| Legal systems are not all about the top court. | | | | that is exactly what a pharmaceutical company |
| There can be many layers underneath where | | | | making an antidepressant would want to hear. |
| cases and principles in dispute bubble up as the | | | | The medication is supposed to change the mood |
| injured seek justice. One of the most contentious | | | | of those who take zoloft for the better. But |
| of the current issues in the United States is the | | | | moods can swing both ways and, just as zoloft |
| idea of pre-emption. That state legislators should | | | | may have its successes, so it may not help or |
| be allowed to shield the pharmaceutical | | | | exaggerate depression. |
| manufacturers from liability even though their | | | | Warning notices are, however, equally two-edged. |
| medications or medical devices may have injured | | | | Also published this month in the Canadian Medical |
| people. The justification is that the Federal | | | | Association Journal is research into the |
| Government has delegated the task of regulating | | | | consequences of the warning published by Health |
| the safety of medications and medical devices to | | | | Canada that there was an increased risk among |
| the Food and Drug Administration (FDA). The | | | | younger patients taking SSRIs including zoloft. In |
| courts therefore do not have the expertise or | | | | the two years after the warning, there was a |
| the right to second-guess the Federal body. | | | | 25% increase in the number of suicides in |
| So, here we comes McNellis v. Pfizer Inc. which | | | | Manitoba. Two further facts may be stated: there |
| was decided by the 3rd U.S. Circuit Court of | | | | was a significant reduction in the number of |
| Appeals in tandem with Colacicco v. Apotex Inc. | | | | younger patients brought forward for treatment, |
| The plaintiffs allege fault because the | | | | and a 14% drop in the number of prescriptions |
| manufacturers of zoloft and paxil failed to give | | | | written for patients under the age of eighteen |
| adequate warnings. Both are Selective Serotonin | | | | years. |
| Reuptake Inhibitors (SSRIs) used to treat | | | | When potentially suicidal people go untreated, |
| depression. Patients taking either zoloft or paxil | | | | some will commit suicide. Let us put the SSRIs |
| committed suicide. Although there is a black box | | | | including zoloft to one side. Therapy and |
| notice that warns of the risk to some extent, the | | | | counselling might have saved more lives. But the |
| FDA refused wording in a stronger and more | | | | warning put out by Health Canada was vague. It |
| explicit form. The cases brought before the state | | | | did not instruct doctors or their patients how to |
| courts of Pennsylvania and New Jersey reached | | | | react. Were they to stop prescribing or taking |
| opposite conclusions. On appeal, it was decided | | | | zoloft? Were they to change the dosage of |
| that state laws do pre-empt the right to claim | | | | zoloft? What change in the symptoms after |
| that there was no adequate warning of the risk | | | | taking zoloft might indicate danger? When some |
| of suicide. | | | | parents are ashamed of their children's illness, it |
| Whether the FDA should or should not enforce a | | | | can be difficult to get them to bring their children |
| more strict labelling system has been the subject | | | | for treatment. Put out a vague warning with no |
| of debate for some years. The SSRIs including | | | | specific recommendation on how to react, and |
| zoloft are associated with changes in mood, | | | | prejudices are confirmed and the children are left |
| particularly among the young. Now, in one sense, | | | | untreated. |