Keralink International, Inc. v. Geri-Care Pharmaceuticals Corporation

60 F.4th 175
CourtCourt of Appeals for the Fourth Circuit
DecidedFebruary 15, 2023
Docket21-2357
StatusPublished
Cited by4 cases

This text of 60 F.4th 175 (Keralink International, Inc. v. Geri-Care Pharmaceuticals Corporation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Keralink International, Inc. v. Geri-Care Pharmaceuticals Corporation, 60 F.4th 175 (4th Cir. 2023).

Opinion

USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 1 of 22

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 21-2357

KERALINK INTERNATIONAL, INC.,

Plaintiff - Appellee,

v.

GERI-CARE PHARMACEUTICALS CORPORATION,

Defendant - Appellant,

and

STRADIS HEALTHCARE, LLC; KAREWAY PRODUCT, INC.; INSOURCE, INC.,

Defendants.

No. 21-2404

STRADIS HEALTHCARE, LLC,

and USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 2 of 22

GERI-CARE PHARMACEUTICALS CORPORATION; INSOURCE, INC.; KAREWAY PRODUCT, INC.,

Appeal from the United States District Court for the District of Maryland, at Baltimore. Catherine C. Blake, Senior District Judge. (1:18−cv−02013−CCB)

Argued: December 6, 2022 Decided: February 15, 2023

Before HARRIS and QUATTLEBAUM, Circuit Judges, and KEENAN, Senior Circuit Judge.

Affirmed by published opinion. Judge Keenan wrote the opinion, in which Judge Harris and Judge Quattlebaum joined.

ARGUED: Danielle D. Giroux, HARMAN CLAYTOR CORRIGAN & WELLMAN, Glen Allen, Virginia; Kelly Marie Lippincott, GORDON REES SCULLY MANSUKHANI, LLP, Alexandria, Virginia, for Appellants. John Augustine Bourgeois, KRAMON & GRAHAM, P.A., Baltimore, Maryland, for Appellee. ON BRIEF: John D. Perry, HARMAN CLAYTOR CORRIGAN & WELLMAN, Alexandria, Virginia, for Appellant Geri-Care Pharmaceuticals Corporation. Jonathan A. Barnes, GORDON REES SCULLY MANSUKHANI, LLP, Alexandria, Virginia, for Appellant Stradis Healthcare, LLC. B. Summer Hughes Niazy, KRAMON & GRAHAM, P.A., Baltimore, Maryland, for Appellee.

2 USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 3 of 22

BARBARA MILANO KEENAN, Senior Circuit Judge:

In this appeal, we consider whether the district court erred in awarding summary

judgment to plaintiff KeraLink International, Inc. (KeraLink), the former operator of a

national network of “eye banks,” on its claim against two suppliers of contaminated

eyewash used to remove donated eye tissue for future transplant. Upon our review, we

hold that the district court properly awarded judgment to KeraLink on its claim of strict

products liability. Under the facts presented here, neither supplier was entitled to invoke

the sealed container defense, an affirmative defense reserved for only certain types of

sellers. Additionally, the economic loss rule barring liability for solely economic losses in

a tort claim was inapplicable because KeraLink also sought damages for injury to property,

namely, the recovered eye tissue rendered unusable by the contaminated eyewash. We also

hold that the district court did not abuse its discretion under Maryland law in awarding the

plaintiff prejudgment interest. We therefore affirm the court’s award of final judgment for

KeraLink against both defendants, jointly and severally, in the amount of $606,415.49 plus

prejudgment interest.

I.

Plaintiff KeraLink is a non-profit corporation with its headquarters in Baltimore,

Maryland, and operated a network of eye banks in many states. These eye banks recover

corneas and other eye tissue from recently deceased donors for future transplant into

patients who suffer from corneal blindness or other ocular diseases. Although prohibited

3 USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 4 of 22

by law from selling recovered tissue, 1 KeraLink collects certain fees for reimbursement of

costs related to the removal, processing, and transportation of such tissue.

To facilitate the recovery of eye tissue, KeraLink purchased from third party

vendors medical equipment and supplies, including “surgical packs” containing “eyewash”

used to irrigate the eye tissue. KeraLink purchased the custom-designed surgical packs at

issue here from defendant Stradis Healthcare, LLC (Stradis), which has its headquarters in

Georgia. KeraLink did not specify any particular brand of eyewash to be included in the

surgical packs. Stradis purchased and placed in each pack a bottle of “GeriCare Eye Wash

– Sterile Eye Irrigating Solution.” Stradis purchased this eyewash from a third-party

wholesaler, which received the eyewash from defendant Geri-Care Pharmaceuticals

Corporation (Geri-Care).

Geri-Care had purchased the eyewash from Kareway Products, Inc. (Kareway), after

requesting that Kareway supply eyewash similar to “Bausch & Lomb Advanced Eye Care.”

Geri-Care further requested that the Geri-Care logo be placed on the eyewash bottles.

Kareway obtained the eyewash from another company that originally manufactured the

product in Korea.

Upon receipt of the eyewash from Kareway, Geri-Care did not test the eyewash for

pathogens but relied on Kareway’s accompanying certification that the contents of each

box of bottled eyewash were sterile. Geri-Care registered the eyewash with the United

1 See Md. Code, Est. and Trusts, § 4-513 (prohibiting the sale of tissue but permitting a person to “charge a reasonable amount of money for the removal, processing, preservation, quality control, storage, transportation, implantation, or disposal of a part”).

4 USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 5 of 22

States Food and Drug Administration (the FDA). The label on the eyewash bottle

displayed Geri-Care’s logo and stated that the eyewash was “distributed by” Geri-Care,

listing its address in New York, and that the eyewash was a “Product of Korea.” There

was no other corporate entity or manufacturer identified on the eyewash bottle or on the

FDA registration.

When the eyewash bottles arrived in Georgia at Stradis’ facility, each bottle was

individually sealed. After ensuring that the plastic seal on the cap of each bottle was secure,

Stradis placed the eyewash bottles into surgical packs for KeraLink. Stradis included in

each surgical pack an insert listing the pack’s contents, including the term “sterile eye

wash.” The insert also included a statement that Stradis had manufactured and distributed

the surgical packs.

In October 2017, the Eye Bank Association of America (EBAA) notified KeraLink

“about a potentially contaminated” eyewash, namely, a certain lot number of the Geri-

Care-brand eyewash. The EBAA instructed eye banks to “pull” this eyewash from their

inventory. After hiring a third party to test the eyewash, KeraLink confirmed the presence

of contaminants in eight of ten bottles tested, and identified certain lot numbers of Stradis

surgical packs containing the potentially contaminated eyewash.

In addition, a surgeon informed KeraLink that the corneas in five of his patients who

had received transplants of KeraLink corneal tissue had tested positive for cultures closely

related to the pathogens identified in the contaminated eyewash. KeraLink confirmed that

it had obtained those five tissues from donors in procedures using the contaminated

5 USCA4 Appeal: 21-2357 Doc: 43 Filed: 02/15/2023 Pg: 6 of 22

eyewash. Corneal tissue recovered with use of this contaminated eyewash ultimately

occurred in numerous states and the District of Columbia.

KeraLink later filed suit against Stradis and Geri-Care (the defendants) in the United

States District Court for the District of Maryland under the court’s diversity jurisdiction,

28 U.S.C. § 1332(a)(1). KeraLink alleged claims under Maryland law for strict products

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