PITTSBURGH – A local couple allege 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 says.
“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 states.
“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.”
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 of White & Williams in Philadelphia, plus Angela M. Alexander Savino of Perez & Morris, in Columbus, Ohio.
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