Tampa Bay Personal Injury Lawyer - Medical Matters

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

Man Regrows a Fingertip

Shannon Weidemann — Sun, 10 Feb 2008 09:58:29 GMT

A man that cut the end of his finger off in a hobby related accident was able to regrow skin, blood vessels, and the nail after using a extracellular matrix powder. About half an inch of finger was regrown in about 4 weeks using the powder. This medical marvel was performed by researchers at the University of Pittsburgh.

This powder is a medical product called extracellular matrix. Made from pig bladders, it is a mix of protein and connective tissue surgeons often use to repair tendons.
But it's the matrix's unusual power to regenerate tissue that's helping launch a new field: regenerative medicine.
"It tells the body, start that process of tissue re-growth," said Dr. Stephen Badylak of the University of Pittsburgh Center for Regenerative Medicine.

Researchers hope this leads the way to regrown limbs and can reduce the need for invasive surgery. The next step is trying to regrow the esophagus of a cancer patient. Other researchers are working on repairing heart muscle that was damaged in a heart attack.

Originally posted at InjuryBoard by Shannon Weidemann

What You and Your Physician Don't Know Can Hurt You

Brenda Fulmer — Tue, 22 Jan 2008 08:33:56 GMT

"When you prescribe drugs, you want to make sure you're working with best data possible; you wouldn't buy stock if you only knew a third of the truth about ."

Over the past several years, drug manufacturers have lauded themselves for their decision to finally come clean, and publish all of their research (whether good or bad for them) in peer reviewed journals in order to ensure that the medical and scientific community can help patients make decisions based upon full and accurate information. A recent New England Journal of Medicine expose, however, indicates that it is still business as usual, and drug companies are still manipulating the science by burying adverse data.

The editors of the NEJM conducted a review of the data provided to the Food & Drug Administration to test its theory that pharmaceuticals companies were continuing to submit only the most favorable research for peer review and publication. This investigation by the journal found, for instance, 74 trials relating to 12 different anti-depressant drugs in the FDA files, but only 31% of those trials were submitted by the drug companies for publication. Not surprisingly, nearly all of the studies that showed favorable results were published. Of the few studies that showed negative results that were actually published, many were written to convey favorable outcomes belied by the actual study data. Drugs used to treat depression earn drug companies over $21 billion each year, and, for many pharmaceutical giants, serve as a bedrock for their companiess . However, these significant financial interests in marketing their products and gaining a competitive edge, does not justify the concealment of critical information or the manipulation of the medical literature into yet another marketing tool rather than the open and honest forum for debate on which so many physicians and patients rely.

On a related noted, Congress has now started an into the actions of Schering-Plough and Merck with regard to the popular cholesterol drugs Vytorin and Zetia. Reports have emerged recently that the manufacturers of these drugs delayed publication of studies that questioned the effectiveness of these expensive medications.

Originally posted at InjuryBoard by Brenda Fulmer

Evidence Mounts on HRT Breast Cancer Dangers

Brenda Fulmer — Tue, 22 Jan 2008 07:56:58 GMT

Yet another study was released earlier this month showing that women who use combination hormone replacement therapy drugs face much greater risks of developing certain types of breast cancer. This latest study from researchers at the Fred Hutchinson Cancer Research Center noted that women taking HRT drugs had a four-fold (400%) increased risk of developing lobular breast cancer and was the first study to focus on lobular cancers and include a review of pathology reports and tissue from tumors (http://seer.cancer.gov/data/). A statistically significant increased risk of ductal-lobular invasive cancers was also noted. This study is also particularly noteworthy in that it found that users of combination HRT drugs (containing estrogen and synthetic progestin) were at significantly increased risk after only three years of exposure, helping to dispel the notion that these drugs are safe if taken for less than 5 years.

Lobular breast cancers are relatively rare, representing only 15% of invasive breast cancers. Unfortunately, lobular cancers are quite virulent in that they are more difficult to detect through mammography and are more likely to be first diagnosed at later stages. Researchers have noted for quite some time, however, that lobular cancers appear to be more prevalent in women who used combination hormone replacement therapy drugs, such as Prempro and Provera taking in combination with Premarin or other estrogen products. This study included 1,044 women (ages 55 to 74) who are part of a Washington State breast cancer registry and who were diagnosed with invasive breast cancer between 2000 and 2004.

Although rates of CHT [combined estrogen and progestin hormone therapy] use have dropped considerably since the publication of the WHI trials, studies of the risks associated with CHT use remain of critical importance given the estimated 57 million hormone therapy prescriptions that are still filled in the United States each year. The results of this study provide further evidence that CHT use increases the risk of ILC (invasive lobular cancer], and they indicate that current use of CHT for as little as 3 years may increase risk of these tumors substantially. Continued research aimed at identifying the biological basis for the relationship between CHT use and lobular carcinoma risk is warranted.

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

Specialized Treatment for HRT Patients With Lobular Breast Cancer

Brenda Fulmer — Mon, 31 Dec 2007 16:15:00 GMT

A study from Turin, Italy published recently in Endocrine Related Cancer noted that former users of hormone replacement therapy drugs who are diagnosed with lobular breast cancers may require specialized treatment based upon the unique characteristics of their tumors. The researchers noted a "growing body of evidence" to "support the association between the use of hormone replacement therapy (HRT) and a higher risk of both invasive lobular carcinoma (ILC) and invasive ductal-lobular mixed carcinoma (IDLC)."

The authors indicated that lobular cancers in HRT users have a different presentation than ductal cancers and are often far more challenging to diagnose early since lobular tumors are generally less concentrated and more disseminated than ductal tumors. The authors suggested that MRI technology may be more precise than traditional mammograms in detecting lobular breast cancers, and that patients with lobular breast cancers may have a greater need to undergo mastectomies than patients with ductal tumors. The authors also concluded that patients with lobular breast cancer tumors associated with their past use of hormone replacement therapy drugs may not have the same response to preoperative chemotherapy as patients with other types of tumors. Finally, the authors concluded that patients with metastatic lobular breast tumors are also unique in that testing often shows that the breast cancer has spread to the gastrointestinal tract, peritoneum, or gynecological organs, a presentation that is not so common with regard to metastases of ductal breast cancers.

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

Chemotherapy Drugs and Congestive Heart Failure

Brenda Fulmer — Mon, 31 Dec 2007 15:32:13 GMT

A study published on October 30, 2007, in the Journal of Clinical Oncology again noted that the use of certain chemotherapy drugs in breast cancer patients can increase the risk of developing congestive heart failure. This potential was first noted more than thirty years ago, but has become more of a problem in the past fifteen years as more early-stage breast cancer patients are receiving anthracycline drugs (also known as Adriamycin or doxorubicin) as a part of their chemotherapy regimen. The authors noted that previous studies had indicated that the incidence of congestive heart failure in these patients might be as high as 50%, depending upon the dose and other risk factors such as diabetes, pre-existing cardiac disease, and hypertension.

This study reviewed the database information for 43,000 women (ages 66 to 80) who were diagnosed with breast cancer between 1992 and 2002. About 20% of these women received chemotherapy and approximately half of those were given anthraclycline drugs. The researchers then analyzed the numbers of these patients who were subsequently diagnosed with congestive heart failure, and made adjustments for other independent causes and predictors of CHF. The authors concluded that their study confirmed the data previously reported that use of anthracycline drugs in chemotherapy does significantly increase the risk of developing congestive heart failure (with a more than doubling of the risk noted in some groups). The study also noted that further research was needed due to the possibility that the race of the breast cancer patient may influence their susceptibility to development of heart failure after chemotherapy and that consideration should perhaps be given to the patient's race in making a determination as to whether use of anthracycline is appropriate since congestive heart failure is more prevalent and causes greater mortality in African-Americans.

Originally posted at InjuryBoard by Brenda Fulmer

University of South Florida Prepares for Bacterial Meningitis Outbreak

Joe Saunders — Mon, 24 Sep 2007 05:35:03 GMT

After a USF student, Rachel Futterman, was diagnosed with bacterial meningitis, the university has braced itself for more cases of the rare but potentially deadly disease. Bacterial meningitis, an infection of the brain and spinal cord lining, is a rare but potentially fatal illness. Early symptoms can resemble the flu, including fever, severe headache, stiff neck, nausea, vomiting, rash and lethargy. The bacteria is spread through direct contact, which would include sharing things like cigarettes, drinking glasses or a kiss.

Originally posted at InjuryBoard by Joe Saunders

Bush Threatens Veto for Expanded Heathcare Coverage for Kids

Joe Saunders — Sun, 23 Sep 2007 01:44:03 GMT

In a move that's been expected for weeks, President Bush has threatened to veto a bill that would expand healthcare coverage for children. The child healthcare program is set to expire September 30 and Congress will most likely vote to renew it, setting a showdown with the President. The program covers children, many of whom would not have access to healthcare without it. Bush has argued that the renewal would go beyond the original intent of the bill. However, it seems to me that its a matter of common sense and good public policy to provide healthcare for as many of our children as possible. Bush has called himself a compassionate conservative but where's the compassion in denying healthcare to children?

Originally posted at InjuryBoard by Joe Saunders