Source: https://masstortnexus.com/Briefcases/Medical-Devices/46/ESSURE-(Bayer)-Philadelphia-Court-of-Common-Pleas
Timestamp: 2019-04-24 14:10:05+00:00

Document:
03/01/2016: On February 29th 2016 the United States Food and Drug Administration took certain actions related to the Essure Permanent Birth Control Device. This paper is intended to address certain questions related to if and how the actions of the FDA will impact certain aspects of the ongoing Essure Litigation specifically related to the defendants Prior Market Approval (PMA) preemption arguments.
The following is intended to provide information and opinion related to the above questions. Nothing in this document should be interpreted as legal advice.
Essure is a permanent birth control method for women designed as an alternative to tuba ligation.
November 2002: Essure gained FDA approval via the Prior Market Approval (PMA) Process on November 4th 2002. More than 750,000 of Essure devices have been implanted in women according to the device maker.
October 1 2003: Essure Developer Conceptus and Gynecare, a division of Johnson and Johnson enter into an exclusive agreement to co-promote Essure.
Women who received an Essure implant allege a variety of injuries caused by the device resulting in a massive number of Adverse Event Reports being filed with through the FDAs adverse event reporting System.
July 2014: The first Essure Lawsuit was filed by Heather Walsh. In the Philadelphia Court of Common Pleas.
December 30, 2014 Heather Walsh and four other Essure cases were later consolidated in US District Court in Philadelphia before District Judge John R. Pavoda.
April 29 2015: Defendant Moves for Judgement on the Pleadings: Arguing Express Pre-Emption arising from 21 U.S.C. § 360c, et seq., as interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008); as well as Fraud on the FDA Claims as interpreted in Buckman v Plaintiff Steering Committee.
January 14 2016: Order Dismissing Certain Plaintiff Claims without Prejudice.
January 15 2016: Joint Submission regarding Remaining Plaintiff Claims.
Ordered Bayer to conduct a post market surveillance study to obtain more data about Essure’s benefits and risks.
Intends to require that a boxed warning and Patient Decision Checklist be added to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device. In addition, FDA issued the draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to provide the public an opportunity to comment on the proposed language to be included in these warnings.
Will the Action taken by the FDA Impact the Essure Litigation?
Will the action taken by the FDA serve to overcome defendants PMA Preemption arguments?
If the post market surveillance ordered by the FDA results in the recall of the Essure Device under 21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18, would that recall serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that recall?
If the post market surveillance ordered by the FDA results in the Essure PMA being withdrawn, under 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46 , would such a withdrawal serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that PMA withdrawal?
The action taken by the FDA in February 2016 was probative in nature and issued non-binding recommendations. The action was not a recall nor did the action serve to withdraw the PMA approval of the Essure device under 21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18.
21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18 (for recalls mandated by the FDA).
Nothing in these regulations can be interpreted as a recall being equivalent to the withdrawal of the Prior Market Approval of the subject medical device.
Steele v. DePuy Orthopedics, Inc., 295 F. Supp. 2d 439 (D.N.J. 2003).
Courts in general have held that no statutes or regulations support the notion that a recall, , is sufficient to void PMA approval. . Courts have further generally held that plaintiffs’ claims, if allowed to proceed, would interfere with the PMA process by second-guessing” the FDA’s decision to approve the device in the first place.
See Mays v. Ciba-Geigy Corp., 233 Kan. 38, 52, 661 P.2d 348 (1983 The proper focus in any products liability claim is on the date of manufacture and sale, not some later date.
As noted in the Sprint Fidelis MDL, “Plaintiffs’ argument ignores that the PMA was in place at the time the leads were implanted,” which “is what matters.” 592 F. Supp. 2d at 1156.
Kemp v. Pfizer, Inc., the court noted that preemption applied despite a recall because, “when the [device] was implanted it had received pre-market approval by the FDA.” 835 F. Supp. 1015, 1023 (E.D. Mich. 1993); accord, Blanco, 70 Cal. 3d at 580-81.
Are there circumstances under which courts have allowed claims to proceed against a PMA approved device based on a recall ?
See: Cornett v. Johnson & Johnson, 414 N.J. Super. 365, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010) (FDA warning letter); Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010) (recall was FDA-mandated, not voluntary).
This article was intended for the use of Plaintiff attorneys involved in or interested in the Essure Litigation. The author of this article John Ray invites comments and contradicting opinions. Please feel free to email any comments or opinions to John Ray at john@masstortnexus.com.
Essure is a registered Trademark. The authors of this documents are not the manufacturer nor the holder of the Essure trademark nor in anyway associated with the holder of the Essure Trademark. The opinions expressed in this document are those of its author.

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