Millions of products are manufactured and used by consumers each year. Consumers rely upon the manufacturers to make safe products. Every year, however, thousands upon thousands of these products are recalled or deemed unsafe. Unsafe or faulty products often lead to preventable injuries or deaths.

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Product Recalls and Safety Alerts


Several government agencies are responsible for ensuring the safety and efficacy of a variety of products. These government agencies issue and/or announce product safety alerts, recalls, withdrawals, and important product labeling changes that may affect the health of all Americans.
The Food & Drug Administration (FDA) is responsible for the safety of drugs, biologics, medical devices, foods, and some supplements. (link to inner page)
The National Highway & Traffic Safety Association (NHTSA) overlooks the safety of automobiles, trucks, motorcycles, and tires. (link to inner page)
The Consumer Protection Safety Commission (CPSC) overlooks the safety of a variety of products including toys, children's products, furniture, tools, and various household items. (link to inner page)  
The Environmental Protection Agency (EPA) is responsible for the safety of pesticides and certain other chemicals. (link to inner page)

A Recall

is an action taken to remove a product from the market. The government agencies cited above monitor the recall and ensure that the product is successfully removed from the market or that the problem is corrected. The agencies also investigate why the product was defective. Recalls are usually initiated voluntarily by the manufacturer or at the request of the appropriate government agency. Government agencies publicize the recall of a harmful or defective product when they believe the public needs to be alerted about a serious hazard. In some cases where a recall is not warranted, the agencies may issue a product safety alert, warning the public about a substantial risk.

Recall Notices


There are several ways that the manufacturer and government agencies notify consumers about a recall:
Direct notification: The manufacturer must notify its direct accounts (such as wholesalers or chain stores) about the recall. The notification must do all of the following:
Inform the reseller that the product has been recalled. Request that the reseller stop distributing the product. If appropriate, request that the reseller notify its customers about the recall.
Public notification: The FDA maintains a list of drug and medical device recalls on its website (www.fda.gov) called Recalls, Market Withdrawals, & Safety Alerts. For the most part, this list includes Class I safety recalls (see Class I, II, and III recalls below).
Media coverage: If a product recall affects lots of people, or causes severe injury or death, often the media will report on the recall and notifications will be seen either online, in newspapers, or on television.


What does the FDA do?


The FDA issues and/or announces product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans. Its Center for Drug Evaluation and Research evaluates new drugs and ensures that they work correctly and that their health benefits outweigh known risks. The Center for Drug Evaluation and Research does not test the drug; rather, the drug manufacturer tests the product on animals and humans, and sends the results to the center, which employs experts to review the results.
Once a drug is approved by the FDA and on the market, the manufacturer must review and report any problems linked to the drug. Consumers may also report problems directly to the FDA through the MedWatch program (a program supported by the FDA for consumers and healthcare professionals to comment on any problems associated with drugs, vaccines, or medical devices).
When a manufacturer initiates a recall, it must notify the FDA and submit progress reports on the recall. The manufacturer is expected to comply if the FDA requests the recall. FDA guidelines for manufacturer recalls are found in Title 21 of the Code of Federal Regulations, Part 7. Visit Nolo’s Legal Research Center to view the Code of Federal Regulations.
Drug Recalls
More than half of all Americans rely on prescription drugs. Pharmaceuticals have helped increase the average American’s life expectancy, have given bald men hair, and have put many patients’ cancer in remission. Unfortunately, there is a flip side. Those same drugs have made depressed people suicidal, caused cancer, and now contribute to more deaths in the U.S. than traffic accidents (see New York Times article). For most drugs that are approved, another is removed from the consumer market. In 2008 the FDA recalled 426 drugs, and in 2009, the FDA was involved in approximately 1,742 drug recalls.
Most drug recalls are due to manufacturing defects (which accounts for majority of drug recalls), design defects, or labeling defects. There are three types of drug recalls:
Class I recall. There is a reasonable probability that a consumer's use of, or exposure to, a drug will cause serious health problems or death.
Class II recall. Use of, or exposure to, a drug may cause temporary or medically reversible health problems, or there is a remote risk that the drug will cause serious health problems.
Class III recall. Use of, or exposure to, a drug is not likely to cause adverse health consequences.

Why are Drugs Recalled?


Most drugs are withdrawn from the market if they are known to cause dangerous side effects, if they are used improperly due to mislabeling or unclear directions, or if they are contaminated.
America’s top 10 recalled drugs, to date, are:

  • Celebrex
  • Zelnorm
  • Heparin
  • Fen-Phen
  • Meridia
  • Cylert
  • Yaz
  • Avandia
  • Vioxx
  • Bextra

Medical Device Recalls


Medical products have helped millions of people in the past decade. However, as more new medical devices are streamlined into an increasingly dependent consumer market, more consumers have suffered from medical device recalls. In one recall - the 2010 DePuy ASR Acetabular hip implant recall - over 90,000 patients were affected. And that’s just one recall. The FDA noted that approximately 2,500 medical devices were recalled in 2010 due to safety issues. This figure is almost double that of 2009, and it marks a 164 percent increase from the year 2000.

Automobile Recalls


Millions of cars, trucks, SUVs are recalled every year, stemming usually from faulty manufacturing, unsafe build, or consumer complaints. Just last year, Toyota recalled over 14 million vehicles, a majority of which due to the deaths associated with the Prius’ “unintended acceleration” issue. Toyota is currently fighting hundreds of lawsuits from plaintiffs seeking reparations for personal injuries or compensation for the death of a loved one.

The Law Protects Consumers Against Unsafe or Defective Products


Various laws protect consumers from unsafe or defective products. When a product is unsafe or does not perform as advertised, the manufacturer of the product may be held liable for any injuries cause by the unsafe product. In some medical device cases, extended parties (such as testing laboratories, doctors, or hospitals) may also be liable. Sometimes, a defective product lawsuit includes a combination of claims against the different liable parties.

Insurance Coverage for Product Injuries


Unfortunately, even though the law does protect consumer rights to seek reparations, there are other issues that can limit that consumer’s compensation. Sometimes, a lack of insurance coverage for product injury cases may drastically limit the amount of money that a claimant wins in reparations. For example, in the early 2000’s, Sulzer Orthopedics, Inc. was a defendant in a number of lawsuits stemming from the recall of defective hip and knee implants.  Sulzer, a Swiss company, was insured by a number of liability policies that excluded coverage for product liability class action lawsuits filed in the United States. While Sulzer contributed to the settlement, and was able to convince its insurers to contribute approximately $215 million as well, the case involved over 20,000 plaintiffs. As a result, the settlement values were limited (due to the insurance issues and Sulzer’s status as a relatively small company) and claimants did not receive their entire due compensation.

Preserving Legal Claims Claim


Every state has mandatory “statute of limitations,” or time limit, in which lawsuits must be filed. If you file your suit after the statute, you run the risk of having your claim thrown out of court. The statutes of limitations for defective product liability claims vary from state to state. Although no state has a statute of less than one year, many states have a 2-year time limit.

When does the Time Limit Begin?


Most statutes begin once the injury has occurred. In the Toyota Prius recall, for example, once a consumer was notified of the “sticky accelerator” issue or suffered an injury due to the manufacturing defect, the statute began. In more complex claims, however, where the injury does not manifest until later, the statutes are less clear. For example, if a child suffers lead poisoning from a toy that is later recalled, does the statute begin at the recall, or when symptoms of the child’s illness emerge? In these trickier situations, the courts decide whether to begin the time limit at when the injury occurred, or when it was discovered. Therefore, the earlier the plaintiff files the claim, the better.
Some states also have additional time limits that cap the amount of time in which a consumer can sue companies for defective products manufactured or sold many years ago. These “absolute” statutes may limit a claim to 10 years from when the product is sold, so a consumer harmed by the products 11 years after it is manufactured is out of luck.

Act now to Protect Your Rights


With all these limitations in place, it is important, as a consumer, to know and protect your rights BEFORE your rights expire. If you may have been injured by a recalled or dangerous product complete our online form for a free case evaluation. 

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