ProPublica Offers Nine Ways to make Tylenol Safer

ProPublica, the investigative newsroom that has often discussed issues of drug safety and pharmaceutical company behavior, recently published an article entitled “Nine Ideas to Make Tylenol and Other Acetaminophen Drugs Safer”.  In the piece ProPublica journalists offer the following ideas to make the drug safer for public use and hopefully decrease the number of users that are seriously injured or killed after taking the drug.

Tylenol misuse, accidental overdose, and even intentional overdose has been a problem for some time.  Between the years of 2001 and 2010, the U.S. Centers for Disease Control and Prevention report that 1,500 Americans died from accidental overdose, and another 1,400 died as a result of intentional overdose.

So what are ProPublica’s suggestions?

• Lower the dose from 4 grams a day to 3 grams a day.

• Clarify dosing instructions for children’s and infants’ Tylenol, including for children under 2.

• Remove acetaminophen from prescription pain killers such as Vicodin and Percocet.  The combination of opioids and acetaminophen does not seem to be particularly beneficial, and contributes to dosage confusion.

• Impose restrictions on how much acetaminophen can be purchased at one time.  This has proven effective in decreasing suicides in the United Kingdom.

• Change the labels to encourage users to begin at the lowest effective dose, and add more pills only if necessary.

• Limit pill strength of over-the-counter acetaminophen to 325 milligrams per pill, as prescription medicines are limited.

• Require over-the-counter acetaminophen advertisements to explicitly warn of side effects.

• Add warnings to all products containing acetaminophen to help warn consumers when they might be taking more acetaminophen than they think they are.

• Add warnings regarding the possibility of death on over-the-counter acetaminophen.  As of now, the FDA only requires it on prescription products containing acetaminophen.

As ProPublica’s list of suggestions highlights, there are currently many inconsistencies between the rules applied to prescription drugs containing acetaminophen and over-the-counter drugs containing it.  The public is much more likely to use the drug correctly if the over-the-counter acetaminophen manufacturers are required to follow the same stringent rules that prescription manufacturers have to.

Have you taken acetaminophen and suffered serious liver complications?  Or have you lost a loved one due to Tylenol complications?  If so, contact a Tylenol attorney at Kirkendall Dwyer LLP to discuss your case.  You may be eligible for compensation.  Contact us today to learn more.

Emails Show that Bard Knew of TVM Problems

Court records from this summer revealed that transvaginal mesh manufacturer Bard knew that they were manufacturing their mesh out of plastic that was not suitable for implantation in humans.  The medical device manufacturer had been told as much by the suppliers of the plastic resin, Chevron Phillips Chemical Company.  Chevron clearly warned Bard that the material was not intended for permanent human implantation, and Bard knowingly ignored this information, going so far as to write in emails that their intentions to use it anyway should be kept from Chevron.  Bard knew that Chevron would be worried about the product liability involved.

Because of these emails, the judge in the Donna Cisson case decided that there were legitimate issues of material fact regarding Bard’s knowledge about the materials they were using in their mesh.  The jury ended up granting Cisson $250,000 in compensatory damages, and $1.75 million in punitive damages.  They found that Bard’s Avaulta Plus Mesh had a defective design and that they filed to warn physicians of the risks involved.

Have you suffered serious complications as a result of transvaginal mesh implantation?   The transvaginal mesh attorneys at Kirkendall Dwyer LLP can help.  Our attorneys can help you get the financial and medical attention you need.  You do not need to suffer through this difficult time alone.  Thousands of women just like you are joining to hold mesh manufacturers responsible.  Contact us today to discuss your case.

Novo Nordisk Seeks New Uses for Victoza

Novo Nordisk’s Chief Science Officer Mads Krogsgaard Thomsen stated that the pharmaceutical company is looking into continuing trials to determine if Victoza could be marketed as a possible Alzheimer’s treatment.  Victoza is currently going through a proof of concept study.  If this is successful, the drug will continue through phase III clinical trials to see if the drug may be approved for Alzheimer’s treatment.  This proof of concept study can take up to three years however, so the drug being on the market for such use is several years off.

Novo is hoping that Victoza can be shown to reverse memory loss in mice, and to reduce the buildup of amyloid plaque in the brain that causes dementia.

Moving an already approved drug through trials for new approvals is much faster and less expensive for drug companies than developing new drugs altogether, making this a tempting route for many pharmaceutical companies.  Novo is not only seeking to gain an Alzheimer’s indication for Victoza in the coming years, but is also seeking to get Victoza approved as a treatment for obesity in both the United States and the European Union.

Novo is not the only drug company seeking an Alzheimer’s indication from a drug currently approved for diabetes.  Takeda is in phase III trials with its diabetes drug Actos to see its effect in people at risk for developing Alzheimer’s.

Should drug companies be seeking wider usage of drugs that have already been shown to be dangerous in the populations taking them?  Both Victoza and Actos have been linked to various serious side effects such as pancreatic cancer, bladder cancer, and pancreatitis.  Suits are currently underway in which thousands of injured patients are seeking compensation from drug companies for their serious injuries after using diabetes treatments such as Victoza, Actos, Januvia, and Byetta.

Have you taken one of these type 2 diabetes treatments and have suffered serious complications?  Contact a dangerous diabetes drug attorney at Kirkendall Dwyer LLP today.  When you contact our offices, you will speak directly to an attorney who can provide you with an immediate assessment of your case.  As always, we work on a contingent fee basis, so we don’t see a dime until we recover compensation for you.  You have nothing to lose.  Do not suffer alone.  Contact us today.

 

Source: PM Live, “Novo backs Victoza’s prospects in Alzheimer’s”

Consumer Reports Calls for Hip Manufacturers to Provide Warranties

In the past years, there has been a huge increase in the number of young people getting hip and knee replacements.  In the past, these devices were reserved for the elderly, but as more and more people live and want to maintain active lifestyles, these implants are becoming an option for the young.

In fact, by the year 2030, Consumer Reports estimates that there will be approximately 4 million hip and knee replacement surgeries performed every year, with 50%  of those surgeries being performed on patients younger than 65.  The issue that then arises is that these implants must last for much longer and endure more wear and tear.

In order to address this problem and to encourage manufacturers to address the changing populations needing replacements, Consumers Union wants device manufacturers to provide warranties to consumers regarding their implants.  The group believes that doing so will:

• Remove the cost burden from the patient and put it back onto the manufacturers.  As of now, patients, insurance companies, and Medicare are responsible for paying for hip and knee revision and replacement surgeries.

• Help patients understand what to expect in terms of longevity and durability of the device.

• Help patients understand what procedures to follow if something does go wrong.

• Encourage manufacturers to make better and more durable devices since otherwise the cost of replacement will be on them.

Hip replacements are an expensive endeavor: they usually result in more complications, and longer hospital stays.  Approximately 18% of hip replacements are revision surgeries, a number which most would think is too high.  Especially given the fact that every major manufacturer of hip devices has recalled at least one product or line of products, there is much room for improvement.

Patient safety advocates also believe that these statistics could be much improved by changes in the FDA’s clearance process.  As of now, if device manufacturers can prove that their devices are substantially equivalent to other devices already on the market, then the new devices will be cleared.  This is a flawed system that has allowed too many dangerous and problematic devices onto the market.  More rigorous pre-market safety testing would prevent such devices from reaching the market in the first place.  However, the strong medical device industry has kept such changes from occurring.

Have you received a metal-on-metal hip implant and had to undergo a painful revision surgery?  Thousands of patients just like you have suffered serious side effects from their metal-on-metal hip implants, including pain, infection, metallosis, and revision surgery.  The hip implant attorneys at Kirkendall Dwyer LLP can provide you with the information you need to move forward.  Litigation is underway and you may be eligible for compensation.  It is critical that you speak with an experienced medical device attorney before you make any decisions.  Do not provide unnecessary information on manufacturer hotlines and helplines.  These companies are looking to limit your compensation and legal rights.  Click here to read more advice on what to do if your device manufacturer issues a recall.

Contact us today for a full case review.  We don’t see a dime until we recover compensation for you, so you have nothing to lose.

Mesh Manufacturers in Talks to Settle

Five mesh manufacturers are said to be moving towards settlement over transvaginal mesh lawsuits that have been consolidated into multi-district litigation in West Virginia.  The manufacturers that are involved in the talks are C.R. Bard, Endo Health Solutions, Boston Scientific Corporation, Coloplast Corporation, and Cook Medical Inc.

Most of the companies face over 12,000 lawsuits, while Coloplast and Cook collectively face about 1000.  Another device giant, Johnson & Johnson, also faces over 12,000 lawsuits, but is not involved in settlement talks at this time.

Plaintiffs are hoping that U.S. District Judge Joseph Goodwin will appoint a settlement committee in order to facilitate talks.  The talks would cover about 30,000 individual cases, a number that could rise to about 50,000.  The settlement is thought to have a multi-billion dollar value.

The history of transvaginal mesh cases going to trial has not been positive to manufacturers:

• Endo has already settled an unknown number of cases for $54.5 million

• A California jury demanded that Bard pay $5.5 million to a woman injured by mesh.  Under the law, the company will be liable for $3.6 million

• A New Jersey jury demanded that Johnson & Johnson pay $11.1 million in damages to a woman injured by Gynecare Prolift

If you have had a transvaginal mesh implant and have suffered serious consequences as a result, including pain, mesh erosion, bleeding, infection, or recurrent revision surgeries, a transvaginal mesh attorney can help you get the help that you need.  Our attorneys understand the sensitive nature of your injuries, and are compassionate and experienced enough to provide you the answers to all your questions.  Contact us today for a free case review.  We always work on a strictly contingent fee basis, meaning that we don’t see a dime unless we recover compensation for you.  You have nothing to lose; contact us today.

 

Source: Bloomberg News, “Bard, Vaginal-Mesh Makers, Said to be in Settlement Talks”

Merck to Stop Distributing Diabetes and Cholesterol Combination Medication

Merck, manufacturer of the controversial diabetes drug Januvia, has made the decision to stop manufacturing a combination of Januvia (sitagliptin) and the high cholesterol treatment simvastatin.  The drug was called Juvisync, and the theory behind it was that the company could increase profits by capitalizing on the large population of individuals that suffer from high cholesterol and diabetes.

This theory has not panned out, and claiming disappointing sales as its sole reason, Merck has decided to stop manufacturing it.

Januvia and its sister drug Janumet are DPP-4 inhibitors, and are the best-selling drugs in their class.  In 2011, over 2 million prescriptions were written for the drugs.  They work by increasing insulin and decreasing sugars made by the liver.  However, Januvia has been linked to serious side effects such as pancreatitis and pancreatic cancer.

Symptoms of pancreatitis include:

• Abdominal pain that may radiate to the back

• Rapid heartbeat

• Pain after eating

• Nausea, Vomiting, and Fever

If you have suffered bouts of acute pancreatitis, or you have developed pancreatic cancer after taking the type 2 diabetes medication Januvia, you may be eligible for compensation for your injuries.  Thousands of individuals have suffered as a result of inadequate warnings, and are filing suit to hold the pharmaceutical companies responsible.  An attorney at Kirkendall Dwyer LLP can provide you immediate answers to your questions.  Do not delay; contact us today to begin the process of recovery.

Judge Tosses Jury’s Verdict Against Actos Manufacturer Takeda

In Maryland, a jury found drug giant Takeda Pharmaceutical Company liable for $1.7 million in damages for not properly warning its user regarding the risks of taking Actos and developing bladder cancer or heart problems.  The subject of the case was a deceased man by the name of Diep An, who was a former U.S. Army translator.  An began taking Actos in 2007, and was diagnosed with bladder cancer in 2011.  He died months later in January of 2012.

Despite it’s findings of Takeda’s guilt, the jury also found that An contributed to his death by smoking for the majority of his life.  Because of this, the judge set aside the jury’s verdict, granting the plaintiff’s estate nothing.

Other similar lawsuits are pending all around the country.  In Louisiana, multi-district litigation involving over 1,200 suits is set to begin in federal court in January.  Despite the fact that this verdict was set aside, the fact that the jury found Takeda Pharmaceutical Company guilty of not properly warning of the risks of Actos sets a positive precedent for future litigation.

Actos has been plagued with problems for some time.  In the U.S., the FDA found that there was indeed an increased risk of bladder cancer for some users of the drug.  In France, the government demanded that the drug be taken off the market.  In Germany, to discourage the use of Actos, the government stopped reimbursing for the drug.

Have you been injured by Actos, or any other diabetes drug?  Actos has been linked to severe complications such as bladder cancer.  You deserve compensation for your injuries.  Contact an attorney at Kirkendall Dwyer LLP today for immediate answers.  When you call our offices, you will speak directly to an attorney.  You have nothing to lose by gathering information.  Contact us today.

 

Source: BloombergBusinessWeek, “Takeda Failed to Properly Warn About Actos Risks, Jury Finds,” by Jef Feeley

Federal Trial Against Johnson & Johnson Delayed

The first federal trial against Johnson and Johnson for its ASR hip implant was supposed to start on September 14, but U.S. District Judge David Katz has signed an order postponing it because of problems scheduling expert witnesses on both sides.  Additionally, there have been problems with general pre-trial discovery because of the fact that this is a bellwether case in a massive multi-district litigation.  A bellwether case may determine the direction in which future settlements with other plaintiffs go.

The trial should go to trial within 90 days.

The plaintiff in this case is Ann McCracken.  The following are some details of her case:

• McCracken received the ASR hip implant in August of 2009

• The product was recalled in 2010

• McCracken had to undergo two revision surgeries: one in January of 2011 for device failure, and a second one in October of 2011 for continuing pain and complications from the hip implant

The following are some claims that McCracken is making:

• Defective design/Design flaws that caused pain, immobility, the need for revision surgeries, and the release of toxic metal ions into the body

• The implant was not reasonably safe, and even after the company discovered this, they failed to warn doctors and patient

• Negligence for failure to properly test safety before taking the implant to market

The importance of the McCracken case can be seen when one takes into account the fact that there are almost 8000 other cases pending against Johnson & Johnson’s DePuy Orthopaedics Unit in federal court, and over 3600 lawsuits pending in state court.  Bloomberg has reported that there are rumors that Johnson & Johnson plans to settle for $3 billion globally.

Have you been injured by a DePuy ASR Implant?  It is not too late to join the ongoing litigation, both to recover compensation to help pay for your medical treatment and injuries, and to hold the pharmaceutical companies responsible for putting out a defective product.  Contact a hip implant attorney at Kirkendall Dwyer LLP today.

 

Onglyza Linked to Increased Risk of Heart Failure

Onglyza, a DPP-4 inhibitors, was the subject of a new study conducted by researchers at the Brigham and Women’s Hospital in Boston.  The study concluded with the following findings:

• Onglyza resulted in an increased risk of heart failure.  Those taking the diabetes medication had a 3.5% increased risk, versus 2.8% in the control group.
• There was no increase or reduction in heart attacks
• There was no increase in rates of pancreatitis or pancreatitic cancer

Onglyza (manufactured by AstraZeneca and Bristol-Myers Squibb) is just one in the DPP-4 class of type 2 diabetes treatments, along with Merck’s Januvia and Takeda’s Nesina.

DPP-4 inhibitors are a form of type 2 diabetes treatment that work by increasing incretin levels, which in turn stimulate an increase in insulin and a decrease in glucagon release.  This in turn has the affect of lowering blood sugar.

The Onglyza study followed over 16,000 women for 2 years.  Another much smaller study of Nesina in 5,000 people did not show an increased risk in heart failure, but experts believe that this is due to the fact that the sample was so much smaller.  Researchers believe that all DPP-4 drugs most likely pose the same heart failure risks, and that those who are more likely to suffer heart problems should not take this class of drugs.

Diabetes medications are big business for pharmaceutical companies.  In 2012, Onglyza brought in $709 million, while Januvia brings in about $5 billion a year.

If you have taken any of these drugs, including Januvia, and have suffered serious side effects as a result, please contact the dangerous drug attorneys at Kirkendall Dwyer LLP.  Our attorneys can answer your questions and give you an assessment of your case’s potential.  Don’t delay–contact us today.

 

DePuy Considers Massive Settlement for Hip Implants

Johnson & Johnson’s DePuy subsidiary is facing massive liability over its metal on metal hip implants, in particular the Articular Surface Replacement (ASR) implants.  In March 2013, a jury granted plaintiff Loren “Bill” Kransky $8.3 million in compensatory damages for medical expenses and pain and suffering.  The jury did not impose punitive damages.

Now DePuy is said to be considering settling all its pending claims for a record-breaking $3 billion.  Over 10,000 suits are pending in various courts across the country, alleging that DePuy failed to warn of the risks of its hip implant.

It is not only the hefty sum of the verdict that came out in the Kransky case.  In addition to that number, several damaging facts have surfaced about DePuy and its handling of the botched implant.

It has come to light that in pre-trial testimony, DePuy itself estimated the failure rates of its ASR implant to be as high as 37%.  In addition, testimony also showed that DePuy was aware that its implants were shedding metal particles into patients’ bodies and bloodstreams, causing major health complications.

Other damaging facts that have come to light:

• Surgeons warned DePuy of major design flaws in the implant
• Surgeons encouraged DePuy to slow or stop sales of the implant altogether
• DePuy considered redesigning the implant to improve its functionality and safety, but decided that the costs to do so were too high

DePuy’s gamble on its faulty product did not pay off.  It now faces paying on average $300,000 per patient for each of the lawsuits pending across the country.  This totals over $3 billion.  The largest settlement for hip implants  until now has been $1 billion.

If you or a loved one have suffered serious injury as a result of a metal-on-metal hip implant, contact one of the defective device attorneys at Kirkendall Dwyer LLP today.  Our attorneys can answer your questions and help guide you through the process of recovery: from finding out what type of implant you have, to safely recovering and storing your device as evidence in case you must undergo revision surgery.  Contact us today.