Creafuse Powder dietary supplement recalled

Ge Pharma of North Haven, Conn., is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA).

DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.

FDA Issues Recall On Stryker Spinal Plate Implants

The U.S. Food and Drug Administration (FDA) has issued a recall on the Stryker Spine OASYS Midline Occiput Plate, due to a defect that can cause dangerous side effects. The plate is commonly used as an implant in spinal surgeries, but fractures in the pin that connects the implant’s head to the plate body have been reported recently. These fractures can cause serious side effects such as blood loss, nerve injury and a need for revision surgery.

The FDA issued a Class 1 recall on the plates, the most serious type of recall that can be issued, claiming there is a “reasonable probability” that using the products could lead to “serious adverse health consequences or death.”

Products made by Stryker that were reported to possibly have fractures were distributed between April 23, 2010 and February 12, 2013. It is estimated the 1,536 units exist in the U.S. and another 880 internationally.

This is not the first time Stryker has recalled a dangerous medical device. In 2009, Rejuvenate and ABG II modular-neck hip stems were recalled due to corrosion at the modular neck junctions. The stems are metal hip implants that led to toxic metal debris entering the blood stream.

The FDA does not have the same regulations for medical devices as they do for pharmaceuticals. Many medical devices make it through the approval phase without being properly tested. When devices such as these implants are defective and inserted into patients, catastrophic injuries and even death can occur.

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm366713.htm

Nationwide Recall of All Lots of Virilis Pro, and Prolifta Capsules Due To Undeclared Ingredients

Williamstown, New Jersey – Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED). This issue was brought to our attention as a result of sample-testing conducted by the FDA.

Sildenafil has the potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, sildenafil may cause side effects, such as headaches and flushing. To date, however, there have been no reported adverse events associated with the presence of sildenafil in Virilis Pro, PHUK or Prolifta.

Virilis Pro, PHUK and Prolifta are labeled and intended to be used as dietary supplements for sexual enhancement. Virilis Pro is packaged in a 1 and 2 capsule blister packs and 10 capsule bottles. PHUK is packaged in 1 and 2 capsule blister packs and 4, 12, 24 capsule bottles. Prolifta is packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles. All three products are distributed nationwide to wholesale and retail customers and via the internet.

Aided with the information provided by the FDA, Haute Health, LLC is notifying its distributors and customers by an email and online notice on the homepage of our websitehttp://www.virilispro.com of this voluntary recall. Although Haute Health, LLC has not yet determined whether unlisted sildenafil is contained in lots of dietary supplements not tested by the FDA, as a precaution, Haute Health, LLC is recalling all lots. Haute Health, LLC will arrange for a return of all recalled products. Consumers that have Virilis Pro, PHUK or Prolifta supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt. Retailers who have Virilis Pro, PHUK or Prolifta supplements should stop selling the product.

http://www.fda.gov/Safety/Recalls/ucm370506.htm?utm_source=dlvr.it&utm_medium=twitter

FDA Inspections Put Compounding Pharmacies In Regulatory Gray Zone

Sobering reading in a  recent report from SC

The FDA has inspected about 70 compounding firms in the past year, said Howard Sklamberg, the director of the FDA Office of Compliance. Sklamberg acknowledged the FDA's authority over compounders is unclear. But he said, "We don't send into a firm lawyers with law books."

"We send scientists and trained professionals who know how sterile drugs are supposed to be made," Sklamberg continued. He said inspectors have found startling conditions, like pharmacists using a coffee filter to filter drugs.

More here:  http://wfae.org/post/fda-inspections-put-compounding-pharmacies-regulatory-gray-zone

Wisconsin Firm Recalls Ready-To-Eat Chicken And Ham Products Due To Potential Listeria Monocytogenes Contamination

Garden Fresh Foods, a Milwaukee, Wisc.establishment, is recalling approximately 19,054 pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes,  the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. These products are being recalled in association with a recall by the same company of products regulated by the Food and Drug Administration (FDA).

 http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/rc-055-2013-release

XZone Premium: Undeclared Drug Ingredient

The FDA is advising consumers not to purchase or use XZone Premium, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that XZone Premium contains sildenafil, tadalafil, and dapoxetine. Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED).

These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369724.htm

FDA warns Pfizer's drug Tygacil raises risk of death

Pfizer Inc's antibacterial drug Tygacil increases the risk of death whether used as authorized by the U.S. Food and Drug Administration or for unapproved conditions last week.Pfizer must place a warning inside a black box on the drug's label, indicating the risk is of the most serious nature. The FDA said the drug, which is usually given intravenously, should only be used when alternative treatments are not suitable.

The drug is approved to treat complicated skin and abdominal infections and community-acquired bacterial pneumonia. It is not approved to treat diabetic foot infection or hospital-acquired pneumonia.

From the FDA:

The U.S. Food and Drug Administration (FDA) is warning that an additional analysis shows an increased risk of death when intravenous (IV) Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses.  As a result, we approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections.  A Boxed Warning is the strongest warning given to a drug.  These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication (DSC) about this safety concern in September 2010.

Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.  Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.  Patients and their caregivers should talk with their health care professionals if they have any questions or concerns about Tygacil.

In the 2010 DSC, we informed the public that a combined analysis, or meta-analysis, of 13 Phase 3 and 4 trials showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 4.0% (150/3788) vs. 3.0% (110/3646) respectively.  The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.1, 1.2).  The increased risk was greatest in patients treated with

Tygacil for ventilator-associated pneumonia, a use for which FDA has not approved the drug.
Since issuing the 2010 DSC, we analyzed data from 10 clinical trials conducted only for FDA-approved uses (cSSSI, cIAI, CABP), including trials conducted after the drug was approved.  This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively.  The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%).  In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

 
 http://finance.yahoo.com/news/u-fda-warns-pfizers-drug-180850373.html

Reumofan Dietary Supplements Update

The U.S. Food and Drug Administration has issued several warnings that Reumofan dietary supplements may secretly contain three prescription medications that can cause dangerous side effects.


The FDA's own site has this:

What are Reumofan Plus and Reumofan Plus Premium?

Reumofan Plus and Reumofan Plus Premium are products marketed as natural dietary supplements that contain several potentially harmful active pharmaceutical ingredients. These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. Reumofan Plus and Reumofan Plus Premium are labeled in Spanish, but versions of these products may also exist with English labeling.

Where are Reumofan Plus and Reumofan Plus Premium manufactured and sold?

Reumofan Plus and Reumofan Plus Premium are manufactured in Mexico by Riger Naturals. However, these products have been sold throughout the United States in some retail outlets, at flea markets, and on various Internet sites.

What hidden ingredients were found in Reumofan Plus and Reumofan Plus Premium?

FDA laboratory analysis revealed that Reumofan Plus contains the undeclared and potentially harmful prescription drug ingredients dexamethasone (a corticosteroid), diclofenac sodium (an anti-inflammatory drug), and methocarbamol (a muscle relaxant). Reumofan Plus Premium was found to contain diclofenac sodium and methocarbamol.   

What should consumers do if they have taken Reumofan Plus or Reumofan Plus Premium?

Consumers taking these products are urged to immediately consult with their health care professional (e.g., doctor) to safely discontinue use of the product. The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening, health consequences. The longer the product(s) is taken, the higher the risk of these serious health consequences.
Reumofan Plus contains the corticosteroid, dexamethasone. Abrupt discontinuation of corticosteroids may cause serious withdrawal syndrome and life threatening adrenal suppression. These risks depend upon a number of variables that need to be assessed by a health care professional, and medical intervention may be necessary. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.

What are the risks associated with the undeclared ingredients discovered in Reumofan Plus?

FDA laboratory analysis revealed that Reumofan Plus contains three prescription drug ingredients: dexamethasone, a corticosteroid; diclofenac sodium, an anti-inflammatory drug; and methocarbamol, a muscle relaxant. These ingredients are not listed on the label and could cause serious harm to consumers.
The risks associated with these ingredients include the following:

• Dexamethasone is a potent corticosteroid used primarily for its anti-inflammatory properties. Corticosteroids can reduce the body’s immune response to infection and have profound effects on various organ systems in the body. Dexamethasone and other corticosteroids can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction.
  In addition to the adverse effects that can result from using corticosteroids, the sudden discontinuation of corticosteroids can also have health consequences. Sudden discontinuation of corticosteroids after long-term use or high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath.
   

• Diclofenac sodium is a non-steroidal anti-inflammatory (NSAID) drug that can cause increased risk of cardiovascular events, such as heart attack and stroke. Diclofenac, like other NSAID drugs, can also lead to serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
  The potential drug interactions that can occur with the hidden diclofenac sodium component of Reumofan Plus and Reumofan Plus Premium are serious. Consumers who take Reumofan Plus and/or Reumofan Plus Premium increase their risk of bleeding and the complications of bleeding. Patients already may be taking other medications/products that can cause bleeding. Taking multiple products that have a risk of bleeding significantly increases the risk and the severity of the bleeding if it does occur.
   

• Methocarbomal is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbomal can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. The risk of injury or death is significantly increased when Reumofan Plus and/or Reumofan plus Premium are taken with other medications/products that can cause these impairments.

  Does FDA suspect that Reumofan Plus and Reumofan Plus Premium may contain other unlabeled ingredients?

FDA analysis reflects only the undeclared ingredients discovered in one product from a specific lot, but ingredients may vary from product to product or from lot to lot. Products marketed as dietary supplements that are found to have hidden drug ingredients generally fail to comply with most current good manufacturing practices designed to ensure product quality and safety. Therefore, consumers should expect that the manufacturing processes for Reumofan Plus and Reumofan Plus Premium are unreliable in their ability to provide consistent amounts of active ingredients or to prevent the introduction of unknown chemicals or other impurities.

 http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm316478.htm

Sanofi Settlement over Obesity Drug Linked to Suicidal Thoughts

Sanofi has reached a $40 million settlement of a U.S. lawsuit accusing the French drugmaker of misleading investors about the safety of a weight loss pill that a U.S. regulatory panel linked to suicidal thoughts.

The all-cash settlement was disclosed in a court filing on Thursday, and requires approval by U.S. District Judge George Daniels in Manhattan.

It resolves claims that arose after a U.S. Food and Drug Administration advisory committee on June 13, 2007 urged that the agency reject Sanofi's drug rimonabant, known by the trade names Acomplia and Zimulti, on concern that using it could increase suicidal thinking and depression.

http://www.reuters.com/article/2013/09/19/sanofi-settlement-idUSL2N0HF2AK20130919

Attorneys General Call On FDA To Regulate E-Cigs, Prohibit Sales To Minors

In a bipartisan letter, the attorneys general urged the FDA to take all available measures to regulate e-cigarettes as tobacco products under the Tobacco Control Act. E-cigarettes are battery operated products that heat liquid nicotine, derived from tobacco plants, into a vapor that is inhaled by the user.
“Some smokers see e-cigarettes as a way to wean themselves off of other tobacco products, but the health effects of these popular alternatives have not been adequately studied and the ingredients are not regulated,” Zoeller said. “Nicotine is highly addictive and, if e-cigarettes are left unregulated, our state’s youth may use them as a gateway to smoking.”

State Attorneys General have fought for years to protect people from the dangers of tobacco products. In 1998, the attorneys general of 52 states and territories signed a landmark agreement with the four largest tobacco companies in the United States to recover billions of dollars in costs associated with smoking-related illnesses, and restrict cigarette advertising to prevent youth smoking.

Zoeller said unlike traditional tobacco products, there are no federal age restrictions that would prevent children from obtaining e-cigarettes. Noting the growing use of e-cigarettes, and the growing prevalence of advertising, the letter highlights the need to protect youth from becoming addicted to nicotine through these new products.

A survey conducted by the Centers for Disease Control and Prevention shows that from 2011 to 2012, the percentages of youth who have tried or currently use e-cigarettes both roughly doubled. The survey estimates that nearly 1.8 million middle and high school students have tried e-cigarettes in 2012.

 http://www.indianasnewscenter.com/news/local/Zoeller-Calls-On-FDA-To-Regulate-E-Cigs-Prohibit-Sales-To-Minors-225204282.html

GE Pharma Announces Recall of Creafuse Powder

Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA).

DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.

The product was distributed nationwide and was sold via telephone and email. There have been no reports of adverse events associated with these products to date.

No other products distributed by Ge Pharma LLC are subject to recall.

http://www.fda.gov/Safety/Recalls/ucm368314.htm

FDA to recall Gsunate Plus Suppository

Tobinco Pharmaceuticals Limited has outlined measures to assist the Food and Drugs Authority (FDA) to recall Gsunate Plus Suppository, an anti-malaria combination of Artesunate 25mg and Amodiaquine 75mg, from the market.

Tobinco, importers of the drug, has directed all hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities having stocks of Gsunate Plus Suppository to immediately handover stocks to its Regional offices or the nearest FDA office countrywide for safe disposal.

http://www.ghanaweb.com/GhanaHomePage/health/artikel.php?ID=286092

Chobani Yogurt Recall: 170 Illnesses Now Reported to FDA

170 people say they fell ill after eating Chobani infected with mold, said Shelly Burgess, a spokesperson for the agency. Cramps, nausea, headache and diarrhea were some of the top symptoms reported, she said. Illnesses have been reported in Arizona, Delaware, New York, Maryland, Ohio, Pennsylvania, California, Indiana and Florida.

Chobani issued a voluntary recall of the yogurt on Sept. 5 after some customers reported nausea and vomiting. All affected yogurt has been long pulled from store shelves, the company says, though the FDA is investigating reports that contaminated yogurt is still for sale, according to OregonLive.com.

At the time of the initial recall, the company described affected containers of Chobani as swollen and bloated, with the yogurt within appearing runny. It's because of "a type of mold commonly found in the dairy environment," Chobani told Food Navigator, an industry publication.

http://www.weather.com/health/chobani-yogurt-recall-170-illnesses-now-reported-fda-20130916

Should FDA Require All Acetaminophen Drugs to Carry Black Box Warnings?

An interesting read from Pro Publica

For prescription drugs, the FDA can require so-called black box warnings when drugs pose a potentially "serious or life-threatening" risk. The agency requires all prescription drugs containing acetaminophen to carry a black box warning that an overdose can result in liver transplant or death. For over-the-counter Tylenol and its generic equivalents, the FDA requires no warning that overdose can be fatal.

http://www.propublica.org/getinvolved/item/should-fda-require-all-acetaminophen-drugs-carry-black-box-warnings

FDA: Label changes for Antimalarial Drug Mefloquine Hydrochloride

News today  that Army Units to Stop Taking Anti-Malarial Drug.

The top doctor for Green Berets and other elite Army commandos has told troops to immediately stop taking mefloquine, an anti-malaria drug found to cause permanent brain damage in rare cases.

The ban among special operations forces is the latest development in a long-running controversy over mefloquine. The drug was developed by the Army in the 1970s and has been taken by millions of travelers and people in the military over the years. As alternatives were developed, it fell out of favor as the front-line defense against malaria, a mosquito-borne disease that international health officials say kills roughly 600,000 people a year.

This is further to a recent FDA report, below: 

The U.S. Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label.  FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears.  The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations (For a more complete list of potential side effects, see Additional Information for Patients).

Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent.  Patients, caregivers, and health care professionals should watch for these side effects. When using the drug to prevent malaria, if a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine should be used.  If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing health care professional.  The patient should not stop taking mefloquine before discussing symptoms with the health care professional.
Malaria is a serious disease caused by a parasite that commonly infects mosquitoes, which then bite humans.  It is a major cause of death worldwide but is less common in the United States.  The disease is a problem primarily in developing countries with warm climates.  Persons who travel to these countries may be at risk of malaria infection and should take drugs to prevent or reduce that risk. 

People with malaria often experience fever, chills, and flu-like symptoms.  Drugs must be taken to treat the disease if you have been infected, but may, themselves, have side effects.
FDA will continue to evaluate the safety of mefloquine and will communicate with the public again if additional information becomes available.

Maryland Justice for a Little Girl Injured for Life Because of Dr. Wrongdoing

Here's a recent report on a verdict for a family from Easton, PA.   Chloe McCarthy who is now 4,  suffers from lifelong cerebral palsy and neurological injuries. She must endure these because a jury has spoken, holding that Dr. Garry C. Karounos' failure to perform a cesarean section and continuing with a natural delivery after Erin McCarthy's labor stalled in August 2009.

Equally tragic? Because of this negligence , Erin McCarthy also was badly injured during the delivery of Chloe.  Chloe still has weakness on her left side as well as cognitive and expressive speech delays. Chloe is currently undergoing treatment including occupational therapy, physical therapy, speech therapy and is enrolled in a special education program. The impact of her delivery on the remainder of her life remains unknown.
 

The young mother, Erin McCarthy, underwent a vaginal delivery of her daughter despite her voicing concerns that the child was abnormally large. Before delivery, she underwent a sonogram that predicted a 10-pound baby four days before the delivery. The resulting 16-hour labor and delivery of her daughter Chloe nearly killed the infant and left the mother with a vaginal tear that extended through her anal sphincter. Chloe had no heartbeat, wasn't breathing or moving and was blue after a traumatic delivery. The child required immediate lifesaving resuscitation in the delivery room and was later transferred to Thomas Jefferson Hospital for emergency head cooling treatment.

According to family lawyers, Dr. Garry C. Karounos did not offer to perform a Caesarian section at any time during McCarthy's labor. He disregarded warning signs that the baby was suffering from shoulder dystocia, a condition in which her shoulder was trapped behind the mother's pubic bone. Karounos instead used forceps to try to deliver the baby. The result was severe injury to both mother and daughter.

Lehigh Valley Health Network was not named as a defendant in the suit. A spokesman for the network said Karounos no longer practices at LVHN.

Read more: http://www.mcall.com/news/local/allentown/mc-allentown-malpractice-verdict-birth-injury-20130911,0,380104.story#ixzz2fMuvFT4j

DMAA - Seizure of products from South Carolina

Is DMAA safe? Read this pleading:

Southcarolina from mzamoralaw

Natural’ Sex Supplements Deemed Unsafe By The FDA Still Being Sold, Marketed In New York City

The Daily News reports that despite known health risks, New Yorkers are still taking sex related supplements which are sold at bodegas, delis, and sex shops across the city. Earlier this year, the U.S. Food and Drug Administration (FDA) issued several warnings about sex supplements and male enhancement products that purport to be “all natural,” but in fact contain traces of prescription-strength medication.

More here. http://www.medicaldaily.com/natural-sex-supplements-deemed-unsafe-fda-still-being-sold-marketed-new-york-city-shops-video-255511

Infant Motrin recalled - plastic specks

Johnson & Johnson is recalling 200,000 bottles of Motrin Infants formula due to the risk that they contain tiny plastic particles.

J&J's McNeil unit said Friday that the recall affects three lots of its popular Motrin Infants' Drops Original Berry Flavor, which is used to lower fever and treat aches and pains in children 2 years old and younger. The company warned that the medicine may be contaminated with specs of PTFE, a plastic also used in Teflon coatings. No illnesses or injuries have been reported to date, according to the company.

http://www.freep.com/article/20130907/BUSINESS07/309070065/Infant-Motrin-recalled-due-to-plastic-specks

Redux: Motions in Limine We Use

Motion in Limine We Use

Here is a reblog of a Motion in Limine post. I share it on various list servers too .. 

I file a Motion in Limine on general issues early so that I can set the tone for depositions and other discovery issues that crop up during a case. Almost always, I file an extensive MIL within sixty days of service of an Answer. The MIL is lengthy, but I have won every single point, or had defense counsel agree to them in advance.

FIRST MOTION IN LIMINE

Plaintiff files this Motion in Limine and moves this Court for an Order prohibiting counsel for the Defense from making any comment, directly or indirectly, in any manner whatsoever, concerning any of the matters set forth:

1.APPROACH THE BENCH: Plaintiff requests that Defense counsel first approach the Bench and obtain a ruling of the Court outside the presence and hearing of all prospective jurors, or jurors ultimately selected in this case, in regard to any alleged theory of such matters contained herein, at trial and mentioned to jury at Voir Dire.

2. INFORM WITNESSES: Plaintiff moves the Court for an Order directing counsel to inform any and all defense witnesses of the Court order regarding these matters, and to instruct any and all such witnesses to refrain from mentioning any such matters in the presence and hearing of all prospective jurors or jurors ultimately selected in this case until defense counsel has obtained a ruling in compliance with this order that such matters would be admissible as evidence in this case.

3.COLLATERAL SOURCE PAYMENTS/BENEFITS: Any reference or suggestion that Plaintiff has received, has been entitled to receive, will receive, or will become entitled to receive, benefits of any kind or character from a collateral source, including, but not limited to, the following: (A) Benefits from collateral insurance coverage; (B) Services furnished without charge; (C) Compensation for time not actually worked; (D) Social Security or pensions; (E) Workers' compensation benefits; (F) Medicaid or Medicare. See Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Georgia Power Co. v. Flagan, 261 Ga. 41 (1991); Bennett v. Haley, 132 Ga. App. 512, 525 (1974). See also Warren v. Ballard, 266 Ga. 408 (2), 467 S.E.2d 891 (1996); Worthy v. Kendall, 222 Ga. App. 324, 474 S.E.2d 627 (1996).

4.OTHER COMPENSATION. That the plaintiff, by reason of age, infirmity, or otherwise, is now or may be entitled in the future to receive any compensation or benefits by reason of the Social Security Law of the United States or from any governmental agency such as the veterans' Administration, Medicare, or sources of this nature.

5. ATTACKS ON PLAINTIFF'S TRIAL COUNSEL BY DEFENSE ATTORNEYS. Any reference or suggestion as a personal attack and uncivil comments about plaintiff's trial counsel by the defendant or their attorneys. Personal attacks on adversarial counsel has no place with the truth-seeking context of litigation.

6. ADVERTISEMENT BY PLAINTIFF'S ATTORNEY. Any reference or suggestion to the advertisement or the fact that plaintiff's attorney advertises. This includes slogans, jingles, or reference to the yellow pages, television or any media. The issue of how attorneys obtain business should not become an issue in the case. The fact that plaintiff's counsel advertises to obtain clients is no more relevant that the practice by defense attorneys to join exclusive organizations in which to wine and dine insurance adjusters and corporate clients for business, in order to obtain business.

7.FINANCIAL STATUS OF ATTORNEY OR MEDICAL PROVIDER. Any reference or suggestion to the income or financial status of the plaintiff’s attorney or the treating physicians. The issue of the wealth or income of the attorneys or treating physicians should not become an issue in the case. On at least one occasion, defense counsel has argued in other cases that plaintiff's attorneys advertised and stated to jury "how do you think these attorneys and these doctors can afford such expensive advertisement and have nice offices".

8.AMERICAN TORT SYSTEM OR PLAINTIFF'S LAWYERS IN GENERAL. Any reference or suggestion or the introduction of any evidence by the defense counsel directly or indirectly attacking the American Court System or plaintiffs attorneys or recent tort reform campaigns.
Neither the American tort system or plaintiffs attorneys in general are on trial in this case. The trial of this case should not be an opportunity for defense counsel to voice opinion regarding tort reform. The injuries sustained by the plaintiff are a result of the defendant’s negligence and the defense should not be permitted to ignore the issues in this case and attack the tort system in general.

The debate surrounding tort reform is irrelevant to this case and would serve only to inflame and prejudice the jury. These references would poison this case with anti-lawsuit and anti-lawyer bias, which has been highlighted in recent corporate, media campaign and emotional propaganda. The only thing to be gained in allowing defense counsel to discuss these issues would be a concealment of the truth. This subject applies to Trial only and not Voir Dire.

9.UNRELATED CLAIMS. Any reference or suggestion that Plaintiff has had unrelated, prior or subsequent claims, suits or settlements or the amounts thereof. See O.C.G.A. §24-2-1 and §24-2-2; Goforth v. Wigley, 178 Ga. App. 558, 559-60 (1986). Further, no mention should be made concerning any injuries to the defendant(s), that they did not bring a claim or suit for.

10. UNRELATED ACCIDENTS AND INJURIES. Any reference or suggestion that Plaintiff has any other unrelated injuries, diseases, conditions, or illness, or the effects thereof, which are wholly disassociated from and do not relate to or serve as a "sole cause" defense to his/her present claims, and which Defendant cannot medically associate and relate to plaintiff's injuries for which compensatory damages are claimed in this case. See O.C.G.A. §24-2-1 and §24-2-2; Goforth v. Wigley, 1788 Ga. App. 558, 559-60 (1986); United Motor Freight Terminal Company Inc. v. Hixon, 76 Ga. App. 653, 655 (1948); Barnes v. Cornett, 134 Ga. App. 120, 122 (1975). Further, No mention should be made about the plaintiffs having previously filed claims or lawsuits.

11.FINANCIAL CONSEQUENCES OF JUDGMENT AGAINST DEFENDANT. Any reference or suggestion that Defendant is uninsured as to Plaintiff's claims, including, but not limited to, any reference as to Defendant as a little person, or small or struggling, or any other such reference which would tend to convey to the jury the impression that Defendant is a party of modest means who cannot afford to pay a substantial judgment. See O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508, (1989); Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Georgia Power Company v. Flagan, 261 Ga. 41 (1991); Northwestern University v. Crisp, 211 Ga. 636, 641 (1955); Brunswick & Western Railroad Co. v. Wiggins, 113 Ga. 842, 850 (1901); Higgins v. The Cherokee Railroad, 73 Ga., 149 (3) (1984); Bennett v. Haley, 132 Ga. App. 512, 525 (1974); See also Georgia State Bar Rules, DR 7-102(A)(3), (4) and (5); DR 7-106(C) (1); Rule 4-102(d) Standard 45 and O.C.G.A. § 9-10-185.

12.PAYMENT OF JUDGMENT. Any indication of any kind that Defendant driver personally will have to pay any judgment that may be entered in this case, especially since Defendant is insured against liability. See O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989); Denton v. Conway Express, Inc., 261 Ga. 41 (1991); Northwestern University v. Crisp, 211 Ga. 636, 641 (1955); Brunswick & Western Railroad Co. v. Wiggins, 113 Ga. 149 (3) (1884); Bennett v. Haley, 132 Ga. App. 512, 525 (1974). See also Georgia State Bar Rules, DR 7-102(A)(3), (4) and (5); DR 7-106(C) (1); Rule 4-102(d) Standard 45 and O.C.G.A. §9-10-185.

13.PLAINTIFF'S USE OF AWARD. Any reference or suggestion as to what Plaintiff will or might do with any award of damages Plaintiff might receive. See O.C.G.A. §24-2-1 and §24-2-2; Gusky v. Candler General Hospital, 192 Ga. App. 521 (3) (1989). See also Hall v. Chicago & Northwestern Railway Co., 125 N.E.2d 77, 86 (Ill.1955); and Law note at 28 ATLA Law Reporter 101 (April 1985).


14.MONEY WILL NOT UNDO DAMAGE. Any reference or suggestion to the effect that "money won't undo the injury and damage the plaintiff may have sustained", because such a suggestion is an improper appeal for jury sympathy toward Defendant. and invites the jury to disregard it's duty to apply the legal measure of damages which the evidence shows have been caused by Defendant's misconduct and instead to base a verdict on improper considerations. See O.C.G.A. §24-2-1; Gielow v. Strickland, 185 Ga. App. 85, 86 (1987) (jury cannot be urged to use some other measure of damages than that prescribed by law); Central of Georgia Railway v. Swindle, 260 Ga. 685, 687 (1990) (trial should not be invaded by improper considerations); Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989) (effect of verdict an improper consideration).

15.DEFENDANT IS “SORRY” OR “APOLOGIZES.” Any reference or suggestion that Defendant is sorry or regrets the occurrence in question, because such a suggestion is an improper appeal for jury sympathy toward Defendant, and invites the jury to disregard it's duty to apply the legal measure of damages by awarding such damages as the evidence shows have been caused by such defendant's misconduct and base a verdict on improper considerations. O.C.G.A. §24-2-1; Adams v. Camp Harmony Association, 190 Ga. App. 506, 508 (1989); Gielow v. Strickland, 185 Ga. App. 85, 86 (1987) (jury cannot be urged to use some other measure of damages than that prescribed by law); Central of Georgia Railway v. Swindle, 260 Ga. 685, 687 (1990) (trial should not be invaded by improper considerations).


16.TAXATION OF RECOVERY. Any reference or suggestion that any recovery by Plaintiff either would or would not be subject to federal or state income tax or any other form of taxation. See O.C.G.A. §24-2-1. Also, that any recovery by Plaintiff would not be subject to federal income taxation or any other form of taxation. Atlantic Coast Line R. Co. v. Brown, 93 GA. App. 805, 807 (1956).

17.EMPLOYMENT OF COUNSEL/FEES. Any reference or suggestion regarding the time or circumstances under which Plaintiff employed any of her attorneys. O.C.G.A. §24-9-21(2). Any reference or suggestion regarding the existence of a contingent fee arrangement between Plaintiff and her counsel. See O.C.G.A. §24-2-1; Stoner v. Eden, 199 Ga. App. 135 (1991).

18.FAILURE TO CALL EQUALLY AVAILABLE WITNESSES. Any reference or suggestion that Plaintiff has not called to testify any witness equally available to both parties in this case. See O.C.G.A. § 24-4-22; Bank of Emmanuel v. Smith, 32 Ga. App. 606 (1924); Bradford v. Parrish, 111 Ga. App. 167 (1965).

19.VOUCHING FOR DEFENSE WITNESSES. Any reference or suggestion as to whether or not Plaintiff or any of Plaintiff's witnesses believe that any of the defense witnesses are honorable or otherwise worthy of belief. O.C.G.A. §24-2-1.

20.PERSONAL BELIEF OF COUNSEL. Any reference or suggestion by defense counsel as to his or her personal belief concerning the credibility of any witnesses, or as to the merits of Plaintiff's claims, injuries, or damages. Manning v. State, 123 Ga. App. 844, 845-6 (6) (1971); Georgia State Bar Rules, DR 7-106 (C) (4); EC 7-24.

21.FUTURE INCOME, ETC. OF PLAINTIFF. Any reference or suggestion as to the future income or employment benefits of Plaintiff.

22.UNDISCLOSED PHOTOGRAPHS. Any reference or suggestion as to the existence or contents of any document, photograph, motion picture film or videotape which has not previously been disclosed in the pretrial order until the same has been tendered to the Court and Plaintiff's counsel, outside the presence of the jury, and shown or exhibited to determine its relevance and suitability for introduction into evidence. See O.C.G.A. §24-2-

23.EFFECT OF CLAIMS ON INSURANCE RATES. Any reference or suggestion regarding the effect or results of a claim, suit of judgment upon insurance rates, premiums, or charges, either generally or as particularly applied to Defendant in this case as a result of this or any other lawsuit or claim. See O.C.G.A. §24-2-1 and §24-2-2.

24.EFFECT OF CLAIMS ON INDUSTRY. Any reference or suggestion that damage awards may drive up the price of products, put manufacturers out of business, or cause jobs to be lost. See O.C.G.A. §24-2-1 and 24-2-2.

25.REQUESTS FOR PLAINTIFF'S FILE MATERIALS. Any demands or requests by defense counsel before the jury for matters found or contained in Plaintiff's or her counsel's files, which would include statements, pleadings, photographs, and other documents directed to the Plaintiff or Plaintiff's counsel during the course of the trial and in the presence of the jury.

26.REQUEST FOR INDEPENDENT OR COMPULSORY MEDICAL EXAMINATION DURING THE COURSE OF TRIAL. During the course of the trial, any demands or requests by Defendant or defense counsel for additional medical examination, physical demonstrations, or other similar requests directed to the Plaintiff or Plaintiff's counsel and in the presence of the jury. See O.C.G.A. § 24-2-1.

27.REQUESTS FOR PHYSICAL DEMONSTRATIONS. Any requests for Plaintiff or any of Plaintiff's witnesses to participate in or assist defense counsel with any physical or other demonstration. See O.C.G.A. §24-2-1.

28.SUPERSEDED PLEADINGS. Any reference or suggestion as to the contents of any pleadings which have been superseded by the current pleadings or the pretrial order on file in this case.

29.EX PARTE STATEMENTS. Any reference or suggestion as to the contents of, or tender of any ex parte statement or report of any person not then and there present in the Court to testify and to be cross-examined by counsel for Plaintiff.

30.TESTIMONY OF UNAVAILABLE WITNESS. Any reference or suggestion as to the probable testimony of a witness available to Defendant who is not called to testify in this case.

31.NOTICE TO DEFENDANT OF SUIT. Any reference or suggestion that no notice of the claim was given to Defendant(s) until the suit was filed in this case, since none is required to be given.

32.SPECIAL EFFORTS REQUIRED BY JURY. Any reference or suggestion that the jury must extend special efforts to be fair and impartial to the defendant.

33.SEAT BELTS. Any reference or suggestion that Plaintiff may not have been wearing a seat belt at the time of the collision made the basis of this suit. O.C.G.A. §40-8-76.2.

34.PRIOR TRAFFIC RECORD. Any reference or suggestion as to any prior moving traffic violations or any prior automobile collisions that Plaintiff may have had in the past. See O.C.G.A. §24-2-1 and 24-2-2; Myers v. Barnard, 180 Ga. App. 192 (1986); Underwood v. Butler, 166 Ga. App 527, 529 (1983). See also Green, Georgia Law of Evidence, 3rd Ed., §§68, 70 and 71 (Harrison Co., 1991 Supp.).

35.CRIMES INVOLVING FIRST OFFENDER STATUS. Any reference or suggestion as to any crimes involving first offender status. O.C.G.A. § 42-8-65(a) obligates the clerk to ensure that such information is disclosed only to those persons authorized to receive it. Witcher v. Pender, 260 Ga. 248 June 8, 1990, held that the first offender record of an adverse witness in a civil case is not admissible for the purpose of impeaching the witness for a crime of moral turpitude. In Georgia, the rule is that a witness may be impeached by proof of a conviction of a crime involving moral turpitude. Hall v. Hall, 261 Ga. 181 (402 S.E. 2d 726)(1991).

FDA: New voluntary recall from compounding pharmacy

The Food and Drug Administration has announced a voluntary nationwide recall of all sterile products from a Texas compounding pharmacy, the latest in a series of recalls since last year's outbreak of fungal meningitis.

Fifteen patients at two Texas hospitals have developed bacterial bloodstream infections after receiving injections from Specialty Compounding from Cedar Park, Texas, the FDA said Sunday.

The patients had received infusions of a mineral supplement called calcium gluconate injections. It can be used as part of treatment for cardiac arrest, to treat calcium deficiency, or to treat very high potassium levels.

The patients developed bacterial bloodstream infections caused by an organism calledRhodococcus equi

http://www.usatoday.com/story/news/nation/2013/08/11/texas-compounding-pharmacy-recall/2641009/

REACTION NUTRITION, LLC issues allergy alert on undeclared milk in LIVE CLINICAL 90 CAPS

Reaction Nutrition, LLC of Carnegie, PA is recalling LIVE CLINICAL 90 CAPS, because it contains undeclared milk. People who have an allergy or severe sensitivity to milk (bovine colostrum powder) run the risk of serious or life-threatening allergic reaction if they consume this product.

The product is in a white plastic bottle with a white lid, the brand is Reaction Nutrition Clinical with a white and blue label. The lot number is PB0091512, expiration date is 08/2014 and UPC code is 283333900111. The lot number and expiration date is printed in red ink and located near the bottom of the bottle.

http://www.fda.gov/Safety/Recalls/ucm366186.htm

Hardmenstore.com Recalls 72HP, Evil Root and Pro Power Ma

From the FDA:

Hardmenstore.com is recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED).

Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

These products are intended to be used as a dietary supplement and sexual supplement. 72HP is packaged in a single blister pack containing 1 dose. Evil Root is packaged in box containing a bottle of 6 pills. Pro Power Max is packaged in a single blister pack containing 1 dose.

All lots of 72HP, Evil Root and Pro Power Max are included in this recall. 72HP can be identified by the yellow packaging with a black horse insignia. Evil Root can be identified by its orange box with blue Chinese characters. Pro Power Max can be identified by the black and red packaging with flames on the bottom of the packaging. These sealed and packaged products were delivered to Hardmenstore.com as having contained only legitimate and lawful ingredients.

Aided with the information provided by the FDA, Hardmenstore.com is now notifying its distributors and customers by an email and online notice on the homepage of our site. It is arranging for a return of all recalled products. Consumers and retailers that have the 72HP, Evil Root or Pro Power Max supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.

http://www.fda.gov/Safety/Recalls/ucm366506.htm

Cubist Pharmaceuticals Recall of Four Lots of Cubicin

From the FDA:

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling four lots of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots.

Product Description	Lot #	Expiration Date	First Ship Date	Last Ship Date
CUBICIN® (daptomycin for injection) 500 mg NDC 67919-011-01	950453F	12/06/2013	05/31/2011	06/27/2011
	090203F	09/07/2014	01/12/2012	01/23/2012
	201703F	08/31/2015	03/4/2013	03/7/2013
	201653F	09/01/2015	03/12/2013	03/18/2013

No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine and discontinue distribution of all recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday, to arrange for return and replacement of affected lots.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.

As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.

FDA Issues Warning on Gilenya, Citing Potential Risk of Dangerous Brain Disease

News about Gilenya is making the rounds.

Gilenya was approved in the US in 2010 for the treatment of a relapsing form of MS, and is currently used by approximately 70,000 patients. Gilenya has been subject to reports of new safety risks since its approval. In May 2012, FDA issued a safety warning and instituted new contraindications for Gilenya after it investigated reports that several patients had died soon after taking the drug.

From the FDA site: 

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod).  The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.  FDA could not definitively conclude that Gilenya was related to any of the deaths (see Data Summary, below). However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients

The FDA also said it recommends cardiovascular monitoring be extended past six hours after the first dose for patients “who are at higher risk for or who may not tolerate” a slowdown in the rate at which their heart beats (bradycardia).

Now, on August 29th, this news:

 The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.

Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems. Some medications, including Gilenya, can weaken the immune system.

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. MS is thought to affect more than 2 million people worldwide. The drug was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.

The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.

Read more here http://www.raps.org/focus-online/news/news-article-view/article/4004/fda-issues-warning-on-gilenya-citing-potential-risk-of-dangerous-brain-disease.aspx