Steroid Recall, Ohio: Ohio facilities that received NECC medications

Ohio facilities that received NECC medications from May 21, 2012 to October 3, 2012, include:

Akron:

Akron Children’s Hospital

Ashland:

Ashland/Mansfield Foot & Ankle Specialists

Beachwood:

Contemporary Cosmetic Surgery

Surgcenter Cleveland LLC

Belpre:

Physicians Outpatient Surgery Center

Blue Ash:

Professional Radiology

Canfield:

Vitreo-Retinal Consultants

Canton:

Eye Centers of Ohio

Ohio Retina Associates

Vitreo Retinal Consultants

Chardon:

Smith Vein Institute

Cincinnati:

The Christ Hospital Spine Surgery Center

Cincinnati Eye Institute

Cincinnati Pain Management, Cornell Road

Greater Cincinnati Pain Management, Hunt Road

Medical Weight Management Center

Middletown Surgery Center, Franklin

Physicians Healthsource Inc.

Western Hills Interventional Pain

SW Ohio ASC, Middletown

Columbus:

Dublin Pain Clinic

Eye Center of Columbus

Mid-West Allergy Associates Inc.

New You Center for Advanced Medical Aesthetics

Taylor Station

Dayton:

Dayton Vitreo-Retinal Associates

Eye Laser and Surgery Center

Kunesh Eye Center

Samaritan North Surgery Center

Dublin:

Artemis Laser Vein Center

Dublin Physical Medicine

Ortho-Spine Rehab Center Inc.

Timeless Skin Solutions

Fairview Park:

Northcoast Opthalmology

Findlay:

Findlay Surgery Center

Franklin:

Middletown Surgery Center

Gahanna:

Scott Gurwin MD

Gallipolis:

Holzer Clinic

Kent:

Western Reserve Surgery Center

Lima:

Eye Surgery Center of Western Ohio

Lorain:

Roman A. Ringel MD

Mansfield:

Mansfield Foot and Ankle Specialists

Revision Advanced Surgery Center

Marion:

BKC Pain Specialists

Marion Pain Clinic

Marysville:

Marysville Surgical Center

Mayfield Heights:

Jason Leedy MD

Medina:

HMT Dermatology

Middleburg Heights:

Medical Eye Associates Inc.

Mentor:

Mentor Surgery Center

Vitreo Retinal Consultants - Mentor

Middletown:

SW Ohio ASC

Painesville:

Surgical Care Center (2165 Mentor Avenue)

Parma Heights:

Northern Ohio Eye Center

Portsmouth:

Eye Specialists of Ohio

Southern Ohio Medical Center

St. Clairsville:

Khoury Eye Center Inc.

Stow:

St. Clare Surgery Center

Tallmadge:

Novus Clinic

Toledo:

Advanced Pain Management

Toledo Clinic Outpatient Surgery Center

Westlake:

George Parras MD

Wilmington:

Eye Services LLC

Wooster:

Skin Care Solutions

Zanesville:

Insight Surgery & Laser Center LLC

http://cleveland.legalexaminer.com/fda-and-prescription-drugs/necc-news-ohio-clinics-from-akron-to-zanesville-that-received-necc-drugs-may-october-2012.aspx?googleid=305022&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+injuryboard+%28InjuryBoard+Local+Blogs%29#

Tennessee: Tainted Steroid Recall: 74 facilities in TN may have the recalled products

The Tennessee Department of Health has now confirmed that 74 healthcare facilities in Tennessee have received suspect material from New England Compounding Center that may pose a risk to some patients. The Food and Drug Administration has characterized the notification effort as recommended “out of an abundance of caution.”

How those facilities were identified:
The evening of Monday, Oct. 15, the FDA provided TDH a list of more than 131,000 shipping invoices for NECC materials that went to medical facilities across the U.S. TDH staff members began work immediately to identify which NECC invoices were for materials going to Tennessee. On Oct. 16, TDH staff members were able to confirm where the majority of shipments had gone and today continue combing the invoices for additional data.

The process to notify patients:
Also on the evening of Oct. 15, TDH asked for and received cooperative assistance from the Tennessee Hospital Association, the Tennessee Medical Association, the Tennessee Pharmacy Association, AMSURG and other healthcare organizations. Through a cooperative effort, TDH and its partners began contacting healthcare facilities today, providing information to help each facility with an action plan for contacting their patients. The facilities are being urged to identify which patients received potentially unsafe NECC products during heart or eye surgeries and to then contact their patients to provide information about the risk for infection. TDH anticipates some patients will begin receiving contacts as early as this week.

TDH and its partners are working with healthcare providers on the important patient identification and contact efforts. To allow time for these facilities to put their notification plans in place, TDH and its partners are providing assistance with necessary processes at all facilities.  TDH estimates this work will occur very rapidly. The department respects and appreciates care providers’ desires to be the first to contact their patients about the potential risk as an important part of their clinician-patient relationship. 

http://www.blogger.com/blogger.g?blogID=11029204#editor/target=post;postID=2282476682341744905

10/17/2012: Steroid Injection Recall - Live Update

From a colleague of mine, this information at the NECC site, the pharmacy that is alleged to be responsible for the tainted steroid and other medication that lead to a nationwide Meningitis outbreak. 

The CDC and FDA are this morning  currently on site at NECC along Mass DPH and various police agencies seizing and impounding all records of the Center. They have been there for several hours and from what we have seen, they are packing up and labeling boxes as they empty out the file drawers. 

Call us at 855-525-3955 if you would like us to investigate any link between an illness you may have and a steroid injection you had. 

10/16/12 Steroid Injection Recall News: New Drugs (Cardioplegic Solution) Tied to Meningitis Outbreak

From the FDA, more worrisome news as of yesterday: 

ISSUE: As a result of the ongoing investigation of New England Compounding Center (NECC), a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm?source=govdelivery

From the WSJ: 

The Food and Drug Administration said Monday that two additional drugs may be linked to the multistate fungal meningitis outbreak stemming from steroid injections made by a compounding pharmacy in Massachusetts.

The FDA said that a cooling solution made by NECC called cardioplegia, used in heart surgery, and a second injected steroid called triamcinolone acetonide now may be involved in the outbreak. That finding is based on its investigation, along with inquiries by the Centers for Disease Control and Prevention and by state health departments.

The triamcinolone injection made by the New England Compounding Center was linked to one case of possible meningitis

http://online.wsj.com/article/SB10000872396390443624204578058941710381504.html

FDA Recalls Certain Mini-Wheat Cereals After Metal Fragments Found

The Food and Drug Administration is warning that some boxes of Frosted Mini-Wheats cereal may contain metal fragments.

The FDA released the recall Wednesday saying that certain boxes of the Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size cereal “have the possible presence of fragments of flexible metal mesh from a faulty manufacturing part.”

The FDA says only Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size with the letters KB, AP or FK before or after the expiration date have the potential to contain the metal fragments.

http://boston.cbslocal.com/2012/10/10/fda-recalls-certain-mini-wheat-cereals-after-metal-fragments-found/

School Districts to Destroy Recalled Peanut Butter

School districts in California will destroy their supplies of peanut butter that are part of a nationwide recall by the manufacturer, Sunland Inc., the state Department of Education announced Friday.

A voluntary recall of some products made with peanut butter produced by Sunland began Sept. 23 after the U.S. Food and Drug Administration reported salmonella contamination in a jar of Trader Joe’s Valencia Creamy Peanut Butter.

On Oct. 5, the FDA announced that the recall had expanded to at least 300 products sold under a variety of brands. Some included almond butter, cashew butter, tahini, and roasted blanched peanut products. The agency at that time said 35 cases of salmonella-linked sickness had been reported in 19 states. 

http://elcerrito.patch.com/articles/school-districts-to-destroy-recalled-peanut-butter

Salmonella recall expands to raw, roasted peanuts

Raw and roasted peanuts made by Sunland, Inc. are now being included in an ongoing nationwide recall of peanut and other nut products over potential salmonella contamination that has affected many popular brands.

Sunland announced on Friday that both in-shell and shelled raw and roasted peanuts within their current shelf life should not be eaten and the products should be disposed of immediately or returned for a refund.

The raw and roasted peanuts available to retail customers were distributed primarily under Sunland's own label and were distributed primarily to produce houses and nationally to numerous large supermarket, grocery and retail chains in addition to online sales, the company said in a Food and Drug Administration press release.

http://www.cbsnews.com/8301-204_162-57532437/salmonella-recall-expands-to-raw-roasted-peanuts/

10/15: Steroid Recall Co-founder Gregory Conigliaro had background in recycling

The pharmacy linked to the nation's deadly outbreak of meningitis is owned by two brothers-in-law who brought different but complementary skills to the venture: One's a pharmacist, the other a risk-taking businessman who made his mark recycling old computers, fishing rope and mattresses.

Now the New England Compounding Center and its practices are under scrutiny as investigators try to determine how a steroid solution supplied by the pharmacy apparently became contaminated with a fungus. The drug has sickened nearly 200 people in 12 states, killing 15. Most of the patients had received spinal injections of the steroid for back pain.

NECC was founded in 1998 by Barry Cadden and Gregory Conigliaro as a compounding pharmacy, a laboratory that custom-mixes solution, creams and other medicines in dosages and forms that often are unavailable from pharmaceutical companies.

Cadden, who is married to Conigliaro's sister, Lisa, had the medical know-how behind NECC, earning a pharmacy degree from the University of Rhode Island. In a 2002 newsletter, he wrote that compounding had rebounded, after falling off when pharmaceutical companies began manufacturing drugs in the 1950s and '60s, and could help patients with painful conditions that demand "novel approaches.

http://www.thereporter.com/news/ci_21770508/new-england-compounding-center-co-founder-gregory-conigliaro

10/12/12: Marion County, FL Recalled Steroid Injection/Meningitis Outbreak

Munroe Regional Medical Center, Ocala Regional Medical Center and West Marion Community Hospital have been checking out patients who present with possible meningitis symptoms. Combined, the three facilities have seen more than 100 patients who have been injected with the tainted steroid. Nearly 50 were admitted into one of the three hospitals for further observation.

Shands at the University of Florida has one such patient. As is the case with all the other hospitals, the patients did not receive tainted shots there; rather, they went to the hospitals for appropriate tests, treatment and observation


http://www.gainesville.com/article/20121011/ARTICLES/121019873/-1/entertainment?p=3&tc=pg

Call us at 855-525- 3955

10/10/12: Meningitis/Steroid Injection Recall News -Doctors Rethink Use of Custom Pharmacies

An interesting read from the WSJ:

The outbreak of a rare form of meningitis is prompting some doctors to rethink their use of a specialized type of pharmacy that created steroid injections tied to 119 illnesses and 12 deaths.
MedStar Health, a health-care provider that includes Georgetown University and Washington Hospital Center in Washington, D.C., said it is reconsidering its currently limited use of compounding pharmacies, which create alternative versions of medicines, such as liquid forms of pills.

More at the source:  http://online.wsj.com/article/SB10000872396390443294904578046990866798054.html?ru=yahoo&mod=yahoo_hs

What is a compounding pharmacy?

Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.
Another form of compounding is by mixing different strengths (g,mg,mcg) of capsules or tablets to yield the desired amount of medication indicated by the physician, physician assistant, Nurse Practitioner, or clinical pharmacist practitioner. This form of compounding is found at community or hospital pharmacies or in-home administration therapy.

 http://en.wikipedia.org/wiki/Pharmacy#Compounding_pharmacy

What does the FDA have to say about compounding pharmacies?

The FDA views traditional pharmacy compounding as the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription.¹ In its simplest form, it may involve taking an approved drug substance and making a new formulation to meet the medical needs of a specific patient. For example, it may involve formulating the product without a dye or preservative in response to a patient allergy. Or it might involve making a suspension or suppository dosage form for a child or elderly patient who has difficulty swallowing a tablet or a capsule. These traditional forms of pharmacy compounding are an important component of our pharmaceutical armamentarium.

Although these products technically may be considered unapproved new drugs because they differ from the approved formulation of the drug, FDA has exercised enforcement discretion to allow these legitimate forms of pharmacy compounding, which are regulated under state laws governing the practice of pharmacy.

Although compounding was widespread when the FD&C Act was first enacted in 1938, there were no provisions specifically dedicated to compounding, as distinguished from manufacturing of drugs. After the 1962 amendments to the Act expanded the universe of drugs that require FDA pre-market approval to include drugs that are not already generally recognized by experts as effective, courts have interpreted expansively the Act’s provisions to require pre-market approval of virtually all prescription drugs. It is widely recognized, however, that compounded drugs could not meet the approval requirements, in part because they traditionally are made in small amounts for individual patients according to a prescription. In addition, it is usually not feasible to study them in clinical trials to establish their safety and efficacy or prepare new drug applications for all of the different types of compounded products that might be prescribed.

 http://www.fda.gov/NewsEvents/Testimony/ucm115010.htm

 http://steroid-injection-lawyer.com/

Former FDA chief David Kessler says J&J broke the law in promoting Risperdal

David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents.

"In my opinion," Kessler wrote in a report submitted for a trial set to begin Oct. 9 in in Philadelphia's Court of Common Pleas, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act."

In his report, Kessler wrote that there were levels of concern in these matter and actions of J&J and Janssen rose fairly high.

Read more: http://www.philly.com/philly/blogs/phillypharma/Ex-FDA-chief-David-Kessler-says-JJ-broke-the-law-in-promoting-Risperdal.html#ixzz28oBbi8ug
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Bupropion pulled from U.S. shelves after FDA finding

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003.

The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.

http://www.baltimoresun.com/news/nation-world/sns-la-heb-generic-antidepressant-equivilency-20121005,0,1724370.story

October 8, 2012: Steroid Injection Recall - Expanded

Here is the most recent news, since the recall has been expanded: 

New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured. While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure.

From the FDA report, here is a link to list of all recalled products (PDF Alert)
 http://www.fda.gov/downloads/Safety/Recalls/UCM322970.pdf

10/5/12: North Carolina Alert Regarding Recalled Steroid Injection -Meningitis Risk

The news is spreading rapidly across the South, and here is more from a state agency in North Carolina:

The N.C. Department of Health and Human Services is assisting the Centers for Disease Control and Prevention (CDC) in investigating a meningitis outbreak involving patients treated with spinal steroid injections at outpatient surgical centers and pain management clinics. One patient has been identified in North Carolina and 11 more, including two patients that have died, have been identified from one clinic in Tennessee.

The form of meningitis in these patients is suspected to be Aspergillus, a fungal infection. It is not transmitted from person to person and the source for the outbreak is not yet known. DHHS’ Division of Public Health is working with outpatient facilities to contact all North Carolina patients who received epidural steroid injections since July 1, 2012 using the same medication used in the Tennessee clinic.

“Meningitis is a very serious illness that can have tragic consequences,” said State Health Director Laura Gerald. “We are working diligently to determine the cause of the infections and prevent additional cases. In the meantime, we strongly encourage anyone who has had this type of procedure since July 1st that may be experiencing symptoms, however mild, to talk with their doctor or other health care provider right away.”
Symptoms of meningitis may appear gradually and include:

• headache, especially one that worsens
• nausea, vomiting
• sensitivity to light
• fever
• stiff neck
• changes in mental status and confusion

There are many different types of meningitis, a general term for an infection or inflammation of the lining of the brain and the spinal cord. The patients in this investigation were found to have negative results for the most common types of bacterial meningitis.

Epidural steroid injections are a common treatment for inflammation associated with low back pain, leg pain, neck pain, or neck related arm pain and are typically given on an outpatient basis. The circumstances of this outbreak suggest a possible contamination of one of the steroid injection products, and this product has been voluntarily recalled. Other possible causes associated with the outpatient procedures are also being investigated.
For more information on meningitis and symptoms, visit http://epi.publichealth.nc.gov/cd/diseases/meningitis.html

Oct. 2012: Steroid Injections to blame for Meningitis outbreak?

Making the news in the South are reports of a meningitis outbreak claimed to be related to steroid injections. Our office is investigating incidents, 404-451-7781 or toll free 855-525-3955. 

The steroid medication suspected in an outbreak of a rare kind of meningitis was shipped to 23 states, according to the Centers for Disease Control. So far there are reports that a pharmacy that made the steroid, New England Compounding Center of Framingham. There were three recalled three lots of the drug last week and the company has closed. 

Facilities that have received and pulled from use the potentially contaminated steroid product include :

Berlin Interventional Pain Management, Berlin, MD
Box Hill Surgery Center, Abingdon, MD
Greenspring Surgery Center, Baltimore, MD
Harford County Ambulatory Surgery Center, Edgewood, MD
Maryland Pain Specialists, Towson, MD
SurgCenter of Bel Air, Bel Air, MD Zion Ambulatory Center, Baltimore, MD

Here is an image of cases by state (Source:   http://www.enewspf.com/latest-news/health-and-fitness/37178-cdc-reports-multi-state-meningitis-outbreak-oct-4-2012.html)




What is meningitis:

Meningitis is an inflammation of the membranes (meninges) surrounding your brain and spinal cord, usually due to the spread of an infection. The swelling associated with meningitis often triggers the "hallmark" signs and symptoms of this condition, including headache, fever and a stiff neck in anyone over the age of 2.

Here's a letter from 2006 involving this same company and its compounding:

On September 23, 2004, investigators from the U.S. Food and Drug Administration (FDA) and the Massachusetts Board of Pharmacy inspected your firm, located at 697 Waverly Street, Framingham, Massachusetts. On January 19, 2005, the inspection was completed. This inspection revealed that your firm compounds human prescription drugs in various dosage forms and strengths.

We acknowledge the receipt of your October 1, 2004, letter addressed to FDA's New England District Office, concerning questions presented during the referenced inspection.

FDA's position is that the Federal Food, Drug, and Cosmetic Act (FDCA) establishes agency jurisdiction over "new drugs," including compounded drugs. FDA's view that compounded drugs are "new drugs" within the meaning of 21 U.S.C. § 321(p), because they are not "generally recognized, among experts . . . as safe and effective," is supported by substantial judicial authority. See Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 619, 629-30 (1973) (explaining the definition of "new drug"); Prof'ls & Patients for Customized Care v. Shalala, 56 F.3d 592, 593 n.3 (5th Cir. 1995) (the FDCA does not expressly exempt pharmacies or compounded drugs from its new drug provisions); In the Matter of Establishment Inspection of: Wedgewood Village Pharmacy, 270 F. Supp. 2d 525, 543-44 (D.N.J. 2003), aff'd, Wedgewood Village Pharmacy v. United States, 421 F.3d 263, 269 (3d Cir. 2005) ("The FDCA contains provisions with explicit exemptions from the new drug . . . provisions. Neither pharmacies nor compounded drugs are expressly exempted."). FDA maintains that, because they are "new drugs" under the FDCA, compounded drugs may not be introduced into interstate commerce without FDA approval.

The drugs that pharmacists compound are not FDA-approved and lack an FDA finding of safety and efficacy. However, FDA has long recognized the important public health function served by traditional pharmacy compounding. FDA regards traditional compounding as the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician's prescription to create a medication tailored to the specialized needs of an individual patient . See Thompson v. Western States Medical Center, 535 U.S. 357, 360-61 (2002). Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced product, or diluted dosages for children.

Through the exercise of enforcement discretion, FDA historically has not taken enforcement actions against pharmacies engaged in traditional pharmacy compounding. Rather, FDA has directed its enforcement resources against establishments whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new drug, adulteration, or misbranding provisions of the FDCA.

FDA's current enforcement policy with respect to pharmacy compounding is articulated in Compliance Policy Guide (CPG), section 460.200 ["Pharmacy Compounding"], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002)).1 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding. These factors help differentiate the traditional practice of pharmacy compounding from the manufacture of unapproved new drugs. They further address compounding practices that result in significant violations of the new drug, adulteration, or misbranding provisions of the FDCA. These factors include considering whether a firm compounds drugs that are copies or essentially copies of commercially available FDA-approved drug products without an FDA sanctioned investigational new drug application (IND). The factors in the CPG are not intended to be exhaustive and other factors may also be appropriate for consideration.

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