It was not that long ago the herbal supplement industry was viewed as left wing subversive community of activists. Back in 1994 when the Dietary Supplement Health Education Act (DSHEA) was passed the supplement industry made a platform arguing that the FDA and pharmaceutical market were in conspiracy to keep a multi billion dollar business thriving by driving up prices of prescription drugs that were generally unsafe to the public and preventing the manufacturing and sale of less costly, safer and healthier herbal supplements. Since then, what is now commonly known as the Dietary Supplement industry or CAM (Complimentary Alternative Medicine) industry, has skyrocketed. No longer do you have to search out small mom and pop stores you can go right to your local pharmacy (ironically) to purchase your supplements. New products are flooding the market that claim to be as effective or better and less expensive than pharmaceuticals. Read the rest of this entry »

What is Big Tobacco doing in the Florida tobacco litigation now? They are sending out teams of lawyers and investigators to track down and interview each smoker’s sons, daughters, grandchildren, Aunt Mary, Uncle Bob, the third cousin twice removed, the neighbors, the neighbors neighbors—you get the idea. Read the rest of this entry »

Are They Timely Ortho-FDA Collaborative Warnings, Or Are They FDA Sanctioned Excuses for the Manufacturer

The FDA has been in the news quite often, recently. Lately, consumers have seen news about caustic and blinding eye care solutions (Bausch & Lomb’ ReNu MoistureLoc and AMO’s Complete MoisturePlus), E. coli in spinach, and most recently the Salmonella laced produce outbreak. The FDA first associated the Salmonella outbreak with tomatoes, but had a hard time determining which tomatoes were causing the problem. And now the FDA suspects that other fresh produce may also be contaminated, but cannot determine the source. Read the rest of this entry »

As if keeping up with what is a brand name versus what is a generic medication wasn’t enough, now you can’t even be certain whether what you’re handed by your local pharmacy is even the real deal anyway. Pretty scary stuff.

So the question is while we all are paying the highest prices in decades for our medication how does this happen? The industry and FDA indicate these are high quality fakes. Sorry, not good enough and I don’t buy it. Frankly, that is taking the easy way out. Consumers deserve better. The facts are in the ever expanding effort to lower costs; the pharmaceutical companies and the retail pharmacies, like so many industries, have defaulted to price and profit over quality and safety. Come on, I don’t care how good these pills look shouldn’t these big companies know and investigate who they are buying from? My late father, a very wise man, used to love to use the phrase “too good to be true”. One wonders if a new supplier comes in to the pharmaceutical market, with seemingly impossibly low prices, who is doing the testing of the product and the background check when the bells should be going off? I guess certain folks simply don’t want the answer to some obvious questions. According to the US News and World Report it is left to consumers like Arthur Soclof, an allergist in Livonia Michigan, who on his own discovered his cholesterol medication, Lipitor, sold to him by his local pharmacy, was a fake. Read the rest of this entry »

So, what is Big Tobacco doing these days in the Florida “Engle” litigation? Are they aggressively trying to bring cases to trial so they can be vindicated? Are they conducting important investigation and discovery in an effort to further justice? Ah, not so much.

I speak with clients each day who want to know why Big Tobacco is sending lawyers (or at least people representing themselves as lawyers) to speak with uncle Joe or their fourth cousin, twice removed, with whom they have not spoken since third grade. They want to know why Big Tobacco needs to know where they have lived through their entire 70+ years of life. Why Big Tobacco insists on bothering their neighbors with interviews?

Well, it is all part of a grand plan, I am sure—right? It is most probably a part of a grand, master plan; but is it one in which the purpose is to further justice? Ah, probably not so much.

In the ‘90’s, there was a movie called “Class Action”; in which Gene Hackman played a lawyer fighting for the rights of victims horribly injured and killed by a defective automobile. In one scene, after discovering the defect the car company president calls in his statistics people, or “bean counters”, as they are affectionately referred to by the president. He asks the bean counters whether lawsuits will cost him more than the cost to retool the line and they tell him that lawsuits will be cheaper than the cost to prevent injuries and deaths. The president decides to continue manufacturing the defective car.

In the Engle tobacco litigation, Big Tobacco faces some 8000 plaintiffs. Tragically and as a direct result of cigarette addiction, these folks are largely older, sick people. I would be quite surprised if Big Tobacco has not consulted the “bean counters” and asked them what number of plaintiffs can be “eliminated” through delay and aggressive litigation tactics. I would suspect the bean counters to let them know how long the litigation needs to be delayed to eliminate “X” numbers of plaintiffs.

Am I being unfair to Big Tobacco? Not so much.

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Several companies, including Stryker, BREG, Inc., I-Flow and DJO, Inc. have manufactured and distributed high volume pain pumps. During surgery and for up to three days afterward, doctors use a variety of pain pumps to deliver anesthesia to shoulder joints. These pain pumps have catheters that surgeons can implant into the shoulder’s joint space. Because the pumps offer the advantage of being ambulatory and disposable, they are particularly attractive to surgeons.  Read the rest of this entry »

Let’s take a closer look at one of the Davol patents, which provides the “blueprint” for the Kugel Mesh Hernia Prosthesis (Canadian Patent CA 2 357 020). A brief review of Davol’s patent shows that the oval shaped Kugel Patch is made from a mesh that will not dissolve, and that it has a flexible ring fastened around the edge of the oval mesh to give it shape. The ring material is supposed to dissolve (resorb) over time, leaving the flexible mesh in place to act as an abdominal wall support. Once in place, the mesh portion of the Kugel Patch adapts to the convex shape of the abdomen. Read the rest of this entry »

In the wake of the new Current Good Manufacturing Process (CGMP) the FDA has now posted “FDA 101 How to Use the Consumer Complaint System and Med Watch” to deal with the growing issue of unsafe and contaminated products that include dietary supplements. Read the rest of this entry »

Not necessarily. The herbal product industry is still a largely unregulated industry and historically we know that many of America’s Corporate Citizens have a hard time policing themselves. When those spreadsheets hit the boardroom tables in Big Corporations, it can be difficult for them to consider safety and not focus exclusively on profit margin, bottom line.

When you pick up an herbal drug, you may ask yourself just how much testing and safety analysis the product has undergone. Until the product causes a problem, no one may know for certain. If the problem does not reach the attention of the FDA or Trial Attorneys, consumers may suffer injury or death without discovery that it is the “natural herbal product” that is the culprit.

International Pharmaceuticals, Ltd. has agreed to recall a product called “Viril-Ity-Power (VIP) Tabs, but only after the FDA analyzed the product and advised International Pharmaceuticals that it could cause dangerous drops in blood pressure in some patients. Viril-Ity-Power was touted as a sexual enhancement in the same category as Viagra and similar, regulated drugs. Consumers with diabetes, high blood pressure high cholesterol, or heart disease often takes these types of products. Those consumers, of course, are at most risk with a side effect that dangerously lowers blood pressure.

Kudos to the FDA for their analysis and action to cause a recall.

A lot has happened since 1994 when the FDA decided to let “their hair down” and deregulate the Herbal Supplement Industry at the pleas of “naturalists” who demanded that the government and pharmaceutical industry were in a conspiracy to keep these less costly “natural products” out of the hands of the consumer.

As herbal supplements became the new “drug of choice”, offering lower costs and “safe” natural alternatives to pharmaceuticals demand skyrocketed and the industry became rife with opportunities for profit and exploitation. It is clear that, as with other industries, recognizing the problems with allowing an industry to “self regulate” might be equated to letting the fox in the henhouse and being surprised when the chickens are gone. According to a new report filed by Global Industry Analysts Inc.

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