J & J faces thousands of Risperdal lawsuits

More than 5,000 lawsuits have been filed against Johnson & Johnson for failure to warn doctors and consumers that Risperdal can cause boys to grow large breasts, a condition known as gynecomastia.

Risperdal Litigation

At least 1,500 Risperdal cases have been consolidated in Pennsylvania on behalf of individuals who allege the drug caused excessive male breast growth and other complications. Complex litigation with multiple plaintiffs takes time. First filed in 2010, Risperdal bellwether trials are currently underway in the Philadelphia Court of Common Pleas.

One case now before a jury was brought by a Risperdal user who was prescribed the drug off-label as an 11-year-old boy to treat symptoms associated with Tourette’s syndrome. The plaintiff, who required surgery to remove excess breast tissue that allegedly resulted from his use of Risperdal, claims that Johnson & Johnson and its Janssen Pharmaceutical unit made millions of dollars by improperly promoting unapproved pediatric use of the drug. The lawsuit also alleges the pharmaceutical companies did not adequately warn doctors and consumers about the association between Risperdal and the development of gynecomastia in boys.

Risperdal in the News

Overall, media coverage of this case has been sporadic at best. However, the Huffington Post has released a massive 58,000-word, 15-chapter “DocuSerial,” which casts a bright light on the far-reaching effects of Risperdal. As part of their extensive reporting, the publication released the following short film, entitled, “The Boy with 46-DD Breasts.” The documentary follows the story of Austin Pledger, who developed “large pendulous breasts” as a teen after he began taking the drug for autism at age eight.

 

The Boy With 46-DD Breasts from HuffPost Highline on Vimeo.

Jury awards $2.5 million in Risperdal lawsuit

Boys and young men who develop gynecomastia after taking Risperdal may be eligible to receive financial compensation for both physical and emotional injuries. In February 2015, Pledger was awarded $2.5 million after a judge declared J & J failed to warn the drug could cause breast development. While some Risperdal cases have gone to trial, others settle out of court. Although the terms are confidential, settlements typically include money for surgery, ongoing medical care and counseling.

UPDATE (11/9/15) – In the third bellwether Risperdal trial in Pennsylvania, a jury ordered Johnson & Johnson to pay $1.75 million to a Maryland man who developed female breasts while taking Risperdal. The plaintiff, who had been prescribed Risperdal off-label when he was 9-years-old to treat symptoms associated with autism, was awarded compensatory damages for disfigurement and mental anguish.

Do lawsuits hurt big pharma?

Damages are awarded in a civil lawsuit to “make the plaintiff whole.” In some cases, punitive damages are also awarded to punish the defendant and (hopefully) deter future misdeeds. Unfortunately, most lawsuits against pharmaceutical manufacturers don’t make any difference in how these behemoths do business. Why? Big pharma has very deep pockets, as evidenced by the following statement, which Johnson & Johnson filed with the Securities and Exchange Commission in 2013—a year when their pharmaceutical segment achieved sales of $28.1 billion.

In the Company’s opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings . . . is not expected to have a material adverse effect on the Company’s financial position.

So, it seems that although Johnson & Johnson—and many of the top pharmaceutical corporations—face thousands of expensive lawsuits, they’ll be just fine. Too bad the same can’t be said for the thousands of hapless victims of corporate greed.

 

Sources:

Brill, Steven. “America’s Most Admired Lawbreaker.” The Huffington Post, September 15, 2015.

Johnson & Johnson. 2013 Annual Report. New Brunswick, NJ: Johnson & Johnson, 2013.

Kristof, Nicholas. “When Crime Pays: J&J’s Drug Risperdal.” The New York Times, September 17, 2015.

Wasserman, Emily. “J&J slapped with 1.75M verdict in Risperdal breast growth case.” FiercePharma, November 10, 2015.

 

 

 

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).

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).

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.

 

Side Effects of Anti-Nausea Drug Zofran

The drug Zofran® , also known as Ondansetron, is approved by the Food and Drug Administration to treat nausea and vomiting resulting from chemotherapy treatment for cancer and after being administered anesthetic during surgery. The medication works by blocking serotonin, a natural substance in the human body, which can cause vomiting, It is manufactured by pharmaceutical giant GlaxoSmithKline and is also available as a generic. The medication comes both in pill form, as a liquid and as an injection.

When the FDA approved the drug for generic manufacture in 2006, Zofran was the 20th most frequently sold prescription medication in the United States, according to the Food and Drug Administration (FDA) website. In 2005, sales of the medication totalled $839,256,543.

Common Side Effects of Zofran

Zofran has side effects, including the following:

  • Diarrhea
  • Headache
  • Fever
  • Dizziness
  • Sleepiness
  • Constipation
  • Rash
  • Blurred vision
  • Muscle spasms
  • Accelerated heartbeat
  • Rash
  • Weakness

Severe Side Effects of Zofran

The common side effects above are not usually life- threatening.  However, Zofran has also been shown to have more serious consequences that include:

  • Abnormal heart electrical signals
  • Abnormal liver function tests
  • Abnormally low blood pressure
  • Acute liver failure
  • Bronchospasm
  • Decreased oxygen in the tissues or blood
  • Extrapyramidal reaction
  • Fast heartbeat
  • Giant hives
  • Life-threatening allergic reaction
  • Prolonged q-t interval on ekg
  • Shock
  • Slow heartbeat
  • Stevens-Johnson syndrome
  • Temporary blindness
  • Toxic epidermal necrolysis
  • Trouble breathing
  • Very rapid heartbeat – Torsades de pointes
  • Vocal cord swelling

Drug Interactions With Zofran

In addition to causing sometimes-severe side effects, Zofran is known to have negative interactions with other prescription drugs and common supplements.  These include medications for

  • Breathing problems
  • Cancer
  • Chest pain
  • Depression or other mental or mood problems
  • Fluid retention
  • High blood pressure
  • Immune system suppression
  • Infections
  • Irregular heartbeat
  • Nausea or vomiting
  • Pain
  • Sleep problems
  • Stomach or bowel problems
  • Swelling
  • Tourette syndrome

In addition to being used for nausea and vomiting after chemotherapy, radiation treatments or surgery, Zofran is also used off-label to treat severe morning sickness in pregnant women.  This use of the drug has been controversial, and we will discuss issues related to off-label use in future blog posts.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

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

 

Whistleblowers Receive $168 Million

In one of the largest payouts in history, people from three states will be taking home a share of the $167.7 million awarded to whistleblowers for exposing Johnson & Johnson’s use of improper marketing and kickbacks.

$2 Billion Settlement

SettlementIn a press conference yesterday, Attorney General Eric Holder told reporters that Johnson & Johnson (J&J) and three of its subsidiaries reached an agreement to pay more than $2.2 billion to resolve criminal and civil claims. J&J was accused of marketing prescription drugs for uses that were never approved and paying kickbacks to physicians, pharmacies, and nursing homes.

The settlement agreements with the U.S. Department of Justice and 45 states involve J&J’s anti-psychotic drugs Risperdal and Invega, and the heart failure drug Natrecor. J&J subsidiary, Janssen Pharmaceuticals, admitted in a criminal plea agreement that it promoted the off-label use Risperdal to health care providers for the treatment of elderly patients who suffered from dementia, even though the drug was only approved to treat schizophrenia.

Risperdal

Risperdal has many serious side effects, including tardive dyskinesia (drug-induced abnormal movements), diabetes, pancreatitis, metabolic disorders, and gynecomastia (abnormal breast tissue growth in boys). The off-label use of Risperdal and other anti-psychotics to deal with challenging nursing home patients and children with ADHD or other behavior disorders has been referred to as a “chemical lobotomy.”

“[T]hese companies lined their pockets at the expense of American taxpayers, patients, and the private insurance industry,” said Holder. He went on to say that J&J’s alleged conduct “…recklessly put at risk the health of some of the most vulnerable members of our society – including young children, the elderly, and the disabled.”

Johnson & Johnson was quick to assuage shareholder anxieties, telling investors through a press release that the settlement was not an admission of any liability or wrongdoing and that the company denies the government’s civil allegations.

In a separate matter, a three-judge panel recently ruled that a whistleblower case against J&J and its subsidiary Ehicon could proceed. Joel Lippman, former vice president of clinical trials for J&J’s unit Ethicon, claims he was fired in 2006 for raising concerns about the safety and effectiveness of the Ortho-Evra birth control patch and other products.

Whistleblowing claims

The False Claims Act (FCA), 31 U.S.C. §§ 3729 – 3733 allows any person (called a “relator”) to bring a claim alleging fraud on behalf of the government. The act of filing such actions is known in the legal community as qui tam, but is commonly referred to as “whistleblowing.” Persons filing whistleblower claims usually receive about 15-25 percent of any recovered damages, but that amount may be higher or lower depending on specific circumstances.

Whistleblowing claims may also be filed under numerous other acts. For example, OSHA’s Whistleblower Protection Program enforces the whistleblower provisions of more than twenty whistleblower statutes protecting employees who report violations of various workplace safety, airline, commercial motor carrier, consumer product, environmental, financial reform, food safety, health insurance reform, motor vehicle safety, nuclear, pipeline, public transportation agency, railroad, maritime, and securities laws.

The statute of limitations on such claims can be as little as 30 days. Therefore, in order to preserve your claim, it is important to contact a qualified attorney and file a claim with OSHA as soon as possible.

 

Sources:

$168 million payout to Johnson & Johnson whistleblowers” by Gregory Wallace, Money CNN, November 4, 2013.

J.&J. to Pay $2.2 Billion in Risperdal Settlement” by Katie Thomas, New York Times, November 4, 2013.

Additional documents and resources relating to the civil and criminal allegations are available on the U.S. Department of Justice website.

What is off-label drug use?

In the United States before a drug is approved by the Food and Drug Administration (FDA), it must undergo extensive testing. These tests, known as clinical trials, are used to determine if a drug safely works the way it is expected, to treat a specific medical condition. Once the FDA is satisfied that the drug works and is safe, a “drug label” is created.

This drug label isn’t the actual label placed on the bottle, but one that is made available to all health professionals who sell or prescribe the medication. It indicates how a drug is to be given, including dosing information and the medical conditions for which it was approved. 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. This may involve differences in dosage, the medical condition the drug is used to treat, or how it is given (route.)

Legal Concerns

Aside from some controlled substances, doctors may legally prescribe drugs in a manner inconsistent with the drug label. However, there are rules prohibiting drugmakers from marketing their drugs to treat conditions not approved by the FDA.

Recent federal and state lawsuits claimed that pharmaceutical company Abbott Laboratories marketed its drug, Depakote, for off-label uses. Depakote, an anti-seizure and mood-stabilizing drug, is approved by the FDA to treat epilepsy, bipolar disorder and to prevent migraines. Earlier this year, Abbott said it will pay $1.6 billion to settle allegations that it improperly marketed the powerful neurological medication for off-label uses. Depakote has also been linked to serious birth defects when taken by pregnant women.

The FDA has ramped up its investigation of off-label drug marketing, resulting in enormous settlements from drug makers.

  • GlaxoSmithKline paid $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others, including Paxil, Wellbutrin, Advair, Lamictal and Zofran
  • Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra
  • Eli Lilly & Co. settled for $1.4 billion for Zyprexa, used to treat schizophrenia.

What this means to you

When your doctor prescribes a medication, be sure to ask if the treatment is consistent with the drug label.  If it isn’t, find out about the risks and benefits, if there is evidence to support the drug’s off-label use to treat your medical condition, and if off-label use will affect your insurance coverage.