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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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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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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New Jersey Appellate Court Ruling of July 25, 2017 Reinstates Accutane Litigation

New Jersey Appellate Court Ruling of July 25, 2017 Reinstates Accutane Litigation

07/28/17 IN RE: ACCUTANE LITIGATION
New Jersey Appellate Court Opinion A-4698-14T1/A-0910-16T1
(CONSOLIDATED)

In the multicounty litigation (MCL) New Jersey Accutane product liability cases, the Appellate Division held that the trial court erred in barring plaintiffs’ experts from testifying as to certain epidemiological issues, and that Accutane can cause Crohn’s disease. Accordingly, the 2015 orders dismissing the lawsuits are reversed and the cases are remanded to the trial court for further proceedings per the July 25, 2017 order. The opinion reviews the legal principles applicable in a Kemp hearing, and provides some guidance for handling MCL cases in which the scientific evidence concerning the product develops over the protracted course of the litigation.

http://www.judiciary.state.nj.us/…/unp…/a4760-14a0164-15.pdf

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Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

“Another Example of Corporate America and Undue Influence on Official Release of Damaging Scientific Data”

Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

Documents released in a lawsuit against Monsanto, see Roundup (Monsanto) MDL 2741 USDC ND California, raised new questions about the company’s efforts to influence public opinion by collusion and steering of data published by mainstream media, various authors and scientific research publications and revealed an internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world, used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most US regulators, the Federal Mass Tort Litigation against Monsanto and Roundup,  pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released, the number of filed cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research, when an academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process, see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction, however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

 

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Missouri Federal Court Dismisses All Non-Missouri Plaintiffs From Bayer-Essure Birth Control Cases Citing Recent US Supreme Court Bristol-Myers “California Plavix” Ruling “Are Plavix Motions The New Defense Strategy?”

 

faviconOn January 19, 2017, plaintiffs who are residents of states around the country including Missouri, filed a joint complaint against Bayer AG, Bayer-Essure and other Bayer entities over its Essure Birth control implant in the Circuit Court for the City of St Louis, Bayer Essure Missouri Court Litigation, which was removed to Federal Court. The women claim Bayer’s device caused “serious and permanent injuries” and Bayer has been well aware of those risks for years,. The implants, considered “high-risk” at the time of their approval, were taken through the US Food & Drug Administration’s “Pre-Market Approval” process. In 2015 it was learned the FDA has received “nearly 10,000 formal complaints,” of debilitating side effects, that are “related to Essure,” and included an independent medical device expert who reviewed those 10,000 reports. The analysis ultimately turned up 303 reports of fetal death associated with the implants, far more than the 5 events cited in the FDA’s publicly-available documents on Essure. Congressman Brian Fitzpatrick (R-PA) is sponsoring a bill in the US congress that would see Essure recalled entirely from the market. For its part, the FDA recently announced that it would require a “black box” warning on Essure’s packaging, and has begun investigating allegations that clinical trial results were falsified to “silence” patients who experienced side effects after receiving the implants.

These claims are now meritless for the non-Missouri plaintiffs after Judge Carol Jackson, USDC ED Missouri, issued a ruling July 14, 2017 dismissing all claims by plaintiffs who are not residents of Missouri, citing the US Supreme Court in the June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix) ruling where in an 8-1 opinion, the court ruled “California courts lack specific jurisdiction to entertain the nonresidents’ claims” which has subsequently been cited by defense counsel in attempts to get non-resident claims dismissed from numerous state and federal non-Multidistrict Litigation and consolidated court cases across the country, when plaintiffs do not reside in the case venues. Will filing a “Plavix” motion be the “go to” strategy for the short term by defense, to see how many claims they can get removed from pending actions and force parties to refile in courts where the plaintiffs reside. What impact will this have on “State Court” complex litigation dockets such as those in New Jersey and Pennsylvania where large numbers of non-resident plaintiffs have claims pending?

Bayer was able to move away from traditional “Pre-Market approval and other defenses thanks to the “Plavix ruling”, but there were numerous motions, briefings and arguments in the Missouri Essure case as Bayer had originally filed the Bayer Essure Motion to Dismiss Re: Lack of Personal Jurisdiction on March 9, 2017 prior to the Supreme Court Plavix ruling. The cases were originally filed January 19, 2017 in Circuit Court for the City of St, Louis as Laveta Jordan et al vs. Bayer Corp et al (original complaint) Case No. 1722-0000173; The same day Bayer filed the Motion to Dismiss (March 9, 2017), they also filed a Motion to Sever Non-Resident Missouri Plaintiffs, With plaintiffs filing a Motion and Memorandum to Remand back to state court on March 16, 2017. Parties continued aggressive briefing arguments until Plaintiffs filed the final Response on July 13, 2017, just one day before Judge Jackson ruled on all the pending motions.
Judge Jackson ruled as follows on the primary issues raised by Bayer Corp. in its motion.

As to General Jurisdiction:
The question of general jurisdiction is easily disposed of here, as none of the defendants is incorporated in Missouri or has its principal place of business in the state. Moreover, none of the defendants have such substantial and extensive contacts such that they are essentially “at home” in Missouri. Plaintiffs’ allegations that defendants conduct “substantial business activities” in Missouri are insufficient to show that defendants are “at home.”

As to Personal Jurisdiction:
Citing the Plavix Ruling:
“Bristol-Myers Squibb Company v. Superior Court of California, 137 S. Ct. 1773 (2017) is dispositive of the specific personal jurisdiction issue in this case. In Bristol-Myers, out-of-state plaintiffs joined California plaintiffs in state court. Together they alleged a host of state-law claims based on injuries purportedly caused by defendant Bristol-Myers (BMS) prescription drug Plavix. 137 S. Ct. 1773, 1777 (2017). Notably, BMS was not a citizen of California, and the California Supreme Court ultimately concluded that general jurisdiction was lacking. Id. at 1778. But, the California Supreme Court determined that California courts had specific jurisdiction over the claims of the nonresident plaintiffs. Id. The California Supreme Court reasoned that BMS’s extensive contacts with the state and the similarity to the claims of the California residents supported its conclusion, the US Supreme Court reversed”
The Court elaborated that when no such connection exists, “specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the state.” The exercise of forum activities unrelated to the cause of action – including the operation of research laboratories not connected to Plavix, employment of sales representatives, and the maintenance of a state-government advocacy office–did not affect the analysis. And “BMS did not develop, manufacture, label, package, or work on the regulatory approval or marketing strategy for Plavix in California”.

As to Bayer Contact with Missouri:

Moreover, defendants Bayer, did not develop, manufacture, label, package, or create a marketing strategy for Essure in Missouri. And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum

As To Plaintiff Diversity:

Of the 94 plaintiffs, seven are citizens of Missouri. One plaintiff is an Illinois citizen who allegedly had the device implanted in Missouri. The remaining plaintiffs are citizens of 25 different states.

On March 9, 2017, defendants Bayer Corporation, Bayer Essure, Inc., Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals, Inc., jointly removed the action to this Court on the basis of diversity jurisdiction, 28 U.S.C. § 1332, and federal question jurisdiction, 28 U.S.C. § 1332.1 Bayer Corporation is a citizen of New Jersey and Indiana; Bayer Healthcare LLC is a citizen of Delaware, Pennsylvania, New Jersey, Germany, and the Netherlands; Bayer Essure, Inc. and Bayer Healthcare Pharmaceuticals, Inc., are citizens of Delaware and New Jersey; and Bayer A.G. is a German corporation.2 Some of the plaintiffs are citizens of Delaware, Indiana, and Pennsylvania. Despite the lack of complete diversity on the face of the complaint, defendants argue that they properly removed this case. Specifically, they contend that removal was proper because the diversity-destroying plaintiffs were misjoined, jurisdiction lies under the Class Action Fairness Act, and plaintiffs plead violations of federal law, thus invoking federal question jurisdiction. Plaintiffs counter that all of the claims are properly joined, and the Court lacks subject-matter jurisdiction over this action in the absence of complete diversity of the parties.

Summary of Ruling On All Motions:
Before the Court are defendants’ motion to dismiss pursuant to Federal Rules of Civil Procedure 8, 9(b), 12(b)(2), and 12(b)(6), and defendants’ motion to sever. Also before the Court are plaintiffs’ motions to remand and stay this action. The issues are fully briefed

Bayer’s Motion to dismiss for Lack of Personal Jurisdiction was granted as to all non-Missouri plaintiffs except plaintiff, Jennifer Dischbein, an Illinois resident who had an Essure device implanted in Missouri. FURTHER ORDERED that remaining plaintiffs Laveta Jordan, Jennifer Baggett, Cheryl Denbow, Jennifer Dischbein, Tiffany Queen, Erica Ware, Michelle Weedman, and Lavena Wilkerson shall have until August 1, 2017, to file an amended complaint setting forth their claims against the defendants.

IT IS FURTHER ORDERED that defendants’ motion to dismiss the complaint for failure to state a claim or federal preemption is denied without prejudice. IT IS FURTHER ORDERED that defendants’ motion to sever is denied as moot. IT IS FURTHER ORDERED that plaintiffs’ motion to remand is denied. IT IS FURTHER ORDERED that plaintiffs’ motion to stay is denied as moot.

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See the Mass Tort Nexus Bayer Essure Missouri Court Litigation briefcase link for additional case related information

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Johnson & Johnson Faces First California State Court Talcum Powder Trial in Los Angeles Superior Court

Talcum Powder Trial

The closely watched first bellwether trial (Eva Echeverria v. Johnson & Johnson, Case No. BC628228), in California state court over claims of cancer caused by Johnson & Johnson’s talc-based products began on Monday July 10th in Los Angeles County Superior Court, in front of Judge Maren Nelson. The trail started following hearings last week over the admissibility of expert witness testimony and the judge’s summary judgment rulings. The first day of trial saw Judge Maren Nelson change her July 5th ruling that J&J talc supplier Imerys Talc America would be included in the trial, where last week she ruled that Imerys reliance on J&J to warn of “talc dangers” was a question of fact for the jury. Prior to the start of the trial on Monday July 10, 2017 Judge Nelson entered a ruling that Imerys is dismissed from the trial. How this ruling impacts J&J’s trial strategy on the first day of trial is unknown, but does direct trial focus entirely onto Johnson & Johnson .

Last week Judge Nelson held “Sargon” hearings, the California equivalent of a “Daubert” hearing where parties argue over which expert witnesses will be permitted to testify at trial and the scope of their testimony. Judge Nelson chose not to exclude any experts or their testimony, but these hearings do reflect the enhanced scrutiny by state court judges, as to expert testimony in talc cases pending in state courts of New Jersey, California, Missouri and Pennsylvania. These pretrial hearings can be as significant as the trials themselves, as proven last October when a New Jersey state court judge canceled the first talc powder trial there after refusing to permit testimony from experts for the plaintiffs over alleged causal links between talc and ovarian cancer. These are the same experts who testified in the recent St. Louis talc trials where verdicts in excess of $300 million have been returned in the last 2 years; however, on June 29th, Judge Rex Burlison (St Louis Circuit Court), granted J&J’s motion for a mistrial, the same day the US Supreme Court ruled on the California State Court Plavix litigation in Bristol-Myers v. Superior Court of California, in an 8-1 opinion, siding with Bristol-Myers and struck down a California Supreme Court ruling allowing out-of-state plaintiffs to join a mass action over the blood thinner Plavix. One of the deceased women in the St. Louis trial was a former Missouri resident, while the other had lived in Texas and Virginia. How the Plavix ruling affects the thousands of other pending cases in the California “JCCP Consolidated Case” docket remains to be seen.

The Bristol-Myers(Plavix) Supreme Court jurisdictional ruling has caused counsel for parties in state court medical device and pharmaceutical cases across the country to change strategy citing to the Plavix opinion as grounds to dismiss thousands of state court cases where plaintiffs are non-residents. The current J&J talc trial in front of Judge Nelson is excluded from the Plavix ruling as Plaintiff, Eva Echeverria is a California resident, who claims she developed ovarian cancer while living in the state after using J&J’s talc products since the 1950’s. Besides being the first state court talc trial outside of Missouri, Echeverria’s case will also highlight a new group of plaintiff attorneys, after the same team represented plaintiffs in each of the previous talc trials.

All the St. Louis talc trials were handled by out-of-state plaintiff firms (Alabama-based Beasley Allen and the Mississippi-based Smith Law Firm), Echeverria’s team consists entirely of local California firms, with Mark P. Robinson Jr. of Robinson Calcagnie as lead counsel and Kiesel Law LLP, Boucher of Boucher LLP, Girardi Keese as liaison counsel. Johnson & Johnson are represented by some of the same firms that represented the companies in St. Louis, like Shook Hardy & Bacon, which is headquartered in Missouri, J&J’s other defense firm, Ohio-based Tucker Ellis, is making its first appearance in a talc trial.

J&J counsel are expected to be extremely aggressive in their attacks on plaintiffs’ experts, the science they rely on and medical treatment testimony, especially in light of the recent J&J defense verdicts in the first 2 Xarelto bellwether trials in the Xarelto MDL 2592 (US District Court Eastern District of Louisiana), where both juries returned defense verdicts within 24 hours of the start of deliberations.

Mass Tort Nexus will be providing ongoing updates to the Echeverria v. Johnson & Johnson trial as the develop.

The consolidated California cases are captioned Johnson & Johnson Talcum Powder Cases, number JCCP4872, and the bellwether case is captioned Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County.

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Public Citizen and PoPS Intervene for Students Victimized by Predatory Schools

WASHINGTON, D.C. – The Trump administration cannot be trusted to protect students defrauded by predatory for-profit colleges and career training programs that receive federal funding, Public Citizen and the Project on Predatory Student Lending said in a motion to intervene filed today in a suit pending in the U.S. District Court for the District of Columbia.

The two groups filed the motion on behalf of Meaghan Bauer and Stephano Del Rose, former students of the for-profit New England Institute of Art (NEIA) in Brookline, Massachusetts. The students allege that NEIA engaged in unfair and deceptive practices against them and other students that left them with a useless education, few job prospects and a mountain of debt. Thousands of students around the country have faced similar circumstances after dishonest recruiters lured them to enroll in predatory schools.

Bauer and Del Rose are counting on an Education Department rule finalized by the Obama administration that prohibits schools receiving federal funds from relying on forced arbitration agreements with their students. This “Borrower Defense” rule will ensure that Bauer and Del Rose have their day in court, but an industry group has filed suit against the Education Department to block the rule. Yesterday the Trump administration announced it would delay key parts of the rule until the litigation is over and begin a new rulemaking to reconsider the rule.

“The Borrower Defense rule is on solid legal ground and has already been the subject of months of negotiation and thousands of public comments,” said Julie Murray, attorney, with Public Citizen’s Litigation Group. “We don’t need more consideration of this rule. We need an Education Department with the spine to stick up for borrowers and the will to abide by its obligation to enforce the law. Since we clearly don’t have that, our clients have moved to intervene in the litigation to defend their interests.”

“Secretary Betsy DeVos’s decision to delay key pieces of the Borrower Defense rule is a disgrace,” said Toby Merrill, director, Project on Predatory Student Lending of the Legal Services Center of Harvard Law School. “The Department is using this litigation as cover for avoiding enforcement of the rule, to the detriment of borrowers like Ms. Bauer and Mr. Del Rose. The delay announced by the Department serves to line the pockets of for-profit executives at the expense of vulnerable students and federal taxpayers. It doesn’t serve borrowers.”

Forced arbitration clauses require students to submit any dispute that might later arise between the students and the institution to binding arbitration, a private process with little right to appeal, instead of a court of law. Students typically cannot band together to bring their claims jointly in arbitration, and they often are forbidden from publicly discussing the arbitration process.

Read the motion here.

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Bard Seeks Summary Judgment in IVC Filter MDL with Novel Preemption Argument

Bard IVC filter
IVC filters cause injuries from migration downward and upward. The IVC Filters can also tilt or shift, making them almost impossible to remove.

In a gambit to dismiss 1,700 lawsuits against its IVC filter, CR Bard is pressing a novel argument that the FDA’s quickie 510(k) approval process has become more rigorous, thus entitling it to a ruling that the plaintiffs’ state-law claims are preempted by federal law.

The argument is a stretch because courts have often declined to hold claims preempted where medical devices were cleared under the shortcut 510(k) process, as opposed to the more rigorous premarket approval (PMA) process.

All of Bard’s IVC filters involved in MDL 2641 – the Recovery, G2, G2, Express, G2 X, EclipseTM, Meridian, and Denali Filters — got approval via the lenient 510(k) process. The case is IN RE: Bard IVC Filters Products Liability Litigation, Case No. 2:15-MD-02641-DGC before US District Judge David G. Campbell in Arizona.

Changed greatly?

Bard argues in its summary judgment motion that the plaintiff’s master long and short form complaints, asserting state-law claims, are expressly and impliedly preempted by federal law.

FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

“The 510(k) program has changed greatly since Lohr (Medtronic v. Lohr, 518 U.S. 470 (1996),” Bard argues. “In 1990, Congress dramatically altered the 510(k) process in section 12 of the SMDA (Safe Medical Devices Act). The language expressly linked FDA substantial findings to “safety” and “efficacy”/”effectiveness”:

[T]he term “substantially equivalent” or “substantial equivalence” means . . . that the device . . . (ii)(1) has different technological characteristics and the information submitted . . . contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device.

Bard says that in its 510(k) approvals:

  • The FDA required compliance with special controls.
  • FDA required Bard to conduct clinical studies of its filters.
  • FDA required additional testing, labeling, and other information during its review.

“These device-specific guidances are intended to address specific risks or issues related to specific devices or device types, and where, as here, FDA has required manufacturers to follow them, they become device-specific federal requirements entitled to preemptive effect,” Bard asserts.

Bard quotes an FDA  2010 Working Report, saying that “the 510(k) program has changed significantly since its inception…. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.”

Similar argument failed

A similar argument failed in a motion for summary judgment by Janssen in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. In that case, US District Judge Eldon Fallon ruled:

“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.

The judge added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”

Plaintiffs argue that IVC filters cause injuries as follows:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

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