All drugs are dangerous. Before a person suffering with a migraine headache takes an over-the-counter medication they should be asking the question “Is the possible benefit worth the risk of taking that drug?” William Osler, M.D. once said “The person who takes medicine must recover twice; once from the disease and once from the medicine.” Sadly, this can be all too true.

Dr. William Bennett, head of nephrology at Oregon Health Sciences University, estimates that over-the-counter painkillers are responsible for as many as 20% of the 125,000 cases of end-stage kidney disease in the United States.

Some medications have side effects that can be more serious than the painful migraine headaches themselves. Aspirin can cause internal hemorrhaging, or bleeding in the stomach. According to the Dec. 1996 issue of Health News and Views taking Tylenol once every 4 days increases the chance of liver damage by more than 400%.

The main pain-relief ingredient in Tylenol is acetaminophen which has been shown to cause liver disease. “Tylenol,” as reported in the January 1998 issue of Forbes magazine, “can be very dangerous in doses not much greater” than the recommended dose. In 1989, Lacy Keele, a 5-year-old, took four extra strength tablets in one day, or twice what a child should receive. The overdose destroyed Lacy’s liver. Within a week she was dead. A jury found Tylenol to be a cause in her death.

There have been hundreds of fatalities and serious liver injuries attributed to acetaminophen, Tylenol’s active ingredient, since Lacy’s death. The biggest reason for these deaths is because people “tend to use Tylenol in a casual fashion.” Think about it: You have a migraine headache so you take a few pills. The migraine doesn’t go away so you take a few more. The difference between a proper dose and an overdose is so small that dangerous amounts can easily be ingested accidentally. “No other over-the-counter drug has a more narrow range between therapy and toxicity than acetaminophen,” says Dr. William Lee, a professor of internal medicine at the University of Texas’ Southwestern Medical Center in Dallas.

L.F. Kebler, M.D. once said “Why should a patient swallow a poison because he is ill, or take that which would make a well man sick?” And O.W. Holmes, M.D., Professor of Medicine at Harvard University said “If all the medicine in the world were thrown into the sea, it would be bad for the fish and good for humanity.”

In the September 29, 1996 issue of the Los Angeles Times Magazine it makes it known that Ibuprofen kills thousands every year. Ibuprofen, the active ingredient in many pain relievers, including Advil, Motrin IB, and Nuprin, is known as a non-steroidal anti-inflammatory drug (NSAID). People that take NSAIDs like ibuprofen regularly to ease their chronic migraine headaches are prone to gastric (stomach) disorders. Dr. James F. Fries, a leading arthritis expert and professor of medicine at Stanford University School of Medicine, says “there’s an epidemic of adverse drug reactions to NSAIDs. The FDA believes anywhere from 10,000 to 20,000 deaths each year are the result of severe bleeding caused by NSAIDs. It’s a big problem.”

When taking medication to relieve migraine headaches it’s always a good idea to read the label carefully. If you decide to take pain-killing medications for your migraine headaches be sure to follow the directions. Using common sense can reduce your chances of experiencing adverse reactions.



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One of the most debilitating issues is to develop chronic lower back pain. This kind of pain can limit mobility, sitting, driving, walking and even laying down. Nothing seems comfortable and the longer you are forced to stand, sit or drive, the stiffer and more painful your back becomes until you stand up and everyone around you sees at the bent over version of what used to be you. Images of the old crone come to mind, and you try to stand erect only to yelp in pain. Things are not good, and you need a good pain treatment like Tramadol.

What is Tramadol?

Tramadol is a pain treatment medication for people, like you and I, who suffer chronic lower back pain. Whether your injury is from a lumbar strain or osteoarthritis, if you slump over every time you get out of a car, it is time to talk to your doctor about chronic pain treatments, like Tramadol. This medication is a man-made pain reliever that is not unlike morphine. It binds to the pain receptors in the brain allowing folks like you and me to lead ordinary lives, which means we can sit at a desk, play ball with our children and even ride in a car without undue agony.

What are the Risks and Side Effects?

Like all pain treatments, Tramadol is not without risks and side effects. One of the greatest risks involved with this medication is dependency. Therefore, care must be taken to avoid abuse of this narcotic. Additionally, once a treatment regimen with Tramadol has begun, it is important not to abruptly stop taking the drug. This is because abrupt withdrawal can cause sleeplessness, anxiety, sweating, rigors, pain, and hallucinations.

Further side effects include:

·Nausea

·Constipation

·Dizziness

·Headache

·Vomiting

·Drowsiness

These effects are the ones most commonly reported, but are usually reported as something that comes and goes. In rare cases, a rash, diarrhea, vertigo or vertigo has been reported, so it is good to be aware of any changes after starting a treatment regimen so that you and your doctor can adjust your dosage accordingly.

Back pain treatments, like Tramadol, are not for everyone. However, if you suffer the chronic variety of back pain, and you have reached the point where it has begun to affect your quality of life, then it may well be time to have a discussion with your doctor about pain treatment and Tramadol.



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he meaning of the word “of” when used in a patent? The Federal Circuit Court of Appeals that deal elusive question in a recent dispute between two pharmaceutical manufacturers and expert testimony of great help to find the answer.

But while the court has accepted the advice of experts on the meaning of “approximately” used in the patent, it appeared an about-face and rejected their testimony as to the ultimate question of infringement.

Ortho-McNeil Pharmaceutical brought the lawsuit against the manufacturer of generic drugs-Caraco Pharmaceutical Laboratories, alleging infringement of its U.S. Patent No. 5,336,691. Ortho patent covered a painkiller composed of two well-known analgesics, tramadol and acetaminophen.

The patent has shown that when combined in certain ratios the effects of both drugs were increased. Involved in this case was the claim of the patent No. 6, which involved a composition where the ratio of the material to acetaminophen is tramadol a weight of about 1:5. “

Ortho continued after Caraco filed an application for abbreviated new drug to disclose its plan to manufacture and sell his own composition containing tramadol and acetaminophen. Caraco said the medicine had an average ratio of tramadol to acetaminophen of 1:8.67 and no less than 1:7.5. Ortho Caraco argued that the drug would infringe its patent.

The district court granted the summary trial and Ortho appealed to the Federal Circuit. Both the district court and on appeal, the case focused on the construction of the term “about 1:5.” Ortho argued that covered a radius of at least 1:3.6 to 1:7.1, and that, under the doctrine of equivalents, the wording of Caraco infringed. Caraco argued for a restrictive interpretation.

The district court adopted the construction asserted by Ortho, the “about 1:5″ means “approximately 1:5, encompassing a range of ratios of no more than 1:3.6 to 1:7.1.” He came to this conclusion relying in part on the intrinsic evidence of the application and the specification and in part to the extrinsic evidence of Ortho experts, Dr. Donald R. Stanski and Dr. Eric Smith. The two experts gave the Notice that one of ordinary skill in the art to conclude that “about 1:5″ limitation include a series of reports that would extend to include and 1:7.1.

The Federal Circuit upheld that construction. As the district court, he found support for this construction as in the claim itself and the testimony of the expert Ortho, Dr. Stanski. “Dr. Stanski has estimated that” about 1:5 “means” about 1:5, which includes up to and including 1:7.1 “, noted the court.

Caraco Accepting this construction means that the product did not literally infringe Ortho patent. Ortho patent covered a maximum ratio of 1:7.1, while Caraco started 1:7.5. The question, therefore, became Caraco if the drug under the violation of the doctrine of equivalents.

Building on its experts, Ortho said it did. One expert, Dr. Stanski, said that the weight of 1:8.76 is substantially similar to a weight ratio of 1:5. Another expert, Dr. Smith said in its report that the “degree of synergy of a composition with a weight of tramadol to acetaminophen of 1:5 is identical to the measure of the synergy of a composition with a weight of tramadol to acetaminophen of 1:8.67.

But the district court agreed. It concluded that a finding of infringement by a formulation with an average weight of 1:8.67 would render meaningless “about 1:5″ limitation.

The Federal Circuit affirmed, finding that the 1:5 critical parameter for the invention. Stretching the limits of this parameter Caraco to cover the drug would be in direct conflict with the patent for the express both the claim of 1:1 and 1:5 ratios, the court said.

“In this case, if the ratio of 1:5 of the analgesic response is statistically different from that of other ratios any time,” the court said. “The intrinsic evidence points to the desirability and thus the criticality of the ratio of 1:5 compared to other ratios.”

“Ortho can not now claim that the parameter is sufficiently broad to encompass, through the doctrine of equivalents, the rate outside the confidence interval expressly identified in the patent,” continued the court. “We agree with the district court that eviscerate the limitation.”

For these reasons, the court said, he concluded that the drug Caraco does not infringe Ortho’s patent and that the district court properly granted a summary of non-infringement.

Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd., Case No. 06-1102 (Fed. Cir. January 19, 2007).

Written by Robert Ambrogi for Bullseye, IMS Expert Services Publication

Robert Ambrogi is the editor of Bullseye, a monthly newsletter distributed by IMS Expert Services. IMS Expert Services is the first expert witness consulting and litigation research firm in the legal industry, focused exclusively on providing custom expert witness in search of lawyers.

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Knee pain does not care about your age or your overall health. It does not care how rich or poor you may be either… Sharp knee pain can effect you differently and we will discuss how to help effectively treat this problem in this article, so read on my friend…

Despite the origination of your sharp knee pain, there is one thing in common: It hurts!

Sharp knee pain can stop you in your tracks, put a damper on your activities, and generally decrease your quality of life. What’s more interesting is that sharp knee pain causes can be difficult to identify because numerous factors may be contributing to your discomfort. If you are able to figure out what your sharp knee pain was caused by, then this is a step in the right direction.

Of all the joints in the human body, the knee joint seems to cause the most trouble for most people. In general, 9 out of 10 individuals will indicate that they have suffered from knee pain problems at some point in their lives.

Sharp knee pain causes are often hard to pinpoint because of the inconsistency of the pain. It may come on from time to time, or it may be present for only certain activities. Actually, this seeming inconsistency may hold the key to identifying sharp knee pain causes, so it is important to keep track of when you experience the sharp pain, and what activities you were doing at the time.

Some of the causes of sharp knee pain are self-evident. Sudden injury to the anatomical structures of the knee joint (i.e. twisting the knee) can result in severe knee discomfort. Moreover, trauma to the knee joint(i.e. falling and hitting the knee cap), can result in sharp knee pain issues. On the other hand, some causes of knee discomfort are not always so noticeable. A few of the more common, less obvious causes are as follows:

Arthritis: Arthritis can develop slowly, gradually affecting the mobility of the knee until one day, you begin to experience sharp pain.

Free-Floating Matter: Bits of bone or cartilage can break off within the knee and shift around, interfering with the mechanics of the knee and causing sharp pain.

Chondromalacia: This condition occurs when the cartilage under the knee cap (patella) becomes soft, allowing the knee cap to rub against the bone, causing sharp pain.

Malalignment: The knee joint can become malaligned, forcing the patella out of place and putting extra stress on the muscles and ligaments. This problem, sometimes caused by such simple things as improper gait, bad posture, and overuse, can be a cause of sharp knee pain.

Bursitis or Tendonitis: Sometimes, the bursae (sacs of fluid) around the knee joint, or the tendons within the knee become inflamed, and becomes another of the many knee pain causes.

There are several other causes of intense knee pain. In order to properly diagnose the causes of your knee pain, you need to be evaluated by a qualified medical professional. Still, in the interim, whatever the cause of your knee pain, you may be able to obtain some relief through the use of a well designed knee brace.

In the vast majority of cases, a knee brace can help protect your knee and help alleviate your painful symptoms. Well designed knee supports can come in several different styles, and they are not difficult to use. Some are more rigid (which can be a good thing) with a hinge that prevents excessive painful movements; others are soft, being more flexible in nature.

Regardless of the style or type, knee braces are designed to help support your knee, helping to take the pressure off the joint and thus helping to reduce any inflammation that may be causing discomfort.

Knee braces are also designed to help keep the knee properly aligned, thus helping to prevent sharp pain caused by malalignment while also helping you to avoid traumatic injury.



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The eardrum is a membrane that separates the outer ear from the middle ear. It vibrates when sound waves strike it, and this starts the process that converts the sound wave into a nerve impulse that travels to the brain. When the eardrum is damaged, the hearing process is interrupted. The eardrum also acts as a barrier to keep outside material from entering the middle ear.

Causes

The eardrum may be perforated when a sharp object is inserted in the ear, such as: a cotton swab or paper clip to clean the ear or relieve an itch; or by an object accidentally entering the ear, such as an unseen low-hanging twig on a tree or a thrown pencil. The eardrum may also be perforated by a sudden increase in inward pressure in the ear, such as with a slap; a swimming or diving accident;  a nearby explosion.

A middle ear infection may cause your eardrum to rupture as the pressure of the fluid in your middle ear increases. Conversely, a ruptured eardrum can lead to an infection because your eardrum is no longer intact, allowing bacteria to enter your middle ear.

The eardrum also acts as a barrier to keep outside material (such as bacteria) from entering the middle ear. When the eardrum is perforated, bacteria can easily travel to the middle ear — causing an infection.

Small objects such as a cotton swab or bobby pin pushed too far into your ear canal can rupture your eardrum. Attempts to clean earwax (cerumen) from your ear can damage your eardrum and cause infection of your outer ear canal (swimmer’s ear).

Symptoms

A ruptured ear drum is often quite painful. Common symptoms include sharp and sudden pain or discomfort in the ear, loss in hearing, ringing in the ear (called ‘Tinnitus’), pus from the ear, blood from the ear, and even a decrease in the ear pain followed by pus or blood from the ear.

Treatment

Medical treatment may include antibiotics to prevent or treat infection. Minor pain may be treated with an aspirin substitute like acetaminophen.

Acetaminophen should not be taken by anyone with known liver or kidney disease. Do not drink alcohol when taking more than 1 dose of acetaminophen. A ruptured eardrum will usually repair itself within 2 months, providing it does not become infected. Hearing is not usually affected permanently. Surgery may be needed for large or unhealed small holes.

Antibiotics may be used to prevent infection or to treat an existing infection. Analgesics , including over-the-counter medications, may be used to relieve pain. Occasionally, the health care provider may place a patch over the eardrum while it heals. Surgical repair of the eardrum may be needed, if the eardrum does not heal on its own ( tympanoplasty ).

Surgery: If your doctor determines that a paper patch won’t provide prompt and adequate closure of the tear or hole in your eardrum, or if attempts with paper patching fail to heal the damage, you may need surgery. During a procedure called tympanoplasty, your surgeon places a tissue patch across the perforation, allowing it to heal. Tympanoplasty is often successful in closing the tear or hole permanently and restoring hearing. This procedure is done on an outpatient basis, meaning you can go home the same day.



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