The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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Direct Filing of Invokana and Atrium C-Qur Lawsuits Now Permitted in Federal MDLs

In separate pretrial orders, the courts overseeing federal multidistrict litigation for Invokana and for Atrium C-Qur both ruled that plaintiffs may file their claims directly in the proceedings.

Direct filing eliminates delays involved in the transfer or removal of cases from other federal district courts.

Invokana MDL

The US Judicial Panel on Multidistrict Litigation (JPMDL) created the Invokana MDL on December 12, 2016. Plaintiffs charge that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate many common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.

Direct filing does not stop the running of any statute of limitation or determine the choice of law. It does not constitute a waiver of Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), which holds that MDL transferee judges lack authority to try cases that originated outside of the transferee court. Upon completion of pretrial proceedings to a directly-filed case, the court will transfer that case to the district court based on the district designated in the complaint.

Any attorney in good standing in any federal court is admitted pro hac vice in the litigation.

Atrium C-Qur mesh MDL

The JPMDL created the Atrium Medical Corp. C-Qur Mesh Products Liability MDL on December 8, 2016. The plaintiffs allege that defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. All the actions involve factual questions about whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.

Direct filing does not constitute a determination that venue is proper, has no impact on the choice of law including the statute of limitation.

Atrium is one of many hermia patch manufacturers facing lawsuits over making defective products. More hernia mesh MDLs may be created –  See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation.

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C-Qur Hernia Mesh Judge Pauses Discovery in New MDL

U.S. District Judge Landya B. McCafferty stayed all discovery proceedings in Pretrial Order No. 1, until an initial case management conference is held on February 24 in Atrium Medical Corp. C-Qur Mesh Products Liability Litigation.

At the conference, attorneys can express interest in the roles of lead counsel. The judge appointed Robert Bonsignore of Bonsignore Trial Lawyers PLLC of Las Vegas, NV, as temporary lead counsel.

Introductory briefs in the case, MDL Docket No. 16-md-2753-LM in the US District Court of New Hampshire, are due February 17 concerning the parties’ views on the appointment of a plaintiffs’ steering committee, the nature of the action and principal defenses, whether a consolidated complaint should be filed, and a list of all prior settlement discussions.

Inflammatory bowel response

Since the Judicial Panel on Multi-district Litigation created MDL 2753 on December 1, a total of 21 actions have been filed.

The litigation involves allegations that defects in defendants’ C-Qur mesh products incite an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

The company announced a worldwide market withdrawal of the product on May 25, 2016, after unpublished registry data indicated that Physiomesh was associated with higher recurrence and revision rates after laparoscopic ventral hernia repair compared to another set of mesh. A Physiomesh lawsuit pending in the U.S. District Court, Southern District of Illinois, will likely be the first case to go to trial, with jury selection scheduled to begin on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF).

Atrium, which is headquartered in New Hampshire promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

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New Mass Tort Dockets Created for Invokana and C-Qur mesh

invokana-warning kidney-damageThe Judicial Panel for Multidistrict Litigation (JPMDL) has created new:

Invokana Diabetes Drug

The Invokana litigation consists of 55 actions involving allegations that Invokana causes diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc. (Janssen), which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.

As requested by the plaintiffs, Judge Brian R. Martinotti of the District of New Jersey will supervise the MDL. Janssen is headquartered there, and many witnesses and relevant documents are likely to be found there. In addition, 37 of the constituent actions are pending in that district, as are multiple tag-along actions.

The JPMDL declined to include other SLGT2 inhibitors in the litigation, such as Farxiga (dapagliflozin) and Jardiance (empagliflozin). Farxiga is marketed and distributed by AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, AstraZeneca PLC, and Bristol-Myers Squibb Co., and Jardiance is marketed and distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, and Lilly USA, LLC.

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

Atrium Medical c-qur surgical mesh
Atrium Medical C-Qur surgical mesh

C-Qur Hernia Mesh

Creation of the C-Qur mesh MDL was expected, see Parties Agree on New MDL for Atrium C-Qur Hernia Mesh. Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

This litigation consists of thirteen actions pending in seven federal court districts, involving allegations that defects in defendants’ C-Qur mesh products incite an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Judge Landya B. McCafferty in federal court in New Hampshire will oversee MDL 2753. Seven of the actions on the motion, as well as a number of state court cases, are pending in this district, and Atrium is headquartered there.

Atrium promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

 

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JPMDL Creates New MDL 2753 for Atrium C-Qur Hernia Mesh

Atrium Medical c-qur surgical mesh
Atrium Medical C-Qur surgical mesh

The Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 8, 2016 created the new MDL 2753 to consolidate lawsuits over Atrium Medical Corp. polypropylene surgical mesh patches.

Atrium promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

Causes complications

The plaintiffs charge that the C-Qur mesh incites an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Atrium agreed in a brief filed on Nov. 1 that the MDL should be assigned to US District Judge Landya B. McCafferty in Concord, New Hamshire.

  • Atrium, based in Merrimack, NJ, had sales of $200 million in 2011, with the U.S. market accounting for 70% of sales and the remaining 30% sales through proprietary sale offices in the United Kingdom, Germany, France, the Netherlands, India, Australia and New Zealand.
  • Half of the pending cases are in the District of New Hampshire and no other district has more than one C-Qur Action.

A total of 15 cases are pending in seven different federal districts. Discovery has already begun in Zissa v. Atrium Medical Corporation, Civil Action No. 5:15-CV-00718 DAE, Western District of Texas, and in Fergerson v. Atrium Medical Corporation, Civil Action No. 2:16-cv-02058, District of Kansas.

Key plaintiff attorneys include Robert J. Bonsignore of Bonsignore, LLC in Belmont, NH, Aaron Broussard of Broussard & Hart in Lake Charles, LA, and Adam M. Evans of the Hollis Law Firm in Prairie Village, KS.

 

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