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A Closer Look at Why HCG Diet Products are Illegal

Posted on January 31st, 2012 by Robert D. Rowland

While last month we posted about the FDA’s HCG alert advising consumers to avoid all HCG weight loss products, I wanted to take a closer look at why HCG is considered dangerous.

Unsafe Claims

Most HCG diet products are marketed in conjunction with extremely low calorie diets – as low as 500 calories a day. These diets claim consumers will lose up to 30 pounds in 30-40 days.

The problem is, any weight loss experienced is a result from severe calorie restriction – not from HCG. The FDA has approved HCG as a prescription drug for the treatment of female infertility and other medical conditions – but not for weight loss. Its prescription drug label states there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

A Dangerous Diet

Eating 500 calories a day is extremely dangerous, and can leave you at an increased risk for gallstone formation, an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, and an irregular heartbeat. Without constant medical supervision for a condition such as obesity, such a restrictive diet could even be fatal.

FDA Legal Action

It’s illegal to sell products claiming to contain HCG as an OTC drug product. Companies marketing and selling these products could face enforcement actions, legal penalties or criminal prosecution. The FDA also advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions.

If you or a loved are on an HCG diet and have experienced any illnesses while taking HCG, contact Robert D. Rowland.

Medtronic INFUSE Bone Graft Off-Label Complications

Posted on December 20th, 2011 by Robert D. Rowland

It is estimated that 900,000 patients may have used the Medtronic INFUSE Bone Graft, a medical device with an active ingredient, rhBMP-2, that’s described as “a “genetically engineered version of a naturally occurring protein that is capable of initiating bone growth in specific, targeted areas of the spine.”

In 2002, the Food and Drug Administration approved INFUSE for only one type of spine surgery – anterior approach lumbar fusion. It has not been approved for any other type of spine surgeries, such as lateral or posterior approach lumbar fusion surgeries, or for surgery on the neck or cervical spine (the portion of the spine that runs from the shoulders to the head).

Despite its limited authorized use, INFUSE has been used off-label in surgeries on the lumbar or cervical spine for many patients. Today, as much as 85% of INFUSE use is off-label. In cases like these, when any drug or medical device is used off-label, the surgeon must fully disclose any and all risks prior to the surgery, so that the patient may make an informed decision as to whether or not to proceed with the surgery.

In June of 2011, a medical journal called The Spine Journal criticized earlier studies by physicians with financial ties to Medtronic that supported the widespread use of INFUSE. The Spine Journal charged “biased and corrupted research,” alleging the studies greatly understated INFUSE’s serious side effects and risks. In fact, in none of the 13 trials funded by Medtronic were any adverse events disclosed.

U.S. regulators and other research has now shown that up to 50% of patients who have received an INFUSE implant have suffered adverse effects, including ectopic bone growth, uncontrolled bone growth, swelling in the neck and throat, infection, inflammatory cyst formation, cancer, and infertility in men.

Have you or a loved one suffered side effects after receiving an INFUSE implant? Contact Robert D. Rowland.

Asthma and pre-term labor medication Terbutaline warning due to infant brain damage

Posted on December 1st, 2011 by Robert D. Rowland

Terbutaline, an asthma medication that’s commonly prescribed to halt pre-term labor and premature birth, has been shown to leave the brains of children susceptible to other chemicals ubiquitously present in the environment. A Duke University Medical Center study found that rats exposed to Terbutaline suffer greater brain cell damage than those not given the drug upon secondary exposure to insecticides.

Nearly 20 percent of all pregnancies in the United States result in early labor, and an estimated one million women are treated with Terbutaline or similar drugs to halt early contractions every year. The use of Terbutaline for use in pre-term labor and premature birth is not approved by the FDA. In fact, in 1997 the FDA issued its first warning concerning the potential dangers associated with the use of Terbutaline for the treatment and prevention of pre-term labor.

Studies show a link between the use of Terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits, which may become noticeable at infancy, continue through adolescence and cause permanent disabilities. Researchers at Duke suggest that exposure predisposes newborns and infants to fall victim to particular ailments and medical conditions later in life.

The National Asthma Education and Prevention Program has now recommended women with asthma no longer take Terbutaline while they are pregnant, as the drug may penetrate to the fetus and affect brain development.

Terbutaline is sold under the brand names Brethine and Bricanyl. If you or a loved one has suffered from the effects of this drug, contact Robert D. Rowland.

Bladder Cancer Warning For Diabetes Drug Actos

Posted on October 26th, 2011 by Robert D. Rowland

In June of 2011, the FDA issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone), after analysis of a 5-year study of the drug by manufacturer Takeda Pharmaceuticals.

The results of the Actos study showed an increased risk of bladder cancer among long-term users of the drug, and a greater risk of bladder cancer among users exposed to the highest cumulative dose. The FDA is now requiring that new information about an increased risk of bladder cancer be added to the Warnings and Precautions section of the Actos label.

The FDA has also acknowledged a recent 10-years study in France, which suggests an increased risk of the bladder cancer with Actos use. As a result of this study, France has banned Actos, and Germany is advising doctors not to start Actos in new patients.

Symptoms of bladder cancer can include:
• Abdominal pain
• Blood in the urine
• Bone pain or tenderness
• Fatigue
• Painful urination
• Urinary frequency
• Urinary urgency
• Urine leakage (incontinence)
• Weight loss

If you or a loved one has suffered using Actos or pioglitazone, contact Robert D. Rowland.

New FDA Warnings for Vaginal Mesh Implant

Posted on October 24th, 2011 by Robert D. Rowland

In August 2011, the FDA issued new warnings for vaginal mesh – a medical implant designed specifically for repairs of pelvic organ prolapse (POP), as well as urinary stress incontinence. During pelvic organ prolapse, the internal structures that support the pelvic organs such as the bladder, uterus, and bowel drop from their normal position and “prolapse” into the vagina.

The FDA warns that the risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, as the number of adverse events has increased since it first issued a safety communication in 2008.

The most frequent complications reported to the FDA for surgical mesh devices for POP repair include:
• Erosion or protrusion of the mesh from the soft tissues
• Pain, including pain with intercourse
• Infections in the area of the mesh
• Urinary tract problems
• Bleeding from the mesh site
• Damage to nearby organs

There have also been reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In a study of almost 12,000 women, approximately 10% of women experienced mesh erosion within a year after surgery (Abed, 2011), and problems with the mesh tend to develop at least a month after surgery for POP (Caquant, 2008).

If you or a loved one have received a vaginal mesh implant and are experiencing issues, contact Robert D. Rowland to discuss your case.

Supreme Court decision protects makers of generic drugs

Posted on September 28th, 2011 by Robert D. Rowland

In a recent 5-4 decision in Pliva v. Mensing, the United States Supreme Court ruled that makers of generic drugs cannot be sued for failing to warn people of potentially dangerous side effects, as long as their warning labels contain the same warnings as their brand-name equivalents.

In Pliva v. Mensing, MN resident Gladys Mensing and LA resident Julie Demahy both sued Pliva and other generic manufacturers under their respective state laws, after they developed a severe neurological disorder after taking generic versions of the drug Reglan for digestive tract problems in the early 2000s. The drug contained the active ingredient metoclopramide, and the women alleged that the manufacturers had a duty to strengthen their warning labels as problems related to the long-term use of metoclopramide became evident.

Justice Clarence Thomas, writing for the majority, held that since federal regulations regulate generic drugs to have the same warning labels as their brand-name equivalent, this pre-empts any state personal injury law that would allow an individual to sue manufacturers for an insufficient label. Under most states’ laws, drug manufacturers must update their warning labels as they became aware of new risks. Justice Thomas even acknowledged that it “makes little sense” that those individuals injured by generic drugs have no state failure-to-warn claim when those injured by brand-name drugs do.

Justice Sotomayor, noted in dissent: “A drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. If a consumer takes a brand-name drug, she can sue the manufacturer . . . if she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue”.

The Mensing decision is a victory for pharmaceutical companies and a defeat for injured consumers. There are still ways to hold some generic manufacturer’s liable for failure to warn of known dangers presented by their drugs, but the road to compensation just got a lot steeper.

Have you been harmed by a prescription drug – brand-name or generic? Let us help. Contact Robert D Rowland.

$25 Million Award in Accutane Inflammatory Bowel Disease Lawsuit

Posted on September 23rd, 2011 by Robert D. Rowland

A New Jersey judge has ordered Swiss drugmaker Roche, the maker of Accutane, to pay $25 million to a former user of the acne medicine who developed severe inflammatory bowel disease (IBD) after taking the drug.

Andrew McCarrell, 38, became sick after taking the drug for several months in 1995. He needed five surgeries, including one to remove his colon, and suffers daily pain and anguish from Accutane IBD. He won the verdict after NJ judge Carol Higbee denied Roche’s request for a new trial or remittitur.

One of the first Accutane cases to reach a jury in the United States, the case was originally filed in 2003 and first went to trial in 2007, resulting in a jury award of $2,619,000. The case was remanded for a new trial when Roche requested to introduce evidence on the total number of Accutane users.

The nine jurors ruled unanimously that McCarrell deserved $25 million in compensation for pain and suffering and $159,000 for past medical expenses. McCarrell claimed Roche violated New Jersey’s consumer fraud law.

Judge Higbee denied Roche’s requests for a new trial or a reduction in awarded damages to McCarrell, indicating that she found no sense of “wrongness” in the jury’s award in a 47-page opinion, stating:

“[McCarrell's] testimony and that of his wife and doctors presented a picture of probably the worst case of pain, suffering and loss of quality of life I ever heard described on my eighteen years on the bench.”

It doesn’t matter when you took Accutane or how long it took for your symptoms to appear – if you feel as though your personal use of Accutane has caused you issues, please contact Robert D. Rowland.

How to choose a personal injury attorney & what to expect

Posted on July 25th, 2011 by Robert D. Rowland

Want to listen to a podcast of this blog? Click the link at the bottom of the post.

Tips on how to pick the personal injury attorney that’s right for you: an interview with GHAR attorney Robert Rowland.

What does personal injury law cover?
Personal injury law covers slipping and falling, auto accidents, medical malpractice, pharmaceutical cases – just to name a few.

What should someone look for in an attorney?
A key consideration is to look for an attorney who has experience representing plaintiffs, but who also has experience working for the defense. An attorney with this understanding will have the knowledge of how both sides work – and they’ll know how to get the best and fastest results for their clients. It’s especially important for people with personal injury claims, as they’re for the most part in dire financial straits and don’t have a lot of time to wait.

What are the top 3 things to consider when hiring an attorney?
1. Experience: You want someone who has experience in the specific type of case you’re dealing with.
2. Support and resources: Make sure they have the lawyers and resources to handle a substantial case.
3. Personal connection: The connection you have with your attorney is like any other business/working relationship. Make sure you get along with the person that’s going to be representing you. It’s also ok to ask for a recommendation from a former client.

How much should your lawyer charge?
There is a standard fee – an amount that goes to the lawyer if they claim anything through settlement or verdict, normally 1/3 or 40%.

It’s fair to ask a lawyer up front, “What do you think about this case?” If you’ve hired an experienced lawyer who has handled a case like yours, they should be able to provide you with insight, and know the appropriate fee.

What should people do if they have anxiety about lawyers?
You can always ask for a second opinion by asking another lawyer his or her thoughts on your case. But don’t see another lawyer if you already have hired a lawyer. Also, do research on the law firm: how long have they been around? What’s their reputation? There are some smaller law firms that ask their clients to front the cost of the case, which is normally a red flag. Ask the lawyer if they’ve ever tried a case, because some may have only dealt with settlements. Also ask, “Do I have to pay if we lose?” The answer should be no, but that may not necessarily be true with every firm.

What happens once you hire a lawyer?
After you’ve decided to hire an attorney, they’ll normally send you a contract of employment along with authorizations. Authorizations allow the lawyers to obtain copies of your medical records and medical bills which can be used in the case. If the person has suffered a loss in income they’ll get wage authorizations, which determines how much they’ve lost. Typically it will take ninety days to six months to get authorizations and records cleared. Unfortunately, there’s nothing the lawyer can really do to speed up the time it takes for doctors to clear these requests. The lawyers may also make settlement demands before they file the lawsuit – if it allows the client to get compensated quicker, it also gives them time with the information before they file the lawsuit.

How often should you expect to speak with someone in the firm that’s representing you?
Once you’ve returned the authorizations, six months is the absolute longest you should have to wait to hear form your attorney. It’s the most time it could take for them to receive your records. After that point, it’s absolutely ok to call and ask about the status of your case. Remember: it’s your case, it’s not their case.

After this point, you should keep up with your attorney on what has been filed for the case: a settlement demand, a complaint or petition, interrogatories (questions from the defense), and eventually the case itself.

How does a personal injury case end?
In the case of a personal injury settlement, there will be a deposition of everyone’s testimonies. Then your lawyer and you would have a conversation about what amount of money they’ll need in a settlement. This pertains to a client’s medical bills, loss of income, future loss of income, ongoing medical costs. You should also ask your lawyer: what are the chances this case will go to trial? Does it look like they’ll settle? Have you seen this sort of case before?

If you would like to discuss your personal injury case, contact Robert D. Rowland.

Listen to an interview podcast on this subject with Robert D. Rowland by clicking below:

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Statute of limitations running out on Accutane

Posted on June 9th, 2011 by Robert D. Rowland

Did you take the drug Accutane and suffer from side effects, or receive a diagnosis of Inflammatory Bowel Disease, Ulcerative Colitis, Crohn’s Disease or Ulcerative Proctitis?

It’s been almost two years since the drug Accutane (most commonly prescribed for skin conditions) was taken off the market. For many states, the statute of limitations runs out after two years, meaning that many patients only have until June 26, 2011, to file a lawsuit. It’s important to contact us as soon as possible to discuss your potential case.

Good news for Accutane plaintiffs
There have been eight consecutive Accutane injury trials in which juries have sided with Accutane patients who allege they were harmed by the drug. The most recent involved three plaintiffs, and resulted in a $2 million verdict.

“I think I have side effects from Accutane – what should I do?”
It’s important first to get confirmation of your diagnosis. For example, if you think you have inflammatory bowel disease, talk to you doctor and get the facts. Then, contact us to discuss your case. Be forewarned, however, about the potential for misdiagnosis – many patients may be told they have allergies, gallbladder or other unrelated issues. If you have symptoms of inflammatory bowel disease – bloating, blood in the stool, constipation, diarrhea or abdominal pain – within four years of stopping Accutane, see a gastroenterologist for an accurate diagnosis. If you’ve completed one or more Accutane cycles and developed noticeable symptoms within four years of completing the cycle, contact us.

Generic Accutane
Generic Accutane manufacturers could be liable as well, since they use the same active ingredient, as well as warning labels. If you’ve used generic forms of Accutane (Amnesteem, Claravis, Sotret) and suffered side effects, contact us.

Long Term Side Effects of Accutane
Those with inflammatory bowel disease often require a lifetime of treatment. Some may require the removal of the colon, and some may end up with an ileostomy bag. But it doesn’t matter when you took Accutane or how long it took for your symptoms to appear – see a specialist, get a diagnosis, and contact us to get the justice you deserve.

If you or a loved one has taken Accutane, contact Robert D. Rowland to discuss your case.

The Topamax and birth defects connection

Posted on April 14th, 2011 by Robert D. Rowland

We read every day about prescription drugs which harm people in ways they never imagined, with risks they would have never taken. As a parent, the only thing worse than taking a drug that harms you unexpectedly, is taking a drug which harms your child unexpectedly. Unfortunately, in March 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and doctors warning of the risk of birth defects from the use of Topamax, a drug prescribed for treatment of epileptic seizures and chronic migraines.

Topamax (Topiramate) has been on the market since 1997. It was originally approved by the FDA for use to treat seizures. In November 2002, it was approved to treat migraines. Around the time of initial approval, literature began to surface suggesting an increased risk of giving birth to children with cleft lip and/or cleft palate to mothers who took Topamax during their first trimester of pregnancy. The tissue that becomes the lip forms as early as 5 to 6 weeks after conception, while the palate forms at 7 to 11 weeks after conception. The damage is done often before the mother even knows she is pregnant!

Despite the known birth defect risk, no warnings were provided to patients or doctors. According to the FDA news release dated March 4, 2011, data received from the North American Antiepileptic Drug Pregnancy Registry showed that the risk of cleft palates in infants exposed to Topiramate (Topamax) was over three times higher than the risk of cleft palates from other antiepileptic drugs. Only 0.07% of infants born to mothers who took no antiepileptic drug were born with cleft palates, while infants whose mothers took Topamax were 20 times more likely to have cleft palates.

Beyond the cleft palate and cleft lip injuries, additional birth defects have been linked to lesser degrees of use of Topamax in the first trimester. Topamax use has also been associated to limb malformation, heart defects, congenital defects, craniofacial defects, spina bifida and genital malformations.

Our firm is currently representing families who have been damaged by Topamax and would be happy to provide more information to concerned parents.

For more information on Topamax and birth defects, contact Robert D. Rowland.