Wednesday, March 23, 2011

FDA Investigating Various Drugs and Medical Devices



As reported last month, El Defenzor has been monitoring FDA approval or recall of various drugs and medical devices that may be endangering the public. As a priority of public concern we have discovered the following information:


1) Proof of use of Accutane the drug used for acne. Many adolescents and young adults used this drug to treat acne and damaged the intestines and gastrointestinal tract (other names for generic drug: Sotret, Amnesteem, Claravis)

2) Diagnosis of Inflammatory Bowel Disease, Ulcerative Colitis, or Crohn’s (not IBS)

3) Latency period (time when symptoms of damage show up) can be as long as 7-10 years.

4) Damages from this drug can lead to surgeries, but many people manage disease with medication (Remicade, Asacol, Prednisone, etc..) or by monitoring diet.


Dupuy Medical Devices may cause pain and suffering because not designed or manufactured correctly. There is a recall on the following:


1) Dupuy ASR XL Acetabular Hip System

2) Depuy ASR Hip Resurfacing System

Some other hip implant devices that are being investigated include:

1) Pinnacle

2) Ultimate

3) Dural

4) Summit

Zimmer: . Knee Devices: These devices are also reportedly causing the medical consumer pain in certain reported cases.

1) NexGen CR-Flex Knee (there are several versions, ie… porous femoral, cemented femoral)

2) NexGen CR Knee (several versions, ie…. porous femoral)

3) NexGen LPS-Flex Knee (primarily femoral component loosening, but may also be a claim for entire system because no difference in range of motion in regular LPS versus LPS – Flex, yet greater rates of loosening in Flex models)

4) MIS Tibial Component Implants (at this point, the ones primarily placed without a stem or low profile stem, but I want to keep them all for now).

5) Revision surgeries are going to be the best cases, meaning client got a Zimmer knee (listed above) and due to loosening or failure had to have a second surgery, or even a third or fourth surgery.

6) Mechanical Loosening cases, these are typically associated with increasing lasting pain in the knee area, stiffness in the knee area, diminished motion in the joint, difficulty putting weight on the knee, limping, etc

Paxil Birth Defects

Many unsuspecting mothers were given Paxil for depression during their first and second and even third trimesters of pregnancy. Some were referred out from Planned Parenthood facilities. They ingested the anti-depressant drug and many unfortunately had children with club feet, cleft palates and other severe birth defects.

Together many of these devices and pharmaceutical drugs are being let out into the market without little or any FDA approval or minimal investigation or being “grandfathered in”. One local attorney, Joe Flores, a family nurse practitioner and trial lawyer, stated: “ It is clear that tort reform law, proposed legislation, and the power of pharmaceutical companies in the lobbying arenas, and that of medical device manufacturers, can cause increased risk to the public on certain devices and drugs and the American people have to be ever vigilant in asking their doctors what the risks are before ingesting a drug or having a surgical procedure. The public relies on FDA and medical and pharmaceutical device research, patents and approval and are at the mercy of the reliable and safety representations made to the patient and to their doctors and nurse practitioners.”


El Defenzor gets the prospective of doctors and ex-pharmaceutical reps on the state of FDA approval of drugs and devices. Stay tuned…

Homero Villarreal

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