Cleveland APL Telethon Raises $50,790

Telethon Raises $50,790

On Friday, March 20, Elk & Elk joined Levin Furniture as the corporate sponsors of the 4th Annual Fur-Get-Me-Not Telethon.

Cleveland APL Fur-Get-Me-Not Telethon
Photo courtesy of Cleveland APL

Telethon Raises $50,790 for Animal Protective League

The fundraiser, which was hosted by WKYC Channel 3, raised more than $50,000 in support of the Cleveland Animal Protective League. Cleveland APL receives no government funding and relies solely on the generous contributions of community members and corporate donations.

Elk & Elk Managing Partner Arthur M. Elk Live on Lakesidejoined Michael Cardamone and Hollie Giangreco during their presentation of the event on WKYC’s “Live on Lakeside,” and a number of Elk & Elk employees volunteered to answer calls during the telethon.

“It is through the support of our community and corporate sponsors like Elk & Elk that we are able to keep our animals healthy and allow them to stay with us until we find each one a home,” said Judy Hunter, Cleveland APL Director of Development.

Donations from the telethon and Cleveland APL’s other fundraisers throughout the year support the variety of programs, services and resources offered by the organization. These include animal adoptions and admissions, spay and neuter services, humane investigations and the Animal Welfare Clinic.APL Puppy

Missed the telethon? It’s not too late to make a donation.

Interested in providing a loving “fur-ever” home for an animal? Cleveland APL’s free app showcases all of the animals currently available for adoption. Visit the Google Play Store on your Android device or the App Store on your iOS device to download.

Dangers of Off-Label Drug Use

We recently reported on the possible dangers of the anti-nausea drug Zofran® and equivalent generics when they are used off-label. But what does “off label” really mean?

What is Off-Label Use of Medications?

As we explained in an earlier post, “When a drug is used in a way that is different from that described in the FDA-approved drug label, it’s said to be an ‘off-label’ use.” The FDA issues instructions and warnings based on clinical studies that drug makers submit to the FDA. If researchers have not tested a drug for a particular use, instructions, dosages and warnings do not appear on the insert or label.

Many drugs are prescribed for off-label use, but is it safe?FDA Does Not Regulate What Doctors Can Prescribe

The bottom line is this:  The FDA regulates drug approvals and thus the ability of the drug manufacturer to make a medication available for sale. It does not control how doctors actually prescribe drugs.  As a consequence, doctors can essentially do whatever they want with drugs, and one medical ethicist has said that off-label use is so common that almost every drug available today has been used off label for something.

Off-Label Use has Benefits, But…

This isn’t necessarily bad, say the experts. And in some cases, drugs that were first used off-label to treat a particular condition eventually receive FDA approval. Beta-blockers are one example of this.  First approved for treatment of high blood pressure, doctors now use some approved beta-blockers to treat patients with heart failure after having been used off-label for this purpose for many years. And using even unapproved beta-blockers now represents the standard of care for treatment of heart failure.

Despite success stories such as this one – and there are others – using drugs in unapproved ways is controversial. Medical ethicists remind physicians that off-label prescribing can expose patients to unnecessary risk.  It can also leave medical providers vulnerable to legal action when an unapproved drug causes injury, illness or death.

Research has showed that even doctors are often not aware that they are prescribing a drug unapproved for a particular use. Sadly, this puts the burden on patients to determine whether the medications they were prescribed received FDA approval for a particular use or not.

No Clear Research Results for One Drug Used Off-Label, the Anti-Nausea Drug Zofran®

In the case of Zofran (ondansetron), doctors learned about the off-label uses in pregnancy from other doctors, at conferences, and, in some instances, from sales reps who allegedly provided kickbacks. The drug, which was approved in 1991 for controlling nausea and vomiting in chemotherapy patients, has not been the subject of many studies for off-label use in pregnancy. The studies that do exist are somewhat contradictory, with some saying that there is no link between Zofran and birth defects in infants while others say that taking the drug during pregnancy can cause birth defects that include heart and kidney problems, cleft palate and other mouth defects, and musculoskeletal problems.

In 2012, GlaxoSmithKline pleaded guilty[1] to “unlawful promotion” and paying kickbacks to physicians to prescribe Zofran and other drugs. As part of a global resolution, GSK consented to pay $3 billion to settle a number of charges. However, in recently filed lawsuits, plaintiffs allege the pharmaceutical giant continued marketed and urged physicians to prescribe Zofran to pregnant women. Since the FDA cannot prevent doctors from prescribing the drug, many physicians still use it for nausea and vomiting in pregnancy.

Recently, there has been enough publicity about Zofran (ondansetron) that some parents whose babies were born with birth defects after taking Zofran have filed lawsuits against GlaxoSmithKline. More are expected.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

Do not stop taking medications except on your doctor’s advice.


 

[1] GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. U.S. Department of Justice, Office of Public Affairs. Washington: Press Release, July 2, 2012. (Civil Division, Consumer Protection, 12-842).

Litigation Update: Transvaginal Mesh & Bladder Slings

For women struggling with incontinence, pelvic organ prolapse and other problems, surgical treatments such as a bladder sling or other procedures using transvaginal mesh (TVM) seemed like a dream come true. Pharmaceutical companies claimed their mesh products would shore up weakened pelvic muscles—supporting internal organs and reducing embarrassing accidents.

Large verdicts and settlements in pelvic mesh cases.Sadly, for thousands of women, the dream of a normal life quickly turned into a nightmare. The mesh that doctors had inserted to support their organs began to degrade and shrink, resulting in painful consequences. The FDA received thousands of complaints, including instances of perforated tissue, damaged organs and pain during intercourse. Additionally, many women were forced to undergo multiple revision surgeries to repair problems caused by transvaginal mesh.

Tens of thousands of lawsuits have been filed against Ethicon (a subsidiary of Johnson & Johnson), American Medical Systems, Boston Scientific, C.R. Bard, Coloplast, Cook Medical, Neomedic, and other vaginal-mesh manufacturers. Although each case must be judged on its own merits, many large verdicts and settlements have been reported.

Transvaginal Mesh Litigation: Recent Events

  • Sept 2014 – A federal jury in West Virginia awarded $3.27 million to a woman injured by a J&J Ethicon mesh implant
  • Nov 2014 – Federal juries in Florida and West Virginia ordered Boston Scientific to pay a total of $45.2 million in damages to eight women who alleged the company’s mesh implants injured them
  • Dec 2014 – Federal judge urged C.R. Bard Inc. to settle thousands of TVM lawsuits because juries may award billions of dollars in damages.
  • January 2015 – J&J’s Ethicon division settles four cases for an undisclosed amount.
  • March 2015 – J&J ordered to pay $5.7 million, including $5 million in punitive damages to a woman injured by their Abbrevo vaginal mesh implant.
  • May 2015 – Boston Scientific ordered to pay $100 million ($25 million in compensatory damages, $75 million in punitive damages) to a woman injured by their Pinnacle and Advantage Fit mesh products.

While these numbers seem very encouraging, it is important to remember that actual damages may vary, based on the extent of injuries and other factors, and not all cases have had favorable results. Women who have suffered physical injuries, endured emotional distress, or incurred financial loss due to pelvic mesh surgery should contact an experienced personal injury attorney today to discuss their case.

 

 

Sources:

Jury hits Ethicon with $3.25 mln verdict in mesh case” by Jessica Dye, Reuters, September 5, 2014

Bard Judge Says Implant Maker Facing Billions in Verdicts” by Jef Feely, Bloomberg News, December 11, 2014.

Johnson & Johnson to settle four cases over vaginal-mesh implantsLos Angeles Times/Bloomberg News, January 22, 2015.

Johnson & Johnson ordered to pay $5.7 million in California mesh trial” by Jessica Dye, Reuters, March 5, 2015.

Boston Scientific ordered to pay $100 million in transvaginal mesh trial” by Jessica Dye, Reuters, May 28, 2015.

Top 7 Spring Driving Tips

Springtime means flowers are in bloom, trees grow new leaves, and… the roads are full of potholes. While beautiful, spring in Ohio presents plenty of driving challenges, so be sure to follow these important tips when you hit the road.

Spring Driving TipsSpringtime presents plenty of challenges for motorists

  • Share the road. Warm weather brings motorcyclists, bicyclists, and pedestrians out on the roads. Many pedestrians are distracted by texting, talking on cellphones, and listening to music, so they may be unaware of the traffic around them. Be extra cautious around intersections and in residential communities.
  • Slow down in wet conditions. Reduce your speed and increase your following distance when it rains—even if it’s only misting. Remember, even a small amount of water can mix with oil and road dust to create slippery conditions.
  • Replace your wiper blades. Be sure your vehicle is ready for spring showers by replacing your windshield wipers at least once a year. Don’t drive faster than your wipers can clear water from the windshield.
  • Avoid driving through puddles. As tempting as splashing through big puddles can be, try to avoid them. Potholes may be lurking beneath the surface and spraying water can impair your brakes, cloud your vision, or cause you to hydroplane and lose control of your vehicle.
  • Keep your eyes peeled for bad road conditions. The spring thaw reveals potholes, crumbling pavement and other hazards. If possible, go around potholes. They can damage your tires or throw your car’s front end out of alignment. Before maneuvering to avoid a pothole, check surrounding traffic to ensure this will not cause a collision or endanger nearby pedestrians or cyclists. If you can’t avoid a pothole, try to slow down without slamming on your brakes.
  • Keep your tires properly inflated. Tires are your car’s first line of defense against damage from potholes and uneven pavement. When checking the pressure in your tires, ensure they are inflated to the manufacturer’s recommended levels, which can be found on a sticker inside the driver’s door.
  • Watch out for animals. Spring means animals are emerging from hibernation and entering mating season. Scan the roadside for critters, keeping in mind that many animals, especially deer, may travel in groups and are most active at dawn or dusk.

Now get out there and enjoy this gorgeous spring weather!

 

Zofran Lawsuits

Zofran® and its generic equivalents have been linked to birth defects and other problems when the medication is taken during pregnancy.  The manufacturer, GlaxoSmithKline, promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery.

Zofran has been linked to birth defects and other problems when taken during pregnancy.

Two Recent Lawsuits Filed Alleging Birth Defects Caused by Zofran

At least two lawsuits were recently filed against GlaxoSmithKline because women who took the drug during pregnancy gave birth to children with heart problems.  One mother from Minnesota[1] charged that she had used Zofran during two pregnancies, and that both babies had been born with heart defects.

Another lawsuit, filed in Massachusetts[2], claimed that the baby was born with several heart abnormalities.  The baby in question has undergone more than a dozen surgeries, has developmental delays and has experienced other problems. The suit also charges that GlaxoSmithKline failed to warn the mother and doctor about the potential side effects and dangers of the drug.

Legal Issues in Zofran Lawsuits

The legal allegations and issues in these lawsuits include:

  • The manufacturer had a duty to ensure the safety of the drug and did not adequately determine its safety
  • The manufacturer did not warn the public about potential side effects and dangers
  • The manufacturer advertised and promoted Zofran as a treatment for the nausea and vomiting of morning sickness during pregnancy without the drug being approved for that use
  • The manufacturer incorrectly relied on animal studies even though the research actually showed the opposite
  • The manufacturer was selective in its evaluation of study results about the safety of Zofran
  • The drug was defective
  • The manufacturer falsely claimed that the drug was not dangerous to pregnant women

In addition to facing lawsuits about its negligence in developing, testing and marketing the drug, GlaxoSmithKline has been accused of bribing physicians to prescribe the drug for patients suffering from severe morning sickness.  This is not unusual for this drug company; according to an article published in the British Medical Journal[3], GlaxoSmithKline has paid out almost eight billion dollars in fines and penalties since 1991 for similar practices with other drugs.

In 2012, the pharmaceutical giant consented to pay $3 billion[4] to settle a number of charges, including that it wrongfully promoted the Zofran for unapproved uses. However, the plaintiffs allege it continued to be marketed and prescribed, despite the company’s agreement to settle.  It is very likely that many more Zofran lawsuits charging the company with negligently marketing the drug for off-label uses will emerge in the coming months and years.

 

Zofran® is a registered trademark of GlaxoSmithKline, LLC.

Do not stop taking medications except on your doctor’s advice.


 Sources:

[1] Flynn v. GlaxoSmithKline, LLC (2:15-cv-00709), United States District Court for the Eastern District of Pennsylvania, Filed: 02/12/2015

[2] LeClair v. GlaxoSmithKline LLC (1:15-cv-10429), United States District Court for the District of Massachusetts, Filed: 02/16/2015.

[3] Escalating criminal and civil violations: pharma has corporate integrity? Not really. BMJ 2013;347:f7507 doi: http://dx.doi.org/10.1136/bmj.f7507 (Published 18 December 2013)

[4] GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. U.S. Department of Justice, Office of Public Affairs. Washington: Press Release, July 2, 2012. (Civil Division, Consumer Protection, 12-842).

Kids and Guns: A Deadly Combination

Gun control is always a hot-button issue in this country. However, stories in the media about shootings that involve children – from Sandy Hook to the Tamir Rice shooting in Cleveland – are guaranteed to spur lively debate, sometimes resulting in calls for new legislation.

A young child takes aim with a rifle.
Photo Credit: Suchart Sriwichai /Freerangestock.com

Recently, a heartbreaking headline appeared on CNN.com, which read, “Accidental shootings plague Houston area as children play with guns.” The media outlet reported that three child shootings had occurred during a span of just four days. The first victim, a 3-year-old boy, died after he found a gun in a residence and accidentally shot himself. Two days later, another child, age 4, also died due to injuries from a self-inflicted gunshot wound—he reportedly found the gun under a bed. In the third shooting, a 5-year-old boy was critically injured when his 6-year-old brother accidentally shot him.

Sadly, each of these tragedies could have been prevented. According to the Law Center to Prevent Gun Violence, Child Access Prevention (CAP) laws have been shown to be effective at reducing unintentional firearm deaths among children. Indeed, one study found that in twelve states where such laws had been in effect for at least one year, unintentional firearm deaths fell by 23%.[1]

Protecting Ohio’s Children

Currently, Ohio has no law specifically penalizing allowing children access to firearms. However, legislation has been languishing in Columbus for more than two years that would establish the crime of criminally negligent storage of a firearm.

The proposed bill (HB 75), reintroduced in 2015 by Rep. Bill Patmon (D-Cleveland), prohibits a person from storing or leaving a firearm in a manner or location in the person’s residence if the person knows or reasonably should know that a minor is able to gain access to the firearm.

“This bill does not impede the Second Amendment,” said Patmon in an interview with the Toledo Blade in 2013. “We have car seats to protect children. Doesn’t it make sense to protect them from a .45 lying on the table?”

 

Sources:

Accidental shootings plague Houston area as children play with guns” by Dana Ford, CNN, March 3, 2015.

“Uncommon sense: Gun safe-storage laws have saved lives around the country, but Ohio remains behind the times” (Editorial) The Blade, March 19, 2014.

 

 

[1] Peter Cummings et al., State Gun Safe Storage Laws and Child Mortality Due to Firearms, 278 JAMA 1084, 1084 (Oct. 1997).

 

Zofran Linked to Birth Defects

The anti-nausea drug Zofran® has often been prescribed off-label to pregnant women suffering from serious morning sickness.  However, the evidence is growing that taking this drug may cause women to give birth to babies with a variety of birth defects.

Zofran was approved in 1991 by the Food and Drug Administration (FDA) for treating nausea and vomiting in cancer patients receiving chemotherapy and surgical patients with reactions to anesthesia. However physicians also prescribed it for severe nausea and vomiting during the first trimester of pregnancy.

Studies About the Safety of Zofran During Pregnancy

A recent article in the American Journal of Obstetrics and Gynecology[1] reported in drugwatch.com found that the babies of women who took Zofran faced a “two-fold increase” in the risk of heart problems in general and a 30 percent chance of suffering serious congenital heart malformations. The study, conducted in August 2013 among 900,000 Danish women, found that around one million pregnant women each year were exposed to Zofran (or the generic version ondansetron) worldwide.

The study also compared Zofran with other anti-nausea drugs and found that there were safer alternatives to the medication, such as doxylamine and pyridoxine. The conclusion: There is no reason to expose women to an unproven drug that carries such risks when there are safer alternatives.

Although early research was inconclusive, more recent studies indicate that there are significant risks to taking Zofran during pregnancy.  For example, a study published in 2013 in the New England Journal of Medicine[2] found that the drug posed no significant risks.  However, the majority of women in the study took the drug after 10 weeks, which is when the vulnerability of fetuses to drugs and other external substances lessens. The more recent Danish study[3], which studied women during the first trimester, when severe nausea and vomiting usually occur, found that 58 women out of the 1,248 who were prescribed the drug in the first trimester had babies with birth defects, a thirty percent increase over the control group.

Birth Defects Linked To Zofran

Babies whose mothers took the drug in the first three months of pregnancy have been born with a variety of birth defects, including:

  • Cleft Palate
  • Cleft Lip
  • Heart Defects (Cardiac Murmurs and Arrhythmia)
  • Limb Defects (Musculoskeletal abnormalities)
  • Kidney Defects
  • Lawsuit Against Zofran’s Manufacturer

The U.S. Department of Justice brought a lawsuit against the manufacturer of Zofran, GlaxoSmithKline for “unlawful promotion” and failure to include research data in safety reports on the drugs it manufactured and sold. The company pleaded guilty in 2012 to illegally advertising the drug as a morning sickness pill and agreed to pay $3 billion to settle the suit.

At least two individual lawsuits have been filed against GlaxoSmithKline, one in Minnesota and another in Massachusetts. Moreover, the manufacturer has been accused of illegal doctors to prescribe Zofran off-label, something that the company is known for doing.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

Do not stop taking medications except on your doctor’s advice.


 

[1] Koren, Gideon, “Treating morning sickness in the United States—changes in prescribing are needed,”  American Journal of Obstetrics and Gynecology, vol. 21, issue 6, December 2014, pp. 602-606.

[2] Pasternak, Bjorn, et. al., “Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes,” New England Journal of Medicine, vol. 368, February 28, 2013, pp. 814-823.

[3] Andersen JT, Jimenez-Solem E, Andersen NL, Poulsen HE. Ondansetron use in early pregnancy and the risk of congenital malformations—a registry based nationwide cohort study. Abstract presented at: 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25–28, 2013; Montreal, Canada. Abstract 25, Pregnancy Session 1. Pharmacoepidemiol Drug Saf. 2013;22(suppl 1):13–14.