Drug Recall Lawyer Blog

Novartis got successive wins last week in jury trials in Kentucky and Missouri, in the Zometa lawsuits. Plaintiffs in both cases alleged that Zometa caused osteonecrosis of the jaw (ONJ), which is just an awful condition that can lead to chronic pain and disfigurement, and is difficult to treat.

The battlefield in both of the lawsuits, as is often the case in drug cases, was the adequacy of the warning. Novartis apparently convinced these jurors that it had properly warned about the osteonecrosis of the jaw side effect that has come for thousands with intravenous bisphosphonate medications like Zometa and Aredia.

Pfizer Inc. has recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic), as an investigation found that some of the blister packs may contain an inexact count of inert or active ingredient tablets, and that the tablets may be out of sequence.

These products are oral contraceptives indicated for the prevention of pregnancy. These tablets were manufactured and packaged by Pfizer Inc. and labeled under the Akrimax Pharmaceuticals brand.

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (the full list of lot numbers is provided here) should notify their physician and return the product to the pharmacy.

These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.

There will be lawsuits here but I don't know what to make of them. Surely, there are potential wrongful birth suits. But the damages are the difference between the cost of having a child you did not want and the joy you get from that child. If you argue in court that your healthy child is more of a burden than the cost warrants... well, you are not a very nice person.

Cephalon has issued a recall for Treanda (bendamustine HCL). The recall affects the 25mg/8mL; and is marked as lot TB30111 with an expiration date of 12/2012. The recall has been made after the presence of particulate matter found was found in a single vial, which has since been identified as glass fragments.

Indicated for the treatment of chronic lymphocytic leukemia (CLL), the affected Treanda lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011.

The recall has been made in consideration of the potential safety issue and risk associated with administration of this product lot. Potential adverse effects after the administration of solutions containing particulates may present as an emboli and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro or macrovasular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised.

Treanda provides a reduced treatment time, as the infusion takes about an hour and can be done on an outpatient basis. Side effects of Treanda have been linked to potentially fatal skin reactions known as Stevens-Johnson Syndrome and toxic epidermal necrolysis. At least one death has been reported after a user experienced severe skin conditions from Treanda.

To date, Cephalon says it has not received any reports of injury.

The MDL Panel has agreed with Actos bladder cancers lawyers that all federal Actos claims should be consolidated in an MDL. You can find more information here.

here.

http://www.accidentinjurylawyerblog.com/2012/01/actos_bladder_cancer_lawsuits.html

The FDA has announced today the recall of Vagifresh Ball and Vagifresh Gel. An analysis by the FDA has found that Vagifresh Gel contains benzocaine, an active ingredient for many anesthetic drug products. An analysis of Vagifresh Ball found the product to contain bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

The FDA has further determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

These products, marketed as cosmetics, are applied by inserting deeply into the vagina for a prolonged period of time. Sold in herbal stores, beauty shops, drug stores, the internet, and by mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid, though this recall does not involve Vagifresh liquid.

Consumers are being instructed to immediately stop using the products and contact their physician if they experienced any problem that may be related to use.

I'm a man. It is not exactly comfortable putting this kind of information out there. But when safety is at issue, you really have to put that kinda stuff aside.

Chantix is mad science messing with the brain

You and Dawson, you both live in the same dreamworld! It doesn't matter what I believe. It only matters what I can prove! So don't tell me what I know, or don't know! I know the LAW!

Lt. Daniel Kaffee, that crazy kid, was on to something here. You can apply Kaffee's logic to Chantix. Chantix is always on the FDA adverse event reports leaderboard, both in terms of breadth and quantity. Where there is smoke, there is usually fire. Not always. But usually.

There is certainly enough of a connection between the smoke in Chantix suicide cases. If someone starts taking Chantix and kills themselves, it will not be difficult to explain to a jury the relationship. It is not a leap to say that if someone has been going through life without killing themselves (obviously), takes Chantix, and then kills themselves, it is going to be more likely than not that Chantix was a contributing cause. Not definitively connected beyond all reasonable doubt - suicide is too complex of an event for that - but certainly more likely that not to be a contributor.

Continue reading "Chantix Lawsuits: What Can Plaintiffs' Lawyer Prove?" »

Last month brought changes to forty (40) medical product labels (down from 48 changes in November), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Multaq (dronedarone hydrochloride) tablets
Dilantin-125 (phenytoin) Oral Suspension
Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets
Relenza (zanamivir) inhalation powder
Tyzeka (telbivudine) tablets and oral solution
Capoten (captopril) Tablets
Danocrine brand of Danazol capsules
Desferal (deferoxamine mesylate) for injection
Edarbi (azilsartan medoxomil) Tablets
Eloxatin (oxaliplatin) for intravenous use
Heparin Sodium Injection
Isentress (raltegravir) scored, chewable tablets, film-coated tablet
Keppra (levetiracetam) Tablets and oral solution
Onglyza (saxagliptin) tablets
Ovide (malathion) 0.5% lotion1
PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
Plavix (clopidogrel bisulfate) tablets
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules

• November 2011 Medication Label Changes
• October 2011 Medication Label Changes
• September 2011 Medication Label Changes
• August 2011 Medication Label Changes

A recent study has found that there is new evidence that statins could increase women’s risk factor for type 2 diabetes.

Statins, often called wonder drugs, are medicines taken to lower cholesterol levels. Zocor, Lipitor, and Crestor are the most popular of these medications that reduce the risk of heart disease and stroke. Tens of millions of Americans take these medications, but a recent study that followed more than 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Doctors say that don't know why statins increase diabetes, and that the research does not implicate any single brand. These findings seem to confirm prior smaller studies.

Now, I’m not saying that anyone should panic and stop taking their medication, since heart disease is one of the major complications of diabetes, but the risk is certainly something to consider and, ultimately, discuss with your doctor. Does the benefit outweigh the risk? It is going to depend on the patient.

• Cardiomyopathy and Diabetes: Crestor Lawsuits
• Zocor Warnings Rewritten

The FDA Safety Information and Adverse Event and Reporting Program is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health.

Due to problems that occurred when certain products were packaged and labeled at their Lincoln, Nebraska site, tablets from one product may have carried over into packaging of another product, resulting in the possibility of a stray pill of one medicine being placed in the bottle of another product. This is being done as a precuationary measure, as Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.

Affected products are as follows:

• Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
• Opana (oxymorphone hydrochloride) CII
• Oxymorphone hydrochloride Tablets CII
• PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
• PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
• ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
• ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
• MORPHINE SULFATE Extended-Release Tablets CII
• ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

Novartis Consumer Health, Inc. (NCH) has announced the recall of all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiration dates of December 20, 2014 or earlier, as well as Bufferin and Gas-X Prevention products with expiration dates of December 20, 2013 or earlier.

The recall is being made as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. These over-the-counter products were distributed nationwide to wholesalers and retailers.

Another Accutane lawsuit in New Jersey ended on Thursday, this time with a hung jury instead of the usual: a big plaintiffs' verdict. The jury had been out for a week; the trial lasted three weeks.

Accutane's manufacturer Hoffman-La Roche said in a press statement that it is "pleased that the jury concluded that [plaintiff] Tanna was unable to prove her case." It said it looks forward to a retrial. I guess if you are wearing rose colored glasses, that is how you would see it. Hoffman-La Roche is taking a beating in these Accutane lawsuits. So maybe a tie is a huge win for them.

As expected, the South Carolina trial judge denied post-trial motions to overturn a $327 million civil penalty against Johnson & Johnson, which was found to have overstated the claims about its antipsychotic drug, Risperdal. The award was $4,000 for each of more than 43,000 letters pushing Risperdal that J&J sendt to doctors, plus $300 each for 509,000 free samples given to doctors that contained detailed package inserts.

Still, J&J made a fortune off of Risperdal, pulling in as much as $3.4 billion a year in sales. Think about that. It is more than a third the size of the NFL and chances are you have never heard of Risperdal. It had ten good years of sales.

The problem, ultimately, is that from an economic standpoint and assuming J&J has no moral compass at all (I don't assume this, by the way), was it still a good play to put Risperdal on the market and push it as they did? Arguably, even after all of the pain (more might come in a lawsuit brought by the country state of Texas), it still probably makes economic sense. That's the problem.