Report Issued on Use of Science in Regulatory Decisions

Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense.  These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.

Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the "politicization" of science actually arise over differences about policy choices that science can inform, but not determine.

With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews.  Accordingly, this report focuses on:

 How should panels be composed and the qualifications of prospective advisory panelists be vetted?
 How should concerns about biases and conflicts of interest of advisory panelists be handled?
 Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
 How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?

For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.

In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property. 

JPML Denies MDL Status to Pain Pump Litigation- Again

For the second time, the JPML has declined to consolidate the federal product liability cases involving pain pumps. In re Ambulatory Pain Pump-Chondrolysis Products Liability Litigation, J.P.M.L., MDL No. 2139 (4/14/10).

In the litigation, plaintiffs allege that they developed chondrolysis, i.e., damage to their joint cartilage, after pumps were used to directly send anesthetic into their shoulder joints following surgery.

In August, 2008 the Panel had denied the motion for centralization in MDL No. 1966, at at time the  docket involved a total of thirteen actions, as well as eighteen potential tag-along actions.  At that point, the panel noted that an indeterminate number of different pain pumps made by different manufacturers were at issue, as were different anesthetic drugs made by different pharmaceutical companies. Moreover, not all of the then-thirteen constituent actions involved pharmaceutical company defendants, and many defendants were sued only in a minority of those actions.

When the litigation grew to 102 actions in 26 districts, and 70 tag-alongs, the plaintiffs tried again. Most defendants opposed the renewed effort. But although the number of related actions had certainly grown, the Panel found that the issues that weighed against centralization in that earlier docket remain. An indeterminate number of different pain pumps made by different manufacturers are still at issue, as are different anesthetics made by different pharmaceutical companies. Most, if not all, defendants are named in only a minority of actions; and several defendants are named in but a handful of actions. Many actions involve no anesthetic manufacturers at all.

In the current litigation, individual issues of causation and liability continue to appear to  predominate, and remain likely to overwhelm any efficiencies that might be gained by centralization. Pain pumps come in different sizes and designs, with differing volume, duration, and flow capacities. The same anesthetic was not used in all surgeries. Plaintiffs have different medical histories (indeed, some have undergone more than one surgery involving a pain pump).

Third, said the Panel, the constituent actions are at widely varying procedural stages. In many, fact
discovery is either over or nearly over. The record showed that expert discovery is underway or has
been completed in a number of actions. It was also noted that while most plaintiffs supported the motion, others requested exclusion on the ground that their cases were too far advanced.

Thus, the Panel was not convinced that centralization would serve the convenience of the parties or promote the just and efficient conduct of the litigation taken as a whole.