Gross is another Trident hip case – litigation that, but for Riegel, may well have grown up to be a mature mass tort. But after preemption, there isn’t very much there there any longer (assuming there ever was). Indeed, our medical device preemption scorecard is rife with decisions holding that all, or virtually all, claims involving this product are preempted. See Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011); Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011); Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011); Desabio v. Howmedica Osteonics Corp., ___ F. Supp.2d ___, 2011 WL 4074391 (W.D.N.Y. Sept. 13, 2011); Wilhite v. Howmedica Osteonics Corp., 2011 WL 2530984 (N.D. Ohio June 20, 2011); White v. Stryker Corp., ___ F. Supp.2d ___, 2011 WL 1131496 (W.D. Ky. Mar. 25, 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. 2010); Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. 2010); Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. 2010); Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010); Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858 (D. Mont. Apr. 23, 2010); Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio Mar. 31, 2010); Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. Mar. 23, 2010); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009); Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. Mar. 5, 2009); Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. 2008).
Thus, some parts of the Gross decision only repeat what has been decided before. We’ll simply note those parts of the opinion and move on: (1) a recall is not a revocation of approval for preemption purposes, 2012 WL 876719, at *2 n.13; (2) TwIqbal applies to actions removed from state court (see our prior post here), id. at *4 n.9; (3) Pennsylvania’s across-the-board application of Restatement §401A, comment k to bar strict liability applies to medical devices as well as drugs, id. at *7-9; (4) lots of different kinds of FDA documents are subject to judicial notice on a Rule 12 motion to dismiss, id. at *9 & n.26 (see our prior post here); (5) all components of a PMA-approved device are protected by Riegel preemption, including those with earlier §510k clearance, id. at *13-15; (6) just as Pennsylvania does not recognize strict liability, it does not recognize implied warranty in prescription medical product cases (see our prior post here), id. at *17 n.34; (7) to plead causation, a warning letter and/or a recall must cover the plaintiff’s particular device, id. at 23; (8) the ultra-liberal Hofts opinion is not a proper statement of TwIqbal pleading standards (see our prior post here), id. at *25; and (9) pleading an express warranty claim requires stating what the warranty is and how it became part of basis of the bargain. Id. at *27.
Gross also comes down on the side of those courts ruling that general GMP regulations are too vague to support parallel violation claims. 2012 WL 876719, at *20-22. The main reason given by prior courts for rejecting vague GMP claims is that they’re not “genuinely equivalent” because their vagueness allows plaintiffs to interpret them differently from the FDA and thus to impose obligations that the FDA itself does not impose. While Gross does not disagree, and indeed embraces this vagueness argument, id. at *21, the court also offers another rationale – that reliance upon generalized GMP regulations applicable to all devices is incompatible with the preemption rationale in Riegel, which bases preemption on “device specific” requirements imposed through PMA approval:
Under the premarket approval process, the FDA imposes federal “requirements” that are “specific to individual devices.” Allowing a plaintiff to plead nonspecific regulations as a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel, as well as the pleading requirements articulated in Twombly, Iqbal, and Fowler [a Third Circuit TwIqbal case]. This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.
Gross, 2012 WL 876719, at *22 (all quotes to Riegel) (emphasis added). Riegel requires device-specific PMA requirements to establish preemption, and thus also requires a violation of device-specific PMA requirements to avoid preemption through the parallel violation loophole:
[P]ursuant to the premarket approval process, medical device manufacturers must adhere to device-specific requirements. As such, violations of same, and not merely any requirement, properly serve as the basis of a parallel claim. . . . In the instant case, the CGMPs cited by Plaintiff . . . are not only general; they apply to all Class III PMA medical devices. Furthermore, because these regulations do not address the manufacturing of the specific device at issue . . ., they cannot establish the requisite standard of care that a particular manufacturer must meet. The regulations delegate the maintenance of device-specific quality control to the manufacturer. Yet, Plaintiff does not plead that [defendant] violated its own policies regarding product safety. Plaintiff, instead, alleges that [defendant] violated very broad CGMPs that are not device-specific to the [device at issue]. As a result, Plaintiff does not plead sufficient facts to support a claim that [defendant] did not comply with these CGMPs.
Id. at *22-23 (citation and quotation marks omitted) (emphasis original). In short, since the device-specific PMA process is what created preemption in Riegel, only a device-specific violation claim can avoid preemption.
Because we haven’t seen a court articulate this rationale in this way before, we thought we’d point it out. Since Riegel hinges preemption on device specific requirements, which the GMPs are not, and because TwIqbal does not allow discovery based upon inadequate pleadings, Gross thus disagreed with the Fifth Circuit bootstrap approach in Bass v. Stryker Corp., ___ F.3d ___, 2012 WL 266985 (5th Cir. Jan. 31, 2012), insofar as the Fifth Circuit let plaintiff slide on pleading GMP violations because later discovery would provide the necessary specificity. 2012 WL 876719, at *22.
The court in Gross also engages in a more detailed analysis of res ipsa loquitur than we’re accustomed to seeing in preemption (or TwIqbal) opinions. Essentially, if the FDA’s GMPs are too vague to support a parallel claim – well res ipsa loquitur is even vaguer:
[T]his Court declines to infer the existence of such negligence in accordance with the doctrine of res ipsa loquitur under Pennsylvania law. Finding res ipsa loquitur here would require the Court to rely on even fewer facts than Plaintiff pled in support of his negligence claim.
Gross, 2012 WL 876719, at *24. In addition, nothing in the complaint ruled out the alternative cause of physician error, particularly since infection (the plaintiff’s claimed injury) was specifically warned of as both an adverse reaction and a contraindication. Id. at *24-25. So remember Gross for another proposition – TwIqbal requires a plaintiff pleading res ipsa loquitur to plead it plausibly by including some factual basis for excluding alternative causes.
A third particularly interesting aspect of Gross, from our standpoint at least, comes in its discussion of the FDA’s recall of some of these devices for “impermissible, excessive manufacturing residuals.” The plaintiff, however, admitted in the complaint that “he has not yet determined whether the residues on the hip prosthesis were” what the FDA had recalled. Gross, 2012 WL 876719, at *2. The court was none too pleased with this failure:
An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations. Plaintiff underwent the [surgery in question] in October 2008. Almost two years later . . ., Plaintiff's counsel [brought suit]. During this approximately two-year time period, Plaintiff's attorney had a duty to investigate whether the residues on Plaintiff's initial hip prosthesis were foreign bodies or native material from the manufacturing process.
Id. at *2 n.11 (citing, inter alia, Rule 11). Rule 11 “imposes on counsel a duty to look before leaping and may be seen as a litigation version of the familiar railroad crossing admonition to ‘stop, look, and listen’.” Id. at *5 (citation and quotation marks omitted).
For similar reasons, the court in Gross rejected plaintiff’s plea for discovery prior to dismissal. In TwIqbal, the Supreme Court had specifically stated that discovery was available only after the plaintiff pleaded a plausible claim. In order to plead a claim, a plaintiff may engage in self-help and nothing more:
To obtain additional information from the FDA to aid in drafting his Complaint, Plaintiff could have submitted a Freedom of Information Act (“FOIA”) request. . . . Plaintiff also had an opportunity to conduct pre-complaint discovery when he commenced this action in [state court]. . . . Finally, the Court finds Plaintiff's request for discovery to be inapposite to Rule 8 and Rule 11(b) of the Federal Rules of Civil Procedure. Rule 8 . . . does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions. A plaintiff who fails to meet the pleading requirements of Rule 8 is not entitled to conduct discovery with the hope that it might permit her to state a claim. In addition, Rule 11(b) requires a pleading to be a representation of “the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances.” An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations. Allowing Plaintiff to “file first and investigate later” contradicts the reasonable inquiry requirement in Rule 11(b).
Id. at 29 (citations and quotation marks, except to Rule 11, omitted).
The court’s several references to Rule 11 echo our own feelings. It’s time for courts to crack down on knee-jerk filings in PMA preemption cases (and everywhere else, for that matter, but that’s a different gripe). Even the barest of investigations would have revealed the preemption issues involving this product. As our earlier list demonstrates, preemption has been on the front burner literally for years. In this situation, it’s not enough “reasonable inquiry” to plead “I dunno but I’ll find out later.” Preemption is a manifestation of congressional intent that certain types of actions should not be brought, and more courts, like Gross, should be willing to uphold that intent, rather than assist evasive plaintiffs.
Needless to say, Gross now enjoys a position of honor on both our device preemption scorecard and our TwIqbal cheat sheet.
Because it found that plaintiff had not come close to pleading an unpreempted claim, and indeed had not properly pleaded most of his preempted claims, the court in Gross dismissed all of the claims with prejudice and without leave to amend. That means there is an appealable order. We’ll keep watching Gross to see what the Third Circuit does with it.