Bisphenol A (BPA): Litigation and FDA Developments

BPA studies, which question the safety of Bisphenol A (BPA), have led to lawsuits and renewed FDA interest.

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Concerns about the safety of Bisphenol A (BPA) in baby bottles, sippy cups, plastic food containers, and baby formula cans have spurred numerous lawsuits and recent FDA attention. BPA has been linked to possible health problems in fetuses, infants, and young children, and new research suggests that BPA may increase the risk of heart disease and intestinal problems in adults.

The U.S. Food and Drug Administration's (FDA) reevaluation of its position regarding BPA, the continuation of a large class action lawsuit involving BPA, and emerging scientific studies linking BPA to other health problems ensure that BPA will remain in the news for quite some time. Read on to learn more about health, legal, and regulatory issues related to BPA.

What Is Bisphenol A (BPA)?

Bisphenol A, commonly known as BPA, is a chemical used in plastic to make it hard and shatterproof. For decades, manufacturers have used BPA in plastic baby bottles, sippy cups, and sports bottles. BPA is also found in the linings of some metal-based food and beverage cans, such as baby formula cans and aluminum water bottles.

Health Effects of BPA

In the 1960s, the FDA approved the use of BPA in food containers. In April 2008, a draft report from the Department of Health and Human Services' National Toxicology Program (NTP) expressed concern over the safety of BPA in food containers. NTP research suggested that BPA could leach from plastic containers into food and beverages and then be absorbed into the body. The NTP's final report, released in September 2009, expressed concern that low doses of BPA might cause health problems in fetuses, infants, and young children, including:

  • early puberty in girls
  • changes in the prostate gland, and
  • behavioral and neural changes.

Despite the NTP's report, the FDA maintained its position that low doses of BPA were safe in food containers, but the agency also said that it would continue to consider research regarding BPA safety.

Recently, research in France and Britain has raised concerns that BPA may cause health problems in adults -- including heart disease and intestinal problems.

BPA Litigation

The release of the NTP's draft report on Bisphenol A prompted nationwide lawsuits against manufacturers of BPA-containing products. Plaintiffs (the people bringing the claims) and their attorneys filed lawsuits against:

  • baby bottle manufacturers such as Evenflo Co., Avent America Inc., Handicraft Co., Playtex, and Gerber Novartis
  • plastic sport bottle manufacturers such as Nalgene and Sigg, and
  • baby formula manufacturers such as Mead Johnson and Abbott Laboratories.

These lawsuits were consolidated into one large lawsuit, also called Multidistrict Litigation (MDL), overseen by a federal judge in Missouri. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug Lawsuits and Other Cases.)

Theories of Liability in the BPA Litigation

The bulk of legal claims in the MDL lawsuits rely upon theories of fraud, violation of state consumer protection laws, and breach of warranty. In supporting these claims, plaintiffs point to more than a decade of research suggesting that BPA-containing products are dangerous and could cause harm to fetuses, infants, and children. They argue that the manufacturers of these products knew or should have known that BPA posed health problems, but chose to market and promote the products anyway without providing disclosures to the public.

The MDL lawsuits do not allege that individuals were actually harmed by BPA-containing products. For this reason, plaintiffs do not allege legal claims that require a showing of harm, such as product liability claims. (In a product liability claim, plaintiffs must prove that a product was defective in some way and that the defect caused injury or harm to plaintiffs. Learn more in Nolo's article Proving a Defective Product Liability Claim.)

FDA's Changed Position on BPA Safety

On January 15, 2010, the FDA reevaluated its position on the safety of BPA in food containers. Based on recent research, the FDA states that it now has "some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children." Although the FDA has yet to ban the use of BPA in food containers, the agency will do the following:

  • review scientific research and conduct new research on the safety of BPA
  • support manufacturers' efforts to eliminate BPA in products
  • support stronger regulation of BPA
  • encourage consumers to follow Department of Health and Human Services guidelines for minimizing the risk of BPA in infants and small children (you can find these guidelines on the HHS website at www.hhs.gov/safety/bpa/), and
  • collaborate with international partners such as Health Canada.

State and Local Government Restrictions on BPA

Many state and local governments are considering (or have already enacted) legislation to ban BPA in baby bottles and sippy cups. Some laws ban (or propose to ban) BPA use in any type of food container. Other proposed laws would not ban BPA use, but would require manufacturers to provide warnings to consumers about BPA's possible negative health effects.

BPA Litigation - Getting Help

As the FDA and other entities continue to investigate the safety of BPA and its link to health risks, renewed interest in BPA litigation is likely. If you want to learn more about existing BPA lawsuits, or how to pursue your own claim, you may want to contact a lawyer who specializes in products liability cases. Read Nolo's article Finding a Personal Injury Lawyer for more information. Or go to Nolo's Lawyer Directory for a list of personal injury attorneys who handle products liability cases in your geographical area.

by: , J.D.

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