IOM Releases Controversial 510K Device Report

Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Process.  The report offers a variety of recommendations and suggested reforms for FDA’s 510(k)  premarket notification pathway, describing the device clearance process as badly flawed.

Readers of MassTortDefense know how the regulatory clearance process has impacted preemption of state law product liability claims, and the significant medical device litigation we have covered here.

The recommendations will likely spark a heated debate within the larger struggles over the need for future medical device regulations. But even before that step, a variety of observers, including the Washington Legal Foundation, have asserted that the FDA is statutorily barred from adopting any of the report’s recommendations.  The charge has been made that the Institute of Medicine failed to adequately balance the panel, in violation of §15 of the Federal Advisory Committee Act. Section 15(a) provides that an agency may not use any advice or recommendation developed by the committee unless it has complied with a requirement that the committee membership be “fairly balanced.”  Using advice from a committee that lacks fair balance would encroach upon the Congressional mandate that each Advisory Committee should be representative of a broad
range of viewpoints. 

FDA had commissioned the IOM to conduct an analysis of the § 510(k) system in 2009.  The IOM
Committee was composed of twelve members:  five doctors, three lawyers, and four academics. Specifically missing were innovators or any product developers familiar with the clearance process, and any representatives of patients or patient advocacy groups that have benefited from the development of medical devices under the current system.
 

 

Yaz Court in NJ Issues Bellwether Trial CMO

The court overseeing the coordinated litigation in New Jersey state court over the birth control pills Yaz, Yasmin, and Ocella recently issued a case management order.  See CMO No. 25 - Bellwether Trial Selection Plan.

Here at MassTortDefense we are always interested in the nuts and bolts of how mass tort litigation is managed, and have posted about bellwether trials before. The NJ court order calls for creation of a pool of 18 cases from which the first trials will come. Nine will be selected by plaintiffs and nine by defendant. Of the nine on each side, 3 must allege each of the three main alleged injuries in this litigation.

Case specific discovery for the cases in the pool will begin in August, 2011, and must be completed in November, 2011. The order establishes a schedule for expert discovery and challenges to experts.

The bellwether trials will be selected from the group of 18.  If the parties cannot agree on a sequence, the Court will decide. The first trial is set for September, 2012.

There are about 1,000 cases pending in the New Jersey proceedings. The Court stated it had not yet decided whether there will be individual trials or consolidations. See In re Yaz, Yasmin, and Ocella Litigation, N.J. Super. Ct., No. 287 (7/8/11). 
 

Dukes Applied to Reconsideration of Class Certification

A state court recently denied the motion of a group of Michigan residents to certify a class action regarding their dioxin claims against Dow Chemical Co. See Henry v. Dow Chemical Co., No. 03-47775-NZ (Saginaw County, Mich., Cir. Ct.,  7/18/11).

Here at MassTortDefense we typically focus on appellate decisions, but we thought it interesting that this court relied heavily on the Supreme Court's decision in Dukes v. Wal-Mart  to re-analyze the prerequisites for class certification under state law.

Plaintiffs live in an area along the Tittabawassee River near Dow's plant in Midland, and allege their properties were contaminated by dioxin from the plant.

The trial court originally certified a class, and on appeal the Michigan Supreme Court vacated the decision and remanded the issue in 2009, calling for the trial court to clarify its evaluative framework, particularly for the general prerequisites of typicality, adequacy, and commonality.

On remand, the court concluded that Dukes has “far-reaching implications for certification of class action lawsuits, including the present case.”  Accordingly the court “must reanalyze whether the commonality prerequisite to class certification was satisfied in this case."


Relying on the Supreme Court analysis in Dukes, the court changed its mind and denied certification based on a failure by plaintiffs to establish the commonality element, because of the absence of a “glue” to hold all of the plaintiffs’ claims together. The only common issue, said the court, was whether the defendant negligently released the chemical, so whether and how each class member was injured involved a highly individualized inquiry regarding issues such as the level and type of contamination allegedly on the specific properties, the different remediation needs of the properties, and the varying stages of ongoing remediation.

Similarly, even under the nuisance claim, it was clear that individual plaintiffs used and enjoyed their properties in different ways. “Whether plaintiffs have suffered an interference with or loss of use and enjoyment of their property requires an individualized factual inquiry into each plaintiff’s use and enjoyment of their property.”

The court rejected plaintiffs' argument that the allegation of "one defendant" with a supposedly singular act of pollution in "one discrete geographic area" distinguished this case from the Supreme Court's commonality concerns in the discrimination context. 

In light of the commonality failing, the court did not reach the reconsideration of the other factors, such as typicality and adequacy.

 


 

Class Certification Denied in BPA MDL

The federal judge in the MDL involving BPA in baby bottles refused last week to certify
three proposed  multistate classes in this multidistrict litigation. In re: Bisphenol-A Polycarbonate Plastic Products Liability Litigation, No. 08-1967 (W. D. Mo. July 7, 2011).

On August 13, 2008, the Judicial Panel on Multidistrict Litigation centralized the cases; there are approximately twenty-four cases left in this litigation.

The court’s discussion focused on three of the components required for certification: commonality, predominance, and superiority. The court said it focused on these issues because they presented "the most insurmountable obstacles to" plaintiffs’ request.

The analysis offered several interesting points:

1. Choice of law.  The court noted that many problems and immense difficulties arose from the vagaries of state law. The difficulties involved in comparing and contrasting all of the nuances of the laws of fifty-one jurisdictions is "undeniably complicated." Several courts have indicated the mere need to engage in such an analysis – and the exponential increase in the potential grounds for error – demonstrates a class action is inappropriate. E.g., Cole v. General Motors Corp., 484 F.3d 717, 724-26 (5th Cir. 2007); Klay v. Humana, Inc., 382 F.3d 1241, 1267-68 (11th Cir. 2004); Castano v. American Tobacco Co., 84 F.3d 734, 751-52 (5th Cir. 1996); In re American Medical Systems, Inc., 75 F.3d 1069, 1085 (6th Cir. 1996); In re Sch. Asbestos Litig., 789 F.2d 996, 1010 (3d Cir. 1986).

Here, the court offered a sampling of the legal disputes that the court was unable to resolve without delving into a legal inquiry more extensive than had been provided by the parties in order to ascertain (or predict) the holdings of the highest courts in these jurisdictions on legal issues. While defendants cannot thwart certification simply by tossing out imagined or slight variances in state laws, it is the plaintiffs' burden to demonstrate the common issues of law. Here, the plaintiffs could not show that the legal groupings they proposed actually satisfy Rule 23(a)(2)’s commonality requirement. And they present significant manageability concerns.

Significantly, the court noted that even if the plaintiffs had correctly grouped similar states’ laws, the application of those laws can turn out to be different even if they appear similar on the surface.  For example, plaintiffs have never alleged that the FDA banned BPA or argued that any government agency has definitively concluded that BPA in baby products is unsafe. Rather, the underlying theory of plaintiffs’ case is that, during the class period, there existed a serious scientific debate or controversy regarding the safety of BPA and that all defendants were aware of this  controversy;  defendants failed to advise them that the product contained BPA, a substance that the FDA approved for use but that was the subject of ongoing scientific discussion or controversy.  But, would every state regard this fact as material and something defendants were obligated to warn about?

2. Common issues of fact? The court relied on the recent Dukes v. Wal-Mart decision to note that commonality requires the plaintiff to demonstrate that the class members have suffered the same injury. This does not mean merely that they have all suffered a violation of the same provision of law. Their claims must depend upon a common contention that is capable of class-wide resolution – which means that determination of its truth or falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.  Even before Dukes, many courts held that commonality required an issue (1) linking the class members (2) that was substantially related to the litigation’s resolution. DeBoer v. Mellon Mortg. Co., 64 F.3d 1171, 1174 (8th Cir. 1995), cert. denied, 517 U.S. 1156 (1996); Paxton v. Union Nat’l Bank, 688 F.2d 552, 561 (8th Cir. 1982), cert. denied, 460 U.S. 1083 (1983).

While there were some common issues, other facts plaintiffs described as “common” clearly were not. For instance, “Plaintiffs’ testimony regarding the purchase of their Baby Products” was not common for all class members. One plaintiff’s actions, decisions, knowledge, and thought
processes are unique to that plaintiff. While this question must be answered for each plaintiff, the question will not be proved with the same evidence or have the same answer for each plaintiff. Even the simple question “Did each Plaintiff purchase a product manufactured by Defendant?” is not a common question because it is not capable of class-wide resolution as required by Dukes.

3. Individual issues.  Numerous individual issues predominated, including damages. Individual issues relating to damages do not automatically bar certification, but they also are not completely ignored. E.g., In re St. Jude Medical, Inc., 522 F.3d 836, 840-41 (8th Cir. 2008) (individual issues related to appropriate remedy considered in evaluating predominance); Owner-Operator Independent Drivers Ass’n, Inc. v. New Prime, Inc., 339 F.3d 1001, 1012 (8th Cir. 2003), cert. denied, 541 U.S. 973 (2004) (individual issues related to damages predominated over common issues); see also In re Wilborn, 609 F.3d 748, 755 (5th Cir. 2010).

Another individual issue in this case was each plaintiff’s knowledge about the BPA "controversy." A consumer’s knowledge of BPA’s existence and the surrounding controversy is legally significant.
Knowledge of the controversy carries with it knowledge of the likelihood (or at least possibility) that a plastic baby bottle contained BPA. A consumer who knew about the BPA knew what defendants allegedly failed to disclose. Similarly, a consumer who knew about the controversy and exhibited no concern about whether the product purchased contained BPA may have difficulty convincing a jury that the seller did anything wrong.

The time and other resources necessary to resolve the individual issues in a single forum, in the context of a single case, in front of a single jury, would be staggering. In contrast, the common factual issues would be relatively easy to litigate, said the court.

4. Adequacy.  The court observed that plaintiffs had elected not to assert consumer protection
claims and warranty claims against certain defendants, apparently motivated by the fact that the class representatives are from states that do not support certification of such claims. But other states may have more favorable law for plaintiffs, and thus the court concluded the class representatives were inadequate to protect the class. There was a problem with  depriving absent class members of his/her opportunity to pursue a warranty claim just because the class representative cannot assert such a claim on his/her own.

Plaintiffs proposed state-wide classes in the alternative, but the MDL court noted that the judges who preside over the individual cases would be best-equipped to rule on the
single-state classes.

 

Dismissal of Bellwether Case in FEMA MDL Upheld

The plaintiff who at one time had been the first-in-line bellwether plaintiff in the FEMA Trailer MDL has lost her appeal of the dismissal of her claims. In Re: Fema Trailer Formaldehyde Products Liability Litigation (Alana Alexander, plaintiff), No. 10-30451(5th Cir. June 24, 2011).

Plaintiffs sued the government, alleging exposure to potentially dangerous, high levels of formaldehyde in their Federal Emergency Management Agency (FEMA) provided emergency housing unit. Following Hurricanes Katrina and Rita, FEMA provided EHUs to the displaced victims of the storms. The hurricanes’ destruction created an urgent and immediate need for an unprecedented number of EHUs. In response, FEMA purchased more than 140,000 new EHUs from manufacturers and dealers. Alexander and her children were among the Louisiana residents who received an EHU. The Alexander family moved into their EHU in May 2006 and almost immediately noticed a “chemical smell” in the unit that caused the children's asthma to worsen. Other physical manifestations allegedly  included  irritation, burning, and tearing of the eyes; irritation and burning of nasal membranes; eczema; headaches; difficulty breathing; wheezing; shortness of breath; and new allergies and worsening allergies.

Alexander admitted that she knew the smell came from the EHU. Shortly after moving in, Alexander claimed, she asked an unidentified Government representative or contractor about  the smell. She claimed that he told her that that the smell was “nothing to worry about.”

In July, 2008, Alexander submitted an administrative claim with FEMA and in early 2009 filed a complaint in the district court, alleging under the Federal Tort Claims Act that the Government was careless, reckless, grossly negligent, and acted with deliberate indifference by failing to disclose the exposure to potentially dangerous and high levels of formaldehyde in the trailers.

Defendant moved to dismiss the complaint as untimely (in cases where the government has waived sovereign immunity, the statute of limitations issue is jurisdictional). Although the FTCA does not define when a claim accrues, it is well-settled that a tort action under the FTCA accrues when the plaintiff knows or has reason to know of the alleged injury that is the basis of the action. The trial court dismissed the case, and plaintiff appealed.

On appeal, Alexander argued that the accrual of her claim was delayed or tolled pursuant to either: (1) the discovery rule, (2) equitable estoppel, or (3) the continuing tort doctrine. The 5th Circuit found these arguments were without merit.

There was no dispute that Alexander was aware of the injuries by May 2006. When the family moved into the trailer in May 2006, almost immediately, the asthma worsened, and the kids
experienced a plethora of other health issues. The primary dispute was thus whether  Alexander knew or in the exercise of reasonable diligence should have discovered the cause of the  injuries such that her claim accrued at that time.

Plaintiff claimed she did not discover the Government’s role in the alleged injuries until July 2007, when FEMA issued its second round of flyers about formaldehyde emissions in the EHUs. This argument was "not convincing."  The court of appeals held that plaintiff had enough information regarding the injury and its cause by May 2006 that would lead a reasonable person in plaintiff's  position to further investigate the specific cause of that injury. All the facts were not in the control of the putative defendant, unavailable to the plaintiff or at least very difficult to obtain. Plaintiff could have established FEMA’s connection to the EHU, from which the “chemical smell” was emanating.

Second, plaintiff argued that because she reasonably relied on the claims of the representative that there was “nothing to worry about,” the limitations period should be equitably tolled. Because the limitations periods in statutes waiving sovereign immunity are jurisdictional, the district court properly held that equitable tolling did not apply to this case. 

Finally, Plaintiff could not cite any Fifth Circuit case law indicating that accrual should be delayed when the plaintiff knows about the injury and could have discovered, with a reasonable inquiry, the putative defendant’s, here the Government’s, potential liability. The court thus declined the invitation to apply the continuing tort doctrine to the facts presented in this case.