October 2013

As reported by DrugStoreNews.com, there has been a lot of discussion in the biotechnology world over the appropriate names of follow-on biologics.  “Follow-on biologics,” also known as “biosimilars,” are “biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods” (Wikipedia).

Because generic pharmaceutical drugs are by law chemically identical to branded drugs, brand name drugs and generic drugs carry the same name.  As such, companies that manufacture biosimilars demand this standard and practice to be used for their products.  For example, Enbrel is an autoimmune drug made by the company Pfizer and Enbrel’s generic name is etanercept.  Generic drug companies in Europe have openly said that the use of the same generic name has not been a problem over the past six years of their availability.

However, some biotech companies assert that biosimilars are actually made from different cell lines, and are therefore chemically unique, thus requiring separate nomenclature and review.

Over the past week, half a dozen US senators have taken concern over the recent development regarding biosimilar naming, as Biotechnology Industry Organization is a trade group that is at risk for losing billions in sales if biosimilars are allowed to use the same names as the drugs to which they are similar.  The Organization is worried about the competition these biosimilars will bring and possible confusion for American citizens.

In the end, what is most relevant here is the risk for confusion among consumers and the medical community.  If doctors believe in a certain case that a biosimilar ought to be avoided in clinical use, but the desired generic or branded drug carries the same name as the biosimilar, it isn’t unreasonable to believe that there may be problems.  Any drug that is chemically unique ought to have a unique name, regardless of how similar it is to another chemical.

A recent article published by Forbes.com purports that Obamacare is harming the American healthcare system.  While the healthcare system we had before the Affordable Care Act was not perfect, it was more fundamentally sound than after the ACA took effect.  Problems with U.S. Health Care System should have been closely examined in 2009 and appropriate changes could have been made but the Obama administration failed to focus on the positive aspects of the U.S. Health Care System and fundamentally changed the way it works.  Obama took away fiscal incentives, the drive to create the best medicines, and the need to provide high quality patient care.  A healthcare provider who has the most advanced medicine practices and the best medicines available will be worth more to the general public, and thus Howard believes this incentive-based drive to be the best is no longer applicable as the fact that the government is taking over the entire system.

Forbes reports that before the Affordable Care Act was installed, as much as 80 percent of American citizens were happy with the care they were receiving.  Of course, before the ACA, many Americans had no health insurance – thus no healthcare to be happy or sad about.

Obama told the American public that his system would not force anybody to lose their plan and make them shift over to Obamacare.  We now see that this is not exactly the case.  Only time will tell whether the care provided to those required to switch coverage plans will have been for the better.  Paul Howard of Forbes believes that as the Affordable Care Act takes some of the choice out of healthcare, the overall quality of the American healthcare system will sharply decline.  This too is yet to be seen.

Howard also purports that the invention of new medications will drastically slow because the pharmaceutical companies that develop these medications won’t have any incentives to be the best:  let the private health care system that created the world’s best medical therapies in the world do its job.

The wide range of tools the internet can provide has proven problematic in the regulation of prescription drugs that are sold from online pharmaceutical companies based in foreign countries.  Counterfeit drugs have exploded onto the scene and as reported by Forbes, the worldwide market for these drugs is estimated to be worth 75 billion dollars.  Maine has recently passed a law allowing the importation of these non-approved FDA drugs to be sold from countries such New Zealand and Australia.  Drug companies are worried their reputations will be lost if subprime medications make their way onto the American scene.

Price control of prescription drugs is seen in most developed and wealthy nations, and despite the U.S. being both wealthy and developed, there are no price controls on prescription drugs.  Prices of certain medications are much higher in America than in other countries in which the government sets controls.  And as such, many Americans are not happy about the fact that they are paying a higher price for the same medications that people in other countries are buying.

There are systems in other countries that work to get cheaper medications to their citizens: some European countries funnel cheaper drugs from poorer countries like Greece through systems of parallel trade.  Recently, drug companies have begun to delay the exportation of their newer, more expensive drugs to poorer countries in order to combat the black market selling of their drugs to wealthier companies.

Unfortunately, this parallel trade gives rise to selling and making of fake and sometimes dangerous drugs.  Many of these fake drugs have made their way to the United States.  One example of these fake drugs are fake doses of Avastin, which is a cancer drug.

These fake drugs have gotten so hard to detect, that even the drug’s manufacturer may have a difficult time sorting through real and counterfeit pills.  It is for this reason the FDA has said it cannot adequately ensure the safety of drugs that are coming from foreign countries.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

The use and implantation of penile implants are hard decisions that many men have to make.  We see these implants used when the pharmacologic route does not work or does not sufficiently solve the patient’s problems.  Author XW Zhu from the Department of Urology at The First Affiliated Hospital, Zhejiang University School of Medicine, in Hangzhou, China, worked on a study called “Prevention and Treatment of the Complications of Inflatable Penile Prosthesis Implantation”, where the objective of the study was to report on the process of making the three piece inflatable penile prosthesis better and identify ways to prevent complications commonly associated with the implant.   The implantation of an inflatable penile prosthesis is a complex procedure that requires careful surgical technique.  Even when these procedures are done by a skilled and experienced surgeon, many serious complications can arise, such as infections, erosion of the implant, and painful reoperations.  Prior to an operation, thorough evaluation of patient history, physical examinations, psychological investigations, and appropriate laboratory testing needs to be done to ensure minimal risk of complications.

Certain medical conditions such as diabetes mellitus, vascular diseases, and radical pelvic surgery may put the patient at a greater risk for complications which may lead to corrective surgery.  In all, 32 patients were with moderate to severe erectile dysfunction, received three piece IPPs.  Zhu XW. States “The surgical techniques were ameliorated in the course of operation. The patients were guided in using the IPP after operation. The effects and complications of the implantation were observed based on IIEF of the patients before and after operation.”

For most of the patients in this study, sexual life continued with little to no complications.  4 of the men in this experiment experienced certain complications that included pump failure, urethral perforation, and penis contractions.  A second operation was needed to achieve normal sexual intercourse.  Occurrence rate of complications in this study was 12.5 percent and sexual intercourse satisfaction was 87.5 percent.

Due to the high rate of complications seen with penile prostheses, a number of penile implant lawsuits have been filed.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Penile prosthetic surgery is one option men have who suffer from erectile dysfunction.  These implants can also be used to help manage urinary drainage when penile retraction has inhibited that process.  The surgery required for this implant is delicate and even when performed by a skilled surgeon many serious complications can arise, such as erosion of the prosthetic, infections, and painful reoperations.  Author DH Zermann, from the Department of Urology at The University Hospital, Friedrich-Schiller-University Jena, in Jena, Germany, conducted a study called “Penile Prosthetic Surgery in Neurologically Impaired Patients:  Long Term Follow-Up”, where the purpose of this study was to examine the long term results for men that underwent penile prosthetic surgery.

Zermann states “Between 1980 and 1996, 245 neurologically impaired patients with a mean age of 40.8 years (range 16 to 75), including 188 with paraplegia, 57 with quadriplegia and 197 with spinal cord injuries, were treated for erectile dysfunction and/or urinary incontinence with penile prosthesis implantation.”  Mean time of paralysis was 11.2 years and after a nuero-urological evaluation all the patients were candidates for penile prosthesis implantation.  A follow program was initiated after the treatment in order to document patient satisfaction, problems, and complications.  The study was done over 17 years and 293 surgical procedures were done with the implantation of 147 semirigid, 113 self contained inflatable, and 33 inflatable 3 piece prostheses.  The subjects were divided in three groups, Urinary management only, erectile dysfunction, and urinary management and erectile dysfunction.  The author of this paper further writes that “At a mean followup of 7.2 years (maximum 17) 195 patients were reevaluated in clinic. In 122 patients (90.3%) urinary management problems were resolved. Erectile dysfunction treatment was successful in 76 patients (82.6%). There were 43 revisions for technical reasons and infections.”

This means that 14.6% of patients who used penile implants required painful reoperation.

In all, 12 patients had infection.  The perforation rate was different for each implant: 15 cases for semirigid devices, 2 cases for self contained inflatable, and 0 for inflatable 3-piece devices.  The author of this paper concludes that despite technical advances, many painful complications are still associated with this procedure.

Since these complications are so frequent in the use of penile prosthesis, a number of penile implant lawsuits have been filed in recent decades.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Millions of men today suffer erectile dysfunction.  A penile prosthesis and other similar types of treatment are forms of treatment for men with erectile dysfunction.  The prostheses used are bendable or inflatable.  Some basic types of prostheses consist of a pair of bendable rod like structures that can be surgically implanted within the erection chambers of the penis.

Penile implant surgery is a risky and sensitive procedure, often accompanied with serious infections and painful reoperations.   Many procedures involving these penile prostheses are accompanied with high rates of postoperative complications, and while the newer penile implant designs are more reliable than their earlier predecessors, there are still cases of implant malfunction.  Certain health factors such as diabetes can increase the risk for postoperative complications.  A thorough physical examination from your doctor will ensure you are a suitable patient for a penile prosthesis and can lower the risk factors involved.

Author Y. Deuk Choi from the Department of Urology and Institute of Andrology, at Yonsei University, College of Medicine, in Seoul, worked on a study titled “Mechanical Reliability of the AMS 700 CXM Inflatable Penile Prosthesis for the Treatment of Male Erectile Dysfunction”, where the goal was to review their experience with the AMS 700CXM prosthesis and assess postoperative complications and reliability.  Deuk Choi states “The AMS 700CXM inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men.”  The study was done from January 1991 to April 1999 and included 273 subjects with erectile dysfunction who had primary penile prosthesis implants.  Medical records and telephone interviews were used after the operations to assess function status of the prosthesis.  Age of the patients ranged from 24 to 78 years of age and the mean follow up was 49 months.  28 complications were reported, 8 were non mechanical and 20 were mechanical.  Infection, erosion, surgical complications, and tube kinking were included in the non mechanical complication group.  Mechanical complications that were seen included cylinder tears, pump failure, and reservoir tears.  Deuk Choi Y. further explains “Mechanical reliability of the device was 98.2% after 2, 95.7% after 3 and 90.4% after 5 years.  The AMS 700CXM is suitable for Asian men and its mechanical reliability is excellent. However, more device modifications are needed to guarantee good reliability during long-term followup.”

Because many men have used penile implants by American Medical Systems unaware of the risks associated with these prostheses, a number of penile prosthesis lawsuits have been filed against the company.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.

Author P. Bansal from the Division of Gastroenterology at the Department of Veterans Affairs Medical Center in Milwaukee, Wisconsin, conducted a study called “Pancreatitis is a Risk Factor For Pancreatic Cancer”, where the main goal was to determine if pancreatitis is a risk factor for pancreatic cancer.  Information for this study was obtained from the Department of Veteran Affairs, which maintains a computerized file of hospital discharges since 1970.

First, a little background.  Pancreatitis is inflammation in the pancreas.  This organ produces enzymes that help digestion and hormones that help with the regulation of processing sugars in the body, and chronic pancreatitis (prolonged inflammation of the pancreas) has been associated with an elevated risk of developing pancreatic cancer.  Some mild cases of pancreatitis may go away without treatment, however chronic pancreatitis may be life-threatening.

The Bansal study was a case-control study that compared the prevalence of pancreatitis in 2639 patients with pancreatic cancer.  Data from this group was compared to a control group of 7,774 subjects.  Bansal states “The odds ratio associated with pancreatitis increased from 2.04 (95% confidence interval [CI], 1.53-2.72) 7 or more years before the first diagnosis of cancer to 2.14 (CI, 1.68-2.72) 3 or more years before cancer diagnosis and to 2.31 (CI, 1.87-2.86) 1 or more years before cancer diagnosis.”  In other words, this data shows that having pancreatitis places one at at least twice as likely to develop pancreatic cancer than if one did not suffer from pancreatitis.

Using statistics to evaluate the data collected more generally, Bansal found that all types of pancreatitis or chronic pancreatitis were connected with a significant risk for pancreatic cancer, the odd ratio for these were 3.42.  (Having pancreatitis makes one more than three times as likely to later have pancreatic cancer.)

Because this study concluded that having pancreatitis increases the risk one faces for developing pancreatic cancer, it can be used in a GLP-1 therapy pancreatic cancer lawsuit.  Recently, a number of diabetes drugs such as Byetta, Victoza, and Januvia (used in GLP-1 therapy for type-two diabetes) have been linked to a dramatically increased risk for pancreatitis.  Because pancreatitis is connected to pancreatic cancer, drugs that are connected to pancreatitis should also include warnings about the risk for pancreatic cancer.  Due to the fact that the manufacturers of drugs like  exenatide (Byetta, Bydureon), liraglutide (Victoza), and sitagliptin (Januvia, Janumet, Janumet XR, Juvisync) have failed time and again to include adequate warnings about pancreatic cancer, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits are currently being filed.

If you or used Byetta, Victoza, Januvia, or another GLP-1 therapy drug and suffered from pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation through a Byetta lawsuit, Victoza lawsuit, a Januvia lawsuit, or a GLP-1 therapy pancreatic cancer lawsuit.  For a free, no-obligation case consultation, contact our team of Byetta lawyers, Victoza lawyers, Januvia lawyers, and GLP-1 therapy pancreatic cancer lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Byetta Lawsuit / Victoza Lawsuits / Januvia Lawsuit Information page is a great place to start if you have any questions about GLP-1 therapy drugs and diabetes drug lawsuits.  Call today and see how we can help!

Recent studies have shown that there is a positive correlation between pancreatic inflammation and an increased risk of pancreatic cancer.  While acute pancreatitis that appears suddenly and may last for only a few days may not put an individual at a higher risk for cancer, chronic pancreatitis may last for several years and is associated with an elevated risk for pancreatic cancer.

David C. Whitcomb, from the American Journal of Physiology – Gastrointestinal and Liver Physiology, wrote a report titled “Inflammation and Cancer V. Chronic Pancreatitis and Pancreatic Cancer”, where he states “the mutations associated with hereditary pancreatitis or cystic fibrosis are not found in sporadic pancreatic adenocarcinomas, suggesting that the effects are indirect by causing recurrent pancreatitis and chronic inflammation. The process of mutation accumulation and clonal expansion that is required for development of invasive pancreatic adenocarcinoma must therefore be accelerated in chronic pancreatitis to account for the high incidence of pancreatic cancer in these patients.”

Recently, several drugs used in GLP-1 therapy to treat type-two diabetes (Byetta, Victoza, Januvia, and others) have been linked to increased risk for pancreatitis.  Since studies such as the one described above document the connection between pancreatitis and pancreatic cancer, one can conclude that the use of Byetta, Victoza, Januvia and similar medications places one at an increased risk for pancreatic cancer.

Due to the fact that the warning labels for these drugs have failed to reflect the risk for pancreatic cancer associated with Byetta, Victoza, and Januvia, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits are currently being filed.  If you or a loved one used a  GLP-1 therapy drug and suffered pancreatitis or pancreatic cancer, contact our team of GLP-1 therapy lawyers at the information provided below for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (855) 452 – 5529 or by e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills required to win the justice you deserve.

Our Byetta Lawsuit / Victoza Lawsuits / Januvia Lawsuit Information page is a great place to start if you have any questions about GLP-1 therapy drugs and diabetes drug lawsuits.

A recent article by Eric Palmer of the pharmaceutical news website FiercePharmaManufacturing.com writes that some trade groups, including PhRMA are trying to overturn a law passed unanimously in Alameda County, California that requires pharmaceutical manufacturers to pay for a medication “recycling” program for currently in place in the San Francisco Bay area.

As the law makes the cost of disposal of unused and expired drugs fall on pharmaceutical companies, of course pharmaceutical companies have been pushing to overturn since its inception a year ago.  Currently, PhRMA is appealing a ruling by the federal district court in San Francisco that upheld the law.  If the appeal maintains its current course, it will take place in April 2014 in the 9th Circuit court of Appeals.  PhRMa, BIO, and the Generic Pharmaceutical Association claim that the industry is not adequately suited to be responsible for drug disposal.  Drug companies and trade groups purport that the new law is forcing them away from their core business and forcing undue responsibilities.

As it currently stands, there are 28 sites where residents can drop off their unused and old medication and the price of the current program is around $330,000 a year.  Part of the new law states that the companies are not allowed to cover the cost with a local point-of-sale fee, and thus PhRMA claims the law is unconstitutional because other American citizens will have to cover the cost.  U.S. District Judge Richard Seeborg of San Francisco disagreed with this constitutionality argument and reports that the law is fair and treats all drug companies the same.

The pharmaceutical companies have a point: one citizen should not be forced to pay for something another citizen does.  However, I believe that drug companies should pay for everything related to their products, and because determining specifically which company’s drugs are being recycled more is exceedingly cumbersome, drug manufacturers should divide the costs of the recycling program based on local market share.  Though that is not a simple task, it ought to be undertaken.  If Company A makes 30% of the drugs sold in the Bay area, they ought to pay for 30% of the recycling program – just food for thought.

NY Times – In Oklahoma, a lawsuit surrounding a fatal car accident that injured an 82 year old woman and left a 70 year old woman named Barbara Schwarz dead, was settled on Friday between Toyota and the families of the two women involved.  For the first time ever, a jury found Toyota responsible for sudden acceleration of their vehicle that caused the crash.  Since Toyota could not show evidence that something other than a defect in the car caused the accident, the jury concluded that Toyota was responsible.  More than 11 million Toyota and Lexus vehicles have had problems such as floor mats causing the accelerator to become stuck, and these vehicles have all been recalled.  These millions of recalls were not great for the reputation of Toyota but despite the public embarrassment, Toyota reported its best earnings in the past five years.  There have been several lawsuits against Toyota recently.  In 2009 and 2010, $1.6 billion was given to Toyota vehicle owners who lost money from unintended acceleration.

Toyota claims it will not end its aggressive defense on all lawsuits against the company, especially the most recent incident involving the death of Barbara Schwarz.  Both sides of the suit are happy a mutually acceptable agreement was made and Toyota is hoping this will help their image of selling their customers safe vehicles.

Some legal experts state that recent verdicts against Toyota could give way to new cases going against the car company that can cost the company billions of dollars in recalls and lawsuits.  Each family of the two women from Oklahoma received $1.5 million in damages.  In this case, it was found that Toyota’s actions were reckless and their electronic throttle control system was flawed.

Toyota was recently cleared in a case involving a 66 year old woman who died when crashing her 2006 Camry, in which the jury decided that the blame should fall on the driver who hit the 66 year old woman and sent her car down the wrong way on a one way street.  The lawyer representing the family of the dead 66 year old women claims Toyota was responsible because they didn’t provide a brake override system.

While Toyota has avoided penalty for some of the accidents caused by defects in their cars, at least some of the victims of these accidents have won compensation.  Hopefully, Toyota takes the high road and fixes the problems with its vehicles’ acceleration so no one else gets hurt.