Reglan: MDL Petition to be Heard on 5/28 in Louisville, KY

Link to the Order here.

I mentioned last week that counsel on cases (friends of mine) had file the Petition - looks like it will be argued next month.

Early indications? Plaintiffs' lawyers want it in Las Vegas.

Botox - Unapproved Use Warning

Health officials are warning doctors and patients about potentially deadly risks of using anti-wrinkle drug Botox and similar drugs for unapproved uses to treat muscle spasms.

The Food and Drug Administration says Botox and two other injections have been linked to rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulism-based drug also is widely used for muscle-spasm conditions.

Regulators say the majority of deaths are in children with cerebral palsy taking the drugs for spasticity in their legs.

Botox and competitors Myobloc and Dysport will carry a boxed warning, the most serious type available.

Link here.

Accu-Chek Insuling Pump Recall

Another day another recall - how is the public expected to know about these nearly once a day recalls?

Roche Holding AG(RHHBY) unit is recalling Accu-Chek Spirit insulin pumps that were sent to the U.S., the Food and Drug Administration said Thursday noted in a recall notice posted on its Web site.

Also, we are working on a SE Georga Law Blog, and you can find more online.

Excessive Selenium Kills 21 Polo Ponies

My office is investigating the damage selenium has caused to people who took an over the counter supplement known as Total Body Formula. This week there is news that selenium killed nearly two dozen horses:

The 21 polo horses that died last week shortly before they were to compete in the U.S. Open polo tournament fell victim to a fatal overdose of selenium, a mineral ingredient in a medication meant to help them recover from exhaustion, according to Florida's state veterinarian.

"Signs exhibited by the horses and their rapid deaths were consistent with toxic doses of selenium," Dr. Thomas J. Holt said today of the circumstances surrounding the loss of the horses, which were all owned by the Venezuela-based Lechuza Caracas team.

The medication was prepared by an Ocala, Fla., retail and compounding pharmacy called Franck's Pharmacy at the request of the veterinarian who treated Lechuza's horses while in Florida. Franck's Pharmacy announced last week that an internal review prompted by the horses' deaths showed that the compound, a substitute for a medication called Biodyl that is unapproved for use in the U.S., was mixed incorrectly.

Sources are many, including here.

Nail Polish Remover Recall

The U.S. Food and Drug Administration announced a nationwide recall of Personal Care-brand non-acetone nail polish remover because of a claimed safety hazard.

The FDA said Personal Care Products Inc. of Bingham Farms, Mich., initiated the recall of the polish remover-conditioner enriched with gelatin because it doesn't meet product specifications and might cause chemical burns to the fingers of users.

Treanda and Stevens Johnson Syndrome

The cancer drug Treanda, in combination with another therapy, may have caused two people taking it to develop a serious skin condition known as Stevens Johnson Syndrome and one has died.


The patients developed a severe form of the condition known as toxic epidermal necrolysis, which is characterized by a blistering and peeling of the top layer of skin, causing it to peel off, leaving damaged areas which can become infected.

Both patients were also taking a drug called allopurinol, which is often used in patients taking chemotherapy to lower high levels of uric acid in the body. The drug is already known to be associated with Stevens Johnson Syndrome/toxic epidermal necrolysis.

Source here.

NSAIDS: Increase Risk of Dementia?

Those who use non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen, shouldn't bank on the drugs helping them ward off dementia.

A study in Neurology suggests that NSAID users do not have lower rates of dementia and that increased use of the pain relievers may actually raise the risk of cognitive decline.

Read the article here.

Golimumab Approved, with a Black Box Warning

Image via Wikipedia

Simponi Approved for Immune-Related Arthritis



From HealthDay News:

Simponi (golimumab) has been approved by the FDA to treat three forms of arthritis that occur when the body's immune system attacks the joints.


The injected drug will be prescribed to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

It arrives on the market with a black box warning in place: Users will face an increased risk of tuberculosis and invasive fungal infections.

Reglan: Generic Drug Makers and Metoclopramide

Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

Four generic drug makers named as Defendants in a Reglan lawsuit that is pending in a USDCT in Vermont won't be granted an immediate appellate appeal the Trial Court’s decision not to grant a pending motion for summary judgment. The argument was that the generic makers did not develop the drug’s warning label.

The lawsuit was filed against Wyeth, which manufactured the drug metoclopramide under the brand name Reglan, and others including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

You can read the opinion here, in PDF format. (D and B blog)





My office is investigating claims of injury related to Reglan, www.markzamora.com

Advanced Bionics Cochlear Implant Recall

Update on a cochlear implant recall:

In 2004, Advanced Bionics issued a recall for the Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system. Advanced Bionics eventually began to distribute the HiRes90k. The FDA had, however, written to the company about the product.
Advanced Bionics then had a 2nd recall on Vendor B HiRes90k implants.

What we are hearing: As many as 20% of HiRes90k vendor B units may fail.

What are the symptoms of a failed or failing Advanced Bionics HiRes 90k or Clarion Cochlear Implant?

*Delays in hearing

*Popping sounds

*Crackling sounds

*Shocks/pain in the head/face

*The implant turns on/off without warning

*Your child is not telling you that the batteries on the implant need charging

*Your child is turning the implant off

What amazes me is how little the news has been out on this recall.Talk to us, on the web at: http://www.markzamora.com/Implant/index.html

Digoxin Recall

Caraco Pharmaceutical Laboratories, has issued a nationwide recall of DIGOXIN, a medicine used to treat heart failure and abnormal heart rhythms. The tablets are being recalled because they may differ in size and could have more or less of the active ingredient, digoxin.

This recall includes all lots of Caraco brand digoxin tablets distributed before March 31, 2009:

Digoxin 0.125 mg tablets - NDC# 57664-437-88 or NDC# 57664-437-18

Digoxin 0.25 mg tablets NDC# 57664-441-88 or NDC# 57664-441-18

Digoxin tablets from other manufacturers are not included in this recall. Last year a similar problem was reported with another manufacturer’s brand of digoxin. At the time this resulted in a massive recall of the heart drug, affecting 60% of the nation's supply. It also helped spur reports of at least 650 patient deaths. However, a direct link to defective tablets was difficult to assess click here.

This source comes from the FDA and other sites.

We're investigating this recalled drug. You can always reach us at markzamora.com/contact

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

Retinopathy of Prematurity, and Richard Shapiro

From my good friend Richard Shapiro, information on a specific type of case he handles:

Retinopathy of Prematurity (ROP) is a potentially blinding eye disorder that primarily affects premature infants weighing approximately three pounds or less, born before 31 weeks of gestation (A full-term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby will develop ROP. This condition is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness.

There is established medical proof that if ROP is treated timely (within 36-38 weeks of gestation or approximately at 6 weeks of age), it is likely that blindness will be prevented. Without proper care, the delay in diagnosis or treatment will often lead to permanent blindness.

What causes Retinopathy of Prematurity?

ROP occurs when abnormal blood vessels grow and spread throughout the retina, the tissue that lines the back of the eye. These abnormal blood vessels are fragile and can leak, scarring the retina and pulling it out of position. This causes a retinal detachment. Retinal detachment is the main cause of visual impairment and blindness in ROP.

Medical experts believe that the periphery of the retina sends out signals to other areas of the retina for nourishment. As a result, new abnormal vessels begin to grow. These new blood vessels are fragile, weak, and can bleed, leading to retinal scarring. When these scars shrink, they pull on the retina, causing it to detach from the back of the eye.

Most premature infants are either born/or treated at children’s hospitals or other pediatric hospital units within general hospitals.

How is ROP treated?

The most effective proven treatments for ROP are laser therapy or cryotherapy. Laser therapy "burns away" the periphery of the retina, which has no normal blood vessels. With cryotherapy, physicians use an instrument that generates freezing temperatures to briefly touch spots on the surface of the eye that overlie the periphery of the retina. Both laser treatment and cryotherapy destroy the peripheral areas of the retina, slowing or reversing the abnormal growth of blood vessels. Unfortunately, the treatments also destroy some side vision. This is done to save the most important part of our sight—the sharp, central vision we need for "straight ahead" activities such as reading, sewing, and driving.

Both laser treatments and cryotherapy are performed only on infants with advanced ROP, particularly stage III with "plus disease." Both treatments are considered invasive surgeries on the eye, and doctors don't know the long-term side effects of each.

In the later stages of ROP, other treatment options include:

* Scleral buckle. This involves placing a silicone band around the eye and tightening it. Infants who have had a sclera buckle need to have the band removed months or years later, since the eye continues to grow; otherwise they will become nearsighted. Sclera buckles are usually performed on infants with stage IV or V.

* Vitrectomy. Vitrectomy involves removing the vitreous and replacing it with a saline solution. After the vitreous has been removed, the scar tissue on the retina can be peeled back or cut away, allowing the retina to relax and lay back down against the eye wall. Vitrectomy is performed only at stage V.

Richard Shapiro may be reached here.

Tysabri and PML

I wrote an earlier post this week on PML. Today, there is this report:


Biogen revealed another new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri.

That means that six patients have developed the potentially deadly brain infection since Tysabri (natalizumab), which is partnered with Ireland’s Elan Corp, was reintroduced to the market in July 2006. The case was confirmed late last week.


In the latest case, the patient had been on the drug for 31 months, the longest duration so far. The previous high had been 26 months and the average now is 19 months.

Source here.

U.S. Supreme Court: Tuna/Mercury Poisoning Case

Image via Wikipedia

An interesting case, and the SCOTUS' decision to let stand a lower court ruling (thanks to the WSJ.com site):

The Supreme Court left in place a lower court ruling that allowed a New Jersey woman to sue a tuna-fish producer over the mercury poisoning she allegedly suffered after her diet consisted almost exclusively of canned tuna for five years.

The woman, Deborah Fellner, said Tri-Union Seafoods LLC, the maker of Chicken of the Sea brand tuna, failed to warn her of the risks of consuming tuna fish.

Tri-Union said U.S. Food and Drug Administration regulations prevented it from placing a mercury warning label on its products. The company said that Fellner's suit should be thrown out because it conflicted with the FDA's regulatory regime.

A federal trial judge had tossed Fellner's lawsuit, but an appeals court in Philadelphia reinstated it, saying the FDA had taken no regulatory action that preempted her legal claims.


"Tri-Union argued that the appeals court ruling put it in the untenable position of facing legal liability under state law for not including a warning label that would have rendered its products misbranded under federal law."

More at the source.

Reglan News: Lawyers seeking to Consolidate in Nevada

What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada.

Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, because those conditions are usually chronic problems, it is often prescribed for longer periods of time. Illnesses include essential tremors, Tardive Dyskinesia, and other movement disorders.

We're investigating this drug and how it may have harmed Georgia consumers. Go here for more information.

Raptiva pulled; An explanation of PML

Raptiva is used to control moderate to severe cases of plaque psoriasis, the most common form of the autoimmune disease, which causes red scaly patches on the skin that can itch and hurt.

PML is a serious infection of the nervous system caused by a virus. It's referred to as the JC virus. This virus attacks the brain's white matter and disrupts nervous system activity.

What are the symptoms? Look to where in the brain the virus hits. Common symptoms include deficits in speech, vision, movement and thought processes. The disease progresses rapidly and inexorably toward serious disability and death.

It's important to note that PML is also seen in those with HIV. PML also does not occur without some underlying risk. The highest risk comes from HIV infection.

With Raptiva off the market, is there another treatment for psoriaris?

There is. The drugs Enbrel, Humira and Remicade are medications for its treatment. None has been linked to PML and all three act in a way different from Raptiva.

Sources are here, as well as here and here.

Law Review Articles: Using Facebook in Litigation, and the Daubert Revolution

From the Torts Prof Blog, links to a recent law review articles worth reading.

Facebook:

Here is an article worth reading on how Facebook.com's pages are deemed discovery in the context of Canadian Court. In the U.S., expect the same treatment.

A quote from the article:Canadian courts have considered web-based networking sites such as Facebook and MySpace pages to be ‘documents’ subject to discovery.

I always ask my client if he/she uses Facebook, Myspace, or other S.M. If you're not, be ready for a surprise at your client's deposition, and I don't mean surprise as in surprise party - I mean it as in, "Wow, is that really you doing a tequila body shot at a Panama City Beach bar? I thought you needed back surgery."


Daubert:

A paper addresses Daubert's limitations and suggests that the relevant problems demand resolution before one can conclude that the Daubert revolution is complete.

Download it here.

Trucking: CVSA Out of Service Criteria Handbook

Attending a lawyer convention this week, I had a chance to hear from a Public Safety Officer regarding truck inspections.

The bible for an officer when conducting an inspection? A book called the North American Standard Out-of-Service Criteria.

Part I details violations which place a driver out-of-service.

Part II identifies critical vehicle inspection items and criteria for placing a vehicle out-of-service.

Part III details unsafe hazardous materials transportation, including both conditions which fail to communicate a hazard and those which are themselves hazards.

Part IV outlines the criteria for placing a motor carrier out-of-service.

If you investigate wrecks involving tractor trailers, it's worth buying. Get it
here.

Intra Aortic Balloon Pump Recall

Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters Recalled.

The FDA announced a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.

The recall is being conducted because of a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.



http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow

FDA stops firm marketing unapproved cold medicines

Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Source here.

Raptiva Recalled

There will be a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.

Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Authorities in Europe, where Raptiva is sold by Merck KGaA (MRCG.DE), recommended in February that the drug be suspended in light of the PML risk.

The European Commission is expected to follow that advice.

There have been three cases of diagnosed PML in patients receiving Raptiva, two of which were fatal, and a fourth patient who developed progressive neurologic symptoms and died of unknown causes.

Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or light therapy.

PML has also become an issue for patients treated with multiple sclerosis drug Tysabri, which is sold by Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I).

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• Genentech withdraws psoriasis drug (money.cnn.com)

Rhino ATV Recall

Yamaha Motor Corp. USA recalled about 145,000 off-highway recreational vehicles Tuesday, after two models were involved in 46 deaths and hundreds of injuries.

The two-passenger Rhino 450, 660 and 700 vehicles are designed for those older than 16 with driver's licenses, though some deaths involved children who were passengers or operated vehicles against recommendations, said the Consumer Product Safety Commission.

All Rhino 450, 660 and 700 model vehicles were recalled to reduce rollover risk and improve handling and keep riders' limbs in the vehicles. Reported deaths occurred between the fall of 2003, when the vehicles were first distributed, through this year.