NJ Judge in Talc Cancer Case Bars Plaintiffs’ Experts, Dismisses Cases

talc johnson & johnsonNew Jersey Superior Court Judge Nelson C. Johnson barred two prominent scientists who were prepared to testify for  plaintiffs in product liability litigation charging that talc mined by Imerys and sold by Johnson & Johnson causes ovarian cancer.

J&J is facing 1,200 lawsuits in Missouri and New Jersey, charging it with failing to warn consumers about the cancer risks. Earlier this year juries in state court in St. Louis awarded 8-figure verdicts in trials charging that the company knew that its talc-based products cause ovarian cancer, and failed to warn women who used it.

In addition, the Judicial Panel on Multidistrict Litigation (JPML) created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

Grants summary judgment

Regardless, Judge Johnson ruled on Sept. 2 that Dr. Graham A. Colditz and Dr. Daniel W. Cramer were barred from testifying in multi-county litigation (MCL), and granted summary judgment for the defense in Brandi Carl v. Johnson & Johnson, Case No.: ATL-L-6546-14, and Diana Balderrama v. Johnson & Johnson, Case No.: ATL-L-6540-14.

The court seemed swayed by numbers, that Cramer and Colditz relied on case-control studies with a total of 18,384 participants while defense experts relied on cohort studies with 191,090 participants. Cohort studies compare the incidence of disease among individuals exposed to a substance with an unexposed group. Case-control studies examine the frequency of exposure in individuals who presently have the disease and compare them to a group of individuals who do not have the disease.

He criticized the scientists for presenting “made-for-litigation” testimony. “Plaintiffs’ experts fail to demonstrate ‘that the data or information used were soundly and reliably generated and are of a type reasonably relied upon by comparable experts,'” citing Rubanick v. Witco Chem. Corp., 125 NJ. 421, 432 (1991).

Graham A. Colditz, M.D., MPH, DRPH, FAFPHM, is the Chief of the Division of Public Health and Sciences in the Department of Surgery at Washington University School of Medicine. Dr. Colditz also serves as co-director of the Biostatistics Core for the Siteman Cancer Center. Dr. Colditz was presented on the issue of general causation of ovarian cancer.

Daniel W. Cramer, M.D., Sc.D., is a Professor of Obstetrics, Gynecology and Reproductive Biology at Brigham and Women’s Hospital, Harvard Medical School, and Professor of Epidemiology at the Harvard T.H. Chan School of Public Health. He heads the Research, Division of the OB-GYN Epidemiology Center. Dr. Cramer was presented on the issues of both general and specific causation of ovarian cancer.

Confused?

The judge waded into the details of cancer research and seemed confused between “ovarian cancer” and “invasive serious cancer,” the lack of inflammation in tissue that contained talc, which was surgically removed from each of the plaintiffs, and evidence about other gynecologic cancers of the vagina, cervix, uterus and fallopian tube (opinion page 20).

The judge flatly accepted the testimony of defense expert Lewis A. Chodosh that talc is inert, has anti-cancer properties, doesn’t cause death to normal cells, and doesn’t cause mutations.

The judge could not grasp the postulation of Cramer and Colditz that the talc flows upstream and lodges in the ovaries; it irritates cells in the ovaries, causes inflammation, which in turn causes immunosuppression, and causes cancer. ”

“Inflammation is an extremely complex issue and it is unclear whether chronic inflammation is sufficient to induce cancer in the absence of a carcinogen,” the judge wrote.

 

 

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Court Closes Vaginal Mesh Suits in Georgia MDL

TVM_Slide_978x250US District Chief Judge Clay D. Land ruled that no new cases will be accepted in MDL 2004 In Re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, involving defective pelvic mesh implants made by Johnson & Johnson that caused painful infections.

“The Court finds that the primary purposes of consolidation have been accomplished, and the benefit of accepting new cases is marginal,” Judge Land wrote. The MDL was created in December 2008 in the Middle District of Georgia in Columbus, GA, with 22 cases. Since then:

Since then:

  • The MDL has grown to include more than 850 cases.
  • The court has decided more than 100 summary judgment motions.
  • Tried three bellwether cases.
  • Forty-nine cases have been remanded to the transferor court or transferred to the district court where venue is proper for trial.
  • More than 450 cases have been dismissed by stipulation of the parties or order of dismissal following a notice of settlement.
  • Nearly 100 cases have been dismissed voluntarily by the plaintiffs via notice of voluntary dismissal or a motion to dismiss.

Accordingly, the judge requested that the Judicial Panel on Multidistrict Litigation (JPML) not transfer any new actions to the MDL after Oct. 31, 2016, and that no new direct-filed actions will be accepted after Oct 31.

Hundreds of women allege that once Mentor’s transobturator vaginal sling known as ObTape was implanted into their bodies, they suffered erosion of internal bodily tissues, including vaginal walls, and most women needed multiple surgeries to correct the problem.

Thousands of transvaginal mesh cases consolidated before Judge Joseph R. Goodwin in the Southern District of West Virginia

Mentor, which discontinued the product in 2006, is also accused of inadequately testing the device before introducing it in 2003.

“The cases pending in this MDL as of October 31, 2016 shall be managed pursuant to the existing phased scheduling orders, with any recent cases being scheduled so that all dispositive motions shall be ripe in those cases no later than March 31, 2018. With this schedule, the Court anticipates that all cases will be settled, dismissed, or remanded no later than August 31, 2018,” the judge wrote.

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California Supreme Court Takes Jurisdiction of Plavix Mass Tort Claims

Plavix bleeding side effectsThe California Supreme Court ruled that state courts can take “specific jurisdiction” over mass tort claims by out-of-state plaintiffs against Bristol-Myers Squibb because of the company’s in-state marketing campaigns, sales and research.

It distinguished a 2014 US Supreme Court ruling Daimler AG v. Bauman that states may take “general jurisdiction” only over companies that are “at home” in the state.

The ruling allows claims to proceed in Bristol-Myers Squibb Company v. Bracy Anderson, S221038, Super. Ct. JCCP No. 4748 (Sept. 29, 2016). It clears the way for lawsuits by 86 Californians and 592 plaintiffs from 33 other states against Plavix, a drug used to inhibit blood clotting, to be tried together in California.

The plaintiffs allege that the drug caused bleeding, bleeding ulcers, gastrointestinal bleeding, cerebral bleeding, rectal bleeding, heart attack, stroke, hemorrhagic stroke, subdural hematoma, thrombotic thrombocytopenic purpura, and 18 deaths. They charge that the Bristol-Myers engaged in negligent and wrongful conduct in the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and sale of Plavix.

According to the complaints, the defendants promoted the drug to consumers and physicians by falsely representing that it provided greater cardiovascular benefits, while being safer and easier on a person‘s stomach than aspirin, but defendants knew those claims were untrue.

Separately, 261 Plavix lawsuits are pending in multidistrict litigation (MDL) before U.S. District Judge Freda L. Wolfson in the District of New Jersey. The United States Judicial Panel on Multidistrict Litigation created the MDL on December 8, 2015.

General jurisdiction

The 74-page opinion upheld rulings in two lower courts and focused on the difference between “general jurisdiction” and “specific jurisdiction.”

United States Supreme Court ruled in Daimler AG v. Bauman 571 U.S. ___ (2014), on the limits of general jurisdiction involving out-of-state defendants and plaintiffs. General jurisdiction requires that a defendant must be “at home” in a state — by being incorporated and having its principal place of business in a state. “The corporation‘s activities must be so continuous and systematic as to render [it] essentially at home in the forum State,” the US Supreme Court held.

Daimler held that California courts did not have general jurisdiction over Argentinian plaintiffs suing DaimlerChrsyler, a German company, over a dispute in Argentina.

In the Plavix case, Bristol-Myers (BMS) argued it was incorporated in Delaware, headquartered in New York City, and maintained operations in New Jersey. The California high court agreed that it did not have general jurisdiction over the company, even though it was registered to do business and California and has an agent for service of process.

Specific jurisdiction

But the California court went on saying it did have specific jurisdiction based on a three-part test:

  1. Whether the defendant has purposefully directed its activities at the forum state.
  2. Whether the plaintiffs’ claims arise out of or are related to these forum-directed activities.
  3. Whether the exercise of jurisdiction is reasonable and does not offend traditional notions of fair play and substantial justice.

Satisfying test 1, “BMS purposefully availed itself of the benefits of California” by marketing and advertising Plavix in California, selling 187 million Plavix pills in California from 2006-2012 resulting in sales revenue of $918 million, employing 250 sales representatives in California, contracting with McKesson, based in San Francisco, to be its pharmaceutical distributor, operating research and laboratory facilities in California, and even having an office in the state capital to lobby the state.

Satisfying test 2, BMS had extensive activities in California, including by marketing and promoting Plavix in the state, conducting research and development in California and targeting California as part of a nationwide campaign. “Because of the defendants‘ relationship with the forum, it is not unfair to require that they answer in a California court for an alleged injury that is substantially connected to the defendants’ forum contacts,” the court ruled.

Satisfying test 3, BMS had adequate notice that it was subject to suit in California. “BMS embraced this risk by coordinating a single nationwide marketing and distribution effort and by engaging in research and development in California. In that regard, BMS was on notice that it could be sued in California by nonresident plaintiffs. In fact, our courts have frequently handled nationwide class actions involving numerous nonresident plaintiffs.”

California has a clear interest

BMS argued that the claims of non-resident plaintiffs had no connection to and did not suffer any injury in California. But the court ruled that the proper focus is on the defendant and whether the corporation has created contacts in the forum state.

California has a clear interest in trying the mass tort cases together to promote efficient adjudication of California residents‘ claims. “Because mass tort injuries may involve diverse injuries or harm not amenable to the efficiency and economy of a class action, they present special problems for the proper functioning of the courts and the fair, efficient, and speedy administration of justice. Without coordination, those who win the race to the courthouse [and] bankrupt a defendant early in the litigation process would recover but effectively shut out other potential plaintiffs from any recovery,” the court ruled.

“Balancing the burdens imposed by this mass tort action, and given its complexity and potential impact onthe judicial systems of numerous other jurisdictions, we conclude that the joint litigation of the nonresident plaintiffs‘ claims with the claims of the California plaintiffs is not an unreasonable exercise of specific jurisdiction over defendant BMS.”

 

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Court Sets Lineup for Cook IVC Filter Bellwether Trials

Cook Celect® IVC Filter
Cook Celect® IVC Filter

US District Judge Richard L. Young, overseeing Cook Medical, Inc., IVC Filters Product Liability
Litigation, MDL 2570, ruled that the first bellwether trial will focus on the Celect IVC filter, and the second on the Gunther Tulip filter.

The current lineup is:

  1. Hill v. Cook Medical, Inc., 1:14- cv-6016-RLY-TAB. In this case, the Celect filter was implanted before Ms. Hill’s scheduled back surgery. She claims the filter migrated and perforated her vena cava and duodenum. She was 57 years old at the time. After at least one failed retrieval attempt, the Celect filter was successfully removed percutaneously two years after implant using advanced retrieval techniques.
  2. Gage v. Cook Medical, Inc., 1:14-cv-1875-RLY-TAB. Mr. Gage was implanted with the Günther Tulip filter after experiencing gross hematuria while on anti-coagulation medicine. He was 61 years old at the time, and has a history of pulmonary embolism and deep vein thrombosis. Mr. Gage alleges that the Günther Tulip filter perforated his vena cava and cannot be removed.
  3. Brand v. Cook Medical, Inc., 1:14-cv-6018-RLY-TAB.  Ms. Brand was implanted with a Celect filter before her scheduled back surgery, as she had experienced a deep vein thrombosis in 2007. She was 51 years old at the time of the implant. More than two years after surgery, she learned that the Celect filter had two fragmented legs. An attempt to remove the filter percutaneously was abandoned after several unsuccessful attempts to snare the hook of the filter from her caval wall. Four years later, she underwent an open surgery, wherein the filter was removed but the fractured pieces from the filter could not be recovered and remain in her body.

900+ cases

More than 900 cases against Cook Medical are consolidated in a multi-district litigation docket (MDL) in the Southern District of Indiana in Indianapolis. The small, umbrella-like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

“Gage is more representative than Brand of the types of injuries and retrieval challenges at issue in this MDL,” Judge Young wrote. Furthermore, according to Cook, approximately 45% of the plaintiffs in the  MDL had a Günther Tulip filter implanted. Gage is the only Günther Tulip case selected as a bellwether. “For these reasons, the court finds trying Gage second furthers the goals of the bellwether selection process. Accordingly, Gage will be the second bellwether trial.”

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NJ Judge Dismisses 160 Cases in Accutane Litigation — 4,000 Remain

accutaneNew Jersey Superior Court Judge Nelson Johnson issued two orders dismissing a total of 160 cases from 20 states against Hoffman-LaRoche Ltd. in Accutane product liability litigation that alleges the acne drug caused inflammatory bowel disease. At least 4,000 cases remain in the consolidated litigation, Case No. 271. The court:

  • Granted summary judgment for the defendants in 86 cases from 35 jurisdictions because the plaintiff’s prescribing physicians are deceased on unable to be located.
  • Similarly dismissed 74 cases from 16 jurisdictions for failure to show proximate cause.

The rulings turned on a doctrine in product liability law known as the “heeding presumption.” This is a rebuttable presumption that the recipient of an adequate warning in a failure-to-warn case would have heeded the warning. It holds that a physician would not have prescribed a drug if its warning had been adequate, and places the burden on the drug maker to prove that the doctor would have heeded a different warning.

Proximate cause

The plaintiffs argued that the testimony of the missing physicians was not required to establish proximate cause because of the heeding presumption. They asserted that this presumption has been upheld in pharmaceutical failure to warn cases in 20 states. The plaintiffs argued that because the defendants did not present evidence to rebut the presumption, that the prescribing physicians would have heeded a stronger warning.

The defendants argued successfully that in a pharmaceutical products liability action alleging failure to warn, a plaintiff must show that a different warning would have altered their physician’s decision to prescribe the medication to satisfy proximate cause. However, there is no physician testimony.

“First, the heeding presumption does not eliminate Plaintiffs’ burden of proving a prima facie case,” the court stated.

The heeding presumption was rebutted because The American Academy of Dermatology (“AAD”) and The American Academy of Pediatrics (“AAP”) both issued statements approving the continued use of Accutane or isotrentinoin for the treatment of acne. The AAD’s statement confirmed the lack of association between isotrentinoin and inflammatory bowel disease and states that physicians should continue to prescribe the medicine while being aware of the risk, the court  said.

“Accordingly, the Court finds that under New Jersey law, a heeding presumption does not apply in cases such as these, and even if it did, Defendants’ FDA approved warning carries a presumption of adequacy until rebutted by Plaintiffs.”

See also Learned Intermediary Doctrine Causes Dismissal of New Jersey Accutane Suits

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Invokana Diabetes Drug Plaintiffs Seek Product Liability MDL in New Jersey

invokana-warning kidney-damageDozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

The motion proposes that the Judicial Panel on Multidistrict Litigation (JPML) appoint Judge Brian R. Martinotti in the US District of New Jersey. He is already supervising 36 Invokana cases. The plaintiff’s attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodiumglucose cotransporter 2 (“SGLT2”) inhibitors.

Off label marketing

The defendants marketed and continue to market Invokana for off label purposes, including weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

The federal court in New Jersey has been home to mass tort litigation involving the Zimmer Durom Hip Cup, Tropicana Orange Juice Marketing, Vytorin/Zetia Marketing, and Hypodermic Products Antitrust litigation.

Judge Martinotti was the mass tort judge in New Jersey state court in Bergen County from 2009 to 2016. In that position he supervised litigation involving Mirena Yaz, Yasmin, Ocella, and the DePuy ASR Hip Implant.

The motion will likely be heard at the JPML next meeting on Dec. 1.

 

 

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PersonalInjury.Com Endorsement: Hillary Clinton For President

Click to read the original editorial from:
PICOM logo

The Choice Could Not Be More Clear

“May you live in interesting times” is an expression that is reputed to be the English translation of an ancient Chinese curse. Without a doubt, this generation of Americans is living in “interesting times.” Never before in modern history has so much been at stake in a presidential election, and never before has the contrast between the candidates been as sharp as the contrast that defines the difference between Hillary Clinton and Donald Trump.

Most importantly for personal injury lawyers who represent the little guy against large corporations, Clinton has spent her lifetime fighting for women and children – the people who are most vulnerable. Some say that she is beholden to corporate interests, but anyone who looks at her long record of service knows that is not true. If all the other reasons to vote for Clinton are not enough, this one is the icing on the cake.

On one side of the aisle we have former Senator and Secretary of State Hillary Clinton, a relentless force for social progress who has dedicated her life to public service. Her first job out of law school was with the Children’s Defense Fund rather than a high-powered corporate law firm; as First Lady she worked tirelessly to secure health care for all Americans (long before the word “Obamacare” had even been incorporated into the English language); as Senator she expanded health care and family leave for military families, and helped pass the Children’s Health Insurance Program that now protects over eight million children; and as Secretary of State she brokered an unlikely cease-fire between Israel and Hamas.

On the other side of the aisle we have Donald Trump, who became a billionaire real estate tycoon after inheriting millions of dollars from his father. A genius at self-promotion, he has kept his name in the public eye through various means including opening gambling casinos, hosting WrestleMania events, buying the Miss Universe contest (and nicknaming one of its winners “Miss Piggy”), turning his name into an international trademark and hosting a reality TV show. And now he has exploited the politics of division and fear to claim the Republican nomination for President of the United States.

During these perilous times we have already witnessed a divided electorate, a paralyzed Congress, skyrocketing racial tensions, a spike in violent crime, the development of a permanently underemployed underclass, declining U.S. influence abroad and growing income inequality at home. Our problems are daunting and growing worse. We need opportunity, not unrestrained greed. We need bipartisanship, not the deliberately divisive tactics of a professional provocateur.

  • Clinton will build bridges; Trump will build walls.
  • Clinton will provide immigrants with a pathway to citizenship; Trump promises to deport 11 million people and build a 2,000-mile Mexican border wall.
  • Hillary Clinton blames partisanship and corporate greed; Donald “You’re Fired!” Trump blames Mexicans and Muslims.
  • Clinton will bring America together; Trump will radicalize U.S. Muslims by treating them as second-class citizens.
  • Clinton will keep America’s international commitments; Trump has threatened to abandon our Balkan NATO allies to Vladimir Putin.
  • Clinton will end unfair tax loopholes, support a higher minimum wage, and create tax credits for poor families; Trump will drastically increase import duties, repeal the Consumer Protection Act and deregulate Wall Street in preparation for another Great Recession.

Hillary ClintonMost importantly for personal injury lawyers who represent the little guy against large corporations, Clinton has spent her lifetime fighting for women and children – the people who are most vulnerable. Some say that she is beholden to corporate interests, but anyone who looks at her long record of service knows that is not true. If all the other reasons to vote for Clinton are not enough, this one is the icing on the cake.

The Future is Not Written in Stone

The prospect of a Trump victory, unlikely as it may be, is chilling enough to bring to mind a gem of wisdom from acclaimed novelist Pearl Buck: “Every great mistake has a halfway moment, a split second when it can be recalled and perhaps remedied.” Buck thereby reminds us that history can turn on a dime.

In the 2000 presidential election, the presidency was decided by a mere 537 votes in Florida – about one vote per precinct. Your vote matters. Use it.

Related articles

As of this writing, for the first time in American History no major news publication has endorsed Donald Trump. In fact many conservative publications have chosen to endorse a Democrat for the first time in recent memory and, in some cases, the first time ever. Others have chosen to encourage voters to vote against Trump or to vote for a third party candidate.  For a complete list of newspaper endorsements that is regularly updated, go tohttps://en.wikipedia.org/wiki/Newspaper_endorsements_in_the_United_States_presidential_election,_2016.

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Crusading Judge Takes Over Taxotere Products Liability Litigation

Chief Judge Kurt Engelhardt
Chief Judge Kurt D. Engelhardt

Judge Kurt D. Engelhardt, who courageously investigated the New Orleans US Attorney’s Office for misconduct in a police murder prosecution, will apply his no-nonsense approach to dozens of mass tort lawsuits against Sanofi S.A. over its chemotherapy drug, Taxotere.

Judge Engelhardt, age 56, has been on the federal bench for 15 years and ascended to Chief Judge in the US Eastern District of Louisiana in New Orleans in 2015. Previously he has supervised two product liability MDLs:

  • Franck’s Lab. Inc. Product Liability Litigation MDL 2454, which was closed on May 21, 2016, when all the parties settled. The MDL was created in 2013. The lab compounded pharmaceutical products that were contaminated by fungus and toxins, which caused rare eye infections and blindness.
  • FEMA Trailer Products Liability Litigation MDL 1873, which was closed on October 26, 2015, after three waves of settlements. Companies that manufactured mobile homes for the Federal Emergency Management Agency after Hurricane Katrina agreed to pay $2.6 million to resolve claims that the mobile homes emitted formaldehyde

Engelhardt will supervise the new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation consisting of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

The plaintiffs charge that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not. The lawsuits allege that Sanofi was aware of this possible side effect and failed to warn patients, and that the defendants marketed Taxotere as more effective than similar drugs when other drugs were equally effective without causing permanent hair loss.

“Grotesque Misconduct” in Federal Prosecution

A notorious criminal trial in New Orleans illustrates the importance that the judge places on the integrity of the courts. From 2012-2013 Judge Engelhardt investigated gross misconduct in the US Attorney’s office in New Orleans in its prosecution of five policemen who were charged in the 2005 killing of two people and injury of four others on the Danziger Bridge after Hurricane Katrina. The cops were convicted of civil rights and other charges in 2011.

The judge threw out the convictions in 2013 after determining that three federal prosecutors improperly attacked the judge, the police and defense lawyers in anonymous online postings, and leaked confidential information. Two investigations by the US Attorney’s office — one led by a guilty prosecutor — were cover-ups of “grotesque prosecutorial misconduct,” according to the judge.

“The public must have absolute trust and confidence in this process,” Engelhardt wrote in overturning the verdicts. “Re-trying this case is a very small price to pay in order to protect the validity of the verdict in this case, the institutional integrity of this court and the criminal justice system as a whole.”

The 5th Circuit upheld Judge Engelhardt’s decision in 2015, and the case finally ended on April 20, 2016, when the five Danziger Bridge cops pleaded guilty.

The Fifth Circuit ruled that the prosecutors’ “insidious” cyberbullying created a mob mentality against the defendants. “[p]rejudice here was shown both from this pattern of misconduct and evasion and from other abusive prosecutor actions,” it said. “A miscarriage of justice harms the substantial rights of a defendant, and it may consist of errors and omissions considered for their cumulative effect on the trial proceedings.”

Judge Engelhardt’s skepticism of the Department of Justice was also highlighted in the three-year sentence he imposed on a corrupt local prosecutor, St. Charles Parish District Attorney Harry Morel Jr. An FBI agent had sent the judge a 31-page letter about ethical lapses in the Justice Department. Engelhardt refused to release the letter but said it was “particularly interesting (and troubling, to say the least).”

The Justice department had ended an investigation into serious allegations that he traded leniency in court for sex from defendants, but let him plead guilty to obstruction of justice. Judge Engelhardt gave Morel the maximum sentence allowed.

Recently he sentenced once-fugitive real estate financier Robert Durst to 7 years and 1 month on a weapons charge that cleared the path for him to face murder charges in California. Durst will serve more than 4 ½ times the maximum under federal guidelines based on a plea deal with prosecutors in Houston, Manhattan and Orleans Parish not to prosecute him on a variety of offenses.

Cited for excellence

As an MDL judge, Engelhardt can be expected to be an efficient stickler for deadlines and details. In 2004 he was appointed by US Supreme Court Chief Justice Rehnquist to serve on the Judicial Conference Committee on Federal-State Jurisdiction, where he served two terms, which may be beneficial in the MDL case management. His work on the Judiciary Commission has been cited for its excellence by the Louisiana Supreme Court.

On the bench, had actually has few criminal case opinions. Most of his rulings focus on insurance coverage disputes, contract actions, legal malpractice and immigration.

In the 2,059 opinions that he’s written since 2002, Judge Engelhardt cites frequently to the 5th Circuit, and often relies on deposition and trial testimony to support his decisions. He writes matter-of-fact and direct opinions and doesn’t stray from the issues of the case.

In scheduling order dates, he does not permit waivers from the dates absent substantive notice to the court by timely motion.

In personal injury cases, he tends to rule in favor of summary judgment defendants where there is any question as to causation or future damages for injuries. In personal injury cases where remand is requested, prior settlement language as to co-defendants is strictly interpreted as to who remains in the case.

Prior to becoming a judge he handled commercial litigation disputes over contracts and insurance coverage disputes. He practiced at Hailey, McNamara, Hall, Larrman & Papale, an insurance defense firm in Metarie, LA. 

The Hailey firm does not appear to have been involved in representing any pharma or drug device clients, there is a brief reference to products liability defense work in the practice summary, but no cases listed to date.

 

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November 2016 Mass Tort Course

Please join us  Nov 11th – Nov 14th  for the

“Four Days to Mass Tort Success Course”

 
Contact Barbara Capasso at (954) 383-3932 
or barbara@masstortnexus.com for more information. 
 
In addition to the hands-on practical knowledge all course attendees receive, we are privileged to have an All-Star panel of attorney speakers discussing current, emerging and ongoing Mass Tort Litigations.
 
Best of all, this program will be interactive.  There will be 
ample Q&A after each presentation.
 
Whether you have dabbled in Mass Torts or are new to the practice area, the “Four Day Mass Tort Success Course” will help you avoid common mistakes, while giving you a road map to success in Mass Torts.  We teach you a step by step process to ensure you understand the methods and metrics of this
practice area. 
 
View the videos to the right to hear what past course attendees have to say about the
Mass Tort Nexus “Four Days to Mass Tort Success Course.”
 
 
 

Taxotere Product Liability Litigation

 
Chris Elliot is the managing attorney of Mass Torts, at the Law Firm of Bachus & Shankner, in Denver, Colorado. Chris was instrumental in filing of the first Taxotere case, as well as the motion for consolidation, which was granted by the JPML on October 4th, 2016 forming MDL 2740.

Chris will be presenting information essential to any attorney interested in the Taxotere  Litigation. Attorneys who wish to expand their knowledge base on this case, will not want 

to miss the opportunity to get the latest information on this emerging 
litigation.

Talcum  Powder Product Liability Litigation

 
James Onder will be speaking on the subject of the Talcum Powder Litigation. He is one of the lead attorneys in the City of St. Louis consolidation, which has already produced multiple Jury verdicts exceeding fifty million dollars each.
 
James, and other members of his firm, have served as co-lead counsel and in various leadership positions on numerous MDLs. The opportunity to hear James speak about a difficult litigation, that he and his co-counsel firms managed to achieve massive jury awards in will be  an opportunity you won’t want to miss.
 

IVC Filter Product Liability Litigation

 
John Dalimonte currently serves on the Steering Committee of the Cook Medical IVC Filter Litigation and the Bard IVC Filter Litigation. He will be speaking about  the Cook and Bard IVC Filter Litigations, as well as other ongoing and emerging IVC Filter Litigations, which involve additional IVC manufacturers. John has served in leadership positions on a number of MDLs and was Co-Lead Counsel in the Vioxx Product Liability Litigation.
The IVC Filter Litigation may be one of the largest mass product liability litigation’s of all time, with respect to the number of plaintiffs and payouts. This litigation puts the “complex” in complex litigation and the 
opportunity to interact with one of the leading attorneys in this case is invaluable.

Pradaxa Ligation Connecticut Consolidation

 
Neal  Moskow served on the Plaintiff Steering Committee of the Traysol Product Liability Litigation MDL 1928.
 
Neal serves in Leadership in the Pradaxa Connecticut State Court Consolidation. 
 
With the abrupt end of the Pradaxa Federal MDL, many firms have found themselves with Pradaxa clients and in need of a consolidated litigation. Neal will be discussing the ongoing Pradaxa State Consolidation, which may provide a home for your Pradaxa cases now that the Federal MDL has closed. 
 

Xarelto, Onglyza and Fluoroquinolones

 
Ryan Thompson will round out the panel speaking and answering questions about three litigations every firm should be considering.  Not yet forty years old, Ryan has already achieved a record of achievements, that most lawyers would consider a stellar lifetime career. He served as Co-Lead Counsel on the Incretin Memetics Litigation, as well as in leadership positions on numerous MDLs. Ryan is often involved in emerging litigations in a major way. His grasp of the science involved in pharmaceutical and medical device litigation and his willingness to take risks, have resulted in his incredible rise in the world of Mass Tort litigation.
 
One of Ryan’s early victories involved taking on a major credit reporting agency and collecting 28 Million dollars, in a litigation other firms had overlooked.
Ryan brings a unique perspective to mass torts. It is a privilege to hear Ryan speak and even more of a privilege to get to know him.

Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com 

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Will the October 11, 2016 FDA Notice Impact the Xarelto Litigation?

alere InRatio medical device
Alere InRatio medical device

We have received numerous inquiries regarding the potential impact on the Xarelto Litigation(s) relating to the  FDA Oct 11th publication of its findings after re-evaluating (re-analysis study) related to the Rocket AF study in relation to the INR Testing Device “InRatio.”

International Normalized Ratio (INR) is a metric which is tested to determine how long it takes for blood to clot in a given individual as compared to a standard range.

The InRatio was used in the Rocket AF Study to measure INR. After the Rocket AF Study was published and used as the primary study considered by the FDA in granting market approval for Xarelto. Then the InRatio device was subjected to a Class 1 Recall due to inaccuracy.

As a result of the recall of the device used to measure INR in the Rocket AF study, the FDA conducted a re-analysis of the Rocket AF study, using data and information provided by Janssen Pharmaceuticals. The re-analysis was for the limited purpose of determining whether or not the use of the defective  “InRatio” device skewed the results of the Rocket AF  study to a sufficient extent to invalidate the results and conclusion of that study.

On October 11, 2016 the FDA published a short notice with a link to the re-analysis study: See excerpt below:

[10/11/2016] In July 2016, the Alere INRatio device was recalled due to the potential to generate inaccurate results. This device was used to monitor warfarin therapy in the control group of the ROCKET-AF clinical trial, which provided the primary data to support the 2011 approval of the blood thinner drug Xarelto (rivaroxaban). Xarelto is indicated to reduce the rates of stroke and blood clots in patients with non-valvular atrial fibrillation.

Because of the concern about the Alere INRatio device, the FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET-AF study results. The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal.  The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation.

Concerns Related to the FDA Notice

This FDA notice has generated concern among some attorneys representing clients in the Xarelto Litigation and gives rise to the question: Will this FDA notice negatively impact the Plaintiffs Claims in the Xarelto Litigation(s)?

After carefully reviewing the re-analysis study as well as the Xarelto Exemplar Complaint in the Xarelto Federal Multidistrict Litigation and the Master Complaint in the Philadelphia Court of Common Pleas Xarelto Litigation, we have formed the opinion that the FDA Notice is not likely to have any major impact on the litigation(s).

Our Analysis Considered the Following Factors:

The re-analysis was limited to answering a single question: Could the FDA conclude that the use of the defective “InRatio” device skewed the results (which were already highly questionable) of the Rocket AF study to warrant rescinding of  the market approval granted by the FDA based on Rocket AF study?

It should be noted that an inconclusive outcome of the re-analysis would not have prompted the FDA to rescind approval. In order for the FDA to rescind approval the re-analysis would have needed to show conclusively that the use of the InRatio Device skewed the results of the Rocket AF Study  to such an extent as to make the study results completely invalid .

We concluded that the FDA notice and the re-analysis should not impact the Xarelto Litigations based on the following:

  1. The re-analysis was not conclusive and did not use commonly accepted scientific methodology.
  2. The re-analysis contains multiple instances of terms such as “were likely” and “it is unclear how relevant the results are” indicating a lack of conclusiveness.

“However, the effects of this increased intensity of anticoagulation on clinical outcomes were likely to have been quite modest.”

There is a moderately large margin for error on safety. Xarelto could increase the rate of major bleeding by as much as 50% compared to warfarin and it would still be considered an approvable therapy

To be complete in describing FDA’s pharmacovigilance efforts involving rivaroxaban, this study of rivaroxaban vs. warfarin in Medicare is presented. However, without inclusion of a control/warfarin arm, it is unclear how relevant these results are to the investigation of INR device issues in the ROCKET trial.

“With the limited data provided, a reliable estimate of variability seems unlikely.”

3. The re-analysis admits a large margin for error as well as a lack of reliability.

4.  The re-analysis was an unscientific flawed analysis of a flawed study. See excerpt below from the FDA initial summary review of the Rocket AF study:

Excerpt from Initial FDA Review of Rocket AF Study:

At each site audited, how many violations involved each of the following specific issues? For each specific violation, list the clinical sites involved and provide a breakdown by treatment group for each site and overall for the four RECORD studies.

  • Enrollment of subjects that did not meet study eligibility criteria.

  • Failure of the Principal Investigator to ensure that all associates and colleagues assisting in the investigation were meeting the commitments of the study protocol.

  • Failure to report adverse events and serious adverse events.

  • Failure to randomize subject preoperatively.

5.  The re-analysis addressed a very narrow issue not related the the majority of claims made in the Xarelto litigation while only being only marginally related to narrow issues to limited number of plaintiff claims.

Concerns Related to Implied Preemption Arguments

Some concern has been expressed due to the language in the FDA announcement and the re-analysis wording related to “No label change being required”.  See excerpt below:

“No changes in rivaroxaban labeling to reflect the impact of use of the INRatio device in ROCKET are warranted. No other major regulatory action should be taken with respect to rivaroxaban.”

This language gives rise to the question: Could the defendants prevail in an implied preemption argument claiming that the FDA would not have allowed changes to the Xarelto label had the manufacture attempted to make changes though the Changes Being Effected (CBE) process?

We do not think an implied  preemption of this nature would prevail. The FDAs decision not to require a label change was due to the fact that the re-analysis was limited in scope and made determination regarding a very narrow issue and was not conclusive. Given the lack of conclusiveness of the re-analysis, it was not sufficiently conclusive to warrant any action by the FDA, that same lack of conclusiveness makes the re-analysis worthless from an evidentiary  stand point.

Although defense may raise an implied preemption argument, claiming that the FDA would not have allowed label changes made via the CBE process, related to broader issues than those observed within the limited scope of the re-analysis, would not be likely to prevail. An argument that the FDA statements related to the re-analysis indicates anything beyond the scope of the narrow focus of the re-analysis would not be supported by fact.

Guidance from  Wythe v. Levine may be applicable to this scenario: “Wyeth argued that this Vermont law was federally preempted because it was in “actual conflict [with] a specific FDA order” regarding drug labeling. The trial court rejected this argument, as did the Supreme Court of Vermont, holding that the FDA requirements merely provide a floor, not a ceiling”

In that FDA approval of a pharmaceutical product does not create an affirmative defense under Wyeth v Levine, the FDA deciding not to rescind a previously granted approval should not create an affirmative defense either.

In Wyeth v Levine the court took note of FDAs approval processes in granting market approval for a pharmaceutical product largely relying on information and data supplied by the applicant. In this instant matter related to the FDA re-analysis of the Rocket AF study, the FDA again relied on information and data from the applicant, rendering any determinations made from the re-analysis no more of an affirmative defense than the initial FDA approval.

Other Xarelto Claims Not Affected

Among the claim being made against the manufacturers(s) of Xarelto are those related to over promotion and misrepresentations made in the promotion of the product.  The FDAs enforcement division issued a warning letter on Judge 6, 2013 to Johnson and Johnson related to false and misleading advertisement. See excerpt below.

DEPARTMENT OF HEALTH & HUMAN SERVICES  Public Health Service

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South P.O. Box 300 Raritan,

New Jersey 08869-0602

RE:   NDA #202439 XARELTO (rivaroxaban) tablets MA #215

 

Dear Ms. McGregor-Beck:

Minimization of Risk Information

Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.  Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis.  The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

  • “If you have atrial fibrillation (AFib)” • “Ready to break your AFib routine?” • “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke—without routine blood monitoring.” • “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal.  Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

Misleading Claim

The Print Ad includes the following claim (emphasis original):

  • “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto.  However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min.  In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….”  Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

See entire FDA Warning Letter 

End Except

Despite the FDAs prior warning to the makers of Xarelto, misleading claims in Television Advertisements continue to be made. The frame from a Xarelto Television Commercial below shows the statement “No Blood Monitoring Required” is still included in Xarelto Advertising.

2015 AD Palmer

 

Although this Xarelto advertisement did not use the language “no dosing adjustments” required, the ad does include the wording “Xarelto has no regular blood monitoring”.  In that the FDA has already determined statements regarding “no dosing adjustments” are misleading as dosing adjustments are needed for many Xarelto patients, the statement “Xarelto has no regular blood monitoring”, indicating that none is needed, is also arguably misleading in that dosing adjustments cannot be made without some form of monitoring.

We invite comments as well as dissenting opinions on this subject.

Nothing contained herein is intended to constitute legal advice.

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