New Round of Essure Lawsuits Filed vs. Bayer Healthcare Pharmaceuticals, Inc in Pennsylvania Federal Court

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS)  On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the  Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, under Essure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP

 

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WEEKLY MDL UPDATE by MASS TORT NEXUS for Week of November 13, 2017

The week in mass torts around the country:

By Mark York, Mass Tort Nexus (November 16, 2017)

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MASS TORT NEXUS

 Verdicts on November 16, 2017: 

J&J gets hit hard again, in a $247 million Pinnacle hip implant verdict, DePuy Orthopaedics Pinnacle Implant MDL 2244, in bellwether trial of 3:15-cv-03489 Alicea et al v. DePuy Orthopaedics Inc et al. (DePuy Pinnacle Hip Implant MDL 2244 Briefcase)

Drug maker Auxilium won a defense verdict in their Testim product bellwether trial, where plaintiffs claimed it caused a heart attack in a verdict reached in the US District Court Northern District of Illinois, Judge Kennelly, in MDL 2545 Testosterone Replacement Therapy. (Testosterone Therapy MDL 2545 USDC ND Illinois)

Johnson & Johnson Wins a Defense Verdict in Los Angeles Court Talcum Powder Mesothelioma Trial, Jury Finds J&J Not Liable in Tina Herford et al. v. Johnson & Johnson Case number BC646315, consolidated in LAOSD Asbestos Cases, case number JCCP4674, in the Superior Court of the State of California, County of Los Angeles.  (J&J Talcum Powder Cancer Litigation Briefcase)

Senator Bob Menendez  judge declares a mistrial in New Jersey federal court trial, after a hung jury cannot agree unanimously on charges. Question is- Are the Senator and his doctor friend in Florida, just that-were they just friends or was there active bribery taking place?

Recent Case Updates:

>Plaintiff in DePuy Pinnacle Hip Implant Trial Asks Texas Jury For A Hundred Million + In Punitive Damages

At the close of arguments in the latest DePuy MDL 2244 trial on Monday November 13, 2017, six New York plaintiffs asked a Texas federal jury to hit Johnson & Johnson and it’s DePuy subsidiary, with at least a nine-figure punitive damages award. Attorneys asked that J&J and DePuy be punished for making and marketing their Pinnacle model hip implants, an alleged defective line of metal-on-metal hip implants, that have caused many thousands of injuries to unsuspecting patients. If this jury follows suit on prior Pinnacle bellwether jury awards, then J&J and DePuy should be ready for a massive verdict, as the last jury awarded California plaintiffs over one billion dollars in December 2016, sending a clear message that the company’s Pinnacle design and subsequent marketing policies have failed.

METALLSOIS DAMAGE

Closing arguments wrapped up on the two-month bellwether trial, where plaintiffs claimed they suffered “metallosis” which caused tissue damage and negative reactions to the Pinnacle Ultamet line of metal-on-metal hip implants made by J&J’s DePuy Orthopaedics Inc. unit. Depending on the jury verdict, perhaps J&J will consider coming to the settlement table if another massive verdict is awarded, or they may continue the aggressive “we’ve done no wrong stance” resulting in more plaintiff verdicts in the future..

 >Travelers Insurance Wins Declaratory Judgment Suit Over Defense Coverage In Orange County and Chicago Opioid Lawsuits:

“California Appeals court says Watson not covered”

Watson Pharma, Inc. and it’s parent Activis, Inc. were denied insurance coverage in a November 6, 2017 ruling by the California State Court of Appeals in the 2014 Declaratory Judgment action filed by Travelers Insurance in an Orange County, CA court where Travelers successfully asserted claims that they were not required to defend or indemnify Watson in the underlying opioid based litigation filed by Santa Clara and Orange County against opioid manufacturers, due to Watson’s “intentional bad conduct” in their business practices related to sales and marketing of it’s opioid products. The Appeals Court also excluded Watson’s coverage in a similar opioid lawsuit against them in a Chicago, Illinois federal case where the City of Chicago filed similar claims against Watson over opioid marketing abuses in 2014. Perhaps other insurance carrier will take notice and look closer at denying policy coverage for many other opioid manufacturers who have been sued across the country in cases with almost the exact claims as those alleged by Santa Clara County and the City of Chicago.

>NEW XARELTO TRIAL:

Former FDA Commissioner Testifies in Philadelphia Xarelto Trial-

“Xarelto Warnings Are Inadequate”

— Former head of the Food and Drug Administration, Commissioner David Kessler testified during the first state court trial in Philadelphia, telling the jury on Tuesday that “warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug”.

David Kessler, FDA Commissioner under President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson’s warning labels for the medication understated the risk of significant bleeding events that had been seen in television and print ads across the country for years, and failed to disclose the true risks associated with prescribing the blockbuster drug. This trial, expected to take six weeks, is the first state court bellwether trial for the blood thinner Xarelto, in the Philadelphia Court of Common Pleas, the prior trials took place in federal courts in Louisiana and Mississippi where the defense prevailed in all 3 trials earlier this year. Those trials were all bellwether trials, as part of the Xarelto MDL 2592 in front of Judge Eldon Fallon, US District Court, ED Louisiana. Will the change of venue to Pennsylvania State Court have a different outcome than the three prior Xeralto trial losses?

>Luzerene County, Pennsylvania Files RICO Suit Over Opioid Marketing Against Drug Makers

Luzerne County in Northeast Pennsylvania has filed a federal RICO based lawsuit accusing pharmaceutical companies including Purdue, Pharma, Endo, Janssen and Teva of violating the Racketeer Influenced and Corrupt Organizations Act by illegally marketing highly addictive painkillers that have contributed to a costly national opioid epidemic. The suit filed in US district Court of Pennsylvania by Luzerne County is one of many cases opioid drugmakers and distributors are facing as state and local governments seek to recoup costs they’ve incurred in the increased marketing and prescribing of opioid painkillers, and the resultant spikes in addiction and overdose.

OPIOID MARKETING ABUSES

“The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction,” the complaint, which was filed on Wednesday, said. “These pharmaceutical companies … turned patients into drug addicts for their own corporate profit.”
“The lawsuit accused the drugmakers of using false and deceptive marketing practices over the course of the last two decades, including pushing the opioid painkillers for treatment of chronic pain, to boost prescriptions for the drugs

COMMON CLAIMS AGAINST ALL OPIOiD MAKERS

Among the companies’ primary claims, cited by Luzerne county and others, evidence the manufacturers intentionally misled consumers, was that the drugs were not addictive when prescribed to treat legitimate pain. This is one of the key claims used by all parties filing suit against the opioid manufacturers, across the entire country.

Case heading is: Luzerne County v. Purdue Pharma LP et al., case number 3:17-cv-2043, in the U.S. District Court for the Middle District of Pennsylvania.

>Opioid Litigation Roundup: An Overview Of Recently Filed Cases and MDL 2804

In addition to the many counties and other communities from across the country that have filed lawsuits against opioid manufacturers in MDL 2802, set for a JPML consolidation hearing November 30, 2017 a new group of plaintiffs have joined the increasing pool of parties filing suit against Big Pharma opioid manufacturers and their distributors. Unions are now joining in the suits alleging that the business practices of the opioid makers and distributors caused catastrophic healthcare and related labor problems everywhere in the country over the last 15 years. Locals from the Electrical Workers; Commercial Food Service and Teamsters are now plaintiffs in the MDL 2804, which if approved at the upcoming JPML hearings in St Louis, will probably cause a flood of additional filings by unions across the country.

State attorneys general, a Native American tribe and individual consumers are among the ever increasing pool of plaintiffs who’ve brought lawsuits against drugmakers, pharmacies and distributors allegedly responsible for epidemic levels of opioid abuse. As word spreads among the network of local governments, and discussion take place about the municipal opioid lawsuits being filed, there will be a flood of new complaints filed, that will match or exceed the number of cases filed in the massive “Tobacco Litigation” which is quickly gaining comparison as the opioid case filings are looking to be comparable in size and probably exceed the tobacco litigation in damages.

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JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

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$417 Million J&J Talcum Powder Cancer Verdict Overturned in Los Angeles Court

JOHNSON & JOHNSON SCORES A POST-TRIAL DEFENSE RULING IN CALIFORNIA STATE COURT

 

 

 

 

 

 

 

 

Last week a California state court set aside a $417 million verdict awarded in August 2017, against Johnson & Johnson in a lawsuit by a woman that claimed J&J’s talc-based product, Johnson’s Baby Powder caused her ovarian cancer after years of feminine hygiene use.

Los Angeles Superior Court Judge Maren Nelson entered a ruling  that’s a further setback facing women and family members who accuse J&J of not warning consumers about the cancer risks of its talc-based products. There are now thousands of lawsuits filed against J&J over the claims that use of talc products leads to ovarian cancer, the cases are files in both state and federal venues across the country including the federal Multidistrict Litigation in J&J Talcum Powder MDL 2738 (USDC New Jersey) as well as thousands of Missouri State court cases, (see J&J Talc Cases in Missouri State Court), where plaintiffs have successfully obtained large verdicts against J&J over the last two years. A single talc verdict won in Missouri state court, was recently overturned based on the June 2017 US Supreme Court Plavix ruling, which defined a plaintiff’s residence as the jurisdictional guide to where state court cases can be filed.

There is another J&J talc related trial currently underway in front of  Judge Edward Simpson, in the same LA County Court, where there plaintiff has alleged use of J&J’s talcum powder products caused her to contract Mesothelioma. This trial started October 19th after plaintiff Tina Herford’s first trial was declared a mistrial on October 6, 2017, when Ms. Herford made a statement on the witness stand related to “talc use and ovarian cancer” causing Judge Simpson to declare a mistrial and quickly move to get the new trial started within 10 days. The J&J California state court trials and others soon to follow across the country, will keep J&J defense counsel busy for the foreseeable future, as more and more of J&J’s behind the scenes manipulation of R&D, paid research papers and suppression of adverse scientific publications is now coming to light, with all this conduct being introduced as evidence in the trials.

Judge Nelson’s ruling followed the jury’s decision in August to hit J&J with the largest verdict to date in Talc litigation, awarding California resident Eva Echeverria $70 million in compensatory damages and $347 million in punitive damages. This trial was fast-tracked due to Ms. Echeverria’s onset of stage 4 cancer and fears that she would not survive the wait for a trial set past August 2017.

Nelson reversed the jury verdict and granted J&J’s request for a new trial, ruling the August trial was underpinned by errors and insufficient evidence on both sides, culminating in excessive damages. The judge added that there also had been misconduct of the jury during the trial.

Mark Robinson, who represented the woman in her lawsuit, said he would file an appeal immediately, “We will continue to fight on behalf of all women who have been impacted by this dangerous product,” he stated.

J&J in a statement said it was pleased with the verdict, adding that it will continue to defend itself in additional trials.  J&J said declarations by two jurors after the trial showed that three members of the 12-person jury who voted against finding the company liable were improperly excluded from determining damages.

J&J also stated that  it faces lawsuits by 4,800 plaintiffs nationally asserting talc-related claims. Many of those cases are in California, where Echeverria’s case was the first to go to trial, and in the previously referenced Missouri court, where J&J has faced five trials, with very limited success.

The Missouri litigation led to four plaintiff verdicts against J&J in which juries issued verdicts totaling $307 million, with J&J only winning a defense verdict in a single trial.

But the Missouri cases do have a legal hurdle to address, the cases have largely been brought by out-of-state plaintiffs, hand now face jurisdictional questions after the US Supreme Court issued the June 19, 2017 Plavix ruling that limited where personal injury lawsuits could be filed, see U.S. Supreme Court Strikes Down California Ruling in Bristol-Myers’ Plavix Jurisdictional Case.

On October 17, 2017 , a Missouri appellate court threw out a US$72 million verdict by a jury in February 2016 to the family of a deceased Alabama woman after ruling the case should not have been tried in St. Louis, see Missouri Appeals Court Throws Out $72 Million Johnson & Johnson Talcum Powder Cancer Verdict.

Mass Tort Nexus will publish additional case updates and additional information regarding all Johnson & Johnson Talcum Powder related litigation across the country as they develop.

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Johnson & Johnson’s Ethicon Files Appeal in Court Ruling Where Defense Verdict in Mesh Trial Sidestepped By Judge

Plaintiffs Gets a Second Chance After Defense Trial Verdict

 

 

 

 

 

 

 

 

In another legal slam against Johnson & Johnson and their Ethicon mesh division, plaintiff Kimberly Adkins, who’s trial in June 2017 ended in a defense verdict, has been granted new life. In post trial pleadings, the judge granted the plaintiff’s petition for a hearing on damages, after determining that the jury findings had found the mesh was designed defectively, even though they entered a defense verdict. The manufacturer of the pelvic mesh involved, Ethicon Inc. (Ethicon), has appealed the judge’s ruling, when he ruled the matter can proceed to a damages hearing. In so doing, Ms. Adkins’ lawsuit, related to a TVT Secur mesh implant surgical deveice, has been revived, at least for the time being.
The primary defendant in the surgical mesh side effects lawsuit is Ethicon, a subsidiary of Johnson & Johnson, is now facing more than 100 lawsuits in the pelvic mesh mass torts currently consolidated in the Philadelphia Court of Common Pleas, Philadelphia. In what was the fifth case in the mass torts docket to go to trial, the jury on June 9 delivered for Ethicon, with what was  defendant’s first win in the 5 cases heard to date. Ethicon faces many thousands of other mesh lawsuits in federal and state courts across the country, and to date, have mounted vigorous defense in all cases.

Shortly after the defense verdict, Ms. Adkins’ trial team responded with a post-trial motion asserting that the jury’s findings were inconsistent with regard to the issue of whether or not a design defect, alleged in the surgical mesh complications lawsuit (a defect acknowledged by the jury) had been the cause of injuries to Adkins. They also stated that she was entitled to a review of the claim for damages based on the jury design defect determination.

The focus by plaintiffs is, that the jury had determined the Ethicon TVT-Secur mesh implanted in Adkins had, indeed been designed with certain defects. But in their verdict determination, by failing to identify that the product that may have caused Adkins’ injuries went against the weight of the evidence.

Adkins’ post-trial petition found merit with the judge in the Philadelphia Court, who revived the surgical mesh lawsuit in July and directed that the case be set for a hearing related to damages.

Ethicon promptly filed an appeal of the judge’s ruling with the Pennsylvania Superior Court. A spokesperson for Ethicon, Kristen Wallace, said in a statement that the trial jury in the Philadelphia Court of Common Pleas had, indeed determined that the Ethicon surgical mesh had not been the cause of the plaintiff’s injuries.

“We have filed an appeal to the Superior Court solely regarding the court granting a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” Wallace said.

Adkins’ legal team announced it would be opposing the appeal, noting that any further delays incurred by Ethicon’s now standard legal strategy of appealing all rulings to delay final determination, will only delay the final determination of damages being awarded to the plaintiff, for the harm, and suffering experienced after she received the Ethicon TVT Secur mesh implant.

The primary plaintiff claims are that Adkins suffered extensive post-surgical injuries, when the Ethicon TVT Secur implant eroded into the plaintiff’s vaginal canal, causing Adkins severe and ongoing pain, after a portion of the surgical mesh was removed by way of follow up surgical procedure in September, 2012 – however the pain continued. even in the aftermath of the revision surgery. The plaintiff has been unable to return to the pre-implant active lifestyle she enjoyed including being unable to enjoy normal sexual relations with her partner of 20 years.

Ms. Adkins initially filed her complaint related to surgical mesh complications in July, 2013. The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

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Why Has Bayer Stopped “Essure” Use In The UK and EU? Is it because women need a hysterectomy to remove the birth control device?

By Mark A. York (September 19, 2017)

Mass Tort Nexus

“Women are forced to undergo hysterectomies to remove a birth control device, Essure which is manufactured and marketed by Bayer AG, according to the British Medical Review Board”

 

 

 

 

 

 

The Essure birth control implant is used to permanently sterilize women, but is now recognized as a cause of significant side effects and complications also known in the healthcare industry as “adverse events” with the United Kingdom and European Union now restricting use of the permanent birth control device. This action has now started the FDA review in the United States of Essure and the process that Bayer stated showed the  device was tested and determined safe.

One woman in Great Britian – who later had her uterus removed – said she was left suicidal due to the “unbearable” pain, and felt she was a burden to her family.

The manufacturer Bayer says Essure is safe and the benefits outweigh the risks, which has been met with speculation as the sale of the implants in the EU was temporarily suspended this month and Bayer has asked hospitals in the UK not to use the device during this time.

“Too painful to move”

Laura Linkson, was alo fitted with the Essure device in 2013, and said the pain left her suicidal.

“The device was sold to me as a simple and easy procedure. I was told that I’d be in and out of the doctor’s office in 10 minutes and that there’d be no recovery time.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal.

The small coil implants, which are made of nickel and polyester (PET) fibres, are used as a sterilization device to stop eggs reaching the womb.

They are inserted into the fallopian tubes where they trigger inflazmation, causing scar tissue to build up and eventually block the tubes, known as a hysteroscopic sterilization.

They can cause intense pain, and some women are thought to react badly to the nickel and plastic.

Because of the way the coils attach to the fallopian tubes, the only way to take them out is to remove a woman’s fallopian tubes and often her uterus.

In other cases the device has been found to perforate fallopian tubes and fallen out, embedding itself elsewhere in the body.

Victoria Dethier was implanted with Essure in 2012 and for three years could not work out why she felt so unwell. “There were moments where I couldn’t get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside,” she said.

She thinks her body was reacting to the PET fibres designed to cause inflammation.

She had a hysterectomy to remove the device in 2015.  “Straight away there was a difference, I’d experienced a horrible taste in my mouth and that had gone,” she explained.as well as  I’d lost a lot of hair and that came back within 12 months, it was incredible.”

“We need acknowledgement by Bayer”

The medicines and healthcare products regulatory agency (MHRA – UK) has been criticized for not responding to the increasing evidence regarding the device.

In 2015, a study published in the British Medical Journal (BMJ) suggested that women who had a hysteroscopic sterilization were 10 times more likely to need follow-up surgery than those who had a traditional sterilization – 2.4% of those surveyed, as opposed to 0.2% amongst those having a standard sterilization.

In the US more than 15,000 women have reported problems to the US Food and Drug Administration (FDA), including pain, allergic reactions and “migration of device” that are involved in thousands of lawsuits versus Bayer Corporation and it’s German parent Bayer, AG.

Carl Heneghan, from the Centre for Evidence-Based Medicine at Oxford University, has criticized the regulator’s failure to act on such findings.  “How much evidence do you need to say let’s withdraw this product from the market?” he asked.

Victoria Dethier is angry that she and so many other women feel they have been ignored “No-one is listening to us, and now there are many women coming forward… we need to be acknowledged.”

Bayer Says “No long-term evidence of adverse events”

The full extent of the problem in the UK is not known.

The MHRA rejected the Victoria Derbyshire program’s Freedom of Information request asking how many women have reported problems.

The NHS does not have figures for the total number of women who have been fitted with Essure, or who have had it removed.

However, the clinical trial that led to the device being approved has been criticized for not considering the long-term effects of the implants, which Bayer has defended to this day. “The trial… only followed up women for one year, so nobody has a real understanding of what happens with this device after two years, three years, five years,” Mr Heneghan explained, and based on worldwide reporting of thousands of “adverse Events” it now seems that Bayer will have to begin the process of accepting responsibility for the Essure device medical problems claimed by the thousands of women who had the device implanted.

Some women who have experienced problems say they were not informed about the risks.

But Ben Peyton-Jones, a British consultant-obstetrician and gynecologist, said the device should still be used in some instances. Starting “I think it has a place for women who can’t have keyhole surgery and who are explained the risks very carefully,” when asked about the continued viability of Essure.

“When used correctly, according to the manufacturer’s guidance and in trained hands, it is safe.”

European Union Essure Use Suspended

The sale of Essure implants in the EU has now been suspended for further investigation and hospitals have been asked by Bayer not to use their existing stocks during this time.  This is a voluntary request and up to individual trusts to decide what to do.

The company said that independent reviews of Essure had concluded that the benefits outweighed the risks.

“Patient safety and appropriate use of Essure are the greatest priorities for Bayer, and the company fully stands behind Essure as an appropriate choice for women who desire permanent contraception,” it added in a statement. Bayer will immediately start damage control in the USA as soon as the UK-EU restrictions on Essure become known, specifically in the massive Essure Multidistrict Litigation, wher thousands of women in the United States are alleging major complications and onset of medical disability due to the Essure “adverse events” even while Bayer insisted the product was safe.

“Many women with Essure rely on this form of contraception without any side effects.”

The MHRA said it had no evidence to suggest this product was unsafe, and that the recent suspension did not suggest any increased risk to patient safety.

It said it was important for healthcare professionals to discuss the risks with patients before a procedure.

 

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Johnson & Johnson and DePuy Pinnacle Hip Implant Trial Continued Until September 18th Based on Appeal

Johnson & Johnson and DePuy Orthopaedics Latest “Pinnacle Hip Implant Trial” Continued Until September 18th Based on Fifth Circuit Appeal 

  • By Mark A. York (September 15, 2017)

  • Mass Tort Nexus

 

 

 

 

 

The latest bellwether trial in the  DePuy Pinnacle MDL 2244 (see DePuy Pinnacle Hip Implant MDL 2244 Briefcase) litigation has been postponed until September 18th, based on the U.S. Court of Appeals for the Fifth Circuit ruling, just days before the trial was to start, where they cited “grave error” by the sitting US District Court judge, in requesting a trial delay. The trial start date was September 5th, where eight plaintiffs from New York were part of the DePuy Pinnacle MDL 2255 multidistrict litigation, who are now facing jurisdictional issues based on the June 2017 SCOTUS “Plavix Ruling” that restricts jurisdiction over plaintiffs who are residents of another state, SCOTUS Plavix Jurisdictional Ruling Strikes Non-Resident CA Plaintiffs. The Plavix ruling forced thousands of non-California residents to determine if and where they can refile their claims against Bristol-Myers Squibb. DePuy Orthopaedics and it’s parent Johnson & Johnson (J&J) are asserting the Plavix ruling by stating that the New York residents are not subject to jurisdiction of the US District Court ND Texas and the trial should be stopped. This seems to fly in the face of the justification of certain tenants of the Joint Panel on Multidistrict Litigation rules of procedure, which assigned the DePuy Pinnacle Hip Implant cases to the Texas court to consolidate the many thousands of cases across the country.

 J&J Wants To Avoid More Massive Trial Verdicts

J&J are simply using evry legal tool available, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip Implant trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to it’s various other medical device and pharmaceutical product lines.

Appeals Panel Denies Writ of Mandamus Petition

On August 23rd, the Fifth Circuit panel denied Johnson & Johnson’s and DePuy Orthopaedics’ petition for writ of mandamus, which sought to halt the upcoming trial. However, two of the three panel members found that the judge proceeding over the consolidated DePuy Pinnacle litigation in Texas had allowed certain trials to take place before him which a “judicial error” including the one that as scheduled to begin yesterday where plaintiffs were New York residents. On September 1st, U.S. District Court Judge Ed Kinkeade of the Northern District of Texas issued an Order delaying the next DePuy Pinnacle hip replacement trial until September 18, 2017.

DePuy Pinnacle Hip Verdicts

The multidistrict litigation underway in the Northern District of Texas, DePuy Pinnacle MDL 2244, currently involves more than 9,000 hip replacement lawsuits related to the metal-on-metal version of DePuy Orthopedics’ Pinnacle hip system that utilizes the Ultamet liner. Plaintiffs claim that this configuration is defectively designed, as it sheds toxic metals into the joint surround the hip, as well as the blood stream, causing adverse local tissue reactions, metallosis, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the joint.

As of August 2017, MDL 2244 Pinnacle hip litigation has convened three bellwether trials. The first concluded in October 2014, with a verdict for DePuy and Johnson & Johnson.

In March 2016, five plaintiffs were awarded a total of $500 million at the close of the second DePuy Pinnacle trial, where the judge overseeing the case reduced the award to $151 million, in order to comply with Texas law governing punitive damages.

The largest hip implant trial verdict anywhere to date was in the DePuy MDL’s third bellwether trial which ended December 2, 2016, where six Pinnacle implant recipients, who were California residents, were awarded more than $1 billion in punitive damages, see $1 billion DePuy Hip Implant Verdict in MDL 2244, with the judgment later reduced to $543 million, by Judge Kinkeade.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials.  Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip replacement lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

 

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Boston Scientific Pelvic Mesh Cases Removed From Philadelphia Court of Common Pleas Based on SCOTUS “Plavix” Ruling

Boston Scientific Mass Tort Mesh Cases Removed From Philadelphia Court of Common Pleas Based On Recent Supreme Court  June 2017, Bristol Myers vs. California Superior Court “Plavix” Ruling

 

 

 

 

 

 

Boston Scientific, Marlborough, MA

By Mark A. York (September 7, 2017)

Plaintiffs who filed suit against Boston Scientific in a Philadelphia court over allegedly defective pelvic mesh, have agreed to have their cases removed from the Pennsylvania Court to other venues based on the June 2017 “Bristol-Myers California Plavix” U.S. Supreme Court opinion.  The Plavix ruling has thrown thousands of non-resident drug and medical device state court cases across the country into turmoil, as the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.  This was based on the Supreme Court ruling that stated Bristol-Myers R&D and sales activity in the State of California related to it’s Plavix blood thinner, (see Mass Tort Nexus “Plavix” CA State Court Briefcase) was not enough of a corporate presence to subject them to California state court jurisdiction, resulting in jurisdictional issue across the country for plaintiff firms.

Last month, Boston Scientific filed motions asking the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court’s both the “Bristol-Myers Squibb v. Superior Court of California”, see US Supreme Court Strikes Down State Court Jurisdiction and “BNSF Railway v. Tyrrell”, see SCOTUS Limits What State Court A Corporate Defendant Can Be Sued In.

According to one of the lead attorneys, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or in Delaware, it’s state of incorporation.

Kline & Specter attorney Shanin Specter said. “An agreement was reached with Boston Scientific to have the cases heard in a courtroom other than the Philadelphia Court of Common Pleas, so the cases can move forward and litigate without the jurisdictional issue creating legal issues. Although Boston Scientific’s motion last month sought to remove 94 cases, Specter said only three cases had been moving forward against Boston Scientific with calls placed to Boston Scientific defense counsel Shook, Hardy & Bacon and attorney Joseph Blum seeking comment have not been returned.

Judge New Asked to Reconsider

Last month, Boston Scientific had filed a motion requesting Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the mesh cases.  New, who is the supervising judge of Philadelphia’s Complex Litigation Center, issued a one-page order saying Boston Scientific’s motion was moot.

As part of the motion, Boston Scientific had sought to have New’s 2015 ruling vacated to allow for additional arguments on the issue, and allowing defense counsel to begin pleading the removal of thousands of other non-resident plaintiff cases currently in in the court’s complex litigation docket.

Ethicon Mesh Motion for Removal

Another major defendant in over one thousand pelvic mesh mass cases , Johnson & Johnson subsidiary Ethicon, has also filed motions recently seeking to have the cases dismissed based the Supreme Court’s recent decisions. Plaintiffs, however, have requested Judge New pend any rulings on these issues, based on the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.

The Supreme Court’s ruling from June 19, 2017 in Bristol-Myers vs. Superior Court of California (see US Supreme Court Denies California State Court Jurisdiction) now seen as the defining game-changing decision, for mass torts in state courts, that has promised to reshape the geography of mass tort litigation across the country. In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers’ conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.

Johnson & Johnson Files For Missouri Removals

Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in “blatant forum shopping on a grand scale.” On June 19, 2017 St Louis City Court Judge Rex Burlison declared a mistrial in the fifth talcum powder cancer trial being heard there, which was the afternoon of the SCOTUS “Plavix” ruling, declaring that the opinion earlier that day prevented the trial from moving forward. The trial was reset for October 2017, and the parties are currently arguing the jurisdictional issues of resuming the trial in front of Judge Burlison, see Mistrial Declared in J&J Talc Trial Due to SCOTUS Ruling.

Boston Scientific Argument

In requesting reconsideration regarding the recent Supreme Court decisions, Boston Scientific contends that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it “at home” in the state, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state’s business registration statute violates the due process clause of the U.S. Constitution and the now precedent “California Plavix” decision, .

“It is undisputed that Boston Scientific’s principal place of business is Massachusetts while its place of incorporation is Delaware,” the motion said. “Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it ‘at home.”

State Court Removal and Refiling Across The Country

The Philadelphia Court of Common Please Complex Litigation Docket appears to be preparing for a departure of many of the thousands of product liability cases, which prior to June 19, 2017 were moving along quite well in the under the direction of Judge Arnold New. State court dockets across the country are now forced to consider the removal of many cases as well as the potential refiling of thousands of cases in the state of incorporation for the medical device and pharmaceutical manufacturers.

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DePuy Pinnacle Hip Implant Trial Set for Today Delayed Based on Appellate Ruling of “Grave Error” By Sitting Judge

DePuy Pinnacle Hip Implant Bellwether Trial Set For September 5th Delayed After Appeals Court Cites Grave Error By Judge

 

 

 

 

 

DePuy Orthopaedics, Inc a subsidiary of Johnson & Johnson

By Mark A. York (September 5, 2017)

Federal Judge Ed Kinkeade has delayed the next DePuy Pinnacle hip implant bellwether trial that was set for today, Sept. 5, 2017 until later this month after a split federal appeals panel requested that he halt the proceedings due to a “grave error.”

In the August 31st opinion, two of three judges on a panel of the U.S. Court of Appeals for the Fifth Circuit refused to grant a petition for writ of mandamus filed by DePuy Orthopaedics Inc. to halt the trial. But two of the three also concluded that U.S. District Judge Ed Kinkeade, who is presiding over 9,300 cases alleging DePuy’s Pinnacle hip implants are defective, committed a “grave error” in allowing certain trials to take place before him, including the one scheduled this month on behalf of eight New York plaintiffs.

Opinion Outline

The opinion stated “despite finding serious error, a majority of this panel denies the writ that petitioners seek to prohibit the district court from proceeding to trial on plaintiffs’ cases,” wrote Circuit Judge Jerry Smith. “A majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial beginning September 5, 2017.”

Skadden, Arps, Slate, Meagher & Flom lead counsel for Johnson & Johnson, DePuy’s parent company, called on Judge Kinkeade to halt the trial, which is the fourth bellwether in the multidistrict litigation over the DePuy Pinnacle hip implant. This may help DePuy and J&J avoid a repeat of the last Pinnacle verdict in the prior bellwether trial where a Dallas jury awarded over $1 billion in damages, subsequently reduced by Judge Kinkeade, see DePuy Pinnacle Hip Implant Dec 2016 Trial Verdict Halved to Just $500 million in December 2016, which DePuy-J&J are appealing.

“We are pleased that the Fifth Circuit has determined that the MDL court does not have jurisdiction to conduct its planned trial of the claims of eight New York plaintiffs in a Texas courtroom,” Beisner wrote in an emailed statement after the ruling.

Plaintiff Counsel Surprised

Lead plaintiffs attorney Mark Lanier called it the “wildest opinion I’ve ever seen.”

“What this small panel has tried to do is change the law in the Fifth Circuit on a mandamus record, and that’s really frowned about,” said Lanier, of The Lanier Law Firm in Houston, who was joined in the appeal by former U.S. Solicitor General Kenneth Starr.

In addition to this month’s trial, the ruling could impact a separate case before the Fifth Circuit in which Johnson & Johnson has raised the same venue arguments in appealing a $1.04 billion verdict in the most recent Pinnacle trial. Oral argument on that appeal hasn’t yet been scheduled.

“Why this court issues an order on another court’s case, which is just an advisory opinion, is just absurd,” said Lanier. “It’s judicial activism.”

Lanier filed a petition for rehearing en banc on Friday. Later that afternoon, Kinkeade ordered the trial delayed until Sept. 18.

Final Bellwether trial

Kinkeade appeared to anticipate the Fifth Circuit’s intervention. On Aug. 25, he ordered that this month’s trial would “be the final bellwether case tried in the Dallas division of the Northern District of Texas” under which both sides have waived venue.  This was an unexpected ruling for the Pinnacle litigation, where Johnson & Johnson has appealed two other verdicts in Kinkeade’s courtroom, both involving consolidated cases that led to major awards in 2016,. Johnson & Johnson won the first verdict in 2014. But a second trial ended with a verdict of $502 million awarded to five Texas plaintiffs, while the third gave $1.04 billion verdict to six California plaintiffs.

All DePuy Hip Implant Litigation

These cases are part of the 8,707 actions consolidated before Judge Kinkeade in MDL 2244, In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, Northern District of Texas in Dallas.

Juries have found that DePuy and J&J have negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to the implant, and concealed its risks. J&J stopped selling the devices in 2013 after the FDA issued a safety communication about artificial-hip damages.

Separately, DuPuy is facing 1,458 product liability actions consolidated before US District Judge Jeffrey J. Helmick in MDL 2197, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation in Toledo, Ohio.

J&J prevailed in the first Pinnacle hip case to go to trial in October 2014 after a jury rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning. In March 2016, a Dallas jury ordered J&J to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.

DePuy Claims “Lexecon” Error

DePuy and Johnson & Johnson have argued that Kinkeade lacked jurisdiction over the trials involving California and New York plaintiffs. MDL judges are assigned to oversee pretrial matters with the intention of sending cases back to their original courts for trial. But defendants often waive that right under the U.S. Supreme Court’s 1998 holding in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, which allows bellwether trials to proceed before an MDL judge.

Johnson & Johnson claims it waived that right as to the first and second trials, but not the third or fourth. Plaintiffs’ attorneys have insisted that Johnson & Johnson agreed to a global waiver over all the trials.

Mass Tort Nexus will provide additional details of the ongoing trial dispute as information becomes available.

 

 

 

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FDA Safety Notice Letter “Recommends The Continued Use Of Forced Air Thermal Regulation Systems During Surgery”

Does the August 30, 2017 FDA Medical Device Safety Notice Letter Impact the BAIR HUGGER MDL 2666 FORCED AIR WARMING DEVICES Litigation? 

3M™ Bair Hugger™ Blanket System

 

 

 

 

 

 

 

 

US Food & Drug Administration Healthcare Provider Notice, August 30, 2017

FDA Safety Information Notice: Forced Air Thermal Regulating Systems: Healthcare Provider Letter – Information About Use

08/30/2017 – Dear Health Care Provider Letter – FDA]

AUDIENCE: Surgery, Nursing, Anesthesia

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

BACKGROUND: Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

RECOMMENDATION: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

FDA Medical Device Safety Notice

“Official Notice Letter”

 Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers

August 30, 2017

Dear Health Care Provider,

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements

As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

FDA ACTIONS

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration

 

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