Frequently Asked Questions about Dangerous Drugs and Defective Medical Devices

Older people are at higher risk from dangerous drugs than the general population because a large percentage of seniors take several medications. The average senior takes four to six prescribed medications, in addition to over-the-counter drugs. People 65 and older constitute only 14% of the US population, yet they take more than 33% of all prescription medications. This increased usage exposes seniors to more different drugs, and also increases the risk of dangerous drug interactions.

FDA approval for a drug means that the agency’s scientists have determined that the benefits of the drug will outweigh the risks when it is released into the general population. During the final stage of clinical trials before approval, as many as 3,000 people will take the drug. But some serious side effects are rare. If a side effect occurs in one of 10,000 people, for example, the manufacturer and the FDA probably will not learn of that side effect until the drug has been approved, and hundreds of thousands of people have taken it.

The FDA defines an adverse event as "any undesirable experience associated with the use of a medical product in a patient."

Doctors and health care professionals generally report adverse events to drug companies, which are then required by law to relay serious reports to the FDA within 15 days. Health care providers should report an adverse event if it results in death, disability, hospitalization, is life-threatening, causes a congenital anomaly, or requires treatment to prevent permanent damage. For the first three years after a drug is approved, the drug manufacturer must also report all of its adverse event information to the FDA quarterly, and after three years, these reports must be submitted annually.

The FDA publishes notices about adverse events, which are frequently reported on the internet, on television news and in newspapers. Drug and device manufacturers sometimes issue warnings to health care providers when they learn of adverse events associated with their products.

For questions about symptoms and side effects, as well as any other aspect of your health, you should consult your physician. Your physician can determine whether a drug or device have caused or contributed to your symptoms.

You should talk as soon as possible with an experienced pharmaceutical lawyer or medical device attorney to determine whether you may have a case against the manufacturer of the drug or device.

Acting on your concerns as soon as possible may make the difference between having a case and not having a case. There are deadlines called statutes of limitation, set by laws which regulate the filing of lawsuits; these vary from state to state. If you or a loved one has suffered a serious injury or a loved one has died from a dangerous drug or faulty medical device, you should not delay in contacting a pharmaceutical lawyer or medical device attorney. If the statute of limitations expires, your right to pursue a claim may be forever barred.

Pharmaceutical companies and medical device companies are often large multinational corporations with their own legal staffs, and extensive financial resources to defend their products. To prevail against such determined and well-funded adversaries, you need to have an experienced drug and device attorney on your side, and a law firm that is fully committed to securing justice for its clients.