Since his investiture, Pope Francis has encouraged a new openness in the Catholic Church that is unprecedented in church history. He has been applauded for beginning dialogues with Jews, atheists, and dissenters from within his own faith.
But the new pontiff has been less than forthcoming in dealing with the plague of sexual abuse committed by Catholic Priests. In spite of his calls for transparency, this past week Pope Francis secretly recalled Archbishop Jozef Wesolowski of the Dominican Republic over allegations of sexual abuse.
Vatican spokesman Federico Lombardi announced that Wesolowski had been “relieved of his duties” only after local media outlets began investigating abuse complaints filed against the Archbishop.
Barbara Dorris, the director for the US-based Survivors Network of those Abused by Priests (SNAP), said “Like all of his predecessors, Pope Francis is acting belatedly, secretively and recklessly.”
“Catholic officials act only when forced to do so by media pressure. When they do act, they act secretively — in this case, by not disclosing the allegations, the suspension or the reason for the suspension,” Dorris added.
Closer to home this same pattern of secrecy and non-disclosure from the Vatican is being used by the Archdiocese of Miami as it faces new and continuing cases of sexual abuse.
Allegations of sexual abuse have recently been leveled against a former teacher at Monsignor Edward Pace High School in Miami Gardens.
In a lawsuit, three former students accuse Marist Brother Kenneth Ward of sexually abusing them while he was the dean of students from 2000 to 2006. The lawsuit also names the Archdioceses of Miami, and accuses it of ignoring obvious signs that Ward was victimizing the boys.
What sets the four former Pace students’ claims apart from dozens of other clergy sex-abuse cases filed against the archdiocese over the past decade is the lengthy period of the alleged abuse and its relatively recent history.
The Miami Archdiocese also continues its ongoing silence regarding Father Rolando Garcia. Previously Garcia had been named in several lawsuits against the archdiocese alleging he engaged in inappropriate sexual contact with alter boys.
However, it wasn’t until September 2012, after another lawsuit was filed alleging Garcia used hush money to conceal another priest’s abuse of an underage boy – that the Church placed Garcia on administrative leave.
Since then petitions have been circulated calling for the removal of Father Garcia and for the Church to release information in regards to the charges against him, both of which the Archdiocese Of Miami refuses to do.
What is abundantly clear in all three of these cases is that in cases of sexual abuse the Catholic Church is continuing its long history of secrecy and denial.
In spite of Pope Francis’ commitment to transparency and open dialogue, the church still strives to protect its pedophile priests rather than care for the victims of these horrifying assaults.
It is also worth noting that Pope Francis recalled Archbishop Jozef Wesolowski from the Dominican Republic after it was apparent that criminal charges would be filed there. Instead, Wesolowski will now be investigated by the Vatican’s Congregation for the Doctrine of the Faith. Under the Catholic Church’s canon law, which doesn’t provide for prison time for guilty verdicts, he will only face canonical sanctions.
When questioned about Archbishop Wesolowski over the weekend, the Vatican could only respond that, at present, his whereabouts were unknown.
Drug Products
Metal on Metal Hip Replacement Implant Manufacturers Take Another Hit
Metal on Metal Hip Replacement Implant Manufacturers Take Another Hit
Caccia v. Biomet
On August 21, 2013, Biomet, and other defendants, Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 2391), Biomet, Inc. and Biomet Orthopedics, LLC, manufacturers of metal on metal hips, suffered a loss in the US District Court of Indiana. Indiana is one of the locations for the multi-district (MDL) litigation of metal on metal hips.
Defense’s Motion to Dismiss and Argument
In Caccia v. Biomet, U.S. District Court Judge Robert Miller, Jr. denied Biomet’s Motion to Dismiss the Plaintiff’s Complaint for failure to state a claim. Biomet’s argued that that they were exempt from Caccia’s claims because standards for clinical trials in the state tort actions were different from FDCA and IDE regulations. Furthermore, Biomet claimed that Caccia’s participation in a clinical trial wasn’t necessary per Berish v. Richard Medical Co. In Berish, the court relied upon a case called Dawson v. Howmedica, which concluded that the court should focus on extensive federal requirements applied to the device in the IDE process and not the intention of the physician.
Judge Miller’s Opinion and Order
Judge Miller disagreed with Biomet’s argument, stating that he did not find the arguments in Berish or Dawson persuasive or binding. Judge Miller’s his order reflected that his interpretation of the pre-emption extended to the device during clinical trials only. Miller also stated that outside the scope of the clinical trial, the results would be uncontrolled, thereby defeating the purpose of the clinical trial. Furthermore, Miller wrote that an investigational device may not be promoted for commercial distribution or test marketed outside the IDE
“I’m not persuaded that a manufacturer that obtains IDE status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from liability for use of that device outside the clinical trial,” stated Miller in his order.
See the link below to see the entire judge’s ruling.
http://scholar.google.com/scholar_case?case=667690375767555376&q=caccia+v.+biomet&hl=en&as_sdt=2,10&as_vis=1
The Direction of the MDL Lawsuits
The case of Caccia v. Biomet, et. al. is not over, but the order is a triumph by degrees for the Plaintiffs as well as for future metal on metal implants victims.
Manufacturers of defective, unregulated products continue to be hit with minor and major defeats.
On Thursday, July 18, 2013, the Canadian Institute for Health Information released the results of a study which revealed failure rates of hip replacement surgeries. The study was undertaken because prior research revealed that metal on metal hip replacements were three times more likely to fail, as well as cause metal particles to leak into the blood stream and have tissue damage around the device. Safety alerts in the U.S., Canada and the U.K. have previously been issued.
The study, reported by the CBC News, CBC Radio Canada, was based on 56,942 hip replacement surgeries from 2003 through 2011, in certain regions in Canada. Metal on metal hip replacement studies were 9% of the 56,942 tested, approximately 5,124. The report found that certain metal on metal hip replacements had a 5.9% chance of requiring a replacement of the hip within five years. Although this percentage may appear small, Canada’s use of metal on metal implants has declined drastically.
In May, Johnson & Johnson announced they were getting out of the metal on metal and ceramic on metal hip replacement business. They deftly cite declining sales rather than admitting their culpability in the face of a mounting stack of scientific evidence.
Metal hip replacements have gained approval through the FDA’s screening process due to the FDA’s 501(k) rule. This rule allows manufacturers to place products on the market based upon similar or equivalent products without going through rigid requirements in place for newly emerging products.
At Saunders and Walker, we strive to update clients and the public by diligently monitoring the most recent medical and legal news.
If you are a victim of a metal on metal implant and are suffering, please call me, Joseph Saunders, or one of my experienced staff at (800) 748-7115 or (727) 579-4500. We are on your side because we care.
Dug Side Effects Under Review
Latest Drugs to Watch
The New England Journal of Medicine reported that double-blind, placebo control testing was performed on 16,492 patients in 26 countries concerning DPP-4 therapies. DPP-4 (dipeptidyl peptidase-4 inhibitors) therapies include Saxagliptin otherwise known as Onglyzan by AstraZeneca and Bristol-Myers Squibb. The study took approximately 2 years and was funded by AstraZeneca and Bristol-Myers Squibb.
Other than Metformin and insulin, prior research has found that most glucose lowering therapies, while controlling glucose levels, increase cardiovascular risks. According to the New England Journal of Medicine, the study “was designed to evaluate the safety and efficacy of Saxagliptin with respect to cardiovascular outcomes in patients with diabetes mellitus who are at risk for cardiovascular events.” The specific cardiovascular events being researched were cardiovascular death (such as those caused by atherosclerosis or hypertension), myocardial infarction (heart attack) or ischemic strokes (strokes caused by blocked arteries).
The results of the study showed that 1,059 patients experienced cardiovascular deaths, myocardial infarction, strokes, hospitalization for unstable angina, coronary revascularization, or heart failure as opposed to 1,034 from the placebo group. This proves an increase in heart failure, but no increases or decreases were found relating to heart attacks.
According to a Reuter’s article dated September 2, 2013, Dr. Christopher Grainger of Duke University Medical Center, found the increase to be concerning, stating that the FDA would possibly be interested in this study. In the September 2, 2013 Reuter’s article, Dr. Anthony DeMaria, editor-in-chief of the Journal of the American College of Cardiology, stated that although the increases of heart failure were low, patients with a high risk of heart failure should probably avoid all DPP-4 therapies.
At Saunders & Walker, we continue to research and monitor the most recent news on prescription drugs as they emerge. We will continue to keep you informed. Please call us at (800) 748-7115 if you have any questions about this article or any legal matter you may have.
Hip Replacement Implant Recall Lawsuit Settlement News
In the first trial over its recalled ASR hip, Johnson & Johnson lost an $8.3 million verdict. The California jury awarded damages to a Montana prison guard and ruled that J&J’s DePuy Orthopedics division designed of the device was defective.
Now, Bloomberg reports that Johnson & Johnson is in discussions over paying more than $3 billion to settle lawsuits over its recalled hip implants. Facing as many as 11,500 lawsuits in the U.S. the company is reportedly considering paying more than $300,000 per case.
A settlement this large would dwarf a previous $1 billion settlement Sulzer AG, a Swiss-based pump maker reached with patients who had received the company’s defective knee and hip implants.
It is suspected however, that any settlements will likely be framed by the outcome of seven A.S.R. product-liability trials scheduled between September and January.
The first trial involves Ann McCracken, 58, of Rochester, New York, who needed two revision surgeries after the failure of her A.S.R. implant. The trial is one of 8,000 cases consolidated on the federal court in Cleveland. Another 2000 cases are pending in the California Judicial Council in Cleveland.
Trials also are scheduled in state courts in San Francisco in October; in Hackensack, New Jersey, in October and January; in West Palm Beach, Florida, in November; in Chicago in December; and in Los Angeles in January.
While Depuy continues to insist that the company acted appropriately and responsibly, and also claims that the A.S.R. hip system was properly designed – any consideration of a settlement would seem to indicate that the company is finally willing to accept responsibility for its role in the largest medical device failure in history.
If Johnson & Johnson does accept responsibility for the pain and suffering caused by the faulty implants, it will be welcome news to the thousands of people affected by their negligence. It should also be a reminder to the company that their first responsibility is not to the shareholders, but to the patients they serve.
The DePuy A.S.R. is part of the biggest medical device failures in decades and it was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.
Mesh Implant Recall Lawsuit
The second federal trial related to a C.R. Bard transvaginal mesh lawsuit came to an early conclusion last week after the parties were able to reach an undisclosed settlement. According to a report from the Charleston Daily Gazette, lawyers in the case were just about to begin their opening statements when the settlement was announced.
It would have been the second trial in a federal multidistrict litigation established for C.R. Bard vaginal mesh lawsuits in the U.S. District Court, Southern District of West Virginia. In the litigation’s first trial, a week prior, the Plaintiff was awarded $2 million in compensatory and punitive damages for vaginal mesh complications she sustained due to C.R. Bard’s Avaulta Plus pelvic mesh device.
These lawsuits are among thousands that have been filed across the country by women who allegedly suffered horrific complications following implantation of pelvic mesh during uro-gynecological surgeries to treat pelvic organ prolapse and stress urinary incontinence.
Numerous medical device makers, including American Medical Systems, C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon unit all have been named in mesh implant lawsuits.
To date, plaintiffs have prevailed in every transvaginal mesh lawsuit that has gone to trial. In addition to last week’s loss in court, a California trial last year involving the same Avaulta Plus mesh device led to a $3 million judgement against C.R. Bard. The first Ethicon mesh lawsuit to go to trial ended in March in New Jersey Superior Court, with the jury awarded awarding more than $11 million in compensatory and punitive damages to woman who was injured by the company’s Gynecare Prolift device.
Synthetic mesh has been popular with surgeons and been used to shore up the vaginal wall in cases of pelvic organ prolapse – a weakening of the muscles and ligaments that support organs like the bladder and uterus. The condition causes extreme discomfort and is potentially dangerous. Symptoms caused by mesh erosion include:
- Bleeding
- Urinary problems
- Vaginal scarring
- Infections
- Pain during sex
- Discomfort
- Bowel, bladder, and blood vessel perforation
Use of transvaginal mesh to repair pelvic organ prolapse had grown in popularity, in spite of early reports of problems caused by the mesh. In 2008, the Food & Drug Administration issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, according to Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse.
A research study released in 2010 in the journal Obstetrics and Gynecology reported 15 percent of the women treated with vaginal mesh experienced potential complications. The study also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.
In July 2011, the F.D.A. warned that it had received an increasing number of adverse event reports associated with the use of such products and since then litigation for mesh implant lawsuits has built steadily.
In lawsuits involving transvaginal mesh devices it has been alleged that these products were defectively manufactured and inadequately tested. It has also further been alleged that transvaginal mesh implant manufacturers failed to provide adequate warnings about their dangers.
The makers of transvaginal mesh continue to deny responsibility for the horrible problems experienced by women who have received the device. However, justice has yet to be on their side as litigation continues to favor plaintiffs. The question remains, are the manufacturers more concerned about their profits, or the patients they serve?
Lawsuit Evidence and FDA Actions Doom Metal Hip Implants
Lawsuit Evidence and FDA Actions Doom Metal Hip Implants
A front page article in the January 23 New York Times, Maker Aware of 40% Failure in Hip Implant, revealed that Johnson & Johnson knew of widespread failure with the troubled all-metal hip joint it had recalled in 2010. Even as the company became aware of the extent of the products failure, it continued to publicly play down similar findings from the British implant registry.
The internal study, conducted by Johnson & Johnson, is just one of hundreds of documents expected to be made public as the first of over 10,000 lawsuits begins this week in California superior court in Los Angeles.
In the analysis, Johnson & Johnson found that nearly 40 percent of the patients who received the now-recalled Articular Surface Replacement, or ASR joint, would experience failure within five years. It also found that thousands more patients will likely experience premature failure in up-coming years and be forced to undergo painful and costly replacement surgery.
The trial is expected to uncover what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problems, both pre- and post-recall, and what actions they took. This episode represents one of the biggest medical device failures in decades and these early documents bring into question how forthright DePuy was in dealing with the problem. Even after the company recalled the device in 2010 it continued to challenge the validity of the British registry findings, which had found a failure rate in at least one-third of patients with the device.
Metal hip implants made by all manufacturers have been failing at an unacceptable rate for years. The DuPuy ASR joint was only the first to be recalled. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint.
As a result of these failures the FDA recently posted a proposed order addressing metal hip implants. The new order, if approved, will require all hip implant manufacturers to go through Premarket Approval Process to keep any existing metal-on-metal hip implant on the market or to put a new metal on metal product on the market.
Metal on Metal joints still on the market such as The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates. Ironically the new order and PMA process faced by these manufacturers might allow them to avoid recalls. By citing the prohibitive cost of preparing a PMA application they can simply cease production without ever acknowledging an admission of failure in the joints.
So, as the trial prepares to begin in California this week, the early release of documents showing that DePuy long knew of the high failure rate while simultaneously trying to downplay the situation would indicate the company was more concerned with limiting its financial liability than being forthright with patients. Even after the company instituted its own recall of the suspect joint in 2010 it methodically continued to challenge medical findings that indicated a high failure rate.
Continued public disclosure of documents from the civil lawsuits and the data collected by the FDA will help protect the public from companies that put their own profits ahead of safety.
Stryker Rejuvenate Metal Hip Implant Cases Moving Forward in Federal CourtStryker Rejuvenate Metal Hip Implant Cases Moving Forward in Federal Court
Stryker Rejuvenate Metal Hip Implant Cases Moving Forward in Federal Court
On July 5, 20013 Minneapolis United State District Judge Donovan Frank filed an order notifying attorneys that he plans to schedule the first federal hearing on the Stryker Rejuvenate in August 2013. All Rejuvenate cases in U.S. federal court have been transferred to Judge Frank for pretrial management.
There are a large number of lawsuits that are moving forward in the New Jersey state court where Stryker is located before Judge Brian Martinotti. So far there have been no jury trials involving the Stryker Rejuvenate metal hips that were recalled last year.
The Stryker Rejuvenate was recalled in 2012 as a result of high failure rates from metallosis in patients. Metallosis is an injury to the tissues in the hip from chromium and cobalt metal particles leaching from the metal hip implant into the tissue and blood of patients. Many Rejuvenate implant patients have had to have revision surgery to remove the implants and replace them with a different product.
The lawsuits are individual cases not class actions so each injured patient who wants to make a claim needs an individual attorney to file their lawsuit. It is important to get prompt legal advice and representation because there are time limits for filing claims. Missing these time limits can cause an injured individual to be left out of any settlement that occurs in these cases. So far, I am not aware of any Stryker Rejuvenate lawsuits that have been settled by Stryker. However, Stryker has arranged to pay co-copays and help uninsured patients pay for revision surgeries through their insurance adjusting firm called Broadspire. Patients should be aware that filing a claim with Broadspire will not protect their legal rights for full compensation or to participate in a larger settlement. Filing a claim with Broadspire also will not satisfy the requirement that a person’s lawsuit be filed within a certain period of time called a statute of limitations. This time period for the statute of limitations varies according to the facts of each case and the state in which the Stryker patient lives or has surgery.
Our law firm, Saunders & Walker, is currently filing lawsuits to protect the rights of injured Stryker patients and to be sure that they do not miss the statute of limitations.
Mutual Pharmaceutical v. Bartlett Lawsuit
Mutual Pharmaceutical v. Bartlett Lawsuit
This week, in a far-reaching decision, the U.S. Supreme Court demonstrated once again that pro-business decisions are defining the Roberts court.
In a case involving Philadelphia’s Mutual Pharmaceutical Co., the court split 5-4 along the traditional conservative-liberal line to award a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration. The court ruled that federal law related to pharmaceutical regulations preempts a person’s ability to sue in state courts and allege that a generic drug is designed badly.
The generic drug industry, which accounts for almost 80 percent of the U.S. market, now has a blanket exemption from liability. The ruling means that consumers who take name-brand drugs can sue for damages, but consumers who take a generic version of the same drug can’t sue
This ruling came from the case of Mutual Pharmaceutical Company v. Bartlett. Karen Bartlett suffered a rare, severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril. She is now legally blind. She claimed not only that Mutual didn’t adequately warn of its drug’s dangers, but also that the product was defective and shouldn’t have been sold. A jury awarded her $21 million for her injuries. Mutual Pharmaceuticals argued that the product and its label were FDA-approved and that those approvals preempt Bartlett’s state-court claims.
The conservative majority wrote that Bartlett’s situation was “tragic and evokes deep sympathy,” but said the law requires that the judgment of the lower court be reversed.
Business decisions by the Supreme Court are almost always overshadowed by cases on controversial social issues. But the business docket reflects something truly distinctive about the court led by Justice John G. Roberts Jr. Studies have shown the current court over all is only slightly more conservative than the courts led by Justices Warren E. Burger and William Rehnquist. Business decisions have been far friendlier to business than any court since at least World War II.
Since the Bartlett decision, Senate Judiciary Committee Chairman Pat Chairman Patrick Leahy (D-Vt.) and five other lawmakers wrote to FDA Commissioner Margaret Hamburg and asked her to rewrite regulations so people can sue generic drug manufacturers for injuries.
“A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” Leahy said.
While the FDA has indicated they will review the court decision, given the language of the federal statute, it is unlikely they will be able to change the regulations. Past rulings by the agency have been unusually favorable to generic drug manufacturers.
But what remains most troubling in the Bartlett ruling is that the court has stripped consumers of their 7th Amendment rights to access the court and allowed a multi-billion dollar industry to operate without impunity over the consumers they serve.
Hip Replacement Implant Lawsuit News
Hip Replacement Implant Lawsuit News
From our main website:
Read more about defective hip implant devices here:
http://saunderslawyers.com or click here to contact us today.
The massive failure of metal-and-metal hip implants is one of the biggest medical device failures in history. It is a cautionary tale of our time — of what happens when the safety of patients succumbs to lax oversight, outright negligence and the drive for corporate profits.
It is, in the simplest of terms, about greed.
When metal-on-metal hips were introduced they were designed to last longer and allow for high-impact activity, such as running and jumping.
But within a few years, problems began appearing. Patients complained of acute pain and becoming immobilized by joint dislocations, infections and bone fractures. Metal-on-metal hip implants were found to be problematic because, according to the Food and Drug Administration, their components were shown to grind together and shed metallic debris. This metallic debris can damage tissue and bone and metal ions can enter the bloodstream.
DePuy Orthopedics, a division of Johnson & Johnson, was the largest maker of metal-on-metal hips and over 93,000 of the company’s A.S.R replacement joint were implanted worldwide. Even before the company began marketing the A.S.R in the United States in 2005, they had been receiving complaints for years from doctors in Europe. Consulting surgeons to DePuy in Europe stopped using the device because of its poor record.
In 2007, DePuy conducted internal tests on the A.S.R and the joint failed, and reported, “The current results for A.S.R. do not meet the set acceptance criteria for this test.”
The company considered a redesign but in 2009 the Food and Drug Administration rejected an application to sell a resurfaced version of the A.S.R. in the United States. In 2010 the company was forced to issue a recall of the defective implants. Documents have since shown that DePuy executives then started calculating when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant.
But DePuy was only the largest maker of metal-on-metal hip replacements. Other companies making metal-on-metal hip implants began receiving eerily similar complaints. Dislocations, infections, and pain were common in recipients.
Stryker, maker of the Rejuvenate and ABGII, recalled both hip replacement systems in July 2012. Worldwide, 30,000 of the Stryker hip systems were installed; 20,000 of them in U.S. patients. Both implants were found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, necrosis and death.
Other smaller manufacturers have also recalled their metal-on-metal hip joints such as the Smith & Nephew R3 and the Zimmer Durom Cup. However, even in spite of the dangerous health threats metal-on-metal joints are proven to pose, several products remain on the market. The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage, remain available, but are all failing at unacceptably high rates.
Unlike new drugs, the metal hip replacements didn’t have to undergo clinical trials before receiving approval from the FDA, the government agency with the role of protecting consumers from dangerous products.
Without rigorous independent testing that would have uncovered the dangers of metal-on-metal joints, the responsibility fell on the companies that manufactured them to insure their safety. In almost every case they failed miserably and decisions were made based on profits rather than the health and safety of the patients they served.
By 2008, DePuy was well aware of the design flaws in the A.S.R. but continued to actively market it to surgeons in the United States, who then implanted it into tens of thousands of patients. Knowing full well they had a defective product, a top sales official in the company wrote to a colleague that, “We will ultimately need a cup redesign, but the short-term action is to manage perceptions”
For the Stryker Rejuvenate and ABGII hip replacement systems, some doctors have predicted the failure rate might go as high as 70 percent. That would mean over 20,000 patients with the implant will have to undergo painful revisions on top of the painful complications they’ve already endured.
According to a filing with the Securities and Exchange Commission, since the A.S.R. was recalled more than 10,000 lawsuits have been filed against Johnson & Johnson.. In March, a California jury awarded $8.3 million to a retired prison guard who sued the company over health complications caused by his A.S.R. implant. Analysts predict total damages for the company could eventually reach a billion dollars or more.
The failure of the Stryker Rejuvenate and ABGII has so far led to over 100 lawsuits being filed in Bergen, N.J., where the company’s headquarters are located. With over 20,000 of the defective implants in U.S. patients, analysts expect the number of lawsuits against the company to grow dramatically.
There are many reasons patients elect to have hip-replacements, but in every case, regardless of the medical cause, patients all expect to have a better quality of life. In tens of thousands of patients, the failure of metal-on-metal joints in patients who elected to have them implanted has damaged their health and quality of life in ways that may be irreversible. Revised artificial hips often perform worse than a first prosthetic because of issues with bone loss and fit, and in addition to the pain and suffering, they are likely to never recover the same quality of life they expected.
More oversight and corporate governance that placed patient welfare above the bottom line could have prevented these patients’ suffering. But as the lawsuits continue to mount, it is clear what was at the root of this health disaster – greed.
Stryker Rejuvenate and ABG II Hip Implant Lawsuits Go to Minnesota Judge
Stryker Rejuvenate and ABG II Hip Implant Lawsuits Go to Minnesota Judge
A June 12, 2013 Court Order assigned lawsuits involving the Stryker modular neck hip implant recall to United States District Judge Donovan W. Frank in Minneapolis, Minnesota. The National Judicial Panel for the federal courts had been considering attorneys petitions to centralize all of the lawsuits involving the recalled Stryker Rejuvenate and ABG II hip implants before a single judge.
This procedure is called multidistrict litigation under the federal court rules. It is not a class action. It merely coordinates all of the individual lawsuits before a single judge to avoid conflicting rulings on the same issues. It also helps to coordinate the progress of all of the cases together in the discovery process. Multidistrict litigation is very common in medical product or drug recall cases where there are many lawsuits over a defect or recall in a single product. The legal issues about the safety of the product and what the manufacturer knew and when they knew it are common issues to all of the cases. Each person who was injured by the product may have somewhat different injuries and financial losses but the legal liability of the Company is likely to be the same in all of the cases.
The federal multidistrict judge will set up a schedule to move the cases forward towards trial and also supervise and encourage the parties efforts to settle the lawsuits.
The Stryker Rejuvenate and ABG II hip implants were recalled in July of 2012 after being on the market for less than three years. These products are designed with a modular neck between the stem in the femur and the ball that goes into a cup that is set in the pelvis. This modular neck was designed to allow the surgeon to pick different lengths and angles for the modular neck to try to get the best alignment and leg length for the artificial hip. Prior implant designs merely had a stem in the femur and a ball that could be placed on the end of the femur stem.
Our lawsuits against Stryker allege that the modular neck design was defective and negligent because the multiple joints involved can move slightly causing damage to the metal, corrosion and leaching of cobalt and chromium into the patients hip tissue and blood stream. This metal poisoning is called metallosis. When the hip tissues become damaged by the metallosis the hip must be removed in an operation call a hip revision and a new hip implanted.
A new article in the Journal of Bone and Joint Surgery confirms the same theory that we are alleging in our lawsuits. The 2013 article is titled Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck. The article was written by H. John Cooper, MD, Robert M. Urban, PhD, Richard L. Wixson, MD, R. Michael Meneghini, MD, and Joshua J. Jacobs, MD.
The peer reviewed scientific article was based upon a case study of 12 hip implants involving the Stryker Rejuvenate and ABG II hip implants that had failed. There are a number of earlier medical studies that had suggested this risk years before that should have put Stryker on notice that a modular neck design would have these problems but Stryker marketed the product anyway. This is one of the key reasons why we believe Stryker should be held liable in the lawsuits.
Read more about the Stryker Rejuvenate at Stryker Hip lawsuit Website