fbpx
When is a Drug Considered Defective?

When is a Drug Considered Defective?

February 8, 2022 | Pharmaceutical Litigation

Some people believe that a drug is defective if the FDA (Food and Drug Administration) recalls it. Between 2017 and 2019, the FDA recalled about seventy drugs a year.

However, mostly for the reasons outlined below, the FDA only recalls drugs in extreme circumstances.

Furthermore, by the time things reach that point, many people have already been seriously injured. Additionally, the reported injury statistics are often just the tip of the iceberg.

The defective drug definition is much broader in civil court. In this forum, a defective drug is basically any medicine that could cause a serious injury. This standard is necessary to protect people who have no idea what they are ingesting.

But this standard is not sufficient to trigger FDA action.

A New York personal injury lawyer keep people safe by pursuing injury claims. The damages available in these cases, particularly the punitive damages, encourage drug companies to change the way they do business and put people before profits.

The FDA Approval Process

Lawmakers created the Food and Drug Administration in the early 1900s. Before then, it was legal to sell anything to anyone for any reason. In the late 1890s, Bayer began selling both aspirin and heroin. Originally, the company marketed heroin as a pain reliever. Later, it marketed heroin as a children’s cough suppressant.

For many years, the FDA was an effective consumer watchdog agency that fought to keep people safe.

Today, user fees account for 65 percent of the FDA’s revenue, in terms of human drug regulation. In other words, the FDA depends almost exclusively on money from drug companies in order to regulate drug companies.

The fewer drugs available for sale, the lower that revenue becomes.

The FDA’s structure can be viewed as problematic since the same bureaucrats usually approve drugs and issue recalls. If the FDA issues a recall, it is essentially admitting that it made a mistake and shouldn’t have approved the drug. No one likes to make such admissions.

In the early 2010s, FDA bureaucrats introduced the 510(k) expedited approval process. If a drug is a “breakthrough” product, and the B-word is not very well defined, the agency could approve it in less than a year.

Your Claim for Damages

Since today’s drugs are very powerful, all of them have risks and side-effects.

However, drug companies have a duty to warn consumers about these risks. This warning must be specific, reasonably tailored to the risk, and highly visible.

Burying a generic statement like “this drug could cause the following serious side-effects” somewhere in the use instructions is normally not sufficient.

Usually, drug makers are fully aware of such serious side-effects.

Companies usually conduct ongoing studies which, they hope, will tout a drug’s safety and effectiveness.

If these studies produce adverse results, the company often buries such results, so drug sales will not be adversely affected.

To prove harm in court, New York personal injury attorneys usually look for illness spikes. If a certain number of people took a certain drug and they all developed the same serious illness, it’s more likely than not that the drug caused their illness.

Attorneys also rely on expert witnesses. These top-notch doctors explain the results of studies and other evidence to jurors, so they can make an informed decision about product safety.

Common drug company defenses in defective drug claims include lack of causation and statute of limitations.

As for causation, drug companies usually have their own “experts” testify that the drug is as safe. Since these tests are rather subjective, this argument often finds traction with jurors.

As for the statute of limitations, under the law, victims only have two years from the date of injury to file a negligence claim. The effects of a dangerous drug, like cancer, often don’t surface for many years.

An obscure legal doctrine, the delayed discovery rule, often protects victims in these situations.

Defective drugs often cause serious injuries. For a free consultation with an experienced personal injury lawyer in New York, contact Napoli Shkolnik PLLC. We do not charge upfront legal fees and only recover a fee when we win your case.

Share This:
CATEGORY: Pharmaceutical Litigation

How Can We Help?

Do you need assistance with a legal matter? Our attorneys have the experience needed to guide you in the right direction.