Tampa Bay Personal Injury Lawyer - Personal Injury Lawyer

Heparin Finger Pointing Has Already Started

Brenda Fulmer — Thu, 06 Mar 2008 08:01:42 GMT

"A series of independent assessments, inlcuding one by the agency's own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilties and is incapable of protecting the public from unsafe drugs, medical devices and food - particularly from China."

While the Food & Drug Administration continues its investigation into contaminated Heparin blood thinner products, the sparring between Baxter Healthcare and its supplier Scientific Protein Laboratories is underway. A March 6, 2008, New York Times article notes the latest findings of the FDA that Baxter's heparin products are contaminated and the investigation continues as to how the contamination occurred, whether it is isolated, why the contamination was not discovered by the product's manufacturer or supplier previously, and whether the nearly 800 reports of adverse reactions and 46 reported patient deaths are attributable to the confirmed contamination.

The article noted that Wayne Pines, a spokesman for Wisconsin-based Scientific Protein Laboratories, wanted to reassure the public that nothing improper had occurred with regard to its procurement and processing of the raw materials utilized in the product, and noted "There is no evidence of counterfeiting or tampering or anything of that nature. No one really knows what happened here." The raw materials supplier also reiterated, again, that "it is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events."

Meanwhile, Baxter and its spokesperson have also entered the fray with finger pointing at Scientific Protein and, perhaps, the FDA. Baxter noted that the contamination problem may not be as isolated as indicated previously, since tained lots of blood thinners came from Scientific Protein Laboratories' processing plants located in China and Wisconsin. According to media reports, Baxter began its investigation into possible contamination in the Fall of 2007 and claims that Baxter's findings "touched on the areas" as those noted in the FDA inspection. Scientific Protein Laboratories, however, questioned the nature of the probems that Baxter contends were noted in the Fall of 2007 and why those problems were not addressed prior to the recent FDA inspections.

The FDA is also under scrutiny with this latest in a long series of serious threats to public safety. The FDA has admitted culpability in failing to properly inspect a Chinese plant implicated in the heparin contamination controversy. There are also concerns about the ability of the FDA to protect consumers from adulterated products. A recent Government Accountability Office report entitled "Preliminary Findings Suggest Weaknesses in FDA's Program for Inspecting Foreign Drug Manufacturers" noted that over a six-year period the FDA was only able to inspect less than 10% of the approximately 700 medical device plants currently operating in China and providing drugs, devices and raw materials to manufacturers in the United States. For years, the FDA has been lamenting that a significant lack of funds and lack of enforcement authority has hampered its ability to properly ensure the safety of the nation's pharmaceutical and medical device products. This is particularly disconcerting as our court system and current administration have been aggressive in their efforts over the past few years to claim that state court actions are pre-empted and to essentially immunize drug and device manufacturers from liability for defective products based upon the obviously false assumption that the FDA has the ability to adequately protect consumers. Hopefully, this latest drug safety failure will refocus attention on this issue, just as the memories of Vioxx are fading, and stem the tide of legal efforts to permit defective drugs to remain on the market and the manufacturers to escape liability or require them to assume proper responsibility to ensure the safety of their products.

Originally posted at InjuryBoard by Brenda Fulmer

First Federal Ortho Evra Trials Scheduled

Brenda Fulmer — Mon, 31 Dec 2007 18:05:24 GMT

On December 6, 2007, Judge David Katz, the federal judge who oversees the Ortho Evra multi-district litigation proceedings in Cleveland issued a scheduling order for the first trials to be conducted in the federal system. Judge Katz oversees more than 1,400 lawsuits pending against Johnson & Johnson (http://www.jnj.com/home.htm) and its subsidiaries relating to the controversial Ortho Evra birth control patch. The patch was marketed as an alternative to modern low-dose oral contraceptives, but it is now known that the patches deliver as much as 60 times higher doses of hormones than other alternatives without providing any greater efficacy. Many years ago, birth control pills contained higher doses of hormones, but the dosages have been reduced over the years after high-dose medications were associated with an unacceptable increase in adverse events, including strokes and blood clots. Ortho Evra has also been associated with an increased risk of heart attacks, strokes, and the formation of blood clots in the lungs and legs.

Seven cases involving plaintiffs from Ohio have been selected for the initial (or bellwether) trial process in the federal MDL proceedings. Five of the cases involving plaintiffs who survived their injuries, including the following plaintiffs: a twenty-four year old woman who suffered blood clots in her lungs and brain in July of 2005 after using Ortho Evra for two weeks; a thirty-two year old woman who developed deep vein thrombosis and a pulmonary embolism in April of 2004; a forty-one year old woman who developed a blood clot in her leg and multiple blood clots in her lungs in July of 2005; a twenty-two year old woman who suffered a heart attack after using the Ortho Evra patch for two months; and a twenty-five year old woman from developed a pulmonary embolism after use of the patch for two months in April of 2003. This bellwether trial group also includes a personal injury claim brought by the parents of a 14 year-old girl who used the patch to regulate her menstrual cycle and suffered a deep vein thrombosis in July of 2005. The remaining case is a wrongful death claim filed by the surviving husband and infant son of a university volleyball coach who died of cardiac arrest at the age of twenty-five after using the patch for one month.

The first trial will begin on June 24, 2008, and a second trial will occur on July 22, 2008. The Court has not yet selected the cases to be included in these first trials, and indicated that the cases that are not selected initially will be tried as soon as the Court's calendar permits. The parties have been ordered to complete fact discovery by January 31, 2008 and expert witness discovery by March 28, 2008. A Daubert hearing on scientific issues has been scheduled for April 15, 2008.

Originally posted at InjuryBoard by Brenda Fulmer

Closing The Chapter on HRT Litigation in 2007

Brenda Fulmer — Mon, 31 Dec 2007 15:37:34 GMT

Great strides were made in 2007 to educate the courts and juries about the great deception over the past few decades that led many to ingest combination hormone therapy products such as Prempro and Premarin in combination with Provera. Conventional wisdom about these hormones is finally shifting, especially in light of an unprecedented drop in national cancer registries that dovetails with the drop in use of the drugs after publication of the WHI Study results in July of 2002. All of this new data is also helping to answer the question of whether these drugs promote the development of breast cancers (and they do). It is a shame that the drug manufacturers were unable or unwilling to provide answers to these important questions during the decades when women were ingesting the drugs after being reassured that the risks of invasive breast cancer and ovarian cancer were non-existent or insignificant, especially when balanced against the "body of evidence" of HRT benefits that included supposed protection against heart disease, Alzheimer's disease, and a number of other significant conditions. Today, many of these supposed benefits have been disproven, and women have far more choices in dealing with menopausal symptoms.

A number of trials were completed during 2007. Several favorable verdicts were obtained in state court in Philadelphia on behalf of plaintiffs against Pfizer and Wyeth with awards ranging from $1.5 million to $3 million. Unfortunately, those verdicts were overturned by judges, but appeals are pending and hopefully the verdicts will be restored by the appellate courts in 2008. Two cases were tried in the federal MDL proceedings in Little Rock, and both of those trials resulted in verdicts in favor of Wyeth. In October of 2007, a state court jury in Reno returned a monumental $134 million verdict on both compensatory and punitive damages in favor of three plaintiffs who all developed invasive breast cancers after long-term ingestion of combination hormone therapy products, which included equine-derived estrogens (such as those contained in Premarin and Prempro) and a synthetic progestin (as was included in the name-brand Provera and in the generic formulation known as medroxyprogesterone acetate). Several other trials were canceled after Wyeth and Pfizer settled the claims of those plaintiffs for confidential sums.

There are a number of additional trials scheduled against Wyeth and Pfizer for 2008 on behalf of women who developed breast cancer after long-term use of HRT drugs. These trials will be held in the federal multi-district litigation proceedings in Little Rock, Arkansas and in state courts in New Jersey, Kentucky, Alabama, and Florida. The law firm of Alley, Clark, Greiwe & Fulmer is currently preparing for the first trial in Florida involving the wrongful death of a Pinellas County woman who died in late 2006 after a valiant battle with advanced breast cancer that was diagnosed after her use of Prempro.

Originally posted at InjuryBoard by Brenda Fulmer

Two Perish in Jacksonville Chemical Plant Explosion

Courtney Mills — Wed, 19 Dec 2007 15:56:57 GMT

The Faye Road chemical plant in Jacksonville exploded this afternoon around 2:30 and burst into flames. The exact reason for the conflagration at the Jacksonville chemical facility was not immediately clear, but one witness described the explosion as an immense 'black mushroom cloud rising up very quickly.'

Buildings near the chemical plant had their windows completely blown out, and people outside the plant were allegedly thrown to the ground by the force of the blast's concussion. Two are confirmed dead so far as a result of the accident.

According to reports, the Jacksonville chemical plant manufactures a toxic chemical. People in the greater Jacksonville area who have COPD and those who have respiratory ailments may wish to exercise special care to avoid the outdoors this afternoon.

For more information on this subject, please refer to the section on Workplace Injuries.

Originally posted at InjuryBoard by Courtney Mills

First Florida Vioxx Trial Underway in Tampa

Brenda Fulmer — Wed, 19 Sep 2007 13:37:22 GMT

Jury selection and opening statements have now been completed in the trial of Refik Kozic v. Merck, the first Vioxx case to proceed to trial in the State of Florida. Refik Kozic, a current resident of Jacksonville and a former long-term resident of Tampa, filed his lawsuit against Merck in 2003 for injuries relating to the heart attack that he suffered after ingesting Vioxx daily for 9 weeks. Judge William P. Levens is presiding over the trial, which is anticipated to last for another 2 1/2 weeks. The Plaintiff's trial team includes Jim Clark and Don Greiwe of Alley, Clark, Greiwe & Fulmer in Tampa and Fred Levin, Troy Rafferty and Pete Kaufman of Levin, Papantonio in Pensacola.

Refik Kozic is popular former soccer player with the Tampa Bay Rowdies and New York Cosmos. He retired from professional sports in the 1980s, but continued to play and coach soccer in the Tampa Bay Area for a number of years. Refik started taking Vioxx in February of 2001 due to knee pain stemming from old soccer-related injuries. Nine weeks later, Mr. Kozic suffered a significant heart attack due to a large blood clot in his heart and underwent surgery to place a metal stent in one of his arteries.

Mr. Kozic filed suit against Merck for his injuries and damages related to his heart attack. His lawsuit includes claims relating to the negligent and defective design, manufacture, and marketing of Vioxx. Also, the court has permitted Mr. Kozic to also bring a claim for punitive damages against Merck.

Vioxx was withdrawn from the market in 2004 after several studies noted a significantly increased risk of heart attacks and strokes in patients using the drug. Currently, there are nearly 40,000 lawsuits pending against Merck in state and federal courts across the country. Most of the claims filed by Floridians who suffered heart attacks or strokes after taking Vioxx are pending in the multi-district litigation proceedings in New Orleans. It is anticipated that many of these cases will be returned to local Florida jurisdictions and set for trials either later this year or in 2008.

Originally posted at InjuryBoard by Brenda Fulmer

What it Means to be an Ambulance Chaser

Staff Writer — Wed, 06 Jun 2007 10:57:21 GMT

The days of society branding personal injury lawyers as simply "ambulance chasers" is over.....at least it should be. The fact is that personal injury lawyers are helping more victims today than ever before. Tort reform has brought the profession into the national spotlight, allowing the country to see that so-called "ambulance chasers" are actually activists for victims' rights.

Personal injury lawyers are widening their practice areas and tackling more important legal topics. A national campaign has ensued to clear the profession's name. It has actually never been a more important time to be an "ambulance chaser." Organizations such as InjuryBoard and the AAJ are doing their part to ensure the "greedy trial lawyer" notion is a thing of the past and that victims are protected now more than ever before.

Originally posted at InjuryBoard by Staff Writer