Product Defect

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, […]

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 […]

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 […]

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 […]

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 […]

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.

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 […]

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 […]

In 1995, David Kessler, former head of the Food and Drug Administration tried to regulate nicotine. His efforts failed when the regulations were struck down in the federal court system. Then, in 2004, the United States Senate passed proposed legislation to do so, only to have the House of Representatives […]

Finally acting on last fall’s huge voluntary recall by most manufacturers of cold and cough medicine, the Food and Drug Administration warned today that giving over-the-counter cough and cold medicine to children under the age of 2 could potentially kill the child. After studying the issue for months and noting […]