... and Justice for All

Senator Charges "Criminal Negligence" In FDA's Failure to Protect Food Supply

    As a salmonella outbreak linked to some types of raw tomatoes sickens hundreds of Americans across 17 states, a Republican Senator, Arlen Specter of Pennsylvania, charges the Bush Administration with "criminal negligence" in not moving faster to provide the Food and Drug Administration (FDA) with monies for food protection efforts, the New York Times reports. 
    Last November the FDA released a "food protection plan" but the Bush Administration did not provide any funds for it and did not ask for any money for until Monday, June 9.  This failure Senator Specter informed health and human services secretary Michael O. Leavitt amounted to "criminal negligence" that was "subjecting people to bodily injury and death."  Since 1990 there have been 13 multistate outbreaks of salmonella poisoning related to tomatoes, according to the Centers for Disease Control and Prevention.

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

Bush Administration Rules Protect Corporate Wrongdoing

    As part of its ongoing and to date very successful effort to insulate corporate wrongdoing from accountability, responsibility and liability, the Bush Administration has adopted since 2005 a total of 51 regulatory rules that preclude lawsuits arising from all sorts of everyday items including drugs, cars, railroads, medical devices and food.

    The legal doctrine is known as "federal preemption."  Here's how it works: say for instance the Food and Drug Administration (FDA) adopts a regulation outlining drug labeling and packaging.  However, the labeling and packaging causes confusion and, as a result, children are badly injured.  That's what happened to actor Dennis Quaid's newborn twins who were given massive doses of blood thinner at a hospital.  The Quaids filed a lawsuit in Illinois state court claiming that the manufacturer -- Baxter Healthcare Corp. -- was negligent n packaging different doses of the product in similar vials with blue backgrounds.  Under the doctrine of "federal preemption," however, the Quaids' suit could be barred because the manufacturer's compliance with a deficient federal regulation preempts any liability it might have for causing harm. 

    Earlier this year FDA Commissioner Dr. Andrew C. von Eschenbach publicly acknowledged that the agency "may fail in its mission to protect and promote the health of every American" and that "peril exists."  That admission followed on the heels of a report late in 2007 from the FDA Science Board 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" and had many other materials failings. 

    Historically, state tort and liability lawsuits have been viewed as complementary to federal agency regulations.  But the Bush Administration has hit upon a successful formula to ensure not consumer safety but corporate immunity from responsibility and accountability: render the regulatory agencies unable to function and preempt any attempt to protect consumers.  The American Association for Justice and other groups are opposing mightily these efforts and you can learn more here.

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