Law

This is a quick-hit post as we head into the Independence Day holiday weekend.  The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015), dismissed claims against the seller of an innovator drug for precisely the right reason:  The defendant neither made nor sold the generic drug that the plaintiff ingested.  That is to say, there is no Conte-style “innovator liability” in West Virginia. 

It seems obvious, doesn’t it?  It has been seven years since the California Court of Appeal issued its wrongly reasoned and wrongly decided opinion in Conte v. Wyeth, where the court held that a plaintiff who used a generic drug could sue the manufacturer of the listed version.  As we like to say, the court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  The late Roger Traynor and his colleagues on the California Supreme Court, who presaged strict product liability way back in 1944 in Escola v. Coca-Cola Bottling Co., must have rolled in their graves. 

The Conte opinion has predictably become an outlier, and courts have rejected the opinion and its reasoning many times over, often expressly.  (Check out our Innovator Liability Scorecard here and our survey of innovator liability here.)  As we reported here, the Alabama legislature abolished innovator liability just a few months ago, and we believe the California Supreme Court overruled Conte in Crane v. O’Neill, 53 Cal. 4th 335 (2011), where it held that a manufacturer has no duty to warn of hazards in another manufacturer’s product due to “foreseeability.” 

So what about McNair?  The plaintiff took a generic antibiotic and sued the manufacturer of the listed version when she experienced acute respiratory distress.  First, how do we know she took a generic product?  The pharmacy records displayed the product’s National Drug Code, which is a unique number that identifies the manufacturer of a drug and other drug information.  McNair, 2015 WL 3935787, at *2.  National Drug Codes are ubiquitous, but we barely notice them.  Take a look at any drug product – cold medicine, contact lens solution, toothpaste – and you will almost always see a long number somewhere on the packaging.  That’s the NDC, and you can determine the manufacturer of the product by referring to the FDA’s web-based NDC Directory.  We have done that multiple times, but this is the first time we have seen a court cite the NDC database in an opinion. 

Second, if the plaintiff had pharmacy records showing that she used a generic product, why did she sue the innovator manufacturer?  She started by contesting whether the records actually revealed the product’s manufacturer, a credibility-blowing position if we ever saw one.  Maybe counsel should have checked the NDC Directory before investing in this lawsuit.  In any event, after Mensing and Bartlett, federal law preempts state-law claims against generic drug manufacturers for failure to warn and design defect.  McNair, 2015 WL 3935787, at **2-4.  So the plaintiff sued the innovator instead, asserting blithely that “‘[e]ven if [the defendants are] correct that plaintiff ingested a generic, that does not and should not relieve [them] of liability’ as a matter of law.”  Id. at *3. 

Actually, it does relieve them of liability and should relieve them of liability, which the district court readily found:

Id. at *5 (emphasis added).  That is about as direct a holding as you can get.  The district court went on to explain that the Fourth Circuit had long ago rejected the contention “that a name brand manufacturer’s statements c[ould] serve as the basis for liability for injuries caused by another manufacturer’s drug.”  Id. (citing Foster v. American Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994).  The court further noted that “every federal circuit court to consider the issue – both before and after the Supreme Court rendered its holdings in Mensing and Bartlett – has reached a similar conclusion, applying the law of several states.”  Id.  The string cite following this statement is impressive, owing we are sure to thorough briefing by the defendants, and we commend it to any of our readers who are researching innovator liability.  The district court therefore correctly declined to extend West Virginia law. 

So enjoy the holiday weekend.  Have a picnic with friends and family, watch fireworks (from a distance), go to a baseball game or watch one on TV, take a long walk, read that article in the New Yorker you have been meaning to get to, catch up on work that has been nagging at you, or do nothing at all.  By the time the weekend is over, we will have added McNair to our Innovator Liability Scorecard.  [Note from Bexis: The case has already been added to the list.]