Opinion
13 Civ. 0079 (BMC)
07-12-2013
LOUIS BERTINI, DEBRA BERTINI Plaintiffs, v. SMITH & NEPHEW, INC., Defendants.
MEMORANDUM DECISION AND ORDER COGAN, District Judge.
Plaintiffs bring this action alleging that they suffered damages following the use of defendant's R3 acetabular hip liner ("R3 liner"). Defendant has filed a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6). For the reasons set forth below, the motion is granted and plaintiffs are granted leave to file an amended complaint within 14 days of the date of this decision.
BACKGROUND
The following allegations are taken from plaintiffs' amended complaint. For the purposes of deciding a 12(b)(6) motion, these factual allegations are assumed to be true. Plaintiff Louis Bertini underwent hip replacement surgery on October 26, 2009. During this procedure, plaintiff was implanted with an R3 liner which was designed and manufactured by defendant. Following the procedure, plaintiff began experiencing physical problems, including, "pain in his left hip, limited mobility, locking of his left hip, instability in his gait, suffering, and other mechanical symptoms." Plaintiff's doctor determined that the R3 liner failed due to "loosening" and on January 10, 2011, plaintiff underwent revision surgery, during which the R3 liner was replaced.
In July 2010, the U.S. Food and Drug Administration ("FDA") investigated defendant's plant and found that the R3 liners produced there were "adulterated within the meaning of Section 501(h) of the [Food, Drug, and Cosmetic] Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation, [we]re not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820."
Plaintiffs further allege that following the FDA investigation, defendant acknowledged performance problems with its R3 liners "including inter alia, loosening, fracture, and metal sensitivity." Defendant subsequently issued mandatory recalls in October 2010, April 2011, and June 2012 of its various R3 liners based on these performance problems."
Plaintiffs allege that the R3 liner implanted in Mr. Bertini was defective in design or manufacture because of its increased risk of loosening. Further, they allege that defendant failed to adequately warn the FDA and medical community of these risks and that they improperly represented that the device was safe for patients undergoing hip replacement procedures. Finally, they allege that defendant was negligent in failing to conduct adequate testing to discover these performance issues.
Plaintiffs allege that as a result of defendant's misconduct, Mr. Bertini has suffered and will continue to suffer severe injuries, economic loss, medical expenses, lost income, pain and suffering, and other damages, and that, as a result of her husband's injuries, plaintiff Debra Bertini has suffered damages including emotional distress, medical expenses and loss of consortium.
STANDARD OF REVIEW
To survive a Rule 12(b)(6) motion, a plaintiff must provide "enough facts to state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S. Ct. 1955 (2007). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937 (2009). "The plausibility standard is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are 'merely consistent with' a defendant's liability, it 'stops short of the line between possibility and plausibility of 'entitlement to relief.'" Id. (quoting Twombly, 550 U.S. 544, 556-557, 127 S. Ct. 1955)).
According to the Supreme Court's "two-pronged" approach for judging the sufficiency of pleadings described in Iqbal, the court should first identify those allegations that are legal conclusions and as such are not entitled to an assumption of truth; second, the court should determine if there are sufficient factual allegations, accepted as true, to "plausibly give rise to an entitlement to relief." Id. at 679, 129 S. Ct. 1937.
DISCUSSION
I. Strict Liability Claims
Defendant argues that plaintiffs' allegations are not sufficient to make out a strict liability claim because they are largely conclusory and do not show how the product was defectively designed or manufactured or how any warnings were inadequate. Plaintiffs contend that they should not be required to identify a particular defect at the pleading stage and that by alleging that plaintiff experienced performance issues with defendant's R3 liner, they have pled sufficient facts to plausibly show that the liner is defective.
Defendant is correct that plaintiffs' strict liability claims are largely conclusory and amount to a recitation of the elements of each claim. For example, plaintiffs allege that "the R3 liner was 'defective' . . . because it was dangerous to an extent beyond that which would be contemplated by the ordinary consumer;" "[t]he R3 liner . . . was defective in manufacture . . . in that, when it left the hands of [d]efendant, it deviated in a material way from [d]efendant's manufacturing performance standards;" and "defendant failed to adequately warn health care professionals . . . of the true risks of the R3 liner." These are all legal conclusions and therefore are not entitled to any assumption of truth.
Aside from these conclusory statements, plaintiffs' only other factual allegations in support of their claims is that defendant's R3 liner "loosened;" that the FDA found the R3 liner to be "adulterated," and that defendant recalled the R3 liner due to problems with loosening, among other issues. These allegations are not sufficient to plausibly show that the device was defectively designed or manufactured or that defendant's warnings were inadequate.
A design defect claim is subject to dismissal where plaintiff fails to plead facts identifying how the device is defectively designed or the existence of a feasible alternative design. See Reed v. Pfizer, Inc., 839 F.Supp.2d 571 (E.D.N.Y. 2012). Similarly, "a manufacturing defect claim is properly dismissed if a plaintiff has not alleged that the [device in his case] had a defect as compared to other samples of that [device]." Id. at 577. Additionally, "a failure to warn cause of action is appropriately dismissed if a plaintiff does not plead facts indicating how the provided warnings were inadequate." Id. at 575.
In Goldin v. Smith & Nephew, No. 12 Civ. 9217, 2013 WL 1759575 (S.D.N.Y. Apr. 14, 2013), the Southern District of New York dismissed as inadequately pled a strict liability claim involving the same defendant and product, as well as essentially the same allegations, as this case. Plaintiff in that case was implanted with defendant's R3 liner during hip replacement surgery in 2009. In 2010, plaintiff's physician discovered that the liner had dislodged and performed revision surgery. Plaintiff further alleged that later that same month, defendant issued a voluntary recall of the R3 liner due to "the risk of intra-operative and post-operative dislocation." The court found plaintiffs' allegations insufficient to state a design or manufacturing defect claim, noting that merely showing that the liner did not perform as intended or that the product was later recalled for the same performance issues does not by itself "identify any particular problem in the design of the product or identify an alternative design" or show that the liner "was defective as compared to other products manufactured pursuant to the same design." Id. at *2- 4.
Similarly, in Reed,, Judge Vitaliano held that plaintiff failed to state a failure to warn claim where she alleged that defendant did not adequately warn of the risks of a known side effect of its drug but failed to identify any specific warnings that were purportedly inadequate. In so holding, the Court concluded that, "the fact (taken here as true) that [plaintiff] suffered from certain conditions that were also identified risks of [defendant's drug] is tragic, but cannot alone make plausible a claim that defendants misrepresented or hid those risks in some way." 839 F.Supp.2d at 575.
As was the case in Goldin and Reed, plaintiffs plead no facts related to any specific warnings or how these warnings were inadequate. Additionally, they fail to show how the vague allegation that defendant's plant was "adulterated" is in any way connected to a design or manufacturing defect. Plaintiffs essentially pled only that the device is defective because it loosened but, as the courts noted in Goldin and Reed, the mere fact that the device did not perform as intended is not by itself indicative of a flaw in the manufacturing or design processes. Similarly, merely alleging that the device was recalled due to this performance issue does not suffice to plausibly show that the device itself was defective. Without further alleging facts as to whether it was feasible to design the R3 liner in a safer manner, or how the R3 liner deviated from its intended design, the fact that the R3 liner loosened and was recalled for the same issue is "'merely consistent with' [defendant's] liability" and "'stops short of the line between possibility and plausibility of 'entitlement to relief.'" Iqbal, 556 U.S. at 678, 129 S. Ct. 1937 (quoting Twombly, 550 U.S. at 556-557, 127 S. Ct. 1955).
Pplaintiffs fail to adequately connect the FDA investigation and recall to the particular liner used in their case. Plaintiffs allege that "Louis Bertini was one of the patients who had been implanted with a defective R3 liner," but provide no facts to support this, nor do they address the fact that, as they allege, the investigation and recall took place after plaintiff's initial surgery. Further, plaintiffs fail to identify which of the three alleged recalls and which of the several alleged performance issues applied to the R3 liner used in their case. --------
Plaintiffs fail to plead any facts to plausibly suggest that it was feasible to design the R3 liner used in their case in a safer manner. It is not enough for plaintiffs to allege that defendant's device poses risks that are "unreasonably greater than other similar products" and that defendant sold other versions of the R3 liner that were less dangerous than the one used in plaintiff's surgery. Not only are these allegations merely conclusory, but they fail to provide any facts as to specific products that have a safer design or whether it would have been feasible for defendant to design this particular R3 in a safer manner. In other words, simply alleging that there were "safer" R3 liners in defendant's possession does not mean that the R3 that was implanted in plaintiff could have been designed in a safer manner. There is no way to tell whether other R3 liners would have even been appropriate for implantation in plaintiff.
Plaintiffs also fail to provide facts as to how the R3 liner implanted in Mr. Bertini deviated from its intended design. They contend that by alleging that the device in their case was adulterated due to loosening, while other devices were adulterated due to metal sensitivity or other factors, they have provided sufficient facts to show that the device in their case deviates from others of the same design. However, bsimply alleging that the device deviates from other products whose design is also allegedly defective does not plausibly show that a device deviates from its intended design.
Plaintiffs contend that defendant seeks to hold them to a higher pleading standard than is set out in Twombly and Iqbal by requiring them to identify a particular defect at the pleading stage. They find support in a line of cases that have held design and manufacturing defect claims adequately pled where plaintiffs do not point to a particular defect. In particular, in Bausch v. Stryker Corp., 630 F.3d 546, 559 (7th Cir. 2010), the Seventh Circuit held that a design defect claim was sufficiently pled where plaintiff alleged that defendant's medical device was defective because the FDA found it was "adulterated" due to "dimensional anomalies," without further specifying a particular design defect. In so holding, the court concluded that failure to specify a design defect should not be fatal because an injured plaintiff may not be in a position before discovery to determine whether his or her injury was caused by a defect in the design or manufacturing stages.
Plaintiffs' reliance on this case is not compelling. First, plaintiff's complaint in Bausch was more sufficiently pled than in this case. Although the plaintiff in Bausch failed to specify a precise defect, his allegation that the device contained "dimensional anomalies" is suggestive of a defective design. Conversely, plaintiffs in this case plead only that the device is defective because it did not perform properly, without even suggesting a design flaw. Second, as defendant points out, other courts have rejected Bausch as contrary to Twombly and Iqbal. See Ali v. Allergan USA, Inc., No. 12 Civ. 115, 2012 WL 3692396, at *14 (E.D. Va. Aug. 23, 2012) ("This is precisely the sort of fishing expedition the Supreme Court sought to avoid . . . [in deciding Twombly and Iqbal.]"). As Judge Vitaliano noted in Reed,_, if a plaintiff could proceed by merely alleging that he suffered harm as a result of using defendant's product, then "anyone experiencing harm after using a product where the harm is a warned-of risk could successfully plead a claim." 839 F.Supp.2d at 575.
II. Breach of implied and express warranty and Negligence claims
Because they failed to plausibly show that the R3 liner is defective, plaintiffs have also failed to plead a necessary element of their implied warranty claim. See Lewis v. Abbot Laboratories, No. 08 Civ. 7480, 2009 WL 2231701, at *6 (S.D.N.Y. July 24, 2009) (dismissing implied warranty claim because plaintiff failed to show that product is defective). Additionally, plaintiffs fail to provide any facts demonstrating that the R3 liner was not fit for its ordinary purposes; they merely conclude that "[t]he R3 liner was not reasonably fit for the ordinary purposes for which such goods are used."
Likewise, plaintiffs' express warranty and negligence claims offer only conclusory allegations devoid of any factual support. Plaintiffs' only allegation as to the nature of defendant's express warranty is that "[d]efendant represented that the R3 liner was safe and effective . . . for use by individuals such as [p]laintiff . . . and/or that it was safe and effective to treat [plaintiff's] condition." However, plaintiffs fail to provide any facts as to what specific representation defendants made or how such a representation was breached. Without such support, plaintiffs do not plausibly show that defendants breached an express warranty in this case, and the claim must be dismissed. See Reed, 839 F.Supp.2d, at 578 (dismissing express warranty claim where plaintiffs alleged that defendant represented that their drug was "safe and suitable for use by women as a daily oral contraceptive medication . . .," finding that these allegations were "unsupported conclusions.").
Similarly, plaintiffs list ten different ways in which defendants allegedly breached their duty of reasonable care, such as the following: "fail[ing] to conduct adequate post marketing surveillance," "failing to make timely and adequate corrections to the manufacture, design and formulation of R3 liner so as to prevent and/or minimize the problems suffered by R3 liner use," and "despite its knowledge [the product's risks], . . . continu[ing] to promote and market the R3 liner." These are boilerplate allegations from some form book. Plaintiffs fail to support them with any specific facts. The negligence claim too must therefore be dismissed. See In re Pamidronate Products Liability Litigation, 842 F.Supp.2d 479, 484-485 (E.D.N.Y. Jan. 30 2012) (dismissing negligence claim where plaintiff alleged that defendants "failed to exercise reasonable care in testing, manufacturing, labeling, marketing, distributing and selling" their drug, because these were merely conclusory allegations with no factual support).
Plaintiffs' loss of consortium claim is derivative of their other claims and thus must also be dismissed.
III. Leave to amend
Plaintiffs have requested leave to amend should defendant's motion to dismiss be granted. Courts "should freely give leave when justice so requires." Fed. R. Civ. P 15 (a)(2). "Leave to amend, though liberally granted, may properly be denied for: undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc." Ruotolo v. City of N.Y., 514 F.3d 184, 191 (2d Cir. 2008) (citation and internal quotation marks omitted). Amendment is futile where the problem with the claim is substantive and thus it cannot be cured by better pleading. See Cuoco v. Moritsugu, 222 F.3d 99 (2d Cir. 2000).
Although plaintiffs have already had one chance to amend their complaint, this is not a case where further amendment would clearly be futile. See Reed, 839 F.Supp.2d, at 580 (granting leave to amend for a second time where "what has been previewed in the amended complaint suggests that . . . plaintiffs may yet be able to plausibly re-plead at least some of their claims."). The deficiencies in Reed were similar to the ones in this case - plaintiffs in both cases pled only injury and side effects associated with the product in their case without pointing to a particular defect. If plaintiffs are able to refine their allegations regarding the performance issue and recall in a way that plausibly suggests that the device deviated from its intended design or that it was feasible to design the device in a safer manner, plaintiffs may be able to cure at least some of the many deficiencies in their complaint.
CONCLUSION
For the foregoing reasons, defendant's motion to dismiss is granted. Plaintiffs are granted leave to file an amended complaint within 14 days of the date of this Order.
SO ORDERED.
Digitally signed by Brian M. Cogan
U.S.D.J. Dated: Brooklyn, New York
July 12, 2013