Product Liability Attorneys Blog

CBS News reports that the U.S. Food and Drug Administration has ordered 21 prosthesis manufacturers to conduct research to determine if metal-on-metal replacements are making people sick or are otherwise defective.

It's possible that any implant can cause damage, instead of easing the pain of people whose own bodies are worn down. Defective medical products can leave the manufacturer open to product liability lawsuits. If you have been adversely affected by hip replacement or other consumer products that have caused you harm, our Defective Medical Product Lawyers are here to help.

It wasn't that long ago that DePuy Orthopedics Inc., a division of Johnson and Johnson, had hip replacement products recalled. As previously discussed by the Product Liability Attorneys Blog, DePuy recalled the ASR XL Acetabular System and the ASR Hip Resurfacing System because of a high failure rate within five years of surgery.

The ASR hip replacement is a metal-on-metal device that has been shown to cause patience to require hip revision surgery because of a design flaw. Now, it appears the FDA is looking into whether these metal-on-metal devices cause metallic particles to get into a person's bloodstream and cause severe pain, shortness of breath, numbness, weakness, damaged organs and other medical complications.

According to CBS News, about one-third of the 250,000 hip replacement surgeries in the United States each year used a metal-on-metal device. The FDA gives a more detailed description of the problem, saying that the metal ball and metal cup in the devices slide against each other during walking or running, which causes metal particles to wear off and enter the bloodstream.

The FDA offers some symptoms:

• Pain in the groin, hip or leg
• Swelling at or near the hip joint
• A limp or change in walking ability

It's possible that those symptoms have nothing to do with a defective product, a thorough evaluation by an orthopedic surgeon may be necessary to determine whether a subsequent surgery is necessary. Patients with these devices are encouraged to pay close attention to changes in their health or new symptoms, related to their:

• Heart (chest pain, shortness of breath)


• Nerves (numbness, weakness, change in vision or hearing)


• Thyroid (fatigue, feeling cold, weight gain)


• Kidney (change in urination habits)

Continue reading "FDA Inquiry Aimed at Metal Hip Replacements" »

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" »

The success of DePuy Hip Replacements was short-lived. After only a few years in the market, on September, 2010, Depuy Orthopedics, Inc. had to take its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System off the market due to a relatively high failure rate within five years of surgery, which required patients to seek additional surgery.

The recall, which was voluntary, is expected to be a big expense for the company, which has reportedly suggested that patients utilizing the recalled products see their implant surgeons for a full evaluation of performance. The cost of any doctor visits, tests and procedures associated with the recall will be carried by the company.

This, however, will not be DePuy's only expense, as those affected by the defective product have already started filing suit. Indeed, so many lawsuits have been filed, that a Multi-District Litigation (MDL) has been established in the Northern District of Ohio to hear all DePuy hip replacement claims filed in federal court. Canada patients have also started demanding compensation for their failing hip replacements.

The countless lawsuits and the additional expense are only some of the problems these devices have brought to the company. Last summer, DePuy came under the scrutiny of the Food and Drug Administration for its marketing practices, which violated the Federal Food, Drug, and Cosmetic Act. According to the FDA, the company violated the Act when it advertised some of its hip replacements without obtaining the required marketing approval.

What would happen to the company next has yet to be seen, but one thing is clear: DePuy's hip replacement will leave their mark on the company's pockets which will have to carry the expense of litigating hundreds of suits.