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.

 

 

 

FDA Issues Warning for Low-T Users

Last year, we told you about an alarming new trend: doctors prescribing testosterone replacement therapy for men who may not need it. Now, the FDA has announced that prescription testosterone products are only approved for the treatment of specific medical conditions, not for low testosterone levels due to aging. Additionally, manufacturers of all low-T medications must update their labels to include information about the possible increased risk of heart attack and stroke.

Testosterone medications linked to cardiac eventsIn 2014, consumer watch group Public Citizen petitioned the Food and Drug Administration (FDA) to add a Boxed Warning to all testosterone medications and require manufacturers to inform patients about the increased risks of heart attacks and other cardiac events. Also referred to as a “black box” warning, this type of labeling is only issued when a drug carries a significant risk of serious or life-threatening adverse effects.

Based on evidence from several studies and expert input from an Advisory Committee meeting, the FDA issued a statement in March 2015, requiring manufacturers of prescription testosterone products to change their labeling to clarify the approved uses. Manufacturers must also add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.

According to FDA officials, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

Testosterone is a male hormone, which is produced in the testicles and regulated by glands in the brain. Low testosterone, also known as androgen deficiency or hypogonadism, can result from problems in the testicles or the brain. This is different from the normal decrease in testosterone levels in men over 30, which is a normal part of the aging process and does not necessarily require treatment.

Benzodiazepines Linked to Alzheimer’s Disease

Most of us take medications knowing there is a risk of side effects, but that risk is small, right? Surely the FDA ensures the health benefits outweigh these minor inconveniences, right? But what if I told you that if your grandmother took a sleeping pill, she’d be 50% more likely to develop Alzheimer’s disease? Do I have your attention now?

Benzodiazepines linked to Alzheimer's Disease.A study published in the British Journal of Medicine has yielded some startling results. Researchers found that for older adults who took benzodiazepines for at least 90 days, the risk of developing Alzheimer’s disease was increased by 43% to 51% during a five year period.

The study also revealed that people who were on a long-acting benzodiazepine like diazepam (Valium) and flurazepam (Dalmane) were at greater risk than those on a short-acting one like triazolam (Halcion), lorazepam (Ativan), alprazolam (Xanax), and temazepam (Restoril).

What are Benzodiazepines?

Benzodiazepines are a class drugs used to treat anxiety, insomnia, and a range of other conditions. Commonly known as tranquilizers, these medications act directly on the brain and central nervous system, affecting a person’s mood. They are one of the most widely prescribed medications in the U.S., particularly among elderly patients. Benzos are commonly divided in groups:

Short-acting anti-anxiety benzodiazepines

  • alprazolam (Xanax)
  • lorazepam (Ativan)
  • oxazepam (Seresta)
  • diazepam (Valium)

Longer-acting anti-seizure and “hypnotic” drugs frequently used to treat insomnia:

  • clonazepam (Klonopin)
  • flurazepam (Dalmane)midazolam (Versed)
  • nitrazepam (Mogadon)
  • temazepam (Restoril)
  • triazolam (Halcion)

The authors of the study warn that doctors should “carefully balance the benefits and risks when initiating or renewing a treatment with benzodiazepines and related products in older patients.” Although the study only included elderly patients, it is important for people of all ages to discuss the use of benzodiazepines with their health care provider.

Other Risks

It is important to note that benzodiazepines may pose other serious risks for seniors. In 2012, the American Geriatrics Society added benzodiazepines to their list of Potentially Inappropriate Medication Use in Older Adults. The group warned that an increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents could pose serious dangers, stating, “In general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults.”

Source:

de Gage, S.B., Moride, Y., Ducruet, T., et al. Benzodiazepine use and risk of Alzheimer’s disease: case-control study. BMJ 2014; 349:g5205. Published September 9, 2014. Accessed October 29, 2014.

Xarelto: Is it the next Pradaxa?

Are the new blood thinners safe?After the recent multi-million dollar Pradaxa lawsuit settlement, patients who suffered a bleeding injury while taking the anticoagulant Xarelto may wonder if they have a legal claim.

For more than 50 years, patients with an abnormal heart rhythm known as nonvalvular atrial fibrillation (AFib not due to valve problems) used a blood thinner called warfarin  to reduce the risk of stroke. While effective, patients taking warfarin had to undergo extensive monitoring to insure safe administration of the medication.

In recent years, a number of new oral anticoagulants (NOACs) have hit the market, each promising to provide the same health benefits—but without the testing required by warfarin (Coumadin). However, unlike warfarin, these blood thinners do not have an antidote. Therefore, in cases of severe, sometimes life-threatening bleeding, patients are left to wait until the body slowly filters the drug from their system.


$650 Million Settlement

The first of the new oral anticoagulants to be approved by the FDA was Pradaxa (dabigatran), which subsequently became the subject of over 4,000 lawsuits filed by patients and their families. They claimed the manufacturer failed to warn consumers Pradaxa caused serious and sometimes fatal bleeding that could not easily be reversed. In May of 2014, German drug maker Boehringer Ingleheim agreed to pay $650 million to settle those claims.

Xarelto may cause fatal bleeding

Now another oral anticoagulant, Xarelto (rivaroxaban), has also been linked to serious side effects. A number of lawsuits have been filed, claiming injuries related to the pill involving severe internal bleeding. While Xarelto is not identical to Pradaxa, a recent study concluded patients treated with both NOACs have an increased risk of gastrointestinal bleeding compared to patients treated with warfarin.

The need for anticoagulants is growing. According to the CDC, nearly 3 million Americans suffer from atrial fibrillation, and experts predict the market for blood thinners could soon exceed $10 billion per year. Although a number of NOAC reversal agents are currently in development, they are likely years away from FDA approval. In the meantime, patients and healthcare professionals should carefully weigh the risks and rewards of taking new oral anticoagulants.

Elk & Elk is actively investigating potential Xarelto claims. To learn more, visit our Xarelto Lawsuit webpage.

 

Sources:

Holster IL, Valkhoff  VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology 2013; 145(1):105-112.

Husten, Larry. Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million. Forbes, May 28, 2014.

Jury Awards $9 Billion in Actos Litigation

In one of the largest jury awards in U.S. history, the manufacturers of the diabetes treatment Actos® were ordered to pay $1.5 million in compensatory damages and $9 billion in punitive damages over hidden cancer risks. According to court documents, a federal court jury found that pharmaceutical giants Takeda and Eli Lilly acted with wanton and reckless disregard for patient safety.

Although more lawsuits are pending, the considerable damages are only for a single case, brought by Terrence Allen, a former Actos user who developed bladder cancer after taking Actos. It was the first federal “bellwether” trial of nearly 3,000 lawsuits, which have been filed in the Actos multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. Such cases are commonplace in mass torts involving a dangerous drug or medical device. The verdicts in bellwether cases may be used to determine settlements for other similarly situated plaintiffs.

Learn more about Mass Torts and Class Action Suits.

The federal Actos multidistrict litigation in Louisiana, entitled In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 2299) is comprised of a total of four bellwether trials. The second, originally set to begin on April 14, has been continued. A new trial date has not yet been announced. The third and fourth trials are scheduled to commence on November 3, 2014 and January 12, 2015, respectively.

Nationwide Actos Litigation

Three other juries have deliberated over allegations that Takeda knew Actos could cause bladder cancer and failed to properly warn doctors and consumers about the risks. Bloomberg reports:

Last year, state juries in California and Maryland ordered Takeda to pay a total of $8.2 million in damages to former Actos users. Judges in both states threw out the verdicts. In December, state court jurors in Las Vegas rejected claims the company failed to properly warn consumers about the risks of Actos.

The thousands of plaintiffs who took Actos to treat Type 2 diabetes and developed bladder cancer allege that Takeda downplayed research indicating Actos caused the cancer and that manufacturer Takeda mislead regulators.

Elk & Elk represents a number of clients who were diagnosed with bladder cancer after taking Actos for diabetes and is continuing to accept new cases for review.

If you or someone you know has been taking Actos (pioglitazone) for a year or longer and has been diagnosed with bladder cancer, call the Actos bladder cancer lawyers at Elk & Elk Co., Ltd., at 1-800-ELK-OHIO or fill out our free, no-obligation online contact form.

 

Source:

Takeda, Lilly Jury Awards $9 Billion Over Actos Risks” by Jef Feeley and Kanoko Matsuyama, Bloomberg, April 8, 2014.

Mass Torts and Class Action Suits

Most of the things we purchase are safe. Unfortunately, however, sometimes a defective product, drug, or medical device causes consumers to suffer an injury. In the U.S., when many people are harmed by the same defendant (or group of defendants), depending on the circumstances, individual lawsuits may be grouped together.

Learn the Lingo

 

A tort is a civil wrong that results in injury to someone’s health or property. The person (or corporation) who commits the tort is liable for the harm suffered by the victim.

If a lawsuit is filed, the victim becomes a plaintiff and party sued is the defendant. The plaintiff typically sues the defendant to recover damages (monetary compensation for the plaintiff’s injury).

To begin preparing for trial, both sides engage in discovery – the formal exchange of information between parties about the witnesses and evidence they will present at trial.

Class Action

A Class Action is a type of legal action where a single lawsuit is filed on behalf of an entire group of plaintiffs who share a set of similar circumstances, damages and injuries. These proceedings are designed to cut down on the number of court cases, and occur when each person’s injury is not worth the time and money of hiring an attorney on an individual basis.

A class action lawsuit must meet certain criteria. Members of the class must be notified of the suit and given the change to “opt out” or find their own private counsel. Before filing a class action lawsuit, a motion is filed in court for the lead plaintiff to act on behalf of the group or class.

Mass Tort

In a Mass Tort action, sometimes referred to as Multi District Litigation (MDL), each plaintiff has an individual claim resulting from distinct damages. Although Mass Tort claims also seek to streamline the court schedule, they are handled differently than a Class Action.

In most cases, Mass Tort claims are brought when dangerous drugs or defective products injure a large number of consumers who reside in different states. Since drugs and product defects can cause a wide range of problems for different individuals, their cases rarely fit into a single class.

Mass Tort litigation allows one attorney (or groups of attorneys) to represent several injured parties in individual cases. To speed things along, pretrial investigations conducted by one attorney can be shared among all cases. This permits a nationwide network of lawyers to pool their resources, information and ideas to help secure fair settlements for all plaintiffs. Once the pretrial discovery phase is complete, each case returns to the local court where it was originally filed for trial.

If you have been injured by a defective product, drug, or medical device, you may be entitled to recover money damages. Call 1-800-ELK-OHIO or contact us online to schedule your free consultation.


Judge Fines Pradaxa Drugmaker $1M over Missing Files

German pharmaceutical company Boehringer Ingelheim has been fined $931,000 in federal court for withholding or failing to preserve documents sought by plaintiffs in hundreds of Pradaxa lawsuits.

According to court documents, Boehringer failed to preserve or produce files belonging to a high-level scientist, sales representatives, consultants and others. The drugmaker also failed to provide access to documents on their computer network and allowed text messages to be deleted.

U.S. District Judge David Herndon, overseeing the multidistrict litigation, called the wrongs “egregious in the eyes of the Court.” In his scathing 51-page decision, Herndon ruled that Boehringer executives acted “in bad faith,” calling their defenses unbelievable and “nonsense.”

This was not the first time Boehringer has been sanctioned for failure to comply with a court order during the trial. In his September 18, 2013 decision, Judge Herndon imposed a $29,540.00 fine  – one he thought would remedy the discovery abuses and prevent them from occurring in the future.

The judge’s patience had obviously worn thin as he imposed the nearly $1 million in additional fines on Monday, “Once again, the defendants do not get to choose which evidence they want to produce and from which sources.”

About Pradaxa

The FDA approved the anticoagulant Pradaxa (dabigatran) in 2010 for the prevention of stroke in patients with atrial fibrillation. Just one year later, there were 3,781 reports of serious adverse events, including 542 patient deaths. According to the Institute for Safe Medication Practices, Pradaxa surpassed all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure.

Court records indicate more than 1,700 lawsuits have been filed in the Southern District of Illinois on behalf of alleged victims of Pradaxa bleeding. Boehringer Ingelheim is accused of concealing knowledge about the drug’s risks. Plaintiffs also allege that the company failed to provide adequate warnings regarding the lack of an effective antidote for Pradaxa bleeding.

The case is titled In re Pradaxa Products Liability Litigation, 12-MD-02385-DRH-SCW, U.S. District Court, Southern District of Illinois (East St. Louis). The first bellwether trial in the Pradaxa Multi District Litigation is currently scheduled for August 2014.

 

Source:

“Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files” by Jef Feeley and Phil Milford, Bloomberg News, December 10, 2013.

Some Supplements Too Good to Be True

miracle cure

It seems you can’t turn on the radio without hearing an ad for dietary supplements claiming to help with everything from diabetes to erectile dysfunction. Sometimes scams are obvious, but such a distinction is not always as clear. Advertisements like these can confuse consumers because the Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations than those covering conventional drug products.

Unlike prescription or over-the-counter drugs, dietary supplements are considered food and as such, are not subjected to extensive clinical trials or other strict regulations. In fact, in most cases, manufacturers don’t even need to register their products with FDA or get FDA approval before producing or selling dietary supplements.

DSHEA/FSMA

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to define the term “dietary supplement” and establish a regulatory framework for dietary supplements. Since Congress generally considers dietary ingredients such as herbs, vitamins and minerals to be safe, dietary supplements containing these ingredients are permitted to be freely marketed, just like regular foods. This free market has allowed supplements to evolve into a $5 billion industry with limited regulations.

Under DSHEA:

  • The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.
  • The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

Signed into law by President Obama on January 4, 2011, the FDA Food Safety Modernization Act (FSMA) has been instrumental in FDA’s enforcement actions regarding dietary supplements. However, with no premarket testing, the FDA is still forced to play catch-up after these products are on the shelves or available online.

Beware of Scams

Health fraud scams can do more than waste your money. They can cause serious injury or even death*, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.”

Warning Signs

While the FDA works to recall dangerous supplements, many products remain in the marketplace. The FDA offers these tips to help you identify rip-offs.

  • One product does it all. Be suspicious of products that claim to cure a wide range of diseases.
  • Personal testimonials. Success stories, such as, “It cured my diabetes” or “My tumors are gone,” are easy to make up and are not a substitute for scientific evidence.
  • Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days” or “eliminates skin cancer in days.”
  • “All natural.” Some plants found in nature (such as poisonous mushrooms) can kill when consumed. Moreover, FDA has found numerous products promoted as “all natural” but that contain hidden and dangerously high doses of prescription drug ingredients or even untested active artificial ingredients.
  • “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “scientific breakthrough” or “secret ingredient.” If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals—not buried in print ads, TV infomercials or on Internet sites.
  • Conspiracy theories. Claims like “The pharmaceutical industry and the government are working together to hide information about a miracle cure” are always untrue and unfounded. These statements are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure.

Even with these tips, fraudulent health products are not always easy to spot. If you’re tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first.

 

*A March 2013 Government Accountability Office (GAO) report found that between 2008 & 2011, the FDA received an average of 2,100 dietary supplement adverse event reports a year compared to less than 400 in 2007. The report also suggested that there is underreporting of adverse events to the FDA because consumers and health care practitioners are more likely to call poison control centers than they are to report a problem to the FDA or manufacturer.

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.

FDA Shuts Down Ohio Drug Company

The U.S. Food and Drug Administration (FDA) announced that a federal judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group of Lewis Center, Ohio for manufacturing and labeling violations. The company repackages and distributes drug products to hospitals across the country.

  • A consent decree is a legal agreement between the FDA and a company that has either continually received violations or has significant violations that pose a serious risk to the public. It typically requires a company to cease manufacturing and/or distribution of affected products until proof can be demonstrated to the FDA that appropriate actions have been taken to comply with applicable regulations.
  • A permanent injunction order is typically issued for the purpose of requiring a person or entity to permanently stop acting in a certain manner. A court can also hand down a permanent injunction for the purpose of compelling a party to perform in a certain way.

According to reports, the FDA regulators discovered several prescription drugs had been mislabeled, including Levothyroxine, Diltiazem and Metoclopramide. In one instance, a batch of a drug incorrectly labeled as opiate painkiller morphine was in fact an oral concentrate of opioid painkiller oxycodone, which is approximately 1.5 times more potent than morphine. Shamrock was also found to have violated current good manufacturing practices by failing to have written procedures for repackaging and quality control.

The FDA had performed five comprehensive investigations of the company’s facilities since 2007, including the Lewis Center plant, and a former facility in Massachusetts. Shamrock had been issued several warning letters, but failed to take corrective actions.

“This company continued to distribute mislabeled drugs despite previous warnings by the FDA,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We will take swift, aggressive enforcement action against firms that violate the federal law.”

Shamrock will not be able to resume operations until an independent expert certifies that necessary corrections have been made and the FDA sends written notice that their operations are compliant with all applicable regulations.

“Mislabeled drugs pose a serious risk to patients who rely on labeling to know what they are taking,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These potential risks include overdose, dangerous interactions with other drugs, unnecessary exposure to toxicity, and potential side effects.

 

Source:

“Federal Judge approves consent decree against Shamrock Medical Solutions Group” FDA News Release, September 18, 2013.