Abell's Kentucky Law Blog

FDA Warns of Fraudulent Swine Flu Cures

The Food and Drug Administration (FDA) has issued a warning about Internet marketing of fraudulent swine flu cures. Learn more about the warning here. 

Robert L. Abell
www.RobertAbellLaw.com

FDA Cites Drugmakers for "Misleading" Internet Ads

The Food and Drug Administration (FDA) has cited 14 drugmakers for “misleading” internet ads according to a report by Bloomberg News, “Drug Makers Cited by FDA for ‘Misleading’ Internet Ads.” The companies failed to identify product names and side effects associated with their drugs on sponsored search results for internet search engines. The FDA ordered the drug makers to stop using the ads.

 

Robert L. Abell
www.RobertAbellLaw.com

Mislabeled Insulin Syringes Recalled

Mislabeled insulin syringes manufactured by Covidien. Ltd. and sold by Wal-Mart and Sam's Club stores have been recalled, according to a report in the New York Times, "Insulin Syringes Are Recalled."  The recall was announced by the Food and Drug Administration.  The mislabeling could cause patients to receive 2.5 times the normal dose; approximately 471,000 syringes, which go by the brand name ReliOn, are said to affected.

Robert L. Abell
www.RobertAbellLaw.com

Unsafe Drugs Approved & Pulled From Market By FDA

23 different drugs have been approved by the Food and Drug Administration only later to be pulled from the market by the agency in the last 11 years when they have been proven unsafe.  The Boston Globe, "No Haven For Dangerous Drugs," reports on this shockingly bad oversight record and on the ongoing efforts by pharmaceutical companies to obtain legal protection from any liability for their dangerous drugs based solely on their ability to obtain approval from the FDA.  This legal strategy by the pharmaceutical companies will be reviewed by the United States Supreme Court in the case of Wyeth v. Levine.  The argument of the drug companies is that if the FDA approves a drug they cannot be held liable or responsible if their drug later kills or severely injures an individual.

The inability of the FDA to exercise proper oversight and review of new drugs has been acknowledged even by the agency itself.  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.  The report is titled "FDA Science and Mission at Risk."   

Robert L. Abell
www.RobertAbellLaw.com

Drugs Being Investigated Listed by FDA

The Food and Drug Administration (FDA) has begun posting quarterly lists of drugs that it is investigating for possible safety issues.  That a drug is listed does not mean that it has safety problems, just that a report has been received from a patient, doctor or even a drug company itself about a possible safety issue with a drug.  The FDA will list each drug and the general nature of the problem reported regarding it but will not detail the number of complaints about it or the seriousness of any of the events.  The current list can be seen by clicking here.

Robert L. Abell
www.RobertAbellLaw.com 

Pregnant and New Mothers Endangered by Proposed FDA Rule

Pregnant and new mothers are endangered by a proposed FDA rule that will allow drug companies to omit information on their warning labels about dangerous side effects of their products.  For leaving out this important information the drug companies would receive the prize of immunity from lawsuits through the doctrine of preemption.  That's justice under the Bush Administration: create a rule that allows drug companies to harm pregnant and new mothers and get away scot-free.  The ever-vigilant American Association for Justice has protested adoption of the proposed rule that you can read by clicking here. 

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

Food-Borne Illness Case Settled

    As a salmonella outbreak tied to tomatoes has spread into 22 states and the Food and Drug Administration continues to fail to protect the American public, the Associated Press reports the settlement of a food-borne illness case from Milwaukee involving the death of a 3 year old girl from an e-coli related syndrome.  The case involved exposure to tainted meat in 2000 at a Sizzler restaurant in Milwaukee.   Along the way, a trial court judge dismissed the case on preemption ground, accepting the meat producer's argument that it should not be held liable, accountable or responsible because it had complied with FDA regulations in handling the beef.   The lawyer for the child's family described the case "as a study in perseverance."  It is also a case study of how inadequate FDA regulation is in protecting the public and how essential is state tort law in holding corporations accountable to that public.

Robert L. Abell
www.RobertAbellLaw.com

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