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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
June 11, 2008

President Bush Should Support Fair Pay Law

President Bush should follow the recent signing of the anti-genetic discrimination bill with support for passage of the Lilly Ledbetter Fair Pay Act, which would restore the ability of women who are unfairly and wrongly underpaid because of gender discrimination to recover the fair pay they have earned.  That ability was taken away last year by the Supreme Court in a 5-4 decision that disregarded the overwhelming consensus of the intermediate federal appeals courts and a common sense appreciation for the regular workplace. 

Lilly Ledbetter worked as an area supervisor for Goodyear in Alabama, the only woman out of a total of 15 area supervisors.  After nearly 20 years of faithful service and hard work, she learned that she was being paid from $500 to $1500 less per month than all her male counterparts including a number with lesser seniority.  She filed suit, a jury ruled that gender discrimination was the basis for her being underpaid and she was awarded some $250,000 of wages she had rightfully and fairly earned. 

The Supreme Court took it away, ruling 5-4 that Ledbetter could recover only that lesser pay that occurred within the last six months of her employment.  Goodyear, of course, like many employers – studies have shown that one-third of private sector employers prohibit employees from discussing their pay – kept a tight lid on salary and pay information.  As a result, Ledbetter, despite her undeniable qualifications and hard work, was grossly underpaid in comparison with her male counterparts for many, many years.  Only when she found out what had been done to her did she file suit.  But the Supreme Court ruled no matter, she waited too late.

The Lilly Ledbetter Fair Pay Act simply seeks to restore what every woman working in America had before the Supreme Court’s decision: that is, a realistic opportunity to recover in court the earnings and benefits that they deserve based on their performance and qualifications but have been denied because of their gender. The House of Representatives passed the bill overwhelmingly, but it died in the Senate in the face of a Republican-led filibuster with both of Kentucky’s Senators, McConnell and Bunning, standing tall against equal pay for equal work.

It would seem a very American notion: that women (and everyone else for that matter) should be paid fairly and equally for the work their skills, abilities and labor enables them to do.  President Bush’s support for the anti-genetic discrimination bill is a sensible and reasoned response to a real world, real life problem. The Lilly Ledbetter Fair Pay Act is the same, and the President, along with Kentucky’s Senators, should line up in support of equal pay for equal work.

Robert L. Abell
June 4, 2008

Criminal Prosecution for Worker Safety Violations

Enacting meaningful criminal penalties for worker safety violations is urged by former Justice Department prosecutor David M. Uhlmann in an op-ed column, "The Working Wounded," in the New York Times.  Mr. Uhlmann reports some disturbing statistics and information: an employer that violates a worker safety rule and kills an employee faces only 6 months in jail under the federal Occupational Safety and Health Act (OSHA); if the employee is maimed and disabled the maximum penalty is up to a $70,000 fine; and since 1970 only 68 cases have been prosecuted under OSHA, although approximately 341,000 people have died at work. 

Robert L. Abell
May 27, 2008

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
May 26, 2008

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
May 15, 2008

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
May 14, 2008

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
April 19, 2008

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
April 9, 2008

Disability Insurers Causing Overload of Social Security

A growing backlog of pending claims for disability benefits from Social Security indicates that the Social Security system is being swamped through the actions of insurance companies compelling their insureds to file benefit claims with Social Security.  Most disability insurance policies have a provision that requires the insured to apply for disability benefits from Social Security and then allows, if that claim is approved, the insurance company to reduce the payment it makes to the insured.  Oftentimes, disability insurers refer their insureds to a law firm or company to help them with their claim to Social Security. 

Approximately 2.5 million people apply annually for disability benefits from Social Security.  A recent study found that 18 percent of these applicants acknowledged being unqualified, because the standard to receive Social Security disability benefits requires that a person be unable to work in any job because of a total and permanent disability.  Typically, disability insurance policies pay benefits when a person is disabled from performing their last job, not any job.  Some insurance companies have stopped paying benefits where there insured has refused to file a claim with Social Security.  An interesting study of this practice and a pending lawsuit was reported as the lead story in the New York Times on April 2, "Insurers Faulted As Overloading Social Security." 

Robert L. Abell
April 2, 2008

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Robert L. Abell is a  Personal Injury and Accident lawyer for Lexington, Winchester, Paris, Georgetown, Frankfort, Versailles, Nicholasville, Richmond, Lancaster, Stanton, London, Corbin, Shelbyville, Danville, Lawrenceburg, Williamstown, Jeffersontown, Louisville, Harrodsburg, Campbellsville, Liberty, Bardstown, Covington, Columbia, Elizabethtown, Newport, Pikeville, Ashland, Morehead, Jackson, Cynthiana and other communities located in central and eastern Kentucky and Fayette County, Scott County, Clark County, Madison County, Laurel County, Powell County, Morgan County, Breathitt County, Harrison County, Woodford County, Bourbon County, Jessamine County, Mercer County, Boyle County, Anderson County, Shelby County, Jefferson County, Owen County, Franklin County, Grant County, Boone County, Kenton County and elsewhere in Kentucky. 
This website does not constitute and is not intended to be legal advice.  You should consult with a lawyer regarding your own situation. 
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