Dalkon Shield, Essure, Paragard?

By Marcus Susen, Esq.

One question that is not raised enough, if at all, is why women disproportionally bear the burden of birth control. Almost all forms of birth control are aimed at women. Consequently, and unfortunately, women bear all the risks associated with these devices/drugs. Why is that?

From the 1970’s through today, women have been targeted by Big Pharma with different forms of birth control devices/drugs from the Dalkon Shield in the 1970s to Mirena, Essure, and Paragard in more recent years. Shockingly, all four of these devices/drugs have been the subject of mass litigation and two have been withdrawn from the market. (Dalkon Shield and Essure) On the other hand, there are no birth control devices for men. Many people are shocked to realize that male birth control pills are possible but Big Pharma is not pursuing this market with the same energy as it does with the devices/drugs aimed at women. Is this because Big Pharma has found, what it thinks, to be their easier “target”? If so, Big Pharma better rethink this strategy.

After the mass litigations regarding the Dalkon Shield, Mirena, and Essure, more recent news has been focused on Paragard birth control. Paragard is a temporary, non-hormonal, non-surgical IUD. It is essentially a T-shaped piece of plastic that is wrapped in copper wire which is intended to interfere with fertilization. However, more and more women have been reporting that the device has been breaking, especially upon removal, often causing significant and life altering injuries, such as infection, perforations, and infertility. Several reports have been made of surgical intervention to remove the broken device including hysterectomy- contradicting selling points made by the manufacturer (i.e. non-surgical, reversible). As a result of several of these incidents, a consolidated litigation has arisen involving Paragard in federal court in Northern GA against Teva Pharmaceuticals USA, Inc. and CooperSurgical, Inc. Once again, women across the country are speaking up.

Since Paragard was approved by the FDA, over 40,000 reports have been made by women and medical providers to the FDA according to the agency’s website. Over 16,000 of these have been labeled as “Serious Cases (including deaths).” However, drug safety experts estimate that only 10% of adverse events are actually reported to the FDA on a yearly basis.
The FDA relies on patients to report issues they have with medical devices or drugs on their MAUDE database. The FDA use this information to regulate devices and drugs. However, if the events are not being reported, the FDA does not have a complete picture of the risk/safety profile of a particular drug

or device. As a result, the FDA is less likely to require more safety studies, updated warnings, or even recall a device or drug.

The Paragard consolidated litigation may be yet another turning point for women. This is because when a woman files a lawsuit the manufacturer is required to report the event to the FDA. The amount of cases filed may help the FDA obtain a more accurate picture of the true risk/safety profile for Paragard. We saw this play out in the Essure litigation where after thousands of lawsuits were filed, the FDA required the manufacturer to conduct post-market studies, implement a black box warning, and patient-doctor decision checklist. Ultimately, the manufacturer pulled Essure from the market.

If manufacturers complain about lawsuits surrounding their drugs/devices, they might want to consider proactively following up with clients to see how their drug/device is doing and report the negative experiences to the FDA instead of waiting for the problems to come up in lawsuits. Maybe this is wishful thinking, but it would sure be cheaper than defending thousands of lawsuits. Then again, they can always begin to promote male birth control.

Marcus Susen

Marcus Susen is lead counsel of the Essure birth control litigation in the EDPA. After Essure was pulled from the market, for the global litigation settled for over $1.6B. He is currently on the Plaintiffs’ Steering Committee for the Paragard birth control litigation and focuses his practice on women’s health advocacy.

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Ethicon Hernia Mesh Litigation News

Case Totals Continue to Increase for Multiple Ethicon Hernia Mesh Products
By: Joshua S. Kincannon

The number of product liability cases filed against Johnson and Johnson and Ethicon for their defective hernia mesh products is on the rise. At the present rate, we can expect New Jersey state court cases to reach or surpass 3,000 by the Fall of 2021.

Cases have been consolidated into three litigations based on product, and all are set to be argued in Atlantic County, New Jersey, before the Honorable John C. Porto. All cases allege that these Johnson and Johnson and Ethicon polypropylene hernia mesh products are defective in their design, manufacture, and warnings. The following Ethicon products are included in the New Jersey Multi-County Litigations:

  • PHYSIOMESH: In Re Physiomesh Litigation Flexible Composite Mesh, Case No. 627, Superior Court of New Jersey, Law Division, Atlantic County.
  • PROCEED FLAT MESH and the PROCEED VENTRAL PATCH: In re Proceed Mesh Litigation, Case No. 630, Superior Court of New Jersey Law Division, Atlantic County.
  • PROLENE HERNIA SYSTEM (“PHS”): In re Prolene Hernia System Litigation, Case No: 633, Superior Court of New Jersey Law Division, Atlantic County.

Physiomesh Litigation

Plaintiffs allege that the Physiomesh implant is defective due to the dual-sided Monocryl coating, which causes the mesh to fail to adhere and leads to migration, recurrence, and device failure. As a result of these defects, the Physiomesh device was voluntarily withdrawn from the market in May of 2016.

Proceed Flat Mesh/Proceed Ventral Patch Litigation

The Proceed line of products differs from Physiomesh in that the polypropylene mesh core is coated with oxidized regenerated cellulose (“ORC”) as opposed to Monocryl. ORC is a poor coating that doesn’t work. It results in a chronic inflammatory response and severe adhesion formation when it fails and the patient’s bowels come into contact with the bare polypropylene mesh core. Further, the Proceed meshes are sterilized using a process known as gamma irradiation in air. This causes a breakdown of the molecular chains of the polypropylene core, weakening the mesh and rendering it ineffective for its designed, intended use. No other mesh product is coated in ORC or sterilized using gamma irradiation in air. Unlike the Physiomesh device, the Proceed line of products continues to be manufactured and sold.

Prolene Litigation

The Prolene Hernia System mesh is manufactured from a heavyweight, small-pore polypropylene mesh. It is a three-dimensional mesh product used primarily for inguinal hernia repair. Bare polypropylene triggers an intense, chronic inflammatory reaction when implanted in the human body. The PHS design only exacerbates this inherent material defect, as the sheer amount of polypropylene coupled with its dense hydrophobic design increases this deleterious inflammatory process exponentially. Defendants continue to sell this product.

Current Status of Litigations

Discovery is ongoing in these cases, with depositions of corporate witnesses continuing throughout the summer. The initial Bellwether pools have been chosen and those cases are being worked up for possible inclusion into the final trial pools. Selection of trial pool cases begins on June 1st with the Physiomesh litigation, where each side and the court will select a total of six cases for the final trial pool. The Proceed trial pool will be chosen in August, with each side and the court choosing nine cases. The PHS pool will be chosen in November, with four court picks and two picks each for plaintiffs and defendants. Trials are scheduled ninety days apart, beginning in May of 2022.

About the Author
Joshua S. Kincannon, Counsel in Wilentz, Goldman & Spitzer, P.A.’s Defective Drug & Device litigation practice, is lead liaison counsel on the New Jersey Ethicon Hernia Mesh cases. He can be reached at: jkincannon@wilentz.com.

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JOHN CARSON SR., M.D. ROUNDUP SETTLEMENT NEWS

In our previous coverage of the Carson matter we discussed what appears to be a pay-for-appeal scandal, arising from the case of Dr. John Carson Sr., M.D. In our initial article we mentioned the fact that several plaintiffs’ firms had filed a motion to intervene in the Carson case. See the documents from the motion to intervene here.

Jim Onder, as well as other major players in the RoundUp litigation will be speaking at the MTN Four Day Mass Tort Immersion Course June 11th – June 14th (register here). Attendees will be provided with up-to-date substantive information on the Roundup settlement negotiations. While newsworthy under the category of “bizarre,” the matter covered herein should not be considered substantive. We are covering a side show. Jim and others will give you a peek inside the “big tent” at our upcoming course.

Since our first article related to the deal Bayer made with plaintiff John Carson Sr., M.D., Bayer has publicly, and in court filings, fired back at the attorneys that filed the motion to intervene, although for the most part, Bayer/Monsanto’s utterances have been without significant, relevant substance, one of Bayer’s contentions seems to conflict with other prior contentions:

1. Bayer/Monsanto has made no secret of the fact that their appeal scheme involving Dr. John Carson Sr. is at least, in part, motivated by the desire to obtain an appellate ruling in the 11th Circuit or on further appeal to SCOTUS, that would benefit them in their defense of the remaining, approximately 125,000 Plaintiff cases.

2. However, when certain attorneys representing the interest of some of the 125,000 plaintiff cases filed a motion to intervene in the Carson appeal, Bayer/Monsanto filed a response asking the court to disregard these third parties’ filings, claiming that they have no interest in the very appeal that was filed with the intent (at least in part) of affecting those interests.

A more reasonable argument would be, the appeal court refusing to consider and hear the pleadings and interests of these third parties, would constitute a denial of the due process rights of these individuals.

Bayer/Monsanto seems to want to have their cake and eat it too:

Having their cake: We want to get appellate rulings that will help us defend against cases brought by Plaintiffs not initially named in the appeal. We want to dispose of the interest those third parties have in their claims against our organization, and this appeal will hopefully help.

Eating it too: Those third party plaintiffs that we hope to deprive of their interest in part via the Carson appeal, lack the necessary interest to intervene and be heard in the very appeal we hope will ultimately extinguish their interests.

THE CASE STANDS CLOSED

Normally, when an appellate court renders an opinion, the matter (case) is remanded back to the lower court, for further adjudication in accordance with the appellate ruling.

In the Carson case, the parties reached a private settlement agreement. Carson amended his complaint to drop the remaining claims that were not found to be preempted. The lower court then entered final judgement in favor of Bayer Monsanto and closed the case on March 30, 2021. (see below)

The settlement agreement, between Bayer and Carson was never filed or entered the docket of the lower Court in any manner. Now Bayer seeks to file a copy of the settlement agreement under seal in the appeals court in support of their argument pushing back against intervenors as well as in support of their arguments that the agreement is relevant to the appeals courts jurisdiction. The first question that must be ask is; How can appellate jurisdiction, in any way, rely or turn on evidence never summitted to nor considered by the lower Court?

Reports of Bayer’s public statements regarding intervenor action:

“Under the settlement, the company agreed to pay Carson $100,000 to drop the surviving design defect claims and to pursue the preemption ruling against him,” Bayer said in the statement. “If he succeeds in the appeal, he gets an additional substantial payment. If Carson drops the appeal, he would simply have to return the $100,000 settlement payment because he would be in breach of its terms. Thus, plaintiffs’ characterization of the $100,000 as a ‘penalty’ in a court filing is completely false, and nothing more than an effort to block this appeal on federal preemption grounds which threatens their interests in this litigation.”

Bayer’s statements are conclusive of the fact that regardless of the outcome of the appeal, there would be nothing for the lower court to adjudicate (reconsider) based on the appeal ruling, as the terms of the settlement agreement governs what occurs after the appeals court rules.

Federal Appellate Court Jurisdiction is limited to the authority to rule on errors in law and abuses of discretion by lower courts. Appellate Courts do not exist for the purpose of playing arbiter of agreements between private parties that are inherently extra judicial, unless and until a breach of said agreement is alleged and an action is filed arising from said breach, over which Federal Jurisdiction would then have to be proven to exist. More simply stated, it is not within the jurisdictional powers of a Federal Appellate Court to hear and rule on matters over which the resulting outcome does nothing more than determine the amount of money that one party pays, or another receives, arising from a private extra judicial agreement.

Stated differently, if no change or reconsideration of a lower court ruling would occur, regardless of the outcome of an appeal, that said appeal is not within the scope and purpose and jurisdiction of Federal Appellate Courts.

LACK OF APPELLANT JURISDICTION

Without regard to the intervenors’ motion, the 11th Circuit has an absolute obligation to affirmatively determine whether Federal Subject Matter Jurisdiction exists over the Carson appeal. Federal Courts are under a continuing obligation to affirmatively assure themselves of their jurisdiction over matters, even if no party (or third party) raises a jurisdictional challenge. See in general Steel Co. v. Citizens for Better Environment, 523 US 83 – Supreme Court 1998, Arbaugh v. y & H Corp., 546 US 500 – Supreme Court 2006, Ruhrgas Ag v. Marathon Oil Co., 526 US 574 – Supreme Court 1999, Insurance Corp. of Ireland v. Compagnie des Bauxites de Guinee, 456 US 694 – Supreme Court 1982.

Voluntary dismissal, moreover, may precede any analysis of subject matter jurisdiction because it is self-executing and moots all pending motions, obviating the need for the district court to exercise its jurisdiction. See Nix v. Fulton Lodge No. 2 of the Int’l Ass’n of Machinists, 452 F.2d 794, 797-98 (5th Cir.1971) University of South Alabama v. American Tobacco, 168 F. 3d 405 – Court of Appeals, 11th Circuit 1999 Id at 409.

It is, by now, axiomatic that the inferior federal courts are courts of limited jurisdiction. They are “empowered to hear only those cases within the judicial power of the United States as defined by Article III of the Constitution,” and which have been entrusted to them by a jurisdictional grant authorized by Congress. Taylor v. Appleton, 30 F.3d 1365, 1367 (11th Cir.1994).

FEDERAL JURISICTION OVER PRIVATE SETTLEMENT AGREEMENTS

Federal Jurisdiction over private settlement agreements is an often misunderstood topic. Parties to a case may agree and seek a consent order in which the Federal Court retains jurisdiction to enforce the terms of the settlement agreement. Otherwise, a settlement agreement is a contract governed by state law, under a given State courts jurisdiction, like any other contract.

For Federal Court to retain jurisdiction to enforce the terms of the settlement agreement, the settlement agreement must be incorporated into a consent order issued by the lower court. No copy of the Carson/Bayer settlement was filed in the lower court, much less incorporated into a consent order.

“Mere involvement in the settlement, however, is not enough. There must be some official judicial approval of the settlement and some level of continuing judicial oversight. Buckhannon, 532 U.S. at 604 n. 7, 121 S.Ct. 1835”.

The point that is often missed or misunderstood regarding a Federal Courts retention of jurisdiction to enforce the terms of the settlement agreement, is contingent on one party alleging breach of the agreement and instituting a new and fresh case and controversy arising from said breach, over which the Federal Court could then (and only then) exercise its retained jurisdiction to enforce the terms of the settlement agreement.

A SETTLEMENT AGREEMENT CANNOT CONFER APPELLATE JURISDICTION

“Subject matter jurisdiction is conferred and defined by statute. It cannot be created by the consent of the parties, see Fitzgerald v. Seaboard Sys. R.R., Inc., 760 F.2d 1249, 1251 (11th Cir.1985) (per curiam), nor supplanted by considerations of convenience and efficiency, see, e.g., E.R. Squibb & Sons, Inc. v. Accident & Cas. Ins. Co., 160 F.3d 925, 929 (2d Cir.1998), Morrison v. Allstate Indem. Co., 228 F. 3d 1255 – Court of Appeals, 11th Circuit 2000 Id at 1261.

“More specifically, the Court did not determine whether a plaintiff could achieve a sufficient “alteration in the legal relationship of the parties” through a settlement entered without a separate consent decree. In fact, private settlements were mentioned only in a footnote, which observed that private settlements do not entail the judicial approval and oversight involved in consent decrees. And federal jurisdiction to enforce a private contractual settlement will often be lacking unless the terms of the agreement are incorporated into the order of dismissal. Id. at 604 n. 7, 121 S.Ct. at 1840 n. 7 (citing Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994)). American Disability Ass’n, Inc. v. Chmielarz, 289 F. 3d 1315 – Court of Appeals, 11th Circuit 2002 Id at 1319 also see Anago Franchising, Inc. v. SHAZ, LLC, 677 F. 3d 1272 – Court of Appeals, 11th Circuit 2012.

THE DISAPPEARING SON – ATTORNEY JOHN CARSON Jr.

In our previous article, we mentioned the fact that a young attorney named John Caron Jr., who appears to the be the son of the plaintiff John Carson Sr. was added to the Certificate of Interest Parties filed by Carson on 04/02/21.

On 04/21/28 as part of the reaction to the intervenors motion, Bayer/Monsanto files a second Certificate of Interested Parties, with no mention of Attorney John Carson Jr.

At minimum, this appearance and sudden disappearance of John Carson Jr. from the appeal record deserves a “Hmmm” or rather a “Hmmmmmmmmmmm!”

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