Drug Companies Say the Doctor Knew and Did Not Tell You

by Bob Schwartz

Product liability cases are filed against drug companies to recover compensation for serious injuries and damages from dangerous prescription drugs. These lawsuits are based on the inadequacy of the written warnings (also referred to as the label or package insert) that come with the drug to warn the patient and prescribing physician of its risks and serious side effects. The lawsuits are premised on the principle that the drug companies have the duty not to injure the patient. Drug companies fulfill that duty when their drugs’ warnings disclose all of the drugs’ risks and serious side effects. Only then can the patient exercise their absolute right to know all of the risks and serious side effects of a drug before they take the drug. When the drug companies fail to fulfill that duty and serious injuries and harm result, the drug company must be held responsible and accountable.

Notice that I said the drug company must be held responsible and accountable. That litigation may or may not involve the doctor who prescribed the dangerous drug. At Bailey & Galyen, litigation against the drug companies rarely if ever involves the prescribing doctor. Prescribing doctors are not sued because they only know what the drug companies tell them. The fact is that the prescribing doctors know little more about a drug’s risks and serious side effects than that, and the information they do have is solely from the drug company’s written warnings. So, if the warnings are inadequate, in all likelihood so is the doctor’s knowledge of the drug’s risks and serious side effects. That effectively makes both the doctors as well as their patients the victims when their patients experience serious side effects that the drug company did not adequately warn about. To add insult to injury, when a lawsuit is filed the drug companies deny any responsibility of wrongdoing and blame both the injured patient and the prescribing doctor for the patient’s injuries and damages. Here is an example of the language drug companies regularly include in their defensive pleadings:

When the drug company takes the prescribing doctor’s deposition, hoping to prove that the doctor would not have done anything differently no matter what was in its warnings and no matter what the prescribing doctor knew, it is important to clearly point out and emphasize to the prescribing doctor that his patient did not sue or make any allegations against him in the case against the drug company. The prescribing doctor must be shown any allegations against him or her, stating the prescribing doctor is responsible and at fault for his or her patient’s injuries and damages, in the drug company’s pleadings filed in the lawsuit.

The drug companies further contend:

  1. even if armed with this knowledge, it wouldn’t matter because the prescribing doctor already knew everything that a supposedly “adequate” warning would have contained;
  2. that the prescribing doctor didn’t read the warnings and, therefore, a different warning wouldn’t have changed the doctor’s decision to prescribe that drug for the patient; and
  3. that even if at the time the prescribing doctor prescribed this dangerous drug to the patient he knew everything that he has since learned about this drug, he still would have prescribed the drug.

To justify this position, the drug companies use the statistics of how many patients might experience a drug’s serious side effects. Drug companies take the callous position that all drugs have side effects, and a side effect is acceptable if one in 10,000 patients experience a serious side effect from their drug because 9,999 people didn’t.

Putting the blame on another in a lawsuit is called alleging an “affirmative defense.” The affirmative defense states that if the drug company did something wrong (which it denies it did), someone else actually caused the patient’s injuries and damages. The drug company’s affirmative defense alleges that its warnings were accurate and complete, and the prescribing doctor caused the patient’s injuries because the drug company passed on to the prescribing doctor all of the information it had about the drug’s risks and serious side effects, and it was the prescribing doctor’s responsibility to then pass that information on to the patient. That works fine if the drug company did make accurate and complete disclosure of all the drug’s risks and serious side effects in its warnings. In that event, the prescribing doctor would have been fully aware of the same and could have passed those warnings on to the patient. Most often, however, that is not the case: the prescribing doctor knows only what he or she reads in the drug company’s warnings.

The fact of the matter is that a prescribing doctor’s learning about a drug’s risks and serious side effects does change his or her prescribing practices accordingly. It does affect which patients he prescribes the drug for, what doses he prescribes, what directions he gives for taking the drug and the risk/benefit discussion he has with the patient before prescribing the drug. It does change the patient’s decision whether or not to take the drug when the patient is aware of and weighs all known risks against the touted benefits of the drug.

The problem is multifold:

  1. The Food and Drug Administration (FDA) approves prescription drugs solely on the information it is provided by the drug company. The FDA does no testing; it is understaffed and underfunded. The FDA relies on the drug companies to test drugs for safety or effectiveness. If the drug company does not adequately test for safety or effectiveness and does not disclose all study results to the FDA, and the FDA approves the drug, it has done so on inaccurate and incomplete information.
  2. The drug company warnings only include that which the FDA makes it include based on what the drug company tells it about the drug’s safety and effectiveness. If the drug company does not disclose all known risks and side effects to the FDA, the warnings will be inaccurate and incomplete.
  3. The drug company’s incentive is not to make accurate and complete disclosure of all known risks and serious side effects to the FDA and in its drug’s label. The reason: doctors will be hesitant to prescribe it and patients will be hesitant to take it, and that reduction in prescriptions written equates to a drop in the drug company’s revenue.

The solution is having the ability to hold the drug companies responsible and accountable for their failing to fulfill their duty to protect patients from known risks and serious injuries.

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