In a previous article we talked generally about products liability law, and we mentioned that one type of products liability claim dealt with prescription drugs in pharmaceuticals. The pharmaceutical companies spend a lot of money on developing a new drug (estimated at $4-11 billion per drug). They also spend a lot of money advertising their new drugs, and it seems wonderful that there is a drug for everything from that pesky acne to arthritis to male pattern baldness. Often, we then see lots and lots of advertisements talking about lawsuits stemming from the side effects from taking some of those drugs.
The basis for a lawsuit is often a failure in the duty to warn consumers of the potential side effects of the drugs. The basis could also be that the formula of the drug was improperly designed, or that there was a problem with the manufacturing process of the drug that led to a tainted drug situation. An attorney experienced in drug litigation will know which of these theories to pursue.
What Are Some of the Drugs Found In Pharmaceuticals?
The list is a long one – many drugs have been recalled over the years, or found to have serious side effects. Often the drugs that have caused injuries are still on the market, such as hormone replacement therapy drugs or antidepressants. This list is by no means complete, but some of the drugs currently in litigation, whether individually or by way of class actions are:
Hormone replacement therapy drugs
- Fosomax , Boniva, Actonel
- Yasmin, Yaz, Ocella
There are even lawsuits against the makers of over- the- counter drugs such as Tylenol and Nexium. Many of the side effects are known to the drug manufacturers, but they choose to market the drug because the cost-benefit analysis shows that the drug will help more people than it will harm, and the money they can make on the drug outweighs the cost of litigation and settlements. Your health and safety just got reduced to an economic equation.
How Does This Happen With Pharmaceuticals?!
We all know the Food & Drug Administration (FDA) is responsible for determining, among other things, which drugs are safe for human consumption. The Center for Drug Evaluation & Research (CDER) is the part of the FDA that approves and monitors drug safety. Therefore, it is a puzzle how drugs that have such serious side effects make it into the marketplace from pharmaceuticals. There are a few ways to achieve approval of drugs for sale. When patents expire on previously exclusive formulas, a company can expedite approval for a generic drug. There is also an expedited process for drugs that move from prescription to over-the-counter status. These drugs are not usually the ones we see causing problems, so we will only discuss new drugs that have come onto the market.
According to the FDA website, in order for a new drug to be approved for sale in the U.S., the company must submit various applications to the agency. (It is interesting to note that the company seeking approval to market the drug is the one responsible for testing the drug for safety and effectiveness, and then providing those results to the FDA. FDA only tests after the fact, or if there are issues) CDER then has a team of physicians, pharmacologists, statisticians, chemists and other scientists review the data and determine whether the drug is safe to move forward for clinical testing.
There are three phases of clinical testing on humans. The first phase usually lasts about one year and has 20-80 healthy volunteers to establish the safety and profile of the drug. The second phase uses 100 -300 volunteers to assess the drug’s effectiveness, and lasts about two years. The final phase uses 1000 – 3000 volunteers in clinics and hospitals to look at effectiveness and to identify adverse side effects. They are closely watched, and this phase takes about 3 years.
It may seems that in the “rush” to get a drug approved (which usually takes about 12 years), the clinical trials do not take into account the long term effects of a drug, or drug interactions with some of the more common drugs people take. It would not be possible to know ALL the potential drug interactions, as the number of drug combinations could be infinite, but some common ones should be identified. Further, the number of people in each test group is really not a very large statistical sample, and that may be where the problem with identifying side effects may lie.
Allegations Against Big Pharmaceuticals
We are aware that the drug companies are in business to make money – that is no crime; it is the goal of every business. When the push to make money comes on the backs of unsuspecting patients who take a medication their trusted doctors have prescribed, and then it turns out the injurious side effects were known but not disclosed, then the drug companies should be responsible. Some of the drug litigation has uncovered some questionable practices by some of the companies – falsified or completely made up research data, conflicts of interest among those responsible for ensuring the safety of a drug, kickbacks, influence pedaling – the list goes on.
Some of these investigations and allegations even charge the FDA with bowing to the influence of the drug companies, because much of their work and budget relies on the ongoing work of those companies. It is a symbiotic (or parasitic!) relationship.
Pharmaceuticals: What Can I Do?
If you or someone you know has been taking one of the drugs, the safety of which is currently being litigated or called into question, you should contact a law firm that has experience litigating with the pharmaceutical companies. They will be able to guide you through the steps of your claim, including what medical treatment and information you will need to pursue that claim. Not everyone who has taken a questionably safe drug experiences the injurious side effects, so merely having taken the drug is not sufficient to successfully pursue a claim. You must show that you have been injured as a result of the drug.
An attorney experienced in this area will be able to evaluate your situation and help you determine the next step. They will be able to fight on your behalf for compensation for the injuries that were the result of an unsafe drug.