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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Does Using Talcum Powder Cause Ovarian Cancer?

Does Johnson & Johnson talcum powder cause ovarian cancer?

(Mass Tort Nexus, August 28, 2017)  Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

 

 

 

 

 

 

A Los Angeles jury said yes, and last week it ordered Johnson & Johnson (J&J) to pay $417 million to 63-year-old Eva Echeverria, She blamed her terminal illness on Johnson’s Baby Powder, which she used for decades starting at age 11. Her argument was, the company should have warned consumers about the risk, which J&J stated was not necessary and the jury chose to believe Ms. Echeverria and her trial team.

The jury award is the biggest yet against J&J, which has lost 5 of 6 trials involving claims that its baby powder and Shower to Shower powder cause ovarian cancer. The company denies there’s a connection between its products and the disease and quickly said it would appeal the Los Angeles verdict. Lawsuits involving thousands more plaintiffs are pending, see Johnson & Johnson Talc MDL 2738 Briefcase.

Medical industry and cancer research experts divide sharply on talc’s role. Some are convinced the powder is linked to an increased risk of ovarian cancer, while other  including government health experts, say the evidence is lacking.

Amanda Fader, a gynecologic oncologist at Johns Hopkins University who was not involved in the studies states “The scientific body of literature is not compelling at this time to support a strong association between talcum powder and ovarian cancer, let alone to say that any one specific case was associated with powder,” and The American Cancer Society says that studies on talcum powder and ovarian cancer “have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.

Yet Fader and others aren’t ruling out that a link might someday be established. The Food and Drug Administration, which says it has found no link, is doing additional research on the topic. Although, J&J has spent millions of dollars lobbying and influencing all areas of FDA and related public oversight and commentary to prevent and type of link between cancer and talcum powder products from being abbounced, even while competitor talc products sold at Wal-Mart and Dollar Tree post warning labels declaring a possible link.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see“New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

Many pediatricians also discourage the use of such powder on babies because the particles can cause breathing problems, according to Jennifer Lowry, a pediatrician and environmental health expert at Children’s Mercy Hospital in Kansas City.

More than 22,000 women in the United States will be diagnosed with ovarian cancer this year, and 14,000 will die. The biggest risk factors, all well established, include a family history of breast or ovarian cancer, mutations in the BRCA genes and age.

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respectedWomen’s Health Initiative.

But critics, including Cramer, say these investigations have their own flaws. Because ovarian cancer is so rare, they say, prospective studies don’t always end up with enough cancer cases to detect a potential link between talcum powder and the disease.

And evidence can change as new research becomes available. That explains why the NCI, which uses expert “editorial boards” to vet the voluminous information it puts out for doctors and consumers, has amended its language on talc.

In February 2014, one editorial board reviewed an analysis of several case-control studies that found genital-powder use was associated with a “modest increased risk” of ovarian cancer. The board decided to add the article to the NCI website and noted a weak association between talc and ovarian cancer. It also added a link to the website of the International Agency for Research on Cancer, a World Health Organization agency that had concluded years ago that talcum powder was “possibly carcinogenic,” when used in the genital area.

But a year later, the same board scrutinized the Women’s Health Initiative study and took another look at previous studies. That’s when it changed the wording on the NCI’s site to say the “weight of evidence” did not support a link. The board also removed the IARC information. This all occurred after Johnson & Johnson used lobbying pressure and alleged payments to various affiliated entities to influence the NCI change of formal opinion

The FDA has wrestled with the issue, too. In 2014, it denied a citizens’ petition asking the agency to require a warning label on talcum powder; its review of the scientific literature found no link between the product and cancer, officials said.

But because the agency continues to get “adverse event reports” involving talcum powder, it is taking another look at the evidence and launching its own laboratory research. The summary for one study, funded by the FDA’s Office of Women’s Health, says that “talc’s effects on female genital system tissues have not been adequately investigated.”

In a statement after the Los Angeles verdict, J&J said that “we deeply sympathize with the women and families impacted by this disease.” But, it added, the science “supports the safety of Johnson’s Baby Powder.”

No matter what side they are on, scientists agree that more research – through lab studies with animals or human tissue – is needed to understand how talcum powder could potentially cause cancer. One hypothesis is that talc applied to the genital area can migrate up the vagina to the ovaries, causing chronic inflammation that eventually results in malignancies. But that is only a hypothesis.

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“New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”

Johnson & Johnson Still Influencing Opinion by Paying Cash to Insiders in Talc Cancer Fight

New Evidence of J&J Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”

 

 

 

 

 

 

 

 

Why did California jurors enter a verdict in favor of a cancer stricken plaintiff last week for $417 million in the latest trial over Johnson & Johnson’s (J&J) talcum powder and links to ovarian cancer?(see J&J Loses Another Talc Cancer Trial) It seems as if the largest talc cancer trial verdict to date, may have been influenced by new evidence, including an emailed photo that arrived at the start of trial, apparent payments to science industry insiders and a key J&J witness who was sanctioned and discredited for false testimony at a trial in North Carolina, according to one of plaintiffs’ counsel in the case.

The jury, in front of Judge Maren Nelson, Los Angeles Superior Court, (Eva Echeverria vs. Johnson & Johnson, Case No. BC628228), awarded Ms. Echeverria $70 million in non-economic damages and $347 million in punitive damages after finding that Johnson & Johnson failed to warn that its baby powder could cause ovarian cancer. Eva Echeverria was diagnosed with ovarian cancer in 2007, and was unable to testify at trial due to her illness.

Thousands of women have brought lawsuits making similar claims, most of which are in California, Missouri and New Jersey. Plaintiffs’ attorney Allen Smith, of The Smith Law Firm, who has tried all six of the previous trials, five of which were in Missouri. A seventh Missouri trial never went to a jury after the judge granted a mistrial, (see J&J Talc Trial Mistrial Declared After SCOTUS Ruling,)  on the day of the California-Plavix state court jurisdictional opinion. The juries hearing cases linking talcum powder to cancer have awarded four prior plaintiffs’ verdicts, totaling over $300 million, with the highest previous verdict being $110 million and all were awarded in Missouri state courts.

Introduction Of Damaging Evidence Against J&J:

Competitor Warning Labels

The California jury award was tied to three new pieces of evidence that other jurors hadn’t heard before, including evidence that baby powder products made by other companies sold at Walmart and Dollar Tree had warnings on the bottles showing the risks of ovarian cancer. Plaintiffs’ lawyers found out about the labels after a client of Ted Meadows, a partner at Beasley, Allen, et al, in Montgomery, AL, one of the trial attorneys, emailed a photo of a product with a warning label to them just before the Los Angeles trial began. “That was very welcome news to us,” Meadows said. “And the way it played out during the trial, I think it was news to J&J.”

Payments To Industry Insiders

Introduction of evidence that two individuals involved in the Cosmetic Industry Review (CIR), which has deemed talcum powder to be safe, which is data J&J has relied on in prior trials, had received payments from Johnson & Johnson for speeches and other engagements. This damaging information was discovered while cross-examining the group’s former director, Alan Andersen, who was a defense witness, and he was forced to disclose the prior unknown financial relationship of the CIR and Johnson & Johnson.

Bad Science

A major blow to J&J’s defense came when a defense witness, Senior Johnson & Johnson epidemiologist, Dr. Douglas Weed, was revealed to have been sanctioned for perjury in another trial in North Carolina, for lying under oath about whether he retained notes to his expert report, which plaintiffs attorneys were able to show.

“J&J presented these unbelievable and non-credible witnesses on an issue that is very important to our case,” Smith said. “Attempts to influence witnesses and alter facts, along with the fact other companies are warning of the cancer link and have been warning for eight to 12 months now. This was new evidence that proved very compelling to the jury as well as a reflection of J&J’s willingness to manipulate the trial process in their favor”, leading many to wonder what else J&J may have done.

In a post trial statement J&J declined to address the specifics of the case, stating: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the U.S. and we will continue to defend the safety of Johnson’s baby powder.”

In response, the Plaintiff team stated “The new evidence that came into the California case could play a role in the next talcum powder trial, which is set for Oct. 16 in Missouri, we certainly think it is evidence that should be presented, and we’ll make every attempt to do so,” Ted Meadows said.

Johnson & Johnson Has Thousands More Talc Trials Waiting

J&J faces thousands more federal lawsuits in the recently consolidated MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Liability Litigation supervised by US District Judge Freda L. Wolfson in the US District Court of New Jersey, in addition, there are the ever growing number of state court cases pending in Pennsylvania, New Jersey and Delaware as well as the remaining thousands of cases in the California State Court consolidation, which are captioned Johnson & Johnson Talcum Powder, Case No. JCCP4872.

Evidence of Johnson & Johnson and misconduct both inside and outside the courtroom can do nothing to further prove their continued claims of “no connection between ovarian cancer and use of J&J talcum powder products”, except provide juries with information which will continue to cause massive plaintiff verdicts to be entered across the country as more damaging evidence against J&J comes to light and is introduced at trials.

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Johnson & Johnson Loses Again In First California Talc-Cancer Trial As Jury Awards Plaintiff $417 million

J&J’s Loses Again In First California Talc-Cancer Trial As Jury Award Plaintiffs $417 million

  • Los Angeles jurors decide Johnson & Johnson failed to warn about risks
  • The Eva Echeverria trial is first of 300 cases in California alleging ovarian cancer

“Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County”

Johnson & Johnson (J&J) found out earlier today, August 21, 2017 that California is no friendlier than Missouri when fighting allegations that its talc powder causes ovarian cancer in women, as a Los Angeles Superior Court awards plaintiff Eva Echeverria $417 million after 3 days of deliberations.

J&J has lost four out of five recent talc cases that went to trial in St. Louis, and is the first trial before a jury in Los Angeles, and is the first case to go to a state-court jury outside Missouri and one of more than 300 similar cases pending in California. This trial follows the US Supreme Court ruling in June 2017 that made it harder for mass tort lawyers to try cases in St. Louis and other cities that have been a destination of choice for litigation against companies that do business nationwide.

The jury verdict shows that J&J is liable for failing to warn Eva Echeverria, 62, about the alleged cancer risks of using its talcum products, which she started using when was 11. She was diagnosed with ovarian cancer in 2007. The Monday morning verdict followed last Wednesday’s closing arguments, with the California jury deliberations coinciding with J&J’s jury trial in the Xarelto blood thinner Mississippi federal trial, which resulted in a defense verdict for J&J on August 18, 2017.  J&J was hoping the Mississippi Xarelto jury verdict was a precursor to the California Talc verdict, which it was not. Ms. Echeverria’s case was chosen as the first bellwether trial due to the onset of final stage ovarian cancer and her failing health, with doubts in some circles that she may not have survived until the trial start.

There are more than 4,800  Talc claims in federal and state U.S. courts accusing J&J, the world’s largest health-care company, of ignoring studies linking its baby powder and Shower to Shower talc products to ovarian cancer and failing to warn customers about the risk, with cases pending in Missouri, New Jersey and California.

In June, the Missouri judge halted the Talc trial there mid-trial in St. Louis, following a U.S. Supreme Court decision, earlier in the day limiting out-of-state plaintiffs joining lawsuits in state court, in the Bristol-Myers (Plavix) state court jurisdictional ruling, Bristol Myers California Plavix Ruling.  Up to then, J&J had been hit with verdicts as high as $110 million by Missouri juries, a favored location for Talc litigation, totaling more than $300 million and J&J, a New Brunswick, New Jersey-based company is appealing these verdicts.

J&J claims the plaintiffs’ allegations aren’t supported by scientific evidence, pointing to a New Jersey state court decision last year tossing out two cases set for trial, due to lack of expert witness supporting evidence.  That judge found evidence linking talc to ovarian cancer was inadequate, however, J&J just happens to be a New jersey based corporation.

The case is Eva Echeverria v. Johnson & Johnson, BC628228, Los Angeles County Superior Court.

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Xarelto Trial: Defense Wins Again in Dora Mingo vs. Bayer AG and Janssen R&D In Third Trial Loss for Plaintiffs

Xarelto Trial Update: Defense Wins Again in Dora Mingo vs. Bayer AG and Janssen R&D In Third Trial Loss for Plaintiffs

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)

 

JACKSON, Miss. – The Dora Mingo vs. Janssen and Bayer trial verdict was entered in favor of the defense this afternoon. This is the third trial verdict for defense in the Xeralto MDL 2592 bellwether trials, the verdict was returned in favor of the defendants not long after after closing arguments completed earlier today August 18, 2017.  Ms. Mingo a resident of Mississippi woman claims that Xarelto which was prescribed as a blood-thinner drug for treatment of a blood clot, caused her to suffer internal bleeding and anemia.

A jury of five men and four women were sitting in the U.S. District Court for the Southern District of Mississippi in front of visiting Judge Eldon Fallon, of the US District Court ED Louisiana, who heard closing arguments earlier today, and are now in deliberations.  The case relates to 69 year-old Dora Mingo of Summit, MS against the Bayer Companies and Janssen R&D and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

In previous back-to-back federal bellwether trials, juries have cleared the manufacturers of Xarelto of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.

However, plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, was something Xarelto’s manufacturers didn’t inform and instruct doctors about. However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

Mingo, a grandmother and retired schoolteacher, was prescribed Xarelto in January 2015 for treatment of a blood clot in her leg. After taking Xarelto, Mingo alleges she suffered severe upper gastrointestinal bleeding and acute blood loss anemia.

As soon as the trial verdict is released Mass Tort Nexus will send update.

 

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Xarelto Trial Update: Dora Mingo vs. Bayer AG and Janssen R&D Trial Finished Earlier Today

Xarelto Trial Update: Dora Mingo vs. Bayer AG and Janssen R&D Trial Finished Earlier Today

(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)

 

JACKSON, Miss. – The third bellwether Xeralto MDL 2592 trial has ended, closing arguments completed earlier today August 18, 2017. Ms. Mingo a resident of Mississippi woman claims that Xarelto which was prescribed as a blood-thinner drug for treatment of a blood clot, caused her to suffer internal bleeding and anemia.

A jury of five men and four women were sitting in the U.S. District Court for the Southern District of Mississippi in front of visiting Judge Eldon Fallon, of the US District Court ED Louisiana, who heard closing arguments earlier today, and are now in deliberations.  The case relates to 69 year-old Dora Mingo of Summit, MS against the Bayer Companies and Janssen R&D and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

In previous back-to-back federal bellwether trials, juries have cleared the manufacturers of Xarelto of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.

However, plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, was something Xarelto’s manufacturers didn’t inform and instruct doctors about. However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

Mingo, a grandmother and retired schoolteacher, was prescribed Xarelto in January 2015 for treatment of a blood clot in her leg. After taking Xarelto, Mingo alleges she suffered severe upper gastrointestinal bleeding and acute blood loss anemia.

As soon as the trial verdict is released Mass Tort Nexus will send update.

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