In football the referees will occasionally change bad calls. Maybe it takes a videotape with unambiguous ocular evidence, but errors can get fixed. By contrast, it’s beastly hard to get judges to change their minds. We recall one instance so clearly because it stands out in our experience. When we were clerking on the U.S. Court of Appeals one of our jobs was to review petitions for reconsideration. They seldom detained us very long. The petitions merely rehashed losing arguments and supplied no real reason to revisit the court’s ruling. But one time one of the judges took an interest, convened a conference call of all three judges plus their clerks, and announced that “we’ve blown it.” The court ended up changing its mind. That judge, by the way, is now on the U.S. Supreme Court, and it is more than a little comforting to know that at least one of the Justices is so devoid of ego and dogma and is truly open-minded and conscientious.
That sort of thing is agonizingly rare.
We’ve been keeping a Mensing scorecard, watching what lower courts have done with generic plaintiffs’ efforts to circumvent preemption. One of the early cases we covered was Fisher v. Pelstring, C.A. No. 4:09-cv-00252-TLW (D.S.C. Sept. 30, 2011). The district court declined to dismiss the complaint, holding Mensing preemption inapplicable because the plaintiff argued that the generic defendant did not timely incorporate in its metoclopramide label certain FDA-approved warnings that were added to the brand label. We blogged about Fisher here. Subsequently, the plaintiff filed an amended complaint. Defendant, PLIVA USA, then filed a motion to dismiss the First Amended Complaint and, in the alternative, requested the court to reconsider its September 30, 2011 order. Dear reader, we have some involvement in metoclopramide litigation, so we must confine ourselves to reporting what happened. We will do so with clenched teeth and pounded keyboard. A copy of the Fisher court’s new order can be found here.
First, the good news. The court did change its mind on one point and dismissed the claim for manufacturing defect. In its earlier ruling refusing to dismiss that cause of action, the court had “reasoned that the evidence of record supported a finding there was an issue of fact as to whether an error in the manufacturing process caused the 2003 or 2004 changes to the Reglan labeling to not be included on PLIVA’s metoclopramide labels.” Slip op. at 13. That was then and this is now. In its new motion, PLIVA observed that “the plaintiffs’ allegations in the First Amended Complaint focus on the product, not the product labeling. For their manufacturing defect cause of action, the plaintiffs allege that ‘defects in the products were caused by the way the products were manufactured.’” Id. (emphasis in original). That point seems unanswerable. And, indeed, the plaintiffs did not respond to it. Additionally, “the plaintiffs provided no evidence showing that the metoclopramide Mr. Fisher ingested deviated in some way from its design specifications or that it was rendered unsafe by an error in the manufacturing process.” Id. at 14. It is not clear why that was not perfectly obvious back in September. Oh well — better late than never.
On all the remaining arguments, the Fisher court stood pat. The defendant argued that the claims for breach of implied warranties were preempted by Mensing. Not so, said the court:
After careful consideration, the Court finds that the plaintiffs’ claims for breach of the implied warranty of merchantability remains viable after Mensing. Unlike an express warranty, the implied warranty of merchantability is not created by labeling content but rather is implied in a
sales contract, unless excluded or modified, where the seller is a merchant of goods of the kind sold. See S.C. Code Ann. Section 36-2-313; id. 36-2-314. Without relying on PLIVA’s labeling content, the plaintiffs could plausibly
demonstrate that long-term use is an ordinary purpose for which metoclopramide is used or that the metoclopramide PLIVA manufactured is objectionable in the trade under the contract description.
Slip op. at 5. Did you notice the word “careful”? You’ll see it again. And again.
The defendant also sought dismissal of the negligence claims. The court refused on the ground that PLIVA did not incorporate “into its generic metoclopramide labeling certain FDA-approved warnings added to the brand-name labeling for Reglan in 2003 and July 2004.” Slip op. at 6. Those warnings pertained to geriatric patients being “at greater risk for tardive dyskinesia” and that “Therapy should not exceed 12 weeks in duration.” Id. at 6-7. The defendant contended that the negligence cause of action was ineluctably based “on statements in PLIVA’s labeling regarding the risk of developing extrapyramidal symptoms and therefore this claim is preempted.” Id. But the court did “not view the plaintiffs’ pleadings so narrowly” because the First Amended Complaint included allegations that PLIVA “encouraged the long term use of these drugs,” that PLIVA failed to investigate the accuracy of its metoclopramide label,” that PLIVA “concealed the fact that long-term treatment was unsafe, and that “PLIVA breached its “duty to exercise the care of an expert in all aspects of the formulation, manufacture, compounding, testing, inspection, packaging, labeling, distribution, marketing, and sale of Reglan/metoclopramide to insure the safety of its drug and to insure that the consuming public…obtained accurate information and instructions for the safe use or non-use of this drug.” Id. (emphasis in original).
PLIVA asserted that even if the plaintiffs included an allegation that PLIVA failed to conform its generic metoclopramide labeling to the brand-name labeling, the claim would still be preempted because “the FDCA provides that only the federal government may bring an action to enforce the FDCA’s provisions.” Id. at 7. But the court concluded “after careful consideration of the authority cited by PLIVA, a sufficient basis has not been presented for this Court to conclude that a negligence action in which the standard of care is defined by statute is the equivalent of private enforcement of the FDCA.” Id. at 8. PLIVA also argued “that a state law claim must be premised on a duty that would exist in the absence of the FDCA, meaning the plaintiffs must show a state common law duty existed for a generic drug manufacturer to ensure its labeling always conformed to that of the brand-name drug.” Id. at 9. The court was unimpressed, because “PLIVA provides no authority in support of this assertion, and assuming PLIVA’s argument is accurate, this Court does not conclude that the duty which must exist in the absence of the FDCA should be defined as narrowly as PLIVA asserts.” Id.
Our teeth are still clenched and now the keyboard has been pounded to smithereens.
In its September 30, 2011 Order, the court had concluded “that PLIVA may have had avenues available to communicate with physicians about the 2003 and 2004 label changes without seeking FDA approval first.” Id. at 9-10. It seems that it would be hard to square that holding with the Mensing Court’s acceptance of the FDA’s interpretation that generic drug manufacturers may not use “Dear Doctor” letters to send additional warnings to prescribing physicians because such letters are labeling and “must be ‘consistent with and not contrary to [the drug’s] approved…labeling.’” Mensing, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 201.100(d)(1)). Here’s how to do it, according to the Fisher court: “If PLIVA had made alterations to its labeling consistent with the 2003 and 2004 changes to the Reglan labeling, a letter alerting physicians to these changes would arguably not be inconsistent with the drug’s approved labeling. This Court finds that the plaintiffs, in their First Amended Complaint, sufficiently plead a theory of recovery based on an argument PLIVA should have done more when the 2003 and 2004 labeling changes occurred, such as issue a “Dear Doctor” letter. “ Id. at 10. Got that?
The fraud claim also lives to vex another day: “After reviewing the First Amended Complaint in its entirety and particularly paragraph 188, the Court concluded that the plaintiffs sufficiently plead a claim for fraud by concealment based on PLIVA’s alleged non-inclusion of the 2003 and 2004 warnings. Therefore, after careful consideration of this argument and PLIVA’s other arguments in support of dismissing this claim, including its citation to Jimenez v. Daimler Chrysler Corp. 269 F.3d 439 (4th Cir. 2001), PLIVA’s motion to dismiss the plaintiffs’ fraud by concealment claim is DENIED.” Id. at 10.
The court also rejected PLIVA’s arguments that the causes of action for violation of the South Carolina Unfair Trade Practices Act and for intentional infliction of emotional distress claim are preempted under Mensing. Again, failure timely to include the new warnings seems key. According to the court, “That therapy should not exceed twelve weeks is part of the risk the plaintiffs may have wished to measure in deciding whether to continue taking metoclopramide.” Id. at 12. Note the word “plaintiffs.” Note the word “may.”
PLIVA also challenged the claim for punitive damages. After quoting the usual standard of “willful, wanton, or in reckless disregard of the plaintiff’s rights,” the court supplied this helpful analysis: “After careful review of the first Amended Complaint, the Court finds the plaintiffs plead sufficient facts to support an award of punitive damages.” Id. at 14. Okay, then. Similarly, the court rejected a statute of limitation defense “[a]fter careful consideration,” and after listening politely to the defendant’s argument that the plaintiff’s filing was untimely, the court “after a careful re-examination of the evidence cited by the parties and the applicable law … declines to alter its previous ruling.” Id. at 17.
The defendant wheeled out what appears to be a pretty strong warning causation argument. Did the plaintiff meet its burden of showing that the allegedly deficient warning made any difference? The defendant cited case law, which the court distinguished because the “possible alternative warnings in this case – the 2003 and 2004 warnings added to the brand-name Reglan label – are not nearly as ‘apocalyptic’” as in the case cited by PLIVA. Id. at 20. The court also held that “Dr. Pelstring’s knowledge of the risks for which the plaintiffs allege proper warnings were not given does not demonstrate as clear an understanding of those risk as the record” in the cited case. Id. “For example, testimony has not been cited showing Dr. Pelstring knew in 2004 that therapy with metoclopramide should not exceed twelve weeks.” Id. The court’s opinion does not disclose the evidence showing that Dr. Pelstring would have acted any differently had he been warned about the twelve weeks limitation. But the court keeps telling us how “careful” it was, so perhaps that evidence is in there somewhere.