FDA reaches $1 million settlement with Pennsylvania medical device firm Globus

From the FDA:

The U.S. Food and Drug Administration has reached a $1 million civil money penalty settlement with Globus Medical Inc., of Audubon, Pa., for the distribution of unapproved medical devices.

The settlement requires Globus Medical to pay a $550,000 penalty and David C. Paul, the firm’s CEO, to pay a $450,000 penalty, for a total of $1 million.

During an inspection of Globus Medical in September 2010, FDA investigators learned that the company had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, as required by law.

“The device-clearance process assures the quality and safety of devices before they reach the market. Firms can’t simply choose to sell devices that FDA has found are not safe and effective,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We took action against Globus Medical to protect patients and we are pleased with the outcome.”

Globus Medical had sought clearance of its NuBone product in January 2009, but the FDA declined to clear the product after determining that it was not substantially equivalent (NSE) to legally-marketed products. The FDA advised Globus Medical that it could not distribute the product, but the firm continued to do so, even after receiving the NSE letter in December 2009.

The FDA then filed a complaint for civil money penalties against Globus Medical and the company’s CEO for distributing the NuBone product without proper FDA approval or clearance. The agency informed Globus Medical and Paul of this action in November 2011, and later participated in settlement discussions leading to the $1 million penalty agreement.

“This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”

FDA adds diabetes, memory loss warnings to statins

The Food and Drug Administration announced on Tuesday the changes to the safety information on the labels of statins such as Pfizer Inc's Lipitor, AstraZeneca's Crestor and Merck & Co's Zocor that are taken by tens of millions of people.

Statins have been shown to significantly reduce the risk of heart attack and heart disease, and the FDA said the new information should not scare people into stopping taking the drugs.

"The value of statins in preventing heart disease has been clearly established," Amy Egan, deputy director for safety in FDA's Division of Metabolism and Endocrinology Products, said in a statement. "Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects."

More at the link: http://www.reuters.com/article/2012/02/28/us-fda-statins-idUSTRE81R1O220120228

Common sleeping pills linked with higher death risk

From Yahoo:

 
Some sleeping pills are linked to a more-than fourfold risk of premature death, according to an American study published in the journal BMJ Open on Monday.

These medications were also associated at higher doses with a 35-percent increased risk of cancer as compared with non-users, but the reason for this is unclear.

Doctors led by Daniel Kripke of the Scripps Clinic Viterbi Family Sleep Center in La Jolla, California, looked at the medical records of more than 10,500 adults living in Pennsylvania who were taking prescribed sleeping aids. These were compared against more than 23,600 counterparts, matched for age, health and background, who did not take these drugs.

The study ranged over two and a half years, and looked at widely-prescribed sleeping pills, including benzodiazepines, non-benzodiazepines, barbiturates and sedatives. The overall number of deaths that occurred during this period was small in both groups, being less than a thousand in total.

But there was a striking difference in mortality, the researchers found.

 http://bmjopen.bmj.com/content/2/1/e000850.short?g=w_open_current_tab

Abstract

Objectives An estimated 6%–10% of US adults took a hypnotic drug for poor sleep in 2010. This study extends previous reports associating hypnotics with excess mortality. 

Setting A large integrated health system in the USA.

Design Longitudinal electronic medical records were extracted for a one-to-two matched cohort survival analysis.

Subjects Subjects (mean age 54 years) were 10 529 patients who received hypnotic prescriptions and 23 676 matched controls with no hypnotic prescriptions, followed for an average of 2.5 years between January 2002 and January 2007.

Main outcome measures Data were adjusted for age, gender, smoking, body mass index, ethnicity, marital status, alcohol use and prior cancer. Hazard ratios (HRs) for death were computed from Cox proportional hazards models controlled for risk factors and using up to 116 strata, which exactly matched cases and controls by 12 classes of comorbidity.

Results As predicted, patients prescribed any hypnotic had substantially elevated hazards of dying compared to those prescribed no hypnotics. For groups prescribed 0.4–18, 18–132 and >132 doses/year, HRs (95% CIs) were 3.60 (2.92 to 4.44), 4.43 (3.67 to 5.36) and 5.32 (4.50 to 6.30), respectively, demonstrating a dose–response association. HRs were elevated in separate analyses for several common hypnotics, including zolpidem, temazepam, eszopiclone, zaleplon, other benzodiazepines, barbiturates and sedative antihistamines. Hypnotic use in the upper third was associated with a significant elevation of incident cancer; HR=1.35 (95% CI 1.18 to 1.55). Results were robust within groups suffering each comorbidity, indicating that the death and cancer hazards associated with hypnotic drugs were not attributable to pre-existing disease. 

Conclusions Receiving hypnotic prescriptions was associated with greater than threefold increased hazards of death even when prescribed <18 pills/year. This association held in separate analyses for several commonly used hypnotics and for newer shorter-acting drugs. Control of selective prescription of hypnotics for patients in poor health did not explain the observed excess mortality.

FDA to Investigate Safety of Inhalable Caffeine

Yes, you read that right. From ABC News:

The Food and Drug Administration will launch a safety investigation of a new product that allows consumers to inhale caffeine through a lipstick-sized portable device,  rather than drinking it.
AeroShot delivers 100 milligrams of caffeine per use, and comes in bright colored packages that describe it as “pure energy,” and “breathable energy anytime, anyplace.”

The manufacturer, Breathable Foods Inc., put it on the market in New York, Massachusetts, and in France late last month.

“You could easily overdose or succumb to toxicity associated with the caffeine ingestion,” Dr. Bruce Goldberger told ABC News. “You could mix it with alcohol in a social setting and also I’m troubled by its availability, potentially at home where young children can get a hold of it.”

Link and source:  http://abcnews.go.com/blogs/business/2012/02/fda-to-investigate-safety-of-inhalable-caffeine/

2/27/12 DMAA news:

Another lawsuit over DMAA. The compound is  1,3-dimethylamylamine, also known as DMAA, is "illegal and dangerous," court filings said. in another case The lawsuit also claimed that "experts in the industry have become concerned that this potent stimulant drug will lead to serious health issues and even death."

The suit was filed by Lynette Bates, who last summer bought a pre-exercise drink powder called C4 Extreme, which promises "explosive workouts."

Bates sued retailer GNC and Cellucor Sports Nutrition, which manufactures, distributes and markets the supplement, for "making false and unsubstantiated representations concerning the efficacy, safety and legality of C4 Extreme," among other claims. Cellucor's parent company, Woodbolt International, is also named in the suit.

C4 Extreme is no longer manufactured with DMAA. But the substance can still be found in a variety of dietary supplements aimed at boosting physical performance or weight loss, such as Jack3d (pronounced "jacked") and OxyELITE Pro, which are sold online and at retail stores.
Advertised as "legal cocaine" on some websites, the powder is also sold in packets or pill form. Medical experts say there are potential health risks from consuming DMAA.


 http://www.news10.net/news/article/181016/2/Sports-supplement-has-dangerous-ingredient-lawsuit-claims

Counterfeit Avastin Trial: Starts in the Middle East

About three years before counterfeit copies of Roche Holding AG's cancer drug Avastin surfaced in the U.S., a case in Syria involved fakes of the same drug, showing the company has been grappling with bootlegging of the product for some time.

More at the link. 

 http://online.wsj.com/article/SB10001424052970204778604577239462185891798.html?ru=yahoo&mod=yahoo_hs

Wisconsin: 29 lawsuits filed 2/23/12 alleged Imprelis-caused Tree Damage

My good friends and fellow trial lawyers Jay Urban (Wisconsin) and Rick Schulte (Ohio) filed these cases this week:

Twenty-nine lawsuits were filed Thursday against DuPont in Waukesha County by property owners alleging that the chemical giant's herbicide Imprelis has killed or is killing their trees.

The lawsuits contend that DuPont marketed the weed killer as being environmentally friendly and safe to use and "that is simply not the truth."

"In its relatively short time on the market, DuPont's Imprelis has proven to be a frighteningly effective tree killer," the suits say.

Coniferous trees are particularly susceptible to being damaged or killed by the herbicide, according to the lawsuits.

Among those who are suing DuPont de Nemours and Co. are Summit Police Chief James Race and Waukesha County Circuit Judge Ralph Ramirez.

DuPont is facing similar lawsuits across the country Imprelis, which was first used in the fall of 2010, over tree death and damage.

The U.S. Environmental Protection Agency in August ordered DuPont to stop the sale and use of the herbicide, which was distributed and sold primarily to lawn care professionals.

Race's lawsuit states that a lawn care service applied Imprelis to his property in Ottawa beginning in June of last year and that the herbicide was applied five times according to directions supplied by DuPont.

In the fall, a certified arborist examined trees on Race's property and noted that 25 Norway spruce trees were 75% to 100% brown, dying and twisted, the lawsuit states and that there were other signs of death on all trees on the property.

Trees on a neighboring property also were damaged or dying, the suit says, even though the herbicide was not used on the property. The neighbors, Steven and Janette Zwicke, also are suing DuPont.

"I have 29 trees that are either dead or dying," Race said Thursday. "I have a group of trees that lost their needles over the winter. DuPont knows they killed a lot of trees. They are not taking responsibility for it."

The Zwickes lost a couple dozen trees, Race said.

Ramirez's lawsuit says a lawn service applied Imprelis on the property of his Town of Waukesha residence one time in June and that by October, all eight trees on his property were showing signs of death.

DuPont spokeswoman Kate Childress said Thursday that the company is evaluating its response to the legal complaints.

"DuPont is committed to proper stewardship of all of its products. We are engaged in a comprehensive claims resolution process that fairly addresses claimed damage due to Imprelis," the statement says.

Attorney Jay Urban, who filed the lawsuits on behalf of the Waukesha County homeowners, said "hundreds and hundreds" of trees have been killed by the herbicide in the county.

"It's kind of a sad situation," said Urban, who filed one similar case last fall in Waukesha County. That case was consolidated with cases filed in Pennsylvania, he said.

Urban said he expected to file about 100 more lawsuits in the next two weeks.

Source: http://www.jsonline.com/news/waukesha/29-lawsuits-filed-against-dupont-over-tree-damage-jm4afsh-140211533.html

Novartis to Add Warnings to Rasilez Blood-Pressure Drug (Europe)

Novartis is changing the product information for Rasilez, sold in the U.S. as Tekturna, to say that the drug should not be used to treat patients with diabetes or kidney problems who are taking certain other medicines.

The drugmaker is also complying with a recommendation of the European Medicines Agency that the label include a warning against combining products containing aliskiren, the active ingredient in Rasilez, with heart drugs known as ACE inhibitors or ARBs, the agency said today in an e-mailed statement. Novartis halted a trial of the drug in December after it was linked to increased risk of stroke and kidney problems.

 http://www.bloomberg.com/news/2012-02-17/novartis-to-add-warnings-to-rasilez-blood-pressure-drug-1-.html

Infant Tylenol Recalled

74,000 bottles of infant Tylenol have been recalled by Johnson & Johnson's McNeil Consumer Healthcare division.
A faulty part of the dosing system -- an interior cap called a "flow restrictor" -- can get pushed down into the bottle. This interferes with the syringe used to measure each dose. It could result in kids getting too much or too little acetaminophen, the painkiller/fever-reducer that is Tylenol's active ingredient.
The recall affects seven lots of infants' Tylenol Oral Suspension 1 oz. Grape, sold over the counter across the U.S. The recalled infant Tylenol:

• Has the UPC code 300450122308
• Has lot numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, or BJL2U00

Read more at the source:  http://www.webmd.com/parenting/baby/news/20120217/infant-tylenol-recalled

Lung Drug May Be Tied to Cardiovascular Deaths, FDA Says

From Bloomberg:

An experimental drug to treat breathing complications tied to a common lung disease may be linked to more instances of cardiovascular deaths at higher doses, U.S. regulators said.
The twice-daily drug known chemically as aclidinium bromide helped patients with chronic obstructive pulmonary disease, or COPD, breathe easier, Food and Drug Administration staff said today in a report. Advisers to the agency are set to meet Feb. 23 to weigh whether safety questions about the medicine have been adequately assessed.

COPD, tied to smoking as a cause, is an umbrella term for conditions that make it difficult to breath, according to the National Institutes of Health. If approved, the drug may have $150 million in sales for New York-based Forest in 2015, according to the average of two analysts’ estimates compiled by Bloomberg.
“It is striking that all the cardiovascular deaths are reported for the higher aclidinium dose,” the FDA said in its report on the drug. “It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal,” the agency said.

 http://www.bloomberg.com/news/2012-02-21/forest-almirall-s-copd-drug-tied-to-increased-deaths-fda-says.html

FDA Shuts Down NJ Dental Company

The Food and Drug Administration says a court order against Accurate Set requires the company to discontinue operations until the agency has verified its dental implants meet federal standards.

 Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

Under the terms of the consent decree, Accurate Set must discontinue its operations until the U. S. Food and Drug Administration clears or approves its products, which include a variety of restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA’s quality standards.

“The FDA has very clear requirements for the clearance, approval, and production of medical devices,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA’s most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.

Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.
Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices. The consent decree also requires them to comply with the QS regulation for all their devices and to retain an independent expert to inspect their operations and certify to the FDA that the necessary corrections have been made.

“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs.

In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree’s provisions.

 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291648.htm

Risperdal Trial: Plaintiff's Lawyer claims that J&J Hid Risperdal Studies to Boost Drug Sales

From Bloomberg:

J and J  hid studies showing its Risperdal anti-psychotic drug caused diabetes to protect billions of dollars in sales, a lawyer said in the first personal-injury claim over the medication to go to trial. Researchers at J&J’s Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators probing links between the disease and anti-psychotic medicines.

Source: 

http://www.bloomberg.com/news/2012-02-02/j-j-hid-risperdal-studies-to-boost-drug-sales-lawyer-says-at-n-j-trial.html

FDA says ulcer drugs may raise diarrhea risk (Nexium & others)

FDA says certain heartburn drugs could cause diarrhea. Clostridium difficile is a bacterium that can cause colitis and other intestinal conditions.

The FDA said patients who develop diarrhea after taking these drugs should be checked for CDAD.

The drugs called proton pump inhibitors (PPIs) are widely used for treating ulcers, acid reflux and other conditions.

Other PPIs sold by prescription include Takeda Pharmaceutical Co Ltd's Dexilant and Prevacid, AstraZeneca's Prilosec and Vimovo, Santarus Inc's Zegerid, and Johnson & Johnson and Eisai Co Ltd's AcipHex.

Generic versions of Prevacid and Prilosec also are available.

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve.¹ Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in the hospital. Factors that may predispose an individual to developing CDAD include advanced age, certain chronic medical conditions, and taking broad spectrum antibiotics. Treatment for CDAD includes the replacement of fluids and electrolytes and the use of special antibiotics.  

The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

http://www.fda.gov/Drugs/DrugSafety/ucm290510.htm

Merck anti-clot compound again shows bleeding risk

An experimental anti-clotting drug that Merck & Co. is developing was found to increase risk of dangerous internal bleeding in a second study, meaning it's unlikely to achieve the blockbuster status once expected — if it's even approved.

Vorapaxar is part of a new generation of anti-clotting drugs meant to prevent the death and disability strokes and heart attacks cause in the millions of people at risk for them. Drugmakers have generally touted their compounds as more effective and safer than Coumadin, known chemically as warfarin, the standard treatment for decades despite the need for frequent blood tests because getting the dosage right is so tricky.

Source:  http://finance.yahoo.com/news/Merck-anti-clot-compound-apf-2671994324.html?x=0

Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV® (Acetaminophen) Injection

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today the voluntary recall of a single lot of OFIRMEV® (acetaminophen) injection. Cadence has notified the U.S. Food and Drug Administration of the recall.


The recall of OFIRMEV lot number V005710 was initiated due to the presence of an unidentified, visible particle in one vial of this lot during routine stability testing.  Lot V005710 was distributed by Cadence to hospitals, wholesalers and distributors beginning in January 2011, and Cadence believes that fewer than 1,000 vials currently remain in the marketplace. Cadence has not received any reports of adverse patient events associated with particulate matter in the product, and has undertaken the recall as a precautionary measure.

"We regret that some of our customers experienced short-term supply delays due to our temporary suspension of shipments from the supplier of lot V005710," said Scott Byrd, Chief Commercial Officer of Cadence. "Fortunately, we were successful in our efforts to accelerate shipments of OFIRMEV from another supplier, which allowed us to quickly resume normal shipments of the product. We do not anticipate any further supply delays."

Source:  http://investors.cadencepharm.com/releasedetail.cfm?ReleaseID=646491

Boston Scientific Mesh Litigation Centralized by the JPML (Feb. 7, 2012)

Here is the Transfer Order:


TRANSFER ORDER

Before the Panel: Before the Panel are three dockets involving allegations of defects in
various models of pelvic surgical mesh products manufactured by three groups of manufacturers.

Plaintiffs in almost twenty actions before the Panel have moved pursuant to 28 U.S.C. § 1407, to
centralize all MDL No. 2325, MDL No. 2326, and MDL No. 2327 actions in the Southern District
of West Virginia.  In MDL No. 2325, defendant AMS has moved to centralize the MDL No. 2325
actionsin the District ofMinnesota or, alternatively, if the Panel deems centralization of three MDLs
to be  appropriate, suggests the  Southern  District of West Virginia  as transferee  district. This
litigation currently consists of approximately150 actions spread across the country, as listed on the
attached schedules. The Panel has been notified of numerous additional potentially related actions.



On the basis of the papers filed and hearing session held we find that the actions contained in
eachMDLinvolve common questions offact, and that centralization of each ofMDL No. 2325, 2326
and 2327 in the Southern District of West Virginia will serve the convenience of the parties and
witnesses and promote the just and efficient conduct of this litigation.
IT IS THEREFORE ORDERED that the motionsfor centralization ofMDL No. 2325,MDL
No. 2326, and MDL No. 2327 in the Southern District of West Virginia are granted.

Find it here: http://www.jpml.uscourts.gov/Panel_Orders/MDL-2326-Initial_Transfer.pdf

News: DMAA – Jack3d and OxyELITE Pro News February 2012

Image via Wikipedia

The United States Army is investigating DMAA dietary supplements – Jack3d and OxyELITE Pro – after two U.S. soldiers died from heart attacks during fitness exercises. The Defense Department removed these products and any products containing the same active ingredient – DMAA – from all military bases. It is unclear at this point what action the FDA will take.

The active ingredient DMAA (dimethylamylamine) is promoted to increase workout energy and efficiency. However, DMAA, found naturally in Asian geraniums, is a dangerous additive. Medical literature from the 1950s discovered the toxicity of DMAA.

DMAA has been banned by numerous sports organizations, including the international body that regulates Olympic athletes and several professional sports.

Already, one lawsuit has been filed against BPISports. A class action claims Florida-based BPI Sports’ bodybuilding and dietary supplements “contain a dangerous amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects.”

BPI’s products include ’1.M.R’ powder and tablets, ‘RoxyLean ECA’ and ‘Rx6.’ These products are purported dietary supplements which are marketed for use as bodybuilding and weight loss supplements. 1.M.R is marketed as a pre-workout bodybuilding supplement. RoxyLean and Rx6 are marketed as ‘fat burning’ weight loss supplements.
The Most Serious Jack3d or OxyELITE Pro Side Effects Include:
Death
Heart Attack
Cardiac Arrest
Heat Stroke
Seizure
Kidney Failure
Rhabdomyolysis
Liver Failure
Loss of consciousness
Heart palpitations

Talk with us if you believe that you or someone you care about took a DMAA product and was hurt by it.

404-451-7781

Antiretroviral Drugs Guard Against HIV but May Lead to Birth Defects?

A study in the January issue ofCleft Palate-Craniofacial Journal analyzed five years of data from the U.S. FDA's Adverse Events Reporting System (AERS). This publicly available database offers a resource for pharmacovigilance. By using "reporting odds ratios," a potential association may be found between drugs and birth defects.

With the use of antiretroviral drug therapy, the risk of HIV transmission from mother to child has been reduced from 15 to 25 percent to less than 1 percent. While this success has made the use of antiretroviral medications a standard of care, none of these drugs has been classified as safe -- category A -- for pregnancy. The potential risks to offspring must continue to be explored.

In this study, 26 events of cleft lip and palate were found in relation to seven antiviral drugs, including efavirenz, lamivudine, nelfinavir, and the combination of abacavir/sulfate/laminudine/zidovudine. Although these drugs showed significantly high reporting odds ratios, this does not establish causality, but serves as an alert to a possible association.

Read more at the source:  http://www.sciencedaily.com/releases/2012/01/120126101612.htm

Study: Pfizer’s Breast-Cancer Drug Worsens Bone Loss in Older Women

From Bloomberg:

According to a recent study, Aromasin worsened bone loss in post-menopausal women, raising the chance of fractures and calling into question whether the pill’s prevention benefits outweigh its risks.

In a trial among 351 women at risk of developing breast cancer, those who received Aromasin lost about three times more bone-mineral density after two years than those who took a placebo, researchers wrote  in The Lancet Oncology.

Find it here: http://www.lancet.com/journals/lanonc/issue/current

DEA Raids FL Pharmacies

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Agents from the DEA raided two CVS pharmacies in central Florida removing controlled substances and suspending the stores' ability to handle or distribute drugs such as painkillers oxycodone and hydrocodone.

The DEA said that during one year, two pharmacies -- both in Sanford, Florida -- ordered more than 3 million oxycodone units from a pharmaceutical wholesaler, while a typical pharmacy orders 69,000.

Source: http://edition.cnn.com/2012/02/06/us/florida-dea-pharmacies/?hpt=us_c2

Healthy People Co. Issues Recall Of Specific Lots Of The Dietary Supplements – Contain Undeclared Drug Ingredients

Healthy People Co. announced  that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers:

Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.

Sibutramine is an FDA-approved drug for appetite suppressant for the treatment of obesity, making dietary supplements: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate unapproved drugs. It is a Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of a qualified health care professional. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from the U.S. marketplace. The active drug ingredient is not listed on the label for the products listed above.

Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Perfect Men Dietary Supplement and Herbal Drink Acai-man Mangosteen Dietary Supplement unapproved drugs.

FDA advises that this poses a threat to consumers because tadalafil 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. Healthy People Co. advises any customers in possession of the products listed above with matching the lot numbers to return any unused product for a full refund to the company directly.

Product Name	Packaging	Lots
Mince Belle Dietary Supplement	30 Capsules	HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305
PERFECT Men Dietary Supplement	30 Capsules	HPCPM/002; UPC7503013203190
EVERLAX Dietary Supplement	30 Capsules	HPCEX/074, HPCEX/076, HPCEX/072; UPC7503013203046
EVER Slim Dietary Supplement	30 Capsules	HPCES-079, HPCES-070, HPCES-071; UPC7503013203053
Herbal Drink Acai-man Mangosteen Dietary Supplement	16.6 fl oz	HPJAC/004 : UPC7503013203015
EVER SLIM Shake Mix Dietary Supplement Strawberry	17.6 oz	HPESSF/168: UPC7503013203084
EVER SLIM Shake Mix Dietary Supplement Chocolate	17.6 oz	HP

Pfizer's Birth Control Recall: Lawsuits?

Image via CrunchBase

News last week that Pfizer recalled one million lots of a contraceptive. Not long after the recall, there were reports about unintended pregnancies and possible legal fallout. 


Several news outlets went in search of lawyers who might be quotable, and some attorneys did not disappoint. Fox News asked one lawyer his opinion, and he said: “I think you potentially may see some very significant verdicts [if a woman gets pregnant], because in essence a person takes birth control pills so they don’t have to address issues that – as a result of the pill not working – they’re now going to have to address,” Gianfocaro said.

Read more: http://www.foxnews.com/health/2012/02/01/contraceptive-recall-could-put-pfizer-at-risk-multi-million-dollar-lawsuit/#ixzz1lc6yi7pA

Well, I call bullshit. I predict no verdicts, much less significant ones. Why? Nearly every sane adult knows that birth control is not 100% effective. Also, practically speaking a Judge (at least in the South) will not likely be comfortable concluding that life is a type of damages. In addition, there are many states that simply do not recognize a cause of action for wrongful conception. 

Take it from step one. If a healthy woman took this birth control and became pregnant, having a healthy child with no issues at all, what then? Especially if the woman has a child after this "unintended" child.  The case would not likely be considered before going through the gauntlet of motions, hearing and more. Imagine bringing a healthy 5 year old polite child into the courtroom? I've tried many cases, and I'm not sure any jury anywhere - upon seeing the child - would award a dollar, much less "significant" dollars. 

Slate.com seems to have it right in its post:   "A company’s liability is likely to be relatively modest, because damages in wrongful pregnancy cases are usually limited to replacement contraception, the cost of prenatal care, labor and delivery expenses, and sometimes a small award for emotional distress."

http://www.slate.com/articles/news_and_politics/explainer/2012/02/pfizer_recall_can_women_sue_the_maker_of_defective_birth_control_pills_for_the_cost_of_an_unintended_pregnancy_.html?wpisrc=twitter_socialflow 

So you may see a rogue lawsuit, but these 'cases' won't go anywhere. They shouldn't.  

Tech: Android Apps for the week of Feb. 6, 2012

Image via CrunchBase

I'm an Android phone user. My HTC has a slideout keyboard, and it's been dropped a half dozen times, no issues.

I am always on the hunt for practical apps. Some I download and use for 10 days or so, others make the permanent grade. Here is my current 'worth a try' list:


1 Weather:  I run nearly every day. I may be in FL one week, in Cincinnatti the next. 1Weather provides  access to accurate, up-to-the-minute weather information, including animated maps and radar,  weather alarms and severe condition alerts. Free.

 Evi: I'm having Siri envy. This app is not the most reliable just yet, but for me it's worth a try. Best description? A poor man's Siri. Server crashes frustrate the crap out of me.

Handy Scanner:  Handy Scanner Free is a mobile application that turns pictures into print-ready PDF documents.  Whether I'm a a courthouse checking a file or at a lawyer's office, this tool lets me take a quick shot and send it to the office in PDF - worth it and an app that is a must have.

Eventbrite:   Not an app for legal, but for signups. Our church uses this for sports registrations, and the android app is very easy to use.

Seesmic Ping: Seesmic Ping: Post & schedule pics & links to Twitter, Facebook Pages, LinkedIn. Multiple Accounts: post to multiple Twitter accounts, Facebook (Pages & Profiles) and LinkedIn accounts. Select where and when to post: quickly and easily schedule posts to be sent at a future date and time.

I use BufferApp on my laptop, and Seesmic is my go to app (for now) for posting when I'm on the road. Easy to use.

Klick To Do: I'm probably the worst To Do list keeper. I am always seeking the holy grail of to do list apps. No such luck yet. This one:

A very simple to use Todo App with philosophy - Keep It Simple. Its one of a kind todo/task app that makes all controls available on a single activity page.
Klick Todo features:
- All properties of the todo just a single click away and on a single Screen ! ( no browsing away from your tasks list )

AndroGet: My download manager of choice. Best yet. Worth the try.

That's it for this week, more from time to time as I have enough to write out in one post.   

DMAA Supplement Lawsuit News February 3, 2012

The Department of Defense temporary halted the sales of products containing 1,3-dimethylamylamine (DMAA) within military facilities after recent reports showed two soldier deaths and additional adverse health effects in other service members may be related to use of the dietary supplements.



The Department of Defense's moratorium will remain in effect pending further review of relevant scientific evidence and reported events.

The Assistant Secretary of Defense for Health Affairs Jonathan Woodson asked the surgeons general of the military services to conduct a review of available scientific evidence and adverse event reports (AERs) to better understand any potential relationship between DMAA and these events.

DMAA has been cited in a class action lawsuit claims bodybuilding and supplements from Florida-based BPI Sports contained undisclosed 1,3-dimethylamylamine (DMAA), an amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects, according to the suit.



The plaintiffs seek restitution and class damages for consumer law violations, unfair competition, false and misleading advertising, breach of express warranty and breach of implied warranty.
DMAA is banned by several athletic organizations, including the World Anti-Doping Agency and Major League Baseball. It is illegal to sell in many countries, including Canada and New Zealand. The lawsuit says the ingredient is supposedly derived from the oil of the geranium plant. DMAA, also known as Methylhexanamine and Geranainine, is a vasoconstrictor and central nervous system stimulant.

 http://www.naturalproductsinsider.com/news/2011/11/lawsuit-claims-supplement-contained-dmaa.aspx

Transvaginal Mesh Lawsuit Update (February 1, 2012)

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Last week the JPML heard arguments regarding centralizing litigation involving mesh implants. 

The Court heard argument on motions filed on behalf of women who claim to have suffered injuries after being implanted with vaginal mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The plaintiffs are asking for the JPML to create separate multidistrict litigation (MDL) cases against three different transvaginal mesh manufacturers: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326) and Ethicon, Inc. (MDL No. 2327).

By pulling together lawsuits that have been filed in federal district courts across the country for pretrial proceedings, the MDLs would make the litigation more efficient, conserve judicial resources and avoid the risk of inconsistent rulings, the plaintiffs argue.

The plaintiffs also are requesting that the cases be transferred to the U.S. District Court for the Southern District of West Virginia and that they be supervised by Chief Judge Joseph R. Goodwin, who currently is overseeing the MDL against another transvaginal mesh manufacturer, C.R. Bard, Inc. (In re Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187)

I expect a decision by 2/15/12. 

A Pancake Warning?

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Yes, you read it right.

The U.S. Food and Drug Administration (FDA) has posted a warning to consumers that certain Aunt Jemima Frozen Pancakes, manufactured by Pinnacle Foods Group LLC, are being recalled because they may contain undeclared soy allergens.

In general, soy contains many dietary components that are thought to provide health benefits. Soy is an excellent source of dietary protein, including all essential amino acids. Soy is also a source of lecithin or phospholipid. Isoflavones found in soy are believed to have estrogen-like effects in the body and may reduce the risk of certain types of breast cancer. There is currently an approved health claim for soy (25g daily) for cholesterol reduction in the United States, and there is clinical evidence to support the use of soy protein as a cholesterol-lowering agent. Soy protein has also been investigated for benefit in terms of other cardiovascular disease risk factors, reducing menopausal symptoms, weight loss, arthritis, memory, and exercise performance enhancement. Unfortunately, for some people, soy has the potential to cause allergies.

The term "food allergens" refers to the parts of foods (usually proteins) that cause allergic reactions. Most allergens can cause allergic reactions even after they are cooked or have been digested. Furthermore, even trace amounts of food allergens may trigger allergic reactions in some patients.

An allergic reaction to food occurs when an individual's immune system mistakes a food protein for a foreign substance, causing immune cells to overreact. During the allergic reaction, the body releases chemicals that trigger symptoms that can then affect the eyes, nose and throat, as well as the skin and the lungs.

The severity and duration of allergy symptoms may vary among patients. Symptoms may develop anywhere from several minutes to several hours after exposure to the food allergen. Anaphylaxis, which refers to the rapid onset of serious allergy-related symptoms, is the most severe type of allergic reaction that may occur. The symptoms of anaphylaxis include low blood pressure, breathing difficulties, shock and loss of consciousness, all of which can be fatal. About 30,000 Americans need emergency room treatment and 150 die each year because of allergic reactions to food, according to the U.S. Food and Drug Administration (FDA).

The responsibility of food manufacturers to clearly state a product's ingredients on the label became a requirement when the U.S. Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The law, which went into effect January 1, 2006, requires food manufacturers to clearly state on their packages whether the food is made with any ingredients that contain protein from the eight major allergenic foods. These foods include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.

Source: http://naturalstandard.com/news/news201201053.asp