Breast Implant Scandal Prompts Action

The European Parliament’s Environment, Public Health and Food Safety Committee’s resolution came as a response to a breast implant scandal involving 400,000 implants manufactured by the French firm, Poly Implant Pothèse (PIP). The “PIP scandal” erupted in early 2012. Initial predictions suggested that the rupture rate for the implants was between two and five percent, but according to a study published in the Journal of Plastic, Reconstructive and Aesthetic Surgery, the implants’ rupture rate could in fact surpass 33 percent. PIP is now defunct.

Using bold language, the resolution states, “The case of PIP implants, as well as the case of hip implants have shown a failure of the current system of certification of compliance … as well as of the controls of the notified bodies and their surveillance by national competent authorities.” It adds, “It is essential to learn from this fraud and to strengthen surveillance and safety controls and placing on the market requirements” for medical devices.

The Environment, Public Health and Food Safety Committee passed the resolution unanimously.

RLG Advocates for ASR Recipients

With any luck, a European Union medical device registry will do much to prevent problems such as those caused by PIP’s breast implants and defective metal-on-metal hip replacements. For anyone who has received an ASR device, though, it won’t make them whole again. Although DePuy is offering to reimburse recipients, those who try to do so might instead receive a larger amount of compensation by filing a hip replacement lawsuit. A plaintiff in a lawsuit can claim damages for medical costs, lost income, transportation expenses, pain and suffering, and punitive damages. If you are interested in a free, confidential consultation with a hip replacement lawyer from the Rottenstein Law Group, click on this link or call 1-877-619-5087.

For more information on the hip replacement recall, download this free brochure.

Click Here to Download RLG's DePuy ASR Recall Brochure

It was thanks in part to the Australia National Joint Registry that orthopedists and government regulators discovered that the metal-on-metal DePuy ASR hip replacement systems failed at higher-than-normal rates. This knowledge precipitated the hip recall. However, some 5,500 Australians received the recalled hip devices, out of the 93,000 total worldwide. As a result, the Australian DePuy hip recall class action lawsuit has gained momentum.

Litigants Claiming $200 Million in Damages

A woman who received her ASR device in 2005 filed the lawsuit as the class representative in June 2011. She underwent a revision procedure in January of that year, though the recall began earlier in August 2010. As of April 2012, 1,000 individuals have joined the Australian DePuy hip recall class action lawsuit, and they are collectively claiming $200 million ($203 million in U.S. dollars). The case is currently proceeding in Sydney Federal Court.

In late 2011 the Australian Senate held hearings on the ASR recall, and the head of the National Joint Registry testified that it took the government three years to recommend the ASR be withdrawn from the Australian market.

For Americans, MDL Is Better Than Class Actions

Typically, when many people are injured by a defective product, the first impulse is to combine resources to form a class action lawsuit. However the amount of compensation from a class action lawsuit is often a flat amount distributed evenly among plaintiffs. Those whose injuries are more severe tend to receive the same amount as those with milder injuries. Consequently, the United States’ justice system created multidistrict litigation (MDL), which provides the benefits of class action lawsuits while allowing plaintiffs to maintain their individual cases. As of March 12, 2012, the DePuy ASR MDL contains 3,665 cases, and 2,000 more cases are pending before state courts.

RLG Represents DePuy ASR Recipients

With any luck, the plaintiffs in the Australian DePuy hip replacement class action lawsuit will receive the compensation they deserve. For those who have not yet sued DePuy and its parent, Johnson & Johnson, the risk of proceeding without experienced legal counsel is that the amount of compensation from a lawsuit might be greater than what recipients can recover via DePuy’s recall reimbursement program. A plaintiff can claim full medical costs, lost income, transportation costs, pain and suffering, and punitive damages. For a free, confidential legal consultation with a recall lawyer from the Rottenstein Law Group, click on this link or call 1-877-619-5087.

First MDL Bellwether Trials Yet to Be Scheduled

Most people who believe their ASR hips injured them sue DePuy in federal court and then have their cases consolidated into multidistrict litigation (MDL) for pretrial proceedings because their cases have common facts and legal questions. After the pretrial phase is over, the parties will choose a handful of plaintiffs whose cases appear typical and try them before juries in bellwether trials. These trials will help the remaining parties determine the strength of their own cases and the extent of DePuy’s liability. They can choose to go to trial themselves or seek a DePuy ASR hip settlement. The DePuy ASR MDL is in the federal District Court for the Northern District of Ohio before District Court Judge David A. Katz.

The plaintiffs in the state cases, however, fight DePuy to keep their cases out of federal court, and therefore MDL, because they believe it will take too long. In reality, though, the MDL isn’t so far behind. Judge Katz required the parties to discuss bellwether trial selection protocols and file their proposals with the court on April 27, 2012. In an open court hearing scheduled May 1, 2012, the parties will further discuss the issues, and they will work towards scheduling the first federal-level trials.

RLG Advocates for Those Injured by Metal-on-Metal Hips

The ASR MDL is progressing steadily, though everyone will watch the state court DePuy hip recall trials nonetheless. If you received a recalled DePuy hip and believe it injured you, it’s not too late to sue DePuy. The amount of compensation from a hip replacement lawsuit might be greater than what DePuy and Johnson & Johnson are willing to offer you via its recall reimbursement program. A plaintiff in a lawsuit might recover damages for full medical expenses, lost income, and damages for pain and suffering. For a free, confidential consultation with a hip replacement lawyer from the Rottenstein Law Group, click on this link or call 1-877-619-5087.

For more information on the recall, download this free DePuy ASR brochure.

Click Here to Download RLG's DePuy ASR Recall Brochure

The DePuy hip replacement recall, which began in August 2010, affected some 93,000 recipients worldwide, and it has spawned thousands of lawsuits as well. With such a large number of people involved, it’s likely the recall will cost DePuy’s parent company, Johnson & Johnson (J&J), a very large amount of money. Although analysts don’t know the full long-term costs, especially those revolving around those who suffered implant failure or metal poisoning caused by the devices, it has already climbed into the billions. With the release of its first quarter financial data, J&J disclosed that its DePuy hip recall costs have grown by another $276 million.

Recall Costs Health Giant Billions

First quarter 2012 is not the first time that J&J has taken a charge on its earnings due to the DePuy ASR recall. In the past, it has taken charges ranging from the hundreds of millions to billions of dollars. For instance, in the fourth quarter of 2011, J&J’s litigation charge topped $3 billion. When that charge occurred, analysts wondered if Depuy ASR hip settlements were in the pipeline. How much of the current charge will go to settlements is unknown.

Aside from the charge, J&J’s sales dipped 2.4 percent, but it managed to rake in net earnings of $3.9 billion nonetheless. J&J’s shares are trading higher than they did last year as well.

RLG Advocates for DePuy ASR Recipients

For the thousands of people who have sued DePuy, new news about money set aside for the litigation means there’s a good chance J&J is looking to settle some of its hip replacement lawsuits. However, those who have not hired a DePuy hip lawyer risk receiving less because the amount of compensation from a DePuy hip replacement lawsuit might be greater than what J&J is willing to offer via its recall reimbursement program. In a lawsuit, a plaintiff can receive damages for full medical expenses, lost income, transportation costs, pain and suffering, and possibly punitive damages. If you received a recalled hip replacement and are interested in talking about it with a lawyer from the Rottenstein Law Group, click on this link or call 1-877-619-5087 now.

Researchers Stress the Need for More Long-Term Data

The National Joint Registry of England and Wales sponsored the study, which compared two groups of hip replacement recipients over the seven-year period after they received their implants: 40,600 who received all-metal implants and 250,000 who received other kinds. Analyzing the data, the researchers found that there was no statistically significant connection between receiving a metal-on-metal hip and developing cancer. They also found that those who received hip resurfacing implants were less likely to be diagnosed with cancer than recipients of metal-on-metal total hip replacement devices and the other types. The findings applied to both men and women.

Rather than claim that the devices did not cause cancer at all, the article’s authors pointed out that their data were only observational, and that cancer related to the all-metal device could strike recipients more than seven years after implantation. One thing the authors did not discuss was whether any individual devices bucked the trend.

RLG Represents People Injured by All-Metal Hips

Hopefully the British Medical Journal article’s findings disprove the metal-on-metal hip replacement cancer connection, but research on the topic is ongoing. However, the article does not affect findings on the tendency of metal ions to cause chromosomal abnormalities or other hip replacement side effects. Consequently, if you have received either a DePuy ASR XL Acetabular System or an ASR Hip Resurfacing System, and you believe it injured you, a DePuy ASR recall lawyer from the Rottenstein Law Group can help. A successful hip replacement lawsuit might result in a higher amount of compensation than going through DePuy’s recall reimbursement program will. A plaintiff can demand compensation for full medical costs, lost income, transportation costs, and pain and suffering. Click on this link or call 1-877-619-5087 and a lawyer will call you as soon as possible.

For more information on the DePuy recall, download this free brochure.

Medical Device Warning Issued for Metal-on-Metal Devices

The warning concerns a combination medical device that uses components manufactured by Finsbury Orthopaedics (now owned by DePuy Orthopaedics) and Stryker Corp. DePuy makes the MITCH TRH acetabular cups and MITCH TRH modular heads for metal-on-metal total hip replacement procedures. These components are interchangeable with Stryker’s uncemented Accolade femoral stem. The MHRA discovered that when the DePuy cups and heads are used with Stryker’s stems, the resulting metal-on-metal device can fail at higher-than-normal rates. The MHRA recommends orthopedists not use the devices together in their patients.

According to the National Joint Registry, hip resurfacing procedures using these components have a cumulative revision rate of 3.1 percent after four years, which is within the National Institute for Health and Clinical Excellence’s guidelines. However, when the components are used in total hip replacement procedures the cumulative revision rate spikes to 8.8 percent over four years. As a result the DePuy and Stryker hip replacement warning applies to total hip replacement procedures and not hip resurfacing procedures.

RLG Represents Those Injured by All-Metal Hip Replacements

All-metal hip replacements were supposed to be durable and last longer, so manufacturers marketed them to younger patients. The DePuy and Stryker hip replacement warning indicates that once again, the problems associated with the devices are not worth the cost. If you received one of these combination total hip replacement devices or a recalled DePuy hip, the Rottenstein Law Group can help. The amount of compensation from a hip replacement lawsuit might be greater than what the manufacturer is willing to offer through its recall reimbursement program. A lawsuit can help a plaintiff recover damages for lost income, full medical expenses, damages for pain and suffering, and possibly punitive damages. For a free initial consultation, click on this link or call 1-877-619-5087 and a DePuy ASR recall lawyer will call you as soon as possible.

For more information, download this free DePuy ASR brochure.

Meeting Open to the Public

The FDA scheduled the two-day meeting on June 27-28, though it has not announced a location yet. The committee that will hold the meeting is called the “Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.” According to the meeting announcement (PDF), the committee will, “seek expert scientific and clinical opinion on the risks and benefits of [metal-on-metal hip replacements] based on available scientific data.”

Given the attention these implants have received, the committee will look into the following hip replacement problems:

• Device mechanisms of failure
• Metal ion testing
• Imaging methods
• Local and systemic complications
• Patient risk factors (preoperative and postoperative)
• Clinical follow-up considerations for patients with metal-on-metal hip systems (total and resurfacing)

According to the FDA’s press release, deputy director of science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, said, “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers.”

RLG Advocates Those Injured by All-Metal Hips

Hopefully the FDA metal-on-metal hip replacement meeting will result in better standards for the devices, but for those who have already received them it will do little good, especially recipients of the ASR XL Acetabular System or ASR Hip Resurfacing System. If you received either of these devices, and you believe it injured you, the Rottenstein Law Group can help. The amount of compensation from a hip replacement lawsuit might be greater than what DePuy is willing to give you via its recall reimbursement program. A plaintiff in a lawsuit can claim damages for medical costs, lost income, transportation costs, and damages for pain and suffering. Click on this link or call 1-877-619-5087 and an attorney will reach out to you as soon as possible and give you a free consultation.

For more information on the DePuy recall, download this free brochure.

High Concentration of Metal Ions ‘Concerning’

In its letter of non-approval (PDF), the FDA listed the steps DePuy would have to take in its resubmission to receive premarket approval for the ASR XL Acetabular System. Two points stand out in particular. The first centers on the device’s failure rate and the second on the possibility that it could cause metal poisoning.

To the first point, the FDA showed some concern that DePuy engaged in “selection bias” regarding the “safety and effectiveness” data it submitted. Selection bias is a research term that means the researcher’s choice of data to include in a survey affects the survey’s outcome. In this case, the FDA believed DePuy excluded data from foreign sources that tended to show the ASR caused hip replacement problems. The agency requested that DePuy include these data if it chose to resubmit its application.

The second point reveals the FDA’s concerns with the ASR’s alleged tendency to cause metal poisoning in recipients. The FDA stated, “You have provided several abstracts with selected blood metal ion analyses from patients implanted with the ASR™ Hip System. The high concentration of metal ions observed in some of these patients is concerning.” Again, the FDA asked DePuy to include these data in its application.

Instead of reassessing its data or recalling the device, according to the Times, DePuy chose to phase out the device by selling the remaining stocks and encouraging orthopedists to use different DePuy devices. DePuy nearly used up its entire inventory of ASR units by May 2010, and it had no intention of recalling the device.

RLG Advocates for ASR Recipients

If DePuy had reapplied for approval and provided the FDA with the hip replacement metal poisoning data it had requested then perhaps many people could have been spared the pain a defective hip replacement can cause. If you received a DePuy ASR device and you believe it injured you, it’s important to know that the amount of compensation from a DePuy hip replacement lawsuit might be greater than what the manufacturer is willing to offer via its recall reimbursement program. For a free consultation with the Rottenstein Law Group, click on this link or call 1-877-619-5087 and a lawyer will call you as soon as possible.

For more information, download this free ASR brochure.

First, however, consider what DePuy has promised: that it “…intends to cover reasonable and customary costs of treatment if you need services associated with the recall of ASR, including revision surgery if it is necessary.” On its website, DePuy names specific out-of-pocket expenses that it might deem “reasonable,” including lost work time and travel expenses.

The orthopedic manufacturer has yet to provide any details on how, or even if, it intends to compensate you for the pain and suffering your DePuy hip replacement may have caused, however. Worse, DePuy will not voluntarily pay you a cent until you call its claim center and sign a medical release form. In other words, only after you speak to a representative who owes you no duty of confidentiality and waive your rights will DePuy even consider compensating you. To protect your interests, you should not call DePuy or sign any document the company provides without first speaking with a lawyer.

Now that you know DePuy’s position, you should be aware of what you might be legally entitled to. In a typical product liability case (such as when a defective medical device has injured you), a victim can potentially recover a combination of “economic” damages (such as medical bills and lost wages) and “non-economic” damages (such as pain and suffering). For a complete overview of these different damages, you should read this article. The most important thing for you to understand, however, is that there is no set amount of damages that applies to all cases, because individual circumstances vary considerably.

That said, a previous class action settlement sheds some light on how the DePuy injury cases might be resolved. In 2000, Sulzer Orthopedics, Inc. recalled approximately 30,000 of its Inter-Op Acetabular Shell units. Because of a defect, many recipients of this hip device required revision surgery, as is the case with the DePuy hip recall. In 2002, a class action settlement of over $1 billion was approved by a court. Those patients who required revision surgery were paid more than $200,000 each, while those who received faulty implants but did not undergo revision surgery received roughly $1,000 each.

It remains to be seen how the hundreds of DePuy ASR lawsuits will proceed, and the outcome described above is not necessarily typical. The fact remains, however, that taking legal action may be your best—and only—chance to recover compensation from DePuy. An attorney from the Rottenstein Law Group can provide you with a much clearer idea of how much money you may be entitled to. To speak with a DePuy hip replacement lawyer, call Rottenstein Law Group at 1-877-619-5087 or contact us online.

Regulators Disagree

According to the BBC, the British Hip Society recommends orthopedists discontinue using all-metal total hip replacements with “large heads” because there is insufficient evidence to show that their benefits outweigh their risks. They include any metal-on-metal hip replacement whose femoral head measures more than 1.4 inches in diameter. Smaller heads and hip resurfacing devices would still be okay.

The Medicines and Healthcare products Regulatory Agency (MHRA), which is similar to the U.S. Food and Drug Administration, disagrees. The MHRA’s clinical director, Dr. Susanne Ludgate, said that all-metal hip replacements help younger patients lead active lives, presumably due to the devices’ alleged durability.

Lancet Study Arrives at Similar Conclusions

On March 13, 2012, the British medical journal, the Lancet, published a study on metal-on-metal hip replacements based on data obtained from the National Joint Registry for England and Wales—the same registry that detected problems with DePuy’s recalled ASR devices. Analyzing 31,000 all-metal joint recipients, the researchers found that those whose hip implants had larger femoral heads tended to fail more often than those with smaller ones. They concluded, “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads.”

RLG Advocates for Recipients of DePuy Hips

If large diameter metal-on-metal total hip replacement devices do in fact provide no additional benefit despite their risks, then a hip replacement ban would likely do little harm. However, if you received a recalled DePuy ASR device, then it would be of little help, and after taking care of your health, the question turns to responsibility for paying for your revision procedure should you need one. The amount of compensation from a DePuy lawsuit might be greater than what the company is offering via its recall reimbursement program. In a lawsuit a plaintiff can claim damages for medical costs, lost income, damages for pain and suffering, and punitive damages. If filing a lawsuit interests you, click on this link or call 1-877-619-5087 and a [inlink id="25" type="page"]DePuy recall lawyer[/intlink] from the Rottenstein Law Group will reach out to you as soon as possible.

For more information, download this free brochure.