House Committee Approves Asbestos Bill

Quick note for our readers who follow asbestos mass tort issues:  the House Judiciary Committee decided in a 17–14 party-line vote this week to reject  various proposed amendments to the Furthering Asbestos Claim Transparency Act of 2013 (H.R. 982).  The FACT Act would require the various asbestos settlement trusts to make public disclosures detailing the claims to the trust and to provide certain information about claims on request (but not confidential medical records).  The amendments were proposed by Democrats opposing the bill.

The Full Committee Markup of H.R. 982 is here.  Hearing information regarding the 3/13 hearing on the bill is here

Passage of the Fact Act would allow defendants to properly assess a plaintiff’s complete exposure history. As it stands, plaintiffs often hide behind trust confidentiality to make solvent defendants believe that their products were far more responsible for the plaintiff’s disease than the true picture.  As asbestos liabilities force more and more companies to file for bankruptcy, legislators need to preserve assets for appropriate claimants; the secrecy and abuse associated with the trusts undermines this as well.

 

Hearing Questions EPA Stance on Fracking

The House Subcommittee on Energy and Environment held a hearing earlier this week to review federal hydraulic fracturing research activities. The hearing examined research activities by the Environmental Protection Agency (EPA), Department of Energy (DOE) and the Department of Interior (DOI) in an inter-agency effort to “address the highest priority challenges” related to the production of domestic unconventional oil and natural gas resources.  Readers may recall we have posted about fracking issues before. 

Chairman Lamar Smith (R-Texas) noted a widely publicized handful of unsubstantiated charges that fracking pollutes ground water; the EPA is at the center of this debate, linking fracking to water contamination in at least three cases, only to be forced to retract their statements after further scrutiny.

Members questioned administration witnesses on the objectives of the interagency initiative as they relate to the administration’s regulatory intentions and track record of unsubstantiated attacks on the safety of hydraulic fracturing.  

Witnesses included:

Dr. Kevin Teichman, Senior Science Advisor, Office of Research and Development, Environmental Protection Agency
Mr. Guido DeHoratiis, Acting Deputy Assistant Secretary for Oil and Gas, Office of Fossil Energy, Department of Energy
Dr. David Russ, Regional Executive, Northeast Area, U.S. Geological Survey
Dr. Robin Ikeda, Acting Director, Agency for Toxic Substances and Disease Registry, Department of Health and Human Services

The hearing also noted the administration’s interagency working group had committed to release a draft of their research plan by October 2012 and complete the final plan by January 2013. The Administration has yet to even release a draft for public comment. 

Energy Subcommittee Chairman Cynthia Lummis (R-Wyo.) noted that her home state of Wyoming is at the center of this issue since the EPA put it in the national spotlight with a “draft” report implying that fracking was somehow responsible for the quality of the water. However, in the days and weeks that followed this announcement, the State of Wyoming, industry, and other federal agencies exposed EPA’s study as deeply flawed.

Environment Subcommittee Chairman Chris Stewart noted that largely as a result of the expanded use of cheap natural gas from 2005 to 2011, the U.S. has decreased its carbon dioxide output more than any other nation, including those countries that have implemented aggressive green energy agendas, such as Germany and Spain.  It is perhaps ironic that many of the most passionate advocates for action on climate change also oppose fracking.

Foreign Manufacturer Liability Act Unlikely to Pass Soon

We have posted before about efforts to pass legislation that would impact the ability of U.S. consumers to sue foreign manufacturers.

As the end of the year approaches, it appears that the latest version, the Foreign Manufacturers Legal Accountability Act (FMLAA) of 2011, will not be approved. Senate Bill 1946 and House of Representatives Bill 3646 are among the latest attempts to impact suits against foreign product makers.  Both would require foreign manufacturers importing products into the U.S. to establish a registered agent to accept service of process. And the registration of the agent would constitute consent to the personal jurisdiction in the U.S.  

Earlier versions of the legislation gained support in the wake of issues relating to products from China and, especially, the Chinese drywall litigation. Supporters of the legislation included some domestic industries, such as textiles. They also garnered opposition from foreign governments, some U.S. manufacturer groups, and non-U.S. manufacturers in the European Union and the Confederation of Indian Industry, and others. Even supporters noted that the bills did not directly address another related issue, the enforcement of U.S. judgments overseas. 

 

Industry Weighs in on "Safe Chemicals" Bill

A variety of companies and chemical industry trade groups weighed in last week on a bill to amend the decades-old Toxic Substances Control Act.   

Several dozen interested parties, including the National Association of Manufacturers, American Chemistry Council, and American Petroleum Institute, sent a letter to the U.S. Senate noting their objections to S. 847 — dubbed the Safe Chemicals Act -- that the Environment and Public Works Committee recently sent to the Senate floor. 

We have posted about this bill before.  It would give the EPA revised authority to regulate a broader range of potentially toxic chemicals.  But it would establish an unworkable safety standard, and would require an enormous amount of additional government resources to implement. The bill would also dramatically increase the time it would take for EPA to review new chemicals and undermine long-standing protections of trade secrets, seriously hampering innovations in new products and technologies.

In their letter, the groups said that the bill that did not reflect the input of the Republican Senators or many of the stakeholders on all the very complex issues involved in updating TSCA. On July 25th, the EPW Committee held a markup of S. 847, and then voted along party lines to approve the bill.

The industry groups said they wholeheartedly support the continuation of a bipartisan process to discuss the right concepts needed in legislation to effectively reform the Environmental Protection Agency’s ability to regulate chemicals. But they believe that S. 847 as reported by the Committee does not accomplish this goal.  They continue to support sound, science and risk-based legislation to update TSCA, and will work with Senators on such new legislation.


 

 

CPSC Commissioners Testify At Hearing Regarding Database

Issues about the product complaint database set up by the U.S. Consumer Product Safety Commission bubbled over again last week.  We have posted on the topic before.

The CPSC-operated database allows consumers, government agencies, and others to submit reports of alleged injury or death allegedly caused by a product. Since the beginning of the database notion, there have been serious concerns about the accuracy and confidentiality of reports of alleged injury submitted and conveyed back to the public in the database. There has always been an apparent lack of attention to legitimate issues of a manufacturer's goodwill and reputation, to the costs of unnecessary panic among product consumers, and the mischief that some plaintiffs' lawyers might cause with unwarranted increase in litigation against manufacturers.  Obviously, false or inaccurate information does not serve the interests of consumers. And CPSC allows reports by parties who are more likely to have an agenda that goes beyond merely advising CPSC of an incident. The possibility that someone might attempt to seed the database with inaccurate or misleading information to provide ostensible support for lawsuits is a real concern for many observers.

As we noted, an anonymous company sued the CPSC last Fall over an apparently false report in the database.

Last week, Commissioner Anne Northup testified before a Subcommittee on Commerce, Manufacturing, and Trade of the House Energy and Commerce Committee at a hearing on “Oversight of the Consumer Product Safety Commission.” She addressed generally the issues with CPSC regulatory approaches. Commissioner Nord also testified, and she has reported that many of the complaints on the database were filed by law firms.

Chairwoman Mary Bono Mack, R-Calif., noted that the public database remains a source of controversy. Manufacturers continue to express their concern that most of the complaints are not vetted by the CPSC before they are made public, "opening the door to all kinds of mischief, whether to fuel law suits or to try and ruin a competitor’s brand."

Video of the hearing here.

TSCA "Reform" Bill Moves To Senate Floor

Over the past several years, Congress has wrestled with chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to this principal toxic substance law. 

Recently, a U.S. Senate committee advanced yet another bill that would revise the decades-old  regulation for chemicals. The Senate Committee on Environment and Public Works voted 10-8 (along party lines) to move S. 847, the so-called Safe Chemicals Act, to the Senate floor.

The bill would require the Environmental Protection Agency to establish new minimum data sets for chemical substances; identify required testing of any chemical substances; create various hurdles for a manufacturer before making any new chemical substance;  update a list of chemical substances warranting placement within one of three priority classes regarding risk management; and, importantly, requires substance manufacturers and processors to bear the burden of proving that chemical substances meet applicable safety standards.  The bill would also establish an Internet-accessible, public database of information on the toxicity of, use of, and exposure to chemical substances.  The bill would also drastically narrow the conditions under which data about chemical substances may be treated as confidential business information.

The chemical Industry remains committed to working with the Senate Committee on Environment & Public Works to pursue reform of TSCA, but views this as a partisan markup of a bill that is inconsistent with balanced reform.  Specifically, the bill would establish an unworkable safety standard, and would require an enormous amount of additional government resources to implement. The bill would also dramatically increase the time it would take for EPA to review new chemicals and undermine long-standing protections of trade secrets, seriously hampering innovations in new products and technologies.

 

 

House Subcommitee Chair Questions EPA Approach on Fracking

We have posted before about the tremendous economic promise of fracking technology, and the attempts of the plaintiffs bar to exploit this promise.  Another piece of the evolving puzzle has been the regulatory issues.

House Subcommittee on Energy and Environment Chairman Andy Harris (R.-Md.) earlier this month sent a long letter to Environmental Protection Agency (EPA) Administrator Lisa Jackson requesting information and documents related to the Agency’s activities with respect to hydraulic fracturing.
 

The letter expressed frustration with EPA's "lack of transparency and responsiveness" surrounding its fracking approach, and with the agency's "confusing and questionable" approach to fracking regulation.  The letter cites numerous examples of EPA "leaping to scientific conclusions before having all the facts."  These include claims that fracking operations in Parker County, Texas, had affected drinking water, later retracted; and alleged fracking contamination in Dimock, Pa. only later to conclude the water was safe to drink.

The letter worries that such examples, while individually very troubling, "collectively suggest EPA is not objectively pursuing an improved understanding of the relationship between hydraulic fracturing and drinking water, but rather is determined to find fault with the technology in order to justify sweeping new regulations.”

 

House Hearing on CAFA- Seven Years Later

A topic near and dear to the hearts of readers of MassTortDefense was the subject of a recent hearing by a subcommittee of the U.S. House Judiciary Committee. Entitled "Class Actions Seven Years After the Class Action Fairness Act,” the hearing was designed to address what has worked with the law, what has not, and what Congress overlooked when it passed CAFA.

Witnesses included a plaintiff-side attorney, who typically complained about CAFA's impact on consumer fraud class actions, and Professor Redish from Northwestern, who talked about the need for legislative revision of the use of so-called “cy pres” awards in class action proceedings in particular.

Rep. Trent Franks (R-Ariz.) is the chairman of the Subcommittee on the Constitution, and has expressed concern over the ability of plaintiffs to engage in a new form of forum shopping under CAFA, filing cases in particular federal circuits they think are more hospitable to class actions.

John Beisner, who typically represents defendants in class actions, testified on behalf of the U.S. Chamber Institute for Legal Reform; he noted that a small number of judicial rulings have ignored Congress’s intent behind this landmark legislation, meriting further legislative attention. From imposing a heightened “legal certainty” standard on defendants with respect to CAFA’s amount-in-controversy requirement to broadly construing CAFA’s narrow exceptions to federal jurisdiction, these rulings run afoul of CAFA’s presumption in favor of federal jurisdiction. Second, he argued that Congress should also assess certain troubling aspects of federal class action jurisprudence that were not affected by CAFA. These issues include: (1) efforts by a small number of federal courts to loosen the requirements of Rule 23; (2) the increasing use of cy pres settlements to support large fee payouts to class counsel; and, he noted, (3) judicial approval of class actions that encompass substantial numbers of uninjured individuals (that is, persons who lack Article III standing).

House Passes FDA Reauthorization Bill

The House of Representatives last week passed a bill (387 to 5 vote) that would reauthorize the Food and Drug Administration's user fee programs and amend the rules regarding marketing exclusivity, medical device safety, drug importation, and other FDA programs. The "FDA Reform Act of 2012," H.R. 5651, reauthorizes and amends various user fee statutes, creates new and additional user fees, reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, changes the rules for public comment on draft guidance documents, and contains new provisions dealing with drug shortages.  The fees are supposed to reflect agreements negotiated between the FDA and industry regarding about $2.8 billion in user fees over five years.

The vote came shortly after the Senate approved its own version of FDA legislation, S. 3187 (the FDA Safety and Innovation Act). The Senate bill was also passed with bipartisan support.

The differences between the House and Senate bills now must be worked out in conference. The bills differ in a variety of ways, such as which antibiotics will be eligible for incentives, which include a five-year extension of market exclusivity. The bills also differ on the details of a national  track-and-trace system for drugs. The Senate bill also included language about Risk Evaluation and Mitigation Strategies (REMS) which is not in the House version. See a comparison of the bills here.  Various observers report that House and Senate leaders expect to have a compromise bill for the President to sign in early July.

 

New Law Takes Effect Regarding Venue, Removal

For all the litigators out there, a reminder that The Federal Courts Jurisdiction and Venue Clarification Act of 2011, H.R. 394, P.L. 112-63. took effect last week.  The act amends the federal jurisdictional statutes regarding diversity jurisdiction (28 U.S.C. § 1332), venue (28 U.S.C. §§ 1390-92, 1404), and removal (28 U.S.C. §§ 1441, 1446, 1454).  Legislative history here.

Among its provision, the new act states that, with respect to diversity, the district courts shall not have original jurisdiction of any civil action between citizens of a state, and citizens or subjects of a foreign state who are lawfully admitted for permanent residence in the United States and are domiciled in the same state.

It modifies the citizenship rules to treat corporations as citizens of any foreign state: (1) by which it has been incorporated, and (2) where it has its principal place of business. It treats insurers as citizens of any foreign state: (1) of which the insured is a citizen, (2) by which the insurer has been incorporated, and (3) where the insurer has its principal place of business.

The law now dictates that, upon removal of any civil action with both removable and non-removable claims, the district court shall sever from the action all non-removable claims and remand them to the state court from which the action was removed.  So no discretion to hold on to such claims.

The law prescribes revised requirements for filing notices of removal, including allowing statements in the notice of the amount in controversy, when it exceeds the necessary amount, if the initial pleading seeks: (1) non-monetary relief; or (2) a money judgment, but where the relevant state practice either does not permit demand for a specific sum or permits recovery of damages in excess of the amount demanded. Removal of the action is proper on the basis of an amount in controversy asserted this way,  if the district court finds, by the preponderance of the evidence, that the amount in controversy exceeds the amount required.

Importantly, the law now allows removal of a case based on diversity of citizenship more than one year after commencement of the action if the district court finds that the plaintiff has acted in bad faith in order to prevent a defendant from removing the action.  This deals with a common plaintiff tactic in mass torts, such as the inclusion of a treater simply to defeat diversity. In 1988, Congress amended the statute to prohibit the removal of diversity cases more than one year after their commencement. This change was intended to encourage prompt determination of issues of removal in diversity proceedings, and it sought to avoid the disruption of state court proceedings that might occur when changes in the case made it subject to removal. The change, however, led some plaintiffs to adopt removal-defeating strategies designed to keep the case in state court until after the 1-year deadline passed. In those situations, some courts have viewed the 1-year time limit as `jurisdictional' and therefore an absolute limit on the district court's jurisdiction.

The new venue provision requires the issue of proper venue of any civil action brought in a U.S. district court to be determined without regard to whether the action is local or transitory in nature. It repeals the "local action" rule that any civil action, of a local nature, involving property located in different districts in the same state, may be brought in any of such districts.  It also allows a district court to transfer a civil action to any district or division to which all parties have consented.

Significantly, the act resolves a circuit split regarding the time each defendant in a multi-defendant case has to file a notice of removal. Traditionally, the defendant had 30 days from receipt of the plaintiff’s complaint to file a notice of removal.  But in multi-defendant cases, some courts have adopted the “first-served” rule, under which each defendant in a case had 30 days from the date on which the first defendant was served, while others adopted the “later-served” rule, which gives each defendant a 30-day period to file a notice of removal after that defendant is served.  The new law adopts the latter view (but keeps the unanimity rule.)

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. 

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. 

 

House Hearing on Food Marketing to Kids -- Seller Beware

Two subcommittees of the House Energy and Commerce Committee, the Subcommittee on Commerce, Manufacturing, and Trade and the Subcommittee on Health, held a joint hearing last week on the issue of “Food Marketing: Can ‘Voluntary’ Government Restrictions Improve Children’s Health?”

Speakers came from the CDC, the U.S. Department of Agriculture, the FTC, Campbell Soup Company, and the Association of National Advertisers.

The background of the hearing is that the 2009 Consolidated Appropriations Act contained report language forming an Interagency Working Group (IWG), comprised of the Federal Trade Commission, the Department of Health and Human Services, and the Department of Agriculture. The IWG was tasked with conducting a study and issuing a report to Congress concerning standards for marketing food to children.  Instead of conducting the prescribed study or providing a report to Congress, the IWG issued a document entitled “Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts.”

The document presented a a sweeping set of “voluntary” principles for marketing foods to kids,  based on nutritional standards that exceed and conflict with those of other government programs. They also reflect a tenuous grasp of science, lacking evidence, critics say, showing that childhood obesity is related to advertising of food that doesn’t comply with the proposed principles.  The guidelines are so restrictive that many healthy foods, like low-fat yogurts, whole wheat bread, and 2% milk could not be marketed to those 17 and under. Even non-sweetened cereals would not meet the IWG guidelines.  According to one analysis, 88 out of the 100 most advertised foods and drinks would be in violation of these standards.

Regardless of whether a child sees a commercial for an item, the ultimate purchasing decision rests with the parent who purchases the groceries – and those groceries carry nutrition labels that every parent can read.  Of course, this is the nanny state rearing its head again. And there are serious issues of infringement of constitutionally protected commercial speech.

But a legitimate concern to our readers is that while these guidelines are labeled as voluntary, what happens when a litigious group sues a food manufacturer because it showed a commercial advertising a new kind of chocolate treat or drink that does not comply?  Our readers are surely familiar with example of courts allowing plaintiff experts to note "voluntary" or "recommended" guidelines.

House Committee Votes To End Funding for CPSC Database

The House Appropriations Committee voted last week (tally 27–21) to send a funding bill to the House floor that would cut off funds from being used for the Consumer Product Safety Commission's new consumer database.

Readers may recall that the Consumer Product Safety Improvement Act of 2008 mandated the creation of a consumer product safety information database, and from the beginning, there was controversy about the absence of a process for addressing false and inaccurate reports that will scare consumers, harm business, and generate no additional safety gains; the need to employ means to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports; the importance of  not putting the governmental imprimatur on voluntary data that has not been verified; and the absence of a sufficient time period allocated for manufacturers to evaluate and respond to any proposed report.

As we have posted, the U.S. Consumer Product Safety Commission gave final approval late last year to the new consumer product safety database, overriding very real concerns about who should be permitted to submit incident reports and how they will be verified as accurate. CPSC commissioners split along party lines in the 3-2 vote, which came after a final discussion of whether the regulation would simply give certain interest groups a new forum to attack product makers and plaintiff lawyers a new tool, giving rise to lawsuits based on a rumor repeated through the echo chamber of the Internet.

Manufacturers have limited control over what information can be removed or amended once posted. The two dissenting votes made an unsuccessful attempt to amend the final rule so as to give manufacturers more time to comment on or respond to the accuracy of postings before they are published to the database and to the public.

The database is accompanied by a weak disclaimer stipulating that CPSC has not verified the accuracy of any report. Observes worry that the agency has not paid sufficient attention to legitimate issues of a manufacturer's goodwill and reputation, to the costs of unnecessary panic among product consumers, and the mischief that plaintiffs' lawyers might cause with unwarranted increase in litigation against manufacturers.

The bill just passed out of committee would cut CPSC's overall budget by about $3.5 million—approximately the same amount needed for the database—from FY 2011 levels, and provides that  no funds may be used to carry out any of the database activities.  It appears the bill will be taken up on the House floor in July. 

While consumer groups have opposed the funding cut-off, the majority on the committee agreed with the concern about the risks of unverifiable and inaccurate consumer comments that may be submitted. In the meantime, a 2011 continuing resolution requires the GAO to conduct an analysis of the database.

 

 

Why We Can't Sue Our Way to Prosperity

The House Judiciary Committee's Subcommittee on the Constitution held a hearing earlier this week on "Can We Sue Our Way to Prosperity?: Litigation's Effect on America's Global  Competitiveness."

Speakers included a public policy expert from NERA; a law school professor; and my friend, esteemed litigator John Beisner.

Paul Hinton testified that the direct cost of the U.S. tort system is estimated to be approximately $250 billion in 2009 or about 2 percent of GDP.  The U.S. costs are the highest as a percent of GDP amongst those reported for other industrialized countries and more than double the estimates for countries such as the U.K, France, and Japan.  Small businesses bear a relatively larger share of tort costs than larger businesses.

Professor Silver from Texas tried to make the case that the civil justice systems contributes greatly to the prosperity of the U.S.  He seemed to think that litigation is the only thing that deters doctors from committing widespread medical malpractice.

John Beisner noted that given the lucrative potential of private lawsuits in the U.S., it is not surprising that fraud has crept into the system. One notable example is the fraud that may have  occurred with respect to asbestos bankruptcy trusts. In addition, some lawyers have engaged in questionable tactics to recruit clients – tactics that have encouraged the filing of frivolous or fraudulent claims. The most notorious of these efforts, he observed, have been the massive screening programs undertaken in the silica and welding-fume litigation, both of which resulted in the mass filing of meritless and even fraudulent claims – and forced defendants to spend huge sums of money defending themselves against groundless allegations. In addition, Beisner pointed out, more and more plaintiff lawyers are using the internet to troll for clients and sow dissatisfaction with products in advance, in the hopes of generating large bodies of claims against targeted defendants. "These efforts have contributed to the deluge of meritless lawsuits that clog the civil justice system."

Another troubling development he noted in the American civil justice system has been the rise in
foreign lawsuits with virtually no nexus to the United States. In addition to transnational tort cases, the American civil justice system has also seen an uptick in efforts to enforce foreign judgments in U.S. courts.

Although the enactment of the Class Action Fairness Act of 2005 dramatically reduced class-action abuse, several serious problems remain in the aggregate litigation arena, including (1) state attorney general actions; (2) the routine deprivation of due process in class actions that remain in state courts; and (3) mass joinder actions.

The hearing comes as the Judiciary Committee considers the Lawsuit Abuse Reduction
Act
, which would call for greater sanctions for Rule 11 violations to deal with frivolous claims. 
 

Senate Judiciary Committee Approves "Sunshine" Bill That Clouds Up Settlements

Here at MassTortDefense we know that while not the "sexy" part of litigation, the nuts and bolts of settlement agreements are crucial to clients.  That is why it caught our eye that the U.S. Senate Judiciary Committee last week approved a bill that would require courts to consider so-called public health and safety concerns before approving the sealing of certain legal agreements and settlements in product liability suits.

The committee voted 12-6 to pass S. 623, the so-called Sunshine in Litigation Act. The bill would  prohibit a federal court, in any civil action in which the pleadings state facts relevant to the "protection of public health or safety," from entering an order restricting the disclosure of information obtained through discovery, or from approving a settlement agreement that would restrict such disclosure, or restricting access to court records, unless in connection with that order the court has first made certain findings of fact.  Specifically, the bill requires the court to find that: (1) the order would not restrict the disclosure of information relevant to the protection of public health or safety; or (2) the public interest in the disclosure of past, present, or potential health or safety hazards is outweighed by a specific and substantial interest in maintaining the confidentiality of the information, and the requested protective order is no broader than necessary to protect the confidentiality interest asserted.

The bill similarly would prohibit the court from enforcing any provision of a settlement agreement that prohibits a party from disclosing that a settlement was reached or the terms of the settlement, other than the amount paid, or from discussing the civil action, or evidence produced in it, that involves matters relevant to the protection of public health or safety -- unless, again, the court finds that the public interest in the disclosure of past, present, or potential health or safety hazards is outweighed by a specific and substantial interest in maintaining the confidentiality of the information or records in question, and the requested order is no broader than necessary to protect the confidentiality interest asserted.

Surprisingly Republican Senators. Orrin Hatch, R-Utah, and Chuck Grassley, R.-Iowa, joined all 10 Democrat committee members in support. But the bill seems ill-conceived and even unnecessary. As pointed out by the American College of Trial Lawyers' Federal Rules of Civil Procedure Committee, the bill would establish an undesirable precedent by circumventing the procedure set out in the Rules Enabling Act that Congress established for amending the Federal Rules of Civil Procedure. These kind of ad hoc legislative initiatives that address specific parts of the Federal Rules contradict the careful, open, deliberative, rigorous ways that the rules have been amended from time to time.

Moreover, the bill would would unduly restrict the discretion of trial judges to regulate civil litigation and would impose substantial new fact-finding burdens on the courts, without a demonstrated need for those changes.  There is no compelling evidence that protective orders governing discovery or confidentiality provisions in settlement agreements are frequently abused. Nor is there evidence that federal courts do not currently have the power to regulate those agreements. 

Moreover, as written, the bill would lead to more confusion, not less, regarding what information has to be released, and when.  As pointed out by Steve Zack, President of the ABA, the language is is vague and indefinite, threatening to sweep up many cases having little to do with true public health or safety.  And it certainly would  require the parties and courts to spend extensive time and resources litigating whether and how the statute applies.  The politicians seem to forget  that protective orders are critical to both plaintiffs and defendants, including by helping to safeguard against dissemination of highly personal sensitive information or trade secrets.  

Perhaps Congress should spend less time on restricting judicial discretion and more on seeing that federal judges are paid a market-competitive wage.  A district court judge on the bench since 1993 failed to receive a total of $283,100 in statutorily authorized but then-denied pay. Appellate court judges have lost even more.
 

Bills to Curb Frivolous Suits Introduced in Congress

With the Republicans in control of the House, many were wondering about the prospects for tort reform at the federal level.  Indeed, President Barack Obama observed in his State of the Union address on January 25, 2011, “I am willing to look at . . . ideas to bring down costs including reform to rein in frivolous lawsuits.” 

House Judiciary Committee Chairman Lamar Smith (R-Texas) earlier this month introduced legislation to reduce frivolous lawsuits. Senate Judiciary Committee Ranking Member Chuck Grassley (R-Iowa) then introduced a companion bill in the Senate (S.533).

The Lawsuit Abuse Reduction Act (LARA), H.R. 966, would impose mandatory sanctions for plaintiff lawyers who file merit-less suits in federal court. 

Chairman Smith argued that lawsuit abuse has become too common in American society partly because the lawyers who bring these cases have everything to gain and nothing to lose. Plaintiffs' lawyers can file frivolous suits, no matter how absurd the claims, without any penalty. Meanwhile defendants are faced with the choice of years of litigation, high court costs and attorneys' fees or a settlement. Our legal system encourages frivolous lawsuits while defendants are left paying the price even when they are innocent. Many of these cases have cost innocent people and business owners their reputations and hundreds of thousands of dollars.

Ranking Member Grassley noted that without the serious threat of punishment for filing frivolous lawsuits, innocent individuals and companies will continue to face the harsh economic reality that simply paying off frivolous claimants through monetary settlements is often cheaper than litigating the case. "This perverse dynamic not only results in legalized extortion, it leads to businesses spending money to defend against baseless lawsuits rather than to create new jobs."

The Lawsuit Abuse Reduction Act would take three steps to help thwart frivolous lawsuits.

* Reinstates the requirement that if there is a violation of Rule 11, there will be sanctions.

* Requires that judges impose monetary sanctions against lawyers who file frivolous lawsuits.

* Reverses the 1993 amendments to Rule 11 that allow parties and their attorneys to avoid sanctions for making frivolous claims by withdrawing them within 21 days after a motion for sanctions has been served.

The House Judiciary Committee has already held a hearing on the House version, at which witnesses included Elizabeth A. Milito of the NFIB Small Business Legal Center, Professor Lonny Hoffman of the University of Houston Law Center, and Victor E. Schwartz, well known tort reform advocate.


 

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.



 

Democrats Release Discussion Draft of FDA Bill

Five Democratic Congressmen released a discussion draft of possible legislation that would alter the powers of the U.S. Food and Drug Administration.  The bill would increase FDA's authority and funding to regulate the importation of foreign-manufactured drugs, and also give the FDA the authority to mandate recalls for unsafe drugs.

Rep. John D. Dingell, Chairman Emeritus of the Energy and Commerce Committee, Rep. Henry A. Waxman, Chairman of the Energy and Commerce Committee, Rep. Frank Pallone, Chairman of the Subcommittee on Health, and Rep. Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, released a discussion draft proposal, which builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year.

The discussion draft calls for "parity" between foreign and domestic drug facility inspections, would increase the number of pre-approval drug inspections, and would prohibit the importation of drugs into the United States lacking appropriate documentation of safety.  The legislation would also require manufacturers to take steps to ensure the safety of their supply chain.

The sponsors noted that the byproduct of Internet communications and a rapidly-evolving international marketplace is an increase in the purchase of medications from foreign sources. Cong. Pallone claimed that, “One of the downsides is quality control and one of the dangers is the threat to the health and safety of consumers. We need to find the best ways to vest the FDA with the ability and the authority to ensure the safety of medications consumed by Americans.”

Cong. Waxman said he would work with the FDA "and all stakeholders to move this legislation forward as soon as possible." But the current Congress is heading home for the November elections, and the measure's fate is unclear if Republicans take control of the House next year.

Senate Moves Forward With Compromise Food Safety Act

U.S. Senate negotiators apparently reached an agreement last week on food safety legislation in order to have it ready for the full Senate to consider when lawmakers return from the summer recess.

The group that negotiated the framework for the new Senate version of the Food Safety Modernization Act included Tom Harkin, D-Iowa; Mike Enzi, R-Wyo.; the bill's authors Dick Durbin, D-Ill., and Judd Gregg, R-N.H.; and lead co-sponsors Christopher Dodd, D-Conn., and Richard Burr, R-N.C.

The bill would require facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration.  It requires importers to verify the safety of foreign suppliers and imported food. It would give the FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently. The bill gives the FDA authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request. It has provisions to enhance surveillance systems to detect food-borne illnesses.

Significantly, this version does not include language banning BPA, as originally demanded by Sen. Feinstein.  Her prior insistence, despite a lack of scientific evidence supporting such a ban, was one of the major logjams for the bill. She says she still plans to introduce an amendment to ban BPA from children’s products as soon as the bill arrives on the Senate floor.  Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf-stable foods and beverages. The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic. What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.



 

 

House Holds Hearing on Proposed Toxic Chemicals Safety Act

The Subcommittee on Commerce, Trade, and Consumer Protection  of the House Committee on Energy and Commerce held a hearing on H.R. 5820, the “Toxic Chemicals Safety Act of 2010,” last week.  The proposed legislation would amend the Toxic Substances Control Act of 1976 to deal with potential risks resulting from chemical exposure.

Witnesses included Steve Owens from the EPA; Calvin M. Dooley, President and Chief Executive Officer of the  American Chemistry Council; and Beth Bosley, Society of Chemical Manufacturers and Affiliates, Inc.

Any approach toward updating federal chemical regulation should balance safety issues with the need to preserve the ability of the United States to serve as the innovation engine for the world; and protect the hundreds of thousands of American jobs fueled directly and indirectly by the business of chemistry.  That is, reforming TSCA to enhance the safety assessment of chemicals while maintaining the ability of the U.S. chemical industry to be the international leader in innovation and manufacturing.

It is clear that the standards established in this bill sets an impossibly high hurdle for all chemicals in commerce, and are guaranteed to produce significant technical, bureaucratic and commercial barriers. For example, the bill requires that “aggregate exposure” to a chemical or a mixture meet the “reasonable certainty of no harm” standard. This apparently means that when a chemical or mixture is listed for a safety determination, the manufacturer carries the burden of showing with reasonable certainty not just that the company’s use of the chemical and any resulting exposures from those uses pose no significant risk of harm, but that all other aggregated exposures from all other uses of the chemical pose no harm. It is not clear to MassTortDefense how any company could actually do that in the real world.  TSCA regulates thousands of chemicals, many with hundreds of uses. TSCA chemicals have multiple important industrial applications and consumer product applications. It is totally unclear how industry or even the EPA would be able to gather enough information to meet this aggregate exposure standard for each and every regulated substance.

The proposed bill thus creates a burden that seems far out of proportion to its benefit. The onslaught of new regulations may simply force customers of the industry to relocate their factories and make the products at issue overseas, outside the EPA's jurisdiction.  The bill would also  discourage the introduction of new chemicals, including new greener chemicals, into commerce in the United States.  Congress, keep working at it.
 

"SPILL" Act Passes House

Readers may recall that last month we posted about H.R. 5503, the “Securing Protections for the Injured from Limitations on Liability Act” (SPILL Act). This is one of many pending and promised bills addressing legal liability issues arising from the Gulf Coast oil spill, including amendments to the Death on the High Seas Act.

Specifically, H.R. 5503 would:

  • Amend the Death on the High Seas Act to permit recovery of non-pecuniary damages (e.g., pain and suffering and loss of care, comfort, and companionship) by the decedent’s family, as well as standardizing the geographic threshold for its application, and permitting surviving family members to bring suit directly rather than through a personal representative.
  • Amend the Jones Act to permit recovery of non-pecuniary damages by the families of seamen who are killed.
  • Repeal the Limitation on Liability Act to the extent it limits the liability of vessel owners to the value of the vessel and its cargo.
  • Amend bankruptcy rules to prevent corporations allegedly responsible for damages under the Oil Pollution Act from certain moves seeking to sever their assets from the legal liabilities.

The bill was supposed to be in response to the Gulf Oil Spill. However, we cautioned that some of  its provisions were not limited to the subject matter of oil spills. For example, Section 5 of the bill as introduced, proposed to amend the Class Action Fairness Act to exclude from its reach any action brought by a State or subdivision of a State on behalf of its citizens. Such a provision could have significant effect on CAFA, far beyond the oil spill litigation. For example, it might impact cases like State ex rel. McGraw v. Comcast Corp., 2010 WL 1257639 (E.D. Pa. Mar. 31, 2010).

The version passed by the House apparently does not contain this provision.  It was passed on motion to suspend the rules and pass the bill, as amended, and agreed to by voice vote.  Republicans and industry groups had expressed some concerns, and since many of the provision purport to be retroactive, wondered what the rush was.  Supporters argued that some of the prevailing laws were written in the mid-19th century to protect American merchant ship owners, and that the liability system needs to be updated.

As amended, Section 2 amends the Death on the High Seas Act (chapter 303 of title 46, United States Code), Section 3 alters recoveries under the Jones Act; Section 4 would repeal the Limitation of  Liability Act and the Oil Pollution Act; and Section 5 would provide new bankruptcy protection for tort claims arising from oil incidents.

Update on Foreign Manufacturers Liability Act

We have posted before about legislative efforts to make it easier for U.S. consumers to sue foreign product manufacturers.

Last week the the House Subcommittee on Commerce, Trade, and Consumer Protection held a legislative hearing on H.R. 4678, the “Foreign Manufacturers Legal Accountability Act.”  The House bill  was introduced last February. The Senate's version, S. 1606, was introduced in August, 2009.

Witnesses included a representative of the Consumer Product Safety Commission, the Consumers Union,  American Association of Exporters and Importers, and a Professor from American University College of Law.

The Act would require foreign manufacturers and producers of several kinds of products to establish registered agents for service of process and to consent to jurisdiction here.  It appears to have bipartisan support, but raises a number of constitutional issues, and may not address the key issue of the enforceability of judgments handed down by U.S. courts.

Supporters of the bill note that the Hague Convention on Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters – of which the United States and many of its major trading partners, including China, are parties – provides a means of serving process on foreign manufacturers in their home countries.  However, this method can be time consuming and costly, because all the legal documents must be translated into the foreign manufacturer’s native language and then provided to a governmental central authority, which in turn attempts to serve the documents on the manufacturer. It can take many months for the central authority to serve the documents on the manufacturer.   In addition, even if a plaintiff successfully serves process on a foreign manufacturer, argue the supporters, the manufacturer will likely challenge the exercise of personal jurisdiction over it by a U.S. court. Before a U.S. court can exercise personal jurisdiction over a defendant it must consider: 1) the defendant’s purposeful minimum contacts with the state in which the court sits, and 2) fairness to the defendant of being subjected to jurisdiction in that state’s courts.  Foreign manufacturers have increasingly turned to litigating this issue to avoid being hauled into U.S. courts.

The Act would require foreign manufacturers and producers that import products into the United States to designate a registered agent who is authorized to accept service of process here in the United States. The agent would have to be registered in a state with a substantial connection to the importation, distribution, or sale of products of the foreign manufacturer or producer. CPSC, the Food and Drug Administration, and the Environmental Protection Agency would each be required to determine, based on the value or quantity of goods manufactured or produced, which foreign manufacturers and producers under their respective authority would be required to designate a registered agent. Registering an agent consistent with the Act constitutes acceptance by the manufacturer of personal jurisdiction of the state and federal courts of the state in which the agent is located.

AAEI, on the other hand, is particularly concerned about the impact H.R. 4678 would have on U.S. exporters if this bill is enacted by Congress. If the United States enacts H.R. 4678 requiring foreign manufacturers to appoint a registered agent to receive service of process, they anticipate that our trading partners will enact similar measures. It will be difficult and expensive for American exporters to maintain registered agents in all the foreign markets to which it exports. Moreover, having a registered agent in foreign markets increase the likelihood that these companies will be
subject to litigation before foreign courts in countries with legal proceedings which are less
transparent than the United States, argued AAEI.

Beware of Legislative Moves Over The Gulf Oil Spill

Last week,  U.S. House Judiciary Committee Chairman John Conyers, Jr. (D-Mich.) and Congressman Charlie Melancon (D-LA) introduced H.R. 5503, the “Securing Protections for the Injured from Limitations on Liability Act” (SPILL Act).  This is one of many pending and promised bills addressing legal liability issues arising from the Gulf Coast oil spill, including amendments to the Death on the High Seas Act.

Specifically, H.R. 5503 would:

• Amend the Death on the High Seas Act to permit recovery of non-pecuniary damages (e.g., pain and suffering and loss of care, comfort, and companionship) by the decedent’s family, as well as standardizing the geographic threshold for its application, and permitting surviving family members to bring suit directly rather than through a personal representative.

• Amend the Jones Act to permit recovery of non-pecuniary damages by the families of seamen who are killed.

• Repeal the Limitation on Liability Act to the extent it limits the liability of vessel owners to the value of the vessel and its cargo.

• Amend bankruptcy rules to prevent corporations allegedly responsible for damages under the Oil Pollution Act from certain moves seeking to sever their assets from the legal liabilities.

The bill is supposed to be in response to the Gulf Oil Spill. However, many of its provisions are not limited to the subject matter of oil spills.  For example, Section 5 proposes to amend the Class Action Fairness Act  to exclude from its reach any action brought by a State or subdivision of a State on behalf of its citizens.  Such a provision could have significant effect on CAFA, far beyond the oil spill litigation. For example, it might impact cases like State ex rel. McGraw v. Comcast Corp., 2010 WL 1257639 (E.D. Pa. Mar. 31, 2010). In that case, the state of West Virginia, in its capacity as parens patriae, filed an action in state court alleging that a cable company's requirements concerning cable boxes constituted impermissible tying behavior, in violation of state antitrust and consumer protection laws. On removal, the federal court held that the action was a “class action” under the Class Action Fairness Act, under which the definition of a class action must be “interpreted liberally.”

The bill has been referred to the following committees: House Judiciary, Subcommittee on House Transportation and Infrastructure, Subcommittee on House Transportation and Infrastructure, Subcommittee on Coast Guard and Maritime Transportation.

Earlier this month, the House Subcommittee on Oversight and Investigations held a field hearing In Louisiana on the local impact of the Gulf oil spill.The House Subcommittee heard testimony from experts on the environment and wildlife, some of whom who warned that the full effects of the spill will not be known until the flow of oil is stopped.  But the most emotional testimony came from two widows, whose husbands died when the Deepwater Horizon Rig exploded in April. The widows urged Congress to reform the Death on the High Seas Act, but also noted that they fully support offshore drilling as essential to our nation's economy.

 

UPDATE: the House Judiciary Committee approved H.R. 5503, Securing Protections for the Injured from Limitations on Liability Act (SPILL Act), by a roll call vote of 16-11, with two Republicans, Reps. Lungren (R-Calif.) and Rooney (R-Fla.), joining the rest of the Democratic committee members in voting in favor.

$700 Billion for "Stimulus" - Apparently None Left For Judiciary

We've had our disagreements with the ABA, in particular with inappropriate policy positions the Association has taken on issues that have divided their membership. (MassTortDefense has high hopes for the leadership of incoming President Steve Zack, an outstanding lawyer from Florida.)

But here is one position we heartily endorse.  The American Bar Association is urging the Supreme Court to take a suit brought by a group of current and former federal judges who are seeking cost-of-living salary raises.  Beer, et al. v. United States, No. 09-1395 (U.S. S.Ct.).  The judges are seeking back pay and declaratory relief because they never received the cost-of-living salary increases that they are entitled to under the Ethics Reform Act of 1989.

The American Bar Association last week filed an amicus brief urging the Supreme Court to rule in Beer vs. U.S. on whether Congressional denial of cost-of-living salary adjustments for federal judges compromises judicial independence, violating the Constitution. Although the Ethics Reform Act of 1989 was intended to establish automatic annual COLAs for federal judges, Congress has refused to authorize these “non-discretionary” raises six times, notes the ABA brief. While inflation-adjusted wages for the average American worker have risen 19.5 percent since 1969, salaries for federal district judges have dropped by 27 percent over the same period. Judicial pay is now so low as to seriously compromise the independence that life tenure was intended to ensure and may becoming insufficient to attract and retain well-qualified jurists from diverse economic and societal backgrounds, argues the ABA. In many cases, former judicial law clerks earn more in salary and bonuses in their first year in private practice than the federal judges for whom they clerked.

While judges know about this pay scale when they answer the call of public service, they certainly could not anticipate that Congress would steadily erode that pay in real terms by repeatedly
failing over the years to provide even cost-of-living increases.
 

EPA Releases Draft Toxicology Assessment of Formaldehyde

The Environmental Protection Agency has released a draft toxicological review of formaldehyde, entitled "Toxicological Review of Formaldehyde Inhalation Assessment: In Support of Summary Information on the Integrated Risk Information System (IRIS).''  (EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. )

EPA announced a 90-day public comment period and a public listening session for the external review draft human health assessment.  The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA said it was releasing this draft assessment for the purpose of pre-dissemination peer review.  Also, a committee of the National Research Council, acting under the auspices of National Academy of Sciences (NAS), will conduct an independent scientific peer review of the EPA draft human health assessment of formaldehyde. The peer review committee will hold meetings, some of which may involve public sessions. Public sessions will be announced before each meeting on the National Academies Web site.  The public comment period and NAS scientific peer review are separate processes that are supposed to provide opportunities for all interested parties to comment on the assessment.

Formaldehyde is present in a wide variety of products including some plywood adhesives, abrasive materials, insulation, insecticides and embalming fluids. The major sources of anthropogenic emissions of formaldehyde are motor vehicle exhaust, power plants, manufacturing plants that produce or use formaldehyde or substances that contain it (i.e. glues), petroleum refineries, coking operations, incinerating, wood burning, and tobacco smoke, says the EPA.  It is used in industry to manufacture building materials and numerous household products and consumer products, including some soaps, shampoos, and shaving cream. 

Of course, alleged exposure to formaldehyde has been involved in numerous toxic tort suits as well as consumer fraud actions.

The draft assessment found that formaldehyde could be more likely to cause cancer than in previous EPA calculations. In the draft, EPA now estimates there could be up to one case of cancer for every 1,000 people breathing formaldehyde at concentrations of 20 parts per billion over their lifetime.  The draft assessment also provides for the first time an agency estimate of a reference concentration (RfC). Lifelong inhalation of formaldehyde at concentrations up to that RfC would not be expected to cause breathing, immune, reproductive, and other non-cancer health effects.

At Section 4.5.4, the report concludes that human epidemiological evidence is sufficient to conclude there is a causal association between formaldehyde exposure and nasopharyngeal cancer, nasal and paranasal cancer, all leukemias, myeloid leukemia and lymphohematopoietic cancers as a group. But, for example, it is questionable whether there really is a demonstrable link between formaldehyde and leukemia.  And the evidence does not appear to support a causal link between formaldehyde and  upper-respiratory tract cancers. See the critical comments of other federal agencies.

Any regulatory decision on this important chemical based on incomplete information could cause significant harm to the economy, as many products critical to the home and commercial building, automotive and aerospace industries, as well as defense-related applications and vaccines used worldwide to prevent polio, cholera, diphtheria, and other major diseases, all use it.  All living things — including people — produce and process formaldehyde. It occurs naturally in the air we breathe and does not accumulate in the environment or in plants, animals or people.

Rep. Henry A. Waxman (D-Calif.) has stated that the draft report is another reason to reform the Toxic Substances Control Act.  He plans to introduce such a bill this Summer. Also, legislation that would amend TSCA to set formaldehyde emissions limits for plywood and other composite wood products was reported out last month by the House Energy and Commerce Committee.  See H.R. 4805, The Formaldehyde Standards for Composite Wood Products Act.

Update: and an alert reader points out that the Senate just this week passed its own version, S.1660, the Formaldehyde Standards for Composite Wood Products Act.  The Senate bill would make the formaldehyde emission standard contained in the California Code of Regulations (relating to an airborne toxic control measure to reduce formaldehyde emissions from composite wood products, as in effect on July 28, 2009) applicable to certain hardwood plywood, medium-density fiberboard, and particleboard sold, supplied, offered for sale, or manufactured in the United States, with certain exemptions, including for composite wood products used inside new vehicles, rail cars, boats, aerospace craft, or aircraft.

IOM Issues Food Safety Report Calling for Reform of FDA

report issued last week by the Institute of Medicine (IOM) and the National Research Council (at the request of Congress) concludes that the FDA is not well equipped to handle potential problems with the food supply.  "Enhancing Food Safety: The Role of the Food and Drug Administration" notes that food-borne illnesses cause more than 300,000 hospitalizations and 5,000 deaths in the U.S each year. Food-borne diseases are caused by a variety of bacteria—such as Escherichia coli or Salmonella—viruses, parasites, or chemical residues.  

The severity of these diseases and the frequency with which they occur spurred this evaluation of how well the current food safety system protects the public’s health. While food safety is regulated by several agencies, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce, seafood, and cheeses. Some food safety experts and some in the media have criticized the FDA’s food safety system and questioned whether it properly safeguards Americans from food-borne diseases. Congress asked the IOM to examine the possible gaps in the current food safety system under the purview of the FDA and to identify the tools needed to improve food safety.

Readers know that many of these food issues have led to litigation.

The IOM determined that the FDA lacks a comprehensive vision for food safety and should take a risk-based approach in order to properly protect the nation’s food. In addition, the FDA should provide standards for food inspection so that states and the federal government follow the same rigorous methods for inspections, surveillance, and outbreak investigations. Most notably, the IOM recommends that Congress take legislative action to provide the FDA with the authority it needs to fulfill its food safety mission. Americans will continue to suffer from food-borne illnesses unless the FDA reevaluates and reworks its approach to food safety management, claims the report.

The FDA, which sponsored the report, responded that through the President's Food Safety Working Group, which includes all agencies involved in food safety, it feels it is making significant progress to ensure government agencies are working seamlessly to protect the American public. But the IOM concludes that in order for the FDA to better ensure food safety, legislative and organizational changes may be necessary. Most notably, it says, Congress should consider taking legislative action to provide the FDA with the additional authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management, says the IOM.

Recognizing that organizational reform will pose challenges, the report recommends that the federal government move toward the establishment of a single food safety agency to unify the efforts of all agencies and departments with major responsibility for safety of the U.S. food supply. The committee recommends establishing a centralized, risk-based analysis and data management center in order to improve efficiency and work toward a safer food supply. This center would include staff and support resources necessary to conduct rapid and sophisticated assessments of short- and long-term food safety risks and to ensure that the comprehensive data needs to support the risk-based system are met.

With regard to legislative changes, Senator Harkin (D-Iowa), head of the Health, Education, Labor and Pension Committee is trying to bring legislation overhauling the food safety system to the Senate floor later this month. He is pushing S. 510, the Food and Drug Administration
Food Modernization Act
, which is co-sponsored by Sens. Dick Durbin (D-Ill.), and Judd Gregg (R-N.H.), among others.  The  bill would give the FDA new authority to track, detect, and halt contaminated food coming from either domestic or foreign suppliers. Food-handling facilities would be required to share additional information with the FDA. Inspections would be more frequent and industry would nee to construct risk-based preventive control plans. The FDA would also get new recall authority.

The House passed its own version of food safety legislation in July, 2009, as we noted.

Gulf Oil Spill Litigation

More than 100 federal and state court actions have been filed against BP PLC, Transocean Ltd., and other companies in connection with the Deepwater Horizon drilling rig accident in the Gulf of Mexico.  (The API has a Q&A on the accident, and the Unified Command on the incident offers updates.)  Like many mass accident scenarios, the spill has generated a variety of kinds of actions. The claims so far fall into several main categories, including personal injury/wrongful death, maritime torts, property damage/lost profits, shareholder claims, and environmental law actions.

The wrongful death actions arise from the 11 workers missing and presumed dead in the accident.  These cases were filed in federal and state courts in Louisiana and Texas.  Gulf-front property owners, fishermen, shrimpers, harvesters, seafood processors, and restaurants in Louisiana, Alabama, Mississippi and Florida are among the entities suing over alleged harm to their businesses and their economic livelihoods. Many of these suits are class actions with overlapping class definitions.  The plaintiffs typically allege that defendants knew of the dangers associated with deepwater drilling and failed to take appropriate safety measures to prevent damage to marine or coastal environments, where they work and earn their income.

These claims potentially implicate caps on damages under the Limitation of Liability Act, and the Oil Pollution Act, which currently caps certain oil spill liability at approximately $75 million.  Plaintiffs have asserted that there are various exemptions from this reach of the Oil Pollution Act, for gross negligence and certain cleanup costs.  Also, the Obama administration and Democrats in Congress have advocated raising the caps retroactively. Bills S. 3305  (the so-called Big Oil Bailout Prevention Liability Act of 2010) and H.R. 5214 would raise the liability for economic damages to $10 billion per spill from the current $75 million. In a Senate hearing, Interior Secretary Ken Salazar warned that raising the trust fund's liability cap to $10 billion would prevent smaller and mid-sized energy companies from operating offshore. Perhaps most importantly, there is some case law suggesting that the Oil Pollution Act will not preempt state common law tort liability.

The administration is also proposing a tax increase, to support the Oil Spill Liability Trust Fund, of a further 1 cent per barrel on petroleum. It is interesting that the administration has been criticized for the slowness of some of its responses to the spill, but is very quick to propose tax hikes, without an opportunity for all stakeholders to be heard and without careful consideration of the availability of the fund for future incidents. A White House summary of its proposals for legislation on oil spill response is available.

Some plaintiffs have proposed that the federal cases be coordinated in an MDL proceeding in the Eastern District of Louisiana.  In Re Oil Spill by the Oil Rig Deepwater Horizon in the Gulf of Mexico on April 20, 2010, MDL No. 2179 (filed 4/30/10). Certain defendants have suggested instead that the Southern District of Texas host the MDL. A large group of plaintiffs' attorneys had met in New Orleans early in the month to plot out litigation strategy.  Interestingly, the Mississippi Bar issued a statement advising potentially affected parties of the risk of improper solicitation by plaintiff attorneys.It will be fascinating to see if the defendants can remain similarly coordinated and avoid unnecessary finger-pointing.  The testimony of various executives for BP Plc, Transocean Ltd., and Halliburton in front of the Senate Energy and Natural Resources Committee and the Senate Environment and Public Works Committee that pointed out the responsibilities of the other companies, raises this issue. 

Another type of pending action is by various shareholders alleging securities fraud in a class action that asserts that defendants made false and misleading statements about their safety procedures. Allegedly as a result of the statements and the company's supposed failure to disclose prior safety issues, the stock prices had been inflated, tumbling after the accident.  Several shareholder derivative lawsuits were also filed against certain officers and directors of the defendants, claiming that they breached their fiduciary duties by supposedly ignoring critical safety issues. The suits also allege that defendants lobbied governmental authorities to reduce the extent of safety  regulation of the companies' gulf operations. (one would think that was protected speech)

Some litigation has named Interior Secretary Salazar and the U.S. Department of the Interior for their oversight of off-shore drilling operations. These case point to the rules regulating the oil companies' blowout and worst-case oil spill preparations.  Some have gone so far as to seek a halt to BP's operations at other oil drilling platforms.  Still others have focused on the oil companies' environmental impact statement posture as in violation of  the National Environmental Policy Act, and their seismic surveys and drilling operations as in violation of the Marine Mammal Protection Act and the Endangered Species Act.

Democratic Senators are pressuring the Justice Department to to open a criminal probe into the accident, and BP's statements to the federal government regarding its ability to respond to oil spills. Earlier this month, Florida Gov. Crist appointed two former Florida state attorneys general to head a newly formed legal team that will represent the state on issues related to the spill.

 

Supreme Court Approves Proposed Amendments to Rule 26

Last week, the Supreme Court approved the proposed amendments to Federal Rules of Civil Procedure 8, 26, and 56, and Illustrative Form 52, and transmitted them to Congress. The amendments were approved by the Judicial Conference of the United States last fall (as covered earlier here).

Readers will recall that with regard to Rule 26, the amendments would extend work-product protection to the discovery of draft reports by testifying expert witnesses and, with three important exceptions, to the discovery of communications between testifying expert witnesses and retaining counsel. The amendments also provide that a lawyer relying on a witness who will provide expert testimony but is not required to provide a Rule 26(a)(2)(B) report – because the witness is not retained or specially employed to provide expert testimony and is not an employee who regularly gives expert testimony – must disclose the subject matter of the witness’s testimony and summarize the facts and opinions that the witness is expected to offer. The prior 1993 amendments to Civil Rule 26 have been interpreted by some courts to allow discovery of all draft expert witness reports and all communications between counsel and testifying expert witnesses. The experience under those amendments revealed significant practical problems in the eyes of many litigators.

Absent congressional intervention, the amendments will become effective on Dec. 1, 2010.
 

 

 

Senator Urges House to Amend FDA Powers on Drugs

Like a cross-over episode from two bad TV shows, Sen. Chuck Grassley, ranking member of the Senate Committee on Finance testified before a subcommittee of the U.S. House of Representatives Committee on Appropriations last week.  His Senate Committee staff is generally regarded as having issues presenting a balanced or complete view of the FDA and industry's efforts to monitor the safety and efficacy of approved medication.

In his testimony, the Senator urged Congress to give the U.S. Food and Drug Administration more power to monitor drugs' safety after they enter the market.

He raised questions about whether or not various post-marketing studies sanctioned by the FDA were properly performed.  He talked about his twice-introduced legislation to establish an independent office of drug safety at the FDA, a Center for Postmarket Drug Evaluation and Research.  This entity would tackle the alleged lack of equality between the Office of New Drugs (OND), which decides whether to approve a drug, and the Office of Surveillance and Epidemiology (OSE). OSE, he said, is the office that monitors a drug’s safety once it’s on the market and being sold to patients.

The supposed imbalance between OND and OSE was apparent, he argued, in various drug safety issues that developed into major mass torts. Individuals in the office responsible for post-market surveillance should be allowed to provide an “independent opinion” based on the best available evidence, he asserted. He claimed vaguely that FDA physicians and scientists committed to post-market monitoring of drugs have sometimes been suppressed or ignored.

Other speakers included a Yale School of Medicine Professor who testifies for plaintiffs in pharma cases, and the Director of the anti-industry Health Research Group of Public Citizen.  More fair balance? Maybe after November.

 

Safe Chemicals Bill Introduced in Senate

Sen. Frank R. Lautenberg, D-N.J., chair of the Senate Subcommittee on Superfund, Toxics
and Environmental Health, introduced this week the "Safe Chemicals Act of 2010," which would
amend the the Toxic Substances Control Act of 1976.

Over the last several months, Congress has held a series of hearings focusing on chemical safety and possible ways to modernize TSCA. Chemical business leaders, public officials, scientists, doctors, academics, and liberal environmental organizations have expressed support for varied methods of reforms to the principal toxic substance law. The “Safe Chemicals Act of 2010” comports with the reform principles laid out by the Obama Administration and groups such as the Safer Chemicals Healthy Families Coalition, and purports to address issues with TSCA identified by the GAO.

The bill (summarized here) is supposed to:

  • provide EPA with sufficient information to judge a chemical’s safety, by requiring manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing. EPA will have full authority to request additional information needed to determine the safety of a chemical.
  • Prioritize chemicals by having EPA categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.
  • Place a new burden of proof on chemical manufacturers to prove the safety of their chemicals, including all foreseeable uses, before the chemical may enter the market or continue to be used.
  • Create more access to chemical information, by establishing a public database to catalog the information submitted by chemical manufacturers and the EPA’s safety determinations. The EPA will impose requirements to ensure the information collected is "reliable."
  • Promote innovation and development of green chemistry, through grant programs and research centers to foster the development of safe chemical alternatives, and bring some new chemicals onto the market using an expedited review process.


     

It is clear that safety must be the primary goal of chemical regulatory reform, and the scientific and technological advances made since the passage of TSCA should allow industry and the regulatory agency to achieve a high degree of safety.  Certainly,  the need to prioritize chemicals for evaluation, a proper risk-based approach to EPA safety reviews, and a reduction in animal testing, are all aspects that should generate bi-partisan support. However, the bill’s proposed decision-making standard may be both legally and technically impossible to meet. Readers know how the articulation and application of the burden of proof can be outcome determinative. It is impossible to prove that something is "safe,” if one means risk-free. Every substance, even water, is hazardous to health at some levels in some exposure contexts. It would be devastating for our economy if this bill was merely a back-door attempt to make the so-called precautionary principle the law in this country, as it is in Europe. It is simply scientifically false that every chemical that is dangerous at high doses is also hazardous at low doses;  it is patently false that every chemical that causes effects in lab animals will also cause those effects in human beings.

And the proposed changes to the new chemicals program could very well hamper innovation in new products, processes, and technologies. In addition, the bill undermines business certainty by appearing to allow states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them.

Congressmen Henry Waxman and Robert Rush have proposed a "discussion draft" on the House side, and that may afford an opportunity for a transparent and meaningful discussion by all key stakeholder groups to ensure that TSCA reforms are based on sound science and protect the safety of all consumers, while promoting jobs and innovation.  In these uncertain economic times, the last thing needed is another expensive government program that risks doing more harm than good.

 

Senate Hearing on TSCA Reform Featured Industry Experts

The Senate Subcommittee on Superfund, Toxics, and Environmental Health convened a hearing last week with leaders of businesses that manufacture or use chemicals to hear their business views on reforming U.S. chemical safety law. The hearing was the third in a series of oversight hearings leading up to the possible introduction of legislation to reform the Toxic Substances Control Act (TSCA). 

Entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws," the hearing featured testimony from Charlie Drevna, President of the National Petrochemical and Refiners Association.  His remarks addressed the call from some observers for a European-style replacement regulatory regime. The European Union has started to implement new legislation – Registration, Evaluation and Authorization of Chemicals (REACH), but many of the perceptions of REACH are incorrect. For example, rather than relieving the government of the burden of chemical safety, REACH only increases the burden on industry while it does not reduce the burden on government. No government authority is going to receive a chemical dossier from industry and take it at face value. Furthermore, REACH places so much burden on industry that small- and medium-sized chemical manufacturers are already facing significant difficulties complying with the program. REACH, contrary to some commentary, is unlikely to spur innovation in safer chemicals. Innovation is a function of spending on research and development and ease of entry into the marketplace. Toxicity and other laboratory testing is considered part of research and development and typically comes out of R&D budgets. That leaves less money for new, and often safer, product development. REACH is a regulatory concept that has never been attempted anywhere in the world, at any time. Authorities in Europe have already been inundated with so much information that they simply cannot keep up.
 

Dr. Neil C. Hawkins, Vice President, EH&S and Sustainability  for The Dow Chemical Company testified that an ideal chemical safety program would base its decisions on a consistent scientific
evaluation of both hazard and potential exposure (an evaluation of risk), using a weight-of-evidence approach. A weight-of-evidence approach requires critical evaluation of the entire body of available data for consistency and biological plausibility. Studies conducted and funded by industry are necessary and valuable contributions to the understanding of potential public health and environmental effects related to the manufacture and use of its products. Industry scientists have expert knowledge of the chemicals they manufacture, especially as this relates to the development and interpretation of the science needed to comply with governmental requirements around
the world. Research should be judged on the basis of scientific merit, without regard for funding source or where the studies are conducted (e.g. academia, government, or industry). 

Also testifying was Linda Fisher, Vice President, Safety Health and the Environment for DuPont.  She stressed in her remarks that as the agency contemplates exposure reductions it is important that the EPA be required to take into account the societal benefits from the use of chemicals and the time and complexity of bringing substitutes to market. Congress should avoid presumptive bans or rigid phase-out schedules. Bans and deadlines for phase-outs or substitution that fail to account for the realities of transitioning to new ingredients, receiving needed customer and regulatory approvals, or modifying manufacturing facilities, are counter-productive. Such actions could lead to unnecessarily disrupting markets, reduce public access to valued products, and cede markets to global competitors.

The issue of confidential business information, or CBI, also needs attention. The ability to preserve legitimate CBI and prevent piracy of intellectual property is critical to U.S. competitiveness and innovation. If companies simply give innovation away there is little reason to innovate.  Intergovernmental sharing of CBI data with proper protections, whether between state and federal governments or nation to nation, should be facilitated.


 

FDA Official Testifies Before Congress on REMS and Sentinel

Last week, the House Energy and Commerce Committee's Health Subcommittee held a hearing on drug safety.  A quick report: Chairman Waxman's opening comments indicated that the committee was eager to hear about FDA’s implementation of the 2007 FDA Amendments Act, giving FDA the authority to require manufacturers to implement “Risk Evaluation and Mitigation Strategies” or “REMS.”

FDA Principal Deputy Commissioner Joshua Sharfstein indicated that using this REMS authority is “a work in progress” and acknowledged a "lack of clarity" in certain provisions of the law with respect to REMS. FDA recognizes that designing and implementing the most comprehensive REMS requires a careful balancing of the need to adequately manage risks and also to maintain patient access to important medications. In the design of REMS with elements to ensure safe use (the most comprehensive REMS programs), FDA is mindful, he said, that the elements to ensure safe use must not be unduly burdensome on patient access to the drug, and be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

If FDA determines that a REMS is necessary to ensure that the benefits of a drug continue to outweigh the risks of the drug, FDA can require manufacturers to have a REMS in place when a drug comes on the market, or implement one later if FDA becomes aware of new safety data. Most of the REMS with elements to ensure safe use include educating prescribers about the risks and appropriate use of the drug as a condition of certification or enrollment in the REMS program. Some programs require the prescriber to monitor the patient immediately following drug administration and for a period of time afterwards. 

The FDA official also gave a brief update on the Sentinel Initiative. FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA officially launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System—a national, integrated, electronic system for monitoring medical product safety. The Sentinel System, testified the Commissioner, once up and running, will enable FDA to actively gather information about the post-market safety and performance of its regulated products—a significant change from the current, primarily passive safety surveillance systems. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012.

FDA has gathered public input on issues related to the creation and development of Sentinel, held numerous meetings and a public workshop, and established a working group consisting of representatives of numerous federal agencies to share information and discuss issues related to ongoing efforts that are complementary to Sentinel. FDA has awarded key contracts for a pilot project to gather information that will be essential to fully implementing the Sentinel System. As we posted about before, there is still work to be done to address significant issues with this plan.

One risk is that plaintiffs’ attorneys will find a way to misuse the system, to “find” spurious associations between drugs and effects, to assert a causal link based on the “government approved, government sanctioned” database program, and to blame the drug companies for not having seen that same link sooner. Fundamentally, the system creates a corresponding need to improve the ability to determine as quickly as possible which findings reflect a genuine and health risk. That determination may take epidemiological investigations or clinical trials before any conclusion about whether a product actually caused an event. And the new system doesn’t change the reality that sometimes patients suffer adverse events after receiving drugs because they are sick, not because the drug has any issues. Plaintiffs have no incentive to place the new product information uncovered in a context of the continuing benefits of the product for many patients, the lack of certainty in the findings, the limitations of the data, etc.

 

House Committee to Hold Hearing on FDA

The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing titled, "Drug Safety: An Update from the FDA" -- tomorrow, Wednesday, March 10, 2010.

 At the hearing, the Food and Drug Administration will detail the Agency's views on current challenges and successes in the area of drug safety. Set to testify is Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration. 

 
 

Companion Bill Introduced To Ease Suits Against Foreign Manufacturers

Previously we alerted readers to the introduction of The Foreign Manufacturers Legal Accountability Act of 2009 (S. 1606),  introduced in the Senate in August 2009 by Sen. Sheldon Whitehouse (D-R.I.). The bill followed up on hearings last Spring during which witnesses testified about the perceived delays and difficulties with serving foreign manufacturers with process and establishing jurisdiction.

Last week, Rep. Betty Sutton (D-Ohio) and several co-sponsors introduced in the House their own version of the Foreign Manufacturers Legal Accountability Act of 2010 (H.R. 4678). The operative provisions of the House bill overlap those in the Senate bill, although the Senate bill also includes a section which discusses the alleged need for the legislation.

The proposed legislation would impact five categories of products: drugs, devices and cosmetics; biological products; chemical substances; pesticides; and consumer products. The bills only apply to manufactured products “in excess of a minimum value or quantity established by the head of the applicable agency" in regulations applying the legislation.

Both bills make consent to jurisdiction and service of process a condition of importing products into the United States. That is, the bills instruct several relevant product-regulating agencies to issue regulations requiring foreign manufacturers and producers to designate a registered agent. A person would not be able to import into the United States a covered product (or component part that will be used in the United States to manufacture a covered product) if such product or any part of such product (or component part) was manufactured or produced outside the United States by a manufacturer or producer who does not have a registered agent. 

Such a system which requiring an agent for service of process for every foreign manufacturer or producer who imports products into the U.S. would render the Hague Convention's  methods for service abroad unnecessary for such companies, and raises the risk that other countries may choose to create similar rules, subjecting U.S. companies to litigation in those other countries where their products may be sold.

Under the bills, a foreign manufacturer or producer of covered products that registers an agent as above thereby consents to the personal jurisdiction of the State or Federal courts of the State in which the registered agent is located for the purpose of any civil or regulatory proceeding.  Presumably, the expanded jurisdiction would also make it easier for U.S. companies to pursue indemnification claims against foreign manufacturers who were upstream suppliers.

Currently, foreseeing that one's product may enter a state is not, on its own, a sufficient basis for that state to assert jurisdiction. Asahi Metal Industry Co., Ltd. v. Superior Court, 480 U.S. 102, 112(1987); but cf. Nicastro v. McIntyre Machinery America Ltd., No. A-29-08 (N.J. 2/2/10).  It has been argued that Congress cannot create jurisdiction where the Constitution would forbid it. And it may be that a constitutional challenge would lie to some applications of the proposed bills. E.g., Texas Trading & Milling Corp. v. Federal Republic of Nigeria, 647 F.2d 300 (2d Cir. 1981). Presumably, the sponsors are looking to bypass the due process concerns by providing for consent to jurisdiction.

It is unclear what the effect of the bills might be on countries around the world regarding their willingness to enforce judgments entered in the United States, as the issue of the lack of foreign manufacturer assets in the U.S. is not addressed by the proposed legislation.


 

 

Senate Holds Hearing on TSCA Issues

The Senate Committee on Environment and Public Works' Subcommittee on Superfund, Toxics and Environmental Health held a hearing earlier this month entitled, "Current Science on Public Exposures to Toxic Chemicals."   Readers from the chemical and energy industries in particular will want to take note of the discussion.

Chairman Lautenberg (D.N.J.) opined that  TSCA fails to give EPA the tools it needs to protect against unsafe chemicals.He claimed that in three decades EPA has tested only 200 of the more than 80,000 chemicals in the products people use every day. He mentioned unnamed "studies" that allegedly have found that as much as five percent of cancers, ten percent of neuro-behavioral disorders and 30 percent of asthma cases in children are associated with hazardous chemicals. That is why, he said, he will soon introduce a bill that will overhaul our nation’s chemical laws, with the "simple goal" to force chemical makers to prove that their products are safe before they end up in a store. 

This bill would fall into place with the ideas of other proponents of radical reform and supporters of the so-called precautionary principle.  Common sense would suggest that principles for any regulatory or statutory changes to TSCA should be based on the best available science, including risk assessment; must include cost-benefit considerations; must protect proprietary information; and must prioritize reviews for existing chemicals. Senator Lautenberg's notion would encourage litigation, allow for activist rather than government enforcement, and would compel unnecessary product substitution that will further damage our weak economy.  Indeed, it would harm small and medium-sized companies and could harm innovation.

Other witnesses at the hearing included Steve Owens, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances Environmental Protection Agency;  Dr. Henry Falk  of the CDC; and Dr. Linda Birnbaum, Director  of the National Institutes of Environmental Health Sciences.

A number of witnesses also talked about bio-monitoring, the concept to potentially identify the concentration of chemicals actually taken up by the human body and the metabolic fate of those chemicals; to identify susceptible populations or particular at-risk groups (e.g. genetic polymorphisms) for chemical toxicity; and to inform discussions regarding levels of exposure consistent with no adverse effects (thresholds). However, bio-monitoring cannot eliminate potential confounders or alternative explanations for identified associations between chemical exposure and disease.  Any environmental chemical will be present to some extent in those who ingest, inhale or otherwise are exposed to it. Thus, the rabble-rousing about  “neurotoxins”, “endocrine disruptors”, or other “harmful chemicals” is essentially meaningless, without specific relationship to dose, exposure timing, and comparison to appropriate control populations. Our ability to measure substances at very low concentrations has outstripped our ability to determine causation.

Unfortunately, bio-monitoring has been abused as a tool. The practical problem with overstating exposure-disease associations is seen every day by medical professionals who evaluate people who are fearful of being “poisoned” by the latest chemical touted in a study as the cause of the same disease blamed on another compound just the month before, noted witness Dr. Charles McKay.

Senate Hearing on Toxic Chemicals Legislation

The Senate Committee on Environment and Public Works and the Subcommittee on Superfund, Toxics, and Environmental Health held a joint hearing yesterday, entitled “Oversight Hearing on the Federal Toxic Substances Control Act.”

The Senators heard testimony from Lisa Jackson, head of EPA; John Stephenson, Director of Natural Resources and Environment for GAO; and Linda Birnbaum, head of NIEHS and the National Toxicology Program.

Administrator Jackson argued that the Toxic Substances Control Act is in urgent need of reform because of "troubling gaps" in knowledge about many chemicals that have come into wide use since. She asserted that manufacturers of various “grandfathered” chemicals weren’t required to develop and produce the data on toxicity and exposure that are needed to properly and fully assess potential risks. [In a bit of drama, EPA’s Jackson was asked about some of the troubling emails recently disclosed about the apparent concerted effort of some to quash any scientific dissent to an aggressive view of global warming.]

The American Chemistry Council has noted that updating the legislation in certain respects made good sense, favoring a comprehensive approach, rather than the current patchwork of state and federal laws governing chemicals.

GAO’s representative testified that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing.

Dr. Birnbaum encouraged Congress to call for utilization of the new kind of toxicological testing that is less expensive and also gives an improved understanding of the actual effects of chemicals on humans. Toxicology is advancing from a mostly observational science using disease-specific models, she said, to a better, predictive science focused upon a broad inclusion of target-specific, mechanism-based, biological observations. This means using alternative assays targeting the key pathways, molecular events, or processes linked to disease or injury, and incorporating them into a research and testing framework.

Democratic legislators, including Sen. Lautenberg (D-NJ) have called for increased requirements for chemicals testing, and that “It's time to sound the alarm.” In an attempt to respond to industry concerns, Lautenberg argued that stronger regulations would somehow protect chemical companies from product liability suits—an ironic assertion at best as Democrats actively work to overturn express preemption for medical devices and extol the Wyeth v. Levine decision restricting implied preemption of drugs.

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.

 

Motion For Default Filed in China Drywall MDL

An Alabama construction company that is a party in the multidistrict litigation over allegedly tainted Chinese-made drywall has asked for a default judgment against a foreign manufacturer/seller of gypsum drywall. Mitchell Co. Inc., et al. v. Knauf Gips KG, et al., No. 09-cv-4115 (E.D. La.).

Mitchell filed a motion last week  in the U.S. District Court for the Eastern District of Louisiana asking for a default judgment against China-based Taishan Gypsum Co. Ltd.  The motion alleges that Taishan has not responded to the plaintiff's complaint nor entered an appearance.  Mitchell filed its original complaint back in March, in the Northern District of Florida, seeking to represent a class of plaintiffs who allege they incurred expenses stemming from defective drywall.  The complaint names several drywall makers and sellers.  The case was later transferred with related actions to the MDL in front of Judge Fallon. In re: Chinese-Manufactured Drywall Products Liability Litigation, No. 09-md-02047 (E.D. La.). 

Interestingly, the motion comes as the Congress debates a bill that would make it easier for foreign manufacturers to be sued when their products allegedly injure U.S. consumers, the Foreign Manufacturers Legal Accountability Act of 2009.

MassTortDefense has posted about the alleged problems with Chinese imported drywall. In litigation over the issues, Lennar Corp., the U.S.' second largest home-builder (by volume), has sued more than two dozen manufacturers, suppliers and installers.  As noted here before, Sens. Bill Nelson, D-Fla., and Mary Landrieu, D-La., have introduced legislation tied to Chinese drywall.  Also, the CPSC reports that it has now received a total of 810 reports related to the allegedly defective drywall, including complaints from two additional states, Pennsylvania and South Carolina. That means the Commission (criticized in some circles for its work on this issue)has received reports from homeowners in 23 states and the District of Columbia. The majority of the reports continue to be from Florida, Louisiana, and Virginia. About 6.2 million sheets of Chinese drywall were imported into the U.S. during 2006.

 

Senator Writes Letter To NIH About "Ghostwriting"

Plaintiffs in pharmaceutical and other biomedical litigation have frequently resorted to allegations of “ghostwriting” to attack various aspects of scientific articles that defendants seek to rely on.  “Ghostwriting” is a somewhat pejorative term used to vilify some versions of a common practice – the use of biomedical communications companies to provide professional assistance in medical research and/or writing. Plaintiffs often imply that the named author had little or nothing to do with the direction or content of the article.

Several courts have rejected such generally overblown allegations. In the HRT litigation, In re Prempro Products Liability Litigation, 554 F. Supp.2d 871 (E.D. Ark. 2008), the court noted that while plaintiff focused heavily on the evidence that Wyeth collaborated with authors to have articles written about HRT, there was no evidence that this practice is inappropriate or that Wyeth supported articles that it knew were false or misrepresented the science. Rather, the articles supported Wyeth’s position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.  Similarly, in In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, slip op. at 3-5 (M.D. Fla. Jan. 30, 2009), Judge Conway held that plaintiffs could not use the words "ghostwriting" or "plagiarism" to characterize the process by which articles were written.

A “ghostwriter” may:
– Analyze data
– Research issues, gather review data
– Organize/format materials
– Assist in writing by, e.g., drafting publications

Such third-parties can save busy scientists time and effort- by doing time-consuming preliminary tasks. Having medical communications specialists involved can make the articles easier to read, more informative The fact is, a great doctor does not mean a great writer; outside writers can expedite publication and eliminate artificial drag in the process.

Nevertheless, Senator Charles E. Grassley, an Iowa Republican, has written a letter to NIH asking for information about possible ghostwriting:
I1) What is the current NIH policy on ghostwriting with regards to NIH researchers?  2) What is the current NIH policy on ghostwriting with regards to NIH grantee institutions? 3) What is the current NIH policy on ghostwriting with regards to primary investigators of NIH grants? 4) Has NIH received any complaints about individual grantee institutions, primary investigators and/or NIH researchers regarding possible ghostwriting, and if so how has NIH handled these complaints? 5) What is the current NIH policy regarding primary investigators found to have violated medical ethics and/or have medical licenses that have been suspended or revoked?

The response, when it comes, may be significant because the N.I.H. underwrites much of the country’s medical research. Many doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could influence new publication guidelines more broadly.

In reality, typically, the named author has access to all data. The authors can reorganize the presentation of the data and edit the article. The articles are subjected to extensive peer review before publication, often in journals the author selects.  In litigation, the plaintiff’s prescriber may not have read or relied on any such articles. And doctors who prescribe are well familiar with the industry practice and custom. Plaintiff’s “ghostwriting” claims also fail to offer proof that the articles which were, in any event, peer-reviewed and medically sound, affected the FDA’s actions.

Any debate on “ghost writing” of medical publications ought to include an understanding of the realities of supply and demand for published research, of the time pressures, needs, and priorities of leading researchers, and the evidence demonstrating the author's control over final publication.

Readers of MassTortDefense interested in these issues should look at the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication;  the American Medical Writers Association's Position Statement and Code of Ethics; and the  World Association of Medical Editors' Policy Statement on Ghost-writing Initiated by Commercial Companies.

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Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

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FDA To Revisit BPA Assessment

The U.S. Food and Drug Administration has reportedly agreed to take a further look at its 2008 decision that bisphenol A in certain food and drink containers doesn't pose a significant safety threat. Newly appointed FDA Commissioner Margaret Hamburg is reported to have put the agency's acting chief scientist in charge of the review, which could take 3-6 months. In her first appearance before Congress as commissioner, Hamburg told the House Energy and Commerce Subcommittee on Health that the FDA is re-examining its position on BPA.

Reps. Henry Waxman, D-Calif., and Bart Stupak, D-Mich., sent a letter to the FDA earlier this month asking the agency to revisit its earlier conclusion. The Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations have been investigating the possible risks of the chemical BPA in consumer products and food product containers, particularly in infant formula containers and other items used by infants and children. The Congressmen pointed to the October, 2008, report of FDA's advisory Science Board Subcommittee, which raised questions about some data aspects of the agency's conclusion. "Based on this information, we request that FDA reconsider the Bush Administration's position that BPA is safe at current estimated exposure levels," said the letter.

In addition to their letter to the FDA, the legislators sent a request to the North American Metal Packaging Alliance, an industry group, creating a straw man about alleged tactics the industry might contemplate using in a future hypothetical public relations strategy to counter efforts to ban BPA. The duo requested a list of all attendees at group meetings, including their affiliations and contact information, certainly a chilling attack on the trade group member's right to free speech and freedom of association.

As reported here at MassTortDefense, FDA had already decided to support additional research with regard to its analysis of BPA safety in plastic baby bottles and food and drink containers. The FDA’s basic position remains that current human exposure to BPA in food-packaging materials provides an adequate margin of safety. FDA has been re-evaluating available data and planning for the acquisition of additional data that will strengthen the exposure estimates from all dietary sources of BPA, with particular attention to dietary sources relevant to infants and children.


Makers of BPA say that the chemical poses no known risk to human health at current exposure levels. In response to public demand, some manufacturers have begun introducing products for infants and children that are BPA-free. The Environmental Protection Agency has calculated that adults and infants can consume 50 micrograms of BPA per kilogram of body weight every day over a lifetime with little appreciable risk of harm.  But Democrats have introduced bills in Congress to ban the chemical.

 

Legislation Might Increase Litigation Against Foreign Product Manufacturers

Sen. Sheldon Whitehouse (D-R.I.) announced last week his plan to introduce legislation that would increase the ability of U.S. plaintiffs to sue foreign manufacturers of allegedly defective products. This development should be monitored by all foreign manufacturers selling into the United States.

Whitehouse announced the proposed legislation at a hearing by the Senate Judiciary Committee's Subcommittee on Administrative Oversight and the Courts. The hearing was entitled, “Leveling the Playing Field and Protecting Americans: Holding Foreign Manufacturers Accountable.” A variety of witnesses testified about the impact of the issue on both American consumers and American business, and whether there was a need for Congress to put foreign companies on a more equal footing with domestic companies in terms of litigation risks, and to reduce a possible “competitive disadvantage” suffered by U.S. manufacturers.

There are three main procedural hurdles faced by plaintiffs seeking to sue foreign parties: (1) obtaining personal jurisdiction; (2) serving process; and (3) enforcing U.S. judgments abroad. That is, a party suing must first be able to find a court that has Constitutional power/authority over the defendant, personal jurisdiction. Asahi Metal Industry Co. v. Superior Court of California, Solano County, 480 U.S. 102 (1987). Then after filing, the party must inform the defendant of the lawsuit and its contents.  And at the end of the lawsuit, the party must be able to collect any money awarded, especially when the defendant's assets are outside of the U.S.  If the defendant is judgment proof, the suit is a waste of time for plaintiffs.

One speaker, Prof. Teitz of the Roger Williams University School of Law, described that as a result of different approaches in other legal systems, U.S. consumers face difficulties recovering in U.S. courts and enforcing U.S. judgments abroad, in fact more difficulty than many foreign consumers face in the reverse situation. In addition, there is an obvious competitive impact on U.S.  manufacturers who are sued more easily and cheaply here for obvious reasons and against whom judgments can be enforced throughout the country under the Full Faith and Credit Clause. Service of process may be governed by international conventions and treaties, or may involve the use of diplomatic channels, the Professor said. Legislation to require domestic agents for service of process would reduce the cost and difficulty of service.

A plaintiff attorney testified that the transition of the U.S. economy away from manufacturing has resulted in a dramatic increase in foreign-made goods entering the country. The volume of imports has tripled over the last decade and is expected to triple again by 2015. He recommended legislation allowing jurisdiction based on aggregate national contacts and import licenses that require liability insurance as well as agents for service of process and consent to jurisdiction.

Another attorney noted a competitive disadvantage for U.S. companies that are subject to what he called the “tort tax.” But he cautioned that legislation should not burden U.S. business by expanding federal jurisdiction and changing choice-of-law rules. He also warned of possible problems with the constitutionality of the discussed legislation. For example, legislation might authorize jurisdiction over foreign entities by virtue of their national contacts in both federal and state courts. That may run afoul of the rule that state courts may only assert personal jurisdiction over defendants who purposefully establish minimum contacts with that forum state. See, e.g., International Shoe Co. v. Washington, 326 U.S. 310, 316 (1945).
 

Senate Holds Hearing on Chinese Drywall

A variety of public health officials testified last week at a hearing before the Consumer Protection, Product Safety, and Insurance Subcommittee of the U.S. Senate’s Committee on Commerce, Science, and Transportation, on the issue of allegedly toxic Chinese drywall installed in recently built homes.

Officials from the Centers for Disease Control and Prevention, the Consumer Product Safety Commission, the EPA, and Florida's Department of Health outlined the plan to study the effects of the drywall in a small number of test homes, to be completed by the end of June, and then expand the studies to a large-scale sample. The CPSC is also working with China's Administration for Quality Supervision, Inspection and Quarantine to find out how the drywall was made and to resolve significant difficulties in tracking the drywall's source.

The testifying officials warned that efforts to mitigate the drywall effects on homeowners shouldn't lead legislators to legislate policy ahead of scientific investigation. For example, Lori Saltzman, division director of the Office of Health Sciences at the CPSC, cautioned senators against legislation rushing to address any drywall issues before the ongoing studies are complete. And another panelist noted that a provision banning imported drywall composed of more than 5 percent organic material in a bill by Sen. Nelson, D-Fla., could shut down virtually all U.S. drywall imports, not just those from China suspected of being toxic.
 

According to allegations of homeowners, certain Chinese-made drywall — imported in the time frame 2005-2007 to meet an uptick in homebuilding demand after Hurricane Katrina — can cause respiratory problems and other health issues, produce a rotten smell, and corrode copper and metal fixtures, leading to fire hazards.

Randy Noel, a representative to the National Association of Home Builders, estimated the cost of replacing the Chinese-made drywall to be as much as $100,000 per home. More than 60 lawsuits have already been filed in seven states over the drywall, without conclusive scientific proof of its toxicity. Noel advocated a stay of the litigation until the CPSC and other agencies have concluded their investigations, identifying the scientific cause of the problems associated with the drywall and establishing a workable remediation strategy. He made the committee aware of a troubling new development in the area of drywall testing: the dramatic increase in the number of companies in the marketplace claiming to have the capability to test someone’s home to determine whether or not they have, or will have, a “toxic drywall” problem.
 

Not everyone has the same notion towards litigation: Saltzman reportedly remarked that the CPSC does not want to jeopardize any potential remedy for homeowners by having inadequate scientific proof to support and advance a possible court case.

 

White Paper Explains Detrimental Impact of Proposed Medical Device Anti-Preemption Bill

Much of the debate over the preemption doctrine, certainly in the media and even in many legal circles, has focused on the alleged inadequacy of the FDA to regulate drugs and devices, and the purported consequent  need to have state juries of lay people “police” the health industry. Comparatively little attention has been given to the other impacts of eliminating federal preemption.

A new white paper demonstrates that erasing this doctrine would decrease access to life-enhancing medical devices, increase health care costs, and reduce medical device industry employment. Congressional Democrats are seeking to do just this in the device context -- the Medical Device Safety Act of 2009 was crafted in response to the U.S. Supreme Court's 8-1 ruling in February, 2008 in Riegel v. Medtronic, upholding preemption for certain medical devices when the devices, and their warning labels, had been approved by the U.S. Food and Drug Administration.


The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” was authored by Ernst Berndt, professor in applied economics at MIT's Sloan School of Management, and Mark Trusheim. They argue that among the effects of the bill would be:

 • Reduced patient access to products and the health benefits they provide

• Unreliable, variable patient access to products and the health benefits they provide as varying state regulations and tort liabilities discourage or eliminate products in some regions but not others

• Increased medical costs and lower net public health compared to what could be achieved with increased medical device innovation and product introductions

• Increased defensive medical practices by physicians to avoid possible litigation, raising health costs and exposing patients to greater risks from the added unnecessary procedures

• Reduction in the number of products being developed as manufacturers and their investors respond to greater uncertainty regarding product approval and economic sustainability

• Transfer of health regulatory decisions to untrained, non-expert juries who are exposed to only a biased fraction of the scientific fact base on which to base their decisions


The authors compare the bill to what happened with vaccines: from 1967 to 2004 the number of vaccine makers plummeted from 26 to 3, leading to reduced access, higher costs, no new products, shortages of existing products, a fragile vaccine supply chain, reduced employment and increases in preventable illness. Congress had to step in and take the vaccines out of the traditional tort system.

Under the bill, the authors note, state juries would be asked to render decisions regarding device safety and efficacy based on a limited range of information focused on individual risk versus broad benefit at a trial typically lasting at most several weeks. Allowing state tort suits to do this will place state juries in the position of replacing, by overriding, professionally trained federal regulators in evaluating and quantifying the risks of medical devices. And unlike federal regulators, state juries will not balance, perhaps not even consider, the benefits to those for whom the medical devices enhances health and quality of life -- who of course are not parties to the action.
 

CPSC Responds To Criticism on China Drywall Investigation

The Consumer Product Safety Commission has issued a report on the imported drywall situation, noting that nearly 200 consumers from at least 13 States and the District of Columbia have reported health symptoms or certain metal corrosion problems in their homes that may be related to drywall imported from China. (CPSC says it is still investigating the scope of the drywall problem, working to identify the links from foreign manufacturers to the U.S. consumers in consultation with the Chinese government and the U.S. Customs and Border Protection.)

The update comes on the heels of criticism by Senator Nelson (D. Fla.) of how quickly the CPSC was moving. The agency, together with the Environmental Protection Agency and the Department of Health and Human Services, is looking at charges of health symptoms or the corrosion of certain metal components in their homes allegedly related to the presence of drywall produced in China. The majority of the reports to the CPSC have come from consumers residing in Florida while others have come from consumers in Louisiana, Virginia, Wisconsin, Ohio, Alabama, Mississippi, Missouri, California, Washington, Wyoming, the District of Columbia, Arizona, and Tennessee. Consumers largely report that their homes were built in 2006 to 2007, when an unprecedented increase in new construction occurred in part due to the hurricanes of 2004 and 2005.

The judicial panel on multidistrict litigation recently agreed to consider consolidating the
more than 30 federal lawsuits filed so far over the drywall.The lawsuits so far name Chinese-based manufacturers, as well as importers, developers and builders, contractors, suppliers and others.

Common features of the reports submitted to the CPSC from homes believed to contain
problem drywall have been:
• “rotten egg” smell within their homes.
• health concerns such as irritated and itchy eyes and skin, difficulty in breathing, persistent cough, bloody noses, runny noses, recurrent headaches, sinus infection, and asthma attacks.
• blackened and corroded metal components in their homes and the frequent replacement of components in air conditioning units.

The federal government is working on an (1) evaluation of the relationship between the drywall and the reported health symptoms; (2) evaluation of the relationship between the drywall and electrical and fire safety issues in the home; and (3) the tracing of the origin and distribution of the drywall. One obvious challenge has been figuring out how much problem drywall there is in any house, given that it is already installed, likely painted and may not be clearly marked.

On the health side, the most frequently reported symptoms are irritated and itchy eyes and skin, difficulty in breathing, persistent cough, bloody noses, runny noses, recurrent headaches, sinus infection, and asthma attacks. Some of these symptoms are similar to colds, allergies or reactions to other pollutants sometimes found in homes. As such, it is difficult to determine if the reported symptoms are related to the drywall and not any other environmental factors or pollutants in the home.

Data being gathered include from in-home air sampling; laboratory elemental characterization studies of domestic and imported drywall; and laboratory chamber studies of domestic and imported drywall to separate and isolate chemical emissions from drywall as opposed to chemicals emitted from other home products (e.g., carpets, cleaners, paint,adhesives, beauty products).

If a house has “problem” drywall, the CPSC is recommending that consumers with health issues consult a physician as soon as possible; those with any of the electrical or fire safety concerns should consult the local gas or electric supplier and a licensed electrician or building inspector as soon as possible. Consumers are cautioned to beware of unqualified testing and remediation services already seeking to o take advantage of consumers struggling to address this issue.

CPSC admits it could be months before it can confidently address the scientific relationships, if any, between the problem drywall and the health and safety concerns raised by consumers.
 

Senator Calls For CPSC Resignation Over China Drywall

Sen. Bill Nelson, D-Fla., has sent a letter to the President calling for the resignation of the current head of the U.S. Consumer Product Safety Commission, and criticizing the agency for its response to reports of Chinese-made tainted drywall installed in U.S. homes.

In a letter addressed to President Obama earlier this month, the senator targeted the CPSC for failing to do enough, in his view, to halt the import of the drywall. Readers will recall that residents claim this product emits a sulfur smell, poses health risks, and also causes electrical problems.

Nelson asserted that the "agency is doing too little, too late to help residents of Florida and other states who are reporting serious health and safety problems associated with living in homes built with tainted drywall imported from China.”  The CPSC reports that it has launched a formal compliance investigation to determine any risk associated with the sulfur-based gases that may be emitted from the imported drywall

Nelson is also a sponsor of the Drywall Safety Act of 2009, which seeks to impose a recall and a temporary ban on imports until federal drywall safety standards are put in place to protect consumers. The legislation also calls for the CPSC to perform a study with the EPA to determine the level of risk posed by the substances in the drywall.

Products litigation has ensued, including a proposed class action was filed in the U.S. District Court for the Middle District of Florida. According to that suit, a shortage of drywall made in the U.S. caused many builders to use imported Chinese drywall during Florida's pre-recession construction boom earlier this decade. There has also been speculation that some of that drywall may have been kept at sea waiting to enter U.S. ports, and was thus exposed to excessive moisture/humidity that caused the alleged fume problems. Such claims are typically inappropriate for class certification because of the individual issues that will be presented by evidence surrounding injury and causation. And at least one U.S. home builder has sued more than two dozen manufacturers, suppliers and installers of drywall imported from China.
 

Bills to Ban BPA Introduced in Congress

In the past few days, bills were introduced in both houses of Congress to ban bisphenol A in all food and beverage containers in the U.S.

The so-called Ban Poisonous Additives Act of 2009 is sponsored Rep. Edward Market, D-Mass. in the House, and by Sen. Dianne Feinstein, D-Calif. and Sen. Charles Schumer, D-N.Y. in the Senate. In the House it is H.R. 1523. In the Senate it is S.593

The proposed legislation would ban the sale of reusable beverage containers like baby bottles and thermoses that contain BPA and prohibit other food and beverage containers, including canned food and formula, containing the chemical from entering the market.

The bill, which would take effect 180 days after it is enacted, allows manufacturers who can show that a particular container cannot be made without BPA to obtain a renewable one year waiver to the ban. During that time, the company must label the product as containing BPA and submit a plan for removing the chemical in the future.

The bill also requires the secretary of HHS to conduct a periodic review of the list of substances that have been deemed safe for food and beverage containers, to determine whether new scientific research shows that the substances pose health risks. This review must take place “not less than once every 5 years,” under the bill.

MassTortDefense has posted about BPA issues before. With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.

Also in the press, six manufacturers — Avent, Disney First Years, Gerber, Dr. Brown, Playtex and Evenflo — announced that they would ban BPA in baby bottles they sell in the U.S. And Sunoco indicated that it had stopped selling BPA to anyone who would not promise to prohibit its use in products intended for children ages three and under.

Many of these companies are defendants in the ongoing BPA litigation, and their voluntary actions reflect the legal risks far more than the science. The companies noted this decision may address growing public concern and confusion regarding products made with polycarbonate plastic, but was not because these FDA-regulated products are not safe.

Any wide-spread ban of this product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistry found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

 

 

 

New Food Safety Bill Introduced in Congress

Two years ago, there was a nationwide outbreak of E. coli linked to consumption of contaminated spinach from a California supplier. That was the 25th reported U.S. outbreak of E. coli infection that had been traced to contaminated leafy green vegetables since 1993. Each year, approximately 110,000 persons get this infection, and 50 of them die. This is despite greatly intensified efforts during the past decade on the part of federal food-safety agencies — the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) — to prevent the spread of such infections.


In a 2008 outbreak, Salmonella was diagnosed in 1407 persons in 43 states. At least 282 patients were hospitalized, and 2 patients died. Although initial epidemiologic evidence suggested that contamination of tomatoes grown in the southwestern United States might be the cause, eventually the outbreak was isolated from jalapeño and serrano peppers that had been grown on a Mexican farm. In the mean time, tomato consumption plummeted, and the industry lost an estimated $200 million in sales.

This year, the disease was diagnosed in 600 persons in 44 states and Canada traced to contamination of one Georgia producer's peanut butter and the processed foods of other manufacturers that contained the company's peanut butter or paste. Beyond a recall of all peanut products produced by the company since January 1, 2008, more than 400 food products (including cookies, crackers, cereal, candy, ice cream, and pet foods) have been recalled.

Many of incidents like these have led to products liability and mass tort litigation. E.g., In Re ConAgra Peanut Butter Products Liability Litigation, MDL-1845, 2008 WL 2885951 (N.D. Ga., July 22, 2008). And this issue has caught Congress’ attention. Senator Durbin last week introduced S.510, the “FDA Food Safety Modernization Act,” a new bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. The bill calls for food manufacturers to conduct a Hazard Analysis and implement Risk-Based Preventive Controls; it calls for regulations to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the agency has determined that such standards minimize the risk of serious adverse health consequences or death.

The bill also calls for inspection of food makers’ facilities, according to their risk profile, based on the facility's history of food recalls, outbreaks, and violations of food safety standards, and the rigor of the facility's hazard analysis and risk-based preventive controls. Some facilities would be designated as high-risk facilities and subject to annual inspections. the proposed legislation would also upgrade the nation’s food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by coordinating Federal, State and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories.

Regarding imports, the bill would require each United States importer to perform risk-based foreign supplier verification activities, and the FDA would be required to establish by 2010 an office in not less than 5 new foreign countries to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the FDA and exported by such country to the United States.
 

Members of Congress to Re-introduce Medical Device "Safety" Bill

Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held  that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.

Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy.  The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency's resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
 

Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic.  H.R. 6381 garnered 62 co-sponsors last time.  Officials for the "American Association for Justice" f/k/a ATLA,  recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.

Two Nano-Technology Support Bills Introduced in House

Rep. Michael Honda (D-Calif.) has introduced legislation that he says will promote the development and responsible stewardship of nanotechnology. His bill, the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R. 820), would expand the federal government's efforts to support the commercialization of products emerging from nanotechnology research. A somewhat similar bill was introduced last month by Rep. Bart Gordon (D-Tenn.), chairman of the House Science and Technology Committee. That bill, the National Nanotechnology Initiative Amendments Act of 2009 (H.R. 554) has 21 co-sponsors so far. The S&T Committee has made ensuring that the U.S. is a leader in the development of nanotechnology a priority for the new Congress.

Gordon's bill aims to reauthorize the multi-agency National Nanotechnology Initiative that Congress formally established in 2003 through the 21st Century Nanotechnology Research and Development Act of 2003. A National Nanotechnology Coordination Office along with the National Research Council of the National Academy of Sciences would supervise a national nanotechnology program. 

While the two bills have much in common, H.R. 820 includes elements like the offering of tax credits for individuals purchasing stock in certain types of nanotechnology firms, such as small or start-up companies. Honda reports that H.R. 820 draws on the work of a Task Force on Nanotechnology that he convened in 2005. That task force highlighted various ways the U.S. government could promote the commercialization of nanotechnology, as other governments already are doing. Accordingly, the NANO Act would authorize up to $100,000 to establish public-private partnerships to advance the commercialization of nano-manufacturing technologies to address critical scientific and engineering needs of national importance.

Gordon's bill, H.R. 554, would encourage nanotechnology research to provide solutions to important problems in such areas as nanoelectronics, energy efficiency, health care, and water remediation and purification. Both bills use various means to support the training of students in nanotechnology to ensure a future workforce.
 

Senate Bill Introduced To Overturn Riegel

Two liberal Senators have followed the lead of liberal Democratic House lawmakers and introduced a Senate counterpart to the proposed Medical Device Safety Act of 2008. The bill would overturn the Supreme Court’s decision in Reigel v. Medtronic, which properly confirmed preemption of state tort suits for FDA-approved medical devices. The bill would permit individuals to sue device makers under state tort laws, and permit state court juries to second-guess the expert decisions of federal regulators. The bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with.

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) introduced the companion bill to H.R. 6381, which has 62 co-sponsors in the House, and which was introduced in the House in June by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.). The Senators’ introductory statement can be viewed here

MassTortDefense has posted on preemption, including here and here.

The Wall Street Journal weighed in on these issues in an editorial August 13th. Describing the Supreme Court's “sensible 8-1 ruling earlier this year” in Riegel v. Medtronic, the Journal noted how the FDA's authority to approve a drug or device pre-empts state product liability laws. “The Court's decision makes sense for many reasons, not least to avoid creating a sort of double-jeopardy for companies -- first having to run the FDA approval maze, then allowing a nationwide quilt of different laws and standards to second-guess that approval.” In 1976 Congress passed the Medical Device Amendments, establishing a national standard with express pre-emption language barring states from imposing their own requirements.

Democratic House member Henry Waxman said the decision "strips consumers of the rights they've had for decades." Who writes this stuff for Henry?, asks the WSJ. Far from representing a radical departure in the law, “the Court's reasoning upheld what had become a common opinion in the federal court system. In half a dozen holdings, federal circuit courts had already ruled in favor of pre-emption, covering states from Texas to Illinois to Pennsylvania.”

The Journal observed, “What Mr. Waxman really wants to restore is the trial lawyer bingo that can net jackpot jury awards while wreaking havoc on national standards. The FDA approval process is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective.” Of the 8-1 vote, the editorial mentioned, “You've got to love it when the tort bar and Democrats accuse those notorious right-wing Justices Stephen Breyer, Anthony Kennedy and David Souter -- who joined the majority opinion -- of being the greedy tools of business. Another liberal, John Paul Stevens, joined the majority with some caveats.”
 

President Signs CPSC Reform Act

Despite some concerns, President Bush on Thursday signed into law the Consumer Product Safety Improvement Act of 2008. A White House spokesman was quoted as saying, "This bill will help to ensure that the products Americans find on their store shelves are safe, and that the regulating agencies have the resources they need to enforce law."  Useful summary here.

The Act will increase funding for CPSC over five years; add whistleblower protections for employees of manufacturers and sellers; require third-party testing of certain children's products; adopt an interim toy safety rule and require CPSC to make new safety rules for toys; create a public database for consumer reports; ban six types of phthalates and lowers lead levels in certain products for children. Three of the phthalates would be temporarily banned pending further study. The American Chemistry Council said although there was no scientific basis for the phthalate restriction, they understood consumer concerns and were committed to working with the CPSC and others to conduct the studies.

One of the most controversial aspects empowers state attorneys general to enforce federal consumer rules.
 

MassTortDefense has posted about the legislation here and here.
 

CPSC Improvement Act Update

The White House received the Consumer Product Safety Commission Improvement Act of 2008 (H.R. 4040)  on August 6th, giving the president until August 18th to sign the bill into law. Apparently the Congress had delayed sending the bill to accommodate the president's travel schedule to the Summer Olympics.

The president has 10 days, excluding Sundays, in which to sign the bill into law.  All indications are that President Bush will sign the legislation.

As noted here at MassTortDefense both houses of Congress passed the CPSC reform bill with near-unanimous support. 

CPSC Legislation Passes Both Houses

A quick update on the CPSC reform legislation: The House voted 424-1 (9 not voting) to agree to the Conference Report on the Consumer Product Safety Commission Reform Act of 2008. Last night, the Senate agreed to the Conference Report by a vote of 89-3 (neither Presidential candidate present to vote). On to the White House.

Compromise Reported On CPSC Reform Act

The approach of the August congressional recess has apparently spurred compromise on the Consumer Product Safety Commission bill. The House passed its CPSC reform bill in December, 2007, and the Senate passed its version, the Consumer Product Safety Commission Reform Act of 2008, in March.  MassTortDefense has posted on the process here and here. And here.

The conference committee has reached an agreement, and will present the new compromise CPSC Improvement Act of 2008 to both houses for a vote, probably late this week.  The House Conference Report is found here.

One sticking issue had been language concerning phthalates, which have been used to soften plastic in children's toys. The original Senate version included a stringent assertedly non-preemptive version of a California law banning toxic phthalates in children's products. But, of course, not all phthalates are created equal. Phthalates are a broad class of chemicals, and each phthalate has distinct properties and safety profiles. The European Union Risk Assessment organization has concluded that one form (DINP) is safe for use in toys, for example. The new bill would ban phthalates from toys and other child-care items.

The compromise bill would name the ASTM international standard No. F963-07 as the temporary safety standard for toys, pending work on a permanent regulation (to take place within a year).  Ideally, this would mean that product safety decisions will be made by experts at the appropriate federal agencies, rather than allow creation of a hodge-podge of varying state standards. But the bill "grandfathers" in, as not preempted, any existing overlapping state regulations on child product safety, and permits states to apply for exemption from preemption for future proposed safety standards.  The CPSC is to consider whether the state standard offers significantly higher protection, the technological and economic feasibility of the standard, and the need for a uniform national standard.

The bill also contains the controversial "whistle-blower" protection provision, and requires third-party testing of certain children's products.  And it would create the consumer product safety database from the original House bill.


Congress Still Wrestling with CPSC Legislation

MassTortDefense has posted before about the competing Senate and House bills to reform the Consumer Product Safety Commission. See here.


Media reports are suggesting that conferees on Consumer Product Safety legislation might not complete their efforts before Congress recesses June 27th. House Majority Leader Hoyer (D-Md.), had predicted that the compromise CPSC bill would come to the floor in June. But debate, and lobbying, on the bill continue.

As noted before, most of the more contentious issues in the bill were included in the Senate version of the legislation, which was passed in March. Sticky issues include provisions granting state attorneys general the power to pursue purported violations of laws enforced by CPSC; whistleblower protections for employees of manufacturers; and a public database for reports of injuries, illness, death, or risk related to consumer products submitted by consumers, local, state or national government agencies.


If the process is not completed by August, Congress will be in campaign mode and that may scuttle the reform legislation for this year.

Senate Judiciary Committee Holds Hearing on Preemption

The Senate Committee on the Judiciary recently held a hearing entitled “Short-Change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.”

On June 11, 2008, the Committee discussed recent preemption decisions by the Supreme Court, and heard from several witnesses including consumers, academics, a representative of the United States Chamber of Commerce, and attorneys. See details here.

Committee Chair Senator Leahy (D. Vt.) took up the cry of Democrats who have suggested that the Supreme Court has narrowly interpreted the laws designed to protect Americans who rely on medical devices to keep them alive. This Supreme Court interpretation has transformed the law, he said, into one that takes away protections from people by extinguishing long-standing state law remedies which hold corporations accountable when they are aware of potential dangers but hide them from consumers. As a result, Americans are allegedly not only deprived of a remedy under state law but are offered no replacement remedy under Federal law.

Sen. Orrin Hatch’s questioning brought out the U.S. Supreme Court's decision in Riegel v. Medtronic, preempting state law claims relating to FDA approval of certain medical devices, was correctly decided. FDA approval of a device pre-marketing-approval application constitutes approval of the physical aspects of a device and its labeling, which results from a comprehensive review of the scientific and medical information relevant to the effectiveness and safety of the particular device. It also reflects FDA’s detailed resolution of tensions between aspects of the device that confer therapeutic benefits and aspects that present risks to safety.

Where the FDA has weighed the advantages and disadvantages of, and has approved, the design and labeling of a particular product, decision-makers applying state law should not be permitted to second-guess FDA’s approval, or re-weigh benefits and risks, or revise trade-offs FDA has already found acceptable, by finding the product’s design or labeling inadequate, Hatch was told.

Hatch noted that it would be difficult to characterize the Supreme Court's 8-1 decision as a ruling by an "activist" court. The court's decision was foreshadowed by prior Supreme Court and federal appeals court rulings.

The hearing was cut off before all witnesses testified live due to procedural issues in the Senate. Clearly, however, certain members of Congress are paying attention to the preemption issues.