... 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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Elderly Diabetics Face Greater Risk From Drug

Elderly diabetics taking the drug rosiglitazone, which is sold under the brand name Avandia, face a greater risk of developing congestive heart failure a Harvard Medical School report has found, according to the New York Times, "Diabetes Drug Linked To Higher Rate Of Death."  The study tracked 28,361 Medicare beneficiaries for up to five years and found that death rates were 15% higher and incidents of congestive heart failure 13% higher for those treated with rosiglitazone compared with those taking pioglitazone. 

Robert L. Abell

www.RobertAbellLaw.com  

Tainted Toys To Remain For Sale, Consumer Product Safety Commission Says

Children's toys, including teethers and pacifiers, tainted by the presence of the controversial chemical phthalate will remain for sale for now and even after a ban takes effect on February 10, 2009, provided they were manufactured before that date, according to a decision by the Consumer Product Safety Commission, the Washington Post reports, "Some Toys With Banned Plastics Will Stay On Market." 

Phthalates are a chemical used in soft plastics and are linked to reproductive problems.  Their use was banned by a law passed in August.  However, the Commission's ruling will allow products made before that date which use the banned substance to be sold, even after February 10, 2009. 

The Commission proposes a remedy that is unworkable; it says that concerned parents can call a product's manufacturer and find out when the item was made.  This is a proposal untethered from reality.  One can first question the reliability of any information a parent would receive.  Do you call before the item is purchased?  Do you identify the item on the store shelf, call and return later hoping to find the same item on the shelf?  Ignoring these realities the Commission caved into industry's complaints about complying with this law protecting families and their children.

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

"Get Out of Jail" Free Cards For Corporations -- American Association for Justice Details Undermining of Family and Consumer Protections

The American Association for Justice has released a report, Get Out of Jail Free: How the Bush Administration Helps Corporations Escape Accountability, detailing the systematic and widespread undermining of family and consumer protections by Bush Administration agencies and political appointees.  Through documents and emails obtained via the Freedom Of Information Act the AAJ report traces the evolution and development of a federal preemption strategy, a legal doctrine by which state law protections for families and consumers are eliminated or "preempted" by federal regulations that insulate corporations from liability, accountability and responsibility for their defective products.

Robert L. Abell
www.RobertAbellLaw.com

Drop Side Crib Recall

Following the death of one child and harrowing incidents involving others the Consumer Product Safety Commission announced today the recall of about 600,000 drop side cribs manufactured by Delta Enterprise Corp.  The drop side of the defective cribs can detach when its spring peg is not engaged.  Further and detailed information can be obtained at the CPSC website by clicking here.

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

ATV Age Guidelines Unsafe

Age guidelines regarding safe operation of ATVs do not assure the safety of young riders.  Far more important concluded a study conducted at the University of Kentucky is the size of the rider.  142 Kentuckians died in ATV accidents between 2003 and 2006.  The Lexington Herald-Leader story can tell you more by clicking here.

Robert L. Abell
www.RobertAbellLaw.com

Family Member Of Asbestos Worker May Sue For Cancer Death Caused By Asbestos Exposure

The daughter of a worker who carried home from work asbestos fibers on his clothing developed mesothelioma, a rare form of cancer whose only known cause is exposure to asbestos.  She (and upon her death her estate) sued Alcoa, Inc., her father's employer, claiming that it had a duty to prevent the exposure to asbestos of family members of its workers.  After her suit was thrown out by a trial court, the Tennessee Supreme Court reinstated it and ruled it should proceed to trial.  Recognizing the great dangers posed by asbestos exposure, which have been well-known for decades now and the relative ease and inexpense of preventing that exposure to workers' families, the court stated, "In light of the magnitude of the potential harm from exposure to asbestos and the means available to prevent or reduce this harm, we see no reason to prevent carpool members, baby sitters, or the domestic help from pursuing negligence claims against an employer should they develop mesothelioma after being repeatedly and regularly in close contact with an employee's asbestos-contaminated work clothes over an extended period of time."  A copy of the opinion, Satterfield v. Breeding Insulation Company, can be read by clicking here.

Exposure to asbestos generally produces two types of illnesses: asbestosis and mesothelioma.  Exposure to asbestos is the only know cause of mesothelioma, which is a cancer that initially forms in the exterior lining of the lung.  Asbestosis is a condition resulting from the accretion of asbestos fibers in the lung interior that eventually and over time causes greatly decreased respiratory capacity and can develop into cancer itself. 

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