YAZ Litigation

The newest litigation on the mass tort front continues to center upon birth control.  Specifically Yaz (drospirenone and ethinyl estradiol), Yasmin and Ocella.  These 4th generation (yes, pills have generations too) birth control pills were lauded for their effectiveness and initial advertisements (for which the FDA issued a warning [...]]]> Source: U.S. Food and Drug Administration

YAZ Litigation

The newest litigation on the mass tort front continues to center upon birth control.  Specifically Yaz (drospirenone and ethinyl estradiol), Yasmin and Ocella.  These 4th generation (yes, pills have generations too) birth control pills were lauded for their effectiveness and initial advertisements (for which the FDA issued a warning to Bayer) suggesting their role in treating PMS.

The Yaz label has underwent a number of revisions to add the numerous warnings associated with the use of YAZ including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and
hypertension. Moreover, YAZ has additional risks because it contains the progestin, drospirenone.

Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking YAZ must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.  Consolidated litigation is currently in the Court of Common Pleas of Philadelphia.  IF YOU BELIEVE THAT YOU WERE HARMED BY YAZ PLEASE CONTACT OUR OFFICE TODAY.

Next up, MasXtreme (Yes, it’s exactly what it sounds like)

Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement (A nod is as good as a wink to a blind bat) contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker. Aildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). This may pose a threat to consumers because Aildenafil 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. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed Nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.

Consumers who have purchased MasXtreme tablets (And you know who you are) are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm¹. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm². Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

~Posted by D.M. Schwadron, Esquire

We elaborated on just one of these but apparently March is National Salmonella month here in the U.S.  Among the products affected are dips, chips (a double whammy), spices and soup.

Just why are there so many products affected with Salmonella?  Maybe it’s time we stopped mass producing food in factories [...]]]> Source:  U.S. Food & Drug Administration

We elaborated on just one of these but apparently March is National Salmonella month here in the U.S.  Among the products affected are dips, chips (a double whammy), spices and soup.

Just why are there so many products affected with Salmonella?  Maybe it’s time we stopped mass producing food in factories and “engineering” foods genetically.  Radical concepts, I’m aware but still, click through the evidence.  The system is broken and needs some fixes.

March 2010

• March 03, 2010 – Earth Island Announces Voluntary Recall On Select Follow Your Heart Products That Contain Natural Flavor Because Of Possible Health Risk³
• March 03, 2010 – Homemade Gourmet Voluntarily Recalls “Tortilla Soup Mix” Because of Possible Health Risk⁴
• March 03, 2010 – Reser’s Fine Foods Inc Press Release⁵
• March 02, 2010 – Tim’s Cascade Snacks Recalls ‘Hawaiian^® Kettle Style Potato Chips – Sweet Maui Onion’ and ‘Hawaiian- Sweet Maui Onion Rings’ Because of Possible Health Risk⁶
• March 02, 2010 – Castella Imports, Inc. Conducts Nationwide Recall of Castella Chicken Soup Base Because of Possible Health Risk⁷
• March 01, 2010 – Heartland Foods, Inc. voluntarily recalls Coarse Ground Black Pepper because of possible Salmonella Contamination⁸
• March 01, 2010 – T. Marzetti Company Announces a Voluntary Recall of Dips Due to Possible Health Risk

~Posted by D.M. Schwadron, Esquire

T. Marzetti Company today announced as a precautionary measure that it is voluntarily recalling certain production codes of T. Marzetti Veggie Dips, Oak Lake Chip Dips and Great Value Chip Dips because an ingredient used in the product has the potential to be contaminated with Salmonella.  [...]]]> Source: U.S. Food & Drug Administration

T. Marzetti Company today announced as a precautionary measure that it is voluntarily recalling certain production codes of T. Marzetti Veggie Dips, Oak Lake Chip Dips and Great Value Chip Dips because an ingredient used in the product has the potential to be contaminated with Salmonella.  (Yeah, that would be a good precaution then).  There have been no reports of illnesses associated with the identified products, and no other types, varieties of flavors of products are affected by this recall.  Products subject to this recall that were distributed nationwide in the United States under the T. Marzetti brand in plastic tubs and sold in the produce section include:

• T. Marzetti Southwest Ranch Veggie Dip, 15.5 ounce (UPC 70200 52004)
  Best By dates: APR2010F, APR2810F, MAY1610F, MAY3110F, JUN0610F, JUN1410F, JUN1910F
• T. Marzetti Fat Free Southwest Ranch Veggie Dip, 13 ounce (UPC 70200 52033)
  Best By dates: MAY1610F, MAY3010F, JUN0810F, JUN1210F, JUN2510F
• T. Marzetti Spinach Veggie Dip, 15 ounce (UPC 70200 52059)
  Best By dates: APR1910F, MAY0910F, JUN0710F

Products subject to this recall distributed in Canada and Laredo, Texas, under the T. Marzetti brand in plastic tubs and sold in the produce section include:

• T. Marzetti Spinach Veggie Dip, Epinards, Trempette A Legumes, 340 gram (UPC 70200 58843)
  Best By dates: 10AL11F, 10AL17F, 10AL24F, 10AL30F, 10MA08F, 10JN12F
• T. Marzetti Southwest Ranch Veggie Dip, Ranch style sud-ouest americain Trempette A Legumes, 340 gram (UPC 70200 58844)
  Best By dates: 10AL17F, 10AL24F, 10AL30F, 10MA08F, 10JN05F, 10JN14F

Product subject to this recall distributed in Ohio under the Oak Lake Farms Brand in plastic tubs and sold in the refrigerated case includes:

• Oak Lake Farms French Onion Chip Dip, 16 ounce (UPC 73534 43480)
  Best By dates: APR2310F, JUN1110F, JUN2610F

Product distributed in the United States under the Great Value brand in plastic tubs and sold in the refrigerated section includes:

• Great Value Ranch Chip Dip, 16 ounce (UPC 78742 43099)
  Best By dates: 042810F, 050810F, 052910F, 053010F, 053110F, 060410F, 060510F, 061110F

T. Marzetti was notified by its supplier, Basic Food Flavors, Inc., of the recall of an ingredient used in these products due to potential Salmonella contamination. Because the safety of consumers is a top priority and out of an abundance of caution, T. Marzetti has voluntarily recalled these product.

T. Marzetti is working closely with Food and Drug Administration to conduct this voluntary recall.   For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s Website at http://www.cdc.gov¹.

Consumers who have purchased the recalled products are advised to discard this product or return it to the place of purchase for a refund. Consumers with questions about the recall should contact T. Marzetti Co. at 1-800-427-0147 between 8 a.m. and 9 p.m. EST or visit the company’s Website at www.marzetti.com².

~Posted by D.M. Schwadron, Esquire

Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production. (Inadvertently added almonds?)

No illnesses have been reported to date in connection with this issue, [...]]]> Source: U.S. Food & Drug Administration

Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production. (Inadvertently added almonds?)

No illnesses have been reported to date in connection with this issue, although people who have allergies to almonds run the risk of serious or life-threatening allergic reactions if they consume these products. The product is safe for consumption by consumers without nut allergies.

The recalled Chocolate Marshmallow Premium Ice Cream is limited only to select stores in central Pennsylvania. All affected stores are directly delivered to and serviced by Turkey Hill Dairy and have been instructed to remove the product from their shelves.

The recall was initiated after it was discovered that the recalled product was distributed in packaging that did not identify almonds as an ingredient. It is believed that less than 150 containers of ice cream were potentially exposed to almonds. All affected containers would have been purchased by consumers after January 28, 2010.

The product comes in a rounded, rectangular, cream-colored, paperboard, 48 oz. packages with farm scene and ice cream scoop graphics. The affected product is marked on the bottom of the package with the code “01/18/2011 56/L1”. Preceding the code is a four-digit number indicating the production time. The recalled product includes a time between 02:25 and 02:35.

Consumers who have purchased affected 48 oz. packages of Chocolate Marshmallow Premium Ice Cream with the previously mentioned code can return them to the place of purchase for a full refund. Consumers with questions may contact Turkey Hill Dairy at 1-800-MY-DAIRY (1-800-693-2479).

~Posted by D.M. Schwadron, Esquire

Trader Joe’s Company of Monrovia, California is voluntarily recalling Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to be contaminated with Salmonella, [...]]]> Source:  U.S. Food & Drug Administration

Trader Joe’s Company of Monrovia, California is voluntarily recalling Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product involved in this recall was distributed at Trader Joe’s stores nationally and comes in a 7.4 oz box marked with Use by/Lot Codes 16JUL10H2 and 17JUL10H1 on the top of the box and stamped individually on the side of each granola bar. Production of the product has been suspended while FDA and Bloomfield Bakery continue their investigation.

No illnesses have been reported to date in connection with this product.

At Trader Joe’s we take the safety of our customers and the integrity of our products very seriously. Customers who have purchased Trader Joe’s Chocolate Chip Chewy Coated Granola Bars, Use by/Lot Codes 16JUL10H2 and 17JUL10H1 are urged to return them to any Trader Joe’s for a full refund. Customers with questions may contact Trader Joe’s Customer Relations Monday through Friday, 6am to 6pm PST at (626) 599-3817.

~Posted by D.M. Schwadron, Esquire

Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.

Salmonella is an organism which can cause serious and [...]]]> Contact:
Chris Hines or Deborah Hines
214-939-0253

Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled product was sold in 8 oz foam trays wrapped in cellophane and carry the UPC code 0 72036 88121 0. The Pine Nuts were distributed solely to Harris Teeter Markets in North Carolina. Consumers who purchased this product between December 30, 2009, and January 14, 2010 should contact Hines Nut Company for information on how to return the product for a refund.

There have been no complaints or any reported illnesses related to the products to date. The problem was discovered through routine sampling by the supplier, Red River Foods.  Consumers with questions may contact Hines Nut Company at 214-939-0253 (M-F, 6:30 AM to 3:30 PM CDT).

And quitting while I am marginally ahead. . .

~Posted by D.M. Schwadron, Esquire

That title could have gone terribly wrong.  Never combine the words “cheese” and…well…in the same sentence…

Company Contact: Lindsey Decker 608-837-5166, ext.364 Customer Service Contact: 800.698.1751

The Wisconsin Cheeseman® announced that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010.  Parkers Farm, Inc., [...]]]> Source:  U.S. Food & Drug Administration

That title could have gone terribly wrong.  Never combine the words “cheese” and…well…in the same sentence…

Company Contact:
Lindsey Decker
608-837-5166, ext.364
Customer Service Contact:
800.698.1751

The Wisconsin Cheeseman® announced that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010.  Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria.

Nine of the recalled products are cheese logs/cheese balls purchased from Parkers Farm, Inc. and then distributed by The Wisconsin Cheeseman®. These products bear the Parkers Farm logo. None of the other recalled products at Parkers Farm, Inc. was purchased or distributed by The Wisconsin Cheeseman®.

The Wisconsin Cheeseman® Food Gifts Impacted by Recall:
Sausage ‘N Cheese Logs – Gift #11
Cheese Logs & Cutting Board – Gift #87
Smorgasbord – Gift #325
Cheese Log Trio – Gift #365
Cheese Logs – Gift #411
Cheese Ball Trio – Gift #441 (WAIT, WHAT?! )
Cheese Logs – Gift #509
Snacker Pack – Gift #751
Cheese Balls & Sausages – Gift #876 (A PERSONAL FAVE!) : P

Consumers who have these products in their possession should not consume them. (Then they would be “purchasers” and not “consumers”, no?) Product should be returned to The Wisconsin Cheeseman® for a refund or replacement. Consumers who believe they may have become ill after consuming these products should contact their health care provider. The Wisconsin Cheeseman® has not received any complaints or reports of illness associated with these products.

Listeria monocytogenes bacteria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Listeria monocytogenes bacteria often experience fever, severe headaches, stiffness, diarrhea, nausea and abdominal pain. In rare circumstances, infection with Listeria monocytogenes bacteria can result in miscarriage or stillbirth among pregnant women.

Yeah, I’ve got nothing left on this one.

~Posted by D.M. Schwadron, Esquire

Unilever US in cooperation with the FDA has issued a nationwide voluntary recall of all Slim-Fast ready-to-drink products for possible Bacillus cereus (Yes, I am serious), a bacteria which could cause diarrhea, nausea and/or vomiting.  That must be the Fast part of the Slim-Fast.

Slim-Fast ready-to-drink is packaged in cartons [...]]]> Source: US Food & Drug Safety Administration

Unilever US in cooperation with the FDA has issued a nationwide voluntary recall of all Slim-Fast ready-to-drink products for possible Bacillus cereus (Yes, I am serious), a bacteria which could cause diarrhea, nausea and/or vomiting.  That must be the Fast part of the Slim-Fast.

Slim-Fast ready-to-drink is packaged in cartons with 6-12 cans of 11 FL OZ (325 ml for the rest of the world).  Unilever stresses that the probability of serious adverse health consequences is remote.  Nonetheless, the company is urging consumers to immediately discard any un-opened Slim-Fast and contact Unilever for a refund at 1-800-896-9479.  Customer Service is available Monday-Friday from 8:30 am to 6:00 pm (ET).

~Posted by David Marc Schwadron, Esquire

A stunning indictment of 6 of the “top” peer-reviewed medical journals –A significant number of medical articles published in 2008 were written by ghostwriters financed by drug manufacturers.  Let’s review that one again, shall we?

10.9% of articles published in the New England Journal of Medicine, 7.9% of articles published in the Journal [...]]]> Source: New York Times

A stunning indictment of 6 of the “top” peer-reviewed medical journals –A significant number of medical articles published in 2008 were written by ghostwriters financed by drug manufacturers.  Let’s review that one again, shall we?

10.9% of articles published in the New England Journal of Medicine, 7.9% of articles published in the Journal of the American Medical Association (JAMA) and 7.6% of the articles published in The Lancet were written, not by independent physicians, but by shills (I love using that word) for drug companies.  Big deal, you say?  It certainly is a big deal. This is not the Sun or the Post (with apologies to both).  These are respected medical journals that physicians look to in determining standards of care and practice for their patients.

And if there are admissions to this shockingly high level of poor editorial standards, you can be assured that the numbers are far higher.

Spokespersons for the Medical Journals had the following to say in their defense, “We feel that [Viagra] there were no [Rogaine] improprieties in the editorial [Pfizer] review and publishing of [Glaxxo SmithKline] articles in our respective [Merk] journals.  We expect [Abbott] and anticipate [Lilly] a full retraction of such allegations.”  Okay, maybe not, but still.

Posted by David Marc Schwadron, Esq.

In order of severity, Singulair has been said to be associated with agitation, aggression, suicidal ideation, depression, insomnia and irritability. Zicam, on the other hand, has been associated with [...]]]> This Week, the Food & Drug Administration (FDA) announced warnings for Zicam Cold remedy Nasal Gel and Nasal Swabs as well as for Singulair, an asthma/allergy medication.

In order of severity, Singulair has been said to be associated with agitation, aggression, suicidal ideation, depression, insomnia and irritability. Zicam, on the other hand, has been associated with anosmia (loss of smell). Not nearly as funny as it sounds.

Merk, makers of Singulair remained confident in the safety of Singulair but accepted an FDA label change to include “psychiatric events.” Matrixx Initiatives, makers of Zicam launched the, “No-one ever told us” defense to the warnings followed by the, “Hey people with colds can’t smell” parry. Zicam has previously been targeted in lawsuits alleging fraud in the marketing of it’s product.

To borrow from Animal House, “Ineffective and potentially deleterious is no way to go through life.” Take with caution and please call your doctor.

posted by David Marc Schwadron, Esq.