating more than 100,000 students during National Distracted Driving Month. Find out how you can join and help get the message out.

Distracted Driving – State Laws

Eleven states have enacted bans on texting while driving, while 30 states and the District of Columbia have also passed such prohibitions for all drivers.

While several states are banning texting and driving, Idaho is taking it one step further by adding a bill that would also apply to law enforcement officials. There have been many reports of law enforcement officers driving distracted, putting no only themselves at risk, but also the public.

Take a moment to visit The Casey Feldman Foundation. Casey, a senior at Fordham University and an award-winning student journalist, died July 17, 2009 at the young age of 21 after being hit as a pedestrian. More true stories of distracted driving accidents can be read on the EndDD Web site.

Turning tragedy into triumph, EndDD has since made a material impact on 10,000s of teenage and adult drivers alike in the name of Casey and others like her. Their efforts continue on a daily basis and we all benefit from their selfless acts in this regard. Plain and simple, this organization is making a material difference and saving lives. Because of this the law firm of Childers, Schlueter & Smith, LLC will be joining hundreds of other lawyers from around the country in a common benefit to help reduce and promote distracted driving awareness in April of 2012. 60 for Safety, http://60forsafety.org/, in conjunction with EndDD.org as denoted above is a very worthwhile program that we are delighted to be a part of and hope other lawyers and civil activists will join us in the days ahead.

For those not yet familiar with 60 for Safety yet, here is an excerpt from their website:

60 for Safety is our ongoing effort to kickstart a safety revolution.

The idea is simple — Give us 60 minutes, either as presenter or participant, and we’ll help you make the world a safer place.

Our presenters are the attorney members of The Injury Board from across North America, who volunteer their time, talent and financial resources to offer exciting and informative 60-minute safety presentations on a variety of topics to a wide range of audiences in their local areas.

Our participants are local schools, PTAs, civic groups and community organizations where we hope our safety messages are not just heard but shared with family, friends, neighbors and co-workers.

Our presentations are created around expert information and advice from our safety partners, non-profit organizations like EndDD.org, KidsAndCars.org and more who promote proven methods to end distracted driving, keep kids safe around cars, put a stop to bullying in schools, and other great ideas that help us create a safer world for the ones we love.

Anyone who would like to join us in this great endeavor can find more information at the web site: 60 for Safety, http://60forsafety.org/, where you can also sign up to join in this student awareness and safety movement.

Originally posted at InjuryBoard by M. Brandon Smith

Metal-On-Metal Hip Implants Including The DePuy ASR System: Is Medical Monitoring Needed For Life?

M. Brandon Smith — Wed, 07 Mar 2012 17:08:59 GMT

According to BBC Newsnight and the British Medical Journal, new information and recommendations has been issued to patients that have been implanted with metal-on-metal hip replacements:

The government's health regulator has advised that patients who have undergone large head metal-on-metal hip replacements should be monitored annually for life.

This new metal on metal (MoM) update is a marked change from previous recommendations that patients with these MoM devices be followed and medically monitored for 5 years post implant. Dr Susanne Ludgate, Clinical Director of the MHRA, said in a statement:

As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal-on-metal total hip replacements that are sized 36 millimeters or more because this particular type of hip replacement has a small risk of causing complications in patients.

According to BBC Newsnight, All-metal hips have a high failure rate and rubbing between the ball and cup can cause metal to break off, seeping into tissue and causing complications. But despite the fact that the risks posed by these minute pieces of metal have been known and well documented for decades, patients have been kept in the dark.

There are numerous forms of the metal-on-metal hip implants devices that are a cause for concern, but perhaps the most note worthy of all stems from DePuy Orthopaedics ASR hip implant devices that were recalled back in August of 2010. The law firm of Childers, Schlueter & Smith, LLC based in Atlanta, Georgia has written extensively on this DePuy ASR Recall and the danagerous side effects of metal-on-metal devices previously.

The Newsnight/BMJ investigation shows that in the face of mounting evidence of risk from metal-on-metal hips manufacturers remained silent and regulators failed to act.

Internal company documents, seen by Newsnight/BMJ, show that as early as 2005 DePuy was aware of the damage that could be done to patients by metal-on metal-implants.

This included the possibility that they might increase the chances of patients getting some types of cancer

"In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic," one memo said.

For these reasons and others, many law firms all over the country, like Childers, Schlueter & Smith, LLC, continue to review and investigate metal-on-metal hip implant claims for patients that are experiencing serious problems and complications from their artificial hip implant devices. Although the long term effects from receiving these devices are still under investigation, they remain a serious cause for concern for the approximately 36,000 U.S. patients alone and countless others around the world.

Originally posted at InjuryBoard by M. Brandon Smith

Georgia's Move Over Law Is In Effect

Darren Tobin — Tue, 06 Mar 2012 14:10:28 GMT

This past Thursday, March 1, 2012, two people were injured after a driver struck a police vehicle. The crash occurred on Interstate 20 near Glenwood Road in southeast Atlanta.

According to the Channel Five Fox News, the officer stopped and left his lights on as he went to check on an abandoned vehicle. When the officer stopped, a female driving another vehicle hit the officer’s patrol vehicle from behind. After hitting the officer’s vehicle, the car spun and ran head on into a concrete wall. It took about two hours to clean up the accident.

The officer was taken to Grady Hospital and fortunately has no serious injuries. The female driver was transported to the hospital with minor injuries. Charges are pending against this driver. She was charged with Georgia's new Move-Over Law. This is a new traffic law in Georgia. It requires drivers to move over one lane if there is an emergency vehicle or tow truck with flashing lights in front of them. However, if you cannot change lanes, the law requires you to drive below the speed limit.

§ 40-6-16. Operating motor vehicle approaching emergency vehicle; violations

(a) This Code section shall be known and may be cited as the “Spencer Pass Law.” (b) The operator of a motor vehicle approaching a stationary authorized emergency vehicle that is displaying flashing yellow, amber, white, red, or blue lights shall approach the authorized emergency vehicle with due caution and shall, absent any other direction by a peace officer, proceed as follows: (1) Make a lane change into a lane not adjacent to the authorized emergency vehicle if possible in the existing safety and traffic conditions; or (2) If a lane change under paragraph (1) of this subsection would be impossible, prohibited by law, or unsafe, reduce the speed of the motor vehicle to a reasonable and proper speed for the existing road and traffic conditions, which speed shall be less than the posted speed limit, and be prepared to stop. (c) The operator of a motor vehicle approaching a stationary towing or recovery vehicle or a stationary highway maintenance vehicle that is displaying flashing yellow, amber, or red lights shall approach the vehicle with due caution and shall, absent any other direction by a peace officer, proceed as follows: (1) Make a lane change into a lane not adjacent to the towing, recovery, or highway maintenance vehicle if possible in the existing safety and traffic conditions; or (2) If a lane change under paragraph (1) of this subsection would be impossible, prohibited by law, or unsafe, reduce the speed of the motor vehicle to a reasonable and proper speed for the existing road and traffic conditions, which speed shall be less than the posted speed limit, and be prepared to stop. (d) Violation of subsection (b) or (c) of this Code section shall be punished by a fine of not more than $500.00.

Drivers should be aware of this new law for two reasons - first and most importantly, it is for safety and may save an officer's life and second, the fine for this charge is $500.

Originally posted at InjuryBoard by Darren Tobin

J&J Getting A New CEO Amid Dozens Of Recalls Including DePuy ASR HIp Implant Concerns

M. Brandon Smith — Mon, 05 Mar 2012 21:27:05 GMT

The New York Times reported last week that Johnson & Johnson recently appointed a new CEO, Alex Gorsky. Normally, a change in leadership at the top might not be big news for litigators, but in this case it is. Johnson & Johnson is the company that owns DePuy Orthopaedics, the company at the heart of a major global recall of nearly 100,000 hip replacement devices. And Alex Gorsky was the Johnson & Johnson executive in charge of the medical device and diagnostic group that includes DePuy.

According to the Times article, Gorsky assumed control over the medical device and diagnostic group just as the DePuy recall issue was really beginning to heat up. The FDA had just denied approval for one of DePuy’s hip implants in the U.S. At the same time, complaints were starting to pour in from around the world about that device. Despite executives continuing to insist that the ASR devices were safe, in August of 2010 a massive worldwide recall of the ASR hip systems was issued.

The recall was based on multiple concerns, but chief among them are the risk of cobalt poisoning, caused by friction of the metal-on-metal device components, and the high likelihood of premature failure and the need for revision surgery. Initial news about the high failure rate indicated that 12% of patients receiving the resurfacing device and 13% of patients receiving the total hip replacement ultimately needed revision surgery. But more recently, news has emerged that the failure rate maybe be as high as 49%. Hip replacement is supposed to be a once in a lifetime event, but instead nearly half of patients receiving the DePuy products are confronted with the unacceptably high possibility of needing a second surgery.

Ongoing litigation against DePuy will certainly help to sort out the extent of DePuy’s knowledge of the risks before they put their medical device products on the market. But it’s hard to overlook the fact that the man who—either directly or indirectly—oversaw a major medical device recall has now been promoted. And as the Times article points out, with his pharmaceutical sales background he was promoted over another candidate with a background in science and research. In light of that, the promotion of Gorsky to CEO of Johnson & Johnson just might be an indication of a company that puts profit above safety.

About Childers, Schlueter & Smith, LLC

If you or someone you know has received a DePuy ASR hip implant, contact the hip impalnt laywers at Childers, Schlueter & Smith, LLC for a free case evaluation and consultation regarding your legal rights. Our hip implant recall lawyers continue to review claims all over the country in an effort to help those affected by this dangerous product.

Originally posted at InjuryBoard by M. Brandon Smith

ASR Hip Implant Sold Over Seas Even After DePuy Recall In United States

M. Brandon Smith — Mon, 05 Mar 2012 20:49:21 GMT

A detailed review of safety studies caused the U.S. Food and Drug Administration (FDA) to reject Johnson & Johnson’s sale of an artificial hip in the U.S., but it didn’t stop the company from marketing it in Europe, according to a recent article by the New York Times.

Although the ASR Hip Resurfacing System was rejected by the FDA, the company gained permission to market a variation of the device in the U.S., known as the DePuy ASR XL Acetabular Hip System, under the FDA’s controversial 510(k) fast-track approval process, which only requires the device to be substantially equivalent to one that has been approved.

The agency sent the healthcare giant a confidential letter informing them that studies and clinical data submitted for the purpose of approval in the U.S., was inadequate to determine its effectiveness and safety. But, the company continued marketing the device overseas without notifying regulatory agencies. Further, the company failed to address the non-approval letter in financial reports or presentations to analysts.

DePuy orthopedic division of Johnson & Johnson began phasing out both of the ASR hip replacement systems in August of 2010, after data from the National Joint Registry of England and Wales suggested that the five-year failure rate linked to these devices was 13 percent (about 1 in 8 patients). At the time of the recall, more than 93,000 of the two hip systems had been implanted in people worldwide.

The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients.

Since that time thousands of lawsuits have been filed against Johnson & Johnson in both state and federal courts throughout the United States by individuals who have experienced problems.

A spokeswoman for DePuy confirmed that the company had received the agency’s so-called non-approval letter. But, they declined to release the letter or to respond to questions.

Originally posted at InjuryBoard by M. Brandon Smith