Eli Lilly Settles Prozac Lawsuit

INDIANAPOLIS -- Eli Lilly and Co. has settled a product-liability lawsuit brought by a woman who alleges the drug maker's anti-depressant Prozac caused suicidal thoughts and led her to slash her wrists.

Lilly settled the case last week for an undisclosed amount. The lawsuit, which sought $4.84 million in tangible damages, had been scheduled to go to trial Tuesday in U.S. District Court in Pittsburgh.

The complaint was filed two years ago by Diane Cassidy and her husband Melvin. In July 2000, the Monroeville, Pa., couple picketed outside Lilly's Indianapolis headquarters, handing out fliers proclaiming, "Lilly, how many people are maimed or dead on your drug today?"

The lawsuit alleged that Diane Cassidy's doctor prescribed Prozac to her for weight loss, leading to suicidal thoughts that led her to slash her wrists and overdose on a painkiller.

The overdose caused intracranial bleeding, which left Cassidy paralyzed on one side and mentally impaired, according to the lawsuit.

The Cassidys were represented by Houston trial lawyer Andy Vickery, who has negotiated settlements of several Prozac cases against Lilly.

Lilly said in a statement that it "made a business decision to settle ... for factors completely unrelated to the safety and efficacy of Prozac," The Indianapolis Star reported in a story Saturday. "Such factors included the extensive time demands that litigation would have placed upon our scientists, keeping them away from their primary objective of discovering lifesaving medicines."

Also last week, a new Prozac lawsuit was filed against Lilly in U.S. District Court in Georgia.

It raises a new claim that has not been raised in previous lawsuits over Prozac, which was approved by the U.S. Food and Drug Administration in 1987 and went on to become Lilly's top-selling drug.

The Georgia wrongful-death lawsuit alleges Lilly failed to publicize research showing some people are "poor metabolizers of Prozac," and a test can reveal if a patient might be affected.

That lawsuit, in which Vickery is assisting the plaintiff, was brought by William H. Shell, the widower of LaVerne M. Shell. She shot herself to death at age 63 in November 2000, 11 days after starting on a prescription of Prozac to treat migraine headaches.

The lawsuit says that a human enzyme dubbed CYP2D6 normally metabolizes or breaks down Prozac and similar drugs in the body, but fails to do so in a minority of people. In their bodies, the active ingredient in Prozac builds up to high levels, putting them at risk of violence and suicide, the lawsuit says.

Lilly spokesman Blair Austin said that company officials had not seen the lawsuit and could not comment on the new allegation.

It does not seem that phen-fen is classified as an SSRI at http://www.fda.gov/cder/news/phen/fenphenqa2.htm .

14. Can selective serotonin reuptake inhibitor (SSRI) antidepressants such as Prozac, Zoloft, Luvox and Paxil be substituted for fenfluramine in the phen/fen combination?

FDA has not reviewed the safety or efficacy of such combinations and has not approved their use. These drugs are active in serotonin metabolism but have somewhat different activity than fenfluramine and dexfenfluramine. No currently available weight-loss drugs have been studied adequately in combinations to permit a recommendation by FDA for combined use.

Now, I'm not too sure about the following, but:
Fenfluramine is a potent releaser of serotonin from serotonergic neurons impinging on the cerebral appetite center. This was from http://www.usaweightloss.com/anchors%20patent/United%20States%20Patent%205,795,895.htm

This is clearly different from a reuptake inhibitor, but the research I found was that Paxil (not Prozac) had the effect when taken in doses greater than the depression treatment level.

And you rec'd your MD where?
Well you got me there don't you.
Just because in certain studies the effect was the same, does not mean that these were valid studies and applicable to everyone - there are many ways to set these studies up. To jump to such conclusions, regardless of how it is reported, is irresponsible. Since we are dealing with brain chemistry, there may be significant differences between those who get better on the drug versus those in the control group getting better with a placebo.

You almost have it. The fact is we know precious little about how changes in our low level brain chemistry affect moods and higher thoughts. All these tools are extremely blunt and imprecise especially the stronger ones used for severe brain illness. What clinical psychiatrists essentially do is supress (or sometimes enhance) certain brain activity in the hope that it changes certain thought patterns. Effectiveness is usually enhanced when the treatment is combined with a psychologist who helps the patient through the thought process changes. I believe that therapy should never be left out even with relatively weak drugs like Prozac.

But the most important fact of all is that many placebo patients undergo the same or similar low level brain chemistry changes that the drugs cause.

If belief is so important, why didn't I get better with Prozac? God knows I thought I would. But I didn't. Perhaps I should have tried harder?!?

Faith in medicine is intrinsic, you have it or you don't. If you don't, you can't "force" yourself to have it. However, you can develop faith in your own healing abilities, with medicine and without. That faith can only develop very slowly with substantial changes in lifestyle, work habits, etc. Diet is also very important but very slow to affect brain chemistry. There are no short cuts; Prozac is not a one step program.

It does not seem that phen-fen is classified as an SSRI at http://www.fda.gov/cder/news/phen/fenphenqa2.htm .

You are right it is not a SSRI but both drugs raise the level of serotonin.

This is clearly different from a reuptake inhibitor, but the research I found was that Paxil (not Prozac) had the effect when taken in doses greater than the depression treatment level.

You really need to find out if the research was funded by one of the drug companies. Eli Lilly has a non-disclosure on all of their research. If it doesn't come out the way they want it, it never sees the light of day. Of course if you are a researcher and your research does not come out the way Eli-Lilly wants it to you don't get any more research! The published research may be skewed a little by this.

You may trust this research if you wish.

Why do you think they maximize the revenue from this single drug?

To make more money?????

Is it the prohibitive testing costs for finding any possible risk from a new drug?

Maybe it is just cheaper to hide known faults and falsify reseach.

The reason these drugs work for all these things is basically a placebo effect.

Yeah right.

I don't know the merits of these various lawsuits, but I do know that they are not generally used to punish wrongdoers. Usually the costs are passed to insurance companies, shareholders, and consumers.

The concept that people should stand by as others lives are destroyed for that moronic reason is so ridiculous it doesn't bear any further discussion.

You are right there - brain chemistry can be changed in many ways. It's almost a chicken or the egg question. I would venture that there are many people who have a chemical imbalance that is so strong that getting the imbalanced fixed is the way to go.

Or, there may be some brains that are not as responsive to non-chemical intervention. There is the thought that children who have undergone trauma or serious long term stress when young have their brains almost hardwired along certain pathways.

I believe that there are also cases where giving up the drugs is not an option. Regardless, I agree that therapy is a necessary part of recovery. (Gosh that sounds so touhy-feely!)

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