Essure Litigation Update Post FDA Action

 essureUpdate on Essure Permanent Birth Control Litigation

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 Litigation Background

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.

Original Device Approval Granted to : Conceptus, Incorporated San Carlos, CA 94070

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.

 

On February 29, 2016 the FDA issued a press release notifying the public of the following actions taken related to the Essure Permanent Birth Control Device:  See FDA Documents from Press Release

  1. Ordered Bayer to conduct a post market surveillance study to obtain more data about Essure’s benefits and risks.
  2. 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.
  3. Is in the process of completing its evaluation of the trade complaint.

 

Will the Action taken by the FDA Impact the Essure Litigation?

The action taken by the FDA on February 29, 2016 has caused renewed interest in the Essure case among Plaintiff Law Firms. The following questions have arose as a result of the FDA action:

  1. Will the action taken by the FDA serve to overcome defendants PMA Preemption arguments?
  2. 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?
  3. 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?

 

 Essure Litigation PMA Preemption Q & A

  1. Will the action taken by the FDA serve to overcome defendants PMA Preemption arguments?

        Highly Unlikely

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.

  1. 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?

Highly Unlikely

Recalls of medical devices are governed either by:

21 C.F.R. §§ 7.40-7.59 (for voluntary field actions)

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.

Withdrawal of approval is governed under 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46

Even in a recall of a PMA device, Mandated by the FDA when the PMA has not been withdrawn by the FDA would still likely bar State Law Claims: See In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155-56 (D. Minn. 2009), affirmed 623 F.3d 1200 (8th Cir. Oct 15, 2010);

PMA Preemption survives so long as the FDA has not revoked PMA preemption: Talbott v. C.R. Bard, Inc., 63 F.3d 25, 28 (1st Cir. 1995)

Many Courts have rejected arguments that the recall of a PMA approved device serves to overcome a defendants PMA preemption arguments:

Minnesota

Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155-56 (D. Minn. 2009)

Kinetic Co. v. Medtronic, Inc., 2011 U.S. Dist. Lexis 42398, slip op. (D. Minn. April 19, 2011

California

Erickson v. Boston Scientific Corp., 2100 WL 7036060, (C.D. Cal. Dec. 12, 2011)

Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr.3d 566, 579-80 (Cal. App. 2008)

New York

Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. Apr. 9, 2009)

North Dakota

Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008)

Texas

Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005)

 

South Dakota

Theofanis v. Boston Scientific Corp., 2003 WL 24049229, at *2 ¶16 (S.D. Ind. June 24, 2003);

New Jersey

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.

 

  1. 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?

          Unfortunately, probably not

 

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 ?

However under the very limited scenario in which the FDA has cited the Manufacturer (defendant) for failure to comply with manufacturing requirements or the FDA has cited the defendant for violations of the conditions of the PMA approval:

See Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. April 18, 2011) (relying upon FDA warning letter regarding manufacturing processes);

Maker of Essure Cited by FDA for Failure to Conduct Follow Up

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. 

John Ray

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena. As a 21-year old graduate of Brenau University in Atlanta, John graduated Magna Cum Laude and started a pharmaceutical and medical device company right out of school, selling it in an eight-figure deal when he was 35. John’s tenure in the pharmaceutical and medical device field allowed him to gain an in-depth understanding of FDA regulatory matters, as well as, a thorough understanding of the science and epidemiology related to gaining FDA approval to market pharmaceuticals and medical devices. John’s inside knowledge of how “Big Pharma” operates gives him a unique perspective and skill sets that are very useful to Mass Tort plaintiff firms. When John brought his “insider knowledge” and business acumen to the Plaintiff Mass Tort Space, one of the first things he recognized was a lack of common terminology and well defined metrics. John realized that firms were expressing the same concepts, but were not using the same terminology. As a result, John set out to define common terms and create methods for formulating important metrics for use by Mass Tort firms when evaluating litigations. The terminology and metrics John Ray developed are now commonly used by major Mass Tort Law firms. John is highly sought after and writes White Papers about both current and emerging torts, which are highly coveted in the industry. The accuracy of John’s analysis of emerging and ongoing litigations is unmatched. The fact that John not an attorney has proven to be an asset. John thinks like a business person, employing creative problem solving and possesses an extensive set of business skills and industry specific knowledge. He assists Mass Tort firms in making sound business decisions before and during any litigation they are involved in or are considering becoming involved in. John is an expert at evaluating cases and looks at each tort as an individual “investment,” which can be quantified resulting in risk mitigation for you and your firm.

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