Product Scares Bring Attention to FDA's Lack of Recall Power

November 04, 2010

Every week there is seemingly a new product recall of some sort in the news. Whether it's automobiles or baby toys, a product is being removed from market shelves across the country. Many people may fail to realize, however, that when it comes to pulling defective food and drugs off market shelves, the Food & Drug Administration (FDA) has no authority to order companies to recall their products. In light of two recent recalls, Congress is proposing bills to reconsider this.

Eggs and Motrin

This past summer, news of eggs tainted with salmonella erupted nationwide. This brought renewed attention to various bills Congress introduced at the start of the 2009 legislative session. The bills, currently still in committee in both the House and Senate, are proposing to allow the FDA to issue recalls of food.

In the spring of 2010, reports surfaced about a "phantom recall" of some versions of the prescription drug Motrin by McNeil Consumer Healthcare, a division of Johnson & Johnson.

In 2009, rather than issuing an official recall of the drugs (which were found to be dissolving incorrectly and thus were not as effective), McNeil hired a private inventory company to purchase the defective Motrin right off of store shelves without telling the store owners or the general public.

When word of the phantom recall reached Congress nearly a year later, the House Oversight Committee held a hearing.

The head of Johnson & Johnson's Consumer Products division said that the plan to buy back the faulty Motrin was merely an "audit" to determine where the faulty pills were shipped. But at a second hearing, the CEO of Johnson & Johnson admitted that the phantom recall was the wrong approach for the company to take in dealing with the defective drugs.

Congressional Examination

Following the first hearing on the Motrin mishap, committee chair Edolphus Towns (D-NY) introduced a bill, HR 5740, which would give the FDA authority to order drug recalls. The bill was referred to the House Committee on Energy and Commerce. However, with the end of the present congressional term approaching, it is unlikely to be passed by the current Congress.

The hearings were not without condemnation and commentary from both Democrats and Republicans. Both members of the committee criticized McNeil's phantom recall approach but also laid blame on the apparent lack of oversight by the FDA. Republicans focused their attention on the FDA being too lax with the companies involved. Democrats blamed the private companies.

Representative Kucinich, one of three co-sponsors of the bill, characterized the committee's role as "not just oversight of the government. It's [also] oversight of misconduct in the private sector."

Kucinich went on to say that if a company knowingly avoided telling the public about a serious health problem, that company's corporate charter should be cancelled--in other words, put out of business.

State Remedies

For the nation's drug companies, neither the FDA nor the federal government currently has the power to revoke a company's corporate charter; that power is held by the state in which it is incorporated.

Fortunately for the public, states across the country have implemented laws that protect consumers against harmful products. Although the defective Motrin example involved a product that was simply less effective than it should have been, when a product causes actual harm, individuals may sue the manufacturer under product liability law.

Specifically, in Ohio, liability may be established under either traditional common-law theories of negligence, or under strict liability laws established under Ohio's Products Liability Act.

Federal Pre-emption

In some cases, however, federal law pre-empts state law. For example, in Ohio, a user of a diet drug claimed that the drug was unreasonably dangerous and sued the drug's manufacturer under both Ohio strict liability law and negligence law. But both of these causes of action were pre-empted, or blocked by federal law, because the FDA, not a state's law, has the authority to determine which drugs are safe and effective enough to be marketed.

As these examples indicate, pursuing legal recourse against a defective product can be complex. Anyone injured as a result of a product improperly labeled or did not do what the manufacturer claimed should discuss the matter with an attorney experienced in product liability cases.

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