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Posts Tagged ‘Daubert’

Diedwardo

Dietary Supplements — Litigating Unregulated “Drugs”

Published by Alyssa Diedwardo in Defective Design, Product Liability

I am asked quite frequently to evaluate supplements cases and thought I would share some information that I have found to be helpful and provide some things to consider.

The following supplements can be very dangerous and I recommend they be avoided. Supplements, which combine these and other ingredients into multi-ingredient supplements, are even worse.

  • Aconite
  • Bitter Orange
  • Chaparral
  • Collodial Silver
  • Coltsfoot
  • Comfrey
  • Country Mallow
  • Germanium
  • Greater Celandine
  • Kava
  • Lobelia
  • Yohmbe

From a litigation perspective, the insurance companies for manufacturers of these compounds are likely to have meticulously excluded cases involving the supplements contained on this list from coverage. Pursuing shell companies without insurance coverage does not, in any way, benefit a client injured by these products.

Being successful in these cases requires very diligent work and insight into these very specialized products is needed. The research is very time consuming when done by even the most knowledgeable people.

The FDA warning to manufacturers relating to misbranding is much like pursuing Al Capone for tax evasion in order to put him in prison for much worse things. A misbranding announcement is the “siren call” for much bigger problems in most cases.

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Hopkins

Ghostwriting Mysteries of the Medical Device Industry

Published by John Hopkins in Corporate Fraud, Defective Design, Mass Torts, Product Liability

Pharmaceutical and medical device manufacturers sell their wares for a profit. Nothing wrong with that. If I sold widgets, I would certainly want to generate a profit. If my widgets carried with them the potential to cause severe injury and death though, I would have the absolute responsibility to not place my profits above safety. I would have the absolute duty to alert the public of any potential dangers from the use of my widgets. If I produced a bad widget or if I discovered that use of my widgets inherently caused injury, I would be absolutely duty-bound to alert the consumer. In other words, I am not permitted to generate profit on the backs of injured consumers.

In the pharmaceutical and medical device industry, manufacturers can profit and lose as a result of scientific studies reporting the efficacy and dangers of their products. This is a good thing, though, right? Well, you would think so. The scientists study medical products and are in a position to alert manufacturers to potential dangers—that is a good thing. Well, it’s a good thing if you are not a CEO, waist deep in substantial investments and needing to generate a profit for shareholders. It’s bad if you are a CEO who discovers (or the scientists illustrate what you already knew) that your profitable product is hurting or killing people.

We have suspected for some time that some scientists and medical experts might be “spinning” their conclusions in medical literature so as to down play the problems with various drugs and devices. We now discover what was published in the New York Times about Wyeth and their hormone replacement therapy products (written by Natasha Singer):

“Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.”

“The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.”

What happens here is a ghostwriter authors a paper that is favorable to the particular drug or medical device and a “recognized expert” is paid to put his or her name on the article in order to lend real credence to it. Win – win, right? Not surprisingly, the articles are often written in a way to obscure or outright dispute problems that the manufacturer knows about or should know about before the product hits the market.

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