The U.S. pharmaceutical industry is a $300 billion annual industry, and drug companies are always looking to develop and market highly-profitable (expensive) drugs to improve their balance sheets. Often times, the drug being promoted as the best may be the newest or most expensive, but not necessarily the most effective, or the safest. Levaquin is one of the latest of these blockbuster drugs with dangerous side effects which remain unknown to the general public until it is too late.

What is Levaquin?
Levaquin is the brand name for levofloxacin, an antibiotic approved to treat bacterial infections of the skin, sinuses, kidneys, bladder, and prostrate. Levaquin has also been approved to treat bronchitis, community-acquired pneumonia, and anthrax. Levaquin, marketed by Johnson and Johnson/Ortho-McNeil, was first granted marketing clearance in 1997. Since then, it has received over a dozen different approvals for different forms, dosages, and treatments.

Among the most serious adverse side effects of the drug are spontaneous ruptures of tendons, the bands of tissue which connect muscles to bones. This swelling or tearing of tendons is especially noticed in the vital Achilles' tendon in the heel. Irreversible peripheral neuropathy (damage to the nerves of the peripheral nervous system) is another danger associated with Levaquin. The drug can cause many other problems as well, especially when it interacts with other medications or herbal or natural supplements. Other conditions include cardiotoxicity (damage to the heart muscle), arrhythmia (abnormal heartbeat), and anticoagulation (preventing the blood from clotting).

These dangerous conditions may show up long after the patient has stopped taking the drug, so that an injured person may not know that Levaquin was the culprit.

On the Shelf with a Black Box Warning
In 2008, the Federal Food and Drug Administration (FDA) required the makers of Levaquin to place a black box warning on the packaging of the drug, warning the public about the dangers associated with taking Levaquin. This warning also applies to other antibiotics in the same family as Levaquin, including Cipro, Factive, Avelox, Noroxin, and Floxin. A black box warning is the strongest, most urgent message that can be ordered by the FDA. It requires the warning to be placed in a box with a thick black border or background to draw the public's eye and attention to the seriousness of the warning.

Regardless of the presence of the warning, Levaquin remains on the market, the makers continue to market the drug as safe and effective, and a great number of people remain uninformed about the risks of the drug.

A Lesson (not) Learned from Cipro
Levaquin is in a family of antibiotics known as fluroquinolones. Another drug in this family is Cipro (floxacin), which gained overnight popularity in 2001 at the height of a national anthrax scare. Cipro was quickly approved and heavily marketed as the drug of choice to treat anthrax, despite the apparent availability of other safer yet equally-effective drugs. As thousands of postal workers, government employees and health care professionals began taking Cipro, serious side effects began to emerge, including tendon rupture and severe pain and problems with tendons and joints. Cipro has also been the subject of an FDA black box warning, as well as many civil lawsuits.

It's Dangerous, but is it Legal?
Despite the known dangers, Levaquin is still a legal drug allowed to be sold in the U.S. Not everyone who takes Levaquin will experience tendon ruptures and the other serious adverse effects noted above. Those who are seriously injured may be able to recover for the damages suffered in a civil lawsuit against the drug's manufacturer. Damages include medical expenses, lost wages in the present and future (in the case of a long-term or permanent disability), and present and future pain and suffering.

Dangerous drug cases are a type of products liability case. In products liability, it is not necessary to prove negligence or fault on the part of the manufacturer. The fact that a dangerous or defective product was placed into the stream of commerce and later caused an injury is all that is required in order to establish liability. Pharmaceutical manufacturers may be liable in a number of ways:

• Manufacturing a dangerous drug
• Manufacturing a defective drug
• Improperly marketing a drug
• Inadequate warnings
• Inadequate or incorrect instructions

Pharmaceutical products liability has manifested itself in many different ways. In the case of Baxter-manufactured Heparin, the company produced the drug overseas in a Chinese facility that was not monitored or regulated by the United States Food and Drug Administration (FDA), resulting in a dangerously defective supply of Heparin being placed on the market. Some drug companies may be liable for promoting a drug for off-label uses or at higher dosages that go beyond the original FDA approval. For instance, the painkiller Bextra was approved for relief of arthritis and menstrual pain, yet was heavily marketed for uses and in doses that far exceeded the scope of the FDA approval, raising profits yet causing the unnecessary suffering of numerous adverse side effects. Pharmaceutical companies hire "detailers" who market directly to physicians and retailers with free samples and gifts, often promoting off-label uses and unapproved dosages in order to sell more product.

Even given the presence of a black box warning, is it still safe to manufacture and market Levaquin? Should doctors prescribe it, given the availability of cheaper, safer, and effective alternatives? It is becoming clear in the medical community that Levaquin should only be prescribed, if at all, in cases of confirmed bacterial infections where other antibiotics have not shown to be effective.

Legal Help is Available
Litigation has been mounted against Levaquin on many fronts. A panel on Multi-District Litigation (MDL) has granted a plaintiff's motion to centralize individual and class action claims in the United States District Court in Minnesota. Also, the New Jersey state courts have certified Levaquin litigation as a mass tort there. Most recently, several lawsuits have been filed in Illinois state courts, alleging that Ortho-McNeil downplayed the risks of Levaquin in marketing to doctors and manipulated study data to hide the real risks to the public.

If you were prescribed Levaquin and later experienced adverse effects of the type described in this article, either during or after completing a course of treatment involving Levaquin, you should seek the advice of an experienced trial lawyer who has handled cases of pharmaceutical products liability. In and around New York City, contact the law firm of Leandros A. Vrionedes for professional advice and representation from an experienced attorney familiar with cases involving dangerous and defective drugs.