Viagra Melanoma Legal Claims

pills2New data suggests an association between melanoma skin cancer and Viagra. This has led many patients suffering from erectile dysfunction to question whether the benefits of this drug justify the risk of death that many accompany it.

If you or someone you love has developed melanoma while taking Viagra, you may have an injury or wrongful death lawsuit against Pfizer who has never adequately warned patients and their doctors of this risk. If you believe you have a claim, call our lawyers for free at 800-553-8082 or get a free Internet consultation. We can discuss your options with you.

The Association Between Viagra and Melanoma

The understanding of the potential risks of melanoma with Viagra took flight in 2014 for the general public when Harvard Medical School released a new study indicating that Viagra users were 84% more likely to develop melanoma skin cancer.

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Prescription Testosterone Concerns

testosterone2

Testosterone supplements have found themselves in the news quite a bit lately.  Unfortunately, for manufacturers, this is not good news. Because these lawsuit are on the fast track to being a very big deal.

There is a lot of research coming out with sudden fury that suggests that testosterone treatments for men can cause an increased risk of heart attacks and strokes that can lead to serious injury and death.  A study published this week in the medical journal Plos One, indicated that researchers found a two-fold increase in the risk of heart attack in the three months after an initial prescription among men aged 65 years and older, and a two to three-fold increase among younger men with a history of heart disease.  This is huge, especially considering millions of men are taking these hormonal treatments, and many are learning for the first time of the extent of the risk.

Products in this category are:

  • Androgel (Abbvie/Abbott)
  • Androderm (Actavis)
  • Axirom (Eli Lilly)
  • Bio-T-Gel (BioSante and Teva)
  • Delatestryl (Indevus)
  • Depo-Testosterone (Pharmacia & Upjohn Company)
  • Fortesta (Endo)
  • Striant (Columbia Laboratories)
  • Testim (Auxilum/GlaxoSmithKline)
  • Testopel (Auxilium)

Testosterone is a 19-carbon steroid hormone.  In men, testosterone plays a key role in the development of male reproductive tissues such as the testis and prostate, as well as promotes secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair.  But it is also for the general health and well-being of a man. Without adequate testosterone, a man may lose his sex drive, experience erectile dysfunction, feel depressed, and have difficulty concentrating.

Unfortunately, many men lose the ability to produce testosterone as they age, and the testosterone levels decrease. This natural decline starts after age 30 and continues throughout life. In addition to others, some causes of low testosterone levels can include:

  • Injury, infection, or loss of the testicles
  • Chemotherapy or radiation treatment
  • Dysfunction of the pituitary gland
  • Medications, especially hormones used to treat prostate cancer
  • Chronic illness
  • Stress 
  • Alcoholism 
  • Obesity (especially abdominal)

Testosterone is approved for the treatment of hypogonadism due to known diseases of the testes, pituitary and hypothalamus. Although its use was never approved by the FDA for any treatment other than to treat men who have medical conditions resulting in lower testosterone than normal, use of the therapy is increasing.  Some doctors are quick to prescribe testosterone to middle-aged men complaining of symptoms including loss of energy and libido – so much in fact, there were over 5.3 million prescriptions written for these drugs in 2011 alone.  Sales in 2012 reached nearly $2 billion.

Testosterone drugs currently carry no mention of an increased cardiac risk in their advertising materials; however, this may soon change as the FDA announced a few weeks ago that it is investigating potential testosterone therapy risks.  Many men who have experienced problems are already considering filing a lawsuit, so assuming the FDA’s investigation will result in some sort of required warning, we anticipate the lawsuits to be filed at an alarming rate.

If you suspect that you or a loved one has had an adverse reaction to any of these medications, contact our attorneys to find out more as our attorneys are currently reviewing potential lawsuits. If you any concerns, or believe you may have a case, call our attorneys at 1.800.553.8082 or online here.

$100,000 da Vinci Robot Verdict | What Went Wrong?

da-Vinci-FlagstaffThe da Vinci lawsuits involve both medical malpractice and product liability claims.  Some of these are wrongful death cases, some of these claims are very minor, and there are a lot of cases in between.

The Insurance Journal reports on a malpractice case in Oregon where the plaintiff received a $100,000 award from an Oregon gynecologist who she alleges improperly removed a healthy ovary.

A jury verdict of $100,000?  Huh?  They took her ovary and they found negligence.  The plaintiff asked for over a million.  So, what gives?

I don’t know.  We just don’t know enough about the case. Was the plaintiff a 50 year-old with no further intention of having a child?  Was she unsympathetic for some other reason? We just don’t know enough.

This was a Oregon case.  We have a malpractice case there set for trial in early 2014. The parties are permitted to do so little discovery there that I wonder if this case did not settle because there was not a clear understand of the damages or the merits of the case.

So, I think $100,000 verdict is a huge loss for plaintiff.  It would be in Maryland.  But it is so cheap to work up a case with discovery in Oregon, so maybe it is not nearly as big of a loss.

One thing is for sure, most of these robotic surgery cases – both the malpractice claims and product liability cases – are worth a lot more than $100,000.

Wait, I screwed up.  Now I see why the case settled for a lot less.  The doctor had already performed a sterilization procedure on the Plaintiff.  I didn’t read that part until just now. I was going to go back and fix the post but I thought I would give you the stream of consciousness blog post here.  Because we don’t have enough of that on the Internet, right?

So, to be honest, our firm probably would not have taken this case because the cost of working it up probably gets too dangerously close to the value of the case.  If you have a 40% contingency fee and you have to spend a lot of money on experts, there really is not enough money left over to make the case work for the Plaintiff.  I don’t want to be handling cases where we can win and the client will not walk away happy.

Anyway, if you are reading this and have a da Vinci case, our law firm is handling these cases.  We just settled a malpractice case against a hospital without filing suit and we are also getting product liability claims around the entire country.  If you want to talk to me about one of these cases, give me a call. My contact number is above and you can also send me your information via an on-line contact form.

 

 

 

 

August 2013 Medication Safety Labeling Changes

August brought changes to thirty-four (34) medical product labels, 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.

pillsFor a complete detailed accounting of the label changes, 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:

Ablavar (Gadofosveset Trisodium) Injection
Aerospan (flunisolilde) Inhalation Aerosol
Avelox (Moxifloxacin Hydrochloride) Tablets and Injection
Cipro (Ciprofloxacin Hydrochloride) Tablets and Oral Suspension
Cipro IV (Ciprofloxacin Hydrochloride) Injection
Cipro XR (Ciprofloxacin extended-release) Tablets
Colyte (Peg-3350 & electrolytes) For oral solution
Crestor (Rosuvastatin Calcium) Tablets
Daliresp (Roflumilast) Tablets
Desoxyn (Methamphetamine Hydrochloride) Tablets
Doxil (Doxorubicin HCL) Liposome Injection
Factive (Gemifloxacin Mesylate) Tablets
Levaquin (Levofloxacin) Tablets, Oral Solution and Injection
Lialda (Mesalamine) Delayed-release Tablets
Mirena (Levonorgestrel-Releasing Intrauterine System)
Noroxin (Norfloxacin)
Letairis (Ambrisentan) Tablets
Omniscan (Gadodiamide) Injection
Optimark (Gadoversetamide) Injection
Quillivant XR (Methylphenidate) Extended-release Oral Suspension
Relistor (Methylnaltrexone Bromide) Subcutaneous Injection
Skyla (Levonorgestrel-Releasing Intrauterine System)
Strattera (Atomoxetine Hydrochloride) Capsules
Sutent (Sunitinib Malate) Capsules
Votrient (Pazopanib) Tablets
Xarelto (Rivaroxaban) Tablets
Xgeva (Denosumab) Injection
Zevalin (Ibritumomab Tiuxetan) Injection

Fosamax Lawsuit – Defense Verdict

It took a New Jersey federal jury one hour and twenty minutes to determine that Fosamax did not cause a Plaintiff’s femur fracture.  In the first verdict in a Fosamax case where the Plaintiff claims that the osteoporosis drug weakened her thigh bone, the jury said that Plaintiff did not prove her case.

After having taken Fosamax for eight years, Plaintiff, now fifty-eight, fractured her right femur requiring surgical repair.  She sued alleging that Fosamax caused her atypical femur fracture, and that the manufacture, Merck, failed to warn her doctor about the risk.  Merck, pleased with the verdict, stated that the company provided appropriate and timely information about Fosamax to consumers.

Plaintiff’s suit had been transferred into the Fosamax femur fracture MDL, sometimes referred to as “Fosamax II” as an earlier Fosamax MDL was formed to deal with claims of osteonecrosis of the jaw (ONJ).  Merck has said that there are about 3,300 Fosamax femur fracture cases, and about 1,230 ONJ cases.

In this case, Merck claimed that the Plaintiff was at risk for a “fragility fracture” that Fosamax reduced, but could not eliminate.  They further claim that Plaintiff did not sustain an atypical femur fracture.

This case had been selected for the second bellwether trial in the MDL.  The first trial ended in a mistrial after the Plaintiff suffered a heart attack.

Johnson & Johnson AsksTo Centralize State Court Tylenol Liver Injury Cases

McNeil-PPC Inc. and Johnson & Johnson have asked that all New Jersey state court Tylenol liver injury cases be centralized before one Judge in the Middlesex County Superior Court, in order to avoid duplicative discovery, inconsistent rulings, and to conserve resources of the judiciary and the parties.  There are currently fourteen Tylenol cases pending in New Jersey state courts with Plaintiffs from twelve different states.

In their request that stated that since the federal Tylenol injury cases were centralized in April, thirty-three new federal cases have been transferred into the multidistrict litigation (MDL).

The defendants are refuting the plaintiffs’ claims that McNeil and Johnson & Johnson failed to warn about the risk of liver injury.  They claim that the risk has been known “for decades” and further claim that the FDA has repeatedly said that Tylenol and acetaminophen are safe when used as directed, and when recommended dosages are not exceeded.

Our lawyers are now reviewing Tylenol liver damage cases throughout the country. If you have suffered liver damage or you believe the wrongful death of a loved one was the result of liver damage from this over-the-counter drug, call our attorneys at 800-553-8083.

 

 

 

July 2013 Medication Safety Labeling Changes

medicineJuly brought changes to thirty-four (34) medical product labels (down from 44 changes in June), 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, 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:

Depakene (valproic acid) Capsules and Oral Solution
Depakote (divalproex sodium) Delayed Release
Depakote ER (Extended Release) Tablets
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
Depacon (valproate sodium) Injection
Nizoral (ketoconazole) Tablets
Nucynta (tapentadol) Immediate-Release (IR) Oral Tablets
Prolia (denosumab)
Rapaflo (silodosin) Capsules
Sarafem (fluoxetine hydrochloride) Tablets
Agrylin (anagrelide hydrochloride) Capsules
Azor (amlodipine/olmesartan medoxomil) Tablets
Azulfidine EN-Tablets (sulfasalazine delayed release tablets, USP)
Bactrim and Bactrim DS Tablets
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets
Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol
Elspar (asparaginase)
Geodon (ziprasidone) Capsules, Injection and Oral Suspension
Lupron Depot (Leuprolide Acetate for Depot Suspension)
MultiHance (gadobenate dimeglumine) Injection and MultiHance Multipack (gadobenate dimeglumine) Injection
Pentasa (mesalamine) Controlled-Release Capsules
Prozac (fluoxetine hydrochloride) Delayed Release Capsules
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules
Tribenzor (olmesartan medoxomil/ amlodipine/ hydrochlorothiazide) Tablets
Vivitrol (naltrexone for extended-release injectable suspension)
Zelboraf (vemurafenib) Tablets

Little Risk in Diabetes Drugs Says European Regulators

pills2According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

In addition to the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.  These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancretic inflammation known as pancreatitis.  While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer,the FDA said the trials were too small to draw firm conclusions.

The recent European news is music to the ears of these diabetic drug manufactures who had more than $9 billion in global sales last year. Januvia and Janumet, also manufactured by Merck, together earned $5.7 billion.

How, Then, Do We Explain the Byetta/Januvia Lawsuits?

This is one study that goes the other way.  But it flies in the face of all of the next evidence suggesting that these drugs can cause pancreatic cancer.  Keep in mind that these were very small trials. The FDA is certainly not buying into and and they are reserving judgment.

I think this is the history of many mass tort claims:

  1. Problem becomes obvious
  2. Lawyers start filing suit, probably prematurely
  3. The science and the studies begin to follow #1
  4. There are a few rebuttal studies, usually of dubious methodology
  5. The case start going to trial
  6. The science becomes even more clear
  7. The case settle in massive numbers

I think we are on Stage #4 right now.

Filing Suit

If you or a loved one has used Januvia or Janumet, or any of the other well known diabetes drugs, and suffered from acute pancreatitis or pancreatic cancer, please call one of our attorneys at 800-553-8082 or click here for a free no obligation consultation.

June 2013 Medication Safety Labeling Changes

medicationJune brought changes to forty-four (44) medical product labels (up slightly from 40 changes in May), 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, 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:

Adderall XR (mixed amphetamine salts) capsules
Aldactone (spironolactone) Tablets
Aldactazide (spironolactone/HCTZ) Tablets
Azactam (aztreonam injection)in GALAXY Plastic Container and Azactam (aztreonam) for injection
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets
Concerta (methylphenidate HCl) Extended-Release tablets
Daytrana (methylphenidate) transdermal system
Depacon (valproate sodium) Injection
Depakene (valproic acid) Capsules and Oral Solution, Depakote (divalproex sodium) Delayed Release and Depakote ER (Extended Release) Tablets, and Depakote Sprinkle Capsules
Dexedrine (dextroamphetamine sulfate) Spansule
Edurant (rilpivirine) tablet
Elaprase (idursulfase) injection
Exelon (rivastigmine) Patch
Eylea (aflibercept) Injection
Focalin (dexmethylphenidate hydrochloride) Tablets and Focalin XR (Extended-Release) Capsules
Fycompa (perampanel) Tablets
Immune Globulin Products (Human) intravenous, subcutaneous, and intramuscular
Istodax (romidepsin) lyophilized powder
Jentadueto (linagliptin and metformin hydrochloride) tablets
Lamisil (terbinafine hydrochloride) Tablets
Lamisil (terbinafine hydrochloride) Oral Granules
Metadate CD (methylphenidate HCl) Extended-Release Capsules
Methylin (methylphenidate HCl) Oral Solution and Chewable tablets
Mozobil (plerixafor) injection
Nordette (levonorgestrel/ethinyl estradiol) tablets
Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Extended-Release Tablets), and Ritalin LA (Extended-Release Capsules)
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution
Stavzor (valproic acid) Delayed Release Capsules
Suprenza (phentermine hydrochloride) orally dissolving tablets
Tasigna (nilotinib) capsules
Tradjenta (linagliptin) tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Tykerb (lapatinib) tablets
Urso and Urso Forte (ursodiol) tablets
Vyvanse (lisdexamfetamine dimesylate) capsules
Welchol (colesevelam) Tablets and Oral Suspension

FDA Reconsiders Changes to Generic Drug Warning Labels

pills2The Food and Drug Administration (FDA) has been considering making changes to its labeling rules with regard to generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

Currently, though generic drug makers are required to advise the FDA of any new evidence that might demand a change, they aren’t allowed to make the change.  They are required to wait until the FDA formally decides that the warning label from the drug, as well as the brand name drug, must be changed.  Under the new rule, there would be parity between brand-name and generic drug makers, and generic drug makers would be able to make unilateral changes to their warning labels.

It’s beyond me why this was not always the case – but let’s give credit where credit is due.  At least the change is expected to be made.