Proposed FDA Regulation Reopens Courthouse Doors to Consumers After the Mensing Decision

This post from my friend Rick Schulte, from the TrialLawyerCenter.com:

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.

FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011).  

The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.

In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.

FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.

The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.

Stay tuned for news on the official ruling in weeks to come.

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf

USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses

From the FDA this weekend:

The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. 

The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.

“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”

The products involved in the recall include:

• OxyElite Pro Super Thermo capsules
  --two count capsules UPC #094922417275
  --10 count capsules UPC #094922417251
  --10 count capsules UPC #094922417268
  --21 count capsules UPC #094922426604
  --90 count capsules UPC #094922395573
  --90 count capsules “Pink label” UPC #094922447906
  --180 count capsules UPC #094922447852
   
• OxyElite Pro Ultra-Intense Thermo capsules
  --three count capsules UPC #094922447883
  --three count capsules UPC #094922447876
  --90 count capsules UPC #094922395627
  --180 count capsules UPC #094922447869
   
• OxyElite Pro Super Thermo Powder
  --Fruit Punch 0.15 oz UPC #094922417237
  --Fruit Punch 0.15 oz UPC #094922447517
  --Fruit Punch 4.6 oz UPC #094922426369
  --Fruit Punch 5 oz. UPC #094922447487
  --Blue Raspberry 4.6 oz UPC #094922426376
  --Grape Bubblegum 4.6 oz UPC #094922447500
  --Green Apple 4.6 oz. UPC #094922426499

By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

OxyElite Pro and a CDC update

An interesting read from the CDC:

Notes from the Field: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building — May–October 2013

On September 9, 2013, the Hawaii Department of Health (HDOH) was notified of seven patients with severe acute hepatitis and fulminant liver failure of unknown etiology. Patients were previously healthy and sought medical care during May-September 2013. Clinicians reported that the seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle gain, before illness onset.

The HDOH, with the CDC and the Food and Drug Administration (FDA), initiated a public health investigation including patient interviews, medical chart reviews, and collection of supplement samples for analysis. Subsequently, a case was defined as acute hepatitis of unknown etiology occurring on or after April 1, 2013 in a person who had consumed a weight loss or muscle-building dietary supplement within the previous 60 days and had a serum alanine aminotransferase level greater than or equal to four times the upper limit of normal (>160 IU/L) and a total bilirubin level greater than or equal to two times the upper limit of normal (>2.5 mg/dL) and a negative evaluation for infections including viral hepatitis. Excluded were other etiologies such as pre-existing autoimmune hepatitis, chronic alcohol use, and chronic liver diseases such as primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, and hemochromatosis.

Clinicians reported 45 possible cases to the Hawaii DOH in response to a public health alert. Of those, 29 have been identified as cases. The patients have a median age of 33 years (range: 16–66); 14 (48%) were male. The date of first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013 (Figure). The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were: aspartate aminotransferase 1,128 IU/L (range: 104–2,184, upper limit of normal ~40); alanine transaminase 1,793 IU/L (range: 347–3,091, upper limit of normal ~40); alkaline phosphatase 150 IU/L (range: 68–251, upper limit of normal ~120); and total bilirubin 12.6 mg/dL (range: 2.8–39.6, upper limit of normal ~1.2). Ten patients had liver biopsy data available at the time of this report; seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Eleven (38%) patients were hospitalized, with a median duration of 7 days (range: 1–45). One patient died, two patients received liver transplants, and two remain hospitalized; all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days before illness onset. Twelve (41%) reported use of OxyELITE Pro and no other dietary supplement, and 12 (41%) reported use of both OxyELITE Pro and at least one additional dietary supplement. Three (10%) reported using other dietary supplements for weight loss or muscle building, but not OxyELITE Pro. Information about use of OxyELITE Pro is not yet known for two (7%) patients. For twelve patients with specified dates of use, the median duration from starting OxyELITE Pro to the onset of symptoms was 60 days (range: 7–130). There was no other dietary supplement or medication use reported in common by more than two patients.

National case finding efforts have included surveillance of poison center data using the National Poison Data System. A call for cases was also disseminated through the United Network for Organ Sharing listserv to transplant programs across the country. These activities have identified four persons in states outside of Hawaii with reported OxyELITE Pro or other weight loss or muscle-building dietary supplement use prior to the development of acute hepatitis of unknown cause. One of these is a resident of Hawaii who obtained their product in Hawaii but was diagnosed in a different state. CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these persons to determine if this outbreak is nationwide.

Results from FDA product testing are pending. While the investigation is ongoing and these data are preliminary, clinical data, laboratory tests, and histopathology of liver biopsy specimens collected thus far suggest drug- or herb-induced hepatotoxicity. Drug- and herb-induced hepatotoxicity have been reported in association with exposure to a variety of drugs and herbs used as dietary supplements and can lead to severe acute hepatitis and liver failure (1,2). Drug- and herb-induced hepatotoxicity often resolves following discontinuation of the product (3). Attributing liver injury to a specific ingredient can be challenging because of multiple ingredients, product variability, and lack of testing to confirm exposure to a product. Clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements as part of a comprehensive evaluation. Clinicians should report patients meeting the case definition to the local or state health department, as well as the FDA's MedWatch program. Clinicians can discuss patient management options with a medical or clinical toxicologist by calling their local poison center at 1-800-222-1222. Persons who use dietary supplements for weight loss or muscle gain should do so with caution and under a medical provider's close supervision.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6240a1.htm

FDA Warning that Pfizer’s Tygacil Increases Risk of Death

News from the FDA on this product:

ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk  of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.

This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370170.htm

FDA Asks Ariad to Halt Sale of Leukemia Drug Iclusig

The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of "life-threatening blood clots and severe narrowing of blood vessels".

• Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
• Patients who are currently taking Iclusig, who are responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues.
• Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.

http://www.medpagetoday.com/HematologyOncology/Leukemia/42637

University Compounding Pharmacy Initiates a Nationwide Recall

University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level.  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.

If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. 

The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013. The preparations would have been sold, directly to customers by pick up and by mail from;

University Compounding Pharmacy 1875 3rd Avenue San Diego CA. 92101. 619) 683-2005

Product Name	Lot Number	Expiry
Testosterone Cypionate (Sesame Oil) 200mg/mL Inj.	511017	11/30/2013
Testosterone Cypionate/Testosterone Proprionate 180-20mg/mL Inj	513593	11/30/2013
PGE-1 NS 20mcg/mL Inj.	497940	9/6/2013
PGE-1 NS 100mcg/mL Inj.	497930	11/5/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.	498616	9/25/2013

University Compounding Pharmacy 1765 4th Avenue San Diego CA. 92101. 619) 398-1800

Testosterone CYP (Sesame Oil) 200mg/mL Inj.	474323	9/13/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.	475475	9/26/2013

Specialty Medicine Compounding Pharmacy: Recall of Compounded Sterile Products

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.

Specialty Medicine Compounding Pharmacy has not received any reports of adverse events related to this recall. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013.  No products were distributed out of state.

All unexpired lots of the following compounded products are subject to the recall:

Human Products
Acetylcysteine, 5%	Acetylcysteine, 10%	Acetylcysteine, 20%
Aluminum Potassium Sulfate	Aminophylline PF, 25mg/ml	Bevacizumab, 0.06ml (repackaged)
Bevacizumab, 0.11ml (repackaged)	Bi-Mix, 15mg/0.5mg	Biotin IM, 1mg/ml
Calcium Chloride PF, 500mg/ml	Ceftazidime, 22.5mg/ml (ophthalmic)	Clorpactin, 0.1%
Combo Eye Gel	Cyanocobalamin, 1000mcg/ml	Cyclopentolate HCL, 2% (ophthalmic)
Dexamethasone NaPO4  ionto-pf, 4mg/ml	Dextrose Vial, 50%	DMSO/Glutath, 3.75%/1.75% (ophthalmic)
Edetate Disodium (0.05m), 1.7%	Epinephrine (PF/SF), 0.5ml in 3ml	Epinephrine PF SF (0.3ml), 1:1000
Epinephrine PF SF (1ml), 1:1000	Fentanyl PF, 50mcg/ml	Fluconazole/Gentamicin, 200mg/480mg/1L
Fluorouracil PF, 50mg/ml	Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged)	Glutathione PF, 60mg/ml inhalation
Glycerin-Chromated (w/v), 72%	Hyaluronidase, pf 100U/ml	Hyaluronidase, pf 150U/ml
Hydroxocobalamin, 10,000mcg/ml	Hydroxocobalamin/thiamine, 1mg/100mg/ml	Lidocaine/Sodium Chloride, 0.4%/18%
Magnesium Sulfate, 1gm/50ml	Magnesium Sulfate, 2gm/50ml	Methocarbamol, 100mg/ml (repackaged)
Methylcobalamin, 1000mcg/ml	Methylcobalamin, 10mg/ml	Methylcobalamin, 25mg/ml
Methylcobalamin, 5000mcg/ml	Methylcobalamin, PF 25mg/ml	Multitrace-4 Pediatric Injection
Naloxone HCL, 0.4mg/ml	Naltrexone MCV, 1mg/ml	Neomycin, 333mg/ml
Papav/Phentol/PG E1, 30mg/1mg/20mcg/ml	Papaverine HCL, (10ml) 30mg/ml	Papaverine HCL, (2ml) 30mg/ml
Papaverine HCL, 30mg/ml	Phenol, 6%	Phenylephrine/Tropicamide, 2.5%/1% (ophthalmic)
Polidocanol, 1%	Polidocanol, 3%	Potassium Phosphate, 4.4meq/3mmol/ml
Proparacaine HCL PF, 0.5% (ophthalmic)	Quad Mix, 0.05mg/25mg/2mg/25mcg/ml	Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Quad Mix, 0.1mg/30mg/2mg/50mcg/ml	Quad Mix, 0.1mg/9mg/1mg/10mcg/ml	Quad Mix, in NaCl (1.8/0.2/0.02)mg/18mcg/ml
Sodium Chloride, 0.9% (repackaged)	Sodium Chloride, PF 14.6%	Sodium Phosphate, PF 3mmol/ml
Sodium tetradecyl SO4, 3%	Sodium Thiosulfate PF, 10%	Super Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Testos Cypionate in Oil, 100mg/ml	Testos Cypionate in Oil, 200mg/ml	Testos Cypionate in Olive Oil, 200mg/ml
Tranexamic Acid, 2gm/100ml	Tranexamic Acid, 2gm/75ml	Triple Mix, 15mg/0.5mg/10mcg/ml
Triple Mix, 15mg/1mg/20mcg/ml	Triple Mix, 30mg/1mg/10mcg/ml	Triple Mix, 30mg/1mg/20mcg/ml
Triple Mix, 30mg/1mg/40mcg/ml	Tropicamide, 1%	Vancomycin HCL, 10mg/ml (ophthalmic)
Vigamox in BSS (0.15%), 0.75mg/0.5ml
Veterinary Products
Amikacin Sulfate, 250mg/ml	Buprenorphine HCL, 0.3mg/ml	Buprenorphine HCL, 0.6mg/ml
Ceftazidime in pluronic 250mg/ml gel	Cyclosporin A Oint, 0.2% (ophthalmic)	Cyclosporin MCT, 0.2% (ophthalmic)
Cyclosporin MCT, 1% (ophthalmic)	Desmopressin Acetate (0.01%), 0.1mg/ml	Desmopressin Acetate (0.0125%), 0.125mg/ml
Desmopressin Acetate (0.02%), 0.2mg/ml	Diclofenac Sodium Oint, 0.1% (ophthalmic)	Idoxuridine Ophthalmic, 0.1%
Phenobarbital Sodium, 65mg/ml	Prednisone, 10mg/ml	Tacrolimus, 0.02% (ophthalmic drops)
Tacrolimus, 0.03% (ophthalmic drops)	Tacrolimus Ointment, 0.03% (ophthalmic)	Ticarcillin in Pluronic, 250mg/ml gel
Xylazine 100mg/ml

Specialty Medicine Compounding Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. Customers with questions regarding this recall may contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT.

Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:

FDA takes enforcement action against Oregon dietary supplement manufacturer

The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.

 

If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under Cole’s custody and control.

 

“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”

 

James G. Cole, Inc. has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

 

The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics, and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.

 

Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

 

The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371516.htm

Meningitis Outbreak, NECC Bankruptcy and the NEJM

On the heels of the New England Compounding Pharmacy's Bankruptcy process moving along with a Notice to Creditors being mailed (The forms are due back in January of 2014) there is a report of a NEJM article on the illnesses suffered by innocent consumers who had NECC products put in their bodies.  


The New England Journal of Medicine has a study out, Clinical Findings for Fungal Infections
Caused by Methylprednisolone Injections. According to the NEJM, the authors reviewed medical records for outbreak cases reported to the Centers for Disease Control and Prevention before November 19, 2012, from the six states with the most reported cases (Florida, Indiana, Michigan, New Jersey, Tennessee, and Virginia). Polymerase-chain-reaction assays and immunohistochemical testing were performed on clinical isolates and tissue specimens for pathogen identification.

http://www.nejm.org/doi/full/10.1056/NEJMoa1304879


It 's worth reading.
 

Trial Lawyer Blog Debuts: Trial Lawyer Center

www.triallawyercenter.com is  up and running. It's an effort from several trial lawyers from across the country. Interesting content with more to come. I'm one of the contributors.

Take a look and tell me what you think.

October 2013 News: OxyELITE Pro gets a Warning Letter from the FDA

Fda (Photo credit: Wikipedia)

You can find the letter here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm371203.htm

This letter concerns your products Oxy Elite Pro and VERSA-1 that are labeled and/or promoted as dietary supplements. The labeling for these products declares aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, as a dietary ingredient.

 

The term "dietary supplement" is defined in 21 U.S.C. 321(ff) [section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act)]. Given that you declared aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that aegeline is a “dietary ingredient” under 21 U.S.C. 321(ff)(1). Assuming that aegeline is a "dietary ingredient," it would also be a “new dietary ingredient” for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6.

 

Under 21 U.S.C. 350b, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under 21 U.S.C. 342(f) unless it meets one of two requirements:

 

1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

 

FDA is not aware of any information demonstrating that aegeline was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is FDA aware of any information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information, aegeline is subject to the notification requirement in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. Because the required notification has not been submitted, your products are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

 

In the absence of a history of use or other evidence of safety establishing that aegeline, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, Oxy Elite Pro and VERSA-1 are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v).  FDA is aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElitePro and Versa-1.

 

The importance of establishing that products containing aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of your product is particularly important in the present setting where public health officials in Hawaii and elsewhere within the United States are actively investigating a number of severe illnesses characterized by hepatotoxicity where affected patients report using a product labeled as Oxy Elite Pro. Several findings suggest a causal connection may exist between ingestion of a product labeled as Oxy Elite Pro and the illnesses reported in Hawaii. First, in a review of twenty (20) medical records submitted to FDA by the Hawaii Department of Health, the records indicated that fourteen (14) patients (70%) had ingested a product labeled as Oxy Elite Pro prior to becoming ill. There were no other consistent commonalities among the fourteen (14) patients other than exposure to Oxy Elite Pro. Importantly, eight (8) patients reported Oxy Elite Pro as the sole dietary supplement they took prior to becoming ill, and most of these patients had been entirely healthy before they became ill. Second, upon discontinuing Oxy Elite Pro following onset of illness, most patients recovered from their illness, implying Oxy Elite Pro was the cause of the illness. Unfortunately, several patients sustained injuries to the liver that required transplantation, and one patient died before transplantation could be undertaken. And finally, rigorous clinical protocols were followed in the care of the patients to exclude and/or rule out known causes of liver disease (e.g., viral causes of hepatitis, autoimmune conditions, hemochromatosis, Wilson’s disease, excess alcohol or acetaminophen ingestion, and alpha-1-antityrpsin deficiency). The absence of these causes of liver disease increases the likelihood that Oxy Elite Pro played a hepatotoxic role in these patients. Therefore, in the absence of a history of use or other evidence of safety establishing that aegeline is reasonably expected to be safe under the conditions recommended or suggested in the labeling of Oxy Elite Pro and VERSA-1, your products are deemed to be adulterated under 21 U.S.C. 342(f).

 

We request that you take prompt action to correct these and any other violations associated with Oxy Elite Pro and VERSA-1 and any other products marketed by your firm that contain aegeline. We again remind you that the notification requirement for a new dietary ingredient applies to any dietary supplement that contains a new dietary ingredient that has not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.

 

Failure to immediately cease distribution of all products containing aegeline may result in enforcement action by FDA without further notice. The Act provides various tools to remedy adulterated or misbranded foods, including administrative detention order(s) and seizure(s) against adulterated or misbranded food products in the marketplace, injunction against the manufacturers and distributors from further violating the Act, and criminal sanctions against persons responsible for causing violations of the Act.

 

We request that you advise us in writing, within fifteen (15) working days of receiving this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to adulterated product currently in the marketplace. Your response should also include an explanation of each step taken to assure that similar and repeated violations do not recur, as well as documentation to support your response. Please submit your response to Mr. Quyen Tien at the above letterhead address. Please provide a copy of your response to Mr. Reynaldo R. Rodriguez, Jr., Dallas District Director, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions, please contact Mr. Tien at 215-717-3705.

 

Sincerely,

/S/ 

William A. Correll Jr

Acting Director

Office of Compliance

Center for Food Safety

    and Applied Nutrition

Florida USDCT Judge Strikes Down FL's New Medical Malpractice Law

A federal judge has struck down a key Florida medical malpractice law that required a patient to allow a defending physician’s attorney to informally discuss the case with the patient’s other health care providers. The law would have allowed those discussions to take place without the patient or their representative being present.

U.S. District Judge Robert Hinkle ruled the state law violates the patient consent provisions of the federal Health Insurance Portability and Accountability Act (HIPAA). Under previous longstanding law, a patient seeking to file a medical malpractice claim against a physician had to provide the physician with a pre-suit notification.

Earlier this year Florida lawmakers added a new requirement that as of June 1, the pre-suit notification must include the patient’s authorization allowing a defending physician, the physician’s attorney, insurer and adjuster to hold ex parte discussions with the patient’s previous and subsequent health care providers without the patient and/or their attorney being present.

Here's the Order:

Murphy v. Dulay stricks down med mal law from mzamoralaw

10/23/13 Bankruptcy Court Approves NECC Litigation Proof of Claim

I'm one of seven attorneys appointed by the  Federal Court to oversee the litigation as part of the Plaintiffs' Steering Committee.   Recently, in Bankruptcy Court, a proof of claim form was approved and mailed. The Court and the Trustee just started mailing out this claim form. The proof of claim form must be completed by an injured party in order to preserve the right to bring a monetary claim against NECC. Anyone who was potentially injured by the tainted steroid injections must submit the proof of claim form by January 15, 2014 to be considered in any settlement negotiations.

The first question I'm being asked is - what do the papers say, and must I sign and return them? In truth, the first question is- have you read the full form? Here is what it looks like:

Necc bar date notice a-georgialawyer from mzamoralaw

I've practiced law for more than 20 years. I've been involved in this case from its inception. There are many questions still unanswered for people who had NECC product put in their bodies, and I'm happy to talk with you.

Januvia update for October 2013

In light of this science, our firm has been investigating and filing lawsuits on behalf of Byetta, Januvia, Victoza and other “Incretin-based therapy” users who developed pancreatitis or pancreatic cancer. As of this month, there are two venues: One a single “judicially coordinated” proceeding involving multiple pancreatic cancer lawsuits in California state court (administered by Judge William Highberger in Los Angeles), and two,a federal “multidistrict litigation” proceeding (typically called an “MDL”) in front of federal Judge Anthony Battaglia in the Southern District of California.

Diabetes medications work by affecting the GLP-1 therapy. As such, there is a claimed risk of   pancreatic cancer.Here's the drug list:

Exenatide
1. Byetta (April 28, 2005) (Amylin / Ely Lilly)
2. Bydureon (January 27, 2012) (Amylin / Eli Lilly)

Liraglutide
  Victoza (January 25, 2010) (Novo Nordisk)

Sitagliptin
  Januvia (October 16, 2006) (Merck)
  Janumet (March 30, 2007) (Merck)
  Janumet XR (February 2, 2012) (Merck)
  Juvisync (October 7, 2011) (Merck)

Saxagliptin
  Onglyza (July 31, 2009) (Bristol Myers Squibb)
  Kombiglyze XR (November 5, 2010) (Bristol Myers Squibb)

Alogliptin
  Nesina (January 25, 2013) (Takeda)
  Kazano (January 25, 2013) (Takeda)
  Oseni (January 25, 2013) (Takeda)

Linagliptin
  Tradjenta (May 2, 2011) (Boehringer Ingelheim)
  Jentadueto (January 30, 2012) (Boehringer Ingelheim)

Pancreatic cancer is a malignant neoplasm originating from transformed cells arising in tissues forming the pancreas. The most common type of pancreatic cancer, accounting for 95% of these tumors, is adenocarcinoma (tumors exhibiting glandular architecture on light microscopy) arising within the exocrine component of the pancreas. A minority arise from islet cells, and are classified as neuroendocrine tumors. The signs and symptoms that eventually lead to the diagnosis depend on the location, the size, and the tissue type of the tumor, and may include abdominal pain, lower back pain, and jaundice (if the tumor compresses the bile duct).

Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns

NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.

BACKGROUND: These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall process.

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348156.htm

Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning

News this month on changes to the label of Rituxan: 

FDA approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later treated with drugs classified as CD20-directed cytolytic antibodies, including Arzerra (ofatumumab) and Rituxan (rituximab). Some cases have resulted in fulminant hepatitis, hepatic failure, and death.

To decrease the risk of HBV reactivation, FDA recommends that health care professionals:

• Screen all patients for HBV infection before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
• Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation due to evidence of prior HBV infection.
• Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during Arzerra or Rituxan therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy with these drugs.
• In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately discontinue the drug and start appropriate treatment for HBV. Also discontinue any chemotherapy the patient is receiving until the HBV infection is controlled or resolved.  Because of insufficient data, no recommendation can be made regarding the resumption of Arzerra or Rituxan in patients who develop HBV reactivation hepatitis.

For Patients:

• Before receiving Arzerra or Rituxan, tell your health care professional if you have or have had any severe infections, including HBV.
• If you have had HBV infection, your health care professional should monitor you for HBV infection during treatment and for several months after you stop treatment with Arzerra or Rituxan.

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369846.htm

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall

It's been a busy few days for the FDA  post-shutdown:

Nephron Pharmaceuticals initiated a voluntary recall, at the retail level, of ten lots of product due to results from an internal monitoring process. NPC performs aseptic process simulation as part of an internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. In accordance with published guidance regarding aseptic processing simulation from the FDA, NPC has initiated this recall as a precautionary measure.

BACKGROUND: The affected product is identified as Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) and lots A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371210.htm

Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

From the FDA:

Hospira announced a nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. See firm's press release below for further information.

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

Dräger recalls Fabius anesthesia machines

From the FDA:
 
Dräger has issued a statement regarding its recall on specific Fabius anesthesia machines. Investigations determined that on some power supply units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained. In extreme cases, the influence of mechanical forces, such as movement of the device, for example, may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected. To date, there have been no reported injuries or reported failures due to this issue.

BACKGROUND: This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013 and May 2013 and distributed in the United States between March 2013 and June 2013. Affected devices were distributed nationally (see firm press release for information on affected serial numbers by model).

RECOMMENDATION: If users of the Fabius anesthesia machines experience such a failure of the automatic ventilation function, they should switch over to the manual ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob, and start manual ventilation. Additional details concerning switching to manual ventilation in case of a fault are provided in the Instructions for Use in the Fault-Cause-Remedy and Ventilator Fail Safe sections. Hospitals are urged to notify their personnel accordingly.

Slim Fortune, Lidiy, and Slim Expert Recalled

B@B Trade of Florida is recalling all lots of Slim Fortune, Lidiy, and Slim Expert because they contain undeclared sibutramine, a previously controlled substance that was removed from the marketplace in 2010.

Sibutramine substantially increases blood pressure and/or pulse rate in some patients and may present a significant health risk to those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product can also interact in life-threatening ways with other medications.


Sibutramine (usually in the form of the hydrochloride monohydrate salt) is an oral anorexiant. Until 2010 it was marketed and prescribed as an adjunct in the treatment of exogenous obesity along with diet and exercise. It has been associated with increased cardiovascular events and strokes and has been withdrawn from the market in countries and regions<sup>.

 http://en.wikipedia.org/wiki/Sibutramine</sup>