Philadelphia Medical Malpractice Blog» product liability

Philadelphia Paxil Litigation Shifts to Settlement

admin — Thu, 24 Jun 2010 15:03:36 +0000

Source: The Legal Intelligencer, June 2010

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such a devastating circumstance. We at the Lewis Law Firm want to hear from any family who has not yet exercised their rights to seek compensation. Contact us.

Posted: Gayle Lewis, Esquire

Gardasil, a controversial vaccine and is it safe?

admin — Thu, 27 May 2010 13:53:36 +0000

Gardasil, Merck Sharp & Dohme’s cervical cancer vaccine caused an uproar in 2006 when it was marketed to girls and women aged 9 to 26. It is estimated that over 25 million young women in the US have received the vaccine which was designed to prevent 4 types of HPV (Human papillomavirus types 6, 11, 16 and 18) which are associated with the risk of genital warts and cause about 70 percent of all cervical cancers.

The vaccine manufacturer’s recommendations have also been extended to boys. But one may (or may not if you read this blog) be surprised to know that there are questions being raised about the safety of Gardasil. A constellation of auto-immune disease symptoms (over 16,000 reports) including: Rheumetoid arthritis and lupus have been reported in otherwise healthy girls and there have been 50 deaths. Well 16,000 adverse events out of approximately 25 million isn’t a lot at all so we’ll just give Merck a pass on that one, shall we? Unless of course your daughter or loved one is one of the 16,000.

Questions have been raised as to whether Gardasil was tested adequately for safety in girls under age 15. Shocking, we’re aware. Not that it matters but…the first quart profits for Gardasil were $390 million. Gardasil is predicted to jump to $3 billion in profits by 2012.

~D.M. Schwadron, Esquire

Friday FDA Alerts -Recalls and Yaz (Not the band).

admin — Fri, 02 Apr 2010 12:32:40 +0000

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

This week let’s recall something new, Salmonella! Oh, wait…

admin — Fri, 19 Mar 2010 13:49:32 +0000

Source: U.S. Food & Drug Administration

Spice Barn, Inc. Voluntarily Recalls Two Lots of Black Pepper

Okay, I still don’t understand the pepper connection. (Even the FDA’s own reports say that it was “unusual”).

Spice Barn is recalling two lots of Black Pepper due to the possibility of contamination with Salmonella. Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. (You really should know this by now). While most individuals recover without medical intervention, the infection can be life-threatening in some cases such as young children, the elderly and those with compromised immune systems. There have been no reports of Salmonella-related illness to date in relation to these products. (Right, we just recall things because it’s fun).

The Products are: Malabar Peppercorns Lot MTC-3258 in 1 and 5 Pound Bags Distributed between: 1/26/10 to 2/8/10; Ground Black Pepper Lot MO-3258T in 1 and 5 Pound Bags Distributed between:12/08/09 to 2/8/10.

All items packaged with this lot number are subject to this recall. The items were distributed to a small number of customers in the following states VT, NY, PA, MA, GA, VA, CA, TX, CO, MO, WA, FL, AL, MI, AZ, AR, WA. Spice Barn is contacting each customer directly and offering a replacement or refund. Consumers who have purchased these products are asked not to us them and to destroy the product. Consumers with questions regarding the products listed may call Spice Barn at 1-866-670-9040 8:30AM-2:30PM M-F(EST) and speak with customer service.

AND JUST IN CASE YOU THINK YOU ARE BEING ALL SAFE AND HEALTHY AND ALLERGEN FREE WITH YOUR GLUTEN FREE SELF…

GFN Foods, LLC of Cranford, NJ (Hi Cranford!) is voluntarily recalling:

Gluten-Free Naturals Pancake Mix – UPC 187058 000043
Lots   09159 (exp 12/8/2010), 09320 (exp 5/16/12) 09322 (exp 5/18/12)
Gluten-Free Naturals Light & Moist Yellow Cake Mix – UPC 187058 000067
Lots   09083 (exp 9/24/10) and 09322 (exp 5/18/12)
Gluten-Free Naturals Cookie Blend Flour – UPC 187058 000029
Lots   09086 (exp 6/24/10), 09219 (exp 11/7/10) and 10035 (exp 5/4/11)

These products, manufactured by GFN Foods, are being recalled because they have the potential to be contaminated with…You got it! Salmonella. The FDA and Thumb Oilseed Producers Cooperative of Ubly, MI found traces of salmonella in Thumb Oilseed’s facility. GFN Foods, LLC is voluntarily recalling the products that contain the ingredient supplied by Thumb Oilseed.

Salmonella is an organism…blah…blah…blah…say it with me…which can cause serious and in some cases 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 can be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result into getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis.

The safety of our products is of paramount importance to GFN Foods. Customers that have purchased the above products should contact GFN Foods at 866-761-6147 for a refund or to arrange for replacement product. You can also email sales@gfnfoods.com or call with any questions.

Okay! It’s Friday. Weekend coming up. Safe eating.

~Posted by D.M. Schwadron, Esquire

A whole ‘lot of Salmonella going on.

admin — Fri, 05 Mar 2010 16:10:06 +0000

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

Friday FDA Alerts -Waiter, there’s Salmonella in my dip.

admin — Fri, 05 Mar 2010 16:03:44 +0000

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

Declare your almonds Turkey Hill!

admin — Fri, 19 Feb 2010 18:58:21 +0000

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

Say it ain’t so Joe! FDA Alert Friday.

admin — Fri, 19 Feb 2010 18:54:20 +0000

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

Second hand smoke? I give you third hand smoke.

admin — Tue, 09 Feb 2010 14:40:56 +0000

Source: BBC Health; PNAS (no laughing) Journal

The Journal for the Proceedings of the National Academy of Science has published a study on lingering tobacco-specific nitrosamines (TSNAs). Researchers in Berkeley, California (say no more Berkeley) have found “substantial” concentrations of toxins upon substances exposed to tobacco products.

What sort of substances? Clothing, furniture and wallpaper for starters. The researchers have suggested that third hand smoke is an unappreciated health hazard and have called for a ban on home and vehicular smoking -where TSNA’s can concentrate in unhealthful amounts. The largest at risk group? Young children who touch and put everything in their mouths.

The director of the Brit smoker’s lobby group Forest (Freedom Organization for the Right to Enjoy Smoking Tobacco) (Yes, everyone has a lobby group nowadays!) was not-surprisingly skeptical, referring to the study as “propaganda dressed up as science.” Oh, lest I be accused of bias, they have a website too. http://www.forestonline.org/output/home.aspx

So is the risk of third hand smoke overstated? Well, maybe. However, one should consider that over 4000 chemical compounds are created by burning a cigarette, many of which are toxic and/or carcinogenic. Carbon monoxide, nitrogen oxides, hydrogen cyanide and ammonia are all present in cigarette smoke. 43 known carcinogens are in mainstream smoke, sidestream smoke, or both. For a complete list of toxins in tobacco, go to http://quitsmoking.about.com/cs/nicotineinhaler/a/cigingredients.htm

And bear in mind that way back when asbestos was hailed as the new “wonder substance” finding it’s way into everything including bakelite jewelery (look it up, I’m not lying) it was felt to be safe. Now years later we know that asbestos fibers can cling to everything, much like, well, third hand smoke.

~Posted by D.M. Schwadron, Esquire

Doctor who found “link” between MMR vaccine and Autism discredited

admin — Fri, 29 Jan 2010 16:20:49 +0000

Source: BBC News

In 1998, Dr. Andrew Wakefield’s vaccination study appeared in the Brit Medical Journal Lancet. The study was seized upon by those of the anti-vaccination set.

The problem? His research has been discredited for a number of reasons including the he is reported to have paid his son’s friends to obtain blood samples while they attended his birthday party and the fact that he was working for attorneys hired by parents pursuing legal action for autism they believe was caused by the MMR (Measles Mumps and Rubella) vaccine.

Dr. Wakefield, who now lives (and works) in the US was, “Extremely disappointed” by the recent rulings of the General Medical Counsel against him. The study, which was later retracted by Lancet, has been cited as a critical factor in causing the plummet of MMR vaccination rates and the expected rise in new cases of measles since 2005.

~Posted by D.M. Schwadron, Esquire