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.

Paxil® could cause congenital defects in newborns!

September 2009

Paxil® is the trade name for Paroxetine. This can be considered a drug in the class of a selective serotonin reuptake inhibitor (SSRI), in simple terms, an anti-depressant. It was the first anti-depressant in the USA that received formal approval to treat panic attacks. Pharmaceutical giant GlaxoSmithKline started marketing this drug in 1992 to treat acute depression, Obsessive Compulsive Disorders (OCD), social phobia, panic, anxiety and so on.

Paxil® Side Effects

Paxil® side effects have been linked to heart problems in newborns. Two studies by the American College of Obstetricians and Gynecologists published in 2006 pointed out that that use of Paxil® during pregnancy could cause cardiac fetal heart defects, some of which require surgical intervention.

A ventricular septal defect (VSD) affects the ventricular septum, the wall that separates the left and right ventricles of the heart.  Atrial septal defects (ASD) affect the interatrial septum of the heart, the critical tissue separating the right and left atria. A defect in the septum or lack of it makes it impossible for blood to flow from the left to the right of the heart or vice versa. This results in unhealthy mixing of arterial and venous blood. Using Paxil® during pregnancy can also affect fetuses with PPHN (Persistent Pulmonary Hypertension of the Newborn), a dangerous lung disease that can cause heart failure.

FDA & Paxil®

Two studies the FDA had reviewed showed that women who had taken Paxil® in the first trimester of pregnancy increased their risk of giving birth to a child with a heart defect by one and a half to two times. In response, FDA is advising health care professionals to discuss potential risk of birth defects with patients taking Paxil® both those who intend to become pregnant or in their first trimester of pregnancy. It also urges them not to prescribe Paxil® unless other treatment options are inappropriate.

We Can Help

If you were one of those prescribed Paxil® in the first trimester, and if your newborn has a heart defect, you are potentially entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Levaquin® can lead to severe tendon injuries!

September 2009

Levoflaxin is available under the brand name Levaquin® and manufactured by Ortho-McNeil-Janssen Pharmaceutical. This is a powerful quinolone antibiotic prescribed in the treatment of bacterial infections of the sinus, skin, kidney, lungs or urinary tract.

Side effects of Levaquin®

Levaquin® is routinely prescribed, but it can lead to severe side effects.

The major side effect of Levaquin® usage is that it can severely affect tendons. This includes tendonitis, an inflammation of the tendon which is not restricted to any particular part of the body but can occur anywhere and is extremely painful. The most common are Achilles tendonitis, which affects the heel, and patellar tendonitis, which affects the knee. A torn tendon is another possible side effect, causing extreme levels of pain that may even leave a patient permanently disabled. Tendon side effects may not cease once usage of the drug is stopped, and they can last for months after.

The other side effects that could appear are skin rash, hives, skin allergies, heartbeat irregularities, problems with swallowing or breathing, and swelling of areas like the face, lips, tongue or throat. It can affect the nervous system too, manifesting as nerve pain, numbness, weakness, tingling sensations and so on.

FDA & Levaquin®

The FDA has insisted on a boxed warning. It also released the following health alert in October 2008, “Fluoroquinolones, including Levaquin, are associated with an increased risk of tendonitis and tendon rupture in all ages. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levaquin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendonitis or tendon rupture, and to contact their health-care provider regarding changing to a non-quinolone antimicrobial drug.”

Contact Us

If you find that you and your loved ones have had serious tendon injuries linked to the usage of Levaquin®, you could be legally entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information, at 866-529-0001, Extension 245.

Accutane can cause severe bowel disorders!

September 2009

The drug isotretinoin is marketed under the brand name Accutane. This drug is usually prescribed for those suffering from severe acne. Discovered in 1979, this produced dramatic results on acne-affected skin making it popular amongst patients. However, what they failed to realize was that this drug also brought with it a share of potentially dangerous side effects. This drug which was once the second largest seller amongst drugs from Roche was withdrawn from the market after the large number of cases filed against it on grounds of personal injury.

Accutane Side Effects

Recent studies have also identified that Accutane could have side effects like Crohn’s disease and ulcerative colitis. Crohn’s diseases shows up with symptoms like abdominal discomfort, cramps and diarrhea. Ulcerative colitis involves side-effects such as abdominal discomfort, cramps, rectal bleeding, and bloody diarrhea. These side effects could continue even after usage of Accutane is discontinued.

Accutane has also been known to sometimes cause severe headaches, vision problems, vomiting, dizziness, nausea, seizures, stroke and muscle weakness as well. Depression and serious mental health problems have also been experienced by some patients. And what’s even worse is that this could take one to the brink of suicide.

FDA & Accutane

The FDA has launched a web page that warns users against buying isotretinoin online. It also states that ` All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.’.

The Law & Accutane

If you or your family have fallen victim to Accutane side effects, it is important that you consult with a legal professional immediately. You may be entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001, Extension 245.

Levaquin, Flouroquinolones and Seeing Double: New Research

September 2009

A father and son research team has published an article in this month’s journal Opthamology that examines a possible causal link between flouroquinolone antibiotics and double vision.

Noting a pattern of eye problems associated with the drugs, Dr. Frederick W. Fraufelder and Dr. Frederick T. Fraunfelder compiled ‘spontaneous’ event reports related to the drugs from a variety of sources, including the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, and the FDA.

171 event reports of diplopia (double vision) were linked to flouroquinolones, drugs widely used to treat infections, and with a list of side effects that gets longer by the day – the most oft-noted one being tendinitis and tendon rupture, linked with the flouroquinolone Levaquin.

At this point the reason why the diplopia occurs is not proven; the researchers said it could be that the drug affects the tendons controlling the eye, interfering with the ability to focus.

However, “According to the World Health Organization criteria, the relationship between flouroquinolone therapy and diplopia is possible.”

The total number of cases may seem small, but in Thomas Maugh’s L.A. Times blog entry he says “…experts note that fewer than 10% of such complications are routinely reported to monitoring bodies.”

Here are the stats on the cases studied: 75 were related to Cipro, 9 to Tequin, 20 to Levaquin, 16 to Avelox, 11 to Noroxin, and 40 to Floxin, with the numbers across the board in proportion to the prescriptions written.

The flouroquinolone drug was stopped in 53 of the cases, and in all of these the double vision stopped and normal vision came back. There were, additionally, five subjects where the patient was given the drug a second time and experienced double vision a second time.

The outcome of all this?

“Doctors need to be aware of this potential reaction when prescribing these antibiotics and consider stopping therapy if diplopia occurs,” Dr. Fraunfelder said.

If you have any questions or concerns about side-effects you or a loved one may have experienced with the flouroquinolone drug Levaquin, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

Why Accutane was Withdrawn: The Bloomberg Article

September 2009

On June 26, 2009, Roche Holding AG pulled Accutane, the acne drug, from the U.S. market. Bloomberg reporters Jef Feeley and Sophia Pearson filed an article that day that has been cited many times and is excerpted here.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.”

The article goes on to say that Accutane went on the market in 1982, and until the patent expired (in 2002) it was taken by approximately 13 million people and netted the drug firm its second-highest sales.

The boom is over; a company representative told Bloomberg that Roche’s market share for Accutane by prescription is now below 5 percent.

Bloomberg communicated with Shelley Rosenstock, a spokeswoman for Roche’s Nutley, New Jersey-based U.S. unit, who said in an e-mailed statement that Accutane’s safety wasn’t part of the decision to yank it off the U.S. market. She said Accutane has also been withdrawn in 11 other countries, including France, Denmark, Austria, Germany, Portugal, Norway and Spain.

“Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” she said in the statement.

At the time the Bloomberg article was written, Roche faced as many as 5,000 personal-injury claims over Accutane.

If you have any questions or concerns about side-effects you or a loved one may have experienced with Accutane, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

People’s Pharmacy warns of the Dangers of Reglan

September 2009

Big banner headline in my local newspaper on Tuesday morning, page 5E:
“Long-term side-effects warning on metoclopramide”, it exclaimed in no uncertain terms.

It was the King Features Syndicate Column People’s Pharmacy, written by Joe and Teresa Graedon, devoted to the subject of alternative health care. A woman had written a letter in order to warn readers about the dangers of Reglan. She begins:

“A dear friend was put on Reglan for acid stomach and left on the drug for nine years. The therapy is only supposed to last a few weeks. She now has tardive dyskinesia. Her tongue is enlarged, and she can no longer speak properly. The side effects did not go away when the drug was stopped. Is there anything that can help her? Please warn your readers about Reglan.”

My first thought was, she needs to find herself a good lawyer.

Here is the People’s Pharmacy reply to the letter:

“Answer: Reglan (metoclopramide) was first approved for use in the U.S. in 1980. It is prescribed for digestive-tract problems such as reflux, delayed stomach emptying, and nausea. Although doctors were warned early on that this drug could cause a neurological disorder, it took the Food and Drug Administration almost 40 years to issue a black-box warning about this complication.

On Feb. 26, 2009, the agency cautioned about metoclopramide: “Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment has stopped.”

That friend needs to know about her legal options; if I had been there I would have cleared my throat and said, well, there is Mulligan Law…

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 the possible link of Reglan® to Tardive Dyskinesia. If you or a loved one has been seriously injured or even died after taking Reglan ®, it is important that you consult with a legal professional immediately. The Mulligan Law Firm has experienced lawyers standing by to help you.

We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not delay, as your rights and compensation may be lost forever if you wait.

Zimmer Durom Cup: Quotes from the FDA Recall Packet

September 2009

Zimmer Holdings suspended sales of the Durom® Cup in July 2008, after the alleged failure of the implant required additional surgeries.

The same product had been very successfully used in hip replacement surgeries since 2001, in international markets.

So what happened?

Zimmer alleges that the problem was that the doctors installing the cup were not properly trained, and needed additional workshops.

I would like to call your attention to the FDA Durom Cup Recall Packet, dated September 26th, 2007, 162 pages, PDF readily available online, loaded with information.

The recall packet starts with another problem, and it is an interesting one:

Page One
The recall packet begins with a product recall dated September 26th, 2007 – it states,
“Zimmer GmbH is initiating a product recall of the DUROM Femoral Component 54 Code T and the Femoral Component 46 Code L…. This action is being conducted because some products of the above mentioned lot have been mixed up during packaging. The packaging for the 54 mm implant from this lot may contain a 46 mm implant and vice versa.”

Page Five
“Description of event: The packaging contains the incorrect device. In packages labeled for the 54mm, there is a 46 mm and vice versa.”

“…it was determined that inadequate work instruction and line clearance activities were the primary root causes. A risk analysis from this investigation was developed leading to a corrective and preventive action plan.”

Page Fourteen – Fifteen (from the Health Hazard Analysis Section)

“Discoverability: There is a very high degree of probability that a misidentified femoral component can be discovered by the end user when opened in surgery. The size difference for the two components is 8mm for both the outer diameter and the inner diameter of the sphere. The misidentified product would be removed from the package after the femoral bone cuts have already been made…

“… a 46mm implant coming out of the 54 mm packaging would be discovered as it has an inner dimension of 39.4mm and would not fit on a bony stump prepared for a 54mm implant.

…a 54mm implant coming out of the 46mm packaging would be discovered as it has an inner dimension of 47.4 and would be grossly loose if placed on bony stump prepared for a 46mm implant.”

Page Seventeen
“To upsize or downsize 2mm the femoral head. To downsize he would have to remove more femoral bone. To upsize he would have to apply a thicker cement mantle to fit the bone cut for a 46mm. In either case, the fit in the natural acetabulum would not be ideal.”

At the bottom of the page,
“Outcome 4: It is an extremely remote probability that an end user would not notice the 8mm difference in the implants. A large mismatch between the femoral head and the acetabular surface (natural or implant) would occur leading to instability, patient pain, compromised leg length, and certain revision surgery. Again, this is considered remote in probability.”

On page 21 the FDA says it agrees with Zimmer’s action to recall because of mislabeling, because otherwise they’d have to start legal action to remove it from the market. They go on to say:

“These recalls have been classified by the FDA as Class II recalls, since FDA considers these devices to be adulterated and/or misbranded. This device presents a moderate risk of adverse health consequences. Our evaluation indicates that your submitted recall plan is adequate.”

Press releases from Zimmer immediately follow, and never again do we hear about a mislabeled, mispackaged, or wrong sized product.

Suddenly it’s all about training doctors.

Page Twenty-Eight
“All monoblock metal-on-metal acetabular cups are recognized as technically challenging devices to implant.”

Page Twenty-Nine
“However, Zimmer does recognize this is a challenging procedure and thus is strongly recommending surgeons seek further training before attempting further Durom Cup implantations.”

If you have any questions or concerns about problems you or a loved one may have experienced with the Zimmer Durom Hip Replacement Cup, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

Contraceptive Yaz® /Yasmin® Usage Could Lead to Hyperkalemia

September 2009

Yaz® /Yasmin® is a relatively new contraceptive manufactured by pharmaceutical giant Bayer Corp. The pills became very popular in the US, at least partly due to aggressive marketing strategies. Besides contraception, this drug is also being prescribed to treat conditions like premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).

Yaz® /Yasmin® are fourth generation combination birth control pills. Yaz® is to be taken on a 24/4 day cycle, a departure from the usual 21/7 day cycle. Yasmin® is taken on the more traditional 21/7 cycle.

Yaz® /Yasmin® Side Effects

The composition of Yaz® /Yasmin® includes a new type of synthetic progestin called drospirenone. This could cause a dangerous increase in the potassium levels, a condition known as hyperkalemia.

Hyperkalemia could cause heart arrythmias which means the irregular beating of the heart, cardiac arrest which can prove fatal and changes in the nerves or neuromuscular system. Possible side effects of using Yaz® /Yasmin® also include strokes, blood clots, pulmonary embolisms, liver failure, kidney failure, organ failure, pancreatis and so on.

Yaz® /Yasmin® & the FDA

The FDA has sent Bayer a warning letter referring to the misleading claims it has made in its promotional material. It states that they make references and /or suggestions about the efficacy of Yaz® but fail to communicate any risk information associated with the use of these drugs.

Yaz® /Yasmin® Lawsuits
If you or a member of your family have taken Yaz® and have been affected by side-effects due to hyperkalemia (high blood potassium), you might be entitled to compensation. This is the right time to find out whether you will be eligible or not. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245

Hyperkalemia and Yaz®: Additional Risks Explained

September 2009

Some of the most serious side-effects of Yaz®/Yasmin® deal with heart problems.
What follows is a discussion of how medication-induced levels of high potassium (a condition known as hyperkalemia) can cause cardiac arrhythmia or arrest.

“Moreover, YAZ has additional risks because it contains the progestin, drospirenone. Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems.”
From the 2008 FDA Warning letter to Bayer Pharmaceuticals, the manufacturer of Yaz® and Yasmin®.

What is Hyperkalemia?

Hyperkalemia is the scientific term for high potassium levels in the blood. Potassium is a vital contributor to muscle contractions, regulating muscle activity. It also plays an important role in digestion, metabolism, and homeostasis (the electrical/chemical balance of the body).

Main causes of elevated blood potassium are:

• Ineffective elimination, due to kidney or adrenal problems.
• Excessive production, as in taking a medication that increases Potassium levels.
• Potassium held in the cells sifting into the blood

Normally potassium comes in through the food we eat, and the kidneys remove the excess potassium from the body through urination. When the kidneys don’t work well, potassium builds up, and hyperkalemia occurs. Potassium can also build up from an excessive release of potassium from the cells into the bloodstream, triggered by other factors such as tissue traumas (burns are an example.).

Hyperkalemia can be very temporary, or it can be an ongoing, very serious condition. In some people it causes deadly complications; in others it is tolerated and barely noticed.

Heart Problems and Hyperkalemia
The heart is our main muscle, beating with regular contractions, and potassium plays a vital role in the regulation of heartbeat. Too much potassium (hyperkalemia) is a medical emergency because it can throw the heart rhythm off, and cardiac arrest can occur as a result.

Cardiac arrhythmia is defined as is abnormal electrical activity in the heart. The heart beat may be too fast or too slow, regular or irregular. Often hyperkalemia is detected after the fact, once the person is hospitalized with cardiac arrhythmia or has died.

When to Seek Medical Help
Hyperkalemia can have no symptoms at all; some patients report

• Fatigue
• Nausea
• Muscle weakness
• Tingling sensations

More serious symptoms include:

• Breathing pattern changes
• Unconsciousness
• Arrhythmia
• Cardiac arrest

If you suspect you may have hyperkalemia, please consult with your physician immediately so that your blood potassium can be checked and risk assessed.
If you or a loved one have taken Yaz® or Yasmine® and have experienced any of these heart problems, contact Eric W. Gruenwald, Attorney/Lawyer for more information at 866-529-0001, Extension 245.
The Mulligan Law Firm is a national law firm located in Dallas, Texas who provides 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, and they are currently investigating injury claims involving Yaz® and Yasmin®.