Drennen v. Olympus America, Inc.

CourtDistrict Court, S.D. West Virginia
DecidedDecember 28, 2022
Docket2:22-cv-00357
StatusUnknown

This text of Drennen v. Olympus America, Inc. (Drennen v. Olympus America, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. West Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Drennen v. Olympus America, Inc., (S.D.W. Va. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION

WOODROW RALPH DRENNEN and LINDA DRENNEN,

Plaintiffs,

v. CIVIL ACTION NO. 2:22-cv-00357

OLYMPUS AMERICA, INC.,

Defendant.

MEMORANDUM OPINION AND ORDER

The Court has reviewed Defendant Olympus America Inc.’s Motion to Dismiss Plaintiffs’ Complaint for Failure to State a Claim (Document 5), Defendant Olympus America Inc.’s Memorandum of Law in Support of Its Motion to Dismiss Plaintiffs’ Complaint for Failure to State a Claim (Document 6), the Plaintiffs’ Response to Defendant Olympus America Inc.’s Motion to Dismiss Plaintiff’s Complaint for Failure to State a Claim (Document 8), and Defendant Olympus America Inc.’s Reply in Support of Motion to Dismiss Plaintiffs’ Complaint for Failure to State a Claim (Document 9), as well as the Complaint (Document 1). For the reasons stated herein, the Court finds that the motion should be denied. FACTUAL ALLEGATIONS1 The Plaintiffs, Woodrow Ralph Drennen and his wife, Linda Drennen, filed their complaint in this Court2 on August 26, 2022. They named Olympus America, Inc., as the Defendant.

1 The factual allegations set forth herein are drawn from the Plaintiffs’ complaint and are treated as true for purpose of the motion to dismiss. 2 The matter was initially assigned to Chief Judge Thomas E. Johnston and was reassigned to the undersigned on October 21, 2022. Olympus is a medical technology company. It manufactured an ESG-100 device, an electro- surgical generator, that is the subject of this lawsuit. The ESG-100 is a Class 2 device under 21 C.F.R. § 876.4300. On August 28, 2020, Mr. Drennen underwent a routine screening colonoscopy at

Charleston Surgical Hospital in Charleston, West Virginia. The physician discovered two polyps, which he planned to remove using the ESG-100 to power a hot snare. The snare is placed over the polyp, and an electrical current provides heat and pressure to remove the polyp and cauterize the site. As the doctor performed the first polypectomy on Mr. Drennen, the snare overheated and burned more of the colon wall than normal. The wire of the snare “was discolored and had a burned appearance to it when it was removed from Mr. Drennen’s colon.” (Compl. at ¶ 12.) The physician “clipped the removal site” that was not properly cauterized and “used a different technique for the second polypectomy.” (Id. at ¶ 13.) The burn from the overheated snare perforated Mr. Drennen’s bowel, resulting in a life- threatening infection. He underwent emergency surgery that night, has received numerous

surgeries since, and will need additional surgeries and other medical care. He has been left “permanently scarred, disfigured, and disabled” and his injuries continue “to cause him immense pain and suffering.” (Id. at ¶16.) Ms. Drennen has and will continue to provide nursing and healthcare services. The Olympus ESG-100 was properly maintained, and medical personnel ensured that “there was no deviation from Olympus’ standard protocol while using the ESG-100 during Mr. Drennen’s procedure.” (Id. at ¶ 20.) “The medical personnel reported that ‘too much energy’ ‘overheated the snare.’” (Id. at ¶ 22.) The ESG-100 manual indicates that a defect or

2 malfunction may cause an undesirably high power output. Because the medical personnel suspected a defect, the ESG-100 “was returned to Olympus for examination and to remedy the defective device.” (Id. at ¶ 24.) Olympus found a “burn mark on the r28 resistor of the ESG- 100 sa communication board” and replaced a faulty component. (Id. ¶ 26.) The defect or

malfunction “resulted in high output power, causing Plaintiff to sustain serious injury.” (Id. at ¶ 28.) No warning or error notification effectively alerted medical staff of the malfunction, and the ESG-100 “has no independent parallel circuit to limit or govern the heat of the hot snare to the specific limit set by the physician and/or user.” (Id. at ¶ 23.) In mandatory FDA reports, Olympus indicated it had received reports of at least 32 instances of problems with the ESG-100 between March 15, 2016 and April 2, 2021, 25 of which involved injuries or burns to a patient. Thirteen reports described energy output problems. At least two previous instances involved energy output failures and included a finding of burn marks on the communication board in the device. Olympus does not instruct consumers to cease use of devices after a specified life span. The Plaintiffs allege that Olympus failed to perform or rely on

adequate testing and research regarding the risks and benefits of the ESG-100. The Plaintiffs allege that the “Plaintiff and Plaintiff’s physicians foreseeably used the ESG- 100 for its intended use, and did not misuse, abuse or alter the ESG-100 in an unforeseeable manner,” and it was in substantially the same condition during his procedure as when it left the possession of the Defendant. (Id. at ¶ 42–43.) The Plaintiffs further allege that the training and information provided to hospitals and physicians was misleading, insufficient, and incomplete. The Plaintiffs assert the following causes of action: Count 1: Strict Liability – Manufacturing, Structural, or Design Defect; Count 2: Strict Liability – Defective Product; Count

3 3: Strict Liability – Failure to Warn; Count 4- Breach of the Implied Warranty of Merchantability; Count 5 – Negligence; Count 6 – Punitive Damages; and Count 7 – Loss of Consortium. They seek past and future damages to include health care expenses, pain and suffering, lost wages, loss of ability to enjoy life, loss of consortium, emotional distress and mental anguish, annoyance and

inconvenience, scarring and disfigurement, the fair value of gratuitously provided physician, nursing, and other healthcare services, punitive damages, pre- and post-judgment interest, and any other appropriate relief. STANDARD OF REVIEW A motion to dismiss filed pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted tests the legal sufficiency of a complaint or pleading. Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009); Giarratano v. Johnson, 521 F.3d 298, 302 (4th Cir. 2008). Federal Rule of Civil Procedure 8(a)(2) requires that a pleading contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). Additionally, allegations “must be simple, concise, and direct.” Fed. R.

Civ. P. 8(d)(1). “[T]he pleading standard Rule 8 announces does not require ‘detailed factual allegations,’ but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp v. Twombly, 550 U.S. 544, 555 (2007)). In other words, “a complaint must contain “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. Moreover, “a complaint [will not] suffice if it tenders naked assertions devoid of further

4 factual enhancements.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557) (internal quotation marks omitted).

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