Product Liability Attorneys Blog

The Consumer Products Safety Commission has launched a new product safety information database, which aims to help consumer identify and report defective products.

Saferproducts.gov will also assist the government in identifying hazardous products quickly and more efficiently.

"Through SaferProducts.gov consumers will have open access to product safety information that they have never seen before and the information will empower them to make safer choices," said Chairman Inez Tenenbaum.

Product liability attorneys know hundreds of defective products are marketed to consumers each year. Defective vehicles, dangerous child products and dangerous medical devices are among the most common. While companies have an obligation to ensure their products are say, they too often fail -- putting profits before consumer safety.

The new system gives the CPSC five days to review online reports and forward concerns to the manufacturer, when warranted. The manufacturer then has 10 days to respond before the report and the manufacturer's comments are posted at SaferProducts.gov.

In thousands of cases, the role a defective product plays in a serious or fatal injury may go undetected. The one-vehicle accident may not be linked to a stuck accelerator or fatal injuries may never be linked to a faulty airbag for instance. This is particularly true with medical products or dangerous pharmaceuticals; patients expect to be helped, not harmed. Yet pharmaceutical companies and medical device makers are among the most egregious offenders when it comes to developing and marketing dangerous or deadly products.

"I believe that an informed consumer is an empowered consumer," added Chairman Tenenbaum. "The ability for parents and consumers to search this database for incidents involving a product they already own or are thinking of purchasing will enable them to make independent decisions aimed at keeping their family safe."

Continue reading "Government Site Empowers Consumers Dealing with Defective Products" »

The War over Lipitor perfectly illustrates the high-stakes fight often waged by pharmaceutical companies over designer drugs that reap billions of dollars in profits in the marketplace.

The Food and Drug Administration has come under increasing fire for doing a poor job of protecting American consumers from dangerous drugs or defective medical products. Whether it's the high-profile case of Avandia -- a dangerous diabetes medication it took years to sanction -- or the recent recall of the defective DePuy Hip Replacement System, patients are not being afforded enough protection in the medical marketplace.

Those are far from rare examples. Other pharmaceuticals with questionable history include Vioxx, Darvon/Darvocet and Accutane.

The FDA relies upon the testing of pharmaceutical companies to determine a drug's market worthiness -- the next billion dollar breakthrough is safe because the company says so -- and such testing is often done in third-world countries, far from the preying eyes of regulators. The agency has also been accused of playing politics with the approval process.

Now CNN reports that Lipitor -- the world's biggest blockbuster prescription medication -- is set to go on sale by the end of the year.

Pfizer is losing patent protection on its vaunted cholesterol-fighting statin. But the controversy rests with Ranbaxy, India's largest pharmaceutical company, which had been expected to launch its generic in the United States on Nov. 30. Federal rules would give the world's 12th largest generic maker a six-month window in which it would have the exclusive rights to market and sell a generic.

However, the FDA accuses Ranbaxy of fraudulent conduct over a period of years, including fabricating data in drug applications, shortcutting quality tests and violating manufacturing standards. So grave were the violations that the FDA barred the company from importing more than 30 different drugs in 2008. Federal prosecutors continue to negotiate civil and criminal penalties that could top $1 billion.

The company's leading generics in the United States include Valtrex (for herpes), Aricpet (for Alzheimer's) and Zocor (cholesterol). It has denied misconduct and contends it is cooperating with the federal government.

Meanwhile, generic makers are "feuding like greedy relatives at Lipitor's graveside," as CNN puts it. One company, Mylan, has even sued the FDA, alleging that the government's indecision has crimped the ability of competitors to plan.

At stake is that six-month window, during which a generic typically charges 70 to 80 percent of the name-brand price. After that, competitors typically join the party and the price drops to just 5 percent of the original drug's price.

Analysts estimate that could amount to $600 million in this case. In 2010, that would have been good enough to amount to about one-third of the company's entire gross revenue of $1.9 billion.

Continue reading "Generic Lipitor Saga Involves Company Accused of Peddling Potentially Dangerous or Defective Drugs" »