Alabama Supreme Court Affirms Jury Award in Med-Mal Case

Today, in Hrynkiw v. Trammell, No. 1101099, the Alabama Supreme Court affirmed a judgment entered in a med-mal case. The jury awarded $1,650,000 to the injured patient and $500,000 as to wife’s loss-of-consortium claim.

Following a fusion surgery, Trammell experienced symptoms of cauda equine syndrome (“CES”).  Dr. Hrynkiw was immediately informed of the symptoms but waited ten days to perform a second surgery.  The second surgery provided no relief. Trammell was permanently partially disabled – “He has very limited mobility because of severe weakness in his hips and legs, and he is impotent and suffers from urinary and fecal incontinence.”

Trammell asserted both medical negligence in performing the initial surgery and post-operative medical negligence in not timely addressing the CES symptoms.  As to both assertions, Dr. Hash was Trammel’s expert witness.  On appeal, Hrynkiw argued that the post-operative claim should not have been presented to the jury because, as to the issue of causation, Dr. Hash’s testimony was pure speculation.  Apparently, Hrynkiw was making a good count/bad count argument in order to secure a new trial.

At trial, Dr. Hash detailed that timely addressing CES symptoms most often eliminated permanent CES or reduced the severity of the CES; that, by waiting more than 48 hours to perform the second surgery, Hrynkiw breached the standard of care; and that the breach probably caused harm to Trammell by worsening his outcome.  Dr. Hash relied on statistics that with timely care, 80% of patients make either a complete or partial recovery. 

Hrynkiw argued that, in his pre-trial deposition, Dr. Hash acknowledged that he could not guarantee the Trammel’s ultimate outcome would have been different if the second surgery had been done with 48 hours.  The Supreme Court rejected Hrynkiw’s argument in detail. 

Also, Hrynkiw argued that the trial court erred in allowing hearsay testimony under the learned-treatise exception.  Dr. Hash testified that he based his opinions on his professional experience and on the medical records, and did not rely on medical treatises.  Hrynkiw argued that the exception applies only if the expert relied on them in reaching his opinions.  The Alabama Supreme Court disagreed and found that, under Rule 803(18), medical treatises could be used to bolster the expert’s opinions.

The Birmingham News wrote an excellent piece on the jury trial about two months ago which was subsequently published on al.com. Click on the link below to read:

http://blog.al.com/businessnews/2011/03/22_million_jury_award_against.html

Drug Maker Abbott Hit With $1.6 Billion in Fines

            Abbott Laboratories reached a settlement with the Justice Department and several states over illegal marketing practices for its anti-seizure drug Depakote, in which Abbott will pay $1.6 billion in criminal and civil fines. The announcement generated heavy media coverage, including a brief mention on ABC World News.

            ABC World News reported, "Tonight one of the largest drug companies, Abbott Laboratories, has agreed to a staggering settlement. Today $1.6 billion in criminal and civil fines for improperly marketing the anti-seizure drug Depakote in nursing homes. The company convinced the nursing homes to use the drug to treat aggression in dementia patients, despite the lack of credible evidence that the drug was effective for that use."

            The New York Times reports, "The settlement comes as the Justice Department and the states have increased scrutiny of the sales and marketing practices of pharmaceutical companies, particularly in cases in which they market drugs for uses that are not approved by the Food and Drug Administration."

            The Wall Street Journal reports that in addition to the fines, Abbott would plead guilty to a misdemeanor charge of violating a federal drug law.

            The Washington Post notes the settlement "is the second-largest in a string of multimillion-dollar payouts in recent years resulting from stepped-up enforcement by the Justice Department and state investigators against drug makers that 'misbrand' their products. The company will to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office."

            The Chicago Tribune reports, "As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters. The company will plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office."

            The Chicago Sun-Times reports, "The company admitted that it trained a specialized sales force to promote Depakote in treating dementia because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes."

Plavix Lawsuits On the Rise

Plavix (clopidogrel) is a blood thinner that prevents blood platelets sticking together to form clots. It is prescribed for stroke reduction, heart attack prevention and to prevent clotting when drug coated stents are used in patients with arteriosclerosis. Marketed by a partnership of Sanofi-Aventis and Bristol-Myers Squibb, Plavix is an antiplatelet drug that works by preventing platelets in the blood from sticking together and forming clots. It is a blockbuster medication, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis. In 2010, $4.6 billion in retail sales made Plavix #3 on a list of Top 200 Pharmaceutical Sales in the United States.

The manufacturers promoted Plavix as a safer alternative to aspirin, which reduces the risk of gastrointestinal problems. However, lawsuits already filed allege that Plavix actually provides no benefits over taking aspirin alone and could actually increase the risk of heart attacks, strokes, gastrointestinal bleeding, severe ulcers and a rare blood disorder known as TTP, or thrombotic thrombocytopenic purpora. These lawsuits also allege that the drug makers failed to provide adequate warnings and information to doctors about the potential problems from Plavix and that the Defendants concealed their knowledge of Plavix defects from the Plaintiffs, the FDA, the public in general and/or the medical community specifically.

The U.S. Food and Drug Administration (FDA) approved Plavix in 1997. In 2003, a stroke prevention study conducted by the National Institute of Neurological Disorders and Stroke found that combination aspirin-Plavix therapy may significantly increase the risk of life-threatening bleeding. Of the 3,000 participants followed by the study, 6.5% with the Plavix-aspirin combination experienced an adverse bleeding event. By comparison, 3.3% of those who took aspirin alone developed similar bleeding symptoms. The study also found that the combination therapy was responsible for a death rate of 5.8%. [nlm.nih.gov/databases/alerts/2011_ninds_stroke.html]

A more recent study, published in the New England Journal of Medicine in April 2006, found that, "Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes." [nejm.org/doi/full/10.1056/NEJMoa060989]

Because Plavix side effects can include ulcers and gastrointestinal bleeding, doctors often prescribe Proton Pump Inhibitors (PPI’s) to reduce stomach acid in patients taking Plavix. In November 2009, the FDA released an advisory saying that taking the Proton Pump Inhibitor omeprazole (marketed as Prilosec/Prilosec OTC) in conjunction with Plavix significantly reduced the effectiveness of Plavix and patients at risk for heart attack or stroke may not be getting the anti-clotting benefits. The makers of Plavix agreed to update the drug labeling to include a warning about drug interaction with omeprazole and to conduct further studies into other drug interactions.

If you or a loved experienced serious, life-threatening internal bleeding, heart attacks, strokes, or a blood disorder, and you believe Plavix is to blame, please contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.