Sunday, October 28, 2012

Contaminated Drug Lawyer Handles Contaminated Drug Lawsuits: Poor Manufacturing and Compounding Practices Can Lead to Contaminated Drug Deaths By Contaminated Drug Lawyer Jason S. Coomer

Contaminated Drug Death Lawyer: Poor Drug Manufacturing Standards and Compounding Standards Have Caused Numerous Contaminated Drug Deaths By Contaminated Drug Death Lawyer Jason S. Coomer

The fierce competition to maximize profits in the drug industry has led to an increasing number of drug manufacturers and pharmacies to use defective manufacturing practices, defective drug ingredients, and defective compounding practices that create dangerous contaminated drugs and adulterated drugs.  These contaminated drugs and adulterated drugs can cause significant injuries and even death to persons taking the dangerous drugs.

Contaminated Drugs Can Be Caused By Contaminated Raw Materials From Active Pharmaceutical Ingredient (API) Manufacturers, Pharmaceutical Intermediate Manufacturers, and Pharmaceutical Excipient Manufacturers
Pharmaceutical suppliers of raw materials to the pharmaceutical industry include suppliers of active pharmaceutical ingredients (APIs), intermediates, and excipients.   It is the United States Food and Drug Administration's expectation that current good manufacturing practices (CGMP) be used for the manufacturing, processing, packing, or holding (i.e., storage) of active pharmaceutical ingredients (APIs), intermediates, and excipients.  Further, the FDA recommends that laboratory controls should include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures to ensure that raw materials, intermediates, APIs, and containers conform to established standards of quality and purity.

Failure to comply with proper manufacturing practices and sound laboratory controls can result in contaminated drugs and adulterated drugs which can be the basis for several different types of legal actions.
The Meningitis Outbreak and Compounding Pharmacy Standards Can Create Dangerous Contaminated Drugs and Adulterated Drugs

The recent Meningitis outbreak has brought the issue of pharmacy contaminated drugs into the public eye.  However, the Meningitis outbreak is not an isolated event.  Numerous compounding pharmacies have produced contaminated drugs and adulterated drugs.  Though some compounding pharmacies are great, others have poor compounding practices and need to be shut down.

The NECC Meningitis outbreak is a serious case and has caused numerous deaths as well as has made numerous people seriously ill.  Below is some information on the recent Meningitis outbreak.   


Poor Sanitation Found at Pharmacy Linked to Meningitis Outbreak - NYTimes.com

"A federal inspection of a company whose tainted pain medicine has caused one of the worst public health drug disasters since the 1930s found greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits, and an air-conditioner that was shut off nightly despite the importance of controlling temperature and humidity."

"The findings, made public on Friday by the Food and Drug Administration, followed a report from Massachusetts regulators on Tuesday and offered disturbing new details in an emerging portrait of what went wrong inside the New England Compounding Center, the pharmacy at the heart of a national meningitis outbreak in which 25 people have died, 313 more have fallen ill and as many as 14,000 people are believed to have been exposed."

Contaminated Drug Lawsuits, Contaminated Drug Death Lawsuits, and Adulterated Drug Lawsuits by Contaminate Drug Lawyer Jason S. Coomer


For more information on contaminated drugs and adulterated drugs, please feel free to click on the following links: Contaminated Drug Lawsuit Information, Meningitis Lawsuit Information, Adulterated Drug Lawsuit Information, Pharmacy Mistake Lawsuit Information, and Defective Drug Ingredient Lawsuit Information.  For questions on contaminated drug lawsuits, please feel free to contact contaminated drug lawyer Jason S. Coomer.

Saturday, October 13, 2012

Health Watch: Use of Medications Can Cause Fatal Skin Drug Reactions by Texas Steven Johnson Syndrome Lawyer Jason S. Coomer

Health Watch: A Build Up of Some Medications Can Cause Fatal Skin Reactions Including  Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis by Texas Stevens-Johnson Syndrome Lawyer and Fatal Skin Drug Reaction Lawyer Jason S. Coomer

Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are two forms of a life-threatening condition affecting the skin in which cell death causes the epidermis to separate from the dermis.  With this condition a person's skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causes the top layer of a person's skin to die and shed.  The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.  Persons with Stevens-Johnson syndrome (SJS) should seek immediate medical treatment.

Medications are thought to be the most common cause of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. More than 200 medications have been reported in association with SJS/TEN. It is more often seen with drugs with long half-lives compared to even a chemically similar related drug with a short half-life. A half-life of a medication is the time that half of the delivered dose remains circulating in the body. The most commonly implicated medications are antibacterial sulfonamides. Other drugs that have been associated with Stevens-Johnson Syndrome include: Anti-gout Medications; Non Sterodal Anti-Inflammatory Drugs (NSAIDs); Sulfonamides; Penicillins; Ibuprofen (Advil, Children's Advil, Motrin, Children's Motrin, Advil Allergy Sinus Tablets; Advil Cold & Sinus Tablets; Advil Liqui-Gels; Advil Migraine Capsules; Children's Motrin Chewable Tablets; Motrin Junior Strength Chewable Tablets; Motrin Cold & Sinus Tablets; Motrin IB Tablets; Motrin Infants' Drops, and Nuprin); Ketek; Antibiotic; COX-2 inhibitors Bextra (Valdecoxib); Vioxx (Rofecoxib); Celebrex (Celecoxib); Barbiturates; Sedatives; Feldene (Piroxicam); Naproxen (Aleve); Antibiotic Medications; Zithromax (also known as a z-pack); Keflex (cephalexin); Coreg (carvedilol) (a popular beta blocker); Tolectin; Antifungals; Antivirals; and Anticonvulsants.
Medical Malpractice Lawsuits Can Arise When A Doctor Misdiagnoses Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis and Prescribes Additional Medications to the Patient

When diagnosing and treating a person with Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), it is important to identify the condition early and discontinue the medications that may be causing the skin reaction.  In identifying and diagnosing Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), it is also important to determine what medications the patient has been taking and if prior to the rash appearing, the patient suffered from a flu-like illness resembling an upper respiratory tract infection with fever, cough, sore throat, difficulty swallowing, runny nose, sore red eyes, conjunctivitis, as well as general aches and pains.

After the flu-like symptoms, there is typically an abrupt onset of a tender/painful red skin rash starting on the trunk and extending rapidly over hours to days onto the face and limbs. These skin lesions typically include changes in surface color, target lesions, and blisters.  The changes in surface color are typically flat, red and diffuse (measles-like) or purple (purpuric) spots.   The target lesions or erythema multiforme consists of a polymorphous eruption of macules, papules, and characteristic “target” lesions that are symmetrically distributed with a propensity for the distal extremities.  The blisters are typically flaccid, that begin to merge to form sheets of skin detachment, exposing red, oozing dermis. These blisters are positive for the Nikolsky sign which means if the blisters are rubbed gently skin will exfoliation the outermost layer. Nikolsky's sign is almost always present in TEN.

Developing Stevens–Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) constitutes a dermatological emergency and failure to timely act can result in a more severe reaction or even death.  When a person has Stevens–Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), immediate treatment should be sought and all medications should be discontinued, particularly those known to cause SJS-TEN reactions.

A skin biopsy or autopsy is usually required to confirm the clinical diagnosis and to exclude Staphylococcal Scalded Skin Syndrome (SSSS) and other generalised rashes with blisters.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Are Variants of the Same Skin Condition and Can Be The Basis Of A Stevens-Johnson Syndrome Lawsuit or a Toxic Epidermal Necrolysis Lawsuit

Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are variants of the same skin condition.  The condition presents as severe mucosal erosions with widespread skin lesions. In Stevens–Johnson Syndrome (SJS), epidermal detachment involves less than 10 percent of the total body skin area; transitional Stevens–Johnson Syndrome (SJS)-Toxic Epidermal Necrolysis (TEN) is defined by an epidermal detachment between 10 percent and 30 percent; Toxic Epidermal Necrolysis (TEN) is defined by a detachment greater than 30 percent.

Skin reactions during SJS-TEN can be horrific and death from or suffering from the condition either Stevens–Johnson Syndrome or Toxic Epidermal Necrolysis can be a horrific experience for everyone involved.  To help the patient recover it is essential Even worse

Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), has a mortality rate evaluated at about 10%.