Tag Archives: FDA

Legal Immunity For Ebola Vaccine Makers

In order to encourage the development and availability of experimental Ebola vaccines, the U.S. Department of Health and Human Services (HHS) has offered liability protection to drug makers who are currently developing Ebola vaccines.

The announcement was made as part of the Public Readiness and Emergency Preparedness (PREP) Act. The goal of this measure is to encourage the development and availability of Ebola vaccines.

As per this protection, companies will have immunity under the US law against any legal claims related to the manufacturing, testing, development, distribution and administration of these vaccines. However, they will not enjoy the same immunity for claims that are brought in courts outside the United States.

Similar protection has been offered previously to vaccine makers in the US with the same objective: to encourage the development of childhood vaccines. This particular announcement is part of an effort by the HHS to address issues in the US and in other countries with respect to the development and use of Ebola vaccines. The HHS Secretary Sylvia Burwell has encouraged other countries to follow suit and to offer similar liability protections.

“As a global community, we must ensure that legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine, an essential strategy in our global response to the Ebola epidemic in West Africa,” she said in a statement.

Thus, as per this law, anyone who is allegedly injured by a vaccine can only sue in federal court if the FDA or the Justice Department investigates and finds definite proof of misconduct by the drug company.

Also, this declaration will apply to three specific countermeasures. First, the liability immunity will protect manufacturers and distributors regardless of whether it’s administered and applied without geographic limitation. This protection will last until December 10, 2015. Any individual who sustains a serious physical injury as a result of the vaccine can seek compensation through a Countermeasures Injury Compensation Program but such a claim will have to be supported with reliable and valid evidence.

This measure is expected to encourage more companies to invest in research and development efforts for an Ebola vaccine without the fear that they may be subject to lawsuits and compensation claims in case the vaccine does not provide the necessary results.

Product Liability: Mattel Pays $2.3 Million Penalty for Toys Containing Lead Paint

In an agreement with the U.S. Consumer Product Safety Commission (CPSC), Mattel and its subsidiary Fisher-Price will pay $2.3 million in civil penalties for toys made in China containing high levels of lead paint. Lead paint has been shown to cause injury when ingested and is banned in the United States. This defective products penalty is the highest of its kind imposed by the CPSC.

The Mattel civil penalty sheds more light over recent concerns by Congress that some Chinese-made products don’t meet United States standards for consumer safety. Defective products originating in China from pet food to baby formula were pulled from U.S. shelves and came under FDA scrutiny when they were shown to contain ingredients that may be harmful to animals and people. The Mattel penalty involves importing and distributing non-compliant toys containing lead paint, including Sarge cars and Barbie accessories.

Experienced Florida product liability lawyers know how to interpret federal and state laws designed to protect consumers from faulty or defective products.

Other Defective Chinese Products: Faulty Drywall in Florida Construction
Earlier this year, we wrote about how some faulty construction materials made in China may be affecting people’s health and the air quality in their homes. (See South Florida Construction Product Liability: Faulty Chinese Drywall to Be Tested.)

Senators are seeking funding to continue studying this problem in Florida construction liabilityand in home building around the country.

Mattel to Pay $2.3 Million Penalty for Toy Hazard
Bloomberg.com June 5, 2009

Senators Seek Funds for Chinese Drywall Study
Environmental Protection June 5, 2009