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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Actemra Research Suggest Congestive Heart Failure Warning Needed

A clinical study conducted by the maker of Actemra (tocilizumab), comparing the drug to its competitor, Enbrel (Etanercept), strongly indicates that a warning on the Actemra Label related to congestive heart failure is warranted.

In the study (see below) Hoffman La Roche compared Actemra to Enbrel. The goal of the study was to demonstrate that Actemra was not inferior to Enbrel.


 

The study demonstrated that patients using Enbrel suffered less adverse events in general however, for the purpose of this article one particular adverse event caught our attention.  The Hoffmann-La Roche study demonstrated that patients taking Actemra experienced congestive heart failure at essentially the same rate as those taking Enbrel with a statistically insignificant difference. One should also take into account that Hoffman-La Roche or those in their employ designed the rules of this “contest” as well as served as “referee”.

 

Whats the big deal?

The study conclusions become significant upon a review of the Black Box Warnings and Warnings and Precautions sections of Actemra and Enbrels FDA approved labels.  Enbrel  warns of Congestive Hearth Failure risks in the Warnings and Precautions section of their warning label and Acterma does not.  Given the fact that Hoffman La-Roache took it  upon themselves to stage this contest against Enbrel (with no input from the makers of Enbrel) and in the process discovered that their product carried essentially the same risk of Congestive Heart Failure (CHF) as Enbrel, Hoffman La-Roache would need to add the same warning related CHF in order not to be inferior to Enbrel.

Reasonably, if two competing drugs put patients at essentially the same risk of an AE and one drug warns potential users related to that AE and the other drug does not, the drug that does not warn is inferior. Given Hoffman La-Roache purpose was to prove non-inferiority to Enbrel, it would seem they may have achieved the opposite. Can theActemra Label be considered truthful and non misleading without a congestive heart failure warning given these facts or are they gaining an unfair advantage over Enbrel by withholding information from their warnings?

From out observations, it would appear that the study demonstrated higher risks for Actemra in most of the cardiac events observed. CHF caught our attention because Enbrel warns and Actemra does not.

Other important observations arose from the research conducted by Mass Tort Nexus specific to the study as well as the differences in the two product labels. Other observations will be covered in separate articles.

See the Black Box and Warnings and Precautions sections of the labels for both drugs below.  We believe these to be the most current versions.

 

 

 

 

 

 

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Dora Mingo vs Janssen and Bayer (Xarelto) Trial Update: Plaintiff Closes Her Case on August 16, 2017

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

 DEFENDANTS’ MOTION FOR JUDGMENT AS A MATTER OF LAW AT THE CLOSE OF PLAINTIFF’S CASE-IN-CHIEF

The third Xarelto MDL 2592, bellwether trial is proceeding in US District Court of Mississippi in front of MDL Judge Eldon Fallon, where plaintiff Dora Mingo resides, see Xarelto MDL 2592 Mass Tort Nexus Briefcase.  At the close of plaintiff’s case-in-chief on August 16, 2017 defendants Janssen Research & Development and Bayer Pharma AG, et al, moved the Court for judgment as a matter of law on Plaintiff’s design-defect and failure-to-warn-or-instruct claims under the Mississippi Product Liability Act (“MPLA”) see, Defendants Motion for Judgment as a Matter of Law.

Plaintiff have asserted two causes of action under Miss. Code Ann. § 11-1-63. Plaintiff first asserts that Xarelto is defectively designed because it was brought to market without an  accompanying rivaroxaban-specific anti-Factor Xa assay. Plaintiff also claims that Xarelto is unreasonably dangerous due to inadequate warning or instruction because Defendants failed to instruct physicians to use Neoplastin PT at the initiation of therapy to identify patients at an increased risk of bleeding.

Defendants state in their assertions that they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because an adjunct rivaroxaban-specific anti-Factor Xa assay to be used with Xarelto is not an alternative anticoagulant design and is therefore not a feasible alternative design under the MPLA.3 See Elliot v. El Paso Corp., 181 So. 3d 263, 273 (Miss. 2015); Clark v. Brass Eagle,Inc., 866 So. 2d 456, 461 (Miss. 2004). In their second assertion, they claim they are entitled to a trial win on Plaintiff’s design-defect claim because Plaintiff has presented no evidence that Xarelto failed to function as expected. See Austin v. Will-Burt Co., 361 F.3d 862, 872 (5th Cir. 2004).

Defendants further plead, they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because Plaintiff has made clear that her design-defect claim is based on a theory that Xarelto should have had a different design at the time it was released to the market (Trial Transcript. 141:19–142:11, 144:1–17), and the Court’s preemption decision so requires. See Order & Reasons on Defs.’ Preemption MSJs (Doc. 7110), at 11 (plaintiff’s “pre-market design-defect claims under the MPLA are not preempted”).

Defendants also include in their request for judgment, plaintiffs abandonment of various claims that were not presented at trial or withdrawn before trial, including the “failure to include the Rocket AF trial data” on participant bleeding rates and that Xarelto was designed without a reversal agent.

Mass Tort Nexus will provide additional Dora Mingo trial updates as they become available.

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Actemra Adverse Events

Actemra Emerging Mass Tort Litigation Preliminary Adverse Event Reports

The following article addresses reports related to adverse events and  medical conditions potentially related to the use of the Rheumatoid arthritis drug Actemra. The article will cover a report published by STAT which identified 5 major adverse events (AEs)  and medical conditions  (MCs) potentially caused by Actemra. We will also cover a larger number  serious AEs and MCs potentially related to the use of Actemra identified by Mass Tort Nexus using our proprietary adverse event indicator algorithm.

The AEs and MCs identified by Stat as well as Mass Tort Nexus only include those arguably not warned of on the product label in the Unitied States.

The report  from Stat was recently published in June 2017. The stat report linked Actemra to the following AEs and MCs:

  • Heart Attack
  • Stroke
  • Heart Failure
  • Interstitial Lung Disease
  • Pancreatitis

The Mass Tort Nexus (MTN) investigation has thus far identified the following AEs and MCs potentially linked to Actemra.  It should be noted that the MTN report is based on a partially automated process in addition to traditional research as a result, the MTN investigation into any medical device or drug is essentially always ongoing. The following is MTNs list:

  • Interstitial lung disease
  • Death
  • Stroke
  • Myocardial infarction, Congestive Heart Failure and other Cardiac Disorders
  • Acute Myelomonocytic Leukemia
  • Bone marrow failure
  • Synovitis
  • Increase in required knee replacements resulting from synovitis
  • Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
  • Psoriasis
  • Psoriatic arthritis
  • Pancreatic cancer
  • Malignancies

The remainder of this article will briefly define the conditions (not commonly known) we have identified as being potentially caused by the use of Actemra as well as our reasoning for the inclusion of theses AEs and MCs on our current list.

Interstitial lung disease

Interstitial lung disease describes a wide range of disorders which result in progressive scarring of the tissues of the lungs. Common among all of these disorders is decreased profusion (inability to breathe).

Mass Tort Nexus included Interstitial lung disease in our findings primarily based on the extremely large number of adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries.

It should be noted that Interstitial lung disease is a common co-morbidity factor in RA patients. Although early indications lead us to believe that the use of Actemra increases the risk of Interstitial lung disease above the baseline for RA patients in general, our research into this matter is ongoing.

Death

Although it is unclear why Actemra users experience a higher death rate than RA patients using other therapies, there is a strong indication that death does in fact occur more frequently in the Acterma user group. This conclusion was based on adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries as well as other factors.

Myocardial Infarction, Congestive Heart Failure and other Cardiac Disorders

The inclusion of MI, CHF and Cardiac Disorders in general was based in part on the drug manufacturers on Clinical Research used to gain FDA approval as well as case reports from sources world wide. This research is also supported by adverse event reporting data.

Acute Myelomonocytic Leukemia

Acute myelomonocytic leukemiais a form of acute myeloid leukemia that involves a proliferation of CFU-GM myeloblasts and monoblasts. Acute myeloblastic leukemia  is a group of malignant bone marrow neoplasms of myeloid precursors of white blood cells.

The inclusion of Acute myelomonocytic leukemiais is based on adverse event report reviews and case reports as well as other published literature deemed reliable.

Synovitis and Increased Knee Replacements

Synovitis describes inflammation of the synovial membrane. This membrane lines joints cavities, known as synovial joints.

Our inclusion of Synovitis and Increased Knee Replacements on this list was a result of adverse event report reviews as well as other data that we believe demonstrates a correlation between the use of Actemra and Synovitis leading to an increased number of knee replacements.

Bone Marrow Failure

Bone marrow failure occurs in individuals who produce an insufficient number of red blood cells, white blood cells or platelets.

Our inclusion of Bone Marrow Failure on this list is based on our adverse event report reviews as well as other indicators. Our inclusion on this list is also based on the significance of the disorder itself. Bone Marrow Failure can lead to a vast number of secondary conditions, may of which are fatal. If further research demonstrates that Actemra causes bone marrow failure (not simply is correlated to bone marrow failure), the significance for existing Actemra users as well as future potential Actemra users could actually be life or death.

Psoriasis and  Psoriatic arthritis

It is worth noting that other drugs such as Humira, also approved to treat RA are additionally approved for the treatment of Psoriasis. In the case of Actemra, there is some indication from case studies, adverse event report reviews as well as published articles from authoritative sources that Actemra may increase the risk of developing psoriasis. This may explain why Roche has not sought approval (as is the case with many RA drugs) for the treatment of Psoriasis given that the market for Psoriasis treatments is exponentially larger than the market for RA treatments.

The inclusion of  Psoriatic arthritis on our list is based solely on the well established fact that a significant percentage of patients that develop Psoriasis will eventually develop Psoriatic arthritis as a secondary condition.

Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome

Demyelinating disorders include  any condition that results in damage to the protective covering (myelin sheath) that surrounds nerve fibers in your brain and spinal cord. Damage to the myelin sheath results in the slowing of nerve impulses and can lead to a number of neurological problems.

Our inclusion of Demyelinating Disorders is based on a Dear Health Care Provider Letter sent to health care providers in 2013, warning of several conditions potentially related to or caused by the use of Actemra. All but two of these conditions have been added to the Actemra Label with the exclusion of Demyelinating Disorders and malignancies.  Indications from our review of adverse event reports also justifies Demyelinating Disorders inclusion in this list.

Malignancies

A malignancy is simply the presences of a cancerous tumor.

Our reason for inclusion of Malignancies in this list is in part based on the Dear Health Care Provider Letter referenced above for the same reasons we included Demyelinating Disorders. There is also support for AEs related to Cancer and Actemra in the review of adverse events, case reports and other reliable literature.

Pancreatitis and Pancreatic Cancer

Our inclusion of Pancreatitis in this list is based on a review of adverse event reports, case reports as well as literature from sources deemed to be reliable.

Our inclusion of pancreatic cancer in this list is based on the well established fact that patients that suffer from Pancreatitis are at an increased risk for pancreatic cancer. Although the number of patients that develop pancreatic cancer secondary to pancreatitis is relatively small, the fact that pancreatic cancer is generally fatal, we feel its inclusion on this list is warranted.

Correlation vs Causation

It is important to note that neither the Stat Report nor the information reported in this article are sufficient to indicate that Actemra causes any of the AEs or MCs listed.  The report and this article observe correlations.  Discovering correlation is a necessary step towards determining causation however, correlation alone does not prove causation.

Even if Actemra does cause every AE and MC listed in the Stat Report and this article, the evidence to prove this causation may never come into existence.  The drug maker has little incentive to fund clinical studies to prove their product causes an adverse event. Developing proof of causation for any AE or MC is largely dependent unintended  outcomes of studies the drug maker may still have motive to publish or information developed by the FDA or FDA equivalents in other countries.

In our opinion, to date,  the strongest causation evidence exists for the following AEs and MCs:

Heart Disorders, including Congestive Heart Failure and Myocardial Infarction.

Demyelinating Disorders

Malignancies

Pancreatitis

As our investigations continue, we are highly likely to find additional evidence related to the AEs and MCs listed as well as others. We expect to be publishing information related to Actemra for the next several years.

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J&J Talcum Powder Cancer Trial Update: California State Court Jury Hears from Plaintiff Eva Echeverria’s Epidemiology Expert

“Plaintiff Eva Evecherria’s Case Selected For First Trial Due to Onset of End Stage Terminal Ovarian Cancer”

Is Johnson & Johnson Baby Powder Dangerous?

Plaintiff Eva Echeverria, whose case was selected for California’s bellwether trial, due to her declining health caused by ovarian cancer, continued to present evidence last week in Los Angeles Superior Court. (see Eva Echeverria vs J&J Talc Trial CA State Court ), and there are additional cases against J&J in Johnson & Johnson Talcum Powder Cases, No. JCCP4872.

On Friday, jurors heard from a Canadian epidemiology expert who was called to offer his opinions on studies linking talc-based powders to ovarian cancer.

Among other things, Jack Siemiatycki, an epidemiologist with the University of Montreal and McGill University, discussed his contributions to the International Agency for Research on Cancer’s 2006 monograph that deemed talc a possible human carcinogen. According to Law360.com, he also testified that his stance has changed since then, as he now thinks that it is more likely than not that talc can cause ovarian cancer.

Under cross examination, Siemiatycki acknowledged that he had not reviewed the plaintiff’s specific case, as his testimony was only intended to address the general link between use of talcum powder and ovarian cancer .

Johnson & Johnson Concerns Are Corporate Image Over Human Life

The talcum powder lawsuit selected for the California trial was filed on behalf of Ms. Echeverria, a 63-year-old woman who allegedly made Johnson & Johnson’s talc-based powders a regular part of her daily feminine hygiene routine in the decades prior to her ovarian cancer diagnosis. Like other plaintiffs around the country, she claims that tiny particles of talc entered her vagina and migrated to her ovaries, resulting in the type of inflammation that encourages the growth of ovarian cancer cells.

During opening statements earlier in the week, Escheverria’s attorney asserted that Johnson & Johnson had known of the alleged link between talc and ovarian cancer for decades, but decided to withhold warnings from the public to protect its image.

“It’s the safe and gentle corporate image of a mother and baby that the defendants are placing over human life, in this case,” he told the jury.

Delaware State Court Plaintiffs Request Coordination

10 plaintiffs who filed talcum powder lawsuits in Delaware Superior Court are seeing coordination of all ovarian cancer cases involving Johnson & Johnson products. In addition to Johnson & Johnson, Imerys Talc America Inc., and the Personal Care Products Council are named as defendants.

Talcum Powder Ovarian Cancer Cases Filed in Canada

In May 2016, a class action lawsuit was filed in Toronto, Ontario on behalf of Canadian women who allegedly developed ovarian cancer due to their long-term use of Johnson & Johnson’s baby powder for feminine hygiene. Plaintiffs assert that the company should have warned consumers decades ago about the alleged link between talc powder and ovarian cancer, and that doing so would have easily prevented many, many cases of the disease.

Missouri Talcum Powder Plaintiff Verdicts

Johnson & Johnson has been named a defendant in more than 3,000 talcum powder claims in state and federal courts throughout the country. In addition to California, similar litigation is currently underway in Missouri, New Jersey and Delaware state courts, as well as New Jersey Federal Court.

The Missouri litigation, has already resulted in 6 talcum powder trials, with plaintiffs winning 4, one defense verdict and the most recent June 2017 trial declared a mistrial due to a US Supreme Court ruling. The first concluded in February 2016, when the family of an Alabama woman who died of the disease was awarded $72 million ($10 million compensatory and $62 million punitive).

Three months later, Johnson & Johnson was ordered to pay $55 million ($5 million compensatory, $50 million punitive) to a South Dakota ovarian cancer victim.

The following October, another Missouri jury awarded $70 million, including $2.5 million in compensatory damages and $67.5 million in punitive damages, to a third plaintiff.

Missouri’s fourth talcum powder trial concluded in March 2017, with a win for Johnson & Johnson. In May, however, the company was hit with its largest talcum powder verdict thus far, when another Missouri jury awarded more than $100 million in compensatory and punitive damages to the plaintiff in the state’s fifth trial. The final trial in June, where Shawn Blaes and other non-Missouri plaintiffs were in mid-trial when Judge Burlison declared a mistrial just hours after the US Supreme Court ruled on the state versus federal court jurisdictional issue in Bristol-Myers vs. California Supreme Court.

How will the Bristol-Myers “California-Plavix” Ruling Affect Missouri and Other State Court J&J Talcum Powder Cases?

On June 19, 2017 in the most recent St. Louis courtroom trial, Estate of Shawn Blaes, et al vs. Johnson & Johnson Case No. 1422-CC09326-01, over Johnson & Johnson’s talcum powder, trial counsel received notice of a US Supreme Court decision that day and were changing trial strategy instantly, and scrambling to determine if the Supreme Court decision handed down that morning doomed their case. The ruling was from a California multi-plaintiff drug case, Bristol Myers-Plavix Litigation JCCP Case No. 4748 (San Francisco County Superior Court) where Bristol-Myers had appealed the August 29, 2016 California Supreme Court decision, where the California court ruled that “foreign resident plaintiffs were able to remain parties to the Plavix litigation in California State Court” see California Court Opinion Jurisdiction of Non-Resident Plavix Plaintiffs 8.29.2016. Bristol-Myers immediately appealed to the US Supreme Court, where appeal arguments were heard on April 24, 2017, see BMSQ California Plavix SCOTUS Appeal Transcript , which left non-resident plaintiffs in state court cases across the country in limbo, pending the ruling.  On June 19th the US Supreme Court in an 8-1 ruling clarified the non-resident question for many plaintiffs, including the three plaintiffs in the pending trial in front of Judge Rex Burlison, who immediately declared a mistrial. The Blaes trial has been reset for October 2017, pending motions and briefings regarding the Plavix ruling and how it applies to the trial.

There are already dismissals in federal and state court cases of non-resident plaintiffs in non-talc lawsuits, so what will the “California-Plavix” ruling do to the thousands of other talc cases pending across the country? That question remains to be answered.

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