Washington Law Blog
Personal Injury, Car Accidents, Trucking Accidents,
motorcycle accidents and consumer law blog...

  • * First Name:
  • * Last Name:
  • * Email:
  • * Phone Number:
  • Comment:
  • Accept Terms *
  • *Denotes Required Field

Law Blog Categories

Car Accidents
3 Reasons to Hire Phillips Webster

Our attorneys have decades of experience negotiating with insurance companies regarding all types of vehicle accidents. If you have been injured in a wreck, contact us today.

  1. We represent EVERYONE in need anywhere in Washington - Minor and Major Injuries
  2. Experienced trial attorneys that will fight for your right to recover compensation
  3. FREE Case Review and we only get paid if you get paid
Learn more about our:
Seattle Car Accident Lawyers

Verdicts & Settlements

$20 MILLION - Commercial Injury
Confidential settlement for a commercial injury case

$19  Million - Grant of Coverage
Grant of coverage in insurance coverage case

$2 MILLION - INSURANCE BAD FAITH
Settlement in insurance bad faith case

$1.5 MILLION - CAR ACCIDENT WRONGFUL DEATH
Vancouver, Washington car accident that resulted in a death

$1 MILLION - DUI ACCIDENT VICTIM
Settlement for young man hit by a drunk driver

Our jury trial experience shows in the results we get both inside and outside of the courtroom.

More Verdicts and Settlements

 

Posts Tagged ‘FDA’

FDA Warns Doctors of New Tysabri Side Affect; Death

FDA, FDA warning, pharmaceutical, side effects

February 5th, 2010: Law Blogger

FDA WarningToday the US Food and Drug Administation (FDA) released a warning to doctors that the Biogen Inc. drug Tysabri (natalizumab) causes a rare brain infection that could be fatal to patients. The drug is used to treat relapsing multiple sclerosis patients. Multiple sclerosis is an autoimmune disease that affects the brain and spinal cord (central nervous system. Doctors also use it to treat Crohn”s disease, an uncomfortable inflammatory bowel disease.

What’s the Cause?

Tysabri is proven to cause progressive multifocal leukoencephalopathy (PML) due to a low autoimmune system. According to the Nation Institute of Health (NIH), PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals. Mortality is around 50% and those who do not die from the disease are generally left severely mentally impaired.

Problems From the Start

The FDA approved the drug in 2004, but Tysabri was pulled in 2005 due to those in the clinical trials coming down with PML. In the FDA report it said that the onset of PML became much higher after Tysabri, usually dispensed under supervised infusion, had been administered regularly for 12 months.

According to the Wall Street Journal, 66,000 people around the world take the drug. Only 1 in 1000 people contract PML. There have been 31 cases reported since it was reintroduced by Biogen in 2006. Biogen attributes the lower number to close monitoring of the patient during the infusion. Also, few patients have received more than 36 infusions.

Warning the Public

On the Tysabri website in the side effects section, it specifically states,

TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML).

The actions of the FDA today specifically require a change in the instructions on the bottle and with the packaging of the drug, warning the public of the chances and risks of PML.

The FDA further deemed that it would not reduce or restrict production because the occurrence of PML in patients is low enough not to outweigh the benefits over all to patients using the drug.

What To Do If You Contract PML from Tysabri

If you or a loved one contracts PML or shows symptoms of PML from taking Tysabri infusions please:

  • Talk to your doctor.
  • Request to be immediately taken off of the drug (as per Biogen’s instructions)
  • Seek legal council by calling Phillips Webster to learn about your legal options.

Tags: , , ,
Posted in Defective Drugs

Meridia Side Effects Report Leads to Different Reactions from FDA and EMA

Abbott Laboratories, EMA, European Medicines Agency, FDA, Meridia, Meridia side effects, Meridia side effects lawyers, SCOUT

January 26th, 2010: Washington Law Blogger

The obesity drug Meridia has been on the market in the United States for almost 13 years, and it’s been used worldwide by millions of people under one brand name or another.  Recent reports of Meridia side effects have led to the initiation of a massive study designed to determine whether the risks of keeping Meridia on the market outweigh the benefits even while Meridia side effects lawyers have filed claims against Abbott Laboratories for the harm the drug has caused many people.  The preliminary results of this massive study have been released, and different regulatory agencies have taken different steps in reaction to this new data.

Meridia Side Effects Study – Lawyers  Focus in

The current study, which is known as the SCOUT study, was undertaken because of reports of Meridia side effects that include heart problems and Primary Pulmonary Hypertension, or PPH.  When the study was announced, the FDA released a statement that it would monitor the study’s progress and determine how to proceed based on the data that was uncovered as a result of this work.

While the final results of the SCOUT study are not expected until March, preliminary conclusions that have been released include the finding that those patients who use Meridia and have a history of heart problems face a higher risk of suffering from heart attacks and strokes than those who do not have this history.  This has prompted different reactions around the world.

Different Legal Reactions to Meridia Side Effects

In response to this preliminary conclusion, both the FDA, which regulates drugs and medications in the United States and the European Medicines Agency (EMA) that oversees drugs and medications in the European Union issued immediate responses to the news.  This release has also led to differing approaches being taken by these regulatory bodies.

The FDA has announced that Abbott Laboratories must attach a ‘Black Box Warning’ to containers of Meridia that clearly warn both doctors and patients of the risk of developing Meridia side effects if the drug is used.  This level of regulation would represent the ‘middle ground’ for the FDA, as it’s more severe than simply issuing a warning and less severe than initiating a recall.

Meanwhile, the EMA has put forth a stronger reaction to this preliminary data.  It has released a ‘Dear Doctor’ letter to physicians, pharmacists and medical professionals across the European Union that directly recommends that those medical professionals stop prescribing Meridia and that the marketing of the drug should also end.  The drug is sold under different brand names in Europe that include Reductil.

How to Proceed in Finding a Meridia Side Effects Lawyer

While the EMA has no jurisdiction over the United States, the fact that it has recommended that people stop using Meridia is certainly evidence that the drug presents the possibility of developing dangerous Meridia side effects.  If you or someone you love has been harmed as a result of using this drug, you need to contact the Meridia side effects lawyers at Phillips Webster as soon as possible to schedule a free initial consultation.

Tags: , , , , , , ,
Posted in Defective Drugs

More Scrutiny Fixed on Yaz and Yasmin

Bayer Healthcare, Deep Vein Thrombosis, DVT, FDA, misleading advertising, pulmonary embolisms, quality control, Yasmin, Yaz, Yaz lawyers

September 28th, 2009: Washington Law Blogger

Yaz and Yasmin are two birth control products manufactured and sold by Bayer Healtchare, and the company has generated nearly $2 billion in revenue as a result of selling these products based on estimates. While these products are generally similar, they are slightly different in terms of the amount of estrogen in each, which is one of the active ingredients in both formulas. Unfortunately for many women, Yaz and Yasmin have been the target of a high degree of scrutiny in recent years for many reasons, leading to dozens of lawsuits already being filed against Bayer around the country by Yaz lawyers.

There are several reasons for this scrutiny, and they range from advertising issues to alleged manufacturing problems to the development of serious side effects in many women that are extremely serious and can be fatal in certain circumstances. These two side effects are known as Deep Vein Thrombosis (DVT) and pulmonary embolisms. DVT is an otherwise relatively rare condition that involves blood clots forming deep inside the body, usually in the legs. These clots tend to grow and travel to the lungs, and clots in the lungs are known as pulmonary embolisms. Each of these can be fatal if they are not detected early and treated aggressively.

Bayer has also encountered problems on other fronts, the earliest of which that involved these products concerned warnings from the government for potentially false advertising. The advertising at issue portrayed the use of Yaz for the treatment of acne and premenstrual syndrome symptoms. The problems with these claims is that neither use was part of the approval of the drugs and PMS treatment was not an accurate depiction of one of the off-label uses. In response to the warnings received from the FDA, Bayer agreed to pull the advertising campaign and to dedicate $20 million to advertising designed to correct the alleged misinformation.

Finally, just last month, the FDA cited Bayer for potential problems with the manufacturing process involved with the quality control aspect of hormone ingredients. Bayer has answered this citation with a denial, and has also come to the public with the results of a study that concludes that these products are safe. However, it should be noted that Bayer funded this study.

Overall, Yaz and Yasmin have proven to be dangerous for many women who have used them. If you have been harmed as a result of using either Yaz or Yasmin, you need to contact the Yaz lawyers at Phillips & Webster today to schedule a free initial consultation.

Tags: , , , , , , , , ,
Posted in Defective Drugs, Product Liability

The Dangers of Anosmia – Why the Zicam Issue Matters

anosmia, defective drugs attorneys, depression, FDA, gas leaks, injuries, loss of sense of smell, recall, side effects, Zicam

June 18th, 2009: Washington Law Blogger

When people hear about products being recalled and the FDA warning the public to stop using them because of a link to serious side effects, most would assume those side effects are more severe than the loss of the sense of smell. Anosmia, as it’s known in medical circles, is a condition that’s been diagnosed more than 130 times in consumers who had used certain Zicam products, and as a result it’s no longer available in retail outlets around the country.

We’ve been posting about the details of the issues involving Zicam lately, but some are wondering why anosmia is something to be concerned with, when other products have been known to cause cancer and death. However, basic research will tell anyone that the loss of the sense of smell, particularly if it’s permanent, can be a dangerous condition for several reasons.

When someone cannot smell, the most obvious danger it creates is that those people may not be able to sense dangers that include smoke from a fire or poisonous substances or gas leaks. However, there are other problems associated with anosmia, and they are directly correlated with the longer duration of this condition.

Those who cannot smell will often fall into a depression, as they understand that they are physically limited and are also concerned about their lack of ability to detect the dangers described above. Medical experts have also noted that those with anosmia will slowly lose weight as a result of a loss of appetite, and this can create many other medical problems that are high-risk in nature.

Ultimately, anosmia is a serious enough side effect that the FDA ordered the makers of Zicam to stop marketing the product and for Matrixx Initiatives, Inc., the manufacturer, to voluntarily pull the products from the shelves. If you or someone you love has been injured as a result of using Zicam, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Tags: , , , , , , , , ,
Posted in Defective Drugs

Zicam Removed from Retail Shelves

ansomia, attorneys, FDA, injuries, Matrixx Initiatives, recall, side effects, warning, Zicam

June 17th, 2009: Washington Law Blogger

Yesterday, we alerted our readers to the fact that the US Food and Drug Administration (FDA) had issued a public warning regarding the dangers associated with several Zicam products. The agency also delivered a letter to Matrixx Initiatives, Inc. stating that they had to stop marketing these products unless they decided to put them through the normal FDA approval process that’s required of other medications.

Today, Matrixx Initiatives, Inc. responded by voluntarily pulling the products in question from retail shelves across the United States until the matter is resolved. The three specific products within the overall product line that were pulled include:

  • Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
  • Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
  • Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

To reiterate the warning issued by the FDA yesterday, you should immediately stop using these products if you have them in your home.

The reason this issue arose is because the FDA received at least 130 reports of consumers using the Zicam products listed above and developing ansomia, which is the loss of the sense of smell. Consumers reported the development of this side effect soon after use, and while no duration of the condition has been defined, some reported that it took several months for their sense of smell to return.

It’s believed that zinc, one of the ingredients in Zicam products, was the reason for this side effect, as it has been known to create similar problems in people who have been exposed to it in the past. If you or someone you love has been harmed as a result of using Zicam, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

Tags: , , , , , , , ,
Posted in Defective Drugs, Product Liability

Zicam Comes Under Fire From FDA

anosmia, attorneys, Defective Drugs, FDA, injuries, loss of smell, Matrixx Initiatives, US Food and Drug Administration, warning letter, Zicam

June 16th, 2009: Washington Law Blogger

Matrixx Initiatives is a company that manufactures, markets and distributes a product line known as Zicam, which is an over-the-counter product sold to help with the symptoms of the common cold. It’s sold in several forms, including nasal spray and swabs, and at least partially as a result of Zicam’s success, Matrixx Initiatives’ stock price has risen and held steady even in the current marketplace.

However, negative news hit the wire today as the US Food and Drug Administration announced that it has sent a letter to Matrixx Initiatives instructing it to stop marketing Zicam unless the company decides to file an application for a drug approval with the agency to continue to market these products. If the company does so, Zicam will be subject to the same testing and analytical standards as any other medication.

The reason for this letter is that the FDA received at least 130 reports of consumers using Zicam products and developing a condition known in medical circles as anosmia, which is the loss of the sense of smell. Some consumers reported this side effect after only one use, and no duration for this side effect has yet been established. Therefore, the FDA is demanding a closer look at the product and the presence of one ingredient in particular, zinc, which has been linked to this side effect in other contexts.

There were three Zicam products subject to the FDA’s letter:

  • Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
  • Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
  • Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

If you are currently using Zicam products, the FDA advises you to stop doing so. If you or someone you love has been injured as a result of using these products, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Tags: , , , , , , , , ,
Posted in Defective Drugs

Reglan Under Fire from FDA

attorneys, black box warning, Defective Drugs, FDA, injuries, Reglan, side effects

May 7th, 2009: Washington Law Blogger

Reglan is a line of products designed to help people manage and treat their gastrointestinal problems, and it’s sold in several forms. It’s manufactured by Baxter Pharmaceuticals, and for a time it sold very well within its market. Reglan products work by speeding up the movement of the patient’s stomach muscles and thereby shortening the amount of time that food spends in the stomach before emptying into the intestines for additional processing.

However, it recent news has been released that shows that Reglan continues to draw the ire of the US Food and Drug Administration (FDA), and after the FDA had earlier required that a ‘black box’ warning be placed clearly on the labels of all Reglan products, Baxter must now also complete a ‘REMS’ study, which stands for Risk Evaluation and Mitigation Strategy. The study is meant to define whether the risks of allowing Raglan products to remain on the market outweigh the benefits.

The products at issue include:

  • Reglan® Tablets
  • Reglan® Oral Disintegrating Tablets
  • Reglan® Injection
  • Metoclopramide Oral Solution

The side effects that were reported include problems that seem to stem from the central nervous system, including uncontrolled movement of the extremities, lip smacking, grimacing and rapid eye movements. If you or someone you love has been harmed as a result of using Reglan products, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

Tags: , , , , , ,
Posted in Uncategorized

Hydroxycut Products Recalled

attorney, Defective Drugs, defective products, dietary supplements, FDA, Hydroxycut, recall, side effects

May 6th, 2009: Washington Law Blogger

The makers of Hydroxycut announced a recall of 14 products, effective immediately on the heels of scrutiny from the US Food and Drug Administration (FDA). The specific products recalled were:

  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Hardcore Liquid Capsules
  • Hydroxycut Max Liquid Capsules
  • Hydroxycut Regular Drink Packets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural

The products were recalled because of at least 23 reports of serious side effects developing in consumers who purchased more than 9 million containers of it within the past year. The side effects involved serious damage to consumers’ kidneys and livers, and one 19-year-old man died after using Hydroxycut.

Hydroxycut was a popular product line because it marketed itself as a ‘natural weight loss’ solution that used natural products. However, it has yet to be determined which ingredient or ingredients are responsible for these side effects, as the ingredients seem to have changed several times.

If you have been using any of these products, you need to stop using them immediately, as was stated by the FDA. If you’ve been injured as a result of using them, you need to contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Tags: , , , , , , ,
Posted in Defective Drugs, Insurance Company, Product Liability, Train Accident