The DePuy ASR Metal-on-Metal Hip Implant: A Scientific Analysis of its Problems

The last ten years have seen surgical replacement of hip joints with an artificial prosthesis increase significantly. The main reason for this surge in hip replacement surgeries is our aging population. With people living longer, more active lives, degenerating hip joints can put a halt to that activity. From 1997 through 2004, the number of hip replacement surgeries increased nearly 50% and if the trend continues it is estimated that the annual number of hip replacements in the United States will reach 600,000 by 2015.

Factors in Hip Replacement Surgery

Primary reasons for patients undergoing hip replacement surgery include chronic pain, impairment of daily functions and severe arthritis in the hip joint. The most common type of arthritis leading to total hip replacement is osteoarthritis and is generally seen with aging or trauma to the hip joint. In some instances necrosis of the hip can be present, usually caused by a fracture, alcoholism, lupus, or taking steroid drugs such as prednisone. Patients may experience progressively worsening chronic pain which prohibits them from walking, climbing stairs or even getting up from a sitting position.

Types of Hip Implants

There are many different types of hip replacement implant including the metal-on metal, metal-on-polyethylene and metal-on-ceramic as well as the implants which are 100% ceramic or polyethylene. Other than the materials the implant is constructed with, the only other major difference is in how the implant is affixed—it can be cemented to the bone or attached in such a manner that it grows into the patient’s remaining bone. The idea behind the cobalt and chromium metal-on-metal hip implant was to create an implant which would not have to be re-done for fifteen to twenty years—unlike the ceramic and polyethylene hip implants which last approximately 8-12 years. 

“ASR” type Chromium and Cobalt Poisoning also being seen in Pinnacle Hip Implant Recipients

The DePuy ASR metal-on-metal hip implant has repeatedly made the news following a voluntary recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not suffered under the recall stigma, many feel that it offers the same risks to implant recipients as the ASR. And, in fact, many attorneys are constantly asked by their clients about the differences between the ASR and the Pinnacle. The primary distinction between the two metal hip devices lies in the fact that the Pinnacle uses an insert liner between the acetabular cup and the femoral head while the ASR does not. It has been theorized that the ASR cup was too shallow for the head, leading to the ball hitting the edge of the cup and metal shavings to shear off into the body, also know as edge-loading.

While the Pinnacle’s cup was designed to give greater depth and allow the femoral head to move more freely within the socket, in some cases it still has been know to cause metallosis in implant recipients when the cobalt and chromium ions migrate around the body. Metal poisoning can cause a wide variety of adverse medical events. Many ASR recipients have had cardiovascular, renal, neurological and thyroid issues although studies done in the 70’s do not definitively tie these metals to cancer. Unfortunately, due to the lack of comprehensive studies on safe levels of cobalt and chromium in the body and the effects of toxic levels, nobody really knows just how dangerous these metals can be should they migrate to the bloodstream. The metal shards can also lodge into the surrounding tissues causing degeneration and destruction.

Attorneys of Sullo & Sullo Seeing DePuy Hip Implant Lawsuits Increasing

While many other firms have seen a drop in the number of metal hip implant clients, Sullo and Sullo attorneys have actually seen those numbers climb. Andrew Sullo, Class Action Lead Counsel & Managing Partner notes that “Although many firms have noticed a slowdown in the number of clients hiring them for DePuy ASR and Pinnacle lawsuits, our firm has not. I believe that is because we are constantly offering our clients new and updated information. Our job is to inform all metal-on-metal hip recipients that even though their hip may not have failed yet, it could and after August 26^th they may lose rights to recover compensation from Johnson and Johnson.”

With the statute of limitations coming up soon on the ASR metal-on-metal hip implant lawsuits, Sullo & Sullo is experiencing an increase in the ASR recipients who are coming forward and asking to be a part of the lawsuit. Many clients in the lawsuit have experienced adverse health effects as a direct result of having an ASR all metal hip implant put into their body.  On the other hand, many have experienced little or no pain with their ASR hip implant but have elected to join the lawsuit that they can be financial protected at a point in the future should their ASR device fail. Through no fault of their own, these people have become victims of a heavily flawed system which allows harmful medical devices to be sold to the public. The ASR was approved in 2005 by the FDA under the controversial 510(k) process which allows medical devices to essentially ride in on the coattails of other medical devices which have come before them. In some cases approval is granted based on a device which has actually been discontinued because of the number of problems associated with it.

Current Updates on the DePuy ASR Hip Recall

The DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon thereafter both DePuy and the FDA began receiving reports of adverse health events. Some believe that the much less rigorous 510(k) approval process which allows manufacturers to skip clinical trials could be at least partially responsible for the adverse health effects in the thousands of ASR recipients. Following a flurry of complaints, DePuy voluntarily recalled the ASR on August 26, 2010. At present there are approximately 4000 DePuy ASR lawsuits consolidated into an MDL in Ohio as well as a smaller mini-state consolidation in Chicago with approximately 600 plaintiffs and another in California containing 1500 or so plaintiffs. Since California is experiencing so many financial problems, the plaintiffs and their attorneys are expected to face problems in getting a trial setting.

The MDL, or multi-district litigation system is meant to streamline the litigation process, taking advantage of the fact that there are similar allegations from all plaintiffs made against the defendants—in this case DePuy and Johnson and Johnson. The first trial regarding the ASR was scheduled to begin in state court in Las Vegas in mid-December although it has been rumored the case settled prior to trial. Should this be true, it would be a positive precedent for all other ASR lawsuits to follow. The metal-on-metal design came about due to its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed the cobalt and chromium ball and cup to shave off microscopic metal ions into the body, entering the surrounding tissues or even the bloodstream. The FDA recently held a two-day panel to discuss the safety of the metal hip implant. 

Problems with the DePuy Pinnacle Hip Implant: Current Reports

As of this date the Pinnacle metal-on-metal hip implant device manufactured by DePuy has not followed in the recall footsteps of DePuy’s other hip implant, the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle has any problems—and, in fact, call it the best metal-on-metal hip implant on the market today—many recipients of the device feel it has some of the same flaws as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the predecessor of the ASR which followed in 2005. The ASR is strictly a metal-on-metal hip implant device while the Pinnacle name includes metal-on-ceramic and metal on polyethylene models as well.

Nearly 150,000 Pinnacle all-metal hip replacements have been implanted compared to 93,000 ASR’s worldwide—approximately half of those in the United States alone. Both the Pinnacle and the ASR all-metal hip implants were approved under the controversial 510(k) FDA approval process. This particular process allows the majority of medical devices to get to market quickly by showing they are substantially comparable to a device which has already gained approval. The process also allows a product to get to market without expensive clinical trials however in some cases the approval process has been predicated on a device which is no longer marketed—even due to poor performance. 

Chromium and Cobalt Poisoning: What are the Long Term Side Effects of Metallosis?

It is likely that the recipients of a metal-on-metal hip implant have heard about the possible consequences from the metal shavings which can be released into the body when the metal cup and ball rub against one another during normal activities. Tiny ions of cobalt and chromium shear off when the two surfaces meet and those ions can lodge in the surrounding tissues or can end up in the bloodstream. As more and more metal hip implant patients are realizing the seriousness of metal toxicity, blood testing for elevated levels of metals is increasing. In many cases patients have been found to have levels of cobalt and chromium in their bloodstream which are as much as a hundred times normal levels. 

Although slightly elevated levels of these metals are fairly normal for patients with metal-on-metal hip implants, extreme elevations can be very dangerous—and anxiety-producing for the patient. DePuy released a report indicating that concentrations of the metals greater than 7 parts per billion are cause for concern. The Mayo Clinic has set somewhat different reference values, stating that blood serum concentrations of chromium greater than 1ng/mL suggests significant wear of the metal implant while serum concentrations greater than 5.0 ng/mL of cobalt can be considered toxic and also suggest significant wear of the prosthesis. Remember that 1 PPB (part per billion) equals 1.0 ng/mL.

Statute of Limitations and the Likelihood of Reimbursements by Broadspire

Broadspire is one of the foremost third-party risk management administrators to large insurance companies and employers. Broadspire has been retained by DePuy to engage in damage control regarding the ASR hip implant claims.  It is likely that few people who have suffered medical harm because of a metal-on-metal hip implant truly understand the lengths such companies will go to in order to save their client as much money as possible. Broadspire is under orders by Johnson and Johnson and DePuy to downplay the public outcry regarding the ASR hip implant recall to the fullest extent possible. One of the avenues Broadspire will use for this specific purpose is to gain as much knowledge about patients as possible through the use of claimant data.

Will Benefits Be Discontinued?

If you or a loved one has suffered an adverse medical event which is directly related to a metal-on-metal hip implant then one look at Broadspire’s website should give you an idea of the true nature of this company and the depths they will go to in order to benefit their client.  Privileged medical records are being used for the benefit of Johnson and Johnson and DePuy via an entire panel of medical professionals at their beck and call. Many of those victims of the hip implant currently rely on the reimbursement benefits being offered through Broadspire which covers their co-pays and deductibles. The question on everyone’s minds now is whether those benefits will continue after the statute of limitations runs out in August, 2012.

Metal-on-Metal Hip Implants Tied to Metallosis?

Corrosion, serious tissue reactions and metallosis are all possible side effects for recipients of the metal-on-metal hip implant. The safety of these devices has come under serious question with many recipients requiring revision surgery to remove the harmful devices. The DePuy ASR was recalled in 2010 due to studies showing it corroded much more quickly than other types of implants, most notably those made of ceramic and plastic. Once corrosion occurs in the metal hip implant the tissues surrounding the implant can become inflamed or soft tissue masses, lesions and necrosis can occur. The femoral heads as well as the acetabular cup of the DePuy hip implants are constructed of cobalt and chromium. The past few years have seen serious concerns regarding the metal chromium and cobalt particles which shave off when the femoral head and acetabular cup rub against one another during any activity. Once the levels of corrosion reach the unsafe stage the implant will likely have to be removed during a revision surgery.

Journal of Anthroplasty Study

A recent study in the Anthroplasty Journal compared the levels of corrosion on the femoral heads of the metal hip implants with those constructed of metal-on-polyethylene which implements a synthetic liner between the metal cup and femoral head. This liner acts as a buffer between the two metal pieces meaning there is less chance of the small metal ions slivering off and causing metallosis or metal toxicity in the bloodstream. The metal ions in the bloodstream can lead to kidney and liver disease or certain types of cancer, while the metal shards which lodge in surrounding tissues can lead to serious inflammation, tumors and even bone loss.

U.S. Drug Watchdog Urges Pinnacle Hip Implant Recipients to Come Forward

Over 130,000 Americans received a DePuy Pinnacle metal-on-metal hip implant between the years of 2005 and 2010. Although its counterpart, the DePuy ASR XL hip replacement system was recalled in 2009, the Pinnacle, while employing the same construction methods and materials, has not been recalled. Because of the recall of the ASR, there is mounting concern that the Pinnacle may also expose recipients to the dangers of metallosis or metal toxicity. The U.S. Drug Watchdog has stated their goal of reaching each and every one of the recipients of the Pinnacle implant to ensure none who have suffered harm are left behind.

Although only about a thousand people have come forward to date, the U.S. Drug Watchdog believes those numbers will grow rapidly, reaching well over 100,000. When the victims are properly identified they will then be provided access to the most knowledgeable attorneys who possess a thorough background in the intricacies of the metal hip implant. The objective of the U.S. Drug Watchdog is to ensure every person who had their health harmed because of a metal-on-metal hip implant receives appropriate compensation for failure of the implant.

U.S. District Judge Expects DePuy MDL to Move Forward

A recent meeting between the Judge chosen to oversee the multi-district litigation in the DePuy Pinnacle hip implant case included attorneys from both sides. The goal of the meeting was to determine the most practical manner of handling the more than 1,000 current DePuy lawsuits. U.S. District Judge Ed Kinkeade—judge for the northern district of Texas—will use the MDL in the interest of expediting and coordinating these consolidated pre-trial proceedings. Unlike many MDL cases, the DePuy case appears to be moving forward with case management procedures expected in the next six weeks to two months.

The initial MDL trials in the DePuy Pinnacle cases are bellwether trials with a purpose of choosing representative cases from those filed to determine how juries will likely react to evidence which is common to all the cases. During a bellwether trial the judge and attorneys are able to gain knowledge which will be helpful in negotiating future DePuy lawsuits. The process dictates that representative attorneys will be chosen to try the DePuy bellwether trials; the knowledge gained from these trials will be extremely helpful in planning strategies and setting precedence for future Pinnacle cases. All attorneys involved in litigating the DePuy Pinnacle metal-on-metal hip implants will be watching the bellwether cases closely as well as the entire MDL.

DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.  

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Reviewing the Safety of Metal-on-Metal Hip Implants

By Independent Staff Writer

According to a recent BBC Newsnight investigation, literally hundreds upon thousands of patients across the globe may have been exposed to potentially toxic substances following the implantation of metal-on-metal hip implants. Even though it is now believed that the dangers of these hip devices—which appear to have been very poorly regulated at best—was well known and documented for decades, recipients of the devices were nonetheless kept in the dark. The implants which are in question are known as “metal-on-metal,” and are constructed via a head at the top and a lining the head fits into which are made of cobalt-chromium alloy.

The Failure Rate of Metal-on-Metal Hip Implants
These hip implants are used in hip replacements and hip resurfacing, and came into wide-spread use in the 1997. The target group for these metal-on-metal hip replacements was younger, still-active patients who expected the hip replacement to last the rest of their life. Unfortunately, the numbers show that the failure rates among both genders are significantly higher than normal—from 11.8% failure in resurfacing to 13.6% for the total hip replacement as compared to rates of only between 3 and 5% for implants made of other materials.

How Many People Have Hip Implants?
Since 2003, the BBC article reports that over 60,000 patients in England and Wales and over a million in the United States have received the potentially dangerous metal-on-metal hip replacement. The metal ions from the cobalt and chromium hip implants are believed to seep into local tissues causing reactions which can not only destroy muscle and bone but can eventually leave the victim with a permanent disability. The fact that cobalt and chromium can lead to such serious health issues was actually documented in scientific journals over three decades ago.

Was There a Cover-up?
DePuy, a major manufacturer of the metal-on-metal hip implant, released an internal memo in 2005 which stated that in addition to possible changes in immune functioning there was additional concern that the metal debris from the device could be carcinogenic. The memo went on to state that the possibility of distant effects of the device was “worrying,” and that one study indicated a three times higher risk of lymphoma and leukemia ten years following the hip replacement. Despite these very real concerns DePuy continued marketing the device and indicated none of the potential health concerns in their subsequent promotional materials.

A Discussion of the Long-Term Health Effects of the Hip Implant
In 2006 the Medicines and Healthcare Products Regulatory Agency convened a meeting to discuss the long-term health effects of the metal-on-metal hip implant made from cobalt and chromium. An advisory board was appointed, however out of the group’s eight members, two were consultants for DePuy and one was the director of product development for Smith and Nephew—obvious conflicts of interest. In the end the group chose to sidestep the potential dangers of the metal-on-metal hip implants, even refusing to warn women of child-bearing age of the potential dangers despite the fact that metal ions had previously been detected in umbilical cord and placental blood among women with the implant. No alert was put out to either surgeons or patients, and it was not until March of 2011 that the British Orthopedic Association sent out a warning advising that the metal-on-metal hip replacements should be “carefully considered and possibly avoided.”

Excessive Levels of Cobalt Resulting from the Hip Implant
Although there are no current guidelines regarding unacceptable levels of cobalt ions in those receiving implants, a designer and consultant for DePuy theorizes that patients whose device is functioning properly should have cobalt levels of no more than 2 ug/L. Subsequent studies, however, have shown that the cobalt concentrations in the blood of those with a metal-on-metal hip implant have reached over 300 ug/L—approximately 600 times the levels in a person without a cobalt hip replacement device.

New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 


Is Johnson & Johnson Telling the Truth About the Failure Rate?
Johnson & Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson & Johnson started using the device in the United States in 2005 and based its failure rate on five years of research.  However, England has a hip registry dating back well before 2005.
This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson & Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.
Here are the real facts:

Becoming part of a mass action lawsuit over the DePuy hip implant gives you an edge that going solo can't afford.

By Independent Staff Writer

Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.

"One Riot, One Ranger"

When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.

Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.

Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.

"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.

So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?

If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.

And in that situation, the math starts to work against the plaintiffs.

Bluffing Without a Hand

Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.

Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.

Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.

Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.

One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.

In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.

Enter the mass action lawsuit.

Could the DePuy ASR™ XL Acetabular System recall have been avoided? Looks like it.

By Independent Staff Writer

In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.

But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.

How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States? 

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view. 

The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market. 

Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word. 

Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.

The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.

 

Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.

Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.

The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.

Choosing a good lawyer isn't as difficult as you might imagine; it's just a matter of asking the right questions.

By Independent Staff Writer

With so many lawyers out there, how should you go about finding a good one? How can you tell a strong lawyer from a weak one? You need solid legal advice, and you want the right attorney. Do not, we repeat, DO NOT just open the phone book, close your eyes, and point to a name. Here are some guideposts to help you. 

A good lawyer is ethical.

You're probably laughing right now. Can the words "ethics" and "lawyer" exist in the same sentence? Actually, it is possible, and you should absolutely insist on it. But how can you tell if a lawyer is ethical? There are some pretty good indicators. 

What types of cases does he take?
Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.
Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury.

Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.

What types of clients does he represent?
Does he represent big corporations or everyday people? Does he fight for the underdog? Does he hold wrongdoers accountable for their behavior? 

Is he honest?
Is she candid about the strengths and weaknesses of your case? A good lawyer will almost never tell her clients that the case is a "slam dunk." Those types of cases are extremely rare. Moreover, is he honest about his own strengths and weaknesses as an attorney? A good lawyer will tell you if he's particularly good in one area, but that he may ask his partner to help out in another area. He knows that two heads are better than one, and he can be honest about it. Is the lawyer truthful about his fees and costs? He should tell you what his services will cost, and there should not be any hidden fees. 

What is the lawyer's reputation in the community?
Is he known for his honesty, his pro bono work, his strong relationships in the legal and general community?
Google the lawyer's name. See what comes up. Look for newspaper articles, websites and blogs.
Make sure the attorney is in good standing with the state. Any sort of disciplinary action is a red flag.
Ask around the community. Does the lawyer have a good name around town?
Have any of your friends or acquaintances had experiences with him?
Check his references. 

A good lawyer values you as a person.

Does he look you in the eye when he's talking with you?
Are you treated as a person or as just some client? Does the lawyer remember personal information about you, including your spouse's or children's names?
Do you actually get to meet with him personally, or are you always sent to talk with a secretary? A good lawyer will make time for you and will return your phone calls quickly.
Does he show that he understands that you have a unique situation that is quite unlike anyone else's?
Has he shown that he respects your time and obligations, or does he talk on and on? Remember, a good lawyer will listen at least as much as he speaks. 

The DePuy ASR XL Acetabular hip replacement system was FDA approved - which might be more cause for worry than relief.

By Lacy Boggs

Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.

It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA. 

The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.

Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health. 

Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.

A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.

The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million. 

The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same?

What, indeed 

The ASR XL Acetabular hip replacement system got its seal of approval from the FDA using the 510(k) process, claiming that its product was substantially equivalent to other hip replacement devices already on the market. The FDA official in charge of approving the device would have gone through a checklist that included the following questions (simplified; the actual document is fairly dense):

• Does the new product treat or solve the same problems as previously approved products?
• Does the new product have the same design, materials, and energy sources as previously approved products?
• Could any new characteristics or combinations of characteristics affect safety or effectiveness?

The first question is easy: there are dozens of hip replacement devices on the market, all designed to help people walk even after their bum hip throws them out of commission. The second question gives us a bit of a hiccup: the ASR XL Acetabular hip replacement system had two parts, a ball and socket

The ball was equivalent to an approved product; the socket was equivalent to an entirely different approved product; and the materials were equivalent to still a third approved product.

Thankfully for DePuy, the FDA had thoughtfully included a caveat that allowed for such an eventuality. Which brings us to question three: could any new characteristics affect safety?

In DePuy's 501(k) application, it declared that the "subject device does not raise any new issues of safety or effectiveness." A brave statement, though one wonders how the company confirmed such a diagnosis without going through any clinical trials. Perhaps if it had, the problem of metallosis would have become evident before the hips were implanted into approximately 93,000 people.   

With such prerequisites for FDA approval, it is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing. 

Which is to say that 90% of claims require no clinical testing whatsoever before being sold to patients.

That's not to say that there is no testing at all. If a mechanical test is available, 510(k) approval process requires that the new product show that it yields similar results to a previously approved product. The DuPuy ASR hip replacement system took a few spins on a robot that went through simulated movements. In a legal suit brought against DePuy for a different hip implant last year, the mechanical test did not include the full range of motion of which a human being is capable.            Read more ....

Johnson & Johnson Accused of Concealing Ortho Evra Risks

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

Home |Personal Injury |DePuy Hip Recall |Traffic Tickets |Family Law |Criminal Defense |Get Informed

HOUSTON — Millions of women across the country rejoiced in 2002 when a new, convenient alternative to daily oral contraceptive pills hit the market.

Ortho Evra, a hormone-containing patch, was praised by public health experts and consumers alike because it eliminates one of the major barriers to perfect birth control use: Remembering to take a daily pill. The patch can be placed on the arm, back or abdomen—anywhere it adheres well and won’t be damaged—and needs only to be changed once a week. Since it’s introduction, over 40 million prescriptions for Ortho Evra have been written, and TIME Magazine named it one of the best inventions of 2002.

But in 2005, the Food and Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system, while those in the patch are absorbed directly into the patient’s blood stream. The latter causes a higher concentration of medication, specifically estrogen, to enter a patient’s body, increasing the risks of pulmonary embolism—a specific type of blood clot—as well as stroke and heart attack.

The first fatality publicly blamed on Ortho Evra occurred in April 2005, when a Manhattan fashion student collapsed in a New York City subway station. An autopsy found that a blood clot had moved into the victim’s lung, which the medical examiner ruled a side effect of the birth control patch.

By November of 2005, the FDA had received 21 reports of life-threatening blood clots and other ailments associated with Ortho Evra. But it wasn’t until 2006, when a study was published that confirmed women using the patch were twice as likely to suffer from venous thromboembolisms (VTEs) as those taking oral birth control pills, that the FDA requested that the Ortho Evra label be changed to include a stronger safety warning.

According to an NBC news report, broadcast September 22, 2010, leaked patient reports from Johnson & Johnson show that the company knew users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at Johnson & Johnson, Dr. Patrick Caubel, quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

Another former vice president, Dr. Joel Lippman, claimed in a lawsuit that he was fired by Johnson & Johnson because he expressed concerns about the patch’s dangerously high estrogen levels prior to its coming to market. The company, he says, “disregarded his concerns and launched the product anyway.”

According to NBC, 24 deaths have been attributed to blood clots induced by the patch, and more than 2,400 women currently have personal injury lawsuits filed against Johnson & Johnson. To date, the company has spent $68 million to quietly settle Ortho Evra lawsuits.

Unfortunately, Ortho Evra remains on the market, despite countless calls to have it pulled. In spite of its risks, the patch is still a big money maker for Johnson & Johnson, which has earned $1.6 billion on its sales.

In response to NBC’s news report, the company issued the following statement:

Thank you for your inquiry to Ortho Women’s Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. We believe it is inappropriate to comment on the details around ongoing litigation and therefore are not providing responses to your individual questions beyond the statement below:

ORTHO EVRA has been a safe and effective birth control option for women and their healthcare providers since 2002. It addresses a birth control need and provides another choice for women who, with the counseling of their healthcare provider, do not want or are unable to take a birth control pill every day. Ortho Women’s Health & Urology has regularly disclosed scientific data regarding ORTHO EVRA to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, ORTHO EVRA remains a safe and effective method of hormonal birth control. It also, like all methods of hormonal birth control, has benefits and risks which, as a prescription medicine, should be the subject of discussion between a woman and her healthcare provider. These benefits, risks and other important safety information are contained in the Detailed Patient Labeling, which is part of the ORTHO EVRA® Prescribing Information, and can be found at http://www.orthoevra.com/sites/default/files/assets/OrthoEvraPI_0.pdf.”

— Jeff Christensen, spokesperson, Johnson & Johnson

If you or someone you know were injured while using Ortho Evra, please contact the experienced team at Sullo & Sullo, LLP. We will aggressively represent women who have suffered heart attacks, strokes, blood clots and other serious injuries while using this drug. Call us at 713.839.9026 or visit our website at www.sullolaw.com for a free legal consultation today.