Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

Premium Edge Cat Food Recalled

If you have a furry little friend who eats Premium Edge cat food, you’ll want to read this:

On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the company’s posted announcement of September 23 when the initial recall information was provided.

Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. At the first stage the cat may show decreased appetite, salivation, vomiting, and weight loss. Later, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. These ultimately may result in the death of the animal if left untreated. If your cat has consumed the recalled product and has these symptoms, please contact your veterinarian.

The affected products were distributed in Maine, New Hampshire, Vermont, Massachusetts, Connecticut, Rhode Island, New Jersey, Maryland, Delaware, New York, Pennsylvania, Virginia, Alabama, Tennessee, North Carolina, South Carolina, Georgia, Florida.

The affected date codes were RAF0501A22X 18lb. (BB28NOV10), RAF0501A2X 6 lb. (BB28NOV10), RAF0802B12X 18lb (BB30FEB11), RAH0501A22X 18 lb. (BB28NOV10), RAH0501A2X 6lb. (BB28NOV10, BB30NOV10, BB08DEC10)

To date, 21 cases of thiamine deficiency in cats have been reported and confirmed by Diamond. The reports have been confined to the New York and Pennsylvania areas and none have been received since October 19.

Diamond has tested the product and found the cat foods were deficient in thiamine. Samples taken by the FDA indicated that there were additional lots with insufficient levels of thiamine. No other complaints have been reported on any other product manufactured by Diamond Pet Foods.

Consumers who have purchased the affected lots are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-977-8797, Monday-Friday, 8:00 am to 5:00 pm Central Time.

Source: Diamond Pet Foods Announces Recall of Premium Edge Adult Cat and Premium Edge Hairball Cat Food

Complete List of Recalled Children’s Tylenol

You’ve probably heard that Children’s Tylenol was recalled earlier this month.  Fresh from the FDA, here’s the complete list of all products that were recalled.  If you have any of them, DON’T USE THEM.

1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottles, Grape Flavor, Oral Suspension, Product code 3910400, UPC 300450391049. Recall # D-1952-2009;

2) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Grape Flavor Oral Suspension. Product code 2960400, UPC 300450296047. Recall # D-1953-2009;

3) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, bubblegum Yum Flavor, Oral Suspension. Product code 4070400, UPC 300450407047. Recall # D-1954-2009;

4) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, very berry Strawberry Flavor, Oral Suspension. Product code 4930400, UPC 300450493040.Recall # D-1955-2009;

5) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Grape Flavor.  Packaged in the following configurations: 1/4 fl oz (7.5 mL) bottle with dropper, a) Product code 1224000, UPC 300450122407; 1/2 fl oz (15 mL) bottle with dropper, b) Product code 1221500, UPC 300450122155; 1 fl oz (30 mL) bottle with dropper, c) Product code 1220100, UPC 300450122018; 1 fl oz (30 mL) bottle with dropper, d) Product code 1221000, UPC 300450122100; (For Hospital/Government Use Only), 1/2 fl oz (15 mL) bottle, e) Product code 1221800, UPC 350580144183. Recall # D-1956-2009

6) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Cherry Flavor.  Packaged in the following configurations: 1/2 fl oz (15 mL) bottle with dropper, a) Product code 1861500, UPC 300450186157; 1 fl oz (30 mL) bottle with dropper, b) Product code 1863000, UPC 300450186300; (For hospital/government use only), 4 fl oz (120 mL) bottle, c) Product code 1230300, UPC 350580123034. Recall # D-1957-2009;

7) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Dye Free Cherry Flavor, Oral Suspension. Product code 1660400, UPC 300450166043. Recall # D-1958-2009;

8) Children's Tylenol, (acetaminophen 160 mg/5 mL), Cherry Blast Flavor, Oral Suspension. Packaged in the following configurations: 4 fl oz (120 mL) bottle, Product code 1230400, UPC 300450123046; 1 fl oz (30 mL) bottle, Product code 1230100, UPC 300450123015. Recall # D-1959-2009;
9) Children's Tylenol Plus, Cough & Runny Nose, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2490400, UPC 300450249043. Recall # D-1960-2009;

10) Children's Tylenol Plus Flu, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3860400, UPC 300450386045. Recall # D-1961-2009;

11) Children's Tylenol Plus Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Grape Flavor, Oral Suspension. Product code 3870400, UPC 300450387042. Recall # D-1962-2009;

12) Children's Tylenol Plus Cough & Sore Throat, (each 5 mL contains: Acetaminophen 160 mg and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2470400, UPC 300450247049. Recall # D-1963-2009;

13) Concentrated Tylenol Infants' Drops, (acetaminophen 80 mg/0.8 mL), 1 fl oz (30 mL) bottle with dropper, Dye-Free Cherry Flavor. Product code 1670100, UPC 300450167019. Recall # D-1964-2009;

14) Children's Tylenol Plus Cold & Allergy, (each 5 mL contains: Acetaminophen 160 mg, Diphenhydramine HCl 12.5 mg, and Phenylephrine 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3900400, UPC 300450390042. Recall # D-1965-2009
CODE
1) Lot numbers: SBM041 exp 1/10, SBM067 exp 2/10, SCM037 exp 2/10, SDM027 exp 3/10, and SEM109 exp 5/10;

2)  Lot numbers: SBM042 exp 2/10, SCM015 exp 2/10, SCM036 exp 2/10, and SDM034 exp 3/10;

3) Lot numbers: SBM043 exp 2/10, SBM044 exp 2/10, and SCM029 exp 2/10;  

4) Lot numbers: SBM045 exp 2/10, SCM011 exp 2/10, SCM030 exp 2/10, and SDM035 exp 3/10;

5) a) Lot numbers: SBM064 exp 2/10, SCM033 exp 3/10, and SDM020 exp 3/10; b) Lot numbers: SCM012 exp 2/10, SCM067 exp 3/10, SDM007 exp 3/10, and SDM068 exp 3/10; c) Lot numbers: SCM082 exp 3/10, SDM039 exp 3/10, and SDM040 exp 3/10; d) Lot number: SDM078 exp 3/10; e) Lot number: SCM034 exp 2/10;

6) a)  Lot numbers: SBM065 exp 2/10, SCM005 exp 2/10, SCM006 exp 2/10, and SDM032 exp 3/10; b) Lot numbers: SDM038 exp 3/10 and SDM009 exp 3/10; c) Lot number: SDM028 exp 3/10;

7) Lot numbers: SBM066 exp 2/10 and SCM068 exp 2/10;

8) Lot numbers: SBM068 exp 2/10, SCM035 exp 2/10, SCM070 exp 3/10, SCM080 exp 3/10, and SDM005 exp 3/10; Product code 1230100, Lot number: SDM064 exp 3/10; 

9) Lot numbers: SBM069 exp 2/10, SBM070 exp 2/10, SCM081 exp 3/10, and SDM006 exp 3/10;

10) Lot numbers: SCM013 exp 2/10, SCM014 exp 2/10, and SCM069 exp 3/10;

11) Lot numbers: SCM016 exp 2/10 and SFM024 exp 5/10;

12) Lot number: SCM017 exp 2/10;

13) Lot numbers: SCM083 exp 3/10, SCM084 exp 3/10, SDM008 exp 3/10;

14) Lot number: SDM033 exp 3/10  
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letters dated August 21, 2009 and September 11, 2009. Firm initiated recall is ongoing.
REASON
The raw material used to manufacture the finished product may have been contaminated with B cepacia.
VOLUME OF PRODUCT IN COMMERCE
7,983,648 bottles
DISTRIBUTION
Nationwide

Source: Enforcement Report for September 30, 2009

More Fentanyl recalls – This Time From Watson Pharmaceuticals

Unlike the previous Duragesic and Fentanyl recalls of millions of patches, this one covers only one lot of one size patch:

Watson Pharmaceuticals has recalled one lot of its 75-mcg/hour fentanyl transdermal system in the U.S. because a small number of patches were leaking a gel form of the pain medicine.

The recalled patches are from lot No. 92461850 with an Aug. 31, 2009, expiration date. They were shipped between Jan. 30 and March 19. No other strengths or lots were affected, and the company does not anticipate any product shortages as a result of the recall, according to its statement.

Source: Watson Voluntarily Recalls Pain Patch Lot

At this time, I don’t know what the specific manufacturing defect in this lot was, or how it was discovered.  But as always, if you think you have a defective Fentanyl or Duragesic patch, do not touch it with your bare hands.  And do not wash your hands with soap if you do touch it. 

I have several pictures of Fentanyl patches, but not of the Watson patches.  You can view my existing photos of Fentanyl here.  If you have any pictures of Watson patches, please send them my way. 

More Fentanyl patches recalled – not Duragesic this time

Watson Pharmaceuticals has announced a recall of all 75mcg Fentanyl patches from lot number 92461850.  These patches are being recalled for the same reason many of Johnson & Johnson’s Duragesic patches were recalled: Manufacturing defects that could lead to leakage.  Here’s an excerpt from Watson’s press release:

CORONA, CA - August 8, 2008 - Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 92461850, have expiration dates of August 31, 2009 and were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between January 30, 2008 and March 19, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

Source: Watson Pharmaceuticals, Inc. | Investor Relations | Press Release

If you have any Fentanyl patches from this lot, you can call 888-667-1508, Mon. through Fri. from 8:00 a.m.-5:00 p.m. Eastern Time, for instructions on how to return the patches.  Watson recommends flushing any patches down the toilet that have already begun to leak, and strongly cautions against touching leaking patches with your bare hands.  If you accidentally touch a leaking patch, wash your hands with water only.  DO NOT USE SOAP as this increases the likelihood you will be injured by the patch.

Many people have already died as a result of leaking Fentanyl patches, and I hope no one dies or is injured from these patches.  Better still, I wish all the manufacturers of Fentanyl patches would switch over to what’s called a Matrix design like they sell in Europe.  Those patches cost a little bit more to manufacture, but they don’t leak and kill people like these patches do.

Duragsesic (Fentanyl) Patch Recall Information

SAFETY ALERT: OVER 60 MILLION DURAGESIC (FENTANYL) PATCHES RECALLED

On February 12th of 2008, Pricara announced a recall of 38 million Duragesic and generic Fentanyl patches because they "may have a cut along one side of the drug reservoir within the patch."  (Duragesic is the brand name of a patch that contains the drug Fentanyl.)  Because of this cut, the Fenantyl inside the patch can leak out and cause an overdose to anyone who handles the patch.  The recalled patches are the 25mcg patches and will have an expiration date on or before December of 2009.  There are two types of patches being recalled: The brand-name Duragesic patches, and the generic Fentanyl batches.  The Duragesic patches will likely have a "Duragesic" label on them, while the generic patches will likely just say "Fentanyl."  The Duragesic patches are sold by Pricara, which is owned by Ortho-McNeil-Jannssen Pharmaceuticals, Inc.  The generic Fentanyl patches are sold by Sandoz, Inc.  All of the patches are made by ALZA corporation, which is why they have the same defect.

If you think you have a defective 25mcg Duragesic patch, call 1-800-547-6646.  If you think you have a defective 25mcg generic Fentanyl patch, call 1-800-901-7236.

On February 2nd and March 3rd of 2008, Actavis announced two recalls of all of their generic Fentanyl patches, which is estimated to be over 21 million patches.  Like the Johnson & Johnson Duragesic Fenatyl patch, the Actavis generic Fentanyl patch suffers from a manufacturing defect that can kill individuals who handle the patch. 

Actavis recalled all of their 25mcg, 50mcg, 75mcg, and 100mcg doses with expiration dates between May and December of 2009.  If you think you have a defective Actavis Fentanyl patch, call 1-877-422-7452.

If you accidentally touch one of these patches, wash your hands with water only.  DO NOT USE SOAP as this increases the likelihood you will be injured by the patch.

How do I know if I've been injured by a Duragesic or Fentanyl patch?

The most serious injury that can occur with a defective Duragesic or Fentanyl patch is death.  If an autopsy was performed, "Fentanyl overdose" or "Fentanyl toxicity" may be listed as one of the causes of death.

Other symptoms of Fentanyl Toxicity include: agitation, circulatory failure, coma, confusion, convulsions, hallucination, hypotension, myoclonic jerks, nightmares, pinpoint pupils, renal failure, respiratory depression, rhabdomyolysis, and vivid dreams.  If you think you’ve experienced an overdose of Fentanyl, get medical help immediately. 

Do I need a Duragesic or Fentanyl Lawyer?  Should I file a lawsuit?

If you or a family member were injured by a defective Duragesic or Fentanyl patch, you may want to consult with an attorney to see what your legal rights are.  I personally know several attorneys involved in Duragesic & Fentanyl litigation, and can put you in touch with one of them to see if you have a case.  The lawyers I know aren't paying me to refer them cases.  And I'm not getting a "cut" of any recovery you may receive.  All I ask from you is that you consider writing a letter to your elected representatives to tell them you oppose FDA preemption, which will prevent many injured citizens from filing lawsuits against manufacturers of defective drugs.

I'm not an attorney - I'm a law student.  So contacting me does not and can not create an attorney-client relationship.  And I will not give you any legal advice, either.  What I will do is listen to your story and put you in touch with an attorney I believe may be able to help you.  I can't promise that the attorney will win your case, if you have one.  All I can promise is that the attorney I put you in contact with will treat you and your family with dignity and respect, and that he or she will vigorously fight for your rights.

Over 60 million defective patches?  What happened?

Several problems contributed to all of these defective patches.  For one thing, it's only recently that the manufacturers implemented an electronic inspection program to verify the patches weren't defective.  Before then, they were relying on purely visual inspection.  This is a problem because the machine that makes the patches was spitting them out at a rate of 240 per minute.  That's four patches every second. No one can look at four patches every second.

Another problem is that the way the patches are made makes it impossible for there not to be leaking patches.  One of the manufacturers even stated that leaking patches are an inherent part of the manufacturing process.  The internal goal was for only 1/10th of 1% of patches each year to leak.    1/10th of 1% is still 8,000 defective patches per year, meaning that if everything went according to plan 8,000 people per year could be injured or die from defective patches.  Does that sound acceptable to you? Unfortunately, the defective lots had a rate closer to 20% of all patches being defective.

The recalled patches were defectively manufactured.  But there's also plenty of evidence that the design of the patch is defective, too.  If the manufacturers switched over to what's called a "Matrix" design, or to a "drug in adhesive" design, there would be little to no risk of leaky patches.  In fact, ALZA corporation even acknowledged to the FDA that a "Matrix" design would eliminate the risk of gel leakage.  In fact, Fentanyl patches sold in Europe do use the Matrix design.  You're probably wondering why we don't use the Matrix design here.  If you've been injured by a Duragesic or Fentanyl patch, perhaps the manufacturer will have to tell a jury why it doesn't use a safer design.

Digitek (Digoxin) Recall Information

Safety Alert: Digitek Recalled in April of 2008

On April 25th of 2008, Actavis Totowa, LLC announced a Class I Recall of Digitek tablets.  A Class I Recall occurs when there is an immediate risk of death or injury from a drug or medical device.

In this case, Actavis announced the recall because certain batches of Digitek tablets contained double the dose of the active ingredient Digoxin.  This high dosage can lead to injury or death from Digitalis Toxicity. 

Actavis hired a company called Stericycle to handle the recall.  They can be reached at  1-888-276-6166, Monday through Friday, from 8am to 5pm Eastern Standard Time.  Actavis has not announced which lots have been contaminated, but Stericycle is only issuing refunds to customers who had prescriptions filled from March of 2006 through April of 2008.  You can read the actual recall notice here.

If you still have any Digitek from that time period, it is critically important that you do not take it.  You should contact your doctor, your pharmacy, or Stericycle to determine how to replace the pills.  If possible, you should keep the defective pills in a safe place in case it becomes necessary to file a lawsuit against Actavis.  But make sure they’re locked in a safe place where there is no risk anyone may take them.

How do I know if I’ve been injured by Digitek?

The most serious side-effect of a Digoxin overdose is death.  If a loved one passed away while taking Digitek, it’s possible that the double-dose of Digoxin contributed to the death.  If the death certificate lists “Digitalis Toxicity” as one of the causes of death, the odds are very high that Digitek is at least partially to blame.  There are other signs that Digitek contributed to someone’s death; feel free to contact me if you’re concerned that Digitek caused the death of a loved one.

Other symptoms of a Digitek overdose include:

• Heart problems, such as dysrhythmia and cardiac arrest.
• Severe nausea, diarrhea, vomiting, etc.
• Visual problems, such as blurred vision and seeing “halos.”

People with kidney problems, the elderly, and women are most likely to have suffered an injury or death due to Digitalis Toxicity.  Especially those who were using the 0.250mg dose of Digitek as opposed to the 0.125mg dose, since the 0.250mg dose actually contained 0.500mg of Digioxin.

Should I file a Digitek lawsuit?  Do I need a lawyer?

Whether to file a lawsuit over Digitek is a decision you should make after contacting an attorney familiar with Digitek litigation.  I’m fortunate enough to have good relationships with several attorneys who are qualified to help people injured by Digitek.  If you email me, we can talk about your potential case and I’ll match you with a lawyer who I believe will take good care of you.  Unlike most attorney lead-generation services, I do not get paid by anyone to refer them your case.  And because I’m a law student and not yet an attorney, it would be illegal for me to get a “cut” of any recovery in your case.  All I ask from you is that you contact your elected representatives and tell them you oppose FDA Preemption, which would eliminate most lawsuits over prescription drugs.

Remember, I am not yet a lawyer, so emailing me does not and can not create an attorney-client relationship.  Nor am I going to offer you any legal advice.  Instead, I’m going to listen to your story and give you the names and contact information of attorneys I think can help you and your family get through this difficult time.

Double the dose?  How did this happen?

While the incident is still being investigated by the FDA, all signs point towards poor quality control at the Actavis manufacturing facility.  In August of 2006, and again in February of 2007 the FDA sent warning letters to Actavis explaining that the company was violating FDA rules on the manufacture and inspection of prescription drugs.  In other words, it looks like Actavis was simply being sloppy.

You can read the August letter here, and the February letter here.  Some of what the FDA found would be comical if it weren’t for the deadly result of their sloppiness: One of the precision machines used to make medication was repaired with duct tape.  The letters give the strong impression that Actavis was cutting corners in their manufacturing facility. 

What do the Recalled Digitek Pills Look Like?

The .125mg Digitek pills that were recalled are yellow and are marked with B 145 on the front:

The .250mg Digitek pills that were recalled are white and are marked with B 146 on the front: