... and Justice for All

Increased Efforts To Prevent Injured Families From Holding Corporations Accountable

The Wall Street Journal reports that the Bush Administration, as it winds down amidst the meltdown of our national economy causing the loss of some $2 trillion of Americans' retirement savings and the faltering wars in both Afghanistan and Iraq, is moving aggressively to erect further bars preventing injured families from holding accountable the corporations responsible.  See "Bush Rule Changes Could Block Product-Safety Suits."  The latest instance of lawsuit-protection language for corporations that have harmed and injured American families is a rule announced Oct. 8 that establishes a limit on the number of seat belts car manufacturers can be required to install and prevents lawsuits by injured persons who were unable to be protected by a seat belt.  This is the latest installment of the Bush Administration's efforts to insulate corporations from responsibility, accountability and liability for their wrongful actions through the legal doctrine of "preemption."  The Bush Administration has wholly abandoned long-standing rules and practices to aid and protect American families in favor of rewarding the corporate interests that it serves.  Unlike the $750 billion bailout for the financial services industry that American families were recently touched upon to fund, the preemption bailout goes on by stealth and largely unnoticed.  Both achieve the same result: shifting to American families the burdens created by irresponsible and wrongful corporate actions.  

Robert L. Abell
www.RobertAbellLaw.com 

Drug Makers Should Be Liable For Defects Under State Law, New England Journal of Medicine Editors Argue To Supreme Court

Approval of drugs by the Food and Drug Administration (FDA) should not preempt any liability under state tort laws for pharmaceutical manufacturers, editors of the New England Journal of Medicine argue in a brief to the United States Supreme Court.  One of the most closely watched cases of the Supreme Court's upcoming term is Wyeth v. Levine.  Levine, a musician, lost an arm after an injection of the nausea drug, Phenergan.  She sued Wyeth, claiming that it failed to adequately warn of the drug's risks and she won a $8.6 million judgment in a Vermont trial court.

Wyeth argues that it is insulated from any liability for Levine's injuries because the FDA approved Phenergan.   This is the legal doctrine of "preemption." 

The NEJM editors argue that "the FDA the FDA is in no position to ensure the safety of prescription drugs.  Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public. Post-approval dangers posed by drugs placed into the market are unfortunately quite common. However, the FDA’s ability to either anticipate these risks or react expeditiously once they have been revealed has been limited by serious information-gathering constraints in both pre- and postapproval settings." The brief can be read by clicking here.

Two former FDA Commissioners, Donald Kennedy and David Kessler, have also submitted a brief supporting Levine.  They argue that the pro-preemption position advanced by the drug companies and the Bush Administration "threatens to undermine, not advance, the underlying goal of our nation’s drug safety laws, which is 'to protect consumers from dangerous products.'”  A copy of their brief may be read by clicking here.

Robert L. Abell www.RobertAbellLaw.com

Railroad Crossing Safety Requires "Active" Warning Systems

Research shows that a stop sign is the most dangerous type of warning system at a railroad crossing.  The safest is an "active" warning system which include flashing lights and gates.  Despite this research, the Federal Highway Administration proposes only to require a stop or yield sign at every railroad crossing in the country. 

Stop signs at railroad crossings pose two types of specific dangers.  One is that large vehicles, such as school buses, require about 10-15 seconds to clear a crossing.  This may not be enough time to clear the crossing before an oncoming train would arrive, even one that could not be seen when the vehicle began crossing.  The second is that some stop signs are placed too far from the crossing to allow a clear line of sight to see if there is an oncoming train.  These problems are why the National Cooperative Highway Research Program has strongly and continually recommended that engineering analysis determine the safest warning system at each railroad crossing.  The American Association for Justice has urged the FHWA to drop this proposal based on decades of research and experience and its letter may be reviewed here. 

This proposed agency rule also offers an illustration of the continuing efforts to use the preemption doctrine to insulate corporations from accountability, responsibility and liability.  The preemption doctrine would hold that installation of a stop sign and the compliance with federal regulation that it would entail would bar any liability under state law for an unsafe crossing.  That is no justice: issue an unsafe federal regulation that encourages dangerous practices and prevents any responsibility or liability. 

Robert L. Abell
www.RobertAbellLaw.com

Preemption and the Decline of States' Rights

    In an astute editorial observer column in the May 23, 2008, edition of the New York Times, Adam Cohen describes the ascendancy of the doctrine of federal preemption under the Bush Administration that has crippled, in some cases prevented, states from being able to protect their citizens.  The Bush Administration has run rough shod over the traditional Republican assertion of "states' rights" to prevent, by the doctrine of federal preemption, states from protecting their citizens. 
    Consumers have been harmed by the Bush Administration's assertion of preemption in a number of areas.  As states mobilized in response to a spike in predatory lending, the Bush Administration's Office of the Comptroller of the Currency issued rules negating state predatory lending laws over the protests of all 5o state banking superintendents, Republican and Democrat.  The 2003 Medicare law prevents states from regulating abuses by private Medicare insurance plans.  The National Association of Insurance Commissioners, which represents the insurance regulators in all 50 states, protests that states no longer have the ability to protect sick, elderly customers.
    States' ability to conserve their resources has also been curtailed by the Bush Administration.  California's laws curbing greenhouse gases from new cars and trucks were blocked by the Environmental Protection Agency. 
    The Bush Administration has rewritten more than 50 federal regulations that will make it much more difficult and in many instances impossible for consumers to sue corporations responsible for unsafe food, drugs and other dangerous products.  An example is a suit brought by the actor Dennis Quaid and his wife, who claim that confusing packaging on a blood thinner caused large doses to be mistakenly given their newborns at the hospital.  Their suit was thrown out of court, because, under the doctrine of preemption, the manufacturer's compliance with Food and Drug Administration labeling requirements barred any lawsuit. 
    What's the upshot of all this?  Cohen describes it right on:  "Manufacturers are more likely to make unsafe products if they know a customer who is injured or killed cannot sue." 

Robert L. Abell
www.RobertAbellLaw.com

FDA Chief Bypasses Bush Administration To Beg Congress for More Money

    The New York Times reports that FDA Commissioner Andrew C. von Eschenbach has bypassed the Bush Administration to appeal directly for more money for the troubled agency, which is charged with protecting Americans' food, drugs and a myriad of everyday items.  Although the Commissioner acknowledged earlier in the year that the FDA was not able to meet its responsibilities and an FDA Science Panel reported last year on the agency's failings, the budget requested by the Bush Administration was insufficient to cover even payroll increases.  Protecting the American public was not considered a priority for the Bush Administration, which meanwhile has issued a series of regulatory rules to insulate corporate wrongdoing from accountability, responsibility and liability through the legal doctrine of preemption. 

Robert L. Abell
www.RobertAbellLaw.com

FDA Report Acknowledges Agency Cannot Protect American Public

    The Supreme Court seems certain to rule within the next year that FDA approval of a drug bars any type of lawsuit that the drug is dangerous and caused injury or death.   This seemingly inevitable ruling makes all the more important the FDA for the protection of the American public. 
    The FDA, as its own Commissioner has acknowledged and as a report presented by the FDA Science Board -- an advisory panel of scientists and industry experts -- chillingly warned, is not up to the task.  In a speech in March, FDA Commissioner Dr. Andrew C. von Eschenbach admitted that the agency "may fail in its mission to protect and promote the health of every American" and that "peril exists."  The commissioner merely echoed the findings of the FDA Science Board reporting, among other things, that the agency does not have the capacity to ensure the safety of the nation's food, cannot adequately regulate the development of medical products based on "new science," cannot fulfill its mission because its scientific base has eroded, its scientific workforce lacks sufficient capability and capacity and its information technology system is inadequate including internal e-mail systems prone to frequently breaking down.  To report is titled "FDA Science and Mission at Risk." 
    In view of the indisputable inability of the FDA to adequately protect the American public, it would seem that insulating from any possibility of liability and hence from responsibility those corporations subject to FDA regulation can serve only to undermine the public interest.  But sometimes that's just what the Supreme Court calls justice. 

Robert L. Abell
www.RobertAbellLaw.com

Drug Companies Find Shelter In Overwhelmed FDA

    Probably in the next year and in furtherance of Chief Justice Roberts's expressed desire that the Supreme Court function to insulate corporate America from accountability, responsibility and liability, drug companies will find themselves immune from any lawsuit arising from harm, damage and injuries caused by their products based on FDA approval and the preemptive shelter the Supreme Court will rule it provides.
    For decades FDA officials have acknowledged that product liability lawsuits against pharmaceutical companies could aid the agency's oversight of safety issues.  Within the last decade suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid, and several antidepressants have illustrated how private liability suits provide absolute necessary help to the FDA's mission to protect the public.  After all and who's kidding who, through politics the big pharmaceutical companies know the FDA can be had but actually having to pay money and accept responsibility can eventually cause a change in corporate behavior.
    The case of the Ortho Evra patch from Johnson & Johnson is a good example.  The company began development of the product in 1996.  Part of the aim was to provide a birth control product likely to expose women to less estrogen, which in high doses is known to raise the risk for blood clots that can cause heart attacks.  But in 1999 a clinical trial indicated the patch delivered excessive estrogen into the bloodstream.  That problem was solved by creation of ...... a "correction factor" that was not part of the study protocol plan filed with the FDA and was not mentioned when a study based on the trial was published in 2002.  Two other studies, another conducted in 1999 and one in 2003, also indicated that the patch delivered excessive estrogen into the bloodstream.  Clinical trials also indicated other side effects caused by the patch.  Nonetheless, the FDA approved the patch and it was marketed as releasing a level of estrogen into the bloodstream that the company now acknowledges was inaccurate.  By November 2005, the FDA, after mounting evidence of the patch's side effects and the death of an 18 year old woman, was moved to issue a warning that the patch, as shown by the company's studies prior to the patch's FDA approval, exposed women to higher levels of estrogen. 
    Over 3000 women and their families have sued Johnson & Johnson over heart attacks, strokes and, in 40 cases, death, they claim were caused by the patch.  The lawsuits have uncovered internal company e-mails showing that the company's researchers had found that the patch delivered excessive estrogen than was publicly reported.  These lawsuits will be dismissed because of the FDA approval, which it looks like occurred because the company succeeded in snookering the agency.

Robert L. Abell
www.RobertAbellLaw.com