Why Didn’t Bayer’s October 2018 Forecast Include Monsanto Roundup Litigation MDL 2741? Several billion possible reasons!

By Mark A. York (March 25, 2019)

Jury Verdict Forms of March 19, 2019 Trial Findings Re: “Monsanto Roundup Caused Plaintiff’s Cancer”

Roundup MDL 2741 Federal Trial Jury Instructions of March 19, 2019

Roundup MDL 2741 Federal Trial Jury Verdict Form of March 19, 2019


Interim Report Third Quarter 2018


Explanatory Notes

Legal Risks

Product-related litigation

Mirena™: As of January 30, 2018, lawsuits from approximately 2,900 users of Mirena™, a levonorgestrel-releasing intrauterine system providing long-term contraception, had been served upon Bayer in the United States (excluding lawsuits no longer pending). Plaintiffs allege personal injuries resulting from the use of Mirena™, including perforation of the uterus, ectopic pregnancy or idiopathic intracranial hypertension, and seek compensatory and punitive damages. Plaintiffs claim, inter alia, that Mirena™ is defective and that Bayer knew or should have known of the risks associated with it and failed to adequately warn its users. Additional lawsuits are anticipated. In April 2017, most of the cases pending in U.S. federal courts in which plaintiffs allege idiopathic intracranial hypertension were consolidated in a multidistrict litigation (“MDL”) proceeding for common pre-trial management. As of January 30, 2018, lawsuits from approximately 400 users of Mirena™ alleging idiopathic intracranial hypertension had been served upon Bayer in the United States. Another MDL proceeding concerning perforation cases has, in the meantime, been dismissed. The Second Circuit Court of Appeals affirmed the perforation MDL district court’s summary judgment order of 2016 dismissing approximately 1,230 cases pending before that court. In August 2017, Bayer reached an agreement in principle with plaintiffs’ counsel leadership for global settlement of the perforation litigation, for a total amount of US$12.2 million. As of January 30, 2018, a total of approximately 4,000 cases would be included in the settlement. The idiopathic intracranial hypertension MDL proceeding is not included in the settlement.

As of January 30, 2018, five Canadian lawsuits relating to Mirena™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.


Xarelto™: As of January 30, 2018, U.S. lawsuits from approximately 22,000 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Xarelto™, including cerebral, gastrointestinal or other bleeding and death, and seek compensatory and punitive damages. They claim, amongst other things, that Xarelto™ is defective and that Bayer knew or should have known of these risks associated with the use of Xarelto™ and failed to adequately warn its users. Additional lawsuits are anticipated. Cases pending in U.S. federal courts have been consolidated in an MDL for common pre-trial management. In May, June and August 2017, the first three MDL trials resulted in complete defense verdicts; plaintiffs have appealed all three verdicts. In January 2018, after the first trial to proceed in Pennsylvania state court had initially resulted in a judgment in favor of the plaintiff, the trial judge vacated the jury’s verdict and granted judgment in favor of Bayer. Further Pennsylvania state court trials are currently scheduled for the first and second quarters of 2018. Bayer anticipates that additional trials will be scheduled.

As of January 30, 2018, ten Canadian lawsuits relating to Xarelto™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Essure™: As of January 30, 2018, U.S. lawsuits from approximately16,100 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated.

As of January 30, 2018, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Class actions over neonicotinoids in Canada: Proposed class actions against Bayer were filed in Quebec and Ontario (Canada) concerning crop protection products containing the active substances imidacloprid and clothianidin (neonicotinoids). Plaintiffs are honey producers, who have filed a proposed nationwide class action in Ontario and a Quebec-only class action in Quebec. Plaintiffs claim for damages and punitive damages and allege Bayer and another crop protection company were negligent in the design, development, marketing and sale of neonicotinoid pesticides. The proposed Ontario class action is in a very early procedural phase. In Quebec, the plaintiff sought authorization (certification) of a class for which a motion was heard in November 2017. Bayer believes it has meritorious defenses and intends to defend itself vigorously.


In connection with the above-mentioned proceedings, Bayer is insured against statutory product liability claims against Bayer to the extent customary in the respective industries and has, based on the information currently available, taken appropriate accounting measures for anticipated defense costs. However, the accounting measures relating to Essure™ claims exceed the available insurance coverage.



Link to US District ND California Monsanto MDL 2741 litigation case outline and case related orders: https://www.cand.uscourts.gov/VC/roundupmdl

[End of Bayer-Mosanto Docket in MDL 2741]

March 6, 2019 https://www.masstortnexus.com/mass-torts-news/bayer-ag-completes-monsanto-purchase-whats-next-on-litigation-dockets/

Patent Disputes

Adempas™: In January 2018, Bayer filed patent infringement lawsuits in a U.S. federal court against Alembic Pharmaceuticals Limited, Alembic Global Holding SA, Alembic Pharmaceuticals, Inc. and INC Research, LLC (together “Alembic”), against MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (together “MSN”) and against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (together “Teva”). In December 2017, Bayer had received notices of an Abbreviated New Drug Application with a paragraph IV certification (“ANDA IV”) pursuant to which Alembic, MSN and Teva each seek approval of a generic version of Bayer’s pulmonary hypertension drug Adempas™ in the United States.

Betaferon™ / Betaseron™: In 2010, Bayer filed a complaint against Biogen Idec MA Inc. in a U.S. federal court seeking a declaration by the court that a patent issued to Biogen in 2009 is invalid and not infringed by Bayer’s production and distribution of Betaseron™, Bayer’s drug product for the treatment of multiple sclerosis. Biogen is alleging patent infringement by Bayer through Bayer’s production and distribution of Betaseron™ and Extavia™ and has sued Bayer accordingly. Bayer manufactures Betaseron™ and distributes the product in the United States. Extavia™ is also a drug product for the treatment of multiple sclerosis; it is manufactured by Bayer, but distributed in the United States by Novartis Pharmaceuticals Corporation, another defendant in the lawsuit. In 2016, the U.S. federal court decided a disputed issue regarding the scope of the patent in Biogen’s favor. Bayer disagrees with the decision, which may be appealed at the conclusion of the proceedings in the U.S. federal court.

Damoctocog alfa pegol (BAY 94‑9027, long-acting recombinant factor VIII): In August 2017, Bayer filed a lawsuit in a U.S. federal court against Nektar Therapeutics (“Nektar”), Baxalta Incorporated and Baxalta U.S., Inc. (together “Baxalta”) seeking a declaration by the court that a patent by Nektar is invalid and not infringed by Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A. In September 2017, Baxalta and Nektar filed a complaint in a different U.S. federal court against Bayer alleging that BAY 94‑9027 infringes seven other patents by Nektar. Regarding the complaint by Bayer, Nektar and Baxalta gave Bayer a covenant not to make any claims against Bayer for infringement of that patent. Bayer amended the complaint to now seek a declaration by the court that the seven other patents by Nektar are not infringed by BAY 94‑9027. The patents are part of a patent family registered in the name of Nektar and further comprising European patent applications with the title “Polymer-factor VIII moiety conjugates” which are at issue in a lawsuit Bayer filed against Nektar in 2013 in the district court of Munich, Germany. In this proceeding, Bayer claims rights to the European patent applications based on a past collaboration between Bayer and Nektar in the field of hemophilia. However, Bayer believes that the patent family does not include any valid patent claim relevant for Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A.

Nexavar™: In 2015, Bayer filed patent infringement lawsuits in a U.S. federal court against Mylan Pharmaceuticals Inc. and Mylan Inc. (together “Mylan”). In 2014 and 2015, Bayer had received notices of an ANDA IV application pursuant to which Mylan seeks approval of a generic version of Bayer’s cancer drug Nexavar™ in the United States. In October 2017, Bayer reached agreement with Mylan to settle this patent dispute. Under the settlement terms, Mylan will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020. In 2016, Bayer had received another notice of such an ANDA IV application by Teva Pharmaceuticals USA, Inc. Bayer filed a patent infringement lawsuit against Teva in the same U.S. federal court. In January 2018, Bayer reached agreement with Teva to settle this patent dispute. Under the settlement terms, Teva will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020.

Stivarga™: In 2016, Bayer filed patent infringement lawsuits in a U.S. federal court against Apotex, Inc. and Apotex Corp. (together “Apotex”) and against Teva. Bayer had received notices of an ANDA IV application pursuant to which Apotex and Teva each seek approval of a generic version of Bayer’s cancer drug Stivarga™ in the United States.

Xarelto™: In 2015, Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit in a U.S. federal court against Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc. (together “Aurobindo”), Breckenridge Pharmaceutical Inc. (“Breckenridge”), Micro Labs Ltd., Micro Labs USA Inc. (together “Micro Labs”), Mylan, Prinston Pharmaceutical Inc. (“Prinston”), Sigmapharm Laboratories, LLC (“Sigmapharm”), Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. (together “Torrent”). Bayer had received notices of an ANDA IV application by Aurobindo, Breckenridge, Micro Labs, Mylan, Prinston, Sigmapharm and Torrent, each seeking approval to market a generic version of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, in the United States. In 2016, Bayer received another notice of such an ANDA IV application by InvaGen Pharmaceuticals, Inc. (“InvaGen”). Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit against InvaGen in the same U.S. federal court.

Bayer believes it has meritorious defenses in the above ongoing patent disputes and intends to defend itself vigorously.

Further Legal Proceedings

Trasylol™ / Avelox™: A qui tam complaint relating to marketing practices for Trasylol™ (aprotinin) and Avelox™ (moxifloxacin) filed by a former Bayer employee is pending in the United States District Court in New Jersey. The U.S. government has declined to intervene at the present time.

Newark Bay Environmental Matters: In the United States, Bayer is one of numerous parties involved in a series of claims brought by federal and state environmental protection agencies. The claims arise from operations by entities which historically were conducted near Newark Bay or surrounding bodies of water, or which allegedly discharged hazardous waste into these waterways or onto nearby land. Bayer and the other potentially responsible parties are being asked to remediate and contribute to the payment of past and future remediation or restoration costs and damages. In 2016, Bayer learned that two major potentially responsible parties had filed for protection under Chapter 11 of the U.S. Bankruptcy Code. While Bayer remains unable to determine the extent of its liability for these matters, this development is likely to adversely affect the share of costs potentially allocated to Bayer.

In the Lower Passaic River matter, a group of more than sixty companies including Bayer is investigating contaminated sediments in the riverbed under the supervision of the United States Environmental Protection Agency (EPA) and other governmental authorities. Future remediation will involve some form of dredging, the nature and scope of which are not yet defined, and potentially other tasks. The cost of the investigation and the remediation work may be substantial if the final remedy involves extensive dredging and disposal of impacted sediments. In the Newark Bay matter, an unaffiliated party is currently conducting an investigation of sediments in Newark Bay under EPA supervision. The investigation is in a preliminary stage. Bayer has contributed to certain investigation costs in the past and may incur costs for future investigation and remediation activities in Newark Bay.

Bayer has also been notified by governmental authorities acting as natural resource trustees that it may have liability for natural resource damages arising from the contamination of the Lower Passaic River, Newark Bay and surrounding water bodies. Bayer is currently unable to determine the extent of its liability.

Asbestos: A further risk may arise from asbestos litigation in the United States. In many cases, the plaintiffs allege that Bayer and co-defendants employed third parties on their sites in past decades without providing them with sufficient warnings or protection against the known dangers of asbestos. Additionally, a Bayer affiliate in the United States is the legal successor to companies that sold asbestos products until 1976. Union Carbide has agreed to indemnify Bayer for this liability. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

There is no official reference to Monsanto Roundup MDL 2741, even though an August 2018 verdict award for the plaintiff in California State Court was for more than $280 million, and showed that non-hodgkins lymphoma was caused by use of Monsanto Roundup herbicide containing Glyphosate. f



Bayer legal Disclaimer October 2018: Cautionary Statements Regarding Forward-Looking Information

Certain statements contained in this communication may constitute “forward-looking statements.” Actual results could differ materially from those projected or forecast in the forward-looking statements. The factors that could cause actual results to differ materially include the following: the risk that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected timeframes (or at all) and to successfully integrate the operations of Monsanto Company (“Monsanto”) into those of Bayer Aktiengesellschaft (“Bayer”); such integration may be more difficult, time-consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs, customer loss and business disruption (including difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater or more significant than expected following the transaction; the retention of certain key employees at Monsanto; the parties’ ability to meet expectations regarding the accounting and tax treatments of the merger; the impact of refinancing the loans taken out for the transaction; the impact of indebtedness incurred by Bayer in connection with the transaction and the potential impact on Bayer’s rating of indebtedness; the effects of the business combination of Bayer and Monsanto, including the combined company’s future financial condition, operating results, strategy and plans; other factors detailed in Monsanto’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) for the fiscal year ended August 31, 2017, and Monsanto’s other filings with the SEC, which are available at http://www.sec.gov and on Monsanto’s website at www.monsanto.com; and other factors discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. Bayer assumes no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.


ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California) Mass Tort Nexus Briefcase


XARELTO-(rivaroxaban)-MDL-2592-(USDC-ED-Louisiana) Mass Tort Nexus Briefcase


XARELTO-Case-No-2349–Philadephia-Court-of-Common-Pleas-Complex-Litigation-(PA-State-Court) Mass Tort Nexus Briefcase)

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WEEKLY MDL and MASS TORT UPDATE by Mass Tort Nexus (February 2, 2018)


Week of January 29, 2018

This Week in Mass Torts Around The Country:

By Mark A. York



Xarelto MDL 2592: Are Settlement Talks Coming to Xarelto Litigation?

> During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Full hearing transcript: XARELTO MDL 2592 Judge Fallon January 31, 2018 Hearing Transcript

 Related-Xarelto Docket briefcase: XARELTO MDL 2592 US District Court ED Louisiana Judge Fallon

Opioid Crisis:


>  Insys Therapeutics Sued by New York Attorney General for “Opioid Marketing Abuses” Even After MDL Judge Schedules Settlement Conference Inviting State AG’s

How will Opiate MDL 2805 Judge Polster view NY AG’s suit after he requested states attend his January 31, 2018 full day opioid “settlement” meeting in Cleveland? More than 200 attorneys for city and county governments as well as unions and others met all day in closed door meetings. The day included presentations by non-legal “opioid experts” including Dr. Anna Lembke from Stanford, Dr. Aaron Kesselheim from Harvard Medical School who offered views on the who, how and why the opioid drug makers were able to create the opioid crisis, including how Congress hindered attempts at controlling Big Pharma as well as Joseph Rannazzi, former DEA Head of Diversion Control who spoke to restrictions on DEA enforcement against opioid abuses by drug manufacturers and distributors.  

>New York State Attorney General Eric T. Schneiderman on Thursday became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
Schneiderman alleged in state court that Insys’ marketing of the drug Subsys for unapproved uses caused physicians to overprescribe the treatment, exacerbating the opioid epidemic currently affecting New York and many other states. The MDL judge has stated he wants all parties to come to the settlement table with an open mind, however behind the scenes parties are expressing different views on a quick settlement, since more and more of the suits filed against “Opioid Big Pharma” are RICO claims and some parties want to punish the drug makers for creating the opioid crisis.

 Opioid Indictments:

Pennsylvania Appeals Court Affirms Doctor Conviction For Opioid Prescriptions


>A Pennsylvania appeals court panel on Jan. 26 affirmed a doctor’s sentence for illegally prescribing opioid medications and submitting fraudulent bills to insurance companies after finding that the jury was properly instructed about the state’s standards for properly prescribing the drugs (Commonwealth of Pennsylvania v. Lawrence P. Wean, Nos. 1165 EDA 2016, 1167 EDA 2016, Pa. Super., 2018 Pa. Super.

Insys Therapeutics Sales Manager Wants Term “Opioid Crisis” Barred From Trial

>A former Insys Therapeutics Inc employee going to trial for paying kickbacks to doctors to prescribe fentanyl, has requested the court bar U.S. prosecutors from referring to the “opioid crisis” at his trial. Defendant, Jeffrey Pearlman, a former Insys district sales manager , filed a motion asking a Connecticut  federal judge to bar references at his trial to the crisis and evidence the dangers opioids pose. His lawyers cited the “rampant media attention” devoted to opioids, stating  “jurors would likely have strong biases against someone like Pearlman whose company sold and marketed opioids:, even though Pearlman and Insys engaged in rampant illegal sales and marketing of Subsys, the Insys Theraputics, Inc. fast acting fentanyl based opioid drug. . Pearlamn is jusyt one of more than 15 people at Insys to be indicted, including billionaire founder, John Kapoor, and the entire Board of Directors, for marketing off-label prescriptions of Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

Rhode Island Doctor Pleads Guilty to Taking Kickbacks from Insys Therapeutics, Inc

>A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC Filters:

See Bard IVC Filter MDL-2641 Briefcase

510(k) Defense Allowed In Bard IVC Bellwether Trial

>An Arizona federal judge overseeing the C.R. Bard Inc. inferior vena cava (IVC) filter multidistrict litigation on Jan. 29 denied a plaintiff motion to preclude evidence about the devices’ 510(k) clearance in an upcoming bellwether trial, but said he will put the evidence in context and will not allow it to be used as evidence that the devices are approved by the Food and Drug Administration (In Re:  Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz.)

Cordis IVC Filters:

See Cordis IVC Filter Litigation Alameda County, California Superior Court

>California State Court Cordis IVC Plaintiffs Argue “No Mass Action” To US Supreme Court

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup)

Pelvic Mesh:

Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — 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 U.S. App. LEXIS 20432).


See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J.)

 Hip Implant Litigation

UTAH FEDERAL JUDGE ASK STATE SUPREME COURT “Does Unavoidably Unsafe Apply To Medical Devices”

A Utah federal judge on Jan. 23 asked the Utah Supreme Court whether the state recognizes the unavoidably unsafe product doctrine for medical devices, such as hip implants, as well as drugs  (Dale Burningham, et al. v. Wright Medical Group, Inc., No. 17-92, D. Utah)

Most Wright Profemur Hip Claims Dismissed in Iowa Federal Court Ruling

See: Wright-Medical-Inc-MDL-2329-Conserve-Hip-Implant-Litigation

>An Iowa federal judge on Jan. 26 dismissed most claims in a metal-on-metal hip implant lawsuit and found no personal jurisdiction of Wright Medical Group Inc. (Rebecca Dumler, et al. v. Wright Medical Technology, Inc., et al., No. 17-2033, N.D. Iowa, Eastern Div).

Related Article: Federal Judge Joins Plaintiff Cases in Wright Profemur Hip California Litigation

Diabetes Drugs

Actos Cases Dismissed in California Court: 2014 Global Settlement Applies

>A California federal judge on Jan. 25 dismissed for lack of jurisdiction an Actos class action because the four plaintiffs previously settled their individual claims against the diabetes drug maker Takeda Pharmaceuticals America Inc. (Gary Bernor, et al. v. Takeda Pharmaceuticals America Inc., et al., No. 12-04856, C.D. Calif)

Birth Control

Non-Missouri Plaintiffs Dismissed From Essure Litigation “No Personal Jurisdiction”

>A Missouri federal judge dismissed 92 plaintiffs from a multiplaintiff Essure lawsuit Jan. 24, finding that the court lacked personal jurisdiction over the non-Missouri plaintiffs see Bayer-Essure Missouri Federal Court Order Dismissing All Non- Missouri Plaintiffs Jan 24, 2018 (Nedra Dyson, et al. v. Bayer Corporation, et al., No. 17-2584, E.D. Mo., Eastern Div.)

Mirena IUD:

>2nd Circuit Appeals Court Excludes Mirena MDL Experts—Litigation Terminated

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir)

Related: Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

Testosterone Replacement Therapy:

See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Seventh Circuit Appeals Court: “Premeption Applies to Thousands of Depo-T Cases”

CHICAGO — The Seventh Circuit U.S. Court of Appeals on Jan. 19 said a regulatory quirk in how the testosterone drug Depo-T is classified means that thousands of product liability claims involving the drug are preempted (Rodney Guilbeau, et al. v. Pfizer Inc., et al., No. 17-2056, 7th Cir., 2018 U).

>Defense Wins 4th AndroGel MDL Bellwether Trial

An Illinois federal jury on Jan. 26 returned a defense verdict for AbbVie Inc. in the fourth AndroGel multidistrict litigation bellwether trial (Robert Nolte v. AbbVie, Inc., et al., No. 14-8135, N.D. Ill.)

Fosamax MDL 1789:

See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey and FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS) BRIEFCASE

>Fosamax Plaintiffs Request Supreme Court To Deny Merck Preemption Argument

Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct.)


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New Round of Essure Lawsuits Filed vs. Bayer Healthcare Pharmaceuticals, Inc in Pennsylvania Federal Court

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus







(MASS TORT NEXUS)  On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the  Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, under Essure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP


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XARELTO in Philadelphia Court: Will The BMSQ “California Plavix” SCOTUS Ruling Affect Out of State Plaintiffs?

XARELTO in Philadelphia Court of Common Pleas: Will The “California Plavix” Supreme Court Ruling Affect Out of State Plaintiffs?

By Mark A. York

Mass Tort Nexus (September 26, 2017)






Bayer, which has a headquarters in Pennsylvania, recently used a June 2017 U.S. Supreme Court decision on out of state plaintiffs and court jurisdictions to dismiss dozens of lawsuits from a Missouri federal court in the “Essure” birth control litigation. It remains to be seen if Bayer will use the same strategy in other jurisdictions, like Philadelphia, where the Xarelto blood thinner cases are piling up, see XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase.

Thousands of out-of-state plaintiffs flocked to Philadelphia recently to file lawsuits over prescription drugs, but a recent U.S. Supreme Court decision might deter that practice in the future, see  June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix Jurisdiction).

The many claimants who have brought their lawsuits in Philadelphia will have to see if pharmaceutical companies like Bayer, Johnson & Johnson and others who are facing many thousands of other claims from out-of-state plaintiffs, will rely on the June 19th U.S. Supreme Court ruling that states an out-of-state plaintiff couldn’t file suit in California, due to a lack of jurisdiction.

The Supreme Court justices ruled 8-1 in favor of Bristol Myers-Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix, should not be able to sue the company in that state.

The Supreme Court ruled that, essentially the “all inclusive view of personal jurisdiction by non-resident plaintiffs has come to an end.” Plavix was not designed or made in California, and the company is headquartered in New York. The ruling may simply force thousands of pending cases across the country to be refiled in other venues, as plaintiff firms are not likely to simply withdraw the cases as massive losses, without having their day in one court or another.

A non-residents plaintiff can file suit in the Philadelphia County Court of Common Pleas, if the defendant is either incorporated in Pennsylvania, or has a principal place of business in Pennsylvania, which limits the legal options for Bayer, based on their corporate headquarters in the state.

Two of the biggest mass tort programs in the Philadelphia Complex Litigation Center docket are the Risperdal litigation, which is produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and allegedly causes males to develop breasts, Janssen has been hit with several large multi-million dollar verdicts in Risperdal trials. The other is Xarelto, a blood-thinner made by Bayer and Johnson & Johnson that allegedly causes uncontrolled bleeding events, and the makers failed to warn of the dangers. The Xarelto MDL 2592 in US district Court ED Louisiana . see Xarelto MDL 2592 Mass Tort Nexus Briefcase, where close to twenty thousand additional Xarelto cases are pending.

Bayer will be having a much harder time using the BMS Plavix decision to dismiss non-resident plaintiffs from the Philadelphia courtroom, given it’s headquarters in Pittsburgh, Pennsylvania.

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Why Has Bayer Stopped “Essure” Use In The UK and EU? Is it because women need a hysterectomy to remove the birth control device?

By Mark A. York (September 19, 2017)

Mass Tort Nexus

“Women are forced to undergo hysterectomies to remove a birth control device, Essure which is manufactured and marketed by Bayer AG, according to the British Medical Review Board”







The Essure birth control implant is used to permanently sterilize women, but is now recognized as a cause of significant side effects and complications also known in the healthcare industry as “adverse events” with the United Kingdom and European Union now restricting use of the permanent birth control device. This action has now started the FDA review in the United States of Essure and the process that Bayer stated showed the  device was tested and determined safe.

One woman in Great Britian – who later had her uterus removed – said she was left suicidal due to the “unbearable” pain, and felt she was a burden to her family.

The manufacturer Bayer says Essure is safe and the benefits outweigh the risks, which has been met with speculation as the sale of the implants in the EU was temporarily suspended this month and Bayer has asked hospitals in the UK not to use the device during this time.

“Too painful to move”

Laura Linkson, was alo fitted with the Essure device in 2013, and said the pain left her suicidal.

“The device was sold to me as a simple and easy procedure. I was told that I’d be in and out of the doctor’s office in 10 minutes and that there’d be no recovery time.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal.

The small coil implants, which are made of nickel and polyester (PET) fibres, are used as a sterilization device to stop eggs reaching the womb.

They are inserted into the fallopian tubes where they trigger inflazmation, causing scar tissue to build up and eventually block the tubes, known as a hysteroscopic sterilization.

They can cause intense pain, and some women are thought to react badly to the nickel and plastic.

Because of the way the coils attach to the fallopian tubes, the only way to take them out is to remove a woman’s fallopian tubes and often her uterus.

In other cases the device has been found to perforate fallopian tubes and fallen out, embedding itself elsewhere in the body.

Victoria Dethier was implanted with Essure in 2012 and for three years could not work out why she felt so unwell. “There were moments where I couldn’t get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside,” she said.

She thinks her body was reacting to the PET fibres designed to cause inflammation.

She had a hysterectomy to remove the device in 2015.  “Straight away there was a difference, I’d experienced a horrible taste in my mouth and that had gone,” she explained.as well as  I’d lost a lot of hair and that came back within 12 months, it was incredible.”

“We need acknowledgement by Bayer”

The medicines and healthcare products regulatory agency (MHRA – UK) has been criticized for not responding to the increasing evidence regarding the device.

In 2015, a study published in the British Medical Journal (BMJ) suggested that women who had a hysteroscopic sterilization were 10 times more likely to need follow-up surgery than those who had a traditional sterilization – 2.4% of those surveyed, as opposed to 0.2% amongst those having a standard sterilization.

In the US more than 15,000 women have reported problems to the US Food and Drug Administration (FDA), including pain, allergic reactions and “migration of device” that are involved in thousands of lawsuits versus Bayer Corporation and it’s German parent Bayer, AG.

Carl Heneghan, from the Centre for Evidence-Based Medicine at Oxford University, has criticized the regulator’s failure to act on such findings.  “How much evidence do you need to say let’s withdraw this product from the market?” he asked.

Victoria Dethier is angry that she and so many other women feel they have been ignored “No-one is listening to us, and now there are many women coming forward… we need to be acknowledged.”

Bayer Says “No long-term evidence of adverse events”

The full extent of the problem in the UK is not known.

The MHRA rejected the Victoria Derbyshire program’s Freedom of Information request asking how many women have reported problems.

The NHS does not have figures for the total number of women who have been fitted with Essure, or who have had it removed.

However, the clinical trial that led to the device being approved has been criticized for not considering the long-term effects of the implants, which Bayer has defended to this day. “The trial… only followed up women for one year, so nobody has a real understanding of what happens with this device after two years, three years, five years,” Mr Heneghan explained, and based on worldwide reporting of thousands of “adverse Events” it now seems that Bayer will have to begin the process of accepting responsibility for the Essure device medical problems claimed by the thousands of women who had the device implanted.

Some women who have experienced problems say they were not informed about the risks.

But Ben Peyton-Jones, a British consultant-obstetrician and gynecologist, said the device should still be used in some instances. Starting “I think it has a place for women who can’t have keyhole surgery and who are explained the risks very carefully,” when asked about the continued viability of Essure.

“When used correctly, according to the manufacturer’s guidance and in trained hands, it is safe.”

European Union Essure Use Suspended

The sale of Essure implants in the EU has now been suspended for further investigation and hospitals have been asked by Bayer not to use their existing stocks during this time.  This is a voluntary request and up to individual trusts to decide what to do.

The company said that independent reviews of Essure had concluded that the benefits outweighed the risks.

“Patient safety and appropriate use of Essure are the greatest priorities for Bayer, and the company fully stands behind Essure as an appropriate choice for women who desire permanent contraception,” it added in a statement. Bayer will immediately start damage control in the USA as soon as the UK-EU restrictions on Essure become known, specifically in the massive Essure Multidistrict Litigation, wher thousands of women in the United States are alleging major complications and onset of medical disability due to the Essure “adverse events” even while Bayer insisted the product was safe.

“Many women with Essure rely on this form of contraception without any side effects.”

The MHRA said it had no evidence to suggest this product was unsafe, and that the recent suspension did not suggest any increased risk to patient safety.

It said it was important for healthcare professionals to discuss the risks with patients before a procedure.


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Plaintiff’s Executive Committee Named in California Essure Birth Control Litigation

Fidelma Fitzpatrick
Attorney Fidelma Fitzpatrick

California Superior Court Judge Winifred Y. Smith named the plaintiff’s executive committee in state litigation against Bayer in Essure Product Cases litigation, Judicial Council Coordinated Proceeding No. 4887.

Some 55 actions were consolidated in state court by some 900 women who alleged that they sustained injuries from Essure. The suits contend that the Bayer product, an FDA-approved medical device that has been on the market since 2002, caused a number of problems and physical injuries in thousands of women who have had the device implanted.

Plaintiffs’ Executive Committee

The court designated as Lead Counsel of the Executive Committee:

Fidelma Fitzpatrick
Motley Rice LLC
55 Cedar Street, Ste 1 00
Providence, RI 02903
Phone: (401) 457-7700
Fax: (401) 457-7708
E-mail: ffitzpatrick@motleyrice.com

As chair of the PEC, Fitzpatrick will lead a five-person Executive Committee, as well as two liaisons, in seeking compensation for alleged harms suffered by the women. The PEC is responsible for coordinating the activities on behalf of all Plaintiffs’ during all pretrial proceedings.

Thousands of women across the U.S. claim Essure  has caused serious and permanent injuries, including hundreds represented by Motley Rice. The FDA reports that more than 9,000 voluntary complaints have been submitted by women allegedly harmed by Essure. While Bayer has denied any wrongdoing, the FDA announced in February 2016 that it will require the company to conduct a clinical study and implement a patient decision checklist to make sure potential users of Essure understand the potential, serious risks implanting the device may cause. Additionally, in October 2016, the FDA added a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.

Reported Essure complications include life-threatening ectopic pregnancy, fetal death, migration of the device causing perforation or tear of pelvic organs, additional surgeries, including hysterectomy to remove the device and repair organs, and other severe side effects.

“We stand firm that our clients and all affected by Essure deserve to have their stories heard,” stated Fitzpatrick. “I welcome the opportunity to represent these women as lead, working closely with fellow members of the Plaintiffs’ Executive Committee, and will do all in my power to achieve justice on their behalf.”

The court also designated:

Erin Copeland
Fibich Leebron Copeland Briggs & Josephson
1150 Bissonnet Street
Houston, TX 77005
Phone: (713) 751-0025
Fax: (713) 751-0030
E-mail: ecopeland@fibichlaw.com

Kim Dougherty
Janet, Jenner & Suggs, LLC
31 St. James Ave., Suite 365
Boston, MA 02116
Phone: (617) 933-1265
E-mail: kdougherty@myadvocatcs.com

M. Elizabeth Graham (CA State Bar 143085)
Grant & Eisenhofer P.A.
10 I California Street
Suite 2710
San Francisco, CA 94111
Phone: 415-365-9585
E-mail: egraharn@gelaw.com

Edward A. Wallace
Wexler Wallace LLP
55 W. Monroe St., Suite 3300
Chicago, 11 60603
Phone: (312) 346-2222
Fax: (312) 346-0022
E-mail: eaw@wexlerwallace.com

Plaintiffs’ Co-Liaison Counsel

The court designated for the Plaintiffs’ Co-Liaison Counsel

William A. Kershaw
Kershaw, Cook & Talley
401 Watt A venue
Sacramento, CA 95846
Phone: (888) 997-5170
Fax: (916) 669-4499
E-mail: bill@kctlegal.com

M. Elizabeth Graham
Grant & Eisenhofer P.A.
101 California Street
Suite 2710
San Francisco, CA 94111
Phone: 415-365-9585
E-mail: egraharn@gelaw.com

Defendants’ Lead and Liaison Counsel

The court designated:

Alycia A. Degen,
Sidley Austin LLP
555 West Fifth Street, Suite 4000
Los Angeles, CA 90013
Telephone: (213) 896-6000
Facsimile; (213) 896-6600

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FDA Advises Discussing Options Before Using Essure Permanent Birth Control

essureThe FDA recommended on Nov. 15 that health care providers thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks of Bayer’s Essure permanent birth control system.

Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

A California judge ordered that all California product liability lawsuits brought against Bayer Corporation and several subsidiaries involving its Essure birth control device will be coordinated before a single judge in Alameda County Superior Court going forward. The case is Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887.

Sterilization options

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Bayer revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.

Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.



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Essure Birth Control Cases Consolidated in California Court

Elizabeth Graham
Attorney Elizabeth Graham
Fidelma Fitzpatrick
Attorney Fidelma Fitzpatrick

A California judge ordered that all California product liability lawsuits brought against Bayer Corporation and several subsidiaries involving its Essure birth control device will be coordinated before a single judge in Alameda County Superior Court going forward.

The Sept. 30 Order Granting the Petition for Coordination will facilitate efficient adjudication in the California court system and coordinate the efforts on behalf of all the women injured by Bayer’ s device. The case is Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887.

Prior to Judge Winifred Y. Smith’s order granting the plaintiffs’ petition, there were some 55 actions brought throughout California by some 900 women who alleged that they sustained injuries from Essure. The suits contend that the Bayer product, an FDA-approved medical device that has been on the market since 2002, caused a number of problems and physical injuries in thousands of women who have had the device implanted.

Judge Smith ruled on Aug. 2, 2016, that the claims of 14 women were not expressly or impliedly preempted under federal or state law, allowing their claims to proceed. See California Judge Rules for Essure Plaintiffs in Preemption Issue

Black box warning


Also read: Bayer’s Essure Birth Control Device Facing Multiple Negligence Lawsuits


The FDA announced in February 2016 that the device will require a black box warning indicating extreme risks and possible serious injuries associated with its usage, and has instructed Bayer to engage in further post-market study of the device’s safety.

Plaintiffs’ counsel Elizabeth Graham of Grant & Eisenhofer and Fidelma Fitzpatrick of Motley Rice argued for the coordination of all state court actions in the Essure litigation on Sept. 30 before Judge Smith in the Superior Court of California in Alameda County.

Kim Dougherty of Janet, Jenner & Suggs and Erin Copeland of Fibich, Leebron, Copeland, Briggs & Josephson, and Ed Wallace of Wexler Wallace also led in the representing of plaintiffs in the litigation. Also handling the case for Grant & Eisenhofer is Thomas Ayala.

Ms. Graham, who leads Grant & Eisenhofer’s complex pharmaceutical and medical device litigation practice, noted that having the Essure matters before a single judge as coordinated proceedings will greatly assist the thousands of women injured by Essure, enabling them to essentially litigate their claims in one courtroom.

“This is a very favorable development for these injured women. Having these cases coordinated before a single judge will avoid inconsistent rulings and allow these women to prosecute their claims in a cohesive and unified manner,” said Ms. Graham. “Coordinated proceedings in the Essure litigation will enable counsel to fast-track the case, streamline discovery. The JCCP coordination will hopefully bring a swifter judicial remedy to all the women who were injured by Bayer’s Essure procedure.”


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California Judge Rules for Essure Plaintiffs in Preemption Issue

essureJudge Winifred Y. Smith in Superior Court of California, Alameda County, issued a decision on Aug. 2, 2016, permitting the claims of 14 women who believe they were injured by Essure to proceed against the manufacturer, Bayer.

The court found that the claims were not expressly or impliedly preempted under federal or state law.

Ruling improves prospects

Motley Rice attorney Lou Bograd argued the preemption issue on behalf of the Plaintiffs and attorney Fidelma Fitzpatrick also participated in July 29 hearing. While this proceeding directly addressed claims in 11 consolidated cases filed in California State Court by the 14 women, it improves the prospects for recovery of thousands of women alleging they were seriously injured by their use of Essure, including hundreds of women represented by Motley Rice.


Also read: Bayer’s Essure Birth Control Device Facing Multiple Negligence Lawsuits


Thousands of women across the U.S. claim the permanent birth control device Essure has caused serious and permanent injuries. Essure manufacturer Bayer asserted that the Plaintiffs, and similarly situated women, are barred from bringing claims against it due to federal preemption law. Bayer claims that because Essure is a Class III medical device that was approved by the FDA in 2002, it is immune from lawsuits brought by the victims of the device.

Judge Smith rejected Bayer’s request for immunity, instead finding that the Plaintiffs could proceed with the causes of action related to:

  • Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects.
  • Claims that Bayer breached Essure’s warranties and misrepresented Essure’s safety and efficacy through advertising and promotional materials that were not approved by the FDA.

Negligently trained physicians

The judge stated that the Plaintiffs’ claims that Bayer negligently trained physicians and manufactured the Essure device improperly could also survive preemption, but that Plaintiffs must replead those claims with more details on how Bayer’s conduct caused the Plaintiffs’ injuries.

“I am extremely encouraged by Judge Smith’s decision,” says Motley Rice Essure lawyer Fidelma Fitzpatrick. “Bayer should not be allowed to hide behind preemption and should be made to answer to each woman injured by Essure.”

In February 2016, the FDA announced it will require Bayer to conduct a clinical study, implement a patient decision checklist to make sure potential users of Essure understand the risks of the product, and add a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.

“Bayer, like many other drug and medical device manufacturers, has been trying to use the doctrine of preemption to immunize itself from liability and deny women alleging injury by its product their day in court,” Bograd says. “In the Essure litigation, we are prepared to tackle all legal hurdles Bayer throws at us and to continue working toward allowing our clients to be heard.”

Also read Update on Essure Permanent Birth Control Litigation

Read the rulings:

Black box warning

The FDA issued a “black box warning” for the device in February 2016 amid allegations that Bayer concealed the risk associated with Essure. The agency’s warning indicates extreme risks and possibly serious injuries associated with the use of Essure and includes warnings that the device can migrate out of place, cause chronic pelvic pain, and related symptoms.

The plaintiffs’ actions are currently being brought as 11 separate suits in California, along with leading plaintiffs’ class action firm Grant & Eisenhofer, the law firms Janet, Jenner & Suggs, LLC and Motley Rice LLC also represent plaintiffs in the actions.

“We believe that Bayer concealed from patients and the public the magnitude of risk associated with Essure, and that thousands of women suffered needless pain as a result of being deprived of vital information regarding the safety of this product,” said Elizabeth Graham, who leads Grant & Eisenhofer’s complex pharmaceutical and medical device litigation practice, and who is litigating the case alongside G&E’s Thomas Ayala.

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Bayer’s Essure Birth Control Device Facing Multiple Negligence Lawsuits

essureA Florida woman who was the first to file a lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control device, has led the way for litigation by others who were severely injured by the implanted device.

The lawsuit, filed in Philadelphia Court of Common Pleas, is not a products liability case, but an action for negligence because Bayer did not provide training to the physician on how to insert the device safely.

Doctor with no training

Heather Walsh obtained the Essure implant from a physician who did not receive any training from Bayer on how to insert the device.  The device – a coil made of stainless steel, titanium and plastic — is inserted into the fallopian tubes.  The coils expand and scar tissue forms around them blocking the fallopian tubes and resulting in sterilization, according to the complaint

Walsh was hospitalized for severe pain and fainting spells two years after getting the implant.  A CT scan revealed the device had migrated in her body and lodged behind her colon.  Walsh underwent a complete hysterectomy and other surgeries to remove the device from her colon.

Walsh is not alone, as more than 4,000 reports of serious complications from use of the Essure device have been reported to the FDA, including the report of woman who died during surgery to remove the implant in January 2015.

Angie Firmalino received the implant in 2009 and after two years, had it removed because the coils broke and migrated to her uterus.  Firmalino required several operations including a hysterectomy.  She started a Facebook page to warn other women about the dangers of the device, which now has more than 17,000 followers.

Claims not preempted by Medical Device Act

Although Essure has been in use since the FDA issued a Conditional Premarket Approval (CPMA) in 2002, Walsh brought the first Essure lawsuit against Bayer in 2014. The Medical Device Act (MDA) contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.

In the complaint Walsh filed, she claims that her negligence and breach of express warranties claims are not preempted by the MDA because the “cause of action has nothing to do with the product itself, but rather [Bayer’s] negligence in” allowing an untrained physician use specific equipment provided by Bayer, that the physician was not qualified to use when he erroneously implanted the device, according to the court documents.

In addition, the complaint asserts that the CPMA issued by the FDA was invalid because Bayer did not comply with the express conditions set by the FDA.

Mass Tort Consultant John Ray has written a white paper about how the FDA actions will affect the ongoing Essure Litigation specifically related to the defendants Prior Market Approval (PMA) preemption arguments.

Bayer violated FDA conditions

According to the complaint, the FDA and the Department of Health cited Bayer and invalidated the CPMA for its failure to report results from Essure trial studies, including failure rates.  It also “actively conceal[ed] [eight] perforations” resulting from Essure implantations.

Bayer was also required to notify the FDA when it took ownership of Essure from its previous manufacturer, Conceptus.  Because of Bayer failing to meet the conditions of the CPMA order, the complaint states that the FDA found that Essure is an “adulterated” product that violates the FDA order if it is marketed or sold.

Product pushed on physicians without training

The complaint also alleges that Bayer was neglectful in its “unreasonably dangerous distribution plan” because it failed to provide training to physicians on the insertion method of the device.

In addition, Bayer provided the untrained physicians with specialized equipment, not approved by the FDA order, required to insert the device, even though the physicians were unqualified to use the specialized equipment.  In return for the equipment, the physicians were required to purchase at least two Essure kits per month, according to the complaint.

The case is WALSH v. BAYER CORP., et al case number 2:15 – cv-00384 in the First Judicial Court of Pennsylvania Court of Common Pleas.

This article is reprinted with permission from The National Trial Lawyers.


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