... and Justice for All

Are FDA Experts Compromised? Money Doesn't Talk It Swears

The Wall Street Journal blog Pharmalot reports that 1/3 of the physicians and other experts sitting on FDA advisory panels reviewing medical devices from 2012 to 2014 have financial ties to the companies whose devices they are reviewing, see What Money? Financial Ties of FDA Device Advisers are Often Undisclosed. Nearly 10% of these experts were directly compensated by the specific companies whose products they were directly reviewing. Interestingly, the FDA disclosed only 1% of these financial ties.

One of the hardest things in the world is getting someone to understand whose paycheck is dependent upon them not understanding.  

Here's the game: medical device companies capture the FDA by buying influence with these experts and secure FDA approval for their devices, which in turn serves as a defense to defective product lawsuits, often a complete defense.  So at the front end it is possible for medical device manufacturers to buy their way out of any accountability or liability to individuals and families hurt be defective medical devices.

And so it goes. Remember money doesn't talk it swears.

Robert L. Abell
www.RobertAbellLaw.com

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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
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Peanut Butter Maker Knowingly Shipped Tainted Product

The Georgia peanut butter maker identified as the source of the salmonella outbreak that has killed eight people and sickened over 500 knowingly shipped salmonella-tainted peanut butter 12 times in 2007 and 2008, the Washington Post reports, "Peanut Processor Knowingly Sold Tainted Products." The Post reports:

Officials at the Food and Drug Administration and the Centers for Disease Control and Prevention, which have been investigating the outbreak of salmonella illness, said yesterday that Peanut Corporation of America found salmonella in internal tests a dozen times in 2007 and 2008 but sold the products anyway, sometimes after getting a negative finding from a different laboratory.

The company was not required to disclose its tainted products to federal or state officials.

In addition to killing eight people and harming more than 500, the salmonella outbreak has caused recall of more than 100 products. To review the list click here.

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

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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