Articles Posted in Products Liability

Consumer product manufacturers always seem to be striving to produce products that are easier to use, are more visually appealing and are improved from previous designs in some way. This kind of innovation often benefits consumers directly. However, new product design models can also harm consumers if these designs are not properly thought-out.

In recent years, both dishwashing detergent and laundry detergent have received a makeover. Instead of compelling the consumer to measure out the correct amount of liquid or dried detergent, manufacturers have placed these substances in single-use pods. These capsules are convenient, visually appealing and often work even better than traditional detergents. Unfortunately, their appealing and easy-to-handle packaging is proving to be quite hazardous to young children.

Young children find these single-use capsules to be visually appetizing. As a result, approximately 10,000 American children were problematically exposed to the capsules’ inner contents in the past year alone, according to the American Association of Poison Control Centers. Most often, children perceive the pods to be candy-like and either try to open the pods, consume their contents or both.

A few weeks ago, Congress passed a bill inspired in part by last year’s fungal meningitis outbreak that originated at a compounding pharmacy on the east coast. Tainted steroid injections produced by the pharmacy ultimately killed 64 people and made approximately 700 additional patients ill. These defective drugs could potentially have been kept out of the hands of patients had they been produced by large manufacturers which are subject to regulatory oversight that compounding pharmacies are not.

In response to this unacceptable patient safety loophole, Congress passed The Drug Quality and Security Act. The director of drugs and medical devices at Pew Charitable Trusts recently praised the passage of this legislation when he noted that, “Congress can still come together to pass meaningful legislation to protect the public’s health. This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”

However, some patient safety experts are not convinced that the new legislation will actually improve patient safety and a safe pharmaceutical culture. For starters, the new bill allows compounding pharmacies to register with the federal Food and Drug Administration (FDA) on a voluntary basis. The choice to adhere to stricter quality testing and sterility measures is also voluntary rather than mandatory, according to the bill. The bill also effectively legalizes large scale compounding without specific prescriptions.

Studies have shown consistently in recent years that Americans are not excellent sleepers. In response to our ever-busy cultural approach to work, play and relationships, to the multitude of electronic devices that rule our lives and the pressure many of us feel to be productive late into the evening, Americans do not tend to get proper amounts of sleep or quality of sleep. As a result, a startling number of Americans choose to use sleep aids either occasionally or with regularity.

Unfortunately, recent studies indicate that sleep aids may indeed be dangerous drugs in certain contexts. Sleep aids are most dangerous when taken in incorrect dosages. Overdosing on sleep medication can be fatal. But these drugs are also dangerous in one other critical context. If not metabolized fully during the night, sleep aids can contribute to drowsy driving behavior the morning after the drugs are taken.

Given that drowsy driving can be as dangerous as drunk driving, the Food and Drug Administration (FDA) is taking a substantial interest in recent research on this phenomenon as it is published. In recent months, it has asked certain sleep aid manufacturers to change their warnings and to reduce recommended dosages of these drugs for certain populations in response. The FDA even went so far as to reject a new sleep aid drug application in July because evidence indicates that some drivers have a difficult time operating their vehicles safely the morning after taking the drug.

The makers of a popular carbonated alcoholic drink guzzled on college campuses are going to be changing the look of its Four Loko cans to settle the government’s charges of deceptive marketing.

Four Loko gained national attention in 2010 after the hospitalization of college students in Washington and other states. The drink, popular among college students, led to overdoses by nine Central Washington University students ranging in age from 17 to 19. Blood alcohol levels among the hospitalized students ranged from 0.12% to as high as 0.35%, perilously close to death.

Some states, including Washington, banned the drink, worried about the caffeine in Four Loko and its potential to mask how much alcohol one could safely consume. Amid a crackdown by the Food and Drug Administration, the drink’s makers removed the caffeine and started selling Four Loko without the energy kick but still with plenty of alcohol.

Just two years after its approval by the FDA, a dangerous flaw in the new drug Pradaxa has come to light. Pradaxa is an anti-clotting drug prescribed to patients with artial fibrillation.

When the F.D.A. approved Pradaxa in October 2010, the drug was hailed as the first in a new category of replacements for warfarin, the nearly 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim. About 725,000 patients in the United States have used the drug, according to the F.D.A.

Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that it is working. Pradaxa required no such monitoring and, compared with warfarin, appeared to be better at preventing strokes.