Philadelphia Personal Injury Lawyer - FDA & Prescription Drugs

GE and Omniscan Face More NSF Trouble

Jamie Sheller — Fri, 04 Dec 2009 14:33:44 GMT

New analysis suggests that 3 MRI contrast agents may be risker than initially thought, leading the FDA to consider further regulation of the drugs. The drugs are linked to a rare, but potentialy fatal disease called nephrogenic systemic fibrosis (NSF). The drugs being examined are Bayer HealthCare's Magnivest, Mallinckrodt's Optimark and GE Healthcare's Omniscan. According to FDA reviewers, Omniscan had a disproportionately high number of NSF reports, compared to its peers. Magnevist, Optimark, and Omniscan are contrast agents, containing the metal gadolinium, which are injected during magnetic resonance scans. Contrast agents are linked to NSF in patients with impaired kidney function. According to researchers, one possible cause is an inability to eliminate gadolinium from the body.

NSF causes a thickening and hardening of the skin around the joints, leading to limited movement and possible incapacitation. Also, internal organs may be affected, potentially resulting in a lung embolism or other life-threatening condition. There is no known cure for NSF. In the U.S., more than 500 NSF cases have been filed, with a majority of those cases involving GE and Omniscan. Further, Omniscan is the contrast agent most cited in reports of NSF filed with the FDA and European regulators. In an FDA review, Omniscan was rated as the least chemically stabale of the contrast agents.

If you or a loved one has had an imaging study with a gadolinium contrast agent, and developed NSF, contact Sheller, P.C., to discuss your potential legal claims. The Sheller firm has a long history of successfully representing people injured by pharmaceutical products and medical devices. Sheller is currently accepting cases of patients who have developed NSF.

Originally posted at InjuryBoard by Jamie Sheller

Big Award In Pfizer HRT Case

Jamie Sheller — Fri, 04 Dec 2009 10:40:11 GMT

Recently, a breast cancer survivor won her hormone replacement lawsuit against Pfizer. Plaintiff, Donna Kendall asserted that three of Pfizer's hormone replacement drugs contributed to her breast cancer, and a jury in Philadelphia agreed with her. The jury found that the drug company failed to adequately warn consumers of the risks of Premarin, Prempro, and Provera, and ordered Pfizer to pay Ms. Kendall $6.3 million in compensatory damages and $28 million in punitive damages. Pfizer became responsible for this and thousands of other hormone replacement lawsuits, when it acquired Wyeth and Pharmacia & UpJohn.

The FDA approved Premarin in 1942 and Prempro in 1994, and they are used to treat moderate to severe symptoms of menopause. Provera was approved in 1959 to treat abnormal uterine bleeding, secondary amenorrhea and endometrial hyperplastia in post-menopausal women who are taking estrogen pills. A study of Premarin and Prempro by the Women's Health Initiative, revealed an increased risk of cardiovascular disease, stroke, and breast cancer. After that study, the use of hormone therapy decreased. One later study linked hormone replacement therapy to a signifcant increase in stroke risk. Hormone therapy was linked to an increased risk for ovarian cancer by a more recent study.

In October, another Philadelphia jury ordered Pfizer to pay $75 million to another plaintifff, whose breast cancer was connected to Prempro. Pfizer says it will challenge both verdicts.

Originally posted at InjuryBoard by Jamie Sheller

Merck Discloses Payments To Doctors

Jamie Sheller — Mon, 02 Nov 2009 14:26:08 GMT

Recently, the drug manufacturer Merck disclosed information showing that in the summer of 2009, it paid $3.7 million to doctors and nurses for giving talks to colleagues about Merck products and health issues. Merck is the second major drugmaker to disclose such payments.

There has been a flurry of criticism by media and lawmakers over what appears to be excessive influence over doctors by drug and medical device makers. In the past, companies tried to gain favor with doctors through wining and dining them. However, since Janary 2009, industry guidelines have barred providing expensive meals, trips and gifts. In addition, major hospitals and universities are reviewing their internal policies regarding what staff doctors can accept, and what they must disclose.

According to Merck, the payment data that is discloses on its website, "shines a light" and addresses a misunderstanding about the relationship between doctors and the industry. Merck says that its programs are balanced and cover a variety of issues, including new research and improving patient care.

Critics argue that disclosing payments is a step in the right direction, but is not enough by itself. They see the compensated talks as paid-for marketing for a particular drug or treatment. Such critics urge medical schools and professional medical societies to be a more influential force in teaching doctors about new products.

Originally posted at InjuryBoard by Jamie Sheller

Antipsychotics Cause Rapid Weight Gain In Children and Youth

Jamie Sheller — Thu, 29 Oct 2009 21:51:54 GMT

According to a study recently published in The Journal of the American Medical Association, the newest generation of antipsychotic medications can cause rapid weight gain and metabolic changes in young children and adolescents. These side effects could lead to diabetes and hypertension. On average, the patients in the study gained one to one and a half pounds per week. One expert, Dr. Wayne Goodman, said that, "the degree of weight gain is alarming." Dr. Goodman is the chairman of psychiatry at Mount Sinai School of Medicine, as well as head of an FDA advisory panel on antipsychotic drugs. Previous studies had detected the drugs' influence on weight and metabolism, but this recent study demonstrated that the speed and magnitude of the effects were greater than previously known.

The study involved 257 patients, ages 4-19 and the four most popular antidepressants, Abilify, Risperdal, Zyprexa and Seroquel. The drugs are used to treat schizophrenia and bipolar disorder. Of the four drugs, Zyprexa had the most severe effects on weight and metabolism. The study was the largest of childhood use of these drugs called atypical antipsychotics. Only 2 of the 4 drugs studied, Abilify and Risperdal, are approved for pediatric use. According to one expert, "more than 70% of atypical antipsychotic use in young children and teenagers has been off-label prescriptions for non-psychotic conditions like attention deficit hyperactivity disorder."

Originally posted at InjuryBoard by Jamie Sheller

Doctors Lack Knowledge About Off-Label Uses

Jamie Sheller — Wed, 28 Oct 2009 21:17:14 GMT

Off-label use is the practice of prescribing medications for uses other than those approved by the FDA. Many doctors engage in the practice. However, according to a recent survey, a substantial minority of doctors mistakenly believe that certain off-label uses are FDA-approved. These off-label uses are often not supported by scientific evidence. "Overall, physicians were able to correctly identify the FDA-approved status of just one half (mean 55%) of the 22 drug-indication pairs (i.e. a particular drug prescribed for a particular condition) that were included in the survey." The mistaken belief that off-label uses are FDA approved may encourage some doctors to practice off-label prescribing. The study was published in the journal Pharmacoepidemiology and Drug Safety. The study's authors urge the need for physicians to learn more about off-label drug use and whether there is support for such uses, especially uses that are ineffective or have unacceptable risks.

The FDA approves drugs for specific indications, and regulates the marketing of drugs. Drug makers are prohibited from promoting their drugs for off-label uses. However, doctors are free to prescribe approved drugs for uses not indicated in the drug's label. Patients are often not aware that they are being prescribed a drug for an off-label use.

Originally posted at InjuryBoard by Jamie Sheller

Plaintiffs Win First Paxil Birth Defects Case

Jamie Sheller — Tue, 20 Oct 2009 21:08:18 GMT

A jury awarded a $2.5 million verdict in the first Paxil birth defects case to go to trial. GlaxoSmithKline is liable for the verdict, after the jury found that it was negligent. The verdict is for compensatory damages. No punitive damages were awarded because the jury did not find that Glaxo's conduct was outrageous. Jamie Sheller of Sheller, P.C. was one of the lawyers representing plaintiff Michelle David who alleged that Paxil caused the life-threatening heart defects suffered by her son Lyam Kilker. Paxil is an antidepressant, and Ms. David took it while she was pregnant. From 1992 through 2005, Paxil was classified as a drug with no known link to increased birth defects. In September 2005, the FDA began warning of a possible association between Paxil and birth defects. Four months later the Paxil warnings were strengthened. Meanwhile, Lyam Kilker was born in October 2005. At two months old, he was diagnosed with heart defects, and he underwent surgery to repair two holes in his heart, spending five months in a Philadelphia hospital. He will also need at least one more heart surgery as he grows. According to Jamie Sheller, Glaxo could have known about the risks of birth defects much sooner.

The Lyam Kilker case was one of over 600 similar cases against Glaxo. Another case is scheduled for trial in Philadelphia in November.

Originally posted at InjuryBoard by Jamie Sheller

Paxil Birth Defect Trial In Philadelphia

Jamie Sheller — Sun, 18 Oct 2009 22:40:09 GMT

According to the lawyer representing a family suing GlaxoSmithKline, company executives intentionally ignored the possibility that Paxil could cause birth defects. Paxil is an antidepressant, and there were studies showing that Paxil posed a risk of birth defects. However, the plaintiff's lawyer argued that due to the fear of harming sales, Glaxo never followed up on those studies. The lawyer made these comments during closing arguments at the Paxil trial in state court in Philadelphia. The Philadelphia case is the first to go to trial, alleging that Glaxo was aware of the Paxil birth defect risks and hid those risks to increase profits. There are more than 600 such cases against Glaxo, the U.K.'s largest drugmaker. The Philadelphia case was filed by Michelle David, the mother of Lyam Kilker, who claims that Paxil wasn't properly tested, and that it caused Lyam's life-threatening heart defects. Mrs. David alleges that information about Paxil's risks was withheld from consumers and regulators.

Paxil was approved in 1992 for U.S. use, and generated approximately $942 million in sales for Glaxo in 2008.

Jamie Sheller, of Sheller, P.C., is one of the lawyers trying the Paxil case in Philadelphia. Sheller lawyers have a long history of succesfully representing individuals and classes of individuals who have been injured by pharmaceuticals and medical devices.

Originally posted at InjuryBoard by Jamie Sheller

Newborns May Have Adverse Effects From Intrauterine Exposure to Antidepressants

Jamie Sheller — Wed, 14 Oct 2009 15:03:09 GMT

A recent report in the Archives of Pediatrics and Adolescent Medicine indicates that use of a certain class of antidepressants by pregnant women may increase the risk of pre-term birth, a low 5-minute Apgar score (a measure of baby's overall health), and admissions to the neonatal intensive care unit. According to the authors, "depression during pregnancy can be serious and has been associated with increased maternal mortality." For almost twenty years, pregnant women in many countries have been treated with selective serotonin reuptake inhibitors (SSRIs). In the recently reported study, though birth weight and head circumference did not differ, babies whose mothers used SSRIs were born an average of 5 days earlier, and were more likely to have a 5-minute Apgar score of at, or below, the minimum indicator of good infant health. The authors noted that earlier studies have shown that SSRIs readily cross the placenta of pregnant women, and appear in the umbilical cord blood of their babies. Pregnant women with depression may need treatment, but they and their doctors need to be aware of the potential effects of certain antidepressants on their babies.

Jamie Sheller, of Sheller, P.C., is litigating the first case in Philadelphia regarding birth defects caused by the drug Paxil. Sheller, P.C. has a long history of successfully representing individuals and classes of individuals who have been injured by pharmaceuticals and medical devices.

Originally posted at InjuryBoard by Jamie Sheller

Problems With Tracing Contaminated Drugs Identified

Jamie Sheller — Tue, 13 Oct 2009 06:38:21 GMT

A new report published in the Archives of Internal Medicine discussed the investigation of recent outbreaks of heparin contamination, and raises concerns about drug safety. The report was done by the Centers for Disease Control and Prevention. According to the CDC, the recent outbreaks were caused by lax compliance with federal regulations. Contaminated heparin syringes caused bacterial bloodstream infections. Outbreaks of bloodstream infections between October 2007 and February 2008 were traced to prefilled heparin syringes produced by a single company. According to the report, the unnamed company violated FDA Good Manufacturing Practices, in its manufacturing facility. After the CDC inspection of its facility, the company recalled its prefilled heparin syringes and stopped producing medical products.

The investigation highlights difficulties with tracing the sources of drug contamination, due in part to the fact that products move through multiple distributors before reaching patients. The CDC investigation also identified several other problems with tracing medical products. These problems should be promptly addressed to enable more efficient handling of contaminated medications. "Drug manufacturers must ensure that they are in full compliance with the FDA requirements, ..., and distributors, healthcare facilities, and pharmacies should keep track of the lot numbers of products they distribute, so contaminated products can be traced to their origins more rapidly."

Originally posted at InjuryBoard by Jamie Sheller

Philadelphia Personal Injury Lawyer - FDA & Prescription Drugs

GE and Omniscan Face More NSF Trouble

Big Award In Pfizer HRT Case

More Problems For Acne Drug Accutane

Merck Discloses Payments To Doctors

Antipsychotics Cause Rapid Weight Gain In Children and Youth

Doctors Lack Knowledge About Off-Label Uses

Plaintiffs Win First Paxil Birth Defects Case

Paxil Birth Defect Trial In Philadelphia

Newborns May Have Adverse Effects From Intrauterine Exposure to Antidepressants

Problems With Tracing Contaminated Drugs Identified