Hammons v. Ethicon, Inc.

240 A.3d 537

Patricia L. HAMMONS

v.ETHICON, INC. and Johnson & Johnson; Gynecare; Secant Medical; Secant Medical Inc.; Prodesco, Inc.; and Secant Medical, LLC

Appeal of: Ethicon, Inc. and Johnson & Johnson

No. 7 EAP 2019

Supreme Court of Pennsylvania.

Argued: March 10, 2020

Decided: October 21, 2020

OPINION

JUSTICE BAER

This case presents a challenge to the exercise of specific personal jurisdiction in Pennsylvania over New Jersey corporate defendants in a case filed by an Indiana resident regarding injuries allegedly caused by a pelvic mesh medical device implanted in Indiana. While the device was assembled by the defendants out of state, the mesh component of the device was manufactured by a separate entity in Pennsylvania. After reviewing recent decisions from the United States Supreme Court revising its personal jurisdiction jurisprudence, we conclude that the imposition of personal jurisdiction in this case meets the relevant constitutional and statutory requirements. Accordingly, we affirm the judgment of the Superior Court.

I. Factual and Procedural History

Appellee-Plaintiff Patricia Hammons ("Hammons") is an Indiana resident who suffered significant injuries following the May 2009 implantation in Indiana of Appellant-Defendant Ethicon, Inc.’s Prolift Kit, which is a medical device used to treat "medical conditions in the female pelvis, primarily pelvic organ prolapse and/or stress urinary incontinence." Plaintiffs’ Master Long Form Complaint ("Master Complaint") at ¶ 23. She received treatment for the injuries in Indiana and Kentucky.¹

The Prolift Kit includes mesh, which has been cut to a specific shape, along with tools to implant it and instructions. The mesh is "woven from filaments of polypropylene and/or other non-biological substances designed and intended to be permanently implanted through surgery in the human body." Id .

As is relevant to the jurisdictional question before us, all parties agree that the mesh is the only aspect of the Prolift Kit produced in Pennsylvania. Ethicon contracted with Secant Medical, Inc. ("Secant"), a Bucks County manufacturer, to weave the mesh according to Ethicon's specifications from Ethicon's proprietary polypropylene filament. As the characteristics of the mesh and the production process are central to the issues in this case, we set forth the details as described in an affidavit by a Secant officer:

Ethicon supplies Secant with spools of PROLENE™ polypropylene filament, which Secant, in response to purchase orders, knits to produce large rolls of mesh per specifications provided and required by Ethicon. Ethicon's specifications govern various characteristics of the mesh, including its elasticity, density, mass, and areal density. Ethicon establishes the specifications for the knitting of the mesh component[,] and Secant is required to follow these specifications. Once the PROLENE™ polypropylene filaments are knit into mesh, samples of the mesh are measured for width, courses, wales, thickness, areal density, and elasticity, and are then ball burst tested. These measurements are taken and recorded to ensure that Secant has knit the mesh per Ethicon's specifications, and Secant completes a Certificate of Conformance for each lot that attests to the mesh's compliance with Ethicon's specifications. Secant then ships the large rolls of mesh to other Ethicon facilities unrelated to Secant where further manufacturing occurs.

Affidavit of Karen West, dated June 2, 2014, at ¶ 5.

In May 2013, Hammons filed a complaint in the Philadelphia Court of Common Pleas against Ethicon, Johnson & Johnson, Gynecare,² and Secant, asserting various claims related to the implanted device. Ethicon is a wholly-owned subsidiary of co-defendant Johnson & Johnson, both of which are headquartered and incorporated in New Jersey (jointly "Ethicon").

After initially being removed to federal court based on Ethicon's claim of diversity jurisdiction, the case was eventually remanded to the Philadelphia Court of Common Pleas, where it was transferred in March 2014 to the Complex Litigation Center Pelvic Mesh Mass Tort Program, which has been coordinated under the caption In re Pelvic Mesh Litigation and docketed as Master Docket Number February Term 2014, No. 829 ("Master Docket").³ The Master Docket included plaintiffs who were residents of Pennsylvania and over one hundred plaintiffs who, like Hammons, were neither residents of Pennsylvania nor had the device implanted in Pennsylvania (jointly "Plaintiffs").

On March 31, 2014, the court entered Case Management Order No. 1. In it, the court set forth procedures for Plaintiffs to file a "Master Long Form Complaint" and individual "Short Form Complaints." It declared that the Master Complaint would "substitute and supersede all [c]omplaints filed in individual Pelvic Mesh Cases pending in the Philadelphia County Court of Common Pleas," which included Hammons’ complaint. Order, dated March 31, 2014, at 3. The court decreed that the defendants could file Master Preliminary Objections as well as a Master Answer in response to the Master Complaint. The order specified that the court's "ruling on the Master Preliminary Objections will be binding on all current and future Pelvic Mesh Cases." Id. at 3.

The case management order explained that, after the expiration of the deadlines for Master Preliminary Objections, each plaintiff should file an individual Short Form Complaint in a form proposed by the Plaintiffs and agreed to by the Defendants. Id. at 3-4. On the Short Form Complaint, the individual plaintiffs could incorporate by reference those counts of the Master Complaint that applied to them and raise any additional claims specific to their situation. Any defendants named in a Short Form Complaint were allowed to file preliminary objections relevant to the new issues raised in that individual complaint.

Plaintiffs filed the Master Complaint in May 2014 against ten defendants raising eighteen claims. Plaintiffs asserted, without development, that jurisdiction over the defendants was based upon Pennsylvania's general personal jurisdiction statute, 42 Pa.C.S. § 5301, infra at 545 n.7. Master Complaint at ¶ 20.

As relevant to Hammons’ claim, Plaintiffs alleged that Ethicon "designed, manufactured, packaged, labeled, marketed, sold, and distributed" the Prolift Kit. Master Complaint at ¶ 25. Plaintiffs also named Secant as a defendant, claiming that it "designed, tested, inspected, wove, knitted, cut, treated, packaged, manufactured, marketed, and/or sold a mesh made from polypropylene and/or other synthetically derived filaments that was the actual mesh utilized" in Ethicon's Prolift Kits. Id. at ¶ 41. The complaint further averred that "no changes" are made to the mesh produced by Secant until it is cut by Ethicon, and it asserted that the mesh "is what remains in the woman's pelvic area." Id. at ¶ 42.

Plaintiffs stated that the Defendants’ products were "promoted to physicians and patients as an innovative, minimally invasive procedure with minimal local tissue reactions, minimal tissue trauma and minimal pain while correcting vaginal prolapse, stress urinary incontinence, pelvic organ prolapse and/or rectocele."⁴ Id. at ¶ 44. Plaintiffs, however, claimed that the polypropylene mesh "was biologically incompatible with human tissue and promote[d] an immune response" that resulted in "degradation of the polypropylene mesh, as well as the pelvic tissue" and could "contribute to the formation of severe adverse reactions to the mesh." Id. at ¶ 45. They averred that the devices had "high malfunction, failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women, including Plaintiffs." Id . at ¶ 51.

As relevant to Ethicon, Plaintiffs identified the following as defective aspects of the Prolift Kit specifically related to the mesh:

a. the use of polypropylene material in the mesh itself and the immune reaction that results, causing adverse reactions and injuries;

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c. the design of the Pelvic Mesh Products to be inserted transvaginally into an area of the body with high levels of bacteria, yeast, and fungus that adhere to the mesh causing immune reactions and subsequent tissue breakdown and adverse reactions and injuries; * * * *

e. [b]iomechanical issues with the design of the mesh that create strong amounts of friction between the mesh and the underling tissue that subsequently cause that tissue to degrade resulting in injury;

f. the lack or porosity in the mesh resulting in the formation of scar plate that prohibits the tissue in-growth, resulting in mesh contractions, nerve damage, pain and erosion of the mesh into other organs, and failure of the device;

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h. degradation of the mesh itself over time which causes the internal tissue to degrade resulting in injury;

i. particle loss and or "shedding" of the mesh both during implantation and following implantation that results in additional undesirable complications including an increased inflammatory response and a migration of those particles resulting in injury;

j. the welding and heating of the mesh itself during production which creates a toxic substances [sic] that contributes to the degradation of the mesh and host tissue alike.

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l. the propensity of the mesh for "creep" or to gradually elongate and deform when subject to prolonged tension inside the body;

m. the propensity of the mesh to contract, retract, and/or shrink inside the body;

n. the inelasticity of the mesh, causing them to be improperly matted to the delicate and sensitive areas of the vagina and penis where they are implanted, and causing pain upon normal daily activities that involve movement in the pelvic region (e.g. intercourse, defecation, walking)[.]

Master Complaint at ¶ 51. Included in the counts asserted in the Master Complaint were strict liability claims of failure...