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Friday, March 29, 2024

Judge approves removal of defendant from suit over FDA-recalled surgical scaffold

Federal Court
Wscotthardy

Hardy | US Courts

PITTSBURGH – A federal judge has approved the dismissal of one medical company from a couple’s litigation alleging that the wife-plaintiff developed breast cancer, after not being informed that a surgical scaffold used in her 2015 breast augmentation surgery was the subject of an FDA recall, 10 days after said surgery.

Jennifer Gillespie and Brian Gillespie of Pittsburgh first filed suit in the Allegheny County Court of Common Pleas on May 2 versus Sofregen Medical, Inc. of Framington, Mass., Allergan, Inc. of Irvine, Calif. and AbbVie, Inc. (as successor-in-interest to Allergan, Inc.) of North Chicago, Ill.

“On May 19, 2015, wife-plaintiff underwent a bilateral implant revision with Seri Surgical Scaffold, internal bra support and implant exchange, which procedure was performed by Simona Pautler, M.D. at St. Clair Hospital due to complications from wife-plaintiff’s April 16, 2012 bilateral breast augmentation with bilateral mastopexies surgery. During the procedure, the internal support of implants was performed using 10 cm x 25 cm. Seri Surgical Scaffold as an internal bra support. It is believed and there averred that Draft Seri Surgical Scaffold Lot# P13091601A was used,” the suit said.

“In August 2015, approximately four months after her surgery, wife-plaintiff started experiencing sharp burning pain and discomfort under her left breast. Wife-plaintiff also developed swollen lymph nodes in her right side, acne on her neck and face, hives, pain in ribs and clavicle and occasion low grade fevers.”

On May 29, 2015, the FDA issued a warning letter to defendant Allergen that “the Seri Surgical Scaffold was being promoted for unintended use as the device was not cleared or approved for use in breast reconstruction using a tissue expander or implant.”

“Wife-plaintiff was not contacted by defendants or others so advised of the May 29, 2015 action by the FDA by any source, including her surgeon. Approximately four years after her surgery, and due to ongoing complaints of pain, discomfort and pulling sensation in wife-plaintiff’s chest area, ribs and clavicle, Dr. Pautler advised wife-plaintiff of a recall on the Seri Surgical Scaffold. On May 13, 2020, wife-plaintiff saw Kevin Cross, M.D., who recommended immediate removal of Seri Surgical Scaffold and implants,” the suit stated.

“On May 26, 2020, wife-plaintiff underwent breast pathology testing, which revealed fibro-membranous tissue with reactive changes and underlying skeletal muscle consistent with capsule, nodular proliferation of nerve fiber bundles consistent with traumatic neuroma. On May 26, 2020, wife-plaintiff underwent bilateral implant removal with bilateral breast lift and fat grafting to the breasts, which procedure was performed by Dr. Cross. In January 2021, wife-plaintiff has been diagnosed with Smoldering Myeloma.”

The case was removed to the U.S. District Court for the Western District of Pennsylvania on May 31, on the grounds of complete diversity of citizenship between the parties and the amount in controversy exceeding $75,000.

On June 7, the Allergan and AbbVie defendants answered the complaint by denying the allegations and putting forth 27 separate affirmative defenses.

“This Court lacks personal jurisdiction over AbbVie and may lack personal jurisdiction over Allergan. There has been insufficient service and service of process on answering defendants. Plaintiffs’ claims are barred to the extent that the forum is improper pursuant to the doctrine of forum non conveniens. Plaintiffs’ complaint fails to state a claim against answering defendants upon which relief can be granted. Plaintiffs’ claims are barred by the applicable statute of limitations and/or statute of repose. Answering defendants are immune from liability for any conduct performed in conformance with government specifications,” according to the defenses, in part.

“Plaintiffs’ claims are barred, in whole or in part, by answering defendants’ compliance with the state of the art, industry standards, and/or applicable statutes and regulations. Plaintiffs’ claims are barred, in whole or in part, by the doctrines of res judicata, laches and/or waiver. Answering defendants are liable, if at all, only for their proportionate share of liability/damages. Plaintiffs’ claims are barred in whole or in part by the Due Process Clause of the Fifth and Fourteenth Amendments to the U.S. Constitution and the Pennsylvania State Constitution. To the extent plaintiffs seek punitive damages in this action, plaintiffs have failed to allege punitive damages with the requisite specificity.”

A mutual stipulation filed on July 12 saw Sofregen Medical, Inc. dismissed from the action without prejudice.

“Pursuant to Rule 41 of the Federal Rules of Civil Procedure…Sofregen Medical, Inc. is hereby dismissed from this lawsuit without prejudice. In the event that discovery reveals that defendant Sofregen Medical, Inc. is a proper party to this litigation, plaintiffs shall be entitled to reassert their claims against defendant Sofregen Medical, Inc. in this action, and defendant Sofregen Medical, Inc. shall waive the applicable statute of limitations as a defense,” the stipulation stated.

The following day, defendants Allergan and AbbVie objected to the stipulation.

UPDATE

On Feb. 1, U.S. District Court for the Western District of Pennsylvania Judge W. Scott Hardy approved the removal of Sofregen Medical, Inc. above their co-defendants’ previous objections, in a memorandum order.

“Here, plaintiff filed the stipulation before Sofregen served an answer or motion for summary judgment (and, indeed, Sofregen filed neither) but after co-defendants Allergan and AbbVie filed their answer. Sofregen contends that the stipulation is timely and proper, and thus ‘invites no response from the district court and permits no interference with it.’ In contrast, Allergan and AbbVie contend that they precluded dismissal of plaintiffs’ action against Sofregen pursuant to Rule 41(a)(1)(A)(i) by filing their answer before plaintiffs filed the stipulation. Yet, neither side of this controversy identifies clear and controlling Third Circuit precedent instructing as to which interpretation of Rule 41(a)(1)(A)(i) is proper, and no such authority appears to exist,” Hardy stated.

“Again, the text of Rule 41(a)(1)(A)(i) provides that plaintiff may dismiss an action without a court order by filing ‘a notice of dismissal before the opposing party serves either an answer or a motion for summary judgment.’ The best reading of this provision interprets ‘the opposing party’ as the party to which the notice of dismissal refers. Had the drafters intended to nullify notices of dismissal in circumstances in which any party who appeared filed an answer or motion for summary judgment, then such broader language would have been chosen as was used in Rule 41(a)(1)(A)(ii). Therefore, the stipulation satisfies Rule 41(a)(1)(A)(i) and automatically effectuates the dismissal of plaintiffs’ action against Sofregen without prejudice.”

For counts of strict liability, successor liability, negligence and loss of consortium, the plaintiffs are seeking damages in excess of the compulsory arbitration limits of Allegheny County, together with interest and costs of suit.

The plaintiffs are represented by Mark F. McKenna of McKenna & Associates, in Pittsburgh.

The defendants are represented by Andrew F. Susko and Joshua Elie Gajer of White & Williams in Philadelphia, Angela M. Alexander Savino of Perez & Morris in Columbus, Ohio, plus Mark Alan Sentenac, Ryan Kearney and Susan Clare of King & Spalding, in Atlanta, Ga.

U.S. District Court for the Western District of Pennsylvania case 2:22-cv-00806

Allegheny County Court of Common Pleas case GD-21-001852

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com

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