Defendants File Motion to Create New MDL for Eliquis Mass Tort Litigation

eliquis-5mg-60slblBristol-Myers Squibb and Pfizer have filed a motion to create a new MDL 2754 consolidating mass tort litigation in US District Court for the Southern District of New York concerning bleeding-related injuries allegedly caused by Eliquis blood thinner.

The companies are facing 34 related actions filed in 13 different federal courts. Plaintiffs’ counsel have promised that they intend to file many more cases in the near future.

Starting in 2015, plaintiffs began filing lawsuits alleging the defendants failed to warn adequately about the risk of bleeding, and that the defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.

Eliquis (also known by its molecular name apixaban) is an anticoagulant medication that thins the blood, prevents the formation of blood clots, and decreases the risk of stroke in patients with atrial fibrillation and certain other conditions. Atrial fibrillation is a common arrhythmia (abnormal heart beat) that causes blood clots to form in the heart, and that is known to be associated with a very high risk of stroke.

The companies claim that the drug is “no less safe than a daily aspirin.” It was approved by the FDA in 2012 and carries a warning that it increases the risk of bleeding that there is no antidote for Eliquis.

The companies requested the New York federal court because they have headquarters there and because half of the actions have been filed there. The court has previously handled 158 MDLs and now is handling 27 MDLs including product liability cases against prescription drugs Rezulin (MDL 1348) and Fosamax (MDL 1789).

Bogus Aristotle Study

Plaintiffs allege that approval of Eliquis was based in large part on clinical trials known as Aristotle, which was conducted under the supervision and control of the defendants, in various countries, including China.

“Defendants, as a means of cutting costs, chose incompetent and untrustworthy agents in China to conduct the Aristotle study Defendants’ agents committed fraud in their conduct of the Aristotle study, by concealing side effects which occurred in test users of Eliquis; a death which went unreported (whereas one purpose of the study was to study the rate of death in Eliquis users compared to others in Coumadin); loss of subjects to follow-up; major dispensing errors including indicating that certain subjects were getting Eliquis when they were not; poor overall quality control; and changing and falsifying records, including records disappearing just before the FDA made a site visit, reportedly on the order of an employee of BMS,” states the complaint in Charlie Utts and Ciara Utts  v. Bristol-Myers Squibb Company and Pfizer Inc.Case 1:16-cv-05668-DLC (S.D.N.Y).

According to the complaint, the companies:

  • Failed to provide adequate warnings about the increased risk of gastrointestinal bleeds in those taking Eliquis, especially, in those patients with a history of gastrointestinal issues and upset;
  • Failed to provide adequate warnings about the increased risk of suffering a bleeding event, requiring blood transfusions in those taking Eliquis;
  • Failed to provide adequate warnings about the need to assess renal functioning before starting a patient on Eliquis and to continue testing and monitoring of renal functioning periodically while the patient is on Eliquis.
  • Failed to provide adequate warnings about the need to assess hepaticfunctioning prior to starting a patient on Eliquis and to continue testing and monitoring of hepatic functioning periodically while the patient is on Eliquis.

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9th Circuit: “Field Preemption” Overrules Local Anti-GMO Ordinances

GMO-corn-seedsDealing a setback to citizens concerned about the effects of genetically engineered crops (GMO), the Ninth US Circuit Court of Appeals issued three decisions striking down county ordinances in Hawaii that banned or limited pesticides and GMO plants.

The rulings on Nov. 18 turned on  the issue of “field preemption,” where a local ordinance covers the same subject area that is the exclusive jurisdiction of a state or federal law. In these cases the ordinances are preempted.

The rulings were a victory for large corporate seed companies including Monsanto Company, Syngenta Seeds, Inc, Pioneer Hi-Bred International, Inc., Agrigenetics Inc. and BASF Plant Science LP.

More than 90% of all corn, soybeans and cotton grown in the US are now GMO varieties. Separately, Monsanto is facing mass tort litigation against its weed killer in Roundup Products Liability Litigation, MDL No. 2741 before U.S. District Judge Vince Chhabria in the Northern District of California.

Uphold summary judgment

The Ninth Circuit opinions are Atay, et al., v. County of Maui, et al.Syngenta Seeds, Inc., et al., v. County of Kauai, and an unpublished opinion, Hawai’i Papaya Industry Assoc., et al., v. County of Hawaii. In each case the Ninth Circuit upheld the trial court’s grant of summary judgment.

Atay v. Maui. In Maui County, voters approved a ballot initiative banning the cultivation of GMO organisms in 2014. The concern was about the environment, that GMO crops would create “superweeds” and other pests resistant to pesticides, and the reduction of biodiversity. The ordinance is expressly preempted by the Plant Protection Act, 7 USC Sec. 7756(b), and is impliedly preempted by five chapters of Hawaii law on harmful plants, seeds and weeds.

Syngenta v. Kauai. The Kauai County Council enacted an ordinance in 2013 concerning insecticides, herbicides and fungicides because residents reported having medical symptoms due to airborne pesticides from GMO farms. The ordinance required growers to warn the public about exactly when and where pesticides would be applied, the required them to create buffer zones between the crops and nearby schools and waterways.

The Ninth Circuit ruled that state laws preempt local laws if (1) the state and local laws address the same subject matter; (2) the state law comprehensively regulates that subject matter; and (3) the legislature intended the state law to be uniform and exclusive.

The Hawaii Pesticides Law, HRS Ch. 149A, governs pesticide notification requirements, and thus impliedly preempts county ordinances.

Hawaii Papaya v. Hawaii. The County of Hawaii enacted an ordinance banning open air testing, propagation and development of genetically-modified organisms. The court said the ordinance is expressly preempted by federal law, by the Plant Protection Act, by impliedly by state law Hawaii law, as set forth in the Atay ruling.

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Taxotere MDL Gets Plaintiffs’ Liaison Counsel and Steering Committee

taxotere2US District Judge Kurt D. Engelhardt in the Eastern District of Louisiana issued Pretrial Order 2 on Nov. 17, 2016 appointing the Plaintiffs’ Liaison Counsel, Defendants’ Liaison Counsel, and the Plaintiffs’ Steering Committee (PSC) for 180 actions in In Re: Taxotere (Docetaxel) Products Liability Litigation – MDL No. 2740.

Plaintiffs’ Liaison counsel: Dawn Barrios of Palmer Lambert Barrios LLP of New Orleans, Louisiana and Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, LLC, also of New Orleans.

Defendants’ liaison counsel: Douglas J. Moore of Irwin Fritchie Urquhart & Moore LLC of New Orleans, Louisiana.

Plaintiffs’ Steering Committee:

Andrew Lemmon                                                  Emily Jeffcott
Lemmon Law Firm, LLC                                     The Lambert Firm, PLC
Hahnville, Louisiana 70057                                New Orleans, Louisiana 70130

Christopher Coffin                                                J. Kyle Bachus
Pendley, Baudin & Coffin, LLP                           Bachus & Schanker, LLC
New Orleans, Louisiana 70112                           Denver, Colorado

Anne Andrews                                                            Karen Barth Menzies
Andrews Thornton Higgins Razmara, LLP          Gibbs Law Group LLP
Irvine, California 92606                                           El Segundo, California

Hunter J. Shkolnik                                               Genevieve Zimmerman
Napoli Shkolnik PLLC                                         Meshbesher & Spence LTD
New York, New York                                            Minneapolis, Minnesota

Abby E. McClellan                                                Lawrence J. Centola, III
Stueve Siegel Hanson LLP                                   Martzell, Bickford, & Centola
Kansas City, Missouri                                           New Orleans, Louisiana

Alexander G. Dwyer                                             David F. Miceli
Kirkendall Dwyer LLP                                         Simmons Hanly Conroy
Houston, Texas 77002                                        Alton, Illinois 62002

Rand P. Nolen                                                       Daniel Markoff
Fleming, Nolen & Jez, LLP                                 Atkins & Markoff Law Firm
Houston, Texas                                                     Oklahoma City, Oklahoma

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Stryker Must Pay $7.6M for Defective Knee Replacements

Unicompartmental knee prosthesis
Unicompartmental knee prosthesis

Stryker Corporation, notorious for its defective hip implants, must also pay a $7.6 million product liability settlement for its artificial knee joint called the Duracon Unicompartmental Knee (or “Uni-Knee”) according to the Sixth US Circuit Court of Appeals.

The ruling ended 15 years of litigation in which Stryker tried to get its excess liability insurance carrier, TIG Insurance Company, to pay for the settlement of 70 product-liability claims dating back to 2000. Stryker v. National Union Fire Insurance Company of Pittsburgh, PA and TIG Insurance Company, Nos. 15-1657/1664 (decided Nov. 18, 2016).

Stryker currently faces 1,772 product liability cases consolidated into MDL 2441 before US District Judge Donovan W. Frank concerning its Rejuvenate and ABG II Hip Implant Products.

Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

Defective knee replacements

There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)

  • More than 7 million people in the U.S. have had a knee or hip replacement surgery
  • Hip and knee devices account for more than 85% of the joint reconstruction and replacement market
  • Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices

In the late 1990s, Stryker purchased a subsidiary of Pfizer, Inc. that made and sold the Duracon Unicompartmental Knee, which turned out to be defective. They were sterilized using gamma rays, which caused ultra-high molecular-weight polyethylene in the artificial knees to degrade and, if implanted past their five-year shelf life, potentially fail. Due to an inventory oversight, a number of expired Uni-Knees were sold to hospitals and implanted in patients.

Two policies, effective during the year 2000, were relevant: a “commercial umbrella” policy, issued by XL, and an “excess liability” policy, issued by TIG. The umbrella policy covered any “batch” of losses that Stryker became “legally obligated to pay by reason of liability imposed by law or assumed by the [i]nsured . . . because of [b]odily [i]njury.” That policy was limited to $15 million, after a $2 million self-insured retention.

The TIG excess liability policy kicked in after the umbrella policy was fully “exhausted,” and extended to Stryker’s “ultimate net loss . . . in excess of all underlying insurance” up to $25 million.

XL covered Stryker’s losses, but did so in non-chronological order: XL paid out the larger Pfizer judgment first, exhausted the limits of its coverage, and left Stryker’s individual product-liability claims on the table.

No written consent

Stryker sued TIG in the Western District of Michigan in 2013, seeking to recover the remaining $7.6 million paid to settle its direct product-liability claims. TIG disputed its coverage obligation, raising a defense that was “unique to [its] policy.” Stryker, 681 F.3d at 825 & n.4. In TIG’s view, the direct Uni-Knee claims did not constitute “ultimate net loss” because Stryker failed to obtain “written consent” at the time the settlements were made.

Stryker claimed that the policy, as applied to the idiosyncratic facts of this case, was latently ambiguous: because XL satisfied the Pfizer judgment first (and exhausted its policy), Stryker was forced to present its direct settlements to TIG years after they were made. Relying on the testimony of TIG’s former claims adjusters and underwriters, Stryker argued that the excess-liability policy did not actually require “consent to the Uni-Knee settlements when they were made.”

The Sixth Circuit disagreed, saying “Because Stryker did not satisfy the consent requirement, its direct settlements cannot constitute ultimate net loss, and there is no coverage under the policy.”


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Court Appoints Leadership In Roundup Cancer MDL

roundup-cancerUS District Judge Vince Chhabria appointed Robin Greenwald of Weitz & Luxenberg, PC, Michael Miller of The Miller Firm, LLC, and Aimee Wagstaff of Andrus Wagstaff, PC as Plaintiffs’ CoLead Counsel of Roundup Products Liability Litigation, MDL No. 2741, Case 3:16-md-02741-VC.

Pretrial Order No. 2, issued Nov. 17, also named them as chairs of the Executive Committee to coordinate and oversee the activities of the MDL. The court further named Michael Baum, Baum Hedlund Aristei and Goldman, Hunter Lundy, Lundy Lundy Soileau & South, and Yvonne Flaherty, Lockridge Grindal Nauen as Executive Committee members.

The court appointed Lori Andrus, Andrus Anderson, LLP and Mark Burton, Audet and Partners as co-liaison counsel. The role of co-liaison counsel will include administrative matters, such as to liaise with Plaintiffs’ attorneys who file cases in this MDL and who are not appointed to leadership in the MDL.

Causes cancer

The Judicial Panel on Multidistrict Litigation (JPML) created the new MDL in the Northern District of California. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in 21 districts. More than 10 different law firms represent plaintiffs in these actions, which were spread across the country.

The MDL Court noted that in the two actions previously pending in the Northern District of California, it had granted Monsanto’s request to bifurcate the proceedings. “However, because not all parties to the MDL have had an opportunity to be heard on this issue, the Court will consider additional arguments regarding bifurcation at the case management conference,” the judge wrote.

These lawsuits allege that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma (cancer of the lymph nodes). Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

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Federal Court to Select Pool of Bellwether Cases in Bair Hugger MDL

bair-hugger-infectionUS District Judge Joan N. Ericksen said she will randomly select 150 cases for bellwether trials from the 809 actions filed in In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666 in Minnesota.

Pretrial Order No. 15, issued on November 16, states that the cases will be designated on Dec. 23 from those that were filed in, removed to, or transferred to MDL No. 15-2666 (JNE/FLN) on or before Dec. 19, 2016.

After the parties submit relevant characteristics or categories to be considered, they will each select 16 cases from the pool of 150 for consideration for bellwether trials. Cases can be drawn from those filed in Ramsey County, Minnesota state court.

Deep joint infections

Bellwether nominations must be made by Jan. 20, 2017. Between then are March 1, 2017 the parties may conduct case-specific discovery, including collecting records from third parties. By March 1 the court will select up to eight of the Bair Hugger lawsuits for the final trial pool, with the first trial commencing on Nov. 6.

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. During an operation, a portable heater/blower takes in and warms ambient air, which is then gently forced through a flexible plastic hose into a single-use, disposable blanket.

Plaintiffs include patients who developed hip and knee infections following joint replacement surgery that involved use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

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Federal Court Reopens Mirena IUD Product Liability MDL

mirena-side-effectsIn an unusual move, the Judicial Panel on Multidistrict Litigation (JPMDL) reopened MDL 2434 for product liability claims against Bayer Healthcare Pharmaceuticals Inc. concerning its Mirena intrauterine device (IUD).

The MDL, In re Mirena IUD Products Liability Litigation, No. 13-MD-(CS), had been closed on Aug. 9 after US Judge Cathy Seibel of the Southern District of New York granted summary judgment on July 28 for defendant Bayer Healthcare Pharmaceuticals Inc. and dismissed all 1,377 cases for lack of causation expert testimony. The decision is on appeal to the Second US Circuit Court of Appeals.

The Nov. 3 decision to reopen the MDL came at the behest of Bayer and over the objections of the plaintiffs. Bayer requested the decision because it expected new cases to be filed against it.

It said that other MDLs have remained open while similar appeals are pending, such as the Incretin MDL in the Southern District of California, the Zoloft MDL in the Eastern District of Pennsylvania and the Fosamax MDL in the District of New Jersey.

New evidence

Citing new evidence, the plaintiffs assert that Bayer appears to acknowledge in a patent application for another IUD, when explaining why it chose a different progestin, that levonorgestrel – the progestin used in Mirena – actually does affect uterine tissues.

“As this Court knows, this position is directly contrary to Bayer’s many assertions in this litigation that levonorgestrel does not affect the uterus. Plaintiffs with newly-filed cases are entitled to take discovery on this evidence and related issues, and to obtain additional expert testimony in support of their claims. This issue is already being briefed in New Jersey, and it would be appropriate here as well if the MDL were re-opened,” wrote plaintiff’s counsel Michael K. Johnson of Johnson Becker in St. Paul.

Mirena is a T-shaped plastic device coated with the hormone levonorgestrel.  It is inserted into the uterus to provide birth control for up to five years. Plaintiffs charge that Mirena can migrate once inserted into the uterus, perforating the uterus or cervix upon insertion, and filed lawsuits alleging that Bayer failed to adequately warn doctors and women about the risk of uterine perforation.

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Citing NJ Decision, Johnson & Johnson Demands MDL Hearing on Whether Talc Causes Cancer

talc johnson & johnsonFlatly denying that perineal use of talc causes ovarian cancer, Johnson & Johnson called on US District Judge Freda L. Wolfson to order Daubert motions to strike expert witnesses on general and specific causation.

There are 57 actions pending in MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practicesand Products Liability Litigation, Case No. 3:16-md-02738-FLW-LHG.

The issue will turn on whether the judge allows the plaintiff’s experts to testify.

The expert witnesses were excluded by New Jersey Superior Court Judge Nelson C. Johnson in the coordinated Multi-County New Jersey talc litigation. See Carl v. Johnson & Johnson, No. ATL-L-6540-14, 2016 N.J. Super. Unpub. LEXIS 2102 (Law Div. Sept. 2, 2016), appeal pending.

Experts lead to three 8-figure verdicts

However, the expert witnesses testified in Missouri state courts resulting in three 8-figure verdicts against Johnson & Johnson in trials before Judge Rex M. Burlison:

  • On October 27 the third jury awarded more than $70 million in damages to Deborah Giannecchini, 62, of Modesto, CA, on her claim that her use of baby powder and other Johnson & Johnson talc products over 40 years caused her ovarian cancer. She was diagnosed with stage 4 ovarian cancer in 2012 and talc was found in her ovaries.
  • In February, a jury awarded $72 million to the family of Jacqueline Fox of Birmingham, AL, who used Johnson’s baby powder for 35 years. She was diagnosed with ovarian cancer in 2013 and died last year.
  • In May another jury in the same courthouse awarded $55 million to Gloria Ristesund of Sioux Falls, SD. She was diagnosed with cancer in 2011 after using J&J’s talc-based feminine hygiene products for almost 40 years.

J&J called on the MDL court to hold a “science day” in January 2017 when experts for each party can outline their positions and arguments. The company requested that the court select several cases that can be worked up for initial expert discovery on general and specific causation. J&J said it has already disclosed 500,000 pages of documents in discovery and that several corporate officers hae been deposed.

Facing widespread litigation

J&J is also facing litigation in state courts:

  • About 200  single-plaintiff cases are pending in the New Jersey state court coordinated proceeding before Judge Johnson.
  • 20 multi-plaintiff cases (with about 1,469 plaintiffs) are pending in the aggregate claim litigation proceedings pending before several judges in the 22nd Judicial Circuit Court, St. Louis (City), Missouri.
  • Finally, 60 cases (with about 249 plaintiffs) are pending in a California coordinated proceeding, Johnson & Johnson Talcum Powder Cases, Judicial Council Coordinated Proceeding No. 4877. Initially, those cases were assigned to Judge Maren E. Nelson of the California Superior Court for the County of Los Angeles.

Three class actions have been transferred to this MDL proceeding: Mihalich, Estrada and Joseph.

  • In Mihalich v. Johnson & Johnson, No. 14-CV-600-DRH-SCW, originally filed in the U.S. District Court for the Southern District of Illinois, plaintiffs seek to represent a proposed class of all consumers who purchased Johnson & Johnson’s baby powder in the state of Illinois, asserting causes of action under the Illinois Consumer Fraud and Deceptive Business Practice Act and for unjust enrichment.
  • In Estrada v. Johnson & Johnson, No. 2:14-cv-01051-TLNKJN (E.D. Cal. filed June 20, 2014), originally filed in the U.S. District Court for the Eastern District of California, plaintiff seeks to represent a proposed class of consumers who have purchased J&J baby powder in California, alleging violations of the California Consumer Legal Remedies Act, Business & Professions Code, as well as negligent misrepresentation and breach of implied warranty.
  • In Joseph v. Johnson & Johnson, No. 3:16-cv-00590-JJB-RLB (E.D. La.), originally filed in the U.S. District Court for the Middle District of Louisiana, plaintiffs seek to represent a proposed personal injury class, alleging negligence, intentional misrepresentation, fraudulent concealment, negligent misrepresentation, failure to warn, design and manufacturing defect, breach of warranty and violation of Louisiana’s Unfair Trade Practices Act.

Also read: Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

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Boston Scientific Settles Nearly Half of 40,000 Transvaginal Mesh Cases

Boston scientific tvc pelvic mesh
In its latest 10-Q filing with the Securities and Exchange Commission, Boston Scientific announced that as of Oct. 31 it has settled 19,000 of 40,000 product liability cases filed against it concerning its transvaginal mesh product.

A total of 17,277 actions are filed in federal MDL 2326 consolidated before US District Judge Joseph R. Goodwin in In RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, Case No. 12-md-2326, D. Mass.).  The company said that more than 3,100 cases are pending in Massachusetts state court.

In addition, the company says it has “made substantial progress” in settlement talks underway with plaintiffs’ counsel representing approximately 3,000 additional cases and claims.

Multiple verdicts

All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing,” the company states.

Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Plaintiffs allege the company knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.

Litigation is pending against 8 TVM manufacturers:

  1. Caldera TVM Class Action In California
  2. Boston Scientific TVM Litigation MDL 2362
  3. Bard TVM Litigation MDL 2187
  4. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  5. Neomedic TVM Litigation MDL 2511
  6. Cook TVM Litigation MDL 2440
  7. Coloplast TVM Litigation MDL 2387
  8. American Medical Systems TVM Litigation, MDL 2325

Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device.

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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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