Abell's Kentucky Law Blog

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

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  

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

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

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