Opinion
Civ. 6:20-cv-00599-MK
06-10-2021
CATHERINE DENISE JOHNSON; and VAN REXFORD JOHNSON, Plaintiffs, v. MEDTRONIC INC.; MEDTRONIC USA, INC.; COVIDIEN LP; and COVIDIEN HOLDINGS, INC., Defendants.
FINDINGS AND RECOMMENDATION
MUSTAFA T. KASUBHAI United States Magistrate Judge
Plaintiffs Catherine Johnson and Van Rexford Johnson (collectively, “Plaintiffs”) brought this action against Defendants Medtronic PLC, Medtronic Inc., Medtronic USA, Inc., Covidien LP, and Covidien Holding, Inc. alleging product liability, breach of warranty, loss of consortium, and punitive damages arising out of an injury caused by a defective medical stapler. Defendants Covidien LP, Covidien Holding Inc., Medtronic, Inc., and Medtronic USA (collectively, “Defendants”) now move to dismiss Plaintiff's First Amended Complaint (“FAC”) for failure to state a claim under Fed. R. Civ. P. 12(b)(6). For the reasons stated, Defendants' motion should be granted in part and denied in part.
In their briefing, Defendants identify themselves collectively as “Covidien.”
BACKGROUND
Plaintiff Catherine Johnson underwent surgery on April 13, 2018 to treat her colon cancer. Sungeyen David Cho, M.D., was Ms. Johnson's primary surgeon during the procedure. The stapler used during Ms. Johnson's surgery failed to bind her incision. Dr. Cho noted in Ms. Johnson's surgical record that a “staple malfunction occurred.” Shortly after Ms. Johnson's first surgery, Dr. Cho informed her that the EEA Stapler used during her operation had malfunctioned. The malfunction created an air leak that required Ms. Johnson to undergo additional, otherwise unnecessary surgery. Plaintiff was discharged from the hospital on April 17, 2018. As a result of the alleged malfunction, Ms. Johnson is now required to use an ileostomy bag, causing severe physical, mental, and emotional damage. The removal of the bag will require an additional surgery.
Upon information and belief, Plaintiffs allege that the stapler that malfunctioned during Ms. Johnson's surgery was Defendants' 28 mm EEA Circular Stapler with Tri-Staple Technology (“EEA Stapler”), released in February 2018. On August 17, 2018, Defendants initiated a recall of the EEA Staplers. The recall notice stated that Defendants had “identified the potential for a device to have an incorrect tissue gap” and that “[u]se of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma.” (ECF 37, ¶ 29.) The Food and Drug Administration (“FDA”) categorized the cause of the recall as a “process design.”
The FDA also revealed that during the period from January 1, 2011 through December 31, 2018, it received close to 110, 000 reports related to problems with surgical staplers. Plaintiffs allege that Defendants intentionally failed to report these problems to the public by opting to report them directly to the FDA in a manner that was lawful but nevertheless hidden from public view. The effect of this decision was to hide the known risks associated with the staplers from doctors and from the public.
Publicly available records now show that Covidien has reported over 250 deaths related to its staplers or staples since 2001. Plaintiffs allege that despite knowledge of the dangers associated with the use of its staplers, Defendants represented and marketed their staplers as safe and effective, and failed to include warnings regarding the known risks of potential malfunctions. Ms. Johnson's surgeon Dr. Cho would not have used the Defendants' stapler had he known of the hidden reports regarding the stapler's risks. Plaintiffs' FAC alleges seven claims: (1) strict product liability due to design defect; (2) strict product liability due to manufacturing defect; (3) strict product liability due to failure to warn; (4) strict product liability due to misrepresentation; (5) product liability due to negligence; (6) breach of express warranty; and (7) loss of consortium. Plaintiffs also plead specific allegations to support a request for punitive damages based on Defendants' intentional failure to publicly disclose the risks associated with the EEA Stapler.
Defendants move to dismiss all seven claims alleged in the FAC, arguing (1) Plaintiffs' products liability claims do not plausibly allege that Defendants' product was defective or that it caused Ms. Johnson's injuries; (2) Plaintiffs fail to offer facts supporting an express breach of warranty claim; (3) Mr. Johnson's loss of consortium claim fails without any surviving claims; and (4) Plaintiffs' allegations and factual inferences relating to Defendants' reporting to the FDA cannot support a punitive damages award.
STANDARD OF REVIEW
To survive a motion to dismiss for failure to state a claim upon which relief can be granted, a plaintiff's factual allegations must be sufficient to raise a right to relief above the speculative level. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). While a complaint need not make detailed factual allegations, a complainant must provide the grounds of his entitlement to relief using “more than labels and conclusions.” Id., at 545 (“a formulaic recitation of a cause of action's elements will not do”).
DISCUSSION
I. Products Liability Claims
Defendants first allege that Plaintiffs have failed to state a claim for products liability under either a strict products liability theory or a negligence theory, arguing that (1) Plaintiffs erroneously ask the Court to apply the consumer-expectations test to their First and Second claims of strict liability; (2) even under the consumer-expectations test, Plaintiffs have failed to adequately plead facts to identify a manufacturing or design defect; (3) Plaintiffs have failed to identify inadequate warnings or misrepresentations to support their Third and Fourth claims of misrepresentation and failure to warn; and (4) Plaintiffs' allegations are insufficient to support Plaintiff's Fifth claim of products liability due to negligence.
1. The Consumer-Expectations Test Applies in Oregon
Defendants argue that Plaintiffs improperly use the consumer-expectations test to defend their claims of strict products liability. Under the consumer-expectations test, the critical question is whether “circumstances of the product's failure permit an inference that the product's design performed below the legitimate, commonly accepted minimum safety assumptions of ordinary consumers.” Bispo v. GSW, Inc., 361 Fed.Appx. 834, 835 (9th Cir. 2010). Defendants argue that the consumer expectations test is inapplicable in this case, citing Bispo for the proposition that the test is not applicable to a strict liability claim regarding a product like the EEA Stapler, since “ordinary consumers [would] have no firm expectations regarding” its functioning. Id. at 836. The Bispo court, however, was applying California law. See Id. The Oregon legislature, by contrast, has designated the consumer-expectations test as the sole test for a dangerously defective product under Oregon law. Burns v. General Motors Corp., 133 Ore. App. 555, 891 P.2d 1354, 199 (Or. Ct. App. 1995); Or. Rev. Stat. § 30.920(3).
Defendants also cite McCathern v. Toyota Motor Corp., 332 Or. 59, 78, 23 P.3d 320, 331 (2001) for the proposition that “some design-defect cases involve products or circumstances that are not so common that the average person would know from personal experience what to expect, ” arguing that therefore evidence relating to the risk-utility balancing test, and not the consumer-expectations test, is “necessary.” The McCathern court, however, went on to note that under circumstances where a claimant alleged a defect in an uncommon product, the trial court would be responsible for ensuring that the jury is supplied with sufficient additional evidence to properly apply the consumer-expectations test, affirming that this test for product design defect claims is mandated under Oregon law. The court emphasized that,
whether or not evidence related to risk-utility balancing is necessary to satisfy a plaintiff's burden of proof, a plaintiff's theory of liability under ORS 30.920 remains the same: That the product was dangerously defective and unreasonably dangerous because it failed to perform as the ordinary consumer expects. In other words, contrary to the Court of Appeals' opinion, “consumer risk-utility” is not a separate “theory of liability” under the statutorily mandated consumer expectations test.Id. at 332. Plaintiffs are therefore correct that the consumer-expectations test applies to their strict product liability claims.
2. Plaintiffs Pled Sufficient Facts to Identify a Manufacturing or Design Defect
Defendants also argue that Plaintiffs' First and Second strict products liability claims based on design and manufacturing defects should be dismissed because Plaintiffs have failed to identify any defects to satisfy the consumer-expectations test. Under Oregon law, to state a claim under any theory of product liability, a claimant must plead facts plausibly showing that a defect rendered the defendant's product “unreasonably dangerous” “to an extent beyond that which would be contemplated by the ordinary consumer.” Harris v. Suniga, 209 Or.App. 410, 149 P.3d 224, 229 (2006), aff'd., 344 Or. 301, 180 P.3d 12 (2008); Becker v. Barbur Blvd. Equipment Rentals, Inc., 81 Ore. App. 648, 726 P.2d 967 (Or. Ct. App. 1986). In Benson Tower Condominium Owners Assoc. v. Victaulic Co., the court stated the consumer-expectations test as follows:
When a plaintiff alleges that a product is in a defective condition unreasonably dangerous to the user or consumer, the plaintiff must prove that, when the product left the defendant's hands, the product was defective and dangerous to an extent beyond that which the ordinary consumer would have expected. Whether a product is dangerous to an extent beyond that which would be contemplated by the ordinary consumer is a factual question to be determined by the jury.105 F.Supp.3d 1184 (D. Ore. 2015).
Here, Plaintiffs have pled sufficient facts to allege that Defendants' product was defective and unreasonably dangerous to an extent beyond which the ordinary consumer would have expected. The FAC alleges that Defendants' EEA Stapler was defectively manufactured, that the Stapler malfunctioned during Ms. Johnson's surgery, and that due to this malfunction Ms. Johnson underwent an otherwise unnecessary ileostomy and will require additional surgery to remove the ileostomy bag. Plaintiffs have thus marshalled sufficient factual allegations, including the treatment notes of Dr. Cho and the FDA's determination of a “process design” flaw in the EEA Stapler, that could lead a jury to find that the EEA Stapler was defective. A defect has therefore been adequately identified and described in the FAC. See Kahle v. Gonzales, 474 F.3d 665, 667 (9th Cir. 2007).
Defendants argue that Plaintiffs' use of circumstantial evidence to support their claims of liability due to defect is inappropriate, citing Adams v. United States, 449 Fed.Appx. 653, 657 (9th Cir. 2011). In Adams, the Ninth Circuit applied Idaho law to conclude that the defendants' Rule 50(b) motion for judgment as a matter of law on claimants' defective product claim was properly denied, because the claimants had presented circumstantial evidence to support their claim and defendants had failed to show that claimants' “evidence permits only one reasonable conclusion.” Id. at 657. Adams is inapposite to this case because it applies Idaho, not Oregon, law, and the Rule 50(b), not the Rule 12(b)(6), standard. Id. Further, contrary to Defendants' suggestion, Adams does not stand for the proposition that the use of circumstantial evidence to support a claim is appropriate only when a claimant rules out any alternative possible causes. Plaintiffs were required only to plead factual allegations sufficient to raise a right to relief above the speculative level. Twombly, 550 U.S. at 555.
In sum, as discussed above, Plaintiffs presented adequate factual allegations to support their First and Second claims for relief under a strict liability theory for design and manufacturing defects. Defendant's motion to dismiss Plaintiffs' First and Second claims should be denied.
3. Plaintiffs have Identified Inadequate Warnings or Misrepresentations
Defendants next argue that Plaintiffs' Third and Fourth strict liability claims for failure to warn and misrepresentation should be dismissed because (1) Defendants had no duty to warn Plaintiffs of the possible risks associated with their product, and (2) Plaintiffs failed to sufficiently identify inadequate warnings and misrepresentations made by Defendants.
Oregon has long recognized that sellers of products have a duty to provide adequate warnings about nonobvious risks associated with the use of their products when they know, or reasonably should know, of those risks of injury. Benjamin v. Wal-Mart Stores, Inc., 185 Ore. App. 444, 454-55, 61 P.3d 257 (2002). Defendants however allege that they had no duty to warn Plaintiffs of the possible risks associated with their product under the learned intermediary doctrine, citing Oksenholt v. Lederle Laboratories, 656 P.2d 293, 296-97 (Or. 1982). In that case, the Oregon court found that certain manufacturers have a duty to warn physicians of possible harmful effects of their products, and that “[t]he manufacturer is directly liable to the patient for any breach of this duty to the physician.” Id. at 297. Here, Plaintiffs have specifically alleged that Dr. Cho would not have used Defendants' product but for Defendants' failure to disclose the known risks associated with product malfunction. Under Oregon law, then, Defendants had a duty to warn Dr. Cho of the known risks associated with their EEA Stapler. Oksenholt, 656 P.2d at 296-97. By alleging that Defendants breached that duty, Plaintiffs establish direct liability to Ms. Johnson, Dr. Cho's patient. On this record, Plaintiffs have sufficiently alleged both duty and breach to support their strict product liability claims consistent with the learned intermediary doctrine. Id., at 297.
Defendants also argue that Plaintiffs failed to sufficiently identify inadequate warnings and misrepresentations made by Defendants to support their Third and Fourth claims for relief. In Oregon, when a complainant alleges that the defendant had reason to anticipate that their product was unreasonably dangerous when sold without a warning about what could occur as a result of that particular use, it sufficiently states a claim for relief. Waddill v. Anchor Hocking, 149 Ore. App. 464, 944 (Or. Ct. App. 1997), rev'd, 330 Ore. 376, 8 P.3d 200 (Or. 2000). Here, Plaintiffs have specifically alleged that Defendants had reason to believe that “danger may result from a particular use” of the EEA Stapler. Griffith, 334 Or. 456. The FAC also alleges that Defendants intentionally concealed from public view the Stapler malfunctions that caused severe injuries and would later lead to a recall or reclassification. (ECF 37, ¶¶ 32, 72.) Further, Plaintiffs allege that defendants intentionally marketed their product as safe and effective, failing to disclose the malfunction information to the public, including Plaintiffs and Dr. Cho. Plaintiffs have also alleged that these inadequate warnings were a substantial cause of their injuries, because Dr. Cho would not have used the EEA Stapler but for Defendants' failure to warn of its dangers. Crosswhite v. Jumpking, Inc., 411 F.Supp.2d 1228, 1235 (D. Or. 2006) (inadequate warning must be a substantial cause of the person's injuries).
Defendants cite Frere v. Medtronic, Inc., No. CV-1502338, 2016 WL 1533524, *6 (C.D. Cal. Apr. 6, 2016) for the proposition that conclusory allegations cannot support a claim of strict products liability under a failure to warn theory. In Frere, the court rejected the claimant's strict products liability claim, noting that “[n]owhere in Plaintiff's FAC does Plaintiff allege any facts to suggest how Defendants' manufacturing defect and failure to warn - as defined by Plaintiff -caused her injuries.” Id. at *6. By contrast with the claimant in Frere, Plaintiffs in this case have specifically identified the use of Defendants' product, and Defendants' failure to warn of its specific propensities to malfunction, as the but-for cause of their injuries. For these reasons, Plaintiffs have provided more than merely conclusory allegations to support their claims of strict liability under a failure to warn theory, and Defendants' motion to dismiss Plaintiffs Third and Fourth claims should be denied.
4. Plaintiffs' Allegations are Sufficient to Support a Negligence Claim
Defendants also argue that Plaintiffs' allegations are insufficient to support their Fifth claim for relief for products liability under a negligence theory. “To state a claim for negligence under Oregon common law, a plaintiff must show that the defendant owed the plaintiff a duty, that the duty was breached, and that the breach caused the plaintiff harm.” Clement v. Ecolab, Inc., 341 F.Supp.3d 1205, 1214 (D. Or. 2018). “When a defendant's negligence is a factual cause of harm to the plaintiff, the defendant is subject to liability to the plaintiff as long as the harm that the plaintiff suffered was a reasonably foreseeable result of the defendant's negligence.” Lasley v. Combined Transp., Inc., 351 Or. 1, 7, 261 P.3d 1215, 1219 (2011).
Here, Plaintiffs have adequately alleged that Defendants' conduct created a foreseeable risk that resulted in Ms. Johnson's injury. Absent a special status, relationship, or standard of conduct, liability in negligence is based on foreseeability. Lasley v. Combined Transport, Inc., 351 Ore. 1, 7, 261 P.3d 1215 (2011). The standard for foreseeability is based on whether a defendant's conduct resulted in a foreseeable and unreasonable risk of harm of the kind that the plaintiff suffered. Towe v. Sacagawea, Inc., 357 Ore. 74, 86 (2015). Here, Plaintiffs alleged that the warnings that accompanied the EEA Stapler failed to provide the level of information that an ordinary physician or consumer would expect when using the product in a manner reasonably foreseeable to the Defendants, and that Defendants recklessly or intentionally minimized and/or downplayed the risks of serious injury or death caused by the EEA Stapler by failing to disclose them publicly.
Defendants argue that Plaintiffs have failed to state a claim under a theory of negligence because Plaintiffs fail to allege sufficient facts to establish that (1) Covidien breached their duty of reasonable care; and (2) Covidien negligently failed to properly design the EEA stapler. With respect to Plaintiffs' burden to plead facts to establish a breach of the duty of care by failing to warn Plaintiffs or their physician of the EEA Stapler's propensity to malfunction, Defendants again argue that Plaintiffs failed to allege which warnings Dr. Cho received prior to surgery, how those warnings were inadequate, or what warnings Covidien should have provided. Defendants argue that these specific details are necessary to state a negligence claim, citing Mills v. Bristol-Myers Squibb Co., No. CV 11-968, 2011 WL 3566131, at *3 (D. Ariz. Aug. 12, 2011).
In Mills, the court dismissed a claimant's negligence claims based on a failure to warn theory because the claimant had failed to plead any facts about what the product's label “said or how it was deficient, ” and because the allegedly harmful product's label had in fact warned of a risk of excessive bleeding, which the claimant later suffered. Id. at *3. This case is distinguishable from Mills because, as discussed above, Plaintiffs have alleged that Defendants knew of specific risks associated with their product including staple misfire, and that they failed to disclose these risks to the public or to Ms. Johnson's physician. Further, as noted, Plaintiffs have alleged that Dr. Cho would not have used the EEA Stapler if he had been apprised of these risks.
Defendants also argue that Plaintiffs fail to state a claim of negligence because they have not alleged that Covidien was negligent due to improper manufacturing or designing the EEA Stapler. To support this claim, Defendants cite Sells v. Nickerson, 76 Or.App. 686, 692, 711 P.2d 171, 175 (1985) for the proposition that a product's failure is not, by itself, sufficient evidence of negligence. In Sells, the court upheld a dismissal of the claimant's negligence claims because they were based solely upon an allegation of product malfunction, with no additional evidence of negligent design. Id., at 692-93. Here, by contrast, Plaintiffs have alleged both a malfunction of the EEA Stapler and evidence of negligent design. Specifically, the FAC notes that Defendants initiated a recall of the EEA Staplers; that the recall notice stated that Defendants had “identified the potential for a device to have an incorrect tissue gap” and that “[u]se of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma;” and that the FDA categorized the cause of the recall as a “process design.” (FAC, ¶ 29.) On this record, unlike the claimant in Sells, Plaintiffs have pleaded facts alleging more than a mere malfunction.
In sum, Plaintiffs have properly pleaded facts to state a cause of action for products liability under a negligence theory. They have alleged that the EEA Stapler would not have been used had Defendants not misrepresented the safety risks, that the EEA Stapler was used during Ms. Johnson's surgery in a manner promoted by the Defendants, and in a manner that was reasonably foreseeable by the Defendants as involving danger that was not readily apparent to Ms. Johnson's physician, Dr. Cho. Additionally, Plaintiffs have properly alleged that Defendants had a duty to design and manufacture a safe stapler, and that this duty was breached when a design or manufacturing flaw caused the EEA Stapler's malfunction, which caused Plaintiffs' injuries. Defendants' motion to dismiss Plaintiffs' Fifth claim should be denied.
II. Express Breach of Warranty Claim
Defendants next argue that Plaintiff fail to offer facts supporting their express breach of warranty claim. In Oregon, an express warranty is created through “[a]ny affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain.” Pac. Botanicals, LLC v. Sego's Herb Farm, LLC, 2016 WL 11187249 (Or. Dis. Ct., Dec. 8, 2016). The elements of a breach of warranty claim are (1) an affirmation of fact or description of the goods; and (2) the factual affirmation or description must be part of the basis of the bargain. Autzen v. John C. Taylor Lumber Sales, Inc., 280 Or. 783, 788, 572 P.2d 1322, 1325 (Or. 1977).
Defendants argue that Plaintiffs' FAC fails to state a claim for relief under a theory of express breach of warranty because it does not satisfy either of the elements articulated in Autzen. Defendants first contend that the FAC provides no allegations regarding the content of the articles or advertisements that were seen by Dr. Cho. Here, however, Plaintiffs have alleged that Defendant Covidien “utilized journal articles, advertising media, and sales representatives/consultants to urge the use, purchase, and utilization of the EEA Stapler and expressly warranted to physicians including Plaintiff's physician and other members of the general public and medical community that it was safe and effective.” (FAC, ¶ 97.) The allegation that Covidien represented its product as safe and effective is sufficiently definite to satisfy the first element of a breach of warranty claim. Autzen, 280 Or. At 788.
Defendants also argue that Plaintiffs have failed to plead facts to suggest that Covidien's representations formed the basis of the bargain with Dr. Cho. Here, Plaintiffs allege that Dr. Cho relied upon Covidien's representations that the EEA stapler was safe and effective, but they fail to allege that any purported warranty formed the basis of the bargain between Defendants and Dr. Cho. (FAC, ¶ 99.) By failing to plead facts identifying the specific affirmation or document that formed the basis of the bargain, Plaintiffs have failed to state a claim for breach of express warranty. Autzen, 280 Or. At 788. For these reasons, Defendants' motion to dismiss Plaintiffs' breach of warranty claim should be granted.
III. Mr. Johnson's Loss of Consortium Claim
Defendants also argue that Mr. Johnson's loss of consortium claim fails without any other surviving claims. Because Plaintiffs' claims One through Five should survive dismissal, however, Defendants' motion to dismiss Mr. Johnson's loss of consortium claim should be denied.
IV. Plaintiffs' Claim for Punitive Damages
Defendants argue, finally, that Plaintiffs' allegations and factual inference relating to proper FDA reporting cannot support a prayer for punitive damages. The Court disagrees. In Oregon, punitive damages may only be awarded when “clear and convincing evidence” shows that the defendant “acted with malice or has shown a reckless and outrageous indifference to a highly unreasonable risk of harm and has acted with a conscious indifference to the health, safety, and welfare of others.” Or. Rev. Stat. § 31.730. The imposition of punitive damages requires a “degree of culpability greater than inattention or simple negligence” and “the evidentiary standard governing a punitive-damages request under Oregon law is more rigorous than the standard governing the analysis of the underlying substantive claims.” Thompson ex. rel. Thorp Family Charitable Remainder Unitrust v. Federico, 324 F.Supp.2d 1152, 1170 (D. Or. 2004).
Here, Plaintiffs allege that Defendant Covidien submitted Medical Device Reports (“MRDs”) to the FDA's Alternative Summary Reporting (“ASR”) Program. By electing to submit to the ASR program instead of the MAUDE database, they effectively hid information regarding the risks of the EEA Stapler from public view. Defendants argue, citing Or. Rev. Stat. § 31.730, that the fact that Covidien was once in compliance with the FDA regulations - which have now been altered, following a public outcry, to eliminate the option to send MRDs to the ASR Program - precludes any claim for punitive damages. The Oregon statute that provides for an award of punitive damages, Or. Rev. Stat. § 31.730, nowhere states that formal compliance with a law or regulatory scheme can preclude a jury award of punitive damages. Defendants' compliance with the now-invalid FDA regulations therefore does not contradict Plaintiff's allegation that the choice to use the ASR instead of MAUDE was intentional, representing either malice or a reckless and outrageous indifference to a highly unreasonable risk of harm, with a conscious indifference to the health, safety, and welfare of others. See Or. Rev. Stat. § 31.730. Defendants' motion to dismiss Plaintiffs' prayer for punitive damages should be denied.
RECOMMENDATION
For the reasons stated above, Defendants' motion under Rule 12(b)(6) (ECF 50) should be GRANTED with respect to Plaintiff's Sixth claim for breach of express warranty. The motion should be DENIED with respect to all other claims. Plaintiffs' Sixth claim for breach of express warranty should be dismissed without prejudice and with leave to file an amended complaint within 30 days of the final order.
This recommendation is not an order that is immediately appealable to the Ninth Circuit Court of Appeals. Any notice of appeal pursuant to Rule 4(a)(1), Federal Rules of Appellate Procedure, should not be filed until entry of the district court's judgment or appealable order. The parties shall have fourteen (14) days from the date of service of a copy of this recommendation within which to file specific written objections with the court. Thereafter, the parties shall have fourteen (14) days within which to file a response to the objections. Failure to timely file objections to any factual determination of the Magistrate Judge will be considered as a waiver of a party's right to de novo consideration of the factual issues and will constitute a waiver of a party's right to appellate review of the findings of fact in an order or judgment entered pursuant to this recommendation.