Norfolk-Portsmouth Personal Injury Lawyer - FDA & Prescription Drugs

Risks From Avandia Mirror Those for Diabetes Itself

Emily Mapp Brannon — Sun, 04 Oct 2009 09:53:00 GMT

Patients with type 2 diabetes run the risk of losing a limb to the disease. Patients taking Avandia--GlaxoSmithKline's branded version of the medication rosiglitazone--also run the risk of fracturing an arm or leg because the drug weakens bones.

Likewise, people with diabetes often have liver disease. Taking Avandia increases patients' risk for experiencing liver disease and damage.

Certainly not last, having diabetes significantly raises a person's risk for having a fatal heart attack. GlaxoSmithKline was compelled to add heart warnings to Avandia's prescribing information in 2007. These warnings drew new attention recently with the publication of data in the Aug. 18 issue of the medical journal BMJ. Researchers examined treatment outcomes for nearly 40,000 patients with diabetes and found not only that Avandia had a greater heart attack risk but also worked no better than its chief competitor Actos, which is Takeda's brand name version of the medication pioglitazone.

All drugs pose some risk for patients, but no treatment should leave a patient worse off than she began. This does happen too often, however. Medical errors ranging from wrong-site surgeries to dispensing the wrong drug in the wrong dose harm patients every day. When the treatments themselves are at least as dangerous as the diseases, patients start two strikes down in their battle to return to or maintain their health.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury, and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our case results to see for yourself. Our primary office is based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

EJL

Originally posted at InjuryBoard by Emily Mapp Brannon

Fentanyl/Duragesic Patch Claims: A History of Death and a Dangerous Drug

John Cooper — Tue, 30 Jun 2009 15:21:44 GMT

Fentanyl, a drug approximately 100 times stronger than morphine, has been linked to many fatalities due to inappropriate use and medical error. Fentanyl, also called Duragesic, was developed in 1959, is used to treat post-operative and chronic pain, and also used in clinical practice as a general anesthetic. Fentanyl is also used illegally, becoming popular in drug culture for its euphoric effects. Fentanyl has been used as a direct substitute for heroin; however, its extreme potency increases the rate of overdose and can lead to respiratory problems and even death.

Recently, Fentanyl has been the subject of law suits involving doctors and pharmaceutical companies. In 2004, five lots of the Duragesic pain patch, produced by Johnson & Johnson were recalled for problems due to Fentanyl. The Duragesic patches have contained Fentanyl since 1990; however, the defect in 2004 allowed the Fentanyl gel to leak from the patch directly onto the patient’s skin. Once Fentanyl came into contact with the patient, it was absorbed by the body in dangerously high levels. The FDA reported hundreds of fatalities due to these defective patches.

A subsidiary of Johnson and Johnson, Janssen Pharmaceutica Products, was sued in 2003 due to Duragesic patches. The family of the deceased sued after the victim’s death was found to be caused by the use of the Duragesic patches for chronic hip pain. The family received 5.5 million dollars as the result of a wrongful death suit against the company. It was more than a year after this event that the company began issuing warnings about the health risks of using Duragesic patches.

Fentanyl has also been linked to medical malpractice and medication error. Cephalon has provided some important safety information to those prescribed any medication or treatment that involves Fentanyl (specifically Fentora).

- No doctor should prescribe Fentanyl products to those who are opioid in-tolerant. Such as patients taking 24 hour opioid treatment.

- Fentanyl should only be used for labeled indications

- Fentanyl is not for acute pain, or sports injuries

- Fentanyl should never be used as a replacement for other medication or treatments such as Actiq

Although there are appropriate uses for Fentanyl, you must be careful that you are not abusing the substance. Many suffer from abuse of Fentanyl simply by accident, through medical malpractice or product defect. Staying aware of possible side effects and complications with your treatment and medication will allow you to recognize problems and catch symptoms early on. Anytime you are introducing foreign substances into your body, whether prescribed or not, make sure you follow directions, and contact a medical provider if you start having any negative effects from the treatment.

Many wrongful death lawsuits against the manufacturers of Fentanyl and Duragesic pain patches have focused on defects, leaks or improper prescription of the pain patches. Our firm has investigated several deaths and it is clear that the cases we investigated involved accidental, not intented death, and toxic amounts of fentanyl, proved by autopsy toxicology reporting.

Prior fentanyl/duragesic articles we have authored:

Lethal Weapon of Overdose Death: Fentanyl

Fentanyl/Duragesic Patches Associated with Death and Overdose

Fentanyl Death Case Results and Information

Being well educated and well informed is the first step to better treatment and a brighter future. It’s your body, and you only get one. Stay healthy, and stay safe.

About the Editors: Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia (VA), near the NE North Carolina (NC) border and handles car,truck,railroad, and medical negligence cases and more. Our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono public information service. Lawyers licensed in: VA, NC, SC, WV, DC, KY.

Originally posted at InjuryBoard by John Cooper

Nestle Toll House Cookie Dough Food Poisoning Connected to Virginia

Rick Shapiro — Sat, 27 Jun 2009 17:10:00 GMT

The Food and Drug Administration (FDA) recently inspected the Danville, Virginia (VA) factory which produced the Nestle Toll House cookie dough which contained E. coli, according to the Daily Press. The reports show a complete lack of compliance on the part of Nestle USA. Between 2004 and 2007, Nestle failed to provide important documents such as complaint logs and pest-control records to the FDA.

So far, 69 people in 29 states – including Virginia (VA) – have been sickened due to the E. coli outbreak from the cookie dough. Clearly, Nestle is at fault for these illnesses due to their procrastination and sheer insolence toward FDA requests.

As an injury lawyer with 20 years of experience representing clients who’ve suffered severe injuries due to big companies failing to follow basic safety measures, it’s frustrating to hear about another company needlessly allowing people to get sick.

Here’s a video talking about the Nestle cookie dough recall due to E. coli…

http://www.youtube.com/watch?v=iLNBo6nygYE

This isn’t the first time Virginia (VA) has been embroiled in a food poisoning controversy. There was a recent outbreak of salmonella connected to peanut butter manufactured by Peanut Corp. in Lynchburg, Virginia (VA), according to Fox News. Two Virginians died as a result of this outbreak and over 500 people were sickened.

Food poisoning affects roughly 25 percent of Americans every year and if you have a case of diarrhea which lasts more than a day, there’s a 1-in-3 chance you had food poisoning, according to chinadaily.com.

When E. coli enters your body it causes abdominal cramping, vomiting, nausea, and the aforementioned diarrhea. Serious complications can occur, especially in young children, older people, and individuals with weak immune systems, according to webmd.com.

If you or a loved one has been sickened by E. coli and/or salmonella and you believe it’s related to cookie dough or peanut butter, you need to seek legal advice.

Originally posted at InjuryBoard by Rick Shapiro

Makers of Zicam Nasal Spray Deny Loss of Smell as Side Effect

Jim Lewis — Fri, 19 Jun 2009 13:49:00 GMT

Matrixx Corp., the makers of Zicam nasal spray, denied the allegations that their product caused a permanent loss of smell when taken by consumers. This denial came after settling multiple lawsuits worth millions of dollars for plaintiffs who stated they did indeed lose their sense of smell after taking Zicam.

After the FDA warned consumers of the potential loss of smell due to Zicam use, Maxtrixx released a statement saying it “believes [Zicam nasal spray] products are safe and do not cause anosmia." Anosmia is the clinical term for a loss of smell. The statement went on to say, "The Company’s position is supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.”

Matrixx also said they believe the FDA warning is "unwarranted."

Matrixx claims no study linked Zicam nasal spray with a loss of smell. However, that’s not completely accurate.

A study was performed by a Dr. Burton Slotnick and a group of researchers, according to Kristina Duda. The results showed only a partial and/or temporary loss of smell in mice when given extremely large doses and the damage was reversed within a couple of weeks.

Here’s the catch – the study was supported in part by a grant from Matrixx. I’m not accusing Dr. Slotnick and his team of researchers of impropriety, but it makes one question the outcome of a study on a product that’s being funded by the manufacturer of said product.

According to doctors not funded by Matrixx, the reports are very different. Dr. Bruce Jafek, an otolaryngologist in Colorado (CO) reported about the loss of smell from patients due to Zicam nasal spray usage at a clinical meeting in 2003.

Dr. Jafek stated, "In my opnion, the product is dangerous in putting zinc ions into the nose ... If a person wishes to continue to use this product certainly they should be warned that they could lose their sense of smell. It's an uncommon problem but for the person who loses their sense of smell, it's devastating."

Matrixx uses zinc gluconate in Zicam nasal spray under the assumption it was less dangerous than its chemical cousin, zinc acetate. However, this is apparently not the case and zinc gluconate causes just as many side effects.

The Taste and Smell Clinic in Washington, DC evaluated several patients who claimed to have lost their ability to smell after using Zicam. Careful measurements of their smell acuity indicated loss of smell function consistent with their clinical complaints, according to tasteandsmell.com. Some patients also experienced distortion of smell consistent with the deafferentation hypersensitivity associated with loss of any significant sensory input (e.g., phantom limb syndrome).

Medical experts have known since 1938 that zinc can harm smell tissue in high doses. In fact, Canadian doctors used a zinc nasal solution to kill the sense of smell in children as part of an experiment to prevent polio, according to The Washington Post.

This isn’t the first-time a zinc-based nasal spray caused serious side effects. Cold-Eeze, a nasal spray with zinc as its primary ingredient, had lawsuits brought against the manufacturer a few years ago. Cold-EEze was removed from the market in 2004 after just one year.

As a personal injury lawyer who’s been practicing for over 20 years, I’m always distressed when I hear about these horrible side effects associated with popular, over-the-counter medications. It’s clear the Matrixx should have done studies to see what side effects occur when injecting zinc gluconate into nasal passages. People’s lives are being forever altered because of Matrixx’s irresponsible actions.

Originally posted at InjuryBoard by Jim Lewis

Zicam nasal spray causes loss of smell

Rick Shapiro — Wed, 17 Jun 2009 17:38:00 GMT

The FDA announced consumers should avoid the nasal spray Zicam due to the risk of permanent loss of smell. 130 people have reported losing their sense of smell after using Zicam products since 1999, according to MSNBC.

Zicam is an over-the-counter product which contains zinc, an ingredient scientists say could potentially damage nerves in the nose needed for the sense of smell. Other products affected by the FDA announcement include adult and kid-size Zicam Cold Remedy Nasal Swabs.

Doctors stated the loss of smell could be life threatening since it would prevent an individual from being able to detect a gas leak or a house fire.

As a personal injury lawyer who’s been practicing law for over 20 years, it always upsets me when I hear about an over-the-counter product harming people’s health. This product should have been tested before hitting the open market. However, the FDA stated Zicam Cold Remedy was never formally approved because it falls under the category of homeopathic products, which usually contain herbs, minerals and flowers.

Homeopathic products are not required to go through federal review, which puts people at risk for horrific side effects (e.g. loss of smell). The laws need to be changed to give the FDA the power to regulate such products. The current regulations just aren’t strict enough, plain and simple.

Here’s a video talking about the FDA warning of Zicam nasal spray…

Video

Zicam is produced by Matrixx Initiatives and is a highly profitable product. In fact, it accounted for 40 percent of the company’s over $100 million dollars in sales from 2008, according to MSBNC.

Matrixx settled numerous lawsuits in connection with Zicam recently, but their web site still claims, “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.” I suppose Matrixx is claiming a substantial settlement is not "winning" a court case, but without quibbling, lets all agree that when the FDA says Zicam has caused permanent injury, we can believe it.

Originally posted at InjuryBoard by Rick Shapiro

Swine Flu Persists in Peninsula Area of Virginia, Global Pandemic Declared

Jim Lewis — Wed, 10 Jun 2009 17:15:00 GMT

Schools in Newport News, Virginia (VA) recently reported three cases of the H1N1 virus, commonly referred to as Swine Flu. The schools in question include Richneck Elementary on Tyner Drive and Mary Passage Middle School on Atkinson Way, according to the Daily Press.

Cases have been confirmed in Williamsburg- James City County, Hampton, York and Middlesex school districts.

The World Health Organization recently declared Swine Flu a global pandemic, according to The Virginian-Pilot. This is the first pandemic in 41 years, according to the Associated Press.

The Virginia (VA) Department of Health showed Chesapeake currently has seven cases while Norfolk, Virginia Beach, and Hampton all have two cases each.

As a practicing personal injury attorney for over two decades, the health of the public is of great concern to me. I want everyone in Virginia (VA) or any other state to be fully informed of ways to prevent and/or treat Swine Flu.

Here is a video discussing the primary symptoms and ways to prevent Swine Flu:

Swine Flu Symptoms and Prevention

If you experience these symptoms or know of someone experiencing these symptoms, seek medical attention immediately to verify if you have been infected with Swine Flu or not.

Why is the Swine Flu so prevalent in schools? Well, according to the CDC, it is due to the fact that children, especially young children, might potentially be contagious for longer periods of time, as opposed to teenagers and adults. However, the CDC is studying the virus and its capabilities to try to learn more.

Two antiviral prescription drugs, oseltamivir or zanamivir, are recommended to help treat Swine Flu. However, if you’re prescribed one of these drugs, take necessary precautions. Always be vigilant with the recommended daily dosage. Our firm has represented clients who’ve endured horrendous physical pain from medical mistakes and prescription errors.

Hopefully, as we continue to contain the spread of the Swine Flu virus, cases will desist in Virginia (VA). Until then, make sure you’re up to date on how to prevent and/or treat this virus.

Originally posted at InjuryBoard by Jim Lewis

Hydroxycut Imitators Should Be Avoided

Rick Shapiro — Tue, 02 Jun 2009 17:57:00 GMT

The FDA urged people to stop taking the popular weight loss product Hydroxycut due to a link with liver damage and one death, according to The Virginian-Pilot. You should also be on the lookout for knockoff Hydroxycut supplements. These imitators can use the same ingredients which could lead to the same devastating health effects as the original Hydroxycut.

For example, there’s a product called Hydroxynol on the market which proudly proclaims it self to be identical to Hydroxycut. Clearly, you should avoid this product and others like it. The side effects associated with Hydroxycut usage include jaundice (i.e. yellowing of the skin), liver failure, and various other debilitating conditions.

In my over 20 years of experience as a personal injury attorney, I’ve dealt with numerous clients struggling with serious medical issues so I’m always concerned about the safety of products and supplements. It’s outrageous for companies to sell supposed “health” supplements without fully understanding the ramifications of their usage.

People are dying, or stricken with life-long health ailments, because they used Hydroxycut and supplements like it in the hopes of improving their bodies.

You might be asking yourself, “How could such volatile products like Hydroxycut and its diabolical imitators make it to the shelves of health stores and supermarkets?” Good question. The answer is the lack of adequate regulation over the dietary supplement industry.

The Dietary Supplement Health and Education Act of 1994 is the primary law that defines what exactly constitutes a dietary supplement and what types of claims manufacturers can make about health benefits, according to the AARP. Unfortunately, the law is not strong enough. These products are not reviewed for safety and efficacy by the federal government. In addition, if a product was on the market before the DSHEA was passed, the FDA can only take action once it has enough evidence to prove that a supplement is unsafe and/or harmful.

This means you, the consumer, need to be aware of what's in the health products and supplements you’re purchasing.

If you’ve taken Hydroxycut in the past I strongly urge you to see your doctor. If you’re experiencing negative side effects, you should also consult an attorney.

Originally posted at InjuryBoard by Rick Shapiro

Reglan Connected To Serious Movement Disorder

Jim Lewis — Sat, 23 May 2009 12:59:00 GMT

Studies show a link between the prescription drug Reglan and a very serious movement disorder called tardive dyskinesia, according to the FDA. The symptoms for this disorder are almost never reversible and there is no known treatment available.

Reglan is commonly used to help treat acid reflux and GI Ulcer symptoms. Prolonged usage of the drug can lead to the aforementioned tardive dyskinesia. As a result of the FDA’s studies, Reglan makers – such as Baxters International - were told to add an informational box on the drug bottle to inform users of the risks associated with prolonged use.

To make matters even worse, if you decide to stop taking Reglan, you’re likely to endure withdrawal symptoms such as dizziness, nervousness, and headaches, according to drugs.com.

I’ve been practicing law as a personal injury attorney for over 20 years and I have experience representing clients who’ve had issues with prescription drugs.

I always get frustrated when I hear about prescription drugs causing such harmful side effects and potentially leading to horrendous medical conditions. Prescription drugs are supposed to help people cope with medical disorders and yet numerous drugs make people feel worse and/or lead to more problematic medical conditions, such as tardive dyskinesia with Reglan.

If you or a loved one has taken, or is currently taking Reglan, I strongly advise you to see your doctor. If you’re experiencing symptoms, or are diagnosed with tardive dyskinesia, you need to seek legal counsel.

Originally posted at InjuryBoard by Jim Lewis

Obama Administration Quickly Halts Effect of Bush Administration Pending Regulations That Snuff Out State Civil/Tort Remedies

Rick Shapiro — Wed, 21 Jan 2009 20:45:28 GMT

One of the first official acts of the Obama administration was to halt the effect of any “last minute” Bush administration “corporate protection” regulations that would wipe out consumer rights to pursue state court lawsuits. The Bush Administration has famously wiped out and "preempted" each of the 50 states civil justice remedies in a wide array of fields, including select regulations involving medications, prescriptions, railroad matters, food and drug issues, and the list goes on. This is also known as complete immunity preemption.

Under this executive mandate, the Obama Administration will have the option not to finalize any proposed rule (or final rule which has not yet become effective) or to ensure that any final version of a pending federal regulation would not preempt (trump or wipe out) state tort law remedies.

For example, the American Association For Justice noted how important this action was to consumers in this news release:

Yesterday’s issue of a memo direct federal departments and agencies to stay regulations that aren’t yet final until a review can be conducted by the new administration froze the rule that could prevent Kimberly Gueldenzoph from receiving justice. One of the pending rules is a Food and Drug Administration (FDA) labeling requirement for prescription drugs for pregnancy and lactation. Kimberly’s daughter Kenndyl died from complications arising from a congenital heart defect Kimberly believes was caused from her taking Paxil during part of her pregnancy. Neither Kimberly nor her doctor knew that taking Paxil during pregnancy is associated with an increased risk of birth defects, but the manufacturer of Paxil, GlaxoSmithKline (“GSK”) did. The FDA rule could prevent people harmed by prescription drugs while pregnant or breastfeeding from seeking justice in the courts. Kenndyl was just two weeks old.

In fact, over 23 pending rules including several dealing with auto safety and products requiring FDA approval were stayed and have no effect on state tort law.

Lets be clear: the new Obama administration will make a difference. Its reassuring to know that federal regulations will be enacted the old fashioned way-in accord with federal law. Backdoor regulatory “preambles” will not be used to foist federal mandates over states—which effectively snuffed out all state tort remedies without public hearings and comments. President Obama’s 12 years teaching constitutional law at the University of Chicago Law School may spell the return of government adhering to the U.S. constitution, rather than looking to avoid it.

Originally posted at InjuryBoard by Rick Shapiro