Thelen v. Somatics, LLC

677 F.Supp.3d 1305

Jeffrey THELEN, Plaintiff, v. SOMATICS, LLC, Defendant.

Case No: 8:20-cv-1724-TPB-JSS

United States District Court, M.D. Florida, Tampa Division

Signed June 12, 2023

Bijan Esfandiari, Pro Hac Vice, Monique A. Alarcon, Pro Hac Vice, Wisner Baum, LLP, Los Angeles, CA, Mark Herbert Schlein, Baum, Hedlund, Aristei & Goldman, PC, Los Angeles, CA, for Plaintiff.

Susan J. Cole, Manning Gross and Massengburg LLP, Miami, FL, Emma Christine Nunn, MG and M, Miami, FL, Jason Arthur Benkner, Pro Hac Vice, Poole Shaffery, San Diego, CA, for Defendant.

ORDER ON JURY INSTRUCTION ISSUES

TOM BARBER, UNITED STATES DISTRICT JUDGE

In this product liability case, Plaintiff Jeffrey Thelen sued Somatics, LLC, alleging injury due to electroconvulsive therapy ("ECT") treatments he received using an ECT device manufactured by Somatics. During the trial, the Court discussed with the parties its approach to issues relating to the jury instructions. For the benefit of the parties, this memorandum provides further detail and explanation for the Court's rulings on these issues.

Background

Thelen has suffered from severe depression and other mental health issues for many years, resulting in hospitalization on more than one occasion. From May 2014 to July 2016, he received over 90 ECT treatments at a hospital in Omaha, Nebraska, using an ECT device manufactured and sold Somatics. Plaintiff alleges that the ECT treatments caused permanent neurological injury, including permanent memory loss and brain damage. On July 24, 2020, Plaintiff filed this product liability suit under various legal theories. After the Court's disposition of counts of the complaint alleging breach of warranty and design defect, the counts remaining at the time of trial were a count for negligence that alleged a failure to test or investigate and a failure to warn (Count I) and a count for strict liability that alleged a failure to warn (Count II).

Analysis

The Court based its approach to the jury instructions in this case on the Supreme Court of Nebraska's decision in Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618 N.W.2d 827 (2000). In Freeman, the court undertook a comprehensive discussion of Nebraska products liability law in the context of a claim of injury from a prescription drug. Two aspects of Freeman dictate the approach taken by the Court here and further discussed below.

First, Freeman expressly adopted the learned intermediary doctrine as set forth in the Restatement (Third) of Torts: Products Liability § 6(d). That section, quoted in full and adopted by Freeman "as the applicable test for determining whether a manufacturer may be liable for a warning defect in prescription drug cases," provides as follows:

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or

(2) the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Freeman, 618 N.W.2d at 842.

Second, Freeman cited with approval the Third Restatement's adoption of a "single theory" approach to product liability claims. As Freeman explained, "[t]he Third Restatement recognizes the merger of doctrines by adopting a single theory approach. Instead of focusing on doctrinal tort categories such as negligence or strict liability, the Third Restatement functionally defines each of the three basic types of product defect claims: design, manufacturing, and warning defect claims." The court continued, "The Third Restatement adopts the position that the definition of 'defect' is the important issue and should remain the same regardless of the doctrinal tort category under which it is brought." Id. at 843. The court then quoted with approval from § 2, comment n of the Restatement:

A separate and more difficult question arises as to whether a case should be submitted to a jury on multiple theories of recovery. Design and failure-to-warn claims may be combined in the same case because they rest on different factual allegations and distinct legal concepts. However, two or more factually identical defective-design claims or two or more factually identical failure-to-warn claims should not be submitted to the trier of fact in the same case under different doctrinal labels. Regardless of the doctrinal label attached to a particular claim, design and warning claims rest on a risk-utility assessment. To allow two or more factually identical risk-utility claims to go to a jury under different labels, whether "strict liability," "negligence," or "implied warranty of merchantability," would generate confusion and may well result in inconsistent verdicts. [emphasis supplied]¹

Id.

The Court's goal in crafting instructions for this case was to provide the jury with an understandable way to apply the principles adopted in Freeman. The Court did not believe the parties' proposed instructions achieved that goal, and the Court accordingly prepared its own set of instructions, which it modified after discussions with counsel.

The Court now discusses three issues relating to the instructions.

Substantive Standard for Failure to Warn

The Court's instructions use the term "adequate instructions or warnings" to mirror the language of Third Restatement § 6(d) adopted in Freeman and further explain that a product lacks such instructions or warnings if it lacks "reasonable instructions or warnings regarding foreseeable risks of harm." The Court's instructions, however, omit the terms "defective" and "not reasonably safe." Under § 6(a) and § (6)(b)(3) of the Restatement, a product is "defective" if it is not reasonably safe due to inadequate instructions or warnings as defined in § 6(d). Under § 6(d), in turn, a product is not reasonably safe due to inadequate instructions or warnings if it lacks "reasonable instructions or warnings regarding foreseeable risks of harm." It appears to the Court therefore that the latter phrase provides the ultimate substantive standard for the jury to apply, and an instruction to the jury framed solely in terms of that standard is simpler and clearer.

Negligence v. Strict Liability

The Court's instructions presented the case to the jury on a single claim of a strict liability warning defect. As noted above, Plaintiff's complaint included a count for negligence, with allegations of failure to warn and failure to test or investigate, and a count for strict liability failure to warn. However, the Court believes that presenting the jury with two failure to warn claims based on essentially the same factual predicate would run directly contrary to Freeman. Freeman endorsed the concept that all product liability claims, whether under a theory of negligence or strict liability, turn on the existence of a manufacturing, warning, or design defect in the product. See Freeman, 618 N.W.2d at 843. Therefore, sending the case to the jury under two different warning theories would lead to confusion and inconsistent results. See id. For example, under a two-theory approach, the jury might conclude under the negligence theory that the manufacturer was negligent (that is, failed to act with reasonable care) with respect to the warnings it provided with its product, while at the same time concluding under the strict liability theory that the warnings were adequate. In the Court's view, this would make no sense. As comment m to § 2 of the Third Restatement notes, "[i]f a product is not . . . defective . . . , it is not negligence to manufacture it that way." Id. (quoting Bilotta v. Kelley Co., 346 N.W.2d 616 (Minn. 1984)).

Thelen argued for the submission to the jury of both negligence and strict liability claims, pointing out that his negligence count included allegations not only that Somatics failed to provide an adequate warning but also that Somatics failed to adequately test or investigate the risks posed by its product. However, the Court believes that submission to the jury of negligent failure to test or to investigate as a separate legal theory in addition to failure to warn would be redundant, would generate confusion, and would be inappropriate under Freeman. Unless Somatics' negligent failure to test resulted in a warning defect, then it could not have caused a cognizable injury and is therefore not independently actionable.

It is also worth noting that a number of courts in different jurisdictions, including Florida, have held there is no separate cause of action for failure to test; it is subsumed within a claim for failure to properly design or properly warn. See, e.g., Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517, 1527 (D. Minn. 1989) ("If the manufacturer designs the product safely, manufactures the product safely, and provides an adequate warning of dangers inherent in the use of the product, then a failure to test the product cannot, standing alone, cause any injury. The duty to test is a subpart of the other three duties because a breach of the duty to test cannot by itself cause any injury."); see also Couick v. Wyeth, Inc., No. 3:09-CV-210-RJC-DSC, 2012 WL 79670, at *7 (W.D.N.C. Jan. 11, 2012) (citing Kociemba and dismissing failure to test claim); Adams v. G.D. Searle & Co., 576 So. 2d 728, 730-31 (Fla. 2d DCA 1991) ("We agree with [Kociemba] that a manufacturer's duty to inspect and test is not a separate cause of action. The duty to test, as that court concluded, is a subpart of a manufacturer's duty to design a product with reasonable care, and thus is subsumed in the plaintiffs' claims for defective design and failure to warn.").

Submission of a product liability case to the jury on a single claim of strict liability failure to warn does not foreclose a plaintiff's...