FDA Flexing its Muscle with Compounding Pharmacies

By Christopher D. Barraza
Published on May 7, 2013

Last week, my colleague wrote about proposed legislation in the Senate that would increase FDA oversight of compounding pharmacies.  As the bill works its way through the legislative process, we thought it might be helpful to talk more about how FDA has been conducting oversight of compounding pharmacies within the existing regulatory framework.  The short answer is that in the wake of New England Compounding Company meningitis outbreak last fall, FDA has brought a record number of enforcement actions.

Consider this statistic: FDA has pursued more enforcement actions in the first four months of 2013 than in the previous five years combined.  Thus far this year, FDA has issued almost four dozen inspectional observations, which are often referred to as “Form 483s”  or “483s,” compared with approximately two dozen 483s and warning letters from 2008 through 2012.   FDA is authorized to perform inspections of compounding pharmacies under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) and uses 483s to document and communicate concerns discovered during these inspections.  Although Form 483s are not a final agency determination, they are often a precursor to regulatory action, which can include a formal warning letter, withholding of product approval, or plant shut down.  And 483s yield results: FDA’s stepped up oversight has lead to six voluntary recalls by compounders so far in 2013. 

There are questions about how long FDA can sustain its recent enforcement action pace, since focusing on compound pharmacies requires FDA to shift resources from other areas.  What is clear, though, is that regardless of pace, FDA is now very much engaged on the issue of regulatory oversight of compounding pharmacies and will continue to pay particular attention to this issue.  Whether that will result in more litigation remains to be seen but FDA tighter regulation often brings more private lawsuits in its wake.  We will continue to monitor developments in this area.

Posted in Legislation, News, Pharmaceutical Law

EPA Report on Greenhouse Gas Emissions May Become Part Of Ongoing Fracking “Debate”

By Jed Winer
Published on May 2, 2013

Here at Weil’s Product Liability Monitor, we keep a close eye on developments relating to hydraulic fracturing — more commonly known as “fracking.”  In a nutshell, “fracking” is a well stimulation technique that employs high-pressure fluids to break up gas trapped in shale rock formations.  My colleague, Sylvia Simson, is a frequent contributor on the subject.  For a recent analysis Ms. Simson wrote along with Arvin Maskin on the subject of fracking in New York State, please click here.

Now comes news from the EPA that one of the controversies relating to fracking — air pollution from the release of the “greenhouse gas” methane during natural gas production – may be of less concern than originally estimated.

Continue reading »

Posted in Legislation, Risk Management Policy, Uncategorized

Iowa Court of Appeals: The Supreme Court Painted Preemption With A Broad Brush

By Emily Pincow
Published on May 1, 2013

Last week, the Iowa Court of Appeals affirmed the dismissal of claims against both a branded and generic drug manufacturer, relying on the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which held that federal regulations pre-empt state law failure-to-warn claims against generic drug manufacturers. 

In Huck v. Trimark Physicians Group (Iowa App. April 24, 2013), Plaintiff was prescribed Reglan (a drug designed to speed the movement of food through the digestive system).  At the time she was prescribed the drug, it contained a warning about possible side effects, including developing tardive dyskinesia or irreversible movement disorder.  In 2004, five months after Huck began taking the drug, the FDA approved additional warning language indicating that “[t]herapy should not exceed 12 weeks in duration.”  Huck, however, ingested the generic form of the drug, manufactured by PLIVA, who did not provide the updated label.

Huck was later diagnosed with tardive dyskinesia and filed suit against Wyeth, Inc. and Schwarz Pharma, Inc. (“Brand Defendants”) and PLIVA.  The district court granted the Brand Defendants’ motion for summary judgment since they did not manufacture the drug ingested by Huck.  PLIVA also moved for summary judgment on the basis of the Supreme Court’s ruling in Mensing, which was granted on the basis that all of Huck’s claims were pre-empted by federal law.  Huck then filed a “motion for relief” from the judgment dismissing the Brand Defendants, but the district court denied the motion.  Huck appealed both the district court’s dismissal against PLIVA and denial of Huck’s motion for relief. 

In holding that all of the state tort claims against PLIVA were pre-empted, the Court of Appeals found that “[t]he plaintiffs in Mensing were in much the same situation as Huck” and thus, the Supreme Court’s decision was “indistinguishable.”  Similar to the plaintiffs in Mensing, Huck took the generic drug for a long period of time and developed tardive dyskinesia.  Quoting from the Supreme Court’s decision, the Court of Appeals explained that federal law required generic drug labels be the same as the brand-name and therefore, it was impossible for manufacturers to comply both with their state-law duty to change the label and their federal law duty to keep the label the same. 

In an attempt to circumvent Mensing, Huck argued that PLIVA was liable because it failed to update its label to conform to the additional warning in 2004.  The Court, however, rejected this contention explaining that the requirement that a generic drug label be the same as the “reference listed drug” label arises from federal law, which explicitly prohibits a private cause of action.

The Court of Appeals acknowleged in a footnote a recent decision by the Sixth Circuit reversing a dismissal of a state law claim premised on the adequacy of PLIVA’s warnings (Fulgenzi v. PLIVA, __F. 3d. ­­ 2013 WL 949096), but noted that both the 8th Circuit and 5th Circuit dismissed state law claims relying on Mensing.  Notably, the Court stated that “the United States Supreme Court painted preemption with a broad brush in Mensing…”

In affirming the denial of Huck’s motion for relief against the Brand Manufacturers, the Court held that under Iowa law, a plaintiff must prove that the injury-causing product was manufactured or supplied by defendant, which was not the case here.  Moreover, the Court held that Mensing did not change state-law principles that required dismissal of a claim brought against a non-manufacturer. 

We will continue to monitor cases applying the Supreme Court’s decision in Mensing that continue to limit liability for drug manufacturers.       

 

 

Posted in Pharmaceutical Law, Preemption

Senate Draft Bill Proposes FDA Authority Over Certain Types of Compounding Pharmacies

By Meghan A. McCaffrey
Published on April 29, 2013

Proposed legislation this past Friday from the Senate Health Committee would provide the FDA with greater authority over certain compounding pharmacies, helping clarify the legal landscape around the FDA’s authority over the industry (as we posited may happen here and here).  The proposal comes in response to vocal criticism from members of Congress that the agency failed to act aggressively enough in its oversight of compounding in the wake of the meningitis outbreak last fall that killed more than 50 people and sickened more than 700.  The outbreak, linked to tainted steroids distributed by the New England Compounding Center, led to calls from FDA Commissioner Hamburg for legislation to clarify the agency’s role.  See our coverage of this issue as it developed here, here and here.    Continue reading »

Posted in Legislation

Dukes Commonality Requirements Taken Seriously in D.C. Circuit

By Melody Akhavan
Published on April 24, 2013

It has been almost two years since the Supreme Court decided Wal-Mart v. Dukes and heightened commonality requirements for class certification under Rule 23(a).  As the D.C. Circuit stated in its recent decision in D.L. et al. v. District of Columbia, Nos. 11-7153, 12-7042, 2013 WL 1489471 (D.C. Cir. April 12, 2013), ”Wal-Mart‘s interpretation of Rule 23(a)(2) has changed the landscape” for class certification, and this fact has been acknowledged by several Circuit courts, namely the 5th, 6th, 7th, 8th, and 10th Circuits.  The D.C. Circuit can now be included in this list.

In D.L., the D.C. Circuit was asked to reconsider the Rule 23(b)(2) certification of a class of District of Columbia children with disabilities.  The class members alleged that the District’s policies and practices had resulted in systemic failures to identify, locate, evaluate, and offer special education and related services, in violation of the Individuals with Disabilities Education Act (IDEA).

The district court initially certified the plaintiff class in 2006, prior to the Dukes decision, finding that the Rule 23(a) commonality requirement was met because “plaintiffs…have a common injury, namely the denial of a [free appropriate public education] under the IDEA.”  The district court further found that the plaintiffs had “pointed to practices which, if proven, constitute a pervasive pattern of failing to identify, locate, evaluate and [offer services]” to the children entitled to assistance pursuant to IDEA.  Subsequently, the District moved to decertify the class, but before the district court made any further rulings, the Supreme Court decided Dukes in June 2011.

In light of Dukes, the District supplemented its motion to decertify the class, arguing, in part, that the plaintiffs’ claims were too broad to establish commonality under Rule 23(a) under Dukes.  In response, the plaintiffs proposed to amend class certification to include four subclasses, and further sought a hybrid certification under Rule 23(b)(2) and 23(b)(3).  The district court denied the motion to decertify, finding that the plaintiffs had “amply demonstrated there are questions of law and fact common to the class,” all members of which “suffered the same injury: denial of their statutory right to a free appropriate public education.”  Importantly, the district court found that the “systemic failures” within the District’s education system were the “glue” binding together the various reasons why individual class members were denied appropriate educational opportunities.

As is now familiar, under the Dukes requirement of “rigorous” class-certification analysis, district courts must ensure that before certifying a class under 23(a)(2), the class members are not merely alleging that they “have all suffered a violation of the same provision of law.”  Moreover, “[w]hat matters to class certification … is not the raising of common ‘questions,’ … but, rather the capacity of a classwide proceeding to generate common answers apt to drive the resolution of the litigation.”  Additionally, as the D.C. Circuit noted, the Supreme Court’s recent decisions in Amgen and Comcast also inform the class certification analysis: “merits questions may be considered to the extent—but only to the extent—that they are relevant to determining whether the Rule 23 prerequisites for class certification are satisfied.”

Applying these guidelines, the D.C. Circuit vacated the order certifying the class and remanded the case to the district court for reconsideration of whether a class, classes, or subclasses may be certified.  The court held: “After Wal-Mart it is clear that defining the class by reference to the District’s pattern of failing to provide [free appropriate public education] speaks too broadly because it constitutes only an allegation that the class members ‘have all suffered a violation of the same provision of law,’ which the Supreme Court has now instructed is insufficient to establish commonality given that the same provision of law ‘can be violated in many different ways.’”  The court suggested that the identification of a single or uniform policy or practice that would bridge all claims could justify certification.

Importantly, the court did not “rule out the possibility of classes or subclasses that are designed around a policy or practice that links the class as a whole; neither would it rule out separate classes in a consolidated case.”  The court also noted that although Rule 23(b)(2) “applies only when a single injunction or declaratory judgment would provide relief to each member of the class,” courts are not barred from granting further equitable relief that “does not reach every plaintiff in the case.”

It will be interesting to see whether the district court certifies the revised classes or subclasses on remand.  In any event, the D.C. Circuit is yet another Circuit court that takes the Dukes commonality requirements seriously.

Posted in Class Action Law Suits