NJ Court Affirms Role of Learned Intermediary Doctrine

A New Jersey court overseeing the centralized litigation regarding the human tissue product AlloDerm has issued a noteworthy ruling in a bellwether case on the duty to warn. See Simineri, et al. v. LifeCell Corp., No. L-5972-11 (Super. Ct. N.J.).

Plaintiffs moved for partial summary judgment on the issue of the learned intermediary doctrine under the New Jersey Products Liability Act. The FDA regulates AlloDerm as a banked human tissue product, not as a drug or medical device, so the motion raised the issue whether the doctrine applied to this type of product. 

Under the Act, N.J.S.A. Sect. 2A:58C-4, an adequate warning must be given to the persons by whom the product is intended to be used, or in the case of prescription drugs and devices, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. Under New Jersey law, a pharmaceutical manufacturer discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities. To the extent that the pharmaceutical manufacturer is relived of the duty to warn the ultimate user, the treating physician as the learned intermediary assumes the responsibility to warn the patient of the risks involved in using the prescription product.

The court here noted that the NJ Supreme Court has established several rationales for favoring application of the learned intermediary doctrine, including: 1) the desire to avoid intrusion into the doctor-patient relationship; 2) the superior position of doctors to communicate important information about risks to their patients; 3) the inability of drug makers to communicate effectively and directly with patients; and 4) the nearly impossible task of translating complex medical information and risk factors into terms understandable to the average consumer.

Plaintiffs argued that the LID was inapplicable to AlloDerm because it was not regulated by the FDA as a prescription drug or medical device and that it was supposedly “well-established” that the LID somehow only applies to FDA-approved drugs and devices. Plaintiffs cited a variety of cases, but, said the court, none of the cases relied on actually based their application of the LID on the FDA’s classification of medical products as drugs or devices. Rather, the cases cited by plaintiffs focused on the traditional rationales underpinning the LID: that where the product is available only through the intervention of a licensed physician, any duty to warn is owed to the physician and not the patient. The cases instead stood for the proposition that prescribing physicians act as learned intermediaries between the manufacturer and consumer, and those doctors stand in the best position to evaluate the patient’s needs and assess the risks and benefits of a particular treatment. What was sufficient, and what plaintiffs seemed to ignore, was the fact that AlloDerm is regulated by the FDA. Plaintiffs were unable to explain how the particular FDA classification had any real bearing on the application of the doctrine.

The court next disagreed with plaintiff’s argument that applying the LID to the product would somehow be an expansion of the doctrine. The court believed it was simply considering the well-established rationales underlying the LID and applying them to the product.  It was significant that the product was not marketed or sold directly to patients. It can only be obtained through a licensed healthcare professional. Indeed it must be implanted into the patient by the physician. The patient is necessarily relying upon the doctor’s knowledge, skill, and services, weighing the risks and benefits before the implantation of the product.

Under these circumstances, to require the defendant “to communicate would unnecessarily intrude on the doctor-patient relationship. In a surgical context…the doctor has even more prominent role in evaluating and selecting the most appropriate course of treatment.” The surgeon, rather than the manufacturer, concluded the court, is best positioned to convey the appropriate information to the patient, who was unlikely ever to inspect the product.   A physician choosing to implant this product must consider a number of factors such as the patient’s medical history and co-morbidities, as well as the specific surgical techniques employed. The physician is in the best position with regard to this product to take into account the susceptibilities of the patient, and to give an individualized warning to the ultimate user.

Plaintiff's motion denied.  

Expert Panel Confirms Safety of BPA Use

We have posted before about the BPA "controversy" egged on by lawyers seeking their next mass tort.  Now comes yet another report on BPA, from the European Food Safety Authority, confirming that the current uses of BPA, including food related uses, pose no significant health risks to consumers of any age.

BPA is a chemical compound used in the manufacture of polycarbonate plastic food contact materials such as re-usable plastic tableware and can coatings (mainly as protective linings). Another widespread application of BPA is in thermal paper commonly used for till/cash register receipts.

EFSA’s expert Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) decided that the publication of a variety of new scientific research on BPA in recent years meant a full re-evaluation of the chemical was timely.

EFSA’s experts estimated the exposure to BPA from dietary and non-dietary sources, and assessed the human health risks posed by exposure to BPA. The resulting risk assessment was just published in the CEF Panel’s “Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs”.

Exposure was assessed for various groups of the human population in three different ways: (1) external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper); (2) internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA); and (3) aggregated (from diet, dust, cosmetics and thermal paper).   BPA toxicity was evaluated by a weight of evidence approach. The CEF Panel established a temporary Tolerable Daily Intake (t-TDI) of 4 μg/kg bw per day. By comparing this t-TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure or from aggregated exposure. The opinion echoes a similar pronouncement last year by the Food and Drug Administration. 

FDA Proposes Two New Food Regulations for Imports

 The U.S. Food and Drug Administration proposed two new rules last week that would impact imported food, including by establishing a program to accredit third-party auditors to certify foreign food facilities.  The rules were called for by the Food Safety Modernization Act of 2011, which revised the regulatory system to deal with risks of food-borne illness. We have posted before about the litigation that can arise from such situations. 

 

Under the proposed rules, which follow on regulations proposed earlier this year, importers would be accountable for verifying that their foreign suppliers are implementing modern, prevention-oriented food safety practices, and achieving the same level of food safety as domestic growers and processors. The FDA is also proposing rules to strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.

Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

The FSMA also directs the FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, the FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.
Importers will not generally be required to obtain certifications, but certifications may be used by the FDA to determine whether to admit certain imported food that poses a safety risk into the United States.

The FSVP proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days. 

 

Advisory Group Recommends Cost/Benefit Analysis for CPSC Regulations

We have posted before about the impact of regulations on clients and indirectly on product litigation. Earlier this month the Administrative Conference of the United States, a federal advisory council, gave its approval to a policy recommendation encouraging independent regulatory agencies to apply formal cost-benefit analysis to their rule-making efforts. One affected agency would be the Consumer Product Safety Commission.

Readers may know that the ACUS is an independent federal agency dedicated to improving the administrative process through consensus-driven applied research, providing nonpartisan expert advice and recommendations for improvement of federal agency procedures. Its membership is composed of federal officials and experts with diverse views and backgrounds from both the private sector and academia.

Several independent regulatory agencies are not subject to the benefit-cost analysis requirements of various Executive Orders or legislation.  The ACUS undertook a project to examine the possible use of benefit-cost analysis at independent regulatory agencies and to highlight any innovative practices those agencies could use. The group adopted a recommendation encouraging agencies to voluntarily adopt certain practices that other agencies have developed when conducting regulatory analyses for major rules. The recommendation, first, identifies various policies and practices used in several regulatory agencies and offers a series of proposals to encourage their use in other agencies. For example, it recommends that each independent regulatory agency develop written guidance on the preparation of benefit-cost and other types of regulatory analyses.

Second, the recommendation highlights a series of analytical practices that OMB has promulgated in the past. For example, it recommends that agencies’ analyses be as transparent and reproducible as practicable, subject to the limitations of law and applicable policies (including preventing the disclosure of proprietary information or trade secrets, or other confidential information). The recommendation does not
seek to establish a one-size-fits-all approach to regulatory analysis, and recognizes that each agency must tailor the analyses it conducts to accord with relevant statutory requirements, its own regulatory priorities, and the potential impact of the analysis on regulatory decision-making to ensure proper use of limited agency resources. 

Note that during the debate on the measure, at least one CPSC commissioner argued against requiring a cost-benefit analysis.

Following the report, Senate Bill 1173 was introduced to require independent agencies to analyze the costs and benefits of new regulations and to tailor new rules to minimize unnecessary burdens on the economy. "The Independent Agency Regulatory Analysis Act of 2013" would apply to any proposed new rule with an economic impact of $100 million or more annually. Sponsors argue there is no good reason the independent agencies should not conduct the same important review other executive agencies must.


 

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. 

Federal Court Offers Cogent Analysis of Warning Causation in Drug Case

A New Jersey federal court granted summary judgment last week to a pharmaceutical defendant in a failure to warn case. See Baker et al. v. APP Pharmaceuticals LLP et al., No. 3:09-cv-05725 (D.N.J.).  The case should be interesting to our readers in part because there really isn't a huge amount of law on warning causation in the busy jurisdiction of New Jersey.

During a hospital stay, plaintiff Baker was administered the commonly prescribed drug heparin. Heparin is an anticoagulant: it prevents blood clots. The opinion noted that the drug is associated  with heparin induced thrombocytopenia (“HIT”), or low blood platelet count. HIT may in a few patients progress to a more serious adverse reaction called heparin induced thrombocytopenia  and thrombosis (“HITT”). Plaintiff received heparin during and after her surgery, and a few days later her  platelet count was down; but according to the opinion it was not known at what point her platelet count reached serious levels because no one measured her platelet level for several days, despite the hospital’s stated protocol to monitor a patient’s platelet count periodically in order to detect possible HIT.

Plaintiff suffered injury to her left foot and leg, and thereafter sued several manufacturers of heparin, asserting they failed to adequately warn of the serious side-effects associated with heparin use. The parties agreed that defendant’s heparin has always contained FDA-approved labeling, including risk disclosures and warnings. In 2001, the heparin label specifically disclosed the risk of HIT and HITT in the “Precautions” section.  In 2005, defendant submitted a supplemental NDA via the “changes being effected” process to include additional HIT and HITT information the “Warnings” section of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of which defendant incorporated into the labeling, and the FDA found the updated labeling “acceptable” in June 2007. 

In New Jersey, product liability actions are governed by the New Jersey Products Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. Under the PLA, in failure to warn cases involving prescription drugs, if the warning or instruction given in connection with a drug has been approved or prescribed by the FDA, there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption, remarked the court. Compliance with FDA regulations gives rise to “what can be denominated as a super-presumption.” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012).  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced" in the rules of evidence. Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom. Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).

In this case, there is no dispute that the heparin labeling was approved by the FDA. Therefore, defendant was entitled to the statutory presumption that its heparin labeling satisfied its duty to warn. Plaintiff tried to rebut the presumption, first, with allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects by the pharmaceutical company, and second with allegations of an economically-driven manipulation of the post-market regulatory process. See McDarby v. Merck & Co., Inc., 949 A.2d 223, 256 (N.J. Super. Ct. App. Div. 2008).

However, significantly, all of the information plaintiff accused defendant of withholding was publicly available in published scientific and medical literature.  And defendant did in fact disclose much
of what plaintiff claimed was deliberately concealed or withheld. For example, when submitting its proposed updated label to the FDA in 2005, Baxter included several scientific articles and a number of adverse event reports relating to HIT and HITT.  As to the second rebuttal effort, plaintiff offered no real evidence that Baxter rejected the FDA’s proposed changes to heparin labeling, or asked pharmaceutical representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated the conclusions of heparin clinical trials, or did anything sufficient to "manipulate" the regulatory process.

The more interesting part of the opinion arises from the fact that even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate, that plaintiff still must prove that the inadequate warning proximately caused her injury. See Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden, a plaintiff must show that adequate warnings would have altered her doctors’ decision to prescribe.” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div. 1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s dissent).

The court noted that “a heeding presumption may be applicable to claims of failure to warn of the dangers of pharmaceuticals.” McDarby, 949 A.2d at 267. A heeding presumption allows one to presume that the plaintiff’s physician would not have prescribed the drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s physician would have heeded the adequate warning. The heeding presumption is rebuttable and can be rebutted if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted. Also. a manufacturer who allegedly fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and already considered the risk in prescribing the product. In that context, the physician’s conduct is the superseding, intervening cause that breaks the chain of liability between the manufacturer and the patient.

Here, the doctor stood by his decision to administer heparin to Mrs. Baker. She required heparin by standard medical procedure, and well documented clinical knowledge, at several different  points during her operation and for several different reasons, he opined.  Since he was aware of the risks of the drug that he prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use to be warranted, the presumption was rebutted as a matter of law.

Moreover, the prescriber testified in his deposition that he does not read the label of drugs he frequently prescribes, which includes heparin. Therefore, a different warning would not have made a difference in plaintiff's treatment or outcome because there was no evidence he would have reviewed it.

Finally, there was a third causation problem; the opinion notes that it was undisputed that, despite doctors orders, the Hospital failed to follow its own heparin treatment protocol. Had that monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner. Plaintiff's own expert admitted that her injuries “would have been substantially mitigated” with a “good chance of avoiding" them.   Therefore, plaintiff failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the conduct of the hospital, that caused her injury.

 Summary judgment on the warning claim.

U.S. Chamber Describes Tort Reform Goals for 2012

Here at MassTortDefense we try to keep at least one eye on important tort reform efforts, and how they may impact  the litigation that we blog about.

That is why we reviewed with great interest the tort reform agenda of the U.S. Chamber of Commerce for 2012, which happens to be the organization's 100th year representing the business community.

The head of the Chamber recently delivered the organization's annual State of American Business address to its members. In it, he noted the need for significant regulatory and legal reform:

The regulatory avalanche confronting our job creators is unprecedented. The Labor Department has 100 rule-makings in the pipeline. Dodd-Frank requires 447 rules, 63 reports, and 59 studies. The health care law established 159 new agencies, panels, commissions, and regulatory bodies. EPA has some 200 regulations in the works. The Chamber supports necessary, sensible, and forward-looking regulations -- but not proposals that fail to meet that test. The Chamber is also working to modernize the overall regulatory system—including legislation to reform the permitting process and update the Administrative Procedure Act for the first time since the Truman administration. 

The Chamber's Institute for Legal Reform will continue to fight the expansion of excessive litigation that is sucking the vitality out of American businesses.  America’s civil justice system is the world’s most expensive, with a direct cost in 2009 of $248.1 billion, or 1.74% of the U.S. GDP.
The tort cost per person was $808 in 2009, a sevenfold increase from 1950 even when adjusted for inflation. While small businesses are responsible for 64% of all new American jobs, lawsuits cost them $105.4 billion in 2008—money that could be invested in more jobs, higher wages, or better benefits. Two out of three senior executives and litigators at America’s largest employers believe that the litigation environment in a state is likely to impact important business decisions at their companies, including whether to grow jobs or do business in a state.

A key focus for 2012 will be the alarming rise of third-party litigation financing. That’s where outside investors fund lawsuits in exchange for a share of the award or settlement. This can encourage the filing of frivolous claims. It may invite testing questionable claims in court. It probably provides an incentive to unduly prolong cases. And it raises serious ethical questions. Who does the lawyer really represent—his client or the outside financial backers?


 

Regulatory Reform Bills Pass House

We have posted before about legislative attempts to limit the harmful effects of excessive federal regulation on product sellers.  Readers know how those regulations can have an indirect but real impact on product liability litigation as well. The House passed two bills on this topic last week, and the White House indicated it would veto them if they passed the Senate.

The Regulatory Accountability Act (H.R. 3010) passed by a vote of 253 - 167.  It would require an agency to consider any reasonable alternatives for a proposed rule, and the potential costs and benefits associated with such alternatives. The Regulatory Flexibility Improvements Act (H.R. 527) passed by a vote of 263 - 159. It would require agencies to conduct initial and final regulatory flexibility analyses to describe alternatives to a proposed rule that minimize any adverse significant economic impact or maximize the beneficial significant economic impact on small business entities.

Republican sponsors have argued that the bills would help prevent oppressive agency regulations and force federal agencies to choose the least costly alternative when developing new  regulations. Federal regulations cost businesses more than $1.5 trillion each year, which has an obvious effect on job creation.

Given the current makeup, the Senate versions (S. 1606 and S. 474) are expected to face stiff Democratic opposition.  The bill is not listed among the Senate Majority's current legislative priorities. 

California Publishes New Draft of Informal Green Chemistry Regulations

Yesterday the California Department of Toxic Substances Control (DTSC) convened a Green Ribbon Science Panel (GRSP) to continue work on the state's Green Chemistry initiative.

Readers may recall from previous posts that the GRSP was established with the passage of two "green chemistry laws" in 2008, and is charged with providing advice and serving as a resource to DTSC and the public regarding the California Green Chemistry Initiative. On the agenda for the meeting this week was input from the GRSP on the recently-posted “Safer Consumer Products Informal Draft Regulations”, which were published late last month.  An earlier draft of those regulations, released by the DTSC last November, drew strong commentary from both industry and environmental groups. According to DTSC, a wide range of stakeholders, including those from industry, environmental groups, scientists, and legislative leaders, raised "substantive and valid concerns" about the prior draft of the regulations. DTSC  eventually withdrew the draft regulations.

The latest draft regulations provide for a four-step process to identify safer consumer product alternatives: 1) create an immediate list of Chemicals of Concern (~3,000) based on the work already done by other organizations, and specify a process for DTSC to identify additional  chemicals as Chemicals of Concern (COCs); 2) require DTSC to evaluate and prioritize product/COC combinations to develop a list of “Priority Products” for which an alternatives assessment must be conducted; 3) require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product.  Manufacturers (or other responsible entities) must perform an "alternatives assessment" for the product and the Chemicals of Concern in the product to determine how best to limit potential exposures to, or the level of potential adverse public health and environmental impacts posed by, the Chemicals of Concern in the product; 4) require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts, if any, posed by the Priority Product/Chemical of Concern.

The draft regulations note that they would not apply to prescription drugs and devices; dental restorative materials; medical devices, and some other categories. But it is clear that they will impose significant new burdens on many product manufacturers, importers and sellers. The new regulations require risk assessments and life cycle analyses for prioritized products, which may lead to use limits for chemicals, reformulation requirements to eliminate targeted chemicals, or even a ban on sales of certain products in California.

And, of course, varying state regulations (in approach and content) frustrate the ability of those companies to design and market products in a global supply chain.

DTSC labels the new draft "informal," perhaps because they make substantial changes to the withdrawn set, which drew such intense scrutiny.   The initial list of “Chemicals of Concern” would be far broader than previously expected; the product prioritization criteria is revised, although it still appears likely to impact children's products, personal health, and other consumer products. But worker exposure has been added to the priority criteria as well. The regulations would also expand the list of hazards to include a wider range of hazard traits and environmental and toxicological testing endpoints. The previous exemption for unintentionally added chemicals would be eliminated, and, significantly, the “no exposure pathway” exemption would also be dropped.  

The regulations would require an alternatives assessment, conducted in two stages, with a report to DTSC regarding each stage. The first stage focuses on product criteria (function, performance, technical, and legal requirements), identification of alternatives to the COC, and screening of the alternatives.  The second stage would involve a detailed assessment of alternatives, focusing on exposure pathways and life cycle segments.

After evaluating the reports of the alternatives assessment, DTSC would then consider the appropriate regulatory response, which could involve a requirement of information disclosure, or more assessment, or limitation of certain uses, up to a ban.

The draft regulations would also require responsible entities to establish and pay for an end-of-life product stewardship program for any product that is to treated as a hazardous waste in California.

Materials for the meeting are here and here. On December 5, 2011, DTSC will hold a workshop on the informal draft regulations. The informal public comment period ends December 30, 2011.  DTSC apparently will then develop a formal new set of proposed regulations.   

House Committee Tackles Regulations

The House Judiciary Committee held a hearing last week on a bill that would require federal agencies to evaluate the costs of proposed regulations before adopting them, and that would arguably make it easier for product sellers to challenge onerous regulations in court.

The hearing focused on the Regulatory Accountability Act of 2011 (H.R. 3010). Rep. Lamar Smith (R-Texas), the committee chairman, introduced the bill this Fall to propel needed changes in the regulatory system, updating out of date aspects of the Administrative Procedure Act, a 1946 statute.  The Senate version of the bill (S. 1606), was introduced in September, and was authored by Sens. Rob Portman (R-Ohio), Mark Pryor (D-Ark.), and Susan Collins (R-Maine). The Regulatory Accountability Act would be the first major revision of the APA’s core regulatory procedures.

The bill would require a more formal rule-making process, under which agency officials would have to defend their regulatory proposals to affected persons. Federal agencies also would be required to give greater weight to the impacts and costs of the proposed rules.  The proposal would limit the ability of agencies to regulate in the guise of voluntary “guidance” documents. (Readers know hos such regulations can impact mass tort and product liability litigation in a real way.)

Witnesses included C. Boyden Gray, Christopher C. DeMuth of the American Enterprise Institute for Public Policy Research, and Arnold Baker, owner of Baker Ready-Mix Building Materials.  Gray argued that the bill would strengthen judicial review of agency actions on questions of regulatory interpretation, factual issues, and cost-benefit analysis, at least in cases where the agency’s own process fails to satisfy the Act’s heightened requirements. Judicial review of agency action requires a delicate balance—the applicable standards of review are somewhat deferential, but those standards must be firmly enforced. The proposed Act strikes that balance well. DeMuth focused on the requirement of a cost-benefit standard, and the provision that agencies must adopt the least costly approach to achieving statutory objectives unless they demonstrate that the additional benefits of more costly rules justify the additional costs.  And Baker offered the example of a business struggling to stay afloat in a sea of regulations, and the need for agencies to do a much better job of understanding the full impact that their regulations will have on businesses and jobs – along with possible alternatives – before they impose the most costly new rules.

A number of law professors oppose the bill, but seem to forget that it is Congress' job to decide if and when regulatory burdens have become too excessive.

Meanwhile, the House Judiciary Committee approved last week the Regulations from the Executive in Need of Scrutiny (REINS) Act (H.R. 10), which would require a vote in Congress before any regulation with an economic impact of more than $100 million could go into effect. Federal regulations cost the economy $1.7 trillion each year. Congress would take a simple up-or-down vote on such huge new government regulations before they could be enforced. 

 

FDA Releases New Strategic Plan for Regulatory Science

This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new medical products and materials.

The strategic plan describes the agency’s intent to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It reportedly also underscores the agency’s emphasis on food safety.

The plan also emphasizes the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information.

The priority areas listed in the report are:

  • Modernize Toxicology to Enhance Product Safety
  • Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
  • Support New Approaches to Improve Product Manufacturing and Quality
  • Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
  • Harness Diverse Data through Information Sciences to Improve Health Outcomes
  • Implement a New Prevention-Focused Food Safety System to Protect Public Health
  • Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
  • Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products
     

 

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.
 

 

Legislation Proposed to Curb EPA Greenhouse Gas Authority

As we have noted in previous posts, one of the many important questions lurking in the climate change/global warning cases currently being litigated is whether the EPA will be the primary regulator of greenhouse gas emissions or whether private parties will be permitted to go directly to court. Should a single judge set emissions standards for regulated utilities across the country—or, as here, for just that subset of utilities that the plaintiffs have arbitrarily chosen to sue? Judges in subsequent cases could set standards for other utilities or industries, or even conflicting standards for these same utilities. At the sane time, many observers question whether the current EPA regulatory direction offers sufficient protection for the jobs and the still shaky economy.

A number of bills have been introduced that could affect this equation. The Chair of the House Energy and Commerce Committee, Fred Upton (R-Mich.), last week spoke of draft legislation that would prohibit the Environmental Protection Agency from regulating greenhouse gas emissions.  The Energy Tax Prevention Act of 2011 would bar the EPA from regulating the so-called greenhouse gases under the Clean Air Act by precluding the agency from taking into consideration the emission of a greenhouse gas due to concerns regarding possible climate change.

Joining in support of this approach were Sen. James Inhofe (R-Okla.), the highest ranking Republican on the Senate Environment and Public Works Committee, and Rep. Ed Whitfield (R-Ky.), chairman of the House Energy and Commerce Subcommittee on Energy and Power.
Senator Inhofe reportedly plans to introduce a Senate version of the bill soon. 

Already in the Senate, Sen. Jay Rockefeller (D-W.Va.) re-introduced the EPA Regulations Suspension Act of 2011 (S. 231) which would delay for two years EPA's greenhouse gas emissions rules covering stationary sources.  Co-sponsors include Democrats: Sens. James Webb (Va.), Claire McCaskill (Mo.), Tim Johnson (S.D.), Joe Manchin (W.Va.), Ben Nelson (Neb.), and Kent Conrad (N.D.).  Rockefeller's version would apparently continue to allow EPA regulation of vehicle greenhouse gas emissions.  Wyoming Republican Senator John Barrasso introduced a more sweeping Senate bill (S. 228) that would reduce federal authority to regulate such emissions under not just the Clean Air Act, but also the Clean Water Act, the National Environmental Policy Act, and the Endangered Species Act.

The White House announced last year that the President would veto efforts to curb EPA authority over these greenhouse gas emissions. But many have expressed concern that the EPA regulations could hurt job growth, particularly for heavy manufacturing states.
 


 

Multi-State Coalition On Chemicals Management Formed

Readers have been following our posts on new state efforts on chemical regulation, such  as California's Green Chemistry initiative. Now comes word that environmental officials from 10 state and local governments have formed an umbrella organization - the Interstate Chemicals Clearinghouse (IC2) - with the stated goals of promoting a clean environment, healthy communities, and a vital economy through the development and use of safer chemicals and products.

The states joining IC2 include California, Connecticut, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, and Washington.

The goals of the IC2 are to:

  • Avoid duplication and enhance efficiency and effectiveness of state, local, and tribal initiatives on chemicals through collaboration and coordination
  • Build agency capacity to identify and promote safer chemicals and products
  • Ensure that state, local, and tribal agencies, businesses, and the public have ready access to high quality and authoritative chemicals data, information, and assessment methods

Launched under the auspices of the Northeast Waste Management Officials' Association (NEWMOA), the new Clearinghouse says it will support state, local, and tribal health and environmental agencies with development and implementation of programs to promote use of safer chemicals and products; support the development of alternative assessment methods and identification of safer alternatives; share data and information on chemical use, hazard, exposure, and alternatives; share strategies and outcomes on chemicals prioritization initiatives; and build the capacity of agencies by sharing materials, strategies, and trainings.  IC2 has a number of projects planned in these areas.

The Northeast Waste Management Officials Association's announcement of the IC2 comes just as many chemical manufacturers are expecting that the federal government (including through an update to TSCA) will take the lead in regulating chemical products, not state regulatory agencies and legislatures.

Industry groups, including the American Chemistry Council, continue to believe that a patchwork of state and local programs has the potential to create more confusion for consumers and manufacturers, and may ultimately simply hamper investment, and threaten future job creation.  As we have noted, some of the bills introduced in the last Congress would have set an impossibly high hurdle for all chemicals in commerce, and were guaranteed to produce significant technical, bureaucratic and commercial barriers. Of particular concern to readers of MassTortDefense would be efforts to eliminate the current risk-based review system under TSCA and force EPA to use the so-called precautionary principle.

It seems more supportable that any overhaul of TSCA should include the notion that scientific reviews must use data and methods based on the best available science and risk-based assessment; must include cost-benefit considerations for the private-sector and consumers; must protect proprietary business information, and should logically prioritize reviews for existing chemicals.



 

California Postpones Green Chemistry Regulations

California has postponed final adoption of its green chemistry rules pending further review to address a variety of stakeholder concerns. As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."

Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals. The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

Now, the state environmental head, Secretary Linda Adams, has announced that the California Department of Toxic Substances Control will reconvene the Green Ribbon Science Panel to take another look at the proposed regulations. Those regulations, released by the DTSC last November, drew strong commentary  from both industry and environmental groups.  According to Adams, a wide range of stakeholders, including those from industry, environmental groups, scientists, and legislative leaders, have raised "substantive and valid concerns" about the most recent draft of the regulations. 

 


 

Update on Greenhouse Gas Emissions Reporting

The White House Office of Management and Budget has reportedly completed its review of the draft final rule to set greenhouse gas emissions reporting requirements for oil and natural gas wells and related equipment, as well as locations that produce fluorinated greenhouse gases. Completion of OMB review is typically the final step before a proposed rule is released by the Environmental Protection Agency for publication.

Readers may recall these rules were proposed in Spring, 2010, and would require oil and natural gas wells and related equipment that emit more than the equivalent of 25,000 metric tons per year of carbon dioxide to report their greenhouse gas emissions. EPA estimates that the proposal would apply to about 3,000 facilities, which would be required to begin collecting data on Jan. 1, 2011.  According to EPA, fluorinated gases account for about 2 percent of U.S. greenhouse gas emissions.

The proposed rule for oil and natural gas systems, like many related rules, seem to impose burdensome testing requirements on natural gas systems rather than calling for use of arguably more cost-effective estimating techniques.  Also controversial is EPA's effort to include smaller facilities by aggregating multiple facilities of a company in a region.

The Nov. 2 elections put Republicans in charge of the House and reduced the Democratic margin in the Senate; this may impact greenhouse gas regulation, and climate change legislation (such as cap and tax) is probably off the table for the next two years. Industry groups may seek to lobby for delay in EPA's greenhouse emissions rules through a variety of techniques, including via the EPA spending bill. Several top House Republicans have been quoted as saying such rules are a priority target.  On the Senate side, Sen. Jay Rockefeller (D-W.Va.) and a few other Democrats have favored a delay in implementing the EPA regulations for two years, so the new math there may also create road blocks.

Another aspect of this is seen in statements, such as those by Rep. Darrell Issa (R-Calif.), who may be in line to chair the House Oversight and Government Reform Committee; he has stated that he will call for oversight hearings on EPA activities, including in this area. Organizations such as the National Association of Manufacturers have argued that if the EPA is allowed to continue forward with an "overreaching agenda" on greenhouse gasses that puts additional and unnecessary burdens on manufacturers and drives up energy costs, it will cause economic harm and instill even more uncertainty into our already fragile economy, and will destroy jobs.

 

Inside Counsel Explores California Green Chemistry Regs

Your humble blogger is quoted in the latest edition of the fine publication INSIDE COUNSEL.  See “Proposed Regulation Requires Companies To Go Green,” Inside Counsel, November 1, 2010.

Readers know we have posted on California's Green Chemistry program.  This new article explores its potential impact, which will likely reverberate far beyond that state’s borders.  for example, I spoke to the publication about the impracticality of making two versions of many products, one for California and one for the rest of the nation. 

The article also suggests that plaintiffs attorneys will likely find plenty of litigation opportunities in the initiative, including the argument that changes made to comply with the regulation could and should have been made earlier, as I discussed with the author.

I also pointed out that there doesn’t appear to be an easy mechanism for getting a chemical or product off the state's target list once it’s finalized, highlighting the importance of the initial comment period.

 

DTSC Green Chemistry Symposium

The California Department of Toxic Substances Control (DTSC) and the state's Department of Public Health (DPH) are hosting a brown-bag symposium, "Green Chemistry through the Lens of Public Health," next week.  The program will examine the potential and intended effects of Green Chemistry on public health. It is set for Monday, October 18, 2010, 10 a.m. – 3 p.m.
 

We have posted on the California Green Chemistry Initiative, from the introduction of legislation for the program, to the proposal of draft regulations, to the final rule making stages.  As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals. The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

The symposium is scheduled to feature interactive discussions with physicians, scientists and some stakeholders on the impact of the new chemicals policy on public health. The keynote speakers are Dr. Margaret Kripke, Ph.D., immunologist, and Steve Owens from the U.S. Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention.

The event is open to the public and is supposed to be accessible via a live webcast at www.dtsc.ca.gov/greenchemistry.
 

 

California's Proposed "Green Chemistry" Regulations Move Forward

California's proposed "green chemistry" regulation took another step closer to completion last week, as the state Department of Toxic Substance Control (DTSC) submitted the draft regulations to begin the final official rulemaking process.  The public has until Nov. 1, 2010 to make comments.  Under state law passed in 2008, the regulations must be finalized before 2011.

As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals.  The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

Earlier in 2010, the agency released a draft Safer Consumer Product Alternatives regulation, then held public meetings and workshops and took written comments.  Last week, the final, slightly revised draft, was issued. DTSC’s regulations call for identifying and prioritizing chemicals in consumer products, for conducting an alternatives assessment, and then an appropriate  regulatory response.

The proposed regulations call for creation of a proposed initial list of Chemicals under Consideration by June 1, 2012, and, from that an eventual list of Priority Chemicals by July 1, 2012. Similarly, the agency is to create a proposed initial list of Products under Consideration (because they contain the relevant chemicals) by March 1, 2013, and eventually a final list of Priority Products by December 1, 2013. In making this determination, the regulations offer a long list of relevant factors, including usage, distribution, disposal and life cycle issues, use by sensitive sub-populations, and a host of toxicity parameters.  One thing for manufacturers to watch: it is unclear how the DTSC will weigh and balance these and other factors. Especially important will be the relative emphasis on realistic, feasible exposure scenarios and dose, as opposed to theoretical risks in the lab.  A second area of potential concern here is that while the proposed regulations include a fairly detailed (and likely lengthy) petition process to challenge regulatory response decisions, they apparently do not include a similar ready process to seek removal of a chemical or product from the priority lists.  Thus, manufacturers and relevant trade associations will have to closely monitor the draft/proposed lists and jump into the comment period before the lists are finalized. Food, drugs, and a few other products are exempt, but the potential list of "consumer products" is quite large.

In the second phase involving Alternative Assessments, product makers will have to provide what may become a quite complex and expensive assessment of potential alternatives to the chemical/product, including a look at hazards, potential exposures, and life cycle.  For example, if the lead of the assessment team works for the manufacturer, the Assessment must be reviewed and verified by an independent third-party consultant.  It is unclear what data DTSC will want to see here, including whether the agency will require additional, new toxicity testing of a product or an alternative.  This may be especially onerous for smaller companies, and for newer technologies (think nano?) in which the existing body of data may not be as robust. One area for companies to watch here is the protection, or lack thereof, of trade secret information.  Ingredients in a product, and possible alternatives that make the product safer, are often a key part of intellectual property, a competitive advantage.  The regulations purport to offer some trade secret protection, but it s not crystal clear how the DTSC will apply this principle.

After receiving the Alternative Assessment, the DTSC is to decide on the best method, if any, to mitigate paternal risks with the product, ranging from no further action to recalls and bans.

The regulations offer a good reminder to double-check company knowledge and comfort with the supply chain, components and agreements, risk sharing provisions, insurance coverage, etc.

California Takes Next Steps On "Green Chemistry"

Readers know how California's often extreme statutory and regulatory initiatives can influence toxic tort litigation.  Now comes word that California regulators last week released a proposed framework for forthcoming regulations to reduce certain chemicals in consumer products, as part of its “green chemistry” initiative.

The California Department of Toxic Substances Control’s release of an outline of the Draft Regulations for Safer Products is a second step in identifying "chemicals of concern" in California. The outline proposes guidelines for scientific and systematic prioritization of chemicals and products of concern, certification of alternatives assessment and development of DTSC’s regulatory response. Those responses may include banning substances or products, and end-of-life management issues. It also described a process manufacturers could use to evaluate the chemicals and safer have to perform an "Alternatives Assessment" for the product. Note that any public or private entity or individual may petition the Department to evaluate a chemical or a chemical and product combination during the prioritization process.

DTSC called for feedback on the outline.  The next step will be creating actual draft regulations based on the outline. The agency said that draft regulations will be released in the very near future, and that it will begin a formal rule-making process. State law requires the regulations be adopted by January 1, 2011.

California's green chemistry initiative, a statutory mandate since 2008, is an effort to identify and to reduce the use of chemicals that regulators conclude pose the greatest risk to public health and the environment. 

 

FDA Proposes Regs on Direct-to-Consumer Prescription Drug Ads

The Food and Drug Administration has proposed to amend its regulations concerning direct-to-
consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. See 75 Fed. Reg. 15,376 (3/29/10). FDA is also proposing standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.

Readers of MassTortDefense know how DTC ads have impacted products litigation, from effects on the learned intermediary doctrine, to influence on the jury pool, to forming part of the basis of substantive information-based claims.

Under the current regulations the presentation of risk information in an advertisement for a prescription human or animal drug is required to be comparable in prominence and readability to the presentation of effectiveness information in the advertisement. If an advertisement presents effectiveness information in a clear and conspicuous manner, risk information is required to be presented in a comparable manner.  The new proposal would require disclosure of the major side effects and contraindications of the drug in a clear, conspicuous, and neutral manner, regardless of the manner in which effectiveness information is presented in the advertisement.

The proposed regulations would define the required clear, conspicuous, and neutral manner, as being met if:

1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of the volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major
statement.

FDA said it recognizes that these standards require judgment in their application. Therefore, the agency does not intend to prescribe a set formula for ‘‘clear, conspicuous, and neutral’’ major
statements because there is more than one way to achieve these standards in a television or radio ad. FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads. Sponsors have the flexibility to be creative in designing their ads as long as all of the standards listed here are complied with such that the major statement is communicated effectively to consumers and the overall message
that the advertisement conveys to consumers is accurate and non-misleading.

Comments on the proposed rule are due by June 28, 2010.

Nanotechnology Legislation Introduced in Senate

Two Democratic legislators have introduced a bill that would create an FDA program to assess the potential health and safety effects of nano-technology ingredients in various consumer products.  Sens. Mark Pryor (D-Ark.) and Benjamin L. Cardin (D-Md.) introduced the "Nanotechnology Safety Act of 2010," S. 2942, last week. Their introductory remarks here.

The FDA established a Nanotechnology Task Force, which issued a report in July 2007. In the task force report, recommendations were made regarding FDA’s future direction for regulating nanomaterial-containing products. Guidance development was included as one the recommendations. The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met In 2008. Among the agenda topics was a discussion of issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products.  Later, FDA held a public meeting to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology.

The bill would create a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.  Specifically, FDA would be charged to assess scientific literature and data on general nanoscale material interactions with biological systems and on specific nanoscale materials of concern to Food and Drug Administration, and collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanoscale materials with biological systems.

Nanotechnology applications in drug development are likely to have a significant impact on the products that FDA regulates. Products containing nanomaterials are being investigated for potential applications as therapeutics, and some products containing nanoscale materials are already on the market. While some of these nanomaterials are nanoscale versions of larger materials used in approved products, other nanomaterials are novel and have never been used in drug products. In 2009, the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth.

The proposed law would also require a report from FDA by 2012 that includes a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative. The bill would send $25 million annual funding to the agency for the program. The bill was referred to the Committee on Health, Education, Labor, and Pensions,

Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave. We have posted on this topic here, here, and here.
 

EPA Releases First Chemical Action Plan

The Environmental Protection Agency recently issued its first Chemical Action Plan (CAP).  The plan deals with  phthalates, which are found in some food packaging and cosmetics.  But anyone in the chemical industry should take notice, as this CAP comes as part of EPA’s efforts to enhance the existing chemicals program under the Toxic Substances Control Act. EPA has identified an initial list of widely recognized chemicals, including phthalates, for action plan development based on one or more of the following factors: their presence in humans; persistent, bioaccumulative, and toxic  characteristics; use in consumer products; or production volume.

Although many in industry support  EPA’s effort to update agency actions for prioritized chemicals under TSCA, there is much to question in this effort so far, including the fact that the initial set of chemicals seem to have been selected based on their current “high-profile” nature. EPA should prioritize chemicals for the CAP program based on scientific criteria that reflect available hazard, use, and exposure information.  Despite the new Administration's campaign promises, there has been little transparency, and in fact great uncertainty, over the scientific basis for the selection of these chemicals.  Unfortunately, the CAP process to date provides no evidence of a systematic, science-based approach to chemicals management.

A large body of scientific data already exists about phthalates, and these products have been subject to numerous government safety assessments.  Bio-monitoring data shows that exposure to phthalates in the general public are below safety limits established by the EPA and the European Union. In assessing potential future restrictions on certain phthalates, EPA plans to weigh the relative toxicity and feasibility of phthalate substitutes. Identification of safer and affordable non-phthalate substitutes will be an important consideration in any action that would restrict the use
of these chemicals.  EPA intends to conduct a Design for the Environment and Green Chemistry alternatives assessment by 2012. The information developed could be used to encourage industry to move away from phthalates in a non-regulatory setting to expand risk management effects beyond whatever regulatory action might be taken under TSCA, or could be used as input to a regulatory action. 

EPA also intends to lay the groundwork to consider initiating in 2012 rulemaking under TSCA section 6(a) to further regulate phthalates. Readers know how regulatory events can spawn and impact toxic tort litigation.  It should be noted  that an Action Plan is intended to describe the courses of action the Agency plans to pursue in the near term to address its concerns. The Action Plan does not constitute a final Agency determination or other final Agency action.

 

 

 

 

IOM To Study 510(k) Process for Medical Devices

The U.S. Food and Drug Administration announced recently that it had commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States. (Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine is supposed to provide independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.)

The IOM study will examine a premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will apparently convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices (highest level of risk) generally require premarket approval to support their safety and effectiveness before they may be marketed. Class I and Class II devices pose lower risks and most Class II devices and some Class I devices can be marketed after submission of certain premarket notifications— the 510(k) applications.  A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective -- that is, substantially equivalent -- to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to pre-marketing approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and thus may require premarket approval.

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals: to make safe and effective devices available to consumers, and to promote innovation in the medical device industry. FDA says that during the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for a review of the adequacy of the premarket notification program in meeting these two goals.

As part of the study, the IOM will convene a committee to answer two principal questions: Does the current 510(k) process optimally protect patients and promote innovation in support of public  health? If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process? The IOM review is supposed to be completed in 2011.

The study comes after the U.S. House Subcommittee on Health held hearings concerning medical devices last June.  The Democratic majority said there is evidence of an approval system that is "broken" - - that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with sufficient confidence in their safety.  However, while critics point to a handful of device recall issues, more than 250,000 devices have gone through the 510(k) process.
 

FDA Considering Rules on Acrylamide in Food

The FDA is considering issuing guidelines on acrylamide content in food.  The agency has published a notice seeking comments from industry on the issue.

Acrylamide is a chemical formed primarily in baked and fried foods by a reaction between sugars and the amino acid asparagine. The reaction is partly responsible for the golden color and tasty flavor of baked, fried, and toasted foods. In 2002, some Swedish scientists reported unexpectedly high levels of acrylamide in carbohydrate-rich foods and also published a study associating the chemical to cancer in laboratory rats. Further research subsequently determined that acrylamide can form in some foods during certain types of high-temperature cooking.

FDA has not yet issued guidance for manufacturers on reducing acrylamide in food. However, it is anticipated by the agency that new information will soon be available about the toxicology of acrylamide, which may shed light on acrylamide's potential carcinogenicity in laboratory animals. Readers of MassTortDefense know how difficult it is to leap from animal studies to causation conclusions in human beings, because of the physiological and metabolism differences between species, the excessive dosages that are (and typically must be) given to experimental animals, and the varying biological defense mechanisms that species have to environmental insults.

International efforts to develop approaches to acrylamide mitigation are also beginning to prove successful. Moreover, FDA is aware that at least some manufacturers in the United States are seeking ways to reduce acrylamide in their products. In this context, FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

Health Canada recently added acrylamide to that nation’s toxic substances list, as part of its ongoing review of over 200 chemical substances in commercial use. It stated that current consumption levels “may constitute a danger in Canada to human life or health,” but it also acknowledged that research into a possible carcinogenic link for humans has so far been inconclusive.

In fact, dietary intakes of acrylamide are not related to increased risks of brain cancer, according to a recently released study of 58,279 men and 62,573 women, published by Maastricht University in the Netherlands. J.G.F. Hogervorst, et al., “Dietary Acrylamide Intake and Brain Cancer Risk,” 18 Cancer Epidemiology, Biomarkers & Prevention (2009).  Researchers have also reported in the Journal of the National Cancer Institute that dietary acrylamide was not linked to lung cancer risk, and that the compounds may even reduce the risk in women. "Lung Cancer Risk in Relation to Dietary Acrylamide Intake," 101(9) JNCI 651-662 (2009).

 

 

In seeking comments, the FDA has asked food manufacturers to respond with details of any manufacturing changes they have made, the success and cost-effectiveness of those changes, methods for acrylamide reduction that could be appropriate for smaller manufacturers, and changes to on-pack instructions for consumers to mitigate acrylamide formation.

 

 

FDA Commissioner Outlines New Enforcement Plans

Readers of MassTortDefense know how FDA actions can instigate and affect potential mass tort litigation involving drugs and devices. Last week, in a presentation to the Food and Drug Law Institute (FDLI), new FDA Commissioner Margaret A. Hamburg revealed that the FDA will implement procedural reforms designed to allow the agency to act more quickly and aggressively on the enforcement of food, drug, and medical device regulations. The FDA commissioner told FDLI that the federal watchdog will be a leaner and meaner organization under her leadership.


In her remarks, the Commissioner noted that while impressed by the commitment to compliance that many companies have made – both in terms of their corporate culture and their investment in compliance systems -- her goal is for all companies to make and implement such a commitment in order to prevent harm to the public. A key part of the strategy to support private sector compliance is more effective enforcement against violations of the law. She suggested that such enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.

An effective enforcement strategy depends on several key elements she said:

  • The FDA must be vigilant. Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, FDA will.
  • The FDA must be strategic, she continued. The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong message to discourage future offenses.
  • The FDA must be quick. The agency must be able to respond rapidly to egregious violations or violations that jeopardize public health.

More specifically, she said the pathways for enforcement action can be too long and arduous. To address this, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, it will expect a prompt response to the findings, generally no more than fifteen working days before the FDA moves ahead with a warning letter or enforcement action.

Second, the FDA will take steps to speed the issuance of warning letters. There will be a new policy to limit warning letter review to significant legal issues.

Third, the FDA will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, she said, the FDA will no longer issue multiple warning letters to non-compliant firms before taking enforcement action. And, in the case of significant health concerns or egregious violations, FDA will consider immediate action – even before issuing a formal warning letter.

Finally, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, it will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. One can imagine how the obtaining or failure to obtain a close-out letter may be anissue in litigation.
 

Presidential Memo On Preemption Sends A Warning

Along with my partner Andy Gaddes, I taught a recent CLE seminar on products liability issues.  One of the topics the attendees -- in-house counsel from a variety of industries -- were most interested in was President Obama's May, 2009 memorandum to federal agencies reversing the Bush administration's well-reasoned preemption policy.
 
The new policy is contained in a memo, not a formal executive order, but it clearly expresses a new view of preemption. Cloaked somewhat ironically in the guise of "state's rights", the policy comes from an administration that apparently has no trouble expanding the role of the federal government in unprecedented ways, taking over the auto companies, banks, and others.
 
The memo provides that heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.  Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the Administration's new interpretation of the legal principles governing preemption.  Finally, heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under the new interpretation of the applicable legal principles governing preemption.
 
The legal basis of the doctrine is not really that malleable. Federal preemption is derived from the supremacy clause of the Constitution that says federal law is the supreme law of the land and any conflicting state law or regulation is without effect.  The policy basis of the doctrine is equally clear: allowing each state to set diverse and individual safety standards can undercut needed uniformity and can subject manufacturers to expensive, unfair, and confusing requirements. It forces product sellers to potentially navigate a confusing, often contradictory patchwork quilt of up to 50 sets of laws and regulations.  Of course, the preemption issue affects more than traditional administrative regulation by the states: companies may become subject to regulation by litigation at the hands of the plaintiffs' bar. 
 
The new policy has the potential to create a real chilling effect in agencies that should be clear about the preemptive intent and reach of their regulations.  While the Obama administration claims its approach breaks no new ground, it may well fundamentally weaken the federal government's ability to address problems on a national level and thus may have untended consequences by allowing states to interfere with parts of the Obama administration's domestic agenda. Regulations for health care and climate change, for example, arguably cannot work absent preemption.
 
Preemption has been applied to drugs and medical devices, vehicular roof crush standards issued by the National Highway Traffic Safety Administration, mattress flammability standards issued by the Consumer Product Safety Commission, pesticides regulated by the EPA and a variety of other products.  A majority of the regulations containing preemptive language were issued by the FDA and NHTSA.   
 

 

Bill to Beef Up FDA Food Safety Power Passes Committee

The House Energy and Commerce Committee last week approved legislation that would give the FDA more funding and power to police food safety.  The unanimous voice vote for a version of the bill offered by committee Chairman Henry Waxman (D., Calif.) came after extensive negotiations between Democrats and Republicans. The "Food Safety Enhancement Act of 2009,"  H.R. 2749, will now go to the entire House.

The bill comes at least in part in response to recent outbreaks of illnesses traced to tainted spinach, peanuts, hot peppers and other foods. The legislation would give the FDA greater authority to order food recalls, impose new civil penalties, and require inspections of so-called high-risk food facilities at least once a year.  It also calls for companies to keep detailed records to help the FDA more quickly trace the distribution of tainted foods and track the source of the contamination.  Specifically, the FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food.
 

The Grocery Manufacturers Association, a food industry group, released a statement in support of the bill, after Democrats agreed to a number of changes. (For example, they added a cap so no company would be charged more than $175,000 in fees to pay for the new bill.)  Critics of the bill argue that it would impose a one-size-fits-all regulatory scheme on big and small farms and on national and local food producers; does not address the major underlying causes of food safety problems such as industrial agriculture practices and the consolidation of our food supply. Others assert that the bill, by apparently empowering the FDA to regulate how crops are raised and harvested, puts the federal government right on the farm, dictating to farmers "good farming practices" on organic farming, use of manure, GMO animal feed, animal drugs, and petrochemical fertilizers and pesticide issues.

At last report, the House hasn't scheduled a vote on the legislation. In the Senate, Illinois Democrat Dick Durbin has introduced similar food-safety legislation.

 

New Report from Project on Emerging Nanotechnologies

A new report from the Project on Emerging Nanotechnologies argues that existing health and safety agencies are unable to cope with the risk assessment, standard setting, and oversight challenges of advancing nanotechnology. The new report, Oversight of Next Generation Nanotechnology, says the nation needs a new agency to deal with the health and environmental impacts of these technically complex products promised by rapid 21st century scientific advances.

Nanotechnology involves working at the scale of single atoms and molecules. The U.S. government defines nanotechnology as “the way discoveries made at the nanoscale are put to work.” The nanoscale is roughly 1–100 nanometers. There are 25.4 million nanometers in an inch and 10 million nanometers in a centimeter.

Nanoscale materials often behave differently than materials with a larger structure do, even when the basic material (e.g., silver or carbon) is the same. Nanomaterials can have different chemical, physical, electrical, and biological characteristics. For example, an aluminum can is perfectly safe, but nano-sized aluminum is explosive.

The novel characteristics of nanomaterials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and environmental risks (and thus product liability and mass tort risks) of the products of nanotechnology. A body of literature speculates about the potential for unusual health and environmental risks given that nanometer-scale particles can get to places in the environment and the human body that are inaccessible to larger particles. Nanomaterials have a much larger ratio of surface area to mass than ordinary materials do. It is at the surface of materials that biological and chemical reactions take place, and so some expect nanomaterials to be more reactive than bulk materials.

The report explains that almost all the current applications of nano are “passive,” in that they involve adding a nanomaterial to an ordinary material as a way of improving performance. For example, adding carbon nanotubes to rubber can greatly increase the toughness of the rubber without reducing its flexibility. Passive nanotechnology applications thus include using materials like carbon nanotubes, silver nanoparticles and porous nanomaterials to add functionality to products by nature of their physical and chemical form, rather than by how they respond to their environment.

Second generation, "active" nanostructures, typically involve nanometer-scale structures that change their behavior in response to changes in their environment. These changes might come about as a result of a mechanical force, a magnetic field, exposure to light, the presence of certain biological molecules or a host of other factors.

A good deal of research, involving a variety of different nanotechnologies, is being devoted to cancer detection and cure. One of the main goals of using nanotechnology for medical purposes, observes the report, is to create devices that can function inside the body and serve as drug delivery systems with specific targets. Another hot area: researchers are exploring the use of nanomaterials and nanotechnology techniques to vastly improve computers.

Even the first-generation nanotechnologies challenge traditional risk assessment methods, argues the report. Multiple characteristics contribute to the potential toxicity of many nanomaterials; they include not just mass or number of particles but also the shape of the particles, the electrical charge at the particle surface, the coating of the particle with another material and numerous other characteristics. Science has yet to determine which of these characteristics are most important under what circumstances.

After describing the current regulatory regime, the paper calls for a more unitary regulatory approach, including a new Department of Environmental and Consumer Protection to oversee product regulation, pollution control and monitoring, and technology assessment.
 

Think Tank Releases Nano-Technology Report

A Washington, DC think tank last week released a new report with suggestions on how the next administration should approach regulation of nano-technology in products.  The Project on Emerging Technologies is based at the Woodrow Wilson Center in Washington. The Project was established in 2005 as a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. The Project is dedicated to helping ensure that as nanotechnologies advance, possible risks are minimized, public and consumer engagement remains strong, and the potential benefits of these new technologies are realized.

Nanotechnologies are hailed by many as the next industrial revolution. They promise to change everything from the cars we drive to the clothes we wear, from the medical treatments our doctors can offer to our energy sources and workplaces. Although focused on very small particles, nanotechnologies offer large potential benefits. From new cancer therapies to pollution-eating compounds, from more durable consumer products to detectors for bio-hazards like anthrax, from novel foods to more efficient solar cells, nanotechnologies are changing the way people think about the future.

The Project on Emerging Nanotechnologies collaborates with researchers, government, industry, NGOs, policymakers, and others to look long term, to identify gaps in knowledge and regulatory processes, and to develop strategies for closing them. The Project's stated mission is to try to provide independent knowledge and analysis that can inform critical decisions affecting the development and commercialization of nanotechnologies.

A source of uncertainty for nanotechnology is regulation. The Project released a 28-page regulatory agenda for the next administration, noting that whichever candidate wins is going to have to deal with this issue, probably sooner rather than later. The next president has the opportunity to ensure that nanotechnology’s benefits will be maximized and its risks identified and mitigated, says the group. 

The report, Nanotechnology Oversight: An Agenda for the Next Administration, calls for the White House and federal agency policymakers to maximize the use of existing laws to improve nanotechnology oversight. Such measures include defining nanomaterials as “new” substances under federal toxics and food laws, thereby enabling the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) to consider the novel qualities and effects of nanomaterials. The group addresses whether the Federal Food, Drug and Cosmetic Act, the Toxic Substances Control Act and the Consumer Product Safety Act need to be amended to cover nanotechnology.

The Project notes that more nanotech products are hitting the market. From March, 2006 to February, 2007, the number of manufactured goods using nanotech tripled to 600.  For fiscal 2009, the federal government has devoted $1.5 billion to nanotech, a sum split up between various agencies. Under the Bush administration, EPA has a Nanoscale Materials Stewardship Program, which is endorsed by the Synthetic Organic Chemical Manufacturers Association, the American Chemistry Council and the NanoBusiness Alliance. Some state governments, however, are pushing forward with their own rules on nanotech.

Coincidentally, consumer advocates said this week that food produced by using nanotechnology is quietly coming onto the market, and they want U.S. authorities to force manufacturers to identify them. New consumer products created through nanotechnology are coming on the market at the rate of 3 to 4 per week, according to The Project on Emerging Nanotechnologies.

MassTortDefense has posted on nanotechnology here and here.