Mojo Nights Dietary Supplements Recall

Evol Nutrition Associates, Inc./Red Dawn (“Evol Nutrition”) announced today that it is conducting a voluntary nationwide recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her to the consumer level. The products are manufactured by and are products of Mojo Health of Lauderhill, FL. 

Testing by the U.S. Food and Drug Administration (“FDA”) revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights only, but Evol Nutrition is also recalling Mojo Nights for Her as a precautionary measure. Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction (ED), making Mojo Nights an unapproved new drug. 

Tadalafil is a PDE5 inhibitor. Tadalafil is also manufactured and sold under the name of Tadacip by the Indian pharmaceutical company Cipla in doses of 10 mg and 20 mg.

On November 21, 2003 the Food and Drug Administration approved tadalafil (as Cialis) for sale in the United States as the third ED prescription drug pill (after sildenafil citrate (Viagra) andvardenafil (Levitra)). 

http://www.infozine.com/news/stories/op/storiesView/sid/53182/

September Stryker Rejunivate Recall News

On May 28, 2012, Health Canada informed that Stryker Rejuvenate was being recalled. The recall at that time affected only Rejuvenate devices sold in Canada and was based on a reported rate of less than one percent for revisions associated with the Rejuvenate. So far, no such Stryker recall has been announced in the US.

In July 2012, Stryker recalled its Rejuvenate and ABG II modular-neck stems from the market. The products were recalled according to reports of fretting and corrosion. According to some reports, the FDA received two adverse events linked to the recalled devices, including one in which the device was removed.

Here is the FDA notice:

Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.

"While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action," said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.

Stryker Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data," said Simpson.

Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.

The Stryker Rejuvenate hip implant uses a ceramic component. This is used as an alternative to the metal-on-metal devices. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion. 

Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible—because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design—the Stryker hip device has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose. 

http://www.fda.gov/Safety/Recalls/ucm311043.htm

September, 2012 DMAA News

The US Food and Drug Administration (FDA) has issued another warning letter for DMAA, with Irvine, CA-based Regeneca receiving the letter for its RegeneSlim product.

http://www.nutraingredients-usa.com/Industry/FDA-issues-new-DMAA-warning-letter

Our office is not only investigating this product as used in dietary supplements, we have taken the lead as court counsel in a recently filed case where it's alleged a young lady died as a result of the product she took (that contained DMAA). 

Latest designer drug called 'Smiles' linked to teen deaths

More articles about this dangerous trend:

Several teenagers’ deaths have law enforcement officials concerned about the next in a long line of illegal synthetic drugs: 2C-I, also known as "Smiles."

Read more: http://www.foxnews.com/health/2012/09/24/latest-designer-drug-called-miles-linked-to-teen-deaths/#ixzz27ZnBPoMW

Read more: http://www.foxnews.com/health/2012/09/24/latest-designer-drug-called-miles-linked-to-teen-deaths/#ixzz27Zn65SU6

"Unlike better-known hallucinogens, it has stimulating effects—meaning it carries some of the risks of meth and other uppers, like potentially fatal dehydration, arrhythmia and stroke. "Combining a psychedelic with a stimulant—it's pretty frightening. It's like taking ecstasy and LSD together," says Dr. Stratyner. But the effects are highly unpredictable when you're talking about synthetic compounds that have yet to be thoroughly researched." 

http://www.thefix.com/content/designer-drug-smiles90667

September:Back Pain sufferers; Steroid Injections - Link to Recall Lots?

There is news that a Massachusetts company has recalled three lots of a steroid injection because of a possible link to a rare form of meningitis. 

The medication was sent to more than twenty according to the Centers for Disease Control and Prevention based in Atlanta. The specialty pharmacy that made the steroid is known as New England Compounding Center of Framingham, Mass. There were three recalled three lots of the drug last week.

The lots are:

• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

From the Meningitis Foundation:

Fungal Meningitis

Fungal meningitis, also known as Cryptococcus neoformans, is yeast found in soil throughout the world that usually strikes people with compromised immune systems. 

Information

General:Fungal meningitis is contracted by inhaling airborne yeast cells. The infection is uncommon and not easily spread to others, but serious and requires immediate medical attention. In the United States, 85% of the cases occur in HIV positive patients. Fungal meningitis patients who receive treatment are still at risk of death, brain damage, hearing loss, learning disabilities, speech complications, seizures, and paralysis.

Prevention: 
There is no current vaccine available to prevent anyone from developing fungal meningitis. 


Symptoms: 

• Irritability
• Fever (below normal)
• Headache
• Nausea/vomiting
• Stiff neck
• Sensitive to light
• Hallucinations

MFA urges anyone with these symptoms to seek medical attention immediately! 


Diagnosis: 
All types of meningitis are diagnosed by growing bacteria from a sample of the infected person's spinal fluid, which is collected by performing a lumbar puncture (spinal tap). Results show whether or not the cerebral spinal fluid (CSF) stains show yeast, culture grows cryptococcus, or it's positive for cryptococcus antigen. A blood test, also known as the serum cryptococcal antigen test, can be sensative to HIV positive patients.


Treatment: 
Amphotericin B, an intravenous therapy, is the most common treatment for patients with fungal meningitis. Intrathecal medication is given to patients through the spinal cord who don't respond positively to intravenous therapy. Antifungal medications are also used for treatment. Fluconalzone, an oral medication, may be effective in high doses.

Source(s): 
www.cdc.gov
www.nlm.nih.gov

Peanut butter recall over salmonella expands to 76 products

Sunland Inc. has expanded its recall to 76 types of peanut butter and almond butter after a product it sold to Trader Joe's groceries was linked to a salmonella outbreak.

The company recalled the products under multiple brand names after the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) linked 29 salmonella illnesses in 18 states to Trader Joe's Creamy Salted Valencia Peanut Butter. Sunland Inc, manufactures and packages the Trader Joe's peanut butter.

http://www.cbsnews.com/8301-504763_162-57519688-10391704/peanut-butter-recall-over-salmonella-expands-to-76-products/

Tresiba CV risk?

The FDA has told Novo Nordisk that an FDA Advisory Committee meeting is tentatively scheduled to be held on November 8, 2012 to discuss the New Drug Applications for the ultra-long-acting insulin Tresiba (insulin degludec) and insulin combination analogue Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes.

There is also a report from JP Morgan detailing the CV risk, found here:  https://mm.jpmorgan.com/stp/t/c.do?i=2A970-73A&u=a_p*d_940113.pdf*h_-dgbn7cl%250d%250a

9/21/12: Kroger Recalls Spinach In Georgia

Kroger has recalled spinach sold at grocery stores in 15 states, including Georgia, due to possible Listeria contamination.

The Fresh Selections Tender Spinach was sold in 10-ounze packages and had a "best if used by" date of Sept. 16.
The grocer told the Associated Press Wednesday that if customers did buy the recalled product, they should return it to stores for a full refund or replacement.

Listeria can lead to severe illness for women who are pregnant or people who have a weakened immune system.

The Kroger Co. said the product was sold in Ohio, Kentucky, West Virginia, Virginia, Georgia, Alabama, North Carolina, South Carolina, Tennessee, Michigan, Indiana, Illinois, Missouri, Kansas and Nebraska.
The recall involves its Kroger, Jay C, Owen’s, Pay Less, Scott’s, Food 4 Less, Dillons, Baker’s and Gerbes stores in selected states.

http://midtown.patch.com/articles/kroger-recalls-spinach-in-georgia-7ca84143

2C-I or 'Smiles': The New Killer Drug

Worth a read, recent news on Yahoo.com:

2C-I--known as"Smiles"--has become a serious problem in the Grand Forks and other areas, according to local police. Overdoses of the drug have also be reported in Indiana and Minnesota. But if the internet is any indication, Smiles is on the rise all over the country.

 2C-I or 2,5-dimethoxy-4-iodophenethylamine is a psychedelic phenethylamine. 2C-I is commonly sold in its hydrochloride salt form, which is a fluffy, sparkling-white powder, which has also been pressed into tablet form. http://en.wikipedia.org/wiki/2C-I



"At the moment I am completely and fully submerged, if you can't tell by my eyes, in a psychedelic world known as 2C-I," says a man who appears to be in his late teens or early 20s on a YouTube video posted back in October. His pupils are dilated. He struggles to formulate a description of what he's feeling-it's hard to tell if its because his experience is profound or if his speech skills are simply blunted.

Smile's effects have been called a combination of MDMA and LSD, only far more potent. Users have reported a speedy charge along with intense visual and aural hallucinations that can last anywhere from hours to days.

 http://shine.yahoo.com/healthy-living/2c-smiles-killer-drug-every-parent-know-234200299.html

As of July 9, 2012, in the United States 2C-I is a Schedule I substance under the Synthetic Drug Abuse Prevention Act of 2012, making possession, distribution and manufacture illegal.

Chicken Strips Recalled

Serenade Foods, Inc is recalling about 2,250 lbs of crunchy chicken strip products that may contain fragments of plastic, the U.S. Department of Agriculture's Food Safety and Inspection Service announced Friday.

The 7.5 lb cases of 30 oz cartons of "Milford Valley Farms Crunchy Chicken Strips" are being recalled from Serenade Foods.

The products have a use by date of Jan. 17, 2014 and were packaged on Jan. 17, 2012. They were shipped to a distributor in Lakeland, Florida for further distribution.

http://www.wishtv.com/dpp/news/indiana/fda-recalls-chicken-strips

Oversized Pills Recall Issued by Qualitest (Hydrocodone Bitartrate and acetaminophen)

 Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), today issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg.

The recall includes the following product lot:

• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13.

It is possible that some tablets from lot C1440512A exceed the weight specification and could be super-potent for the ingredients Hydrocodone Bitartrate and Acetaminophen.

Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.

No injuries have been reported to date.

Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lot, C1440512A, was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.

Consumers who have lot C1440512A should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot number should consult their pharmacy or health care professional.

Pharmacists and wholesalers are asked to check their inventories for lot C1440512A, segregate any material from the lot, and to contact MedTurn at 1-800-967-5952 for instructions on product return. Pharmacies that received lot C1440512A will receive a copy of this press release with their recall notification information. In order to make your patients aware of this recall, please post the enclosed press release prominently in the pharmacy area.

http://www.fda.gov/Safety/Recalls/ucm318827.htm?source=go%20vdelivery

Another Court Decision Regarding Social Media and its Discovery

Robinson v. Jones Lang LaSalle Americas, Inc., No. 3:12-cv-00127-PK (D. Or. Aug. 29, 2012), is the case, and it is worth a read. We will have this ready in our arsenal.

In Robinson the litigation involved employment law issues. In discovery sent to the Plaintiff, her former employer sought  discovery all of Robinson's email and text message communications with current and former Jones Lang employees and  (2) all social media content involving Robinson since July 1, 2008, including photographs, videos, and blogs, as well as Facebook, LinkedIn, and MySpace content that reveals or relates to Robinson's. "emotion, feeling, or mental state," to "events that could be reasonably expected to produce a significant emotion, feeling, or mental state," or to allegations in Robinson's complaint.

In Robinson the court noted that social media can provide information inconsistent with a plaintiffs allegation that defendant's conduct caused emotional distress, whether by revealing alternate sources of that emotional distress or undermining plaintiff s allegations of the severity of that distress.  The Robinson Court cited  another court opinion, that authorized discovery of:

[A]ny profiles, postings, or messages (including status updates, wall comments, causes joined, groups joined, activity streams, blog entries) and [social media] applications for [plaintiffs] for the [relevant period] that reveal, refer, or relate to any emotion, feeling, or mental state, as well as communications that reveal, refer, or relate to events that could reasonably be expected to produce a significant emotion, feeling, or mental state.

***

Third-party communications to [plaintiffs] ... if they place these [plaintiffs'] own communications in context.

The Robinson Court went on to write that generally consistent with the principles explained in Simply Storage regarding the proper scope of electronic discovery relevant to alleged emotional distress damages, the court also orders plaintiff to produce:

(I) any:

(a) email or text messages that plaintiff sent to, received from, or exchanged with any current and former employee of defendant, as well as messages forwarding such messages; or

(b) online social media communications by plaintiff, including profiles, postings, messages, status updates, wall comments, causes joined, groups joined, activity streams, applications, blog entries, photographs, or media clips, as well as third-party online social media communications that place plaintiff's own communications in context;

(2) from July 1, 2008 to the present;

(3) that reveal, refer, or relate to:

(a) any significant emotion, feeling, or mental state allegedly caused by defendant's conduct; or

(b) events or communications that could reasonably be expected to produce a significant emotion, feeling, or mental state allegedly caused by defendant's conduct.

This decision is instructive in that it does not permit a kitchen sink type of document production of social media, balances what is discoverable, and attempts to set reasonable limits. 

Model Jury Instruction - Use of Tech to Research a Case or Communicate

Our office has tried 5 jury cases in the last 10 months in Metro Atlanta, and the Court's instructions regarding the use of social media has not always been consistent. For a lawyer who thinks that because she practices in a small town in a rural part of our country and therefore don't have to worry about things like Facebook and blogs, think again. A recent USA Today article pointed out the extensive use of social media by prospective jurors in Lauderdale County, Alabama, where the county seat has less than 30,000 residents.

Here is - to us - the best and most concise jury instruction yet regarding regarding tech to communicate when seated as a juror:    

Model jury-instructions aug2012 - social media from mzamoralaw

http://www.fpd-ohn.org/sites/default/files/files/model-jury-instructions%20Aug2012%20-%20social%20media.pdf

FDA Warns of Burns from OTC Pain Patches

The U.S. Food and Drug Administration (FDA) is alerting the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin. The various formulations include creams, lotions, ointments, and patches.

When applied to the skin, the products produce a local sensation of warmth or coolness; they should not cause pain or skin damage. However, there have been rare cases of serious burns following their use (seeData Summary below). Some of the burns had serious complications requiring hospitalization. In many cases, the burns occurred after only one application of the OTC topical muscle and joint pain reliever, with severe burning or blistering occurring within 24 hours of the first application. Based on the reported cases, the majority of second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient, and products containing both menthol and methyl salicylate, in concentrations greater than 3% menthol and 10% methyl salicylate. Few cases reported using a capsaicin-containing product.

http://www.fda.gov/Drugs/DrugSafety/ucm318858.htm

Ads lose balance when drugs become over-the-counter

Interesting read from: http://news.yahoo.com/ads-lose-balance-drugs-become-over-counter-200518959.html?_esi=1

 When prescription drugs become available over-the-counter, advertisers start spotlighting the benefits and downplaying the risks, a new study finds.

Researchers scrutinized ads for four drugs that have made the transition and found only 11 percent of ads mentioned side effects after the drugs became available without a prescription versus 70 percent before.

"In many, many cases information about risks simply disappeared from the ads once the drugs became over-the-counter," said Dr. Jeremy Greene of Johns Hopkins University in Baltimore, who led the work. "A commitment to fair balance in drug promotion is clearly lost when a drug moves from prescription-only to over-the-counter status."

The study, published in the Journal of the American Medical Association, was supported by CVS Caremark. It includes a sample of 133 television and print direct-to-consumer ads for Claritin (generically known as loratidine), Zyrtec (cetirizine), Xenical/Alli (orlistat) and Prilosec (omeprazole).

U.S. Pulls Drug Licenses from 2 Florida CVS Pharmacies

Two Central Florida CVS pharmacies have lost their licenses to dispense controlled substances after the U.S. Drug Enforcement Administration accused them of ignoring the state's prescription drug abuse epidemic by dispensing excessive amounts of oxycodone, USA TODAY's Donna Leinwand Leger reports.

More here: http://content.usatoday.com/communities/ondeadline/post/2012/09/11/cvs-florida-prescription-drug-abuse-licenses/70000145/1#.UFHnkbJlS0M

Texas Fed. Court Remands Class Action against Ingenix for Violation of Privacy of ERISA Participants & Beneficiaries

Quintana filed a class action suit in Texas state court against Ingenix relating to its practice of reaching out to liability insurers.  To assist in collecting ERISA subro claims, Ingenix would contact the TF’s insurer and make disclosures of private and confidential matters.  This class action asserts “claims that include violation of privacy under Texas common law, negligent invasion of privacy under the Texas medical privacy statutes, negligence, negligent invasion of privacy under Texas law, and violation of the Texas Administrative Code.”  

Ingenix removed the case to federal court claiming protection under ERISA preemption. This court holds that the class action is “not completely preempted by federal law” and remands the case to state court."

You may find the Order here: http://www.lienresolutiongroup.com/quintanavingenix.pdf

Covidien: Recall of DGPHP RFA High-Power Single Use Grounding Pads & Cool-tip™ RFA Electrode Kits

Covidien  announced that it is conducting a voluntary recall of certain production lots of the DGPHP RFA high-power single use grounding pads and Cool-tip™ RFA electrode kits that contain DGPHP RFA high-power single use grounding pads.

Covidien has voluntarily decided to recall specific lots manufactured prior to August 30, 2011, due to the potential degradation of foil within the DGPHP grounding pad. Covidien has received reports of four serious injuries, burns at the pad site on the patient, which may be related to this product quality issue.
 
For ore information, go here: http://www.fda.gov/Safety/Recalls/ucm316017.htm

Respironics California, Inc. Recall Limited Number Of Respironics V60 Ventilators

Respironics California, Inc., a division of Philips Healthcare announced that it has completed notifying its United States customers of a voluntary recall of 116 Respironics V60 Ventilators in the United States and has confirmed that 33 have already been updated. The recall was initiated on July 31, 2012 to address a manufacturing issue that may have affected these ventilators. Two reports of blower motor failures were received and while there were no reports of patient injury at the time of this action, Respironics California, Inc. made the decision to voluntarily replace all affected blowers.

The Respironics V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

An internal Respironics data review found that when the blower assemblies of the recalled ventilators were manufactured, the force used to press the impeller onto the blower motor shaft was less than the specified minimum force. This could result in the impeller moving up the motor shaft and coming in contact with the inside of the blower housing. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. This could pose a risk for injury to the patient. The V60 ventilator will alert users to malfunctioning blowers by annunciating audible and visual alarms.

http://www.fda.gov/Safety/Recalls/ucm317943.htm