Facts Sheet on Vioxx, Side Effects, Complications and Litigation

We refer to the earlier article published on our web site dated the 25 th November, 2004. Additional to the information contained in this document, we have discovered more recently that Vioxx litigation worldwide will probably be one of the largest mass torte litigations ever undertaken. Suits in The States are now being brought by many forums for heart attacks, sudden cardiac death, strokes as well as a number of other injuries discussed hereinafter. The litigation driven by the withdrawal of Vioxx worldwide at the end of September, 2004 was an event so sudden that it caught the U.S. Food & Drug Administration (FDA) and other medical professionals by complete surprise. This recall has led to a cascade of events including a review of other drugs known as Cox-2 inhibiting drugs, Bextra and Celebrex.

Vioxx was marketed in Australia from June, 1999 and as previously discussed, approximately 300,000 people have taken the drug regularly.

Cox-2 inhibiting drugs are known as super "aspirin" type drugs which are non-steroidal anti-inflammatory drugs (Nsaids) which allegedly wouldn't cause stomach problems like other pain relieving drugs such as Ibuprofen and Naprosin. It is our understanding that the over the counter pain relief such as Naprosin, Ibuprofen had 2 types of enzymes Cox-1 and Cox-2 and that the Cox-1 caused the gastric (stomach) irritation. The theory was that if the drug only inhibited Cox-2 it would greatly reduce the gastric side effects and of course, wouldn't add any new problems such as Vioxx also known as Rofecoxib. It turns out that there may have been an incorrect assumption from the research that is currently being published in that the specialised drugs Vioxx still causes stomach problems and more importantly the use of Vioxx to inhibit Cox-2 enzymes without simultaneously inhibiting Cox-1 leads to clotting of blood which ultimately gives rise to the numerous and serious side effects being the basis for the litigation.

Arguably, inhibiting Cox-2 allows a pro-thrombotic factor called "Thromboxane" to increase whereas alone Cox-1 to remain unrestrained stop this prostacycim whose job it is to inhibit platelet aggregation thus the balance in users was switch towards plotting by use of the Vioxx.

One of the major side effects is in relation to heart and stroke cases where a clot forms in either the heart or brain region which blocks the arteries and leads to ischemia (loss of blood due to mechanical obstruction) beyond that point. This may occur often with people who are predisposed to such a problem such as older people or those with heart disease. The person may have a heart attack and ultimately require open surgery and/or stents placed.

Some of the other major side effects apart from stroke and heart attack are as follows:-

• deep vein thrombosis and pulmonary embolism;
• clotting on the venous side;
• clots in the arteries leading to the legs;
• angina;
• hypertension;
• gastric problems;
• serious ulcers etc;
• kidney problems.

Whilst the criteria for determining who may have a claim vary greatly, the most recent information suggests that the following issues are important:-

(a) length of use - Merck has intimated that you need to be on the drug for at least 18 months to have side effects but objective studies show that clotting may occur much earlier within the first 9 months or even less;

(b) dosage - Merck has implied the problem only exists with daily dosages of above 25 milligrams but studies also show otherwise and yet to be clarified;

(c) length and effect;

(d) it is unresolved how long the clotting potentially exists in Vioxx users. Many feel that a good case is one where side effects occur while he is still on the drug or within a few days of going off it although arguably if damage is done through narrowing of arteries due to previous build up of clots, quite arguably the drug could have caused the narrowing of the artery ultimately resulting in a heart attack and/or stroke some months or even years later even though a patient had stopped using the drug a significant time earlier.

Since most prescription drug litigation will turn on the risks known to the user such as warnings etc, we would need to examine what warnings if any were given and what warnings were placed on the drugs that were supplied to prospective patients. It is clear that Merck, the manufacturer of Vioxx did not warn that there was a population of users who were more at risk of heart attack and stroke than the average nor did they warn the Doctors prescribing it of its risks.

In fact Merck remarkably advertised directly to the public in the U.S. enticing them to take the drug and that it had a favourable cardio-vascular profile.

Remarkably many prestigious and highly acclaimed medical journals around the world including "The Lancet" editorialised that Merck a hundred billion dollar U.S. firm that manufactured Vioxx had "acted out of ruthless, short sighted and irresponsible self interest" 11 th May, 2004.

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