Thursday, February 11, 2010

Containing Conte

The aberrant Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), decision had its first birthday a couple of months ago – not that we’re celebrating, or anything.


It would be more accurate to say that we’re doing everything we can do to strangle Conte in its crib. If you’re new around here and don't know what we mean, you can click on “Conte” in the Topics list on the right hand side of your screen and you’ll get a complete list of our efforts.

Fortunately, it seems to be working. At age one, Conte is an only child. It has no siblings. By that we mean that no court anywhere has followed Conte. At worst we could say that it’s spawned one rather ugly cousin.

That cousin comes from, you guessed it, California. We blogged about that case, Dorsett v. Sandoz, Inc., 2009 WL 3633874 (C.D.Cal. Oct 28, 2009), here.  Even Dorsett isn’t 100% compatible with Conte. Remember how in the original Conte decision the court had the nerve to claim that imposing liability upon a name brand manufacturer for a purported “defect” in a generic drug’s labeling wasn’t a novel thing? We sure do. Conte stated:

Our decision today is rooted in common sense and California common law. We are not marking out new territory by recognizing that a defendant that authors and disseminates information about a product manufactured and sold by another may be liable for negligent misrepresentation.
Conte, 85 Cal. Rptr.3d at 311.  If one of our clients said something that contrafactual, it would get sued for violating California consumer fraud laws.

We’ve called that statement “hogwash.” We were being polite. When Conte first came down we also characterized it as “the very definition of ‘unprecedented.’”

So – what did the only court in the last year not to dismiss Conte out of hand have to say about Conte’s “no new territory” assertion? The Dorsett court didn’t believe a word of it. Instead, that court held that Conte’s liability theory was so completely novel and unprecedented that it related back to stop the statute of limitations from running under California’s liberal “John Doe” pleading policy:

Plaintiff was unaware that the law permitted her a cause of action against [the brand-name defendant] until the California Court of Appeal’s decision in Conte. . . . Prior to Conte, every single court to address the issue of brand-name-manufacturer liability for conduct leading to or arising out of the generic version of a drug had concluded that the brand-name manufacturer was not liable. The Conte court was the first to allow brand-name manufacturer liability for a generic drug. Because Plaintiff was unaware prior to Conte that a cause of action existed against [the brand-name defendant], the substitution of [it] relates back to the filing of the original complaint.
Dorsett, 2009 WL 3633874, at *2.

We think that the result in Dorsett is crazy. We don’t think that the sheer unprecedented nature of a liability theory should be a basis to give statute-barred plaintiffs a new lease on life. Granted, Conte adopted a screwball pro-plaintiff theory of liability. Isn’t that enough? There’s something wrong with the law when the utter screwballiness (we just made up the word) of a novel theory is enough to confer upon plaintiffs not only a new theory, but also more time to pursue it than is available to plaintiffs who followed traditional law.

But it’s California – what’s that old joke about loose nuts rolling to the coast?

Outside, of California, however, we’re pleased to report that there has been no movement towards Conte. However, that’s probably an unintended favorable consequence of another really lousy decision,. The big picture changed with Wyeth v. Levine, 129 S. Ct. 1187 (2009), throwing a wet blanket over preemption in prescription drug cases. A lot of the incentive for courts to distort the law à la Conte came from the way that preemption was impacting upon cases involving generic drugs.

Preemption was a subtext in Conte itself. While the judges who dreamed up that case’s bizarre “misrepresentation” theory were able to dodge the preemption issue, the trial judge in Conte had also dismissed the plaintiff’s claims against the generic manufacturer on preemption grounds. See Conte v. Wyeth, Inc., 2006 WL 3939262 (Cal. Super. Sept. 26, 2006), aff’d in part and rev’d in part, 85 Cal.Rptr.3d 299 (Cal. App. 2008). And Conte wasn’t the only case. Check out our pre-Levine drug preemption scorecard. There were quite a few cases that bought generic preemption – that the FDCA (Hatch-Waxman division) mandated that generic labels be the “same” as brand name labels, so the common law couldn’t simultaneously demand that generic labels be different.

The prospect of widespread generic drug preemption created pressure to find another deep pocket for plaintiffs who took generic drugs to sue. The only deep pocket left was the brand name manufacturer. Conte was the weak link where the judiciary failed under the pressure.

Levine, however, seems to have put the kibosh on generic drug preemption arguments, even though it was not itself a generic drug case. Since Levine, most courts have held that there is no preemption in generic drug cases. See Demahy v. Actavis, Inc., ___ F.3d ___, 2010 WL 46513 (5th Cir. Jan. 8, 2010); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009); Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. 2009); Munroe v. Barr Laboratories, Inc., 2009 WL 4047949 (N.D. Fla. Oct. 15, 2009). So the stopcock’s been opened and the pressure has receded. Most courts, even those with a judicial activist bent, aren’t particularly inclined to seize upon bizarre and unprecedented liability theories when they don’t have to. With plaintiffs once again able to sue the actual manufacturers of generic drugs, Conte becomes a fifth wheel – and a square and clunky one at that.

Thus, the impact of Conte has been marginal outside of California because other judges throughout the country have been singularly unimpressed with its reasoning on the brand name liability question. Take Mensing, for example. To date, that’s the only appellate decision to consider Conte. Mensing gave Conte a dismissive brush off – even though both cases involved the same drug (Metoclopramide/Reglan) – holding that “[w]hatever the merits of Conte under California law,” it was contrary to the law of Minnesota, which required there to be a “duty of care.” 588 F.3d at 613. Conte’s pure foreseeability analysis did not impress the Mensing court:

[Plaintiff] focuses on the foreseeability of harm from the defendants’ action. . . . [W]e conclude that holding name brand manufacturers liable for harm caused by generic manufacturers stretches the concept of foreseeability too far. As for [plaintiff’s] negligent misrepresentation claim, the Minnesota Supreme Court has recognized negligent misrepresentation involving damages only for pecuniary loss.” We find it unlikely the Minnesota Supreme Court would extend the doctrine to misrepresentation involving the risk of physical harm in these circumstances.
588 F.3d at 613-14 (citations and quotation marks omitted).

Other courts considering Conte have been less diplomatic. Just the other day the court in Levine v. Wyeth, Inc., No. 8:09-cv-854-T-33AEP, order at 2 (M.D. Fla. Feb. 10, 2010) - no, not that Levine v. Wyeth - the court adopted a magistrate’s report recommending summary judgment for a brand name manufacturer named in a generic case. The magistrate blanched at the plaintiff’s Conte argument under Florida law:

The holding in Conte is not binding on this Court, and runs counter to the overwhelming majority of case law, including that of Florida. The Court cannot impose a duty of care on Defendants here where the generic manufacturers are responsible for the contents of their label, and where the Defendants lacked direct control as to the contents of that label.
Levine v. Wyeth, Inc., No. 8:09-cv-854-T-33AEP, magistrate’s report, at 7-8 (Mag. M.D. Fla. Jan. 13, 2010). Again, the same drug – different result. If you’re keeping score, Levine also rejected (in addition to Conte-style misrepresentation), claims for negligence (including negligence per se), strict liability, implied warranty, liability as a “component part” manufacturer, and fraud.

Thanks to Ed Gerecke and Dave Walz at Carlton Fields for sending along the Levine opinion – it was extremely timely.

The magistrate in Levine was positively restrained compared to Moretti v. Wyeth, Inc., 2009 WL 749532 (D. Nev. March 20, 2009).  Even though Nevada often looks to next-door California precedent in deciding product liability questions, Conte was caustically rejected:

Court rejects Plaintiff’s argument that this Court should create a duty in light of a recent California intermediate appellate decision. The Conte decision, including its foreseeability analysis, is contrary to well-established Nevada law. Moreover, with the exception of Conte, every other court that has considered this issue has rejected Plaintiff's arguments. Those courts have correctly held that brand name manufacturers do not have a legal duty to warn about the risks associated with their competitors' generic drugs. Simply put, Conte stands alone and is contrary to Nevada law and public policy.
Moretti, 2009 WL 749532, at *4 (citations and footnote omitted). Once again, Moretti involved the same drug as Conte.

The hits keep coming. In Burke v. Wyeth, Inc., another case involving Metoclopramide/Reglan (don't they all?), the court dismissed Conte as “anomalous” and declined to follow it. 2009 WL 3698480, at *3 (S.D. Tex. Oct. 29, 2009). Still another court correctly observed that Conte was “the only decision in several like actions that has allowed the plaintiff to proceed,” and disregarded that decision. Meade v. Parsley, 2009 WL 3806716, at *3 (S.D.W. Va. Nov. 13, 2009) . A Florida trial court also criticized Conte:

Plaintiffs rely upon a lone case from a California intermediate appellate court, as the only decision supporting their position. In fact, Conte is the lone outlier against the overwhelming weight of authority on this point. As of the date of the summary-judgment hearing here, thirty-four decisions had applied the laws of twenty different states to hold that name brand manufacturers are not liable for injuries caused by generic products. . . . No case before or after Conte has agreed with its reasoning. Of the cases after Conte to address this issue, all ten courts. . .have refused to follow Conte.
Dietrich v. Wyeth, Inc., 2009 WL 4924722 (Fla. Cir. Dec. 21, 2009).

Thus, even though California precedent has historically had considerable impact upon the development of product liability law, Conte seems to be an exception. No court outside California has shown the slightest inclination to follow Conte down the slippery slope to liability for other people’s products. With Levine - yes, that one - seeming to have removed the impetus for Conte-style disregard for traditional tort boundaries, we’re hoping that Conte goes the way of “enterprise liability” and other bad ideas whose time has passed.

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