Wagners Serious Injury Lawyer Blog

Hundreds of people across Canada have sustained tendon injury as a result of taking a popular prescription medication called Levaquin.

Levaquin is a prescription antibotic generally prescribed for the treatment of numerous bacterial infections. Many people use Levaquin to help combat ear infections, bronchitis, pneumonia and chlamydia. Levaquin is a fluoroquinolone antibiotic. It is concentration-dependent, so bacteria are killed most efficiently when the right amount of medicine is absorbed into the body.

Levaquin is the most prescribed fluoroquinolone antibiotic in the world. The drug is a product of Johnson and Johnson. It was approved by Health Canada in 1997 for the treatment of bacterial infections in adults.

Since that time, a growing number of injuries have been reported. In fact, over 450 reports of injury have been submitted to Health Canada in association with Levaquin. Many of these complaints relate to tendon ruptures and related injuries. The FDA has received notice of even more complaints. According to the FDA database: at least 262 reported case of tendon ruptures have been reported, 274 cases of other tendon disorders, 259 cases of tendonitis, and 61% of these tendon ruptures were caused by Levaquin.

Although prior epidemiological studies indicated that Levaquin was associated with an increased risk of tendonitis and tendon rupture, the drug manufacturers chose not to adequately warn the public and the consumers of this risk. Ultimately, they were forced to. On July 8, 2008, the FDA ordered the manufacturers to add a Black Box warning to Levaquin. A Black Box warning is the strongest warning available for prescription drugs. These blackbox warnings apply to pills, tables, capsules and injectable formulas. The FDA also required that a guidebook be provided to patients warning about the possible side effects.

A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is named for the black border that usually surrounds the text of the warning. A black box warning will typically indicate that medical studies reveal that the drug carries a significant risk of serious or even life-threatening adverse effects.

A black box warning is the most severe and urgent warning possible. Through its mandatory black box warning, the FDA declared that the evidence suggested that use of Levaquin could lead to tendon rupture and other similar injuries. The FDA also claimed that these types of injuries could lead to extensive surgery to repair.

This type of warning was necessary because the manufacturers and distributors of Levaquin had previously decided to "hide" any caution within the small print of an exceedingly long Levaquin label. Compared to the severity and probability of the injuries, this was felt to be an inadequate warning to both doctors and patients.

Patients and their doctors must be able to rely on drug manufacturers to provide fair and adequate warnings on any safety issues associated with the use of the drug. It is only when all risks are sufficiently disclosed that a patient can make a proper determination of whether to take the drug.

In the pharmaceutical business, sometimes full disclosure will take a back seat to the pursuit of higher profits. When this happens, the patients and consumers suffer. Wagners Law Firm has commenced a class action lawsuit against the manufacturers and distributors of Levaquin. The class action seeks to include all Canadians who have been harmed by the drug and the defendants' choice to provide inadequate warnings in the face of known risks.

The purpose of the class action is two-fold: provide an efficient means of providing justice for those wronged by the wrong-doings of the pharmaceutical companies and promote behaviour modification by holding these companies accountable.

Consumer products are goods companies place into the marketplace for sale and consumption. The primary goal of the market is profits. Usually product safety objectives and responsible advertising work in conjunction with profit maximizing. However, sometimes they do not.

Occasionally, companies will cut-corners or provide the public with misleading product or safety information. This can have an adverse effect on an individual's heath. Injuries stemming from product defects are becoming increasingly more common. Some speculate that this is due to the modern marketplace, where there is an increased consumer demand and pressures on companies for speedier innovation to the market.

Fortunately there is good news coming. Next week, on June 20, 2011, the Canada Consumer Product Safety Act will be coming into force. The Act will be of great benefit to the public and will undoubtedly provide Canadian consumers with increased product protection.

The Act imposed certain responsibilities on manufacturers, packagers, distributors and advertisers. The obligations are in force in every province in Canada, including Nova Scotia, New Brunswick and P.E.I. The obligations seek to protect the public from injury and loss.

The Act applies to merchandise items, like children's toys, household/building products, sporting goods (hockey helmets, fishing rods, etc) and miscellaneous equipment (car booster seats, textiles, etc.). The legislation does not apply to cars/trucks, food, drugs or natural health products. These consumer products are already covered by other Canadian legislation.

The new legislation is intended to address dangerous products by placing responsibilities on companies and empowering officials to recall products that are a "danger to human health or safety". The Act describes that as meaning:

"any unreasonable hazard - existing or potential - that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual's health - including an injury -whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health"

The Act requires that companies report to Health Canada of any product defects or product safety issues that can cause death or injury to a consumer. This "early warning" provision will enable Health Canada to independently investigate and assess potential defects that could reasonably be expected to result in death or harmful injury. This obligation also applies to inadequate product labeling or instructions that could lead to the same results.

With the implementation of the Act, there will now be a general statutory prohibition of manufacturing, selling or advertising any consumer products that could pose an unreasonable danger to the health and safety of consumers in Nova Scotia, New Brunswick and PEI, along with all other Canadians.

The Act prohibits the advertisement or labelling of product information that could pose a danger to the health and safety of Canadians.

A further key component of the Act requires a manufacturer, distributor and advertiser to maintain accurate records and paperwork so that unsafe products can be traced back to their source and ultimately liability can be established.

When requested to do so, companies must provide evidence (via testing or studies) of their compliance with the Act. In short, they must establish that their products are reasonably safe and that their consumers do not risk injury through purchase. One of the major effects of the Act is that it authorizes the Canadian Government to affective action to issue recalls when required. Surprisingly, Health Canada didn't already have the power to recall unsafe products. The government has had to rely on voluntary recalls by responsible companies and not all companies are responsible.

It remains to be seen how much of a role the new legislation will play in lawsuits when a victim is injured by a product. Where a company chooses to place a defect product on the market in a manner which contravenes the legislation, it is forseeable that the Act will afford injured victims greater access to justice by way of class actions. Ultimately however, the lawyers at Wagners see this as one of the most important pieces of legislation to come into effect in recent years as it is hoped that manufacturers, advertisers and distributors of consumer products will take note of the legislative changes and that less injuries will result from defective products.