The public is virtually at the mercy of a pharmaceutical industry bent on making profits even at the risk of patients’ health. Unfortunately, the national watchdog — The Food and Drug Administration — often does an inadequate job making sure that drugs entering the marketplace are safe and effective for their intended purpose. A patient who suffers injury or illness because of the side-effects of drugs often has little other option but to file a lawsuit and hope to recover the cost of treatment. Some patients, indeed, suffer injuries that are permanent, and some even die. If you have suffered serious side effects because of a drug that has been prescribed to you, it is very important that you work with an aggressive and knowledgeable personal injury attorney who will fight for you.
Profits over Safety
Anyone who has been prescribed a drug in recent years knows that prices are very high. Even with medical insurance some patients spend hundreds of dollars a month on medications in order to stay alive. If this were not enough, many of the drugs ostensibly designed to benefit them actually cause more harm than good.
Meanwhile, the profits enjoyed by pharmaceutical manufacturers are no less than astronomical. Drug Watch reports that Eli Lilly made $36 billion between 2004-2008 just for its drug Zyprexa. During these years Pfizer made $245 billion. While it is true that companies are sometimes fined for drugs they manufacture that are dangerous, considering the enormous profits they make these fines are insubstantial. $7 billion in fines spread throughout the entire industry is akin to a baseball player making $20 million per year being fined a thousand dollars. Such a meager fine is unlikely to deter him, and it isn’t deterring pharmaceutical manufacturers from continuing to release drugs that at times are dangerous.
Classifications and Examples of Dangerous Drug Claims
Dangerous drugs are classified by the same standards as defective medical products:
- Defect in manufacture. This category includes drugs that are tainted or are improperly manufactured.
- Dangerous side effects. These are drugs that, by their nature, produce negative side effects in patients which are serious enough to cause injury. Often a drug is inadequately tested before being released to an unsuspecting public. In some cases resulting side effects may not be evident until later, thereby causing even greater harm to the patient.
- Drugs that are improperly marketed. The marketing of a drug has to do with warnings, instructions, contraindications, and recommendations for use. Often drug companies fail to provide accurate or adequate warning of the potential for harmful side effects.
The list of dangerous drugs is truly enormous. Some increase the risk of heart attack and stroke, while others lead to a higher incidence of birth defects. Certain drugs prescribed with the intention of reducing symptoms of depression, indeed, actually leave the patient feeling suicidal.
Many of these dangerous drugs also cause patients to become physically addicted. Liver damage is common to many of these drugs, and some may also cause bladder cancer, Crohn’s disease, and uncontrollable bleeding.
FDA Regulations and Reporting
The FDA requires drugs to be thoroughly tested before their release, both on animals and humans, and extensive research taking years can go into the approval of a single drug. At least this is what the public is led to believe. Perhaps it is the bureaucratic nature of the Food and Drug Administration, or maybe it is greed on the part of drug manufacturers, but all too often drugs are released, only to be found later to cause severe side effects and harm. To its credit, the FDA maintains a website which provides recall and reporting information to the public.
The FDA has also established a database which is used for the reporting of device and drug defects. The Manufacturer and User Facility Device Experience (MAUDE) is apparently
intended as a means of tracking the incidence of problems related to drugs and medical devices that cause injury. However, MAUDE does an inadequate job on a number of fronts:
- There is no way to verify that a given report is accurate.
- It is not possible to definitively link the drug to the injury simply through the report.
- There is no way to know whether all problems are reported through MAUDE, though it is doubtful.
- MAUDE data does not reflect all safety information relevant to a particular drug.
Determining Who the Defendant Is
It is important in dangerous drug liability cases to name all potential defendants. These can be:
- The manufacturer
- The testing facilities
- The sales representative
- The prescribing doctor
- A hospital or clinic involved in prescribing or administration of the drug
- The pharmacy filling the prescription
The claimant will need to show that he was injured, that the drug has dangerous side effects, and that these side effects caused the injury. It is very important to keep in mind that there is a strict statute of limitations for filing a dangerous drug claim.
What to Do if You Are Injured
If you are injured as a result of being prescribed a dangerous drug, you would do well not to try to fight the pharmaceutical company on your own. These companies have very deep pockets, and retain a staff of expert attorneys whose primary job is to make sure you don’t receive compensation. You should instead hire a personal injury attorney who has a stake in your success, and who has the aggressive spirit and deep knowledge of dangerous drug torts to provide you with the highest standard of legal representation. Call Nadrich & Cohen, LLP today.