A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For

By Kurt R. Karst –      

In what appears to be the first federal court decision on the so-called Reference Listed Drug (“RLD”) theory of liability, Judge Marvin H. Shoob of the U.S. District Court for the Northern District of Georgia (Atlanta Division) recently ruled in Moore v. Mylan, Inc., No. 11:1-cv-03037-MHS (N.D. Ga. Jan. 5, 2012), that a failure-to-warn claim against a generic drug manufacturer whose drug product has been designated by FDA as the RLD is preempted under the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011).  In Mensing, the Supreme Court ruled that generic drug manufacturers are not permitted to change their labeling except to mirror the label of the brand, RLD manufacturer whose drug product is approved under an NDA.

As we previously reported in what has been referred to by some FDA Law Blog readers as the “Betelgeuse Post,” the RLD theory posits that FDA’s regulations impose new or additional responsibilities on an ANDA sponsor whose drug product is unilaterally designated by FDA as an RLD, and that the Court’s Mensing decision is inapplicable under such circumstances.  Often, FDA designates an ANDA-approved drug product as an RLD once the brand-name RLD drug product (usually approved under an NDA) is discontinued and withdrawn from the market; however, the Moore decision shows us that the RLD theory of liability can arise in other circumstances.

DILANTIN KAPSEALS (extended phenytoin sodium) Capsules, 100 mg, is a brand-name anti-epileptic drug product marketed by Pfizer’s Parke-Davis unit that FDA approved on August 27, 1976 under ANDA No. 084349 (presumably as a generic version of a pre-1962 drug under the pre-Hatch-Waxman ANDA approval procedures, based on the 80,000 series application number).  On December 28, 1998, FDA approved Mylan’s ANDA No. 040298 for a generic version of DILANTIN KAPSEALS Capsules, 100 mg, pursuant to FDC Act § 505(j), which was added by the 1984 Hatch-Waxman Amendments.  After approving a suitability petition (Docket No. 2000P-1462), FDA approved, on December 6, 2001, two additional strengths under ANDA No. 040298 – 200 mg and 300 mg – stating that “[t]he new strengths of Extended Phenytoin Sodium Capsules USP, 200 mg and 300 mg, can be expected to have the same therapeutic effect as that of the listed drug product upon which the Agency relied as the basis of safety and effectiveness” – i.e., DILANTIN KAPSEALS Capsules, 100 mg.   The 200 mg and 300 mg drug products are listed in the Orange Book with the brand name PHENYTEK, and the 300 mg strength is designated as an RLD. 

In Moore, which was initially filed in the State Court of Fulton County and was removed to the U.S. District Court for the Northern District of Georgia (Atlanta Division) based on federal diversity jurisdiction, the Plaintiffs alleged, among other things, that the decedent, George L. Frazier, ingested Mylan’s 100 mg phenytoin drug product and that he suffered certain adverse reactions that were caused by the drug product.  According to the Plaintiffs, both Pfizer and Mylan had a duty to warn the decedent, his physician, and the public of the health risks associated with their drug products, among myriad other claims in the Complaint. 

Of particular interest to us is Plaintiffs’ assertion that “FDA’s designation of Mylan’s 300-mg phenytoin as an RLD gave Mylan the authority to use the [Changes Being Effected (‘CBE’)] process to change its 300-mg phenytoin label,” and that as such, the court should employ the impossibility preemption analysis utilized in the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009).  Under Plaintiffs’ theory, wrote Judge Shoob:

Mylan would have had two avenues for changing the label on the generic 100-mg phenytoin: (1) after Mylan changed the 300-mg label, Mylan would have been required to change the generic 100-mg phenytoin label to match the label of the 300mg label because the generic l00-mg must match the RLD; or (2) because Mylan was an RLD holder of 300-mg phenytoin, Mylan had the same rights as a brand name drug manufacturer, and therefore, could have used the CBE process to change the 100-mg phenytoin label.

Mylan, in its Motion to Dismiss – response and reply briefs available here and here – argued that Plaintiff’s case against Mylan is preempted by Mensing, regardless of product-liability claim.

Judge Shoob found several problems with Plaintiffs’ arguments, including that:

[P]laintiff assumes without authority that because Mylan’s 300-mg phenytoin was designated as the RLD, Mylan is “considered as having the same rights and obligations as a ‘brand-name’ manufacturer of phenytoin,” including the right to use the CBE process to change labels.  However, plaintiff has not shown how Mylan acquired all of the same rights as a brand name drug manufacturer simply by manufacturing one drug that was an RLD.  Plaintiff has not shown that Mylan’s manufacture of one RLD converted Mylan into brand name drug manufacturer with the right to use the CBE process to change the label of any of its drugs or how listing 300-mg as an RLD converted the generic 300-mg phenytoin into a brand name drug. [(Internal citations omitted)]

Accordingly, Judge Shoob found that: (1) “FDA’s designation of Mylan’s 300-mg phenytoin as an RLD would not have permitted Mylan to use the CBE process to change the label of 100-mg phenytoin to conform to state law;” (2) “Plaintiff has not shown any other federal statute or regulation that would have allowed Mylan to change the 100-mg phenytoin label;” and (3) “Mylan, as the generic drug manufacturer of 100-mg phenytoin, was prevented from independently changing the 100-mg label to conform with state law.”  As such, any failure-to-warn claim is preempted by Mensing, wrote the court in dismissing Plaintiffs’ claim against Mylan and granting Mylan’s Motion to Dismiss. 

The Moore decision is the first federal court decision we are aware of in which a court has ruled on ANDA RLD theories of liability.  In November 2011, Judge Douglas H. Hurd of the Superior Court of New Jersey recognized in an Oral Ruling in Sincoskie v. West-Ward Pharms., No. MER-L-2643-10 (N.J. Super. Ct. Law Div. Nov. 4, 2011), that regardless of whether FDA unilaterally has designated a manufacturer’s ANDA drug product as the RLD, “[t]he bottom line is that they are an ANDA manufacturer and that’s the whole distinction here.” 

Thanks to Matt Wendler of Pietragallo Gordon Alfano Bosick & Raspanti, LLP for alerting us to the Moore decision.