In August Bloomberg news reported that Johnson & Johnson was reportedly considering a $3 billion settlement regarding more than 11,000 DePuy ASR hip lawsuits. Bloomberg went on to report that the settlement offer would depend on the outcome of a series of ASR trials that were to take place this Fall.
Since that initial report, events have unfolded that lead me to believe that Johnson & Johnson is strongly considering a settlement.
The first trial in the federal consolidation was scheduled to begin on Sept. 24 in Cleveland, Ohio. U.S. District judge David Katz granted a 90 day delay to allow more time for pre-trial processes and scheduling for expert witnesses. In my experience Federal Judges are reluctant to grant delays over witness scheduling conflicts. The more likely reason is that a realistic settlement offer from Johnson & Johnson is on the horizon and more time is needed for negotiations.
In California on October 1, Johnson & Johnson settled with a plaintiff for an undisclosed sum. This settlement happened before the start of 2000 cases that were consolidated and to be heard before Judge Richard Kramer in San Francisco.
On October 8, another ASR suit was deemed resolved by the Bergen County District Dourt in New Jersey and removed from the trial calendar
In Las Vegas last year three DePuy ASR cases were settled before verdict
Only two ASR cases have gone to trial. In the first trial Johnson & Johnson lost an $8.3 million verdict. A California jury awarded damages to a Montana prison guard and ruled that J&J’s DePuy Orthopedics division designed of the device was defective.
Six weeks later a Chicago jury ruled for DePuy and rejected a defective design claim by an Illinois nurse.
It was though that the win in Chicago would help prolong DePuy’s strategy of proceeding on a case-by-case basis in an effort to avoid any type of settlement. But since the Chicago trial DePuy has quietly settled a handful of cases and had a major trial delayed.
I think that the DePuy is leveraging the Chicago verdict in a few individual settlements, while at the same time trying to negotiate a larger class action settlement. Any further rulings against them would weaken their negotiating platform so it is their best interest to delay any trials before a settlement can be reached.
The ASR is part of the largest medical device failure in history, and Johnson & Johnson needs to be held accountable and take responsibility for the pain and the suffering they have caused. The time has come for them to settle this horrible tragedy and help the people they have harmed.
Medical Device Tax
Medical device manufacturers scream that the medical device tax of the Affordable Care Act tax is unfair and they are willing to spend what it takes to buy politicians to defeat it. This is legal and is called lobbying. Republicans demanding repeal of the medical device tax state the tax will increase healthcare costs and inhibit new methods and ideas.
Johnson & Johnson, owner of DePuy, a medical device manufacturer, earned a total (pharmaceuticals included) of $2.98 billion for the third quarter, compared with $2.97 billion, in 2012. This is in spite of the 2 percent decline of sales in the medical devices division and lawsuits involving metal on metal hip replacement implants. Johnson & Johnson was reported in the New York Times as stating the reason was due to people being reluctant to undergo elective surgeries.
Despite having made millions in profits, Johnson & Johnson has not lowered healthcare costs. Furthermore, what new technology has been introduced?
According to an article on Medical Device Development posted on the American Heart Association’s website, “Although large medical device companies typically develop successive iterations of existing devices, most new device categories are typically developed by venture-backed start-up companies.”
Medical manufacturers spend very little of their total profits in new technology. Most of the time, they simply piggyback reworked devices on prior approval of similar devices. One could even insinuate that medical device manufacturers expect some devices to fail and are willing to pay the cost of the fallout.
Finding out the actual cost of a medical device may require the services of Sherlock Holmes. According to the New York Times, prices are confidential, many times even to the physicians. Manufacturers lobby medical providers just as they do politicians, except that it is legal to provide gifts to doctors and medical facilities. The incentive of gain is enough for healthcare providers to attempt to use one or more medical device manufacturers exclusively. We may not find out how much the devices cost, but we do know that the market mark-up for the United States is higher than many other countries.
The New York Times stated that with Johnson & Johnson’s profit of $7.2 billion in 2012, the medical device tax would have cost them about $300 million, its research and development investment, $1.7 billion, leaving them a a profit of $5.7 billion. Remember, their profit went up this year.
The New York Times reported that Senator Charles E. Grassley, Republican of Iowa, sponsored legislation to post online price information for implantable medical devices. This would encourage competition, something currently sadly missing, between manufacturers.
If manufacturers are so worried about the bottom line, perhaps they should stop spending their profits in Washington, stop rushing reconfigured products through the FDA, and start exercising fair commercial practices.
Depuy settles New Jersey ASR hip implant lawsuit in New Jersey weeks before October trial date. A New Jersey state court judge released an order on October 8 cancelling the scheduled jury trial.
Last week a California Depuy ASR lawsuit was settled right before trial. Earlier this year Depuy was hit with an 8 million dollar verdict in the first ASR lawsuit to go to trial.
It has been three and a half years since the recall of the ASR. There are 12 thousand lawsuits currently pending against DePuy and Johnson & Johnson.
Saunders & Walker P.A. Hip Implant Lawsuit Settlement Center
In what is likely to be the first of potentially many defective hip replacement implant lawsuits across the country, DePuy Orthopaedics ( maker of the Johnson & Johnson DePuy ASR ) has settled a California case ahead of it’s scheduled October 15th trial date.
Link to more information about this hip implant lawsuit settlement: Hip Replacement Lawsuit Settlement
To read more about this settlement and other defective hip implant replacement lawsuit settlements visit our firm’s website at http://www.saunderslawyers.com
On Wednesday September 25, two Pennsylvania legislators will hold a press conference to unveil bills that would change the State’s current statute of limitations in cases of child sex abuse.
State Rep. Mark Rozzi, along with state Sen. Rob Teplitz, have teamed together to garner support for legislation that would increase the statute of limitations for victims of child sexual abuse to take civil action against alleged abusers.
Similar legislation has been passed in California and Delaware brought hundreds of sexual predators to justice and protected a generation of children.
Under the current statute of limitations in Pennsylvania, child victims of sexual abuse only have 12 years, or until they are 30, to bring charges against their abuser. After that, if they file claims, the victims can be sued by their predator for harassment.
The statute of limitations plays an important and long-standing role in criminal and civil jurisprudence. However, young victims of sex abuse are often reluctant to come forward. There are significant and unique barriers that prevent children from reporting what they intuitively know is inappropriate behavior.
In recent years revelations about the abuse of minors has rocked the Catholic Church, the Boy scouts of America, the Ultra-Orthodox Jewish Communities in New York, and the Jehovah’s Witnesses. Many of the cases uncovered go back decades, and had never been previously reported.
Both measures before the Pennsylvania legislature would establish a two-year window during which the civil statute of limitations would be suspended to allow past victims of child sex abuse to access the justice system and expose guilty perpetrators.
For Representative Mark Rozzi this bill is personal. He was 38 when he finally admitted that a priest at Catholic School had abused him when he was 13. The trigger for Rozzi was the suicide of a close friend who had also been abused by the same priest when they were children.
As Rep. Rozzi and Sen. Teplitz ready their bills it is also being reported that one of the most notorious sexual predators in Pennsylvania, Jerry Sandusky, is preparing to appeal his conviction. It has been hinted at that his appeal will challenge that many of the charges brought against him fell outside the State’s statute of limitations.
Please visit our dedicated Sexual Abuse Lawsuit website for more information
Priest abuse lawyer website
Win for Vaginal Mesh Plaintiffs
The first Federal Bellwether case in Virginia ended with a jury of four men and four women awarding a $2 million verdict to Donna Cisson. A Bellwether case is one of similar claims and theories among a specific number of test cases used to set a standard for the remaining lawsuits. All vaginal mesh cases have been consolidated due to the volume of lawsuits filed and will be tried in the U.S. District Court, Southern District of West Virginia.
Ms. Cisson’s case involved an Avaulta Plus implant device made by C.R. Bard. Ms. Cisson experienced pain during sexual intercourse, bleeding and bladder spasms. The jurors deliberated for only 12 hours before deciding that Bard’s design of the Avaulta implants were flawed and Bard failed to warn both physicians and patients about the defects. Ms. Cisson’s attorneys accused the company of putting profits before people with “malice, fraud or wantonness.” Bard officials advised they will appeal.
The Cisson v. C.R. Bard, Inc. verdict is the first of four test cases for all vaginal mesh implants cases, including, Ethicon, Johnson & Johnson, C.R. Bard and Boston Scientific. However, it is the second loss for Bard. The first was last July, 2012, where a jury awarded a total verdict of $5.5 million verdict to Christine Scott, of which Bard’s portion was $3.6 million. The second of the four Bellwether trials started on August 19, 2013.
Avaulta implants were removed from the market in 2012 after the FDA ordered a study of the devices for pain linked to sex, organ damage and infection. Bard’s stock dropped 1.7% to $133.47 in the New York Stock exchange on August 16, 2013 and to $114.54 as of August 22, 2013.
The Ethicon, Johnson & Johnson, C.R. Bard, and all mesh manufacturers involved in lawsuits will be forced to examine the potential impact to their companies due to the outcome of these Bellwether cases. They will have to and make a decision whether to continue to hold and defend their position through trial, or to begin the process of settling and removing products which have been proven in Federal Court, to be defective.
We continue to monitor and keep you updated on these Bellwether verdicts. We believe that justice will prevail for patients and physicians whose trust was betrayed by corporate greed.
If you are suffering from injuries due to a vaginal mesh implant, you may be entitled to compensation for lost wages, pain and suffering, medical bills and future medical care among other things. Call Saunders & Walker at (800) 748-7115 to find out how we can be of service to you.
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.
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.
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.
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.
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.