According to the article posted May 17, 2013, the company says its decision to discontinue sales of the Ultamet Metal-on-Metal Articulation and the Complete Ceramic-on-Metal Acetabular Hip System on August 31, 2013, was fueled by lower demand for metal-on-metal hips, which as a class have been associated with early failure rates. In turn, this has led to the filing of more DePuy Pinnacle hip replacement lawsuits in a multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of Texas.

As of May 1, 2013, court records indicated there were 4,087 claims over the Ultamet liner pending in the proceeding.

Did Metal Hip Sales Plummet Because of DePuy Pinnacle Hip Replacement Lawsuits?

Sales of Metal-on-metal hips in the U.S. and Europe plunged from 20 percent of the market in 2007 to less than 2 percent last year, according to the article, which also said the halt on sales of related products through 2014 will hopefully simplify and streamline offerings from the manufacturer. According to the company, this action was not prompted by concerns over safety and effectiveness, however, and does not signify a recall.

“We won’t have any metal-on-metal or ceramic-on metal hips any longer,” confirmed a spokeswoman for DePuy Orthopaedics. “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industrywide in the U.S. and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”

Discontinuing its sales of metal-on-metal hips may be a smart move for DePuy if and when The U.S. Food and Drug Administration’s proposed regulations for approving this class of devices go into effect. Announced in January 2013, the agency spoke of new rules that would require all metal hip manufacturers to submit all designs for premarket approval, where they would undergo rigorous testing for safety and effectiveness. In April 2013, 11,000 consumers signed a letter from Consumers Union urging the agency to put these new regulations into action.

This would make the devices ineligible to receive clearance through the agency’s 510(k) process, which allows a product to enter the market if its maker can prove it is substantially to one that has already been approved.

DePuy hip replacement lawsuits point out that the metal Ultamet liner of the Pinnacle hip was cleared in 2005 via the FDA’s 510(k) program.

Starting the Process of Filing a DePuy Pinnacle Hip Replacement Lawsuit

In taking your first steps toward filing a claim against DePuy after suffering complications that may include metal ion poisoning (known as metallosis), pain and swelling and infection, it is in your best interest to contact a lawyer at Bernstein Liebhard LLP. Call the Firm at (877) 779-1414.

In a regulatory filing issued by Wright Medical Inc. on April 30th, the maker of the Wright Profemur hip replacement admitted that the mounting lawsuits and safety issues surrounding the Stryker Orthopaedics-manufactured Rejuvenate and ABG II hip stems have prompted the industry to keep a watchful eye on similarly designed hip devices. The Rejuvenate and ABG II hip stems, which are also comprised of cobalt and chromium, have already amassed hundreds of complaints alleging injuries associated with early hip failure.

Wright Medical’s in April filing with the U.S. Securities and Exchange Commission followed a similar notification issued by the company in August 2012 stating that the Stryker hip recall may affect sales of its Profemur modular-neck hip stems given their similarities.

Despite Lack of Wright Medical Hip Implant Recall, Complaints Continue to Be Filed in U.S. Courts

Recipients of these devices have filed similar claims against Wright Medical. In a case settled on March 20th, the plaintiff alleged his Profemur implant fractured in 2010, just a year after he received it. This later created the need for revision surgery, according to his Wright hip lawsuit.

The settlement was announced just days after a judge in California federal court dismissed a motion filed by Wright Medical to dismiss the case, which was originally filed in San Francisco Superior Court in 2011.

Although a Wright Medical hip implant recall has not been issued, the manufacturer is currently facing a number of lawsuits over another one of its products as well.  According to court records, at least 40 claims involving the Wright Conserve Total Hip Implant System, Conserve Total A-Class Advanced Metal Hip Implant System, as well as the Conserve Resurfacing System had been filed in the U.S. as of May 2013. These claims are now pending in a multidistrict litigation (MDL) underway in the Northern District of Georgia, and allege high metal ion levels and other complications indicating early hip failure.

Side effects common to both the Wright Conserve and Profemur hip replacements include, but are not limited to metallosis, biologic toxicity, infection, inflammation, tissue necrosis, pseudotumors and premature hip replacement failure.

Wright Medical Lawsuits Allege Complications Indicating Early Hip Failure

After receiving the Conserve or Profemur implant, you may have experienced one or more of the injuries associated with these Wright hip replacements. Contact a lawyer at Bernstein Liebhard LLP to find out about seeking legal action against the company by calling (877) 779-1414.

According to a May 13th report, the surgeon was paid $940,857 to promote products and train doctors in Asia on how to use them between 2009 and 2011 by the British manufacturer of artificial hip systems, Smith & Nephew. Given this time frame, one may wonder whether the doctor trained surgeons in how to use the optional metal liner of its R3 Acetabular Hip Replacement System, which was recalled in June 2012 after the manufacturer discovered exceptionally high revision rates in patients who received the device.

Were Doctors Paid to Promote Metal Liner Affected by Smith and Nephew Hip Recall?

The annual revision rate associated with implants affected by the Smith & Nephew recall was found to be 1.6 percent, well above Britain’s National Institute for Health and Clinical Evidence’s accepted standard of 1 percent. The Smith and Nephew hip recall of the R3 system’s metal liner component affected approximately 7,700 individuals. According to the company, this implant was used mostly in stemmed total hip replacements.

The article points out that medical device and drug companies treating top doctors with dinner, as well as paying them to attend lectures and continuing medical education courses as well as underwrite conferences is nothing new. Over two-and-a-half years, manufacturers paid more than $76 million to physicians licensed in Massachusetts, according to a recent study in The New England Journal of Medicine.

When asked if being compensated for promoting a company’s products is a conflict of interest for a doctor, the chief of orthopedic surgery at St. Peter’s University Hospital said, “It’s a legitimate concern.”

However, information about corporations paying health providers is now available to the public, and will be available nationally when the federal Physician Payment Sunshine Act is officially implemented. According to the New York Times, companies were asked to begin collecting information last year.

Once patients are aware of this information, it remains to be seen whether the widespread side effects associated with metal hip implants like those involved in the Smith and Nephew recall may lessen with time.

Dr. Aaron S. Kesselheim, an assistant professor at Harvard says it may help individuals make the right decision when comparing opinions from two doctors.

“It’s another piece of data for patients to examine as they consider treatment options,” he told The New York Times. “If they go to an orthopedic surgeon who recommends a knee transplant, and they go to another who recommends watching and physical therapy, it might be interesting for the patient to wonder to what extent those two physicians have relationships with industry.”

Seek an Attorney’s Help in Filing a Smith & Nephew Hip Recall Lawsuit

If you are reading this article after receiving the recalled metal liner component of Smith & Nephew’s R3 system, you may now be feeling a bit outraged about the complications you have experienced. Take the first step in realizing your day in court by calling an attorney at Bernstein Liebhard LLP today at (877) 779-1414.

Filed with the Court on April 9th, 2013, the motion to create a consolidated litigation in the state will involve lawsuits brought by patients allegedly injured by a number of artificial hips marketed by the British manufacturer. Claims filed over a recalled metal liner component of the R3 Hip Replacement System, as well as Birmingham Hip Resurfacing implants and “all other Metal-on-Metal modular hip implant components manufactured by defendant” should be transferred to this location, according to the request.

Motion to Create Consolidated Litigation Filed by Plaintiffs in Smith & Nephew Recall Lawsuits

Approximately 7,700 individuals were affected by the Smith & Nephew recall of July 2012 after it was revealed that implantation of the R3 system’s optional metal liner, which was used mostly in stemmed total hip replacements, may lead to exceptionally high revision rates, according to the company. Prior to the recall, clinical testing revealed that the annual revision rate in patients who received the R3 system’s metal liner was 1.6 percent, which was well above the 1 percent rate the Britain’s National Institute for Health and Clinical Evidence deems acceptable for artificial hip systems.

The R3 system’s metal liner was introduced in 2007 before being launched globally in 2009.

In citing the reasons why a consolidated litigation of Smith & Nephew recall lawsuits would be beneficial for all parties, the Plaintiffs pointed to the Tennessee Rule of Civil Procedure 42, which states, “When actions involving a common question of law or fact are pending before a court, the court may order all the actions consolidated or heard jointly, and may make such orders concerning proceedings therein as may tend to avoid unnecessary costs or delay.”

Many Smith & Nephew hip recall lawsuits similarly allege the company failed to warn about the potential for its R3 system’s optional metal liner to cause fractures, infections, and dislocations. The device, which was designed defectively, was on the market for five years without the general public knowing the risks, according to claims.

Smith & Nephew Recall Likely to Prompt More Lawsuits

For patients suffering infection, fractures, dislocations and other complications associated with the implants affected by this recall, the unpleasant aftermath may severely reduce their overall quality of life. The lawyers at Bernstein Liebhard LLP understand this, and want to help you navigate your legal rights. Call the Firm to learn more at (877) 779-1414.

The  May 8^th Notification also informed  customers of precautions to take before using the scissors to ensure patient safety, according to a Wall Street Journal report. While Da Vinci robot customers will also be notified when replacements for the scissors are available, Intuitive Surgical did not go so far as to issue a recall for the instruments. The company stated that  it has received one complaint of injury, but  that a subsequent analysis didn’t indicate energy leakage.  It has also notified the U.S. Food & Drug Administration (FDA) of the issue with the scissors.

Da Vinci Robot Lawsuits Continue to Pile Up

Intuitive Surgical is facing a growing number of da Vinci surgical robot lawsuits that allege patients undergoing robotic surgery suffered serious injuries, including surgical burns, due to defects in the machine and/or inadequate surgeon training on the device.  In an April 30^th filing with the U.S. Securities and Exchange Commission, Intuitive disclosed it had so far been named in 26 such lawsuits.

Currently, the nation’s first trial of a da Vinci robot lawsuit is underway in Washington State Superior Court. According to the Seattle Times, the case was originally filed in 2009 by the wife of a man who died of heart failure years after a botched da Vinci prostatectomy.  The lawsuit alleges that da Vinci complications he sustained in that procedure hastened his death. The doctor who performed the operation had never used the da Vinci unassisted before, and stated in court documents that had he known the truth about the steep learning curve and time needed to master the robot, he would never have used the device. The doctor further  asserts that Intuitive Surgical led him to believe that he would become proficient with only a company training course and  two supervised surgeries.

For its part, Intuitive Surgical challenges any suggestion that in an attempt to increase the use  of the da Vinci robot,  it engaged in inadequate surgeon training or improper certification resulting in harm to patients.

Suffered Da Vinci Complications?  Get a Free Legal Consultation Today.

If you suffered surgical burns or other da Vinci complications in a robotic surgery procedure, filing a da Vinci robot lawsuit might enable you to obtain compensation for your injuries. The attorneys of Bernstein Liebhard LLP can evaluate your potential lawsuit for free.  To learn more, please contact on of our attorneys by calling 1-877-779-1414 today.

According to a May 12th, 2013 report from The Star Phoenix, women held up signs outside Saskatoon City Hospital urging patients to avoid transvaginal mesh procedures designed to treat pelvic organ prolapse and stress urinary incontinence. There, women from across the province told stories of the pain, difficulty walking, and other complications they experienced stemming from the devices, the article stated.

Canadian Protesters Allege Transvaginal Mesh Complications

One woman said, “Two weeks after my surgery, I had excruciating pain. I felt like I had a vice grip on my pelvis with razor blades in it. I couldn’t sit.”

According to the Star Phoenix, protesters gathered for several reasons. Some went to simply educate others about the risk for transvaginal mesh complications, while others went to try and stop doctors from performing the procedures at Saskatoon City Hospital altogether. They also say surgeons failed to inform them about a public health alert issued by Health Canada in 2010 that said the agency was “concerned” about a rising number of side effect reports.

“It’s hell. I haven’t worked since the first surgery. I can’t vacuum. It will take me half an hour some days to sweep my little kitchen. I can’t lift my grandchild,” another protester told the Star Phoenix. “I say no more mesh surgeries. Come up with something else.”

Nearly 2,700 Surgical Mesh Lawsuits Now Pending in N.J. Litigation

The rising number of surgical mesh lawsuits that have been filed in U.S. courts proves these Canadian women are not alone. According to a Case List update on May 4th, 2013, 2,682 Ethicon mesh lawsuits had been filed in a consolidated litigation underway in New Jersey’s Atlantic County Superior Court. Jeffrey S. Grand, a partner at Bernstein Liebhard LLP, is serving as Co-Liaison Counsel for the proceeding. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10).

These claims were brought on behalf of patients who allege transvaginal mesh complications stemming from products manufactured by Johnson & Johnson subsidiary, Ethicon.

The first trial for this litigation concluded in March with a verdict to award $11 million to a transvaginal mesh lawsuit Plaintiff who suffered injuries. That amount included $7.76 million in punitive damages.

Firm partner Jeffrey S. Grand also served on the trial team for this case.

In the U.S. District Court for the Southern District of West Virginia, thousands of federally-filed mesh lawsuits are pending in multidistrict litigations (MDL) involving products marketed by C.R. Bard, American Medical Systems, Boston Scientific and Ethicon.

How to File a Transvaginal Mesh Lawsuit

If you experienced pain, urinary problems, bleeding, mesh erosion or another complication after being implanted with vaginal mesh, contact an attorney at Bernstein Liebhard LLP. You may be eligible to file a surgical mesh lawsuit against the manufacturer. Contact the Firm to learn more at (877) 779-1414.

According to a recent report from The Global Mail, Boehringer-Ingelheim will facilitate educational events on stroke prevention this year to more than 4,000 cardiologists in China, which houses the world’s biggest market. The article published April 24th, 2013 indicates the company’s efforts to sell Pradaxa will be aided by the American College of Cardiology.

That last bit may come as a surprise to the medical community considering the fact that the medication, prescribed to prevent strokes in patients with non-valvular atrial fibrillation, has been linked to more than 500 deaths, according to adverse event reports filed with the U.S. Food and Drug Administration (FDA). Since it was approved in 2000, the drug has also been named in a growing number of Pradaxa lawsuits.

Pradaxa Lawsuits Continue to Be Filed in Federal Litigation

More than 600 claims were pending in a federal Pradaxa litigation (MDL) underway in U.S. District Court, Southern District of Illinois as of May 2013, court records indicate.

But perhaps most importantly, the glaring issue Boehringer-Ingelheim fails to address involves the irreversibility of Pradaxa side effects. Not only do they seem to be widespread, they are also life-threatening since doctors are often unable to stop the internal bleeding in patients once it begins. The blood thinner is currently being prescribed in more than 90 countries and has generated more than 1 billion in U.S. sales, the drugmaker told The Global Mail.

Pradaxa has been linked to the following life-threatening side effects: • Cerebral hemorrhage – Pradaxa bleeding in the brain. • Severe Pradaxa internal bleeding following a minor trauma, such as a fall. • Gastrointestinal (stomach) bleeding. • Death from serious Pradaxa internal bleeding.

A Mar.5, 2013 article published by Medicalxpress.com said that scientists at Portola Therapeutics in San Francisco have created a recombinant protein that can reverse the effects of two other anticoagulants, Eliquis (apixaban) and Xarelto (rivaroxaban), that utilize factor Xa inhibitors to prevent blood clotting, but not Pradaxa.

The report states that Boehringer was in its first phase of developing its own antidote for Pradaxa, which had been named in 932 FDA reports of serious adverse events as of March 2011. These side effect reports included 120 deaths and 500 reports of severe bleeding, according to the agency.

How to File a Pradaxa Lawsuit

If you or a loved one experienced the life-threatening complications associated with Pradaxa, you may be eligible to file a claim against the manufacturer. To file a lawsuit alleging Pradaxa side effects, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414.

During a conference call held in April to discuss first-quarter earnings, Fresenius executives acknowledged the company had been named in a number of personal injury lawsuits related to the GranuFlo recall, but declined to discuss what those lawsuits might ultimately cost the company. They also declined to provide more detail on the pending Fresenius lawsuits when asked, other than stating the company intends to vigorously defend itself.

GranuFlo Recall Details

In March 2012, Fresenius issued an Urgent Product Notification to the thousands of clinics using GranuFlo and NaturaLyte, warning that use of the drugs had been associated with elevated bicarbonate levels, and advising physicians to adjust dosage accordingly. Elevated bicarbonate levels can lead to catastrophic heart side effects in dialysis patients, including sudden cardiac death, heart attacks and strokes. Shortly thereafter, the U.S. Food & Drug Administration (FDA) granted the notification Class I status, its most urgent safety recall. Products listed under Class I have the potential to cause serious health risks or even death.

Plaintiffs in Fresenius lawsuits allege the company was aware of the serious risks associated with GranuFlo and NaturaLyte, but neglected to provide adequate warnings in order to protect sales of the drugs. Last year, the FDA was leaked an internal memo circulated to Fresenius dialysis clinics that concluded that patients administered GranuFlo were six times more likely to die as a result of cardiopulmonary arrest. Among other things, the memo revealed 941 patients at Fresenius clinics died from cardiac arrest in 2010 that was likely caused by elevated bicarbonate levels.

Fresenius Lawsuits Consolidated in Massachusetts Federal Court

In March, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federal Fresenius lawsuits stemming from the GranuFlo recall transferred to U.S. District Court, District of Massachusetts for pretrial proceedings. According to the Panel’s March 29th Transfer Order, the consolidated litigation consisted of 11 federal claims filed since the GranuFlo recall. However, dozens of potential tag-along GranuFlo lawsuits were also pending in a number of additional federal districts, the Panel said.

Dialysis patients who experienced serious heart problems within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation. For more information about the GranuFlo recall, please call 1-877-779-1414 for a free Fresenius lawsuit consultation today.

“Our South African clients were unable to sue DePuy in South Africa, and therefore started proceedings in England instead,” said one attorney representing plaintiffs in cases involving the metal hip implant.  

The article published May 8th, 2013 indicates that patients who filed claims over the DePuy ASR XL total hip replacement system and DePuy ASR Hip Resurfacing System are now seeking millions in damages.  They were recently given the go-ahead to sue the Johnson & Johnson subsidiary in English court after a jurisdiction objection from the manufacturer was dismissed there, according to Enca.com.

These suits can now head to trial, where attorneys for plaintiffs plan to argue that the implants sold prior to the DePuy ASR hip replacement recall were “unsafe and defective,” and that the company should be ordered to compensate patients for their “pain, suffering and financial losses,” the report states.

DePuy ASR Hip Replacement Recall Spurs Lawsuits Around the World

Claims over this metal hip implant were brought by patients who allegedly suffered pain and swelling, loosening of the implant, inflammation, infection and other side effects. Complications associated with metallosis (metal ion poisoning), which result when the chromium and cobalt components of the device fret and corrode, causing metallic debris to shed into the patient’s blood stream,  have also been named in claims related to the implants.  

93,000 devices were affected by the DePuy ASR hip replacement recall after a British study found unusually high revision rates in patients who received the implants.

In the U.S., over 10,000 claims over the DePuy ASR metal hip have been filed in federal courts, many of which are now pending in the U.S. District Court for the Northern District of Ohio.

To perhaps curb this rising number of DePuy ASR lawsuits alleging injuries from its products, the company has since partnered with third-party claims administrator, Broadspire Services Inc. to work directly with patients seeking reimbursement for medical treatment, testing, and other costs incurred by their injuries.

“Since the recall, DePuy has worked to provide patients and surgeons with the information and support they need,” a spokesman for the company said in a statement to Enca.com.

Considering a DePuy ASR Lawsuit? Contact an Attorney Today.

If you experienced complications after the DePuy ASR hip replacement recall of August 2010, you may be eligible to file a claim against the manufacturer. Contact a lawyer at Bernstein Liebhard LLP to learn more about DePuy ASR lawsuits at (877) 779-1414.

According to an article published May 7th, 2013, Endo Health Solutions reported $123 million in total device sales for American Medical Systems this quarter, which reflected a decrease mostly related to U.S.-based sales of its Women’s Health products. The company admits the U.S. Food and Drug Administration (FDA)’s advisory committee meeting in September 2011, which discussed the safety and effectiveness of transvaginal mesh products, may have played a role in its financial shortfalls.

Despite the complications named in mesh lawsuits, the manufacturer continues to reiterate the safety of its products. According to the article, “AMS remains focused on educational activities as part of an overall effort to continue to encourage patients and physicians to discuss the risks and benefits of AMS’s surgical mesh devices as an important treatment option for patients who suffer from stress urinary incontinence and pelvic organ prolapse.”

International sales of products manufactured by its subsidiary, American Medical Systems, increased approximately three percent compared to the first quarter of 2012 and total revenue for Endo Health Solutions equated to $709 million.

Additionally, reports published in March 2013 revealed that in its fourth quarter of last year, the manufacturer’s earnings statements revealed a net loss of $716.3 million for the quarter in March of 2013, which reflected a $640 million write-down at American Medical Systems.

Endo expects to see 2013 revenues in the range of $2.80 billion to $2.95 billion, the Wall Street Journal stated.

American Medical Systems Facing Thousands of Surgical Mesh Lawsuits

It is uncertain whether the cost of defending a rising number of mesh lawsuits will impact the financial future of American Medical Systems, however.

As of March 2013, approximately 5,100 surgical mesh lawsuits involving vaginal mesh implants manufactured by American Medical Systems had been filed in U.S. courts. Most of these claims have been consolidated in a multidistrict litigation (MDL) underway in the U.S. District Court, Southern District of West Virginia and allege the following complications:

• Erosion through vaginal tissue
• Pain
• Infection
• Urinary problems
• Recurrence of prolapse and/or incontinence.
• Bowel, bladder, and blood vessel perforation
• Vaginal scarring
• Pain during sexual intercourse

Thousands of mesh lawsuits have also been filed over devices manufactured by Johnson & Johnson subsidiary, Ethicon, C.R. Bard Inc. and Boston Scientific. Many of these claims are pending in the U.S. District Court for the Southern District of West Virginia.

How to File a Surgical Mesh Lawsuit

If you suffered injuries after being implanted with a vaginal mesh device manufactured by American Medical Systems, contact an attorney at Bernstein Liebhard LLP to find out if you are eligible to file a surgical mesh lawsuit. Call the Firm directly at (877) 779-1414.