Drug Recall Lawyer Blog

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.

• The Justice Department has recovered $2.2 billion in civil enforcement actions against pharmaceutical companies this year.
• Yes, Tylenol, even at "safe" levels, can hurt you.
• The FDA has warned California Lap-Band practices to stop it with the misleading ads.
• The FDA says it's premature to draw any link between SSRIs during pregnancy and babies with a condition called persistent pulmonary hypertension of the newborn.
• Pfizer has to pay three women who alleged a link between hormone replacement drugs and their breast cancer. HT:TortsProf.

The FDA is advising that an additional concentration of liquid acetaminophen marketed for “infants” is now available. The new concentration, 160 mg/5 ml, will affect the amount of liquid given to an infant, and should be especially noted by consumers who re used to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

The Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.

Acetaminophen is marketed under brand names such as:

• Tylenol
• Little Fevers
• Triaminic
• Infant/Pain Reliever
• Pedia Care
• Triaminic Infants’ Syrup Fever Reducer/Pain Reliever
• store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.)

The FDA is recommending that consumers read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.

• Hydrocodone/Acetaminophen Recall
• Tylenol Linked to Asthma?
• Use of Acetaminophen in Pregnancy Associated With Increased Asthma Symptoms in Children
• Tylenol Liver Damage Symptoms and Information

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.

The FDA Safety Information and Adverse Event Reporting Program has announced that the FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Gilenya is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults, and is used to reduce the frequency of flare-ups and delay physical disability.

The FDA believes - as do most neurologists - that Gilenya provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA recommends - obviously - that patients with MS not stop taking Gilenya without talking to their doctor.

The FDA is continuing to evaluate this case as they are not able to conclude whether the drug resulted in the patient's death. The FDA will communicate any new information that results from this investigation.

I suspect Gilenya is a great drug. But the FDA is doing the right thing is taking adverse reports seriously with all drugs, particularly those that are new to the market.

Last month brought changes to forty-eight (48) medical product labels (holding steady with 48 changes in October), 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:

Cerebyx (fosphenytoin sodium)
Dilantin (phenytoin sodium, USP)
Dilantin (phenytoin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Mytelase (ambenonium chloride)
Onglyza (saxagliptin)
Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
Combivir (lamivudine/zidovudine)
Emtriva (emtricitabine)
Epivir (lamivudine)
Epzicom (abacavir sulfate and lamivudine)
Isentress (raltegravir potassium)
Lioresal Intrathecal (baclofen injection)
Methotrexate Sodium for Injection
Retrovir (zidovudine)
Tekamlo (aliskiren/amlodipine)
Toviaz (fesoterodine fumarate)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trizivir (abacavir sulfate, lamivudine, and zidovudine)
Twynsta (telmisartan/amlodipine)
VFEND (voriconazole)
Videx (didanosine)
Videx EC (didanosine, USP)
Vimovo (naproxen/esomeprazole magnesium)
Viread (tenofovir disoproxil fumarate)
Zerit (stavudine)
Ziagen (abacavir sulfate)
Zyflo CR (zileuton)

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

Several FDA groups met on December 8 to review warnings on Bayer’s five drospirenone-containing birth control pills. This meeting is the product of several months of mounting evidence that these birth control pills are unreasonably dangerous, particularly in light of safer alternatives.

First a review: Bayer (through Berlex, a company later enveloped by Bayer) developed and released Yasmin in May 2001. Ocella, manufactured by Barr Laboratories, is the generic of Yasmin. These drugs contain an active progestin ingredient to help prevent ovulation. Many other birth control pills contain the progestin levonorgestrel, but Yasmin and Ocella use the newer (and less tested) “fourth-generation” progestin known as drospirenone.

Yaz was approved by the FDA in 2006, and that’s when the heavy marketing (and sales) really took off. Bayer wasn’t actually printing money, and they didn’t have a printing press in their basement, but this was the closest thing to it. Yaz marketing was calculatingly directed at women’s sense of individuality and freedom. Nefariously, it was also directed to uses not approved by the FDA, including PMS, bloating, muscle fatigue and aches. Because of the excellent marketing campaign, Yaz and Yasmin profits were $998 million in 2008.
Predictably, the problems then started surfacing: venous thromboembolism (blood clots) and pulmonary embolism, all leading to strokes and heart attacks. There is also a significant number of studies and anecdotal evidence suggesting a link between drospirenone and gallbladder injuries. Many young and healthy women with no other risk factors are having their gallbladders surgically removed. The only commonality is that they all use a member of the Yaz-family of birth control pills.

After the FDA slapped Bayer with an order requiring $20 million in corrective advertising to undo all of the damage they had done, Bayer needed something to help its new image problem. The answer? A Hollywood-style reboot of the formerly famous pills: Safyral (Yasmin with vitamin B) and Beyaz (also with vitamin B). These are lackluster attempts to regain market share.
A few days ago the FDA had a meeting. The Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met and took a vote. 21 out of 26 members concluded that the risk profile of these drugs was not adequately reflected in package warnings. They noted, however, that benefits of the drugs may outweigh the risks. In this case, though, it seems it might be a good idea to warn about those risks and let patients and their doctors decide. This was an advisory committee meeting, and the FDA will now have the chance to follow its recommendations and require a new warning (the likely result), or opt to leave the situation alone.

For more information about Yaz, Yasmin and Ocella, see our main webpage.

An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.

Continue reading " Stronger Label Urged for Birth Control Products, Yaz and Yasmine " »

The FDA is evaluating post-marketing reports of serious bleeding events in patients that are taking Pradaxa (dabigatran etexilate mesylate). Pradaxa, a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), contains a drug label that warns about significant and sometimes fatal bleeds, bleeding that may lead to serious or even fatal outcomes.

In a large clinical trial involving 18,000 patients, Pradaxa and warfarin were compared, with major bleeding events occurring at similar rates with the two drugs.

The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

At this time, the FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label. Are there right about this? Who knows? Clearly, patients with AF should not stop taking Pradaxa. Should they be talking to their doctor about these new concerns? Of course.

The FDA says it will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

• Pradaxa Problems and Real Costs Compared to Coumadin

DePuy issued a U.S. recall of its metal-on-metal ASR hip implants in August of 2010 (after 93,000 implant procedures) because of an extremely high failure rate requiring patients to have revision surgeries. Evidence so far indicates that the device is exceedingly difficult for orthopaedic surgeons to implant properly. For background on the DePuy saga, see our DePuy Recall website and prior DePuy Drug Recall Lawyer Blog entries.

The hip implant was withdrawn from the Australian market in late 2009. DePuy (a subsidiary of Johnson & Johnson) told the public in the U.S. shortly thereafter that it was phasing out the implant because they were “focusing on newer technologies.”

The Australian Senate likened these hip implants to “ticking time bombs.” They want a system put in place to monitor adverse outcomes for hip implant patients, and they want to make sure doctors and patients are aware of the problems they may be facing. Most importantly, they want to make sure implant patients are continually monitored for future problems.

The medical monitoring program would help people to be regularly evaluated for metallosis, blood poisoning caused by metal fragments from the implants. So far, 430 out of 5,500 Australian patients have undergone a second surgery because of the faulty implant—that’s almost a ten percent failure rate. The real number is probably higher—many patients may be in line for that surgery, and experts believe that many more installed devices will fail within about six years of implant.

If you have had a DePuy ASR hip implant, and you are experiencing problems or have had to replace the implant, contact us at 800-553-8082 or get a free online consultation.
Sources: Sydney Morning Herald

• All Metal Hip Replacement: No Advantage Over Older Implants
• Metal On Metal Hip Replacents - A Colossal Failure?
• New Repor Highlights Metal Hip Problems
• Hip Replacement Profits