Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

Click here for more information on the 2014 CMF Distraction System recall

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit.  For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

(Image: DePuy Synthes)

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA)

These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for microbial infection, and according to another FDA safety alert for Siemens MicroScan panels published September 4th, “using the MicroScan WalkAway System” may lead to a “false susceptible” reading or “false intermediate results for imipenem and meropenem antimicrobial susceptibility”. (emphasis added)

“This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

These panels use new, innovative technology and are generally considered effective for determining a patient’s susceptibility to infection by some bacteria, but not others.  In 2002, medical researchers Caroline M. O’Hara and J. Michael Miller of the Centers for Disease Control and Prevention (Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia) published a paper titled  “Ability of the MicroScan Rapid Gram-Negative ID Type 3 Panel To Identify Nonenteric Glucose-Fermenting and Nonfermenting Gram-Negative Bacilli” in which they write, “With an accuracy approaching 75%, this product may be used for the identification of the commonly isolated non-Enterobacteriaceae bacteria but may present problems in identification of other non-glucose-fermenting gram-negative bacilli.”

If you were recently tested for a microbial infection by one of these bacteria, consider asking your doctor if he or she used a Siemens MicroScan Synergies plus® or MicroScan® rapID/S plus Negative Panels kit.  Using antibiotics when you don’t need them can compromise your immune system, which could be just as dangerous as a false negative reading or the use of the wrong antibiotic drug.

An article titled “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”, written by the United States Department of Agriculture’s Food Safety and Inspection Service, reports that the agency has forced the recall of 5,616 pounds of Armanino brand Bolognese sauce products.  The company did not properly label all of their products including milk as one of the ingredients found in the food.  This undeclared allergen could cause serious health problems for some people, and every product must be labeled with any and all known allergens it contains.

The products were sold in Hayward and San Francisco, California.  They did not have the USDA mark of inspection.  While there have been no reports of negative reactions from consumption of the mislabeled products, anyone who is concerned should contact their healthcare provider.

The Food Safety and Inspection Service has ways to check that their recall ability is effective,  making sure that recalling firms are performing their duties by notifying customers of the recall and ensuring that the product is no longer being sold.  The Food Safety and Inspection Service has a virtual representative that can be used 24 hours a day for any consumers who have questions or concerns.

On 11-9-2013, the FDA announced a recall of dietary supplement OxyElite Pro (USPlabs LLC, Dallas) “after officials linked it to cases of liver failure and acute hepatitis in 29 people” in Hawaii, CNN reports.

Several sources now report that one of two patients who required liver transplants has died.  WebMD writes that other people “are awaiting liver transplants in connection with the supplements, which are used for weight loss.”

Due to the fact that OxyElite Pro is classified as a “dietary supplement,” not a drug per se, FDA approval for the compound was not required.  WebMD continues, stating “The FDA sent a warning letter to USPlabs last month telling the company they must stop distributing OxyElite Pro and another dietary supplement, VERSA-1.The supplements contain the ingredient aegeline. The FDA says the ingredient ‘lacks history of use or other evidence of safety.’”

“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.” (Outbreaks > FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro)

 

The FDA writes “Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.  Investigations are ongoing into a potential causal relationship.  [USPlabs, LLC] agrees with FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.”

Here is a list of products subject to this OxyElite Pro recall:

“OxyElite Pro Super Thermo capsules

2 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

3 count capsules UPC #094922447883

3 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”

FDA on symptoms of acute hepatitis:

“Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.”

If you or someone you know has purchased OxyElite Pro, stop using the product immediately, and advise loved ones to do the same.  The FDA states that one can “return it to where [one] purchased it for a refund.”  If you or a loved one experienced adverse effects while taking OxyElite Pro, contact your health care professional or go to the nearest emergency room.

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA)

These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for microbial infection, and according to another FDA safety alert for Siemens MicroScan panels published September 4th, “using the MicroScan WalkAway System” may lead to a “false susceptible” reading or “false intermediate results for imipenem and meropenem antimicrobial susceptibility”. (emphasis added)

“This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

These panels use new, innovative technology and are generally considered effective for determining a patient’s susceptibility to infection by some bacteria, but not others.  In 2002, medical researchers Caroline M. O’Hara and J. Michael Miller of the Centers for Disease Control and Prevention (Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia) published a paper titled  “Ability of the MicroScan Rapid Gram-Negative ID Type 3 Panel To Identify Nonenteric Glucose-Fermenting and Nonfermenting Gram-Negative Bacilli” in which they write, “With an accuracy approaching 75%, this product may be used for the identification of the commonly isolated non-Enterobacteriaceae bacteria but may present problems in identification of other non-glucose-fermenting gram-negative bacilli.”

If you were recently tested for a microbial infection by one of these bacteria, consider asking your doctor if he or she used a Siemens MicroScan Synergies plus® or MicroScan® rapID/S plus Negative Panels kit.  Using antibiotics when you don’t need them can compromise your immune system, which could be just as dangerous as a false negative reading or the use of the wrong antibiotic drug.

Citing concerns about sterility, Lowlite Investments (d/b/a Olympia Pharmacy) in Orlando, FL has recently recalled “all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product,” according to a recent FDA report.

With respect to the present concern over the safety of products sold as sterile by Olympia Pharmacy, The FDA stated on May 29th, “In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.”

Though no reports of injury resulting from contaminated Olympia Pharmacy products have been made to the FDA to-date, if you bought products manufactured by Olympia Pharmacy that have a “use by date of 09/25/2013 or earlier.”  The FDA also states that “Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.”

Thankfully, according to a report by Megan Brooks at MedScape.com, Olympia Pharmacy has stated this recall was “conducted as a ‘precautionary measure’.”

According to the FDA, “Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/30/2013 – Press Release – Olympia Pharmacy]

[05/30/2013 – Recalled Product List – Olympia Pharmacy]”

This recall, however, is simply only one of many compounding pharmacies recently to recall products with questionable sterility.  Here is table explaining recent similar recalls, provided by the FDA.

Please click the image below to enlarge

FDA-Compounding-Recall-Lawyer-Recall-Lawsuit-Lowlite-Olympia-Lawsuit

 

On August 11th of this year, the United States Food and Drug Administration issued a “nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.  There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.”[1]

So far, “The FDA has received reports of 15 patients from two Texas hospitals who received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9 percent for Injection, supplied by Specialty Compounding.  Then the patients developed bacterial bloodstream infections caused by Rhodococcus equi.”[2]  It is the position of the FDA that these infections are related to the gluconate injections.

According to USA Today, this is “the latest in a series of recalls since last year’s outbreak of fungal meningitis.”[3]

The FDA warns that “All sterile use products produced and distributed by Specialty Compounding are being recalled and none of these products should be used by patients or administered to patients. Facilities, health care providers and patients who have received the products since May 9, 2013 should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding.”[4] (emphasis added)

Use of these products thought by Dr. Janet Woodcock, director of the Center for Drug Evaluation and research at the FDA, to “create an unacceptable risk for patients,”[5] and Dr. Woodcock states that “Giving a patient a contaminated injectable drug could result in a life-threatening infection.”[6]

In a statement regarding the recall from Ray Solano, R.Ph., a leading pharmacist at Specialty Compounding, the company “deeply [regrets] the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”[7]

CNN reports that “Over the past year, the FDA has stepped up its investigations of compounding facilities after dozens of people died and hundreds more were made sick by contaminated injections from a compounding facility in Massachusetts” and “A bill with bipartisan support is under consideration in Congress: The Pharmaceutical Compounding Quality and Accountability Act would step up some of that regulation.”[8]

With “[compounding drugs making up] about 1% to 3% of the U.S. prescription drug market,”[9] the sterility of these products is of upmost importance.

In a current announcement recorded in the Star Tribune, Medtronic, Inc. reported that 14 total patient deaths have occurred in connection to their SynchroMed infusion pumps.  The deaths have been reported as occurring between spring of 1996 and spring of 2013.  The article reports that just one day prior to the public announcement from Medtronic, the U.S. Food and Drug Administration issued their highest priority Class I recall on SynchroMed infusion pump devices, indicating that “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.” (emphasis added)

The deaths have been attributed to three major problems: first, several deaths were caused by medication being delivered to the tissue area surrounding the pump, rather than into the patient’s spinal fluid, as well as blockage in the pumps.  Secondly, one of the fourteen tragic deaths was attributed to a SynchroMed device short-circuiting.  Lastly, the devices have been observed as occasionally over-delivering or diluting medication because of the delivery method of the device to the catheter that sits under the patient’s skin.

The Star Tribune article states that Medtronic has made claims that they have warned patients about the potential dangers as well as issuing special detailed instructions to medical professionals who implant the devices as to ensure the safety of their product’s use.

The current controversy following the recalls for the SynchroMed infusion pump provide a clear example of the potential risks that patients face when given a device that has been deemed as potentially hazardous to their health.  If you or a loved one has been implanted with the SynchroMed infusion pump, then you may be at risk of suffering the potentially life-threatening complications caused by such products.  You may be eligible for a SynchroMed lawsuit, in which you may be compensated for the medical use of a dangerous device.  Contact us today and let us represent you to ensure that you receive the legal support you need to win justice for your suffering.

For more information regarding SynchroMed and SynchroMed lawsuits, or for a free case consultation, contact our team of Synchromed lawyers by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, resources, and skills required to win the justice you deserve.

Patent foramen ovale (PFO) is a birth defect that occurs when then a hole between the right and left atria fails to close after birth.  It is can be caused by maternal use of SSRI drugs during pregnancy.  Anyone unlucky enough to have been born with PFO may now have just been dealt another blow:

 

The FDA issued the highest-risk label on St. Jude Medical’s (NYSE:STJ) recall of its Amplatzer TorqVue FX delivery system.

 

St. Jude recalled a component of its Amplatzer Occluder over concerns that part of the delivery system may fracture, potentially causing adverse consequences or even death, according to the FDA report.

The Amplatzer device was designed to treat a condition called patent foramen ovale, in which a naturally occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.

 

Source: FDA slaps highest risk label on St. Jude Medical’s Amplatzer TorqVue FX recall | MassDevice

 

The recalled devices were those made from August 24th of 2012 through September 24th of 2012.  They were distributed from October 1st of 2012 through January 9th of 2012.  The recall was initiated on January 18th, but it took a little time to make its way to the FDA website.  Here is the FDA on the recall. 

 

I’m not sure how widely used the product was.  On the one hand, as many as 1 in 4 people may have a PFO.  (Many people never even know they have it.)  But on the other hand, this product was only manufactured for a month.  There can’t be ten million of them in the marketplace.  Time will tell if there will be any Amplatzer TorqVue lawsuits or other legal issues to blog about here.

If you’re like me, you have a couple of “frequent shopper” cards in your wallet that give you discounts at the grocery stores you frequent.  You probably already know that those frequent shopper cards enable retailers to track every purchase you make.  And you probably already know that retailers get notified by the FDA when products are recalled.  Well, this bill would make retailers connect the dots between those two sources of information:

The Consumer Recall Notification Act would require grocery stores and distribution centers to list specific recalled products and notify customers who had purchased them within 24 hours after the Food and Drug Administration issues recall.

Source: N.Y. Senator Calls for Recall Law

The retailers will of course oppose this on the grounds that it will (a) increase product costs, (b) needlessly alarm consumers, and (c) cause the sky to fall.  But to me, it sounds like a great idea.