Kennedy Hodges, L.L.P. Legal Blog

An Oklahoma jury has ordered Farmers Insurance Co. to pay $80 million to a class of policyholders who claimed that the insurer underpaid claims. In the lawsuit, policyholders alleged that Farmers engaged in bad faith and fraud by failing to pay for general contractors. The award includes $50 million in compensatory damages and $30 million in punitive damages. Staff and Wire Reports, Tulsa World 09/26/2008
Read Article

Chicago Tribune reporter

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

Baxter recalled its heparin products in February in the wake of the spike in the number of the allergic reactions. In recent months, federal health officials and Baxter believe the oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China.

Baxter said it would not comment on the FDA's analysis, saying it has not been able to review it.

"We haven't seen this data and look forward to working with [the] FDA to understand this new information," said Baxter spokeswoman Erin Gardiner. "However, these findings appear to indicate what our own analysis has shown—that only a very small portion of the number of deaths reported seem to have a definitive link to heparin."

Before Baxter recalled and stopped producing heparin earlier this year, the company received heparin's active ingredient from Wisconsin-based Scientific Protein Laboratories, which manufactured the raw ingredients for Baxter's heparin at a plant in China. Scientific Protein's supply chain stretched through unregulated village workshops and farms in rural China. Heparin's active pharmaceutical ingredient is derived from pig intestines.

Earlier this year, the FDA tallied more than 90 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter since Jan. 1, 2007.

After months of investigating 93 death reports from Jan. 1 to March 31, the agency Tuesday said it is able to give its most definitive evaluation. Of the remaining 83 reports, 13 were described as "potential complications of heparin use" such as bleeding; 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure.

"In the remaining 45 deaths, clinical information in the adverse-event reports is insufficient to specify the cause of death with clinical certainty," an FDA spokeswoman said. Woodcock added not enough information was given by providers or others who filled out the reports to make an adequate determination.

"While some of these [reports] appear definitely related [to contaminated heparin] many are still in the gray zone," Woodcock said. "We have looked over all of these death reports and a number of them were probably not related to the contaminated heparin."

Chinese health officials continue to question whether the problems may have originated elsewhere. The Chinese maintain the problems did not originate with active ingredient sourced in China despite analysis by FDA, Baxter and outside experts.

Commonly prescribed inhalers used to treat chronic obstructive pulmonary disease, or COPD, have been linked to an increased risk of heart attack, stroke and heart disease. According to a study, published this week in the Journal of the American Medical Association, patients treated with the drugs tiotropium or ipratropium were statistically more likely to develop cardiovascular disease or suffer cardiovascular death when compared to patients not treated with tiotropium or ipratropium. Tiotropium or ipratropium can be found in brand name drugs Spiriva, Atrovent and Combivent. Rita Rubin, USA Today 09/23/2008
Read Article

A large construction contractor and its subsidiary violated federal labor laws during the housing boom, according to a lawsuit filed Tuesday in Los Angeles. In the lawsuit, workers for Building Materials Holding Corp. and its subsidiary SelectBuild Construction Inc. say they were not paid overtime, forced to sign blank time sheets, skip breaks and travel without compensation. The lawsuit, which seeks class-action status, seeks unspecified damages for lost wages. Tiffany Hsu, LA Times 09/23/2008
Read Article

Two doctors and a suburban Chicago hospital will pay $5.5 million to settle allegations that that they were negligent in the birth of a child with severe brain damage. In the lawsuit, Eva Liberato claimed the child was deprived of oxygen after a family medicine physician at Westlake Hospital failed to deliver the baby. The child was subsequently delivered by C-section but too late to prevent permanent injury. AP, Chicago Tribune 09/22/2008
Read Article

The overdose of Dennis Quaid’s children last year has brought added attention to a problem that experts say is more prevalent than commonly thought. Studies show that about one in ten children will be the victim of a medical error during their hospital stay and nearly one quarter of those errors are preventable. Still, the very nature of being a child puts young patients at greater risk of injury or death when compared to adult patients, experts say. Laurie Tarkan, The New York Times 09/14/2008
Read Article

Hospitals routinely fail to provide emergency room patients with adequate information to care for themselves upon discharge from the hospital, according to a recently released study. Researchers say that confusion among patients about self-care leaves patients at risk for medication errors and serious complications. Other studies have produced similar results with non-emergency room patients and Medicare recipients. Laurie Tarkan, The New York Times 09/15/2008
Read Article

The growing popularity of herbal and other alternative medicines has drawn many to ayurveda supplements, an ancient Indian medical system. However, recent reports have linked ayurveda supplements purchased on the Internet to dangerous heavy metal contaminants. Researchers say that such findings may be the tip of the iceberg in terms of impurities that may be lurking in these unregulated medicines. Abby Ellin, The New York Times 09/17/2008
Read Article

The family of Yani Bocanegra, a 19-year-old student killed in a bus crash in Mexico, is finding out the hard way that most of the protections they expect in the United States essentially end at the border. Since the 1980s, insurance companies have worked to limit the payment of claims for accidents that occur in Mexico – even if the insured primarily does business in the U.S. The Bocanegra’s story highlights a growing safety problem among bus companies operating routes along the U.S and Mexican border. James Pinkerton and Terri Langford, Houston Chronicle 09/17/2008
Read Article

An Illinois softball league was responsible for the electrocution death of an 8-year-old boy last summer, a lawsuit filed Wednesday alleges. In the lawsuit, the mother of the boy claims that the Limestone Girls Softball Association failed to ensure that the field was safe before holding a tournament the drew 400 people. The boy died after touching a defective utility pole. Andy Kravetz and Leslie Fark, Peoria Journal Star 09/17/2008
Read Article

The Food and Drug Administration released a list of 20 medications Friday that are currently under investigation for potential safety problems. The release of the list comes after Congress last year ordered the agency to produce a quarterly report of drugs being investigated by regulators. Consumer advocates have complained that the list, which states little more than the name of the drugs and their potential safety problems, will be of little use to patients. Ricardo Alonso-Zaldivar, Yahoo News 09/05/2008
Read Article

The following is the list:

Arginine Hydrochloride Injection (R-Gene 10)
Pediatric overdose due to labeling / packaging confusion

Desflurane (Suprane)
Cardiac arrest

Duloxetine (Cymbalta)
Urinary retention

Etravirine (Intelence)
Hemarthrosis

Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric)
Adverse events due to name confusion

Heparin
Anaphylactic-type reactions

Icodextrin (Extraneal)
Hypoglycemia

Insulin U-500 (Humulin R)
Dosing confusion

Ivermectin (Stromectol) and Warfarin
Drug interaction

Lapatinib (Tykerb)
Hepatotoxicity

Lenalidomide (Revlimid)
Stevens Johnson Syndrome

Natalizumab (Tysabri)
Skin melanomas

Nitroglycerin (Nitrostat)
Overdose due to labeling confusion

Octreotide Acetate Depot (Sandostatin LAR)
Ileus

Oxycodone Hydrochloride Controlled-Release (Oxycontin)
Drug misuse, abuse and overdose

Perflutren Lipid Microsphere (Definity)
Cardiopulmonary reactions

Phenytoin Injection (Dilantin)
Purple Glove Syndrome

Quetiapine (Seroquel)
Overdose due to sample pack labeling confusion

Telbivudine (Tyzeka)
Peripheral neuropathy

Tumor Necrosis Factor (TNF) Blockers
Cancers in children and young adults

A class of prescription drugs is being blamed for the deaths of a dozen patients who suffered from rheumatoid arthritis, Crohn’s disease and other conditions. The Food and Drug Administration announced Thursday that so-called TNF blocker medications have been linked to serious fungal infections including histoplasmosis, coccidioidomycosis and blastomycosis. The agency in now urging stronger warning labels for drugs such as Remicade by Johnson & Johnson, Humira by Abbott Laboratories, Cimzia by UCB and Enbrel from Amgen and Wyeth. Susan Heavey, Reuters 09/04/2008
Read Article

A series of spinal procedures involving the Medtronic Infuse Bone Graft that resulted in severe complications have been linked to doctors with financial ties to the medical device maker. According to the Food and Drug Administration, the device has not been approved for procedures in the cervical spine and could cause life threatening problems. Previous lawsuits have accused Medtronic of providing improper financial incentives to physicians who used the device. Jacob Goldstein, WSJ Blogs 09/04/2008
Read Article

The Food and Drug Administration on Thursday concluded that patients treated with an experimental osteoporosis drug were more likely to die than those treated with a placebo. The FDA analysis noted that patients who took the drug Fablyn, produced by Pfizer Inc., showed a statistically significant increase in death and were also more likely to develop blood clots when compared to others in the test group. The FDA is still evaluating the overall safety of the drug. Reuters, Reuters 09/04/2008
Read Article

Wal-Mart should pay nearly 200,000 current and former Pennsylvania employees about $185 million for forcing employees to work without pay, a Philadelphia common pleas judge has ruled. The opinion by Judge Mark I. Bernstein affirms a jury verdict that found the retail giant forced employees to work off-the-clock and to skip required rest breaks. The cases are Braun v. Wal-Mart and Hummel v. Wal-Mart. Amaris Elliot-Engel, Law.com 09/04/2008
Read Article

Supermarket chain Gristede’s wrongly denied overtime pay to more than 400 current and former lower-level managers, a federal judge ruled last week. Federal District Judge Paul A. Crotty found that Gristede’s had sought to treat the managers as hourly workers for some purposes but as salaried employees for the purposes of overtime. Attorneys for the plaintiffs estimate that damages could reach $25 million. Steven Greenhouse, The New York Times 09/02/2008
Read Article