Drug Recall Lawyer Blog

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

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

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.

Johnson & Johnson, eager to pad its record recall year before 2011 closes out, is recalling certain lots of MOTRIN IB, because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer level recall, meaning consumers do not need to dispose of or return the product.

There is no safety concern if consumers continue taking the product in accordance with its label; there may just be a delay in experiencing relief. The recall is NOT being made on the basis of any adverse events.

The lot numbers for the recalled product can be found on the side of the carton label. The recalled lots are as follows:

• MOTRIN IB 24 COATED TABLETS - Lot Numbers: ADA069, ALA168, ALA244 AMA286, APA001, ASA001 - UPC Code: 300450463029
• MOTRIN IB 24 COATED CAPLETS - Lot Numbers: ACA310, ACA460, ADA407 AEA262, AFA226, AJA170, ALA037, ALA163, AMA012, AMA331, AMA342, APA035, ASA082, ASA123, ASA285, BDA238, BDA260, BDA383, BEA065, BEA148, BEA269 BEA277, BFA064, BFA144, BFA244, BHA078, BHA147, BHA167, BHA198, BJA164, BJA221, BMA144, BMA215, BMA271, BSA022, BSA056, CBA063, CBA107, CCA028, CDA003, CFA065, CFA100, CHA012, CHA044, CHA066, CHA080, CMA028, CMA035, CMA057, CMA102, CMA108 - UPC Code: 300450481030
• MOTRIN IB 24+6 COATED CAPLETS - Lot Numbers: ACA761, ALA265 - UPC Code: 300450481641

The products were distributed in the United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.

Is this a serious safety hazard for Motrin users? No. But it continues to underscore that Johnson & Johnson needs to get its act together. Drug companies are going to have recalls. Even the best companies are going to have to recall product from time to time. J&J just has way too many.

A new study from Canada suggests that women who use relatively benign painkillers like ibuprofen and naproxen early in pregnancy may have an increased risk of miscarriage.

Researchers found that of nearly 52,000 Quebec women who had been pregnant, those who had taken these commonly used painkillers with a favorable safety profile were more than twice as likely to suffer a miscarriage. The study included all non-aspirin NSAIDS such as Advil, Motrin, Aleve, Naprosyn, and Celebrex.

Is there a cause and effect relationship? No one really knows. But pregnant women are already advised to avoid using any medication if they possibly can. What should you do? I think that is something you want to address with your doctor. Everyone is different. But is it worth mentioning this study to your doctor? I think it is.

There have not been any medical device recalls announced by the FDA since early June. This is a good thing. But there are a lot of silent recalls when a product is taken off the market because sales are crashing in response to all of the reasons why there should be a recall in the first place.

From a plaintiffs' lawyers' standpoint, the best cases to try are those cases where a bad product was given a soft recall but the product is left on the market until the shelves clear. Defense lawyers are not racing to the courthouse steps to try these cases and they usually settle in the highest value range of a mass tort settlement (or the plaintiff opts out of the settlement and gets a higher offer later).

The FDA put out a proposed new rule to to withdraw 21 CFR § 203.50(a) to deal with court orders striking it down. The courts' problem with the rule was a regulation that requires that certain information be included in a pedigree, which documents the custody of certain prescription drugs in the drug supply chain.

The FDA has defended its rule while noting the courts' objections to it. This new rule hopes to reconcile the courts' concerns.

The rule was struck down in 2006. The FDA gets around to solving it five years later. Maybe "FDA approved" should not be a "get out of jail free" card for drug companies.

• Some calcium gluconate injections, used to treat a variety of conditions, are being recalled because they may contain silicone particles.
• Two consumers allege that the drug Humira causes nerve damage.
• Litigation over the Arkansas attorney general's claims that AstraZeneca concealed the risks associated with Seroquel use from Arkansas Medicaid participants will go to trial next September. The state claims the company knew before it started marketing the anti-psychotic drug that it could lead to weight gain and diabetes. The FDA is also adding a heart health warning to Seroquel.
• An Indian news outfit reports that Rite Aid is suing Indian drug company Ranbaxy over the company's generic version of the anti-nausea drug Reglan. The drugstore chain alleges that Ranbaxy breached its agreement to defend Rite Aid in litigation over the medication, which some consumers allege causes movement disorders.
• What happens when the plaintiff in a drug wrongful-death case doesn't know which company manufactured the medication that allegedly killed the decedent?

• Europe's look at Actos

In the middle of a not so good stock market Friday after the jobs report, Amylin Pharmaceuticals went up 5% after a new study of its diabetes drug Bydureon took a step forward towards reaching the market.

Rezulin, Actos, Byetta, Avandia... it seems there are a few diabetes drugs that have come on to the market with controversy and, yes, lawsuits. Is Bydureon different? I guess we are going to find out.

Our firm is now reviewing potential Bydureon lawsuits. Call us today for a free consultation. (I'm just kidding, by the way. Hopefully, Bydureon is a safe and efficacious drug that just helps people like the vast majority of drugs and medical devices.)

American Regent is recalling a Caffeine & Sodium Benzoate Injection lot because some of the vials contain visible particulates. The concern is floating particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation and granuloma formation as well as concerns that the body will react poorly to foreign particles as it often does.

Hospitals, emergency rooms, and other health care providers are being told they should not use this lot and should immediately quarantine any product for return.

The FDA information is here.

It has otherwise been a thankfully slow drug recall week with only one other drug recall.

There seem to be a lot of recalls that are published by attaching either a .pdf document or a Microsoft Word document. Why? Could it be that providing this information in this format is less sticky for search engines?

If the only mention on your website related to a recall of your product is a .pdf/Microsoft Word document, this makes me more than a little suspicious.

I was unaware until just today of the Accutane lawsuit filed by James Marshall. You don't know who James Marshall is? Yes you do. He was the guy who gave the Code Red to Santiago (the other one, not the guy who said, "There is an officer on deck" at the end, creating a lot of pollen in my house). Apparently, Martin Sheen testified at trial, reversing a family policy to stay out of the public eye.

• Accutane lawsuit (an overview)

Tony Soprano: Sil, break it down for 'em. What two businesses have traditionally been recession-proof since time immemorial?

Silvio Dante: Certain aspects of show business and our thing.

Let's add one more: anything fear related. For time immemorial. The FDA is telling consumers to beware of buying fake iodide drugs that are supposed to help protect against radiation.

The demand for potassium iodide a full half a world away has skyrocketed since the radition leaks in Japan. The crazy thing is people would be so much safer if they just pledged to keep two hands on the steering wheel and didn't talk on the cell phone. People are driving unsafely to the store to get potassium which is jumping over dollars to pick up pennies.

Qualitest Pharmaceuticals has recalled about 11,000 bottles of its hydrocodone with acetaminophen tablets. The drug is used to relieve pain, combining hydrocodone (an opiate narcotic) with acetaminophen (a non-narcotic pain reliever).

The recall came from a mix up that led to the discovery of a bottle mislabeled as Phenobarbital. The fear is that patients may unintentionally take hydrocodone and acetaminophen when they are supposed to be taking Phenobarbital.

So will lawsuits follow? Sure if two things happen. First, someone has to actually make the mistake of taking this drug instead of Phenobarbital. Second, there has to be some injury from this error. I put the chances of these things happening together on par with the likelihood of Brett Favre hosting The View. But I applaud Qualitest for recalling the product anyway.

You can read more on this recall here.

The FDA announced that PGxHealth's Vilazodone (Viibryd) has been approved for treatment of major depression. Vilazodone is yet another serotonin reuptake inhibitor with a few other pharmacaclogical twists.

No matter what you think of the SSRIs, they have been battle tested for a long time. When you combine the regulatory environment with drug companies looking for a quick score, you have to look somewhat skeptically at the safety and efficacy on any new antidepressant. But, hopefully, this drug works well for those who have struggled to get relief from the antidepressants currently on the market.

According to the drug's manufacturer, PGxHealth, the approval was based primarily on two eight-week clinical trials comparing vilazodone with placebo. The drug was also tested in a 52-week uncontrolled study with efficacy results similar to those seen in the randomized trials.

Vilazodone's label will include a boxed warning and about risk of suicidal thinking and behavior in patients younger than 25 years-old.

The New York Times reports that the number of ER visits from patients misusing or abusing prescription drugs almost doubled over the last five years.

Doubled. You read so many statistics these days. It is mind numbing to the point where incredible statistics like this get glossed over in the next 3 hour news cycle. I read the article and I still have no idea how this could be. We need the Freakanomics guys to figure this out.