Rowe v. Mentor Worldwide, LLC

297 F.Supp.3d 1288

Colleen ROWE, Plaintiff,

v.MENTOR WORLDWIDE, LLC and Does 1–100, Defendants.

Case No: 8:17–cv–2438–T–30CPT

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

Signed March 2, 2018

John W. Adams, Jr., Adams Law Association, P. A., Valrico, FL, for Plaintiff.

Caycee Hampton, David J. Walz, Carlton Fields Jorden Burt, PA, Tampa, FL, for Defendants.

ORDER

JAMES S. MOODY, JR., UNITED STATES DISTRICT JUDGE

In 2015, Plaintiff Colleen Rowe had breast augmentation surgery using Defendant Mentor Worldwide, LLC's MemoryGel Silicone Gel Breast Implants ("MemoryGel Implants"). The left MemoryGel Implant failed, and was replaced seven months later. Now Rowe is suing Mentor for negligence, strict liability, and breach of implied warranty. The Court concludes all but one of the claims must be dismissed because they are preempted or are otherwise unavailable to Rowe.

BACKGROUND

Mentor designs, manufactures, tests, and distributes MemoryGel Implants for use in breast augmentation surgeries. (Doc. 1, ¶ 55). The MemoryGel Implants are a Class III device under the Medical Device Amendments ("MDA") to the Federal Food, Drug and Cosmetic Act ("FDCA"), and require premarket approval ("PMA") from the Food & Drug Administration ("FDA"). (Doc. 1, ¶¶ 6–7, 10). Mentor filed a PMA application for the MemoryGel Implants in December 2003. (Doc. 1, ¶ 56). The FDA provided the PMA in November 2006, allowing Mentor to market the MemoryGel Implants. (Doc. 1, ¶ 57). A condition of the PMA required Mentor to conduct six post-approval studies regarding the long-term safety and effectiveness of the MemoryGel Implants. (Doc. 1, ¶¶ 58–87).

Plaintiff Rowe had breast augmentation surgery on April 2, 2015, and was implanted with MemoryGel Implants. (Doc. 1, ¶ 125). Nearly seven months later, Rowe began experiencing pain and limited functionality in her left arm. (Doc. 1, ¶ 127). Rowe also experienced "extreme and chronic fatigue, anxiety, depression, muscle pain, muscle weakness, muscle cramps, nausea, bone pain, swelling [in] her joints, stiffness in her joints, irritability, shortness of breath, signs of silicone toxicity, and weight gain." (Doc. 1, ¶ 127). On November 6, 2015, Rowe underwent a second surgery that revealed the left MemoryGel Implant had ruptured. (Doc. 1, ¶ 129). Her surgeon removed the ruptured MemoryGel Implant and replaced it. (Doc. 1, ¶ 129).

Despite replacement of the ruptured MemoryGel Implant, Rowe continued to experience "pain, discomfort, swelling and soreness to her left side at the surgical site...." (Doc. 1, ¶ 131). Rowe also continued to experience "extreme and chronic fatigue, anxiety, depression, joint pain, joint stiffness, irritability, weight gain, shortness of breath, muscle cramps, muscle weakness, nausea and other ailments." (Doc. 1, ¶ 132).

In December 2015, Rowe's surgeon recommended a third surgery conditioned on Rowe signing a release and hold harmless agreement in favor of Defendant Mentor. (Doc. 1, ¶ 133). Rowe has not yet undergone that surgery, but says she intends to have her MemoryGel Implants removed. (Doc. 1, ¶ 139).

Now Rowe is suing Mentor for negligence, strict liability, and breach of implied warranty. (Doc. 1). Rowe alleges generally that Mentor failed to properly conduct the post-approval studies, and failed to warn consumers and physicians about known risks associated with the MemoryGel Implants. Rowe also alleges that her MemoryGel Implant was somehow defective. Finally, Rowe alleges that the MemoryGel Implant was not of merchantable quality, nor reasonably fit for its intended purposes.

MOTION TO DISMISS STANDARD

Federal Rule of Civil Procedure 12(b)(6) allows a complaint to be dismissed for failure to state a claim on which relief can be granted. When reviewing a motion to dismiss, courts must limit their consideration to the well-pleaded allegations, documents central to or referred to in the complaint, and matters judicially noticed. See La Grasta v. First Union Securities, Inc. , 358 F.3d 840, 845 (11th Cir. 2004) (internal citations omitted); Day v. Taylor , 400 F.3d 1272, 1276 (11th Cir. 2005). Furthermore, they must accept all factual allegations contained in the complaint as true, and view the facts in a light most favorable to the plaintiff. See Erickson v. Pardus , 551 U.S. 89, 93–94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007).

Legal conclusions, though, "are not entitled to the assumption of truth." Ashcroft v. Iqbal , 556 U.S. 662, 664, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). In fact, "conclusory allegations, unwarranted factual deductions or legal conclusions masquerading as facts will not prevent dismissal." Davila v. Delta Air Lines, Inc. , 326 F.3d 1183, 1185 (11th Cir. 2003). To survive a motion to dismiss, a complaint must instead contain sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (internal quotation marks and citations omitted). This plausibility standard is met when the plaintiff pleads enough factual content to allow the court "to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. (internal citations omitted).

DISCUSSION

Mentor seeks dismissal of the Complaint on multiple grounds, but primarily based on Rowe's claims being expressly and impliedly preempted. (Doc. 11). The Court agrees, except as to Rowe's negligent manufacturing defect claim. So all of Rowe's claims will be dismissed except that one.

But first the Court will address a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings. Federal Rule of Civil Procedure 8 requires claims and defenses to be pleaded in "short and plain" statements. Fed. R. Civ. P. 8(a)(2), (b)(1)(A). Pleading allegations also "must be simple, concise, and direct." Fed. R. Civ. P. 8(d)(1). As the Eighth Circuit explained 50 years ago, "The clear purpose of the rule is to give notice to the other party and not to formulate issues or fully summarize the facts involved." Clausen & Sons, Inc. v. Theo. Hamm Brewing Co. , 395 F.2d 388, 390 (8th Cir. 1968).

Courts are also directed to construe pleadings "so as to do justice." Fed. R. Civ. P. 8(e). To that effect, the liberal federal pleading standard "reject[s] the approach that pleading is a game of skill in which one misstep by counsel may be decisive to the outcome and accept[s] the principle that the purpose of pleading is to facilitate a proper decision on the merits." Beem v. Ferguson , 713 Fed.Appx. 974, 979 (11th Cir. 2018). So a pleading generally is sufficient if it gives notice of the claims or defense and the grounds upon which they rest. Lombard's, Inc. v. Prince Mfg., Inc., 753 F.2d 974, 975 (11th Cir. 1985).

There is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material. In other words, it lacks "simple, concise, and direct" allegations that provide "short and plain" statements of the claims. This happens when, to borrow from a familiar analogy, attorneys throw every allegation they can think of into a pleading to see what sticks.

Inevitably, opposing counsel then moves to dismiss. The parties ask the courts to carefully comb through the pleading, determining whether the facts alleged are sufficient to support a claim and whether all of the necessary elements have been pleaded. In doing so, parties skirt their Rule 8 pleading requirements and rely on the Court's obligation to construe the pleading so as to do justice. But this flips Rule 8 on its head and is not required even under the most liberal view of the federal notice-pleading standard.

Rowe's Complaint is such a pleading. The four-count Complaint is a sprawling 60 pages, with an additional 151 pages of exhibits. Count I, for negligence, begins at paragraph 143 on page 41. None of the preceding allegations are incorporated into this count (or any other), indicating that the first 40 pages of the Complaint was unnecessary.

To compound these issues, Rowe's actual claims are far from "short and plain" statements contemplated by Rule 8. The negligence count itself is eight pages long and, as far as the Court can determine, includes six separate negligence theories that are confusingly interwoven among each other. Rowe alleges causation and damages for some of the theories, but not others. She also repeats the same allegations within and among the various theories, making it unclear to which theory certain allegations pertain.

These problems continue into the other counts as well. For instance, in count II for strict liability for failure to warn, paragraphs 198 and 208 are nearly identical.¹ And while Rowe separated her strict liability claims for failure to warn (count II) and manufacturing defect (count III), both counts contain allegations only relevant to the other claim.

Having painstakingly reviewed the Complaint, the Court can say without doubt that Rowe threw every allegation into the Complaint to see what would stick. And to borrow another saying, the Court is tempted to throw the baby—in this case, one potentially viable claim—out with the bath water. But to do so would not do justice.

So the Court will instead parse through the Complaint and explain why all but one of Rowe's claims fail. But this Order shall serve as notice that this Court will no longer accept pleadings that deviate so drastically from the requirements of Rule 8, and will instead either dismiss the pleading upon proper motion or order a repleader.

A. Law Governing Preemption under the MDA

Rather than re-invent the wheel, the Court relies on the Eleventh Circuit's recent primer on federal preemption law under the MDA:

The Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360c et seq. , give the FDA regulatory authority over medical devices. [ Mink v. Smith & Nephew, Inc. , 860

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