1. What is Pharmaceutical and Drug litigation?

This is a unique practice area in which an individual brings a claim against a pharmaceutical company for injuries caused by a drugs manufactured or sold by that corporation. While one individual alone may bring a claim, often a drug has injured many others. These cases often involve thousands or sometimes tens of thousands of claimants who have suffered injuries.

2. What are some recent examples of pharmaceutical litigation?

There are a number of recent examples of litigation in which drugs have caused injury to consumers. One recent example is the drug Vioxx, a non-steroidal anti-inflammatory that was manufactured by Merck to treat chronic pain. The company touted it as being more effective than aspirin without the gastro-intestinal side effects. After it was approved and put on the market numerous studies showed it caused or contributed to cause heart attack and stroke in thousands of people. Bextra/Celebrex were Pfizer products, also non-steroidal anti-inflammatory or pain medications that presented many of the same issues.

Other examples would be Zyprexa/Seroquel- anti-psychotic medications that resulted in many patients developing diabetes; Phen Fen, a diet drug that resulted in heart valve damage and Reglan/Metoclopramide, a medication used to treat gastric reflux that has been associated with tardive dyskinesia, a condition of involuntary movements, twitching and spasms.

3. Who is responsible when injuries are caused by these products?

The defense will often argue that every medicine has risk. Even aspirin when not taken as directed can cause injury. Generally, in these cases three entities, the pharmaceutical company, the physician and, depending on the specific facts, even the pharmacist might have or share in the responsibility when an injury occurs.

Physicians have the responsibility to balance the risks and benefits of a medication in prescribing it to any individual patient. But the physician cannot do his or her job if the drug company has actually concealed or not adequately warned or downplayed the dangers or risks of a drug. The reality is that there are a tremendous number of medications out there and physicians rely heavily on information provided to them by the drug company. This can be especially dangerous to the patient if a pharmaceutical company engages in "off-label" marketing or promoting a drug for use outside of the use approved by the FDA.

There are also times when physicians make mistakes and give drugs for patients in situations in which the drug in contra-indicated or for to long a period of time or in combination with other medicines that create dangerous interactions.

Finally, pharmacists often serve as the last opportunity to protect the patient. More and more pharmacies have computer programs in place which automatically "red flag" certain drug combinations or medicines which may be contra-indicated in a patient. The pharmacist can then contact the physician to confirm that he or she is aware of other medications the patient may be taking.

4. What can a person do when injured by a drug or medical device?

The first thing to do of course is to immediately seek medical advice to minimize any harm a drug or device might have caused. In some cases, it will then be appropriate to consult with a lawyer to determine if you might be entitled to compensation for your injury.

5. Are pharmaceutical cases handled like other "class actions"?

Generally, pharmaceutical litigation for personal injury cases are not handled as a "class action." Class actions are a form of lawsuit in which one or several plaintiffs bring a representative claim on behalf of a large group of similarly situated individuals. There are a number of specific criteria that must exist before a case can be brought as a class action. One of those requirements is that the legal and factual claims plaintiffs have in common outweigh their individual issues. Class actions are in part intended to overcome the situation in which a corporation took some action that may have wrongly cost consumers millions of dollars. However, any individual's right to recovery may be so limited there is no incentive to bring an individual case.

More often than not, courts have found while a number of plaintiffs may have suffered similar injuries, the individual facts, circumstances and causation issues make a class action inappropriate in pharmaceutical cases involving personal injury. These claims are therefore generally brought as individual cases although they are often centralized in one court - often referred to as Multi-District Litigation or MDL.

6. Whose responsibility is it to warn of the dangers presented by drugs?

The pharmaceutical company or medical device manufacturer has the initial responsibility to warning of the risks of a drug or piece of equipment. Years ago, the pharmaceutical company primarily fulfilled that responsibility by providing warning to the patient's physician. The standard of care might then require the physician to warn the patient of certain risks associated with use of a drug. With more and more pharmaceutical companies advertising directly to consumers a strong argument can be made the responsibilities of the pharmaceutical company have expanded to ensure their advertisements provide adequate, user friendly information about the risks and dangers of a product.

7. Why is there so much drug advertising on TV?

Only two countries in the world, the United States and New Zealand, allow pharmaceutical companies to advertise directly to consumers. From 1997 through 2005, the amount of money pharmaceutical companies spent in the US for this kind of direct advertising went from $700 million to over $2.0 billion. Companies are in fierce competition and in business to sell their product to you, the consumer. The danger in advertising directly to consumers, however, is that patients begin requesting their physicians to prescribe medications to them based on slick advertising and not objective medical facts.

8. Has direct consumer advertising played a role in the number of recent recalls?

The pharmaceutical industry puts tremendous pressure on the FDA to get drugs approved and in some instances get them "fast tracked" to market. Approval of these drugs is based on studies in which the number of participants are limited sometimes to as few as a Few hundred of people. If the risk of a drug causing a serious illness is one in a thousand, you might not see evidence of this risk only the pre-approval study only had five hundred participants. After approval, the drug is put on the market, undergoes a mass advertising campaign and then is sold to hundreds of thousands or even millions of people. Suddenly you see people dying from a serious risk that only became apparent after the drug was placed out into the market.

9. What is the FDA's role in all of this?

The FDA is the governmental agency charged with overseeing the approval of drug and medical devices. The FDA, however, has limited resources and relies heavily on the pharmaceutical industry for information and to highlight a drug's potential risks and dangers. Despite these limitations the pharmaceutical industry has tried to use the FDA as a shield, insulating themselves from public scrutiny and the consumers' right to a jury trial. In the recent Supreme Court case of Wyeth v Levine, the pharmaceutical industry argued that FDA approval of a drug pre-empted or precluded a plaintiff's from contesting the adequacy of the drug's warnings in a trial by jury. In that case, the plaintiff Levine lost her right hand to gangrene when she was injected with Phenergan anti-nausea drug made by Wyeth. Ms. Levine won the jury trial under the theory that the drug's label did not adequately warn of this particular risk. Wyeth appealed and argued that the FDA's approval pre-empted or barred any claim under state law. The Supreme Court in a 6-3 vote held that federal regulatory approval did not shield a manufacturer from state law claims.