Archive for September, 2009

The Acne Drug Accutane® has been Potentially Linked to Inflammatory Bowel Disease, Crohn’s Disease, and Ulcerative Colitis

September 2009

Along with other side-effects, Accutane® is suspected as a possible cause of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Even after treatment with Accutane has been discontinued, these serious digestive disorders can persist.

If someone has taken the acne medication Accutane and is now diagnosed with Crohn’s disease or Ulcerative colitis, they may be entitled to compensation. Contact the Mulligan Law Firm at www.mulliganlaw.com

Dallas, TX September 30, 2009 — Accutane (also known as Isotretinoin) has been used by about 13 million people since it first became available in 1982. Its primary use is for the treatment of severe nodular acne, in patients who fail to respond to other acne treatments such as antibiotics.

Accutane works by reducing the amount of oil released by oil-glands in the skin, and helps the skin to renew itself. It was Roche’s second-biggest selling drug until the patent expired in 2003, at which time generic versions could be sold.

Potential Side Effects of Accutane: Inflammatory Bowel Disease (IBD)
Inflammatory Bowel Disease (IBD) is defined as a group of inflammatory conditions of the colon and small intestine. The main forms of IBD are Crohn’s disease and ulcerative colitis. While the diseases have features in common, there are important differences.

Ulcerative colitis causes inflammation and sores (ulcers) in the lining of the rectum and colon. The sores form when inflammation has killed the cells that line the colon, which then bleed and produce pus. The main symptom of the disease is recurrent diarrhea mixed with blood. Mucus may also appear in the stool if the lining of the colon is damaged.

Crohn’s disease causes deeper inflammation than Ulcerative Colitis. It can potentially affect other parts of the digestive system, including the small intestine, anus, esophagus, mouth and stomach.

While Crohn’s disease has no known cure, ulcerative colitis can often be cured by surgery, but surgical removal of the large intestine and/or colon are as permanent and life-changing as the disease itself

About The Mulligan Law Firm
The Mulligan Law Firm is a national law firm located in Dallas, Texas, providing information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995.

The Mulligan Law Firm is currently investigating injury claims involving Accutane’s possible role in inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis. Someone who has been seriously injured after taking Accutane should consult with a legal professional immediately, and the Mulligan Firm has experienced lawyers ready to help. Contact Eric Gruenwald, Lawyer/Attorney or Attorney/Lawyer at 866-529-0001, EXT 245.

All cases are taken on a contingency-fee basis, which means the prospective client does not pay for our services unless an award or compensation is received.

The Mulligan Law Firm is Investigating Injury Claims: Acne Drug Accutane® has been linked to Inflammatory Bowel Disease, and Other Serious Side-Effects

September 2009

The Mulligan Law Firm is currently investigating injury claims involving Accutane’s possible role in inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis.

Someone who has been seriously injured after taking Accutane should consult with a legal professional immediately. The Mulligan Law Firm has experienced lawyers standing by to help them.

Dallas, TX September 30, 2009 — The Mulligan Law Firm is a national law firm located in Dallas, Texas, providing information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995.

The Mulligan Law Firm is currently investigating injury claims involving Accutane’s possible role in inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis. Someone who has been seriously injured after taking Accutane should consult with a legal professional immediately. The Mulligan Firm has experienced lawyers standing by to help them. Contact Eric Gruenwald, Lawyer/Attorney or Attorney/Lawyer at 866-529-0001, EXT 245.

Along with other side-effects, Accutane® is suspected as a possible cause of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Even after treatment with Accutane has been discontinued, these serious digestive disorders can persist. While Crohn’s disease has no known cure, ulcerative colitis can often be cured by surgery, but surgical removal of the large intestine and/or colon are as permanent and life-changing as the disease itself.

In the United States, several jury trials have awarded at least $33 million dollars to patients as compensation for injuries attributed to Accutane use. The total number of claims against Roche Holding Ltd., the maker of Accutane, is believed to exceed 5,000, with at least 425 injury cases pending.

After the outcome of these jury trials, Roche Pharmaceuticals notified the FDA that they were immediately discontinuing the distribution and manufacture of Accutane in the United States. One of the reasons given by Roche for the decision: the high cost of personal-injury lawsuits.

The Mulligan Law Firm takes all cases on a contingency-fee basis, which means the prospective client does not pay for our services unless an award or compensation is received.

About Accutane
Accutane (also known as Isotretinoin) has been used by about 13 million people since it first became available in 1982. Its primary use is for the treatment of severe nodular acne, in patients who fail to respond to other acne treatments such as antibiotics.

Accutane works by reducing the amount of oil released by oil-glands in the skin, and helps the skin to renew itself. Accutane was Roche’s second-biggest selling drug until the patent expired in 2003, at which time generic versions could be sold.

The names of these generic versions of Isotretinoin/Acutane are Amnesteem®, Claravis™, Clarus™, Decutan, Isotane, Izotek, Oratane®, Sotret®, Isotrex®, and Isotrexin®.

Avandia® linked to Congestive Heart Failure, Heart Attacks & Fractures

September 2009

Avandia® or rosiglitazone maleate is a prescription drug for diabetics. Manufactured by GlaxoSmithKline, this is specifically used to treat Type II diabetes or non-insulin dependent diabetes. The drug works by helping to control blood sugar levels.

Side Effects of Avandia®
Some of the common side effects resulting from the use of Avandia® are headaches, weight gain, back pain, anemia, broken bones, and increased susceptibility to bruising. The more severe side effects are congestive heart failure and heart attacks. Congestive heart failure can be fatal as the heart will be unable to pump well enough to meet the body’s demand for oxygen. Heart failure symptoms include breathlessness, difficulty in breathing, chest pain, and swelling of the extremities. Heart attacks can also be caused by this drug.

Those who have increased vulnerability to side effects arising from Avandia® use are patients with cardiovascular disease, diabetes-related eye problems, liver disease, and stroke.

FDA & Avandia®
An FDA Alert on 19th November, 2007 called for Avandia®’s manufacturer to modify the prescribing information for rosiglitazone (Avandia®) including a new Boxed Warning. It also called for changes to the label stating the potential increased risk of myocardial ischemia. FDA also requested the manufacturer to create a Medication Guide for patient use that would contain guidelines on the use of rosiglitazone.

On 14th August,2007, FDA announced yet another alert. It called for a new Boxed Warning on Avandia®. It also asked them to update the content under Warnings, Precautions and Contraindications stressing that rosiglitazone could cause or exacerbate heart failure, especially in certain patients. Never stop any medication, including Avandia®, unless under the specific directions of your fully informed and licensed physician / medical doctor

The Law & Avandia®
If you or your loved ones have used Avandia and suffered from side effects like congestive heart failure or heart attacks, you could be entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Zimmer Durom® Cup can cause major hip complications

September 2009

The Zimmer Durom® Cup is an artificial hip component used in hip replacement surgeries. It has been used in Total Hip Arthroplasty (THA) surgeries in the USA and overseas for hip resurfacings. Manufactured by Zimmer Holdings Ltd, it is a solid metal cup made from cobalt chromium alloy and sprayed with a titanium plasma-sprayed coating. It was introduced in 2006 and has been implanted in an estimated 12,000 patients.

Side Effects of the Zimmer Durom® Cup
The side effects reported with the Zimmer Durom® Cup were blood clots, infections, changing of leg length, feeling of the leg giving away, difficulty in climbing, pain in the groin, joint stiffening, loosening of the cup causing pain or even breakage of the Durom® cup inside the body. Many have been forced to have revision or additional surgery done to correct the problem. Usually, symptoms appeared after 90 days of surgery or more.

FDA & the Zimmer Durom® Cup
The Zimmer Durom® Cup was approved by the FDA in 2006. Later, Zimmer found itself under mounting FDA pressure, and on July 22, 2008,  temporarily suspended marketing and distribution of the device.

It also sent a letter to U.S. orthopedic surgeons asking them to stop using this product. However, this seemed just a cosmetic initiative as it later resumed sales shifting the blame onto surgical error for the problems.

Who We Are
Have you or your loved ones faced hip complications as a result of using the Zimmer Durom® Cup? Don’t wait, you could be potentially entitled to compensation.
Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Fen-Phen Years Ago equals echocardiogram now: Subtle symptoms, hidden damage

September 2009

Fen-Phen was everywhere in the mid nineties. It was the gold standard for obesity treatment, prescribed by weight-loss clinics and M.D.s alike, and widely available through mail order.

The patented drugs used in the Fen-Phen “off label” combination were Pondimin® and Redux®; in 1996 the two drugs made $300 million for their manufacturer, American Home Products, now Wyeth Pharmaceuticals.

As more people used Pondimin® and Redux®, the list of negative reports and studies of serious side effects began to grow longer, and in 1997 both drugs were withdrawn from the US market.

This was over ten years ago.

The problems caused by the drugs were very significant; in the New England Journal of Medicine article that broke the story, Dr. Heidi Connelly of the Mayo Clinic published a study where valvular heart disease and primary pulmonary hypertension (PPH) were identified in 24 women treated with Fen-Phen who had no previous history of heart problems.

Then the FDA became involved, and in a further study 30 percent of the patients being evaluated had significantly abnormal echocardiograms.

These patients reported a total lack of physical symptoms. They had suffered damage, significant damage, but there was no sign.

What was true then could also be true today – heart disease is known as the ‘silent killer’ – and for many people, especially women, the first sign of heart disease from whatever cause might be a massive heart attack.

If you took Fen-Phen back when, for any amount of time, and you have not been evaluated for heart damage, it is important to have an echocardiogram done. The damage done by the drug combination may not be detectable by physical symptoms.

The other major Fen-Phen side-effect, Primary Pulmonary Hypertension (PPH), does have reported symptoms, though they can be subtle in that they are also the symptoms of obesity.

The American Heart Association’s PPH website says that: “One of the great difficulties in treating PPH is that the diagnosis is often delayed due to the slowly progressive and insidious onset of the symptoms.”

Look for tiredness and fatigue, breathing difficulty, fainting spells or dizziness. In later stages of primary pulmonary hypertension there is swelling of the lower extremities, a bluish cast to the skin, chest pain, and coughing up blood.

Take Note

If you or a loved one have taken the Fen-Phen combination weight loss drug, contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com. The consultation is free of charge, and all cases are taken on a contingency-fee basis – you do not pay for any services unless you receive an award or compensation.

Fen-Phen linked to deadly primary pulmonary hypertension (PPH)

September 2009

Fen-Phen was an anti-obesity medication that became very popular in the 1990`s. In fact, in 1996 and 1997, over 6 million people were on this drug which was a cocktail of two drugs fenfluramine and phentermine. It claimed to be a wonder drug that curbed appetite by significantly altering the glucose (sugar) consumption by body tissues.

Side Effects of Fen-Phen

The usage of Fen-Phen can lead to a serious and potential life threatening cardiovascular disorder called primary pulmonary hypertension (PPH). In PPH the blood pressure in the pulmonary artery rises enough to put strain on the heart. The heart has to work much harder, and the result can be symptoms like dizziness, breathlessness, fainting, fatigue, chest pain, and even heart failure.

A study published in the New England Journal of Medicine in August 1996 revealed that the use of Fen-Phen® for a period of three months or longer can result in a twenty-three fold increase in the risk of developing primary pulmonary hypertension (PPH).

Fen-Phen & FDA

In July 1997, 24 cases of rare valvular disease were identified in women who took Fen-Phen by researchers at the Mayo Clinic and Mayo Foundation. The FDA immediately alerted medical doctors since it had received nine more reports to the same effect.

Following this, the, FDA received 66 additional reports of heart valve disease linked mainly to Fen-Phen usage. The reports flowed in continuously and in September 1997, this drug was recalled by the FDA.

Fen-Phen & the Law

If you or your loved ones have used Fen-Phen and faced PPH problems, you could be potentially entitled to receive compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Calaxo® Bone Screw Update

September 2009

Manufactured by Smith & Nephew, the Calaxo® screw (officially known as the Calaxo Bioabsorbable Interference Screw) was approved by the FDA and first made available for use in the U.S. in March of 2006. As soon as the screw began to be used in ACL (anterior cruciate ligament) knee surgery, reports began to come in about the Calaxo® screws breaking inside the body and causing severe knee pain.

The last FDA word on the Calaxo® Screw was in the March 26, 2008 FDA Weekly Enforcement Report. In it the FDA details the recall under RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II.

Here follows the FDA Enforcement Report for March 26, 2008:

Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

PRODUCT
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw (all the different sizes detailed)
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007.
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
REASON
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
VOLUME OF PRODUCT IN COMMERCE
68,285 units
DISTRIBUTION
Nationwide and Internationally

Comments on the listing above
In this short listing, the story is told. The manufacturer, Smith & Nephew, Inc, and the Endoscopy manufacturing division, located in Mansfield, MA, initiated a recall by letter on August 21 and then again on August 23, 2007. The company itself initiated the recall and the recall is ongoing.

Three reasons for the recall are given here:

First is mention of a post operative fluid pocket, fluid that in some cases built up in the body reaction to the implanted screw after surgery.

Additionally listed is “the potential for graft failure”, which could be talking about the side effect of infected or dead tissue or bone that has to be surgically removed (a process known as debridement).

The final mentioned reason, “premature material degradation”, means that in some cases the screws broke into pieces and had to be surgically removed

The number of units recalled is now known to be exactly 68,285 units.

The final note was that the Calaxo screw had been distributed both nationally and internationally – there is no mention of what other countries might have been affected, or what proportion of screws were distributed in the US versus abroad.

In any case, if you have reason to suspect that you or a loved one were implanted with one of these Calaxo Bioabsorbable Interference Screws in ACL surgery, surgery that almost certainly took place between March 2006 and November 2007, you may be entitled to compensation.

Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245, or by email at help@mulliganlaw.com for a free consultation.

The Chronicles of Avandia®: Heart Disease Warnings in May of 2007, and thereafter

September 2009

Avandia® has been on the market since 1999, and it has been a hugely popular diabetic drug, controlling blood sugar by the increase of insulin sensitivity. Usually used in tandem with other diabetes drugs, Avandia® was heavily marketed and netted $3.4 billion for manufacturer GlaxoSmithKLine in 2006.

Then came an article published in the New England Journal of Medicine in May of 2007, estimating that Avandia® users faced a 43 percent higher risk of heart attack or cardiovascular event. The article made a huge impression. GlaxoSmithKLine disputed the findings, which were also the subject of much internal dispute within the FDA.

The Food and Drug Administration convened a special meeting to monitor Avandia’s safety risks on July 30, 2007 in Gaithersburg, Md. The finding of the panel was to leave the drug on the market, and on November 14, 2007 a boxed warning was added to Avandia®. The press release says, “Agency says drug to remain on market while safety assessment continues”.

Patients with diabetes already have increased potential for heart disease; it’s a known result of the condition. The American Diabetes Association says that 2 out of 3 people with diabetes die from heart disease and stroke. If you were prescribed Avandia you have been potentially subjected to even higher risks of heart disease.

If you or a loved one have taken Avandia® and have experienced heart attacks or heart disease, or a significant worsening of an already existing cardiac condition, or if someone you know has died as a result of taking Avandia®, contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com The consultation is free of charge.

Excerpts from the November 14 Warning:

FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia
Agency says drug to remain on market, while safety assessment continues
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia…

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Persistent Pulmonary Hypertension of the Newborn: The Ongoing Study of the role of Paxil® and the other SSRIs

September 2009

A baby in the womb does not need to breathe.
Oxygen comes in through the umbilical cord, and while in the uterus, a baby’s circulation bypasses the lungs. When the birth is normal, the baby is born and begins to breathe air and the until-then unused circulatory system ‘wakes up’ and quickly adapts to the new conditions outside the womb. The air is breathed in and the lungs inflate. 

Persistent Pulmonary Hypertension (PPHN): The circulatory system of the baby does not switch to “Breathe” mode.
What happens with Persistent Pulmonary Hypertension is that the circulatory system of the baby does not switch over to now take oxygen from the lungs, and the baby’s blood flow continues to bypass the lungs. The baby breathes, but the oxygen does not reach the bloodstream, and the organs quickly become stressed from lack of oxygen.

What are the Symptoms of Persistent Pulmonary Hypertension?

  • cyanosis – the skin has a blue tinge even with additional oxygen
  • difficulty breathing; flared nostrils of grunting
  • tachypnea – rapid breathing
  • elevated heart rate

PPHN is not common; it occurs in an estimated one out of each 700 births, often as an isolated condition appearing from the time of birth until about twelve hours after birth.

How is the depression/anxiety medication Paxil® implicated in Persistent Pulmonary Hypertension?
As the result of clinical studies, the FDA issued an alert:

Paroxetine (marketed as Paxil®)
FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet)… Neonatal PPHN is associated with significant morbidity and mortality … The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

Considerations: (also from the alert) Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.

SSRI Drug Names: Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine), Symbyax (olanzepine/fluoxetine), Zoloft (sertraline).

Never stop any medication unless under the specific directions of your fully informed and licensed physician / medical doctor.  As the FDA alert above says, this is a work in progress; the FDA will provide more information as it becomes available and more studies are done. In the meantime, if you or someone you know took Paxil® or one of the SSRI drugs listed above while pregnant, and the baby developed Persistent Pulmonary Hypertension, you may be entitled to compensation. Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com

Calaxo® bone screw can cause debilitating complications

September 2009

The Calaxo® Osteoconductive Interference Screw is commonly known as the Calaxo® Bone Screw and used in knee surgeries. Specifically, these are used in ACL (Anterior Cruciate Ligament) reconstruction and are a replacement for the metal screws that were previously used. Manufactured by Smith & Nephew, Calaxo® is a  bio-absorbable polymer and calcium device. When it was first marketed, many hailed this innovation, little knowing that it could bring side effects with far-reaching consequences.
 
Calaxo® Side Effects
Calaxo® bone screws can create many painful complications for patients. The side effects that these can cause are fever, redness, swelling, fluid build-up, infection and increasing levels of pain at the incision site. Many patients have reported local soft tissue swelling in the tibial area. The worst side effect that has been noticed is that these screws have broken into fragments inside the body and caused excruciating pain. In some cases, patients have had to have them surgically removed. The usual time frame that these side effects have been observed is between 2 and 36 weeks after the ACL reconstructive surgery.
 
FDA & Calaxo®
The FDA approved the Calaxo® screw and it came into usage in March 2006. Almost immediately, there was an alarming increase in reports of complications arising from the use of Calaxo® bone screws. At this, the FDA reacted and issued a recall in August 2007.
 
Calaxo® & The Law
If you or someone you know has been injured due to the usage of the Calaxo® screw, you may have legal rights that entitle you to compensation.
Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.