Galveston Bay Personal Injury Lawyer - Defective Drugs

Diabetic Foot Gel May Increase Cancer Risk

Scott Kappes — Fri, 28 Mar 2008 16:33:58 GMT

This week the FDA launched an investigation into an increased risk of cancer and death that may be associated with the Johnson & Johnson foot gel, Regranex. The foot gel, approved by the FDA in 1997, is used to treat leg and foot wounds most commonly associated with diabetes. A study found an increase in the number of cancer deaths among patients who had been prescribed the medication three or more times.

"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex," the FDA said in a statement. "Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient."

A study preformed in 2001 found more cancers in patients that had used Regranex than in those that had not used the gel. The FDA has not said who conducted or the size of the sample group used in the current study.

Originally posted at InjuryBoard by Scott Kappes

Judge Dismisses Case Due to Chantix Induced Psychotic Episode

Scott Kappes — Thu, 27 Mar 2008 23:35:20 GMT

A federal judge has dismissed the case of a 25 year-old California man who charged the cockpit of a plane on Thanksgiving forcing an emergency landing in Fargo, North Dakota. Prosecutors asked for the interfering with an airplane flight crew charge to be dropped against Andrew Smith after psychiatric exam revealed that Smith was suffering from psychotic disorder caused by Pfizer's smoking cessation medication Chantix.

Reports of adverse effects associated with prompted an FDA investigation of the drug. The FDA issued an warning that drug could be linked to serious psychiatric disorders and possibly even suicidal acts. No causal relationship has officially been established but the FDA has said that a link cannot be ruled out at this time.

Originally posted at InjuryBoard by Scott Kappes

Alaska's Zyprexa Suit Settled For $15 Million

Scott Kappes — Thu, 27 Mar 2008 12:05:18 GMT

Three weeks into the trail, yesterday it was announced that Eli Lilly has agreed to pay $15 million to settle a lawsuit brought by the state of Alaska over the popular antipsychotic medication Zyprexa. The lawsuit alleged that Zyprexa caused patients to develop diabetes after taking the medication. The state was seeking to recover Medicaid money spent on both the medication itself and the treatment of diabetes resulting from patients taking Zyprexa.

The $15 million settlement is viewed to be quite a large payment for a state with such a low population, just over 670,000 residents. Several other states have initiated similar claims or are participating in settlement talks being headed up by federal prosecutors in Pennsylvania.

While there is no way of knowing whether the $15 million payment to Alaska will represent a benchmark for the broader talks. But if it does, Lilly might need to pay billions of dollars to resolve the bigger cases. Lilly and the prosecutors have already discussed an overall settlement of the state and federal investigations and suits that would require Lilly to pay $1 billion to $2 billion in fines and restitution, according to people who have been briefed on the talks.

This coupled with the $1.2 billion spent to settle some 30,000 individual lawsuits from patients claiming that they developed diabetes from taking Zyprexa, Lilly could be looking at paying out around three billion or more to settle Zyprexa lawsuits.

Originally posted at InjuryBoard by Scott Kappes

Enbrel Gets Black Box Warning

Scott Kappes — Wed, 19 Mar 2008 17:30:22 GMT

This week Amgen and Wyeth updated the warning label for their rheumatoid arthritis medication, Enbrel, to inform healthcare professionals and patients of an increased risk of infection associated with the drug. The drug already carried a risk of infection warning; however, the update expands this warning to include information about screening and monitoring patients for tuberculosis (TB). In analysis of more than 20,000 patients worldwide TB was observed in 0.01 percent of patients.

The medication inhibits tumor necrosis factor (TNF), a protein involved in inflammation. But the drug can also interfere with the body's ability to fight infections. Enbrel is approved for adult use in several conditions, and for kids 2 and older who have juvenile idiopathic arthritis.

While the risk is small patients and healthcare professionals should be informed about this elevated risk. Enbrel accounted for over three billion in sales last year for Amgen and was responsible for an additional two billion in sales for Wyeth. The manufacturers have been under fire from healthcare authorities over allegations of off-label marketing tactics.

Originally posted at InjuryBoard by Scott Kappes

Preemption NOT Extended to Paxil Lawsuits, Judge Rules

Scott Kappes — Fri, 14 Mar 2008 14:16:34 GMT

This week a Pennsylvania judge ruled that federal law cannot preempt a state product liability lawsuit regarding GlaxoSmithKline's antidepressant Paxil. The ruling was centered on the alleged failure of GSK to warn patients and healthcare professionals about an increased risk of suicide associated with the medication. Judge Allan L. Tereshko concluded that federal preemption does not prohibit plaintiffs from arguing that the drug manufacturer failed to fulfill its obligation to those taking the medication when it failed to warn of an increased risk of suicidal ideation and action that has been linked to the drug.

The defense argued that the plaintiffs should be precluded from making that argument in state court under implied conflict pre-emption, saying that allowing the state court action over the adequacy of the Paxil label would result in conflicts with the "FDA's exclusive authority to determine the content of the label," Tereshko said.

Tereshko cited the Federal, Food, Drug and Cosmetic Act's silence on the issue as reasoning for the no preemptive decision. He said that he does not believe that the intent of Congress was to extend federal preemption to lawsuits of this nature.

This decision will be ridiculed by defense attorneys and hailed as president by plaintiff's lawyers. This issue has been a hotbed for discussion in recent months, and even more so following the Supreme Court's recent decision to allow medical device lawsuits to be preempted under federal law.

Originally posted at InjuryBoard by Scott Kappes

Life-Threatening Events Associated with Tussionex

Scott Kappes — Tue, 11 Mar 2008 20:20:33 GMT

Today the FDA informed health care professionals of life-threatening adverse events and death in patients taking Tussionex Pennkinetic Extended Release Suspension. According to the FDA website doctors have prescribed the hydrocodone containing cough suppressant to children under the recommended age of six. Additional reports of physicians prescribing the medication at more frequent intervals than recommended have also surfaced. Tussionex must not be given to patients under six due to the elevated risk of respiratory failure in younger patients.

Patients have also incorrectly administered the drug due to misinterpretation of dosing instructions or incorrect measurements. Although Tussionex is much more dangerous for younger patients, fatal respiratory depression has been reported in adult patients.

When taken as directed Tussionex is a safe and effective treatment to control a persistent cough

Originally posted at InjuryBoard by Scott Kappes

Black Box Warning Added to Anemia Drugs

Scott Kappes — Tue, 11 Mar 2008 13:19:19 GMT

Last Friday the FDA added the strictest warning available to three anemia medications. The black box warning warns of an increased risk of death and tumor growth associated with the medications. Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit have been shown to accelerate tumor growth in patients with several different types of cancer. The drugs had been linked to similar risks in November, but the new warnings include increased risks for cervical and breast cancer patients.

The medications are usually used to treat anemia in patients with renal failure or in patients undergoing chemotherapy. This Thursday a panel of outside experts is set to advise the FDA about additional warnings or restrictions that should be placed on the blockbuster medications.

In documents posted to the agency's Web site Tuesday, the FDA said there is " insufficient data" to rule out a risk of death and tumor progression in any cancer other than non-small cell lung cancer when the drugs are used according to doses recommended in the labels.

The FDA noted that currently ongoing studies to evaluate the drugs' impact on cancer patients undergoing chemotherapy, but the results will likely not be available for years.

Originally posted at InjuryBoard by Scott Kappes

Jury Awards $27 Million in Hormone Lawsuit

Scott Kappes — Mon, 10 Mar 2008 10:33:10 GMT

Last Thursday a jury ordered Wyeth Pharmaceuticals and Upjohn to shell out over $27 million in compensation to an Arkansas woman who developed breast cancer after taking hormone replacement therapy. The jury ruled in favor of Donna Scroggin citing that the companies failed to provide adequate warnings of the drugs Premarin and Prempro. The jury decided that Scroggin should receive $19.3 million from Wyeth and $7.7 million from Upjohn in punitive damages.

Lawsuits against Wyeth have had mixed results. A Little Rock woman, Helene Rush, lost her case against Wyeth last year and a federal appeals court upheld the decision in February. A federal jury in Little Rock also ruled for Wyeth in 2006 in the first in a series of lawsuits against the New Jersey drugmaker.
An Ohio woman was initially awarded $3 million in a case in Pennsylvania, though a judge later overturned the award. In Reno, Nev., last year, jurors awarded $134 million to three Nevada women who sued over the hormone therapy. But a judge in February cut that amount to about $58 million total - $23 million in compensatory and $35 million in punitive damages.

Every case involves that drugs Premarin and Prempro which are commonly used by hundreds of thousands of women to combat symptoms of menopause. The drugs remain on the market despite concerns about a possible breast cancer link.

Originally posted at InjuryBoard by Scott Kappes

Mother Files Lawsuit Over Birth Defects

Scott Kappes — Thu, 06 Mar 2008 13:01:03 GMT

In September of 2005 Faith Gibson of Canada gave birth to Meah, a beautiful baby girl. Meah was born with a hole in her heart, which required surgery and a seven-month hospital stay. Faith believed at the time that her daughter's condition was just an unfortunate happenstance, but last year after reading an article about birth defects associated with the prescription antidepressant Paxil she started to speculate that the Paxil she took during her pregnancy could have been responsible for Meah's terrible birth defect. In December of 2005, the same month Meah was born, the FDA issued a warning for an elevated risk of cardiovascular birth defects associated for the children of women taking Paxil during pregnancy. Faith is now launching a lawsuit against GlaxoSmithKline, the makers of Paxil, alleging that the company failed to provide adequate safety information regarding the risks of taking Paxil during pregnancy.

Gibson's lawsuit alleges that GSK "knew or ought to have known . . . that there was a significant risk of serious adverse cardiovascular complication for newborns from pregnant mothers ingesting Paxil" and that the hole in Meah's heart was caused or contributed to by the use of Paxil.

The 2005 FDA warning came in response to a major U.S. study that found the occurrence of major birth defects, particularly cardiovascular defects, associated with the children of mothers taking Paxil during their first trimester to be twice that of women not taking the drug. A later study out of Sweden reaffirmed these findings.

Gibson's lawyer, David Rosenberg, said part of what the suit will clarify is what GSK knew about the dangers of the drug and when.

GlaxoSmithKline has not issued a public statement regarding the lawsuit.

Originally posted at InjuryBoard by Scott Kappes

Anemia Drugs Cited For Death Risks

Scott Kappes — Tue, 26 Feb 2008 19:36:47 GMT

Today an article published in the Journal of the American Medical Association claims that commonly used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death in cancer patients by about 10 percent. The publication, based on new analysis of existing clinical trial data, comes just as the FDA is planning to convene an advisory panel to address concerns associated with the medications. Amgen's Aranesp and J & J's Procrit will be evaluated by the panel to see if further restrictions should be placed on the drugs' labels. The new analysis may play heavily on the advice of the panel.

One option that analysts expect to be discussed at the meeting in March would be to bar use of the drugs for specific types of cancer, such as breast cancer and head and neck cancer. Another option would be to delay treatment with the drugs until patients became more anemic than the current threshhold, a change that would more closely match the Medicare reimbursement policy.

The study also found a 57 percent increased risk of blood clots associated with the medications, reaffirming earlier concerns. A meta-analysis published in 2006 showed an 8 percent increased risk of death but this was just under the threshold of being considered statistically significant. The new study looked at 51 clinical trials of over 13,600 patients. This time the 10 percent increased risk was established to be statistically significant prompting publication and heightened concern about the future of these medications. The FDA advisory panel will convene on March 13th.

Originally posted at InjuryBoard by Scott Kappes