The Food and Drug Administration (FDA) has declared that those without a gallbladder should not use the drug, Viberzi. The medication is used to treat Irritable Bowel Syndrome (IBS) with diarrhea. IBS is essentially the contracting of the large intestine, which causes a number of symptoms, such as cramping, pain, and gas, among others. Millions of people suffer from IBS in the United States, but its underlying cause is unknown. Viberzi treats IBS by lowering the number of these contractions, which in turn relives symptoms and improves stool consistency.

However, instead of easing the symptoms of IBS in those without a gallbladder, Viberzi has potentially dangerous side effects. The FDA’s interest in the drug peaked when two gallbladder-less patients died from taking the medication. They died from different, yet interrelated causes. One of the two was afflicted with pancreatitis, or inflammation of the pancreas. The pancreas is an organ that produces hormones in order to help break down sugars going through the digestive system, and it is located proximate to the gallbladder. Coincidentally, those who were at high risk of developing pancreatitis were excluded from clinical trials.

The second of the two patients who died was stricken with spasms from their Sphincter of Oddi (Oddi) and died from complications. Oddi is a muscular valve that connects the duodenum to both the gallbladder and the pancreas and controls the flow of gastric juices and hormones between the two sections. During clinical trials, 8 cases of Oddi contractions were reported, and they were all in patients who did not have gallbladders. It is thought that the contractions of Oddi are the cause of pancreatitis, in this case. Patients who suffered from this were seemingly at a higher risk of developing the inflammation.

Pancreatitis is a common complication Viberzi users face, with 120 cases or deaths reported to the FDA. 118 cases of pancreatitis were reported to the FDA as of February 2017, in addition to the two aforementioned deaths. Of those 120, 68 reported “gallbladder status”, and of those 68, 56 did not have a gallbladder, which shows a strong correlation. Disturbingly, symptoms of pancreatitis, such as stomach pain and vomiting, developed in patients after only a dose or two of Viberzi.

Despite the fact that Viberzi’s label suggests patients without gallbladders should not take the drug, this idea seemingly was alleged to have not been placed at the forefront by its manufacturer, Allergen. Most patients just took a smaller dosage (75mg).

The FDA is working to address all safety concerns.

Actemra is a drug used to treat rheumatoid arthritis, which affects 1.5 million Americans. It can be taken via injection or intravenously. With 760,000 patients worldwide, one would expect the drug to be safe; however, post-clinical studies have found that Actemra can lead to the following noxious side effects:

  • Heart attack
  • Heart failure
  • Lung Complications
  • Death

Actemra is a product of Roche Holding AG and its subsidiary Genentech. They made $1.6 billion off of Actemra in 2016.

The side effects in and of themselves are not usual for an arthritis drug such as this, although some appear at a higher rate. What is alarming is that none of these side effects are listed on the drug’s warning label.

Actemra was approved for general use in 2010, but as reported by STAT, the long-term repercussions of use were not properly studied. These lethal issues came into the public eye in a variety of ways. In one instance, 13,500 cases of the aforementioned effects were reported to Advera Health Analytics through their online initiative, the FDA Adverse Effects Reporting System (FAERS). This is meant to track developments that were not discovered during clinical trials. It found that Actemra patients suffered similar side effects than those taking Humira and other arteritis medications, but many of those were not currently on the drug’s label.

That being said, Actemra may cause cardiovascular disease more than its competitors, as shown by recent studies, but still does not warn patients at all about such potential risk.  Similarly, the rare disease, Pancreatitis, or inflation of the pancreas, appeared in many Actemra patients due to the drug increasing the user’s lipid count, according to post-clinical studies.

Despite the newly discovered facts, the FDA is having a hard time getting the warnings added to the label. This is because they require more evidence than is presented in these studies.

The story of Actemra is analogous to another arteritis drug, Vioxx, which was pulled from the market. Both of the drugs had long-term side effects that were not properly studied during trials and ended with many people getting hurt from those they did not know even existed. Other arteritis drugs have had their effects extensively studied, like Humira, and they appear on its label.

It is important to note that these known cases were either reported to the FDA or an outside source, like FAERS. There are likely many more, different complications that have never been reported, and the ones mentioned may occur at greater rates.

 

Abbvie Pharmaceuticals was ordered to pay out $150 million by a federal court in Illinois for misrepresenting their drug, AndroGel. The medication is meant to treat low testosterone (Low-T) in middle age and older men.

The jury found that Abbvie created a false narrative around the condition, going as far as essentially making it up, in order to profit off of the ignorance of their customers. However, the company was not found guilty of causing adverse effects, like the heart attack the plaintiff had while taking to drug. They verdict was made up of only punitive damages and not compensatory damages.

AndroGel and other Low-T drugs can be taken in many forms, including:

  • Gel (as the name would imply)
  • Injection
  • Pellets
  • Patches

AndroGel is only approved for treating hypogonadism, which is condition that causes the body to produce lower-than-normal levels of testosterone. Over the years, it has made Low-T synonymous with aging, meaning any man can potentially take these drugs. In this sense, the condition being treated is made up in most situations.

Abbvie has done this in several ways. One way is simply having doctors not check the patient for hypogonadism; they may not even be aware of the requirement. Hypogonadism can be found through a routine blood test. ¼ of all AndroGel users never had the test done, and ½ of those taking the drug were not diagnosed with it in the first place.

Another example would be Abbvie’s website, which contains a self-diagnosis test with overly broad questions, like “Are you tired?” or “Are you grumpy?” These questions could apply to nearly everyone. Yet, the website will suggest that the test taker should pursue testosterone treatment. This greatly expands their customer base.

Although the recent verdict did not find Abbvie guilty of causing the man’s heart attack, they still have a long, unsound relationship with the FDA. AndroGel was found to increase the chance of heart attack or stroke in their otherwise healthy patients, and they found it doubled the chance in those taking the drug with a heart condition.

These findings are even more startling, given the fact that the effects were studied only three months into therapy. As a result, the FDA ordered Abbvie to place warnings for heart attack and stroke on their label in March, 2015. The manufacturer was urged to put a warning for an increased risk of blood clots after the correlation was found in a study, too.

The recent verdict was issued for what is known as a bellwether trial. This is a trial used to assess the likelihood of the verdict for the class action suit and gives the two sides the option to settle. There are currently 6,000 plaintiffs in the class action consolidated in Chicago. Abbvie will likely appeal the decision, but the verdict should give them a bleak outlook for minimizing exposure in future cases.

In order to control their blood sugar levels, some diabetics use Invokana, the better-known name of the chemical canagliflozin. It is a sodium-glucose cotransporter-2. The drug functions as a cell function inhibitor. To lower the body’s blood sugar levels, Invokana helps the kidneys to reabsorb glucose in the blood stream. It is removed from the body as urine. Although this might sound harmless, Invokana has been linked to many serious health problems. These include:

  • Urinary Tract Infections (UTIs)
  • Renal issues, such as kidney failure and kidney stones
  • Ketoacidosis (acidification of the blood stream)
  • Brittle bones
  • Amputation due to lack of blood flow
  • Heart attack
  • Death

Jansen Health, a subsidiary of Johnson & Johnson, manufactures Invokana, which

really shouldn’t come as any surprise given the substantial continuing legal troubles Johnson & Johnson have found themselves in over the past 18 months.  See here.

Doctors and health officials alike has disavowed Invokana. Dr. Sydney Wolfe testified before Congress about the dangers of Invokana and how its clinical trials were misrepresented in order to gain FDA approval in early 2013. He is the cofounder of the Public Citizen advocacy and lobbying group. The advocates renounced the drug further, calling for it to be pulled from the market in 2015. (Read more about it HERE.) Public Citizen has over 350,000 members nationwide and has successfully gotten additional warnings on drugs or had them pulled from the market due to dangerous side effects.

The FDA and Invokana have a long history together. Since being approved, the FDA has added the following adverse effects to the drug’s label:

  • May 2015: Invokana must warn patients about the increased risk of ketoacidosis on their label. Type 2 diabetics are twice as likely to develop this. It was also given a “black box” label, the most serious warning the FDA can place on a product because of newfound data showing that Invokana increased the risk of limb amputation.
  • September 2015: Invokana must warn patients about the increased risk of bone weakening on their label.
  • December 2015: Invokana must warn patients about the increased risk of UTIs and diabetic ketoacidosis on their label.
  • June 2016: Invokana must warn patients about the increased risk of renal problems, such as kidney stones, on their label.

One can only ask themselves, what’s the next warning on the horizon with this drug?

xarelto lawyer If one were to watch or read an advertisement for Xarelto, one would likely think it perfectly safe to use for various medical applications. These would include:

  • Blood thinning, including clotting prevention
  • Stroke prevention
  • Systemic and pulmonary embolism prevention
  • Deep vein thrombosis prevention

Xarelto is manufactured by Jenssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Bayer Health.

Yet, the drug’s primary use is for blood thinning, and there are still many issues associated with this function. Blood thinners make it difficult for the body to clot in the event of a large wound, so one would, if using a blood thinner, continue to bleed until they ran out of blood.

Competitors, such as Warfarin, remedy this potentially fatal flaw by recommending the administering of vitamin K to the effected patient. However, there are no antidotes like this for Xarelto. This means that if a user suffers an injury where they would lose a great deal of blood, they have an increased likelihood of death.

Ironically, Xarelto launched a massive marketing campaign where it stated that it was a superior alternative to Warfarin and other well-known anticoagulants.

Apart from this gruesome error, Xarelto has been linked to the following potentially deadly side effects:

  • Stroke
  • GI tract bleeding
  • Hemorrhaging

Most other blood thinners require that the user take periodic blood tests to make sure that the drug is working like it should be. This is not the case with Xarelto, which is contributing factor to the abundance of the aforementioned effects.

The FDA was alerted to this very important fault. Since then, Xarelto’s producers have added warnings regarding these deadly potential side effects and its issues with thinning blood, but there remains concern that the manufacturers have failed to do any additional testing and have continued advertising the drug.

Many lawsuits versus Jenssen and Bayer are already under way. There are approximately 18,000 lawsuits pending in federal and state courts around the country. Two of these cases, Walsh v. Janssen Research & Development LLC et al and Roman v. Janssen Research & Development LLC et al., have both been won in the manufacturers’ favor in the Supreme Court of the State of New York, New York County. Both suits contended that Bayer and Jenssen hid their knowledge of the blood thinning issues due to a lack of clinical trials. Both Walsh and Roman claim that they suffered “life-threatening” bleeding as a result of taking Xarelto.

Another, similar drug, Pradaxa, is facing similar scrutiny for similar reasons, such as their marketing campaign stating Pradaxa is better than its competitors. Boehringer Ingelheim, the manufacturer, has already paid out $650 million in settlements.

Litigation is fully expected to continue against these “newer” anticoagulants.

The US has been hit very hard by the recent opioid crisis. Deaths from opioid-related overdose have quadrupled since 2003, with 33,000 deaths in the nation last year alone. But nowhere in the US has been affected as drastically as Indian Country. To paint a picture, Native American high school students abuse OxyContin at twice the national average. The Cherokee Nation, which, is represented by 14 counties in northeastern Oklahoma, is taking a stand by filling a lawsuit against the US’s top pharmaceutical distributors, following in the footsteps of Ohio and Mississippi, among other states (read about it here). There have been 350 overdose-related deaths in these Oklahoma counties between 2003 and 2015. Cherokee officials knew it was time to take action.

The numbers regarding opioid prevalence in the Cherokee Nation speak for themselves:

  • 845,000,000 million milligrams worth of drugs were distributed to the 14 counties in 2015
  • This means that every opioid addict in the area had roughly 360 to 720 pills
  • 6 percent of American Indian 12th graders have tried heroin, twice the national average

Attorneys representing the Cherokee Nation hope that their lawsuit accomplishes two objectives. Number one, it will compensate those affected by the opioid crisis, as much as a lawsuit can. Financial penalties from these companies will go toward law enforcement costs and reimbursing the child welfare service, which has had to cope with the influx of addicted babies. The money currently being spent by the state could be going towards other families without these issues.

Secondly, the Cherokee Nation’s attorneys hope that the lawsuit will change the behavior of the pharmaceutical distributors named as defendants. These include:

  • Walmart
  • CVS Pharmacies
  • Walgreens

As well as the nation’s three largest distributors:

  • AmerisourceBergen
  • McKesson
  • Cardinal Health

Plaintiffs allege that the named defendants did not take the necessary steps to stop their drugs from getting into the hands of the black market. For example, they turned a blind eye to doctor shopping and filling multiple opioid prescriptions at once, both of which violate the Controlled Substances Act. Distributors should, under the act, file any suspicious activities, such as these, with the federal government. The Cherokee Nation’s attorneys state that the crisis boils down to the simple problem of market oversaturation. There are more drugs, ones that should be rare and difficult to get in the first place, in the market than there should be. They have ignored known issues in their supply chain to get to this point.

Defendants, however, contest that they have done nothing wrong. As Courtney Tobin, a spokesperson for Cardinal Health, puts it:

Cardinal Health is confident that the facts and the law are on our side, and we intend to vigorously defend ourselves,” Tobin wrote. “We believe these lawsuits do not advance the hard work needed to solve the opioid abuse crisis – an epidemic driven by addiction, demand and the diversion of medications for illegitimate use.

All of the defendants who could be reached for comment by The Rolling Stone felt similarly about the case.

The suit was filed in tribal court on April 20th, 2017. While the defense will likely ask the judge to move jurisdiction to a federal court, a tribal court will allow plaintiffs to get access to corporate records sooner.

Like the rest of the country, Wyoming’s Indian population has been hit hard by the opioid epidemic. State officials are sensitive to the issue and have been working to address it. For example, in Fremont County, drop boxes for unneeded drugs can now be found at clinics and city halls. These have been added to combat the spike in opioid overdoses over the last several years and decades.

Fremont County has a large Native American population at 20% and is home to the Wind River Reservation. Learn move about the drop boxes and other initiatives [HERE].

Regardless of the trials outcome, we at the Ochs Law Firm hope for relief and will join the fight for all of those affected by the epidemic in the Cherokee Nation and Wyoming.

wyoming opiate abuse

It happened in the 90’s when state attorney generals across the country were concerned with the costs associated with tobacco use and smoking, and they turned to litigation to help solve the economic drain.  Could the recent AG lawsuits against a variety of opioid manufacturers prove to be similar?

I read with great curiosity when on May 31, 2017, the Ohio Attorney General, Mike Dewine, filed a  lawsuit against  against five opioid painkiller manufacturers.

The lawsuit accused the drug makers of misrepresenting the addiction risks associated with the powerful pills, and further pointed the finger at the misrepresentation as being the cause of the nationwide epidemic of opioid addiction and death.

The Washing Post reported that Mr. DeWine brought his case in an Ohio state court, choosing his venue the courthouse in Chillicothe, a small city whose struggle with the addiction crisis was the subject of a report by The Post’s Joel Achenbach.  Read the Washington Post story here.

With the news of the lawsuit, and having read the complaint and being astounded by some of the statistical allegations contained therein, I set off to research whether my home state of Wyoming had a same or similar problem, at least statistically.

This is what I found nationally:

  1.  Almost 2 million Americans abused or were dependent on prescription opioids in 2014.
  2. 91 Americans die every day from an opioid overdose (including prescription opioids and heroin).
  3. Since 1999 the amount of prescription opioids sold in the United States has nearly quadrupled.
  4. Most people who abuse prescription opioids get them for free from a friend or a relative.

See here.

Looking at Ohio as the baseline since they were the first to file, in Ohio:

5.4% of the prescription claims made in Ohio are opioid claims.

Total Opioid Claims: 4,559,597 
Total Claims: 84,350,475
Providers: 52,848 

How does Wyoming compare to Ohio?

5.2% of the prescription claims made in Wyoming are opioid claims.

Total Opioid Claims: 92,917 
Total Claims: 1,786,399
Providers: 1,816 

Wyoming Opiate Facts (per the Wyoming RX Abuse Stake Holders):
  1. Deaths related to prescription drug overdose has increased five times from 2004-2005 to 2014-2015.
  2. Wyoming ranks 23rd for age adjusted drug overdose deaths in the United States with 16.4 deaths per 100,000.
  3.  As of 2013, cocaine and other opiates were the primary substance of abuse for people 12 years of age and older in the years spanning 2002-2012 according to the Center for Behavioral Health Statistics and Quality, SAMHSA.
  4. In 2014-2015, there were 96 deaths with prescription drugs as a contributing cause of death.
Wyoming appears to have the same epidemic problem as many other states, and the statistics support a worsening problem.  The costs are substantial to the tax-payer for Medicaid, unpaid medical bills, and even Department of Family Services and the related court costs associated with so many child neglect cases related to opiate abuse.  Wyoming should join the fray and seek to recover these enormous costs from the drug makers.
Punitive verdicts across the country against J&J
Punitive verdicts across the country against J&J

In a continued effort to bring to you updates in regards to what we have previously blogged could very well be a record-setting-year for Johnson & Johnson with respect to jury verdicts, we wanted to report the latest in our series.

This past week on May 26th, a Philadelphia jury awarded $2.1 million to a woman who suffered serious complications after having an Ethicon (Johnson & Johnson) Gynecare Prolift mesh device surgically inserted.

The verdict is the fourth such verdict in a row against Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit.

Prolift mesh was used to treat stress urinary incontinence and pelvic organ prolapse suffered by the Plaintiff.  She asserted at trial that the mesh had eroded into her private areas resulting in permanent complications.  The jury deliberated for approximately nine hours before coming to a decision.

The verdict follows a $20 million, $12.5 million and $13.5 million decision in Pennsylvania against Johnson & Johnson and Ethicon, all related to transvaginal mesh.

Our blog will continue to update with additional J&J news, especially as we are closely watching the Xarelto trial that just began against Johnson & Johnson in Florida this past week.

pancreatitis painThe Food and Drug Administration has issued a safety alert warning of the increased risk of pancreatitis in patients taking the irritable-bowel syndrome (IBS) drug Verbizi (eluxadoline).

Verbizi is most often prescribed for IBS with diarrhea in both men and women.  The drug is relatively new with FDA approval occurring in May 2015.

The FDA warned that the drug should not be taken by patients who do not have a gallbladder.  The FDA warning states that an FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, the FDA advises that they are working with the Viberzi manufacturer, Allergan, to address the safety concerns.

The FDA advised Health care professionals to not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients.

The FDA further advised that hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder.

Pancreatitis is the inflammation of the pancreas.  The pancreas helps to regulate how the body processes sugar.

Mild cases of pancreatitis can resolve without medical intervention, however severe bouts of pancreatitis can be life-threatening.  Learn more about pancreatitis here.

See the full FDA alert here.

invokanaThe US Food and Drug Administration has issued a warning regarding the relatively new diabetes 2 drug most notably known as Invokana regarding leg and toe amputations.

The warning states:

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

The FDA further advises that anyone taking the medication consult with their doctor immediately should they experience any pain or tenderness, sores, ulcers or infections in the lower limbs.  They do not recommend stopping the medication without first consulting with a physician or other healthcare provider.

Healthcare professionals are advised to consider any factors that may predispose a patient to amputations before starting the medication, which may include issues such as:

  • Any prior amputations
  • Peripheral vascular disease
  • Neuropathy
  • Diabetic ulcers in the feet

The two clinical trials referenced in the FDA safety announcement include results from the Canagliflozin Cardiovascular Assessment Study (CANVAS) and A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R).  Both studies published findings that indicated “leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment.  The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

  • 9 out of every 1,000 patients treated with canagliflozin
  • 8 out of every 1,000 patients treated with placebo

The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

  • 5 out of every 1,000 patients treated with canagliflozin
  • 2 out of every 1,000 patients treated with placebo”

The most common amputations were of toe or middle foot but also included the leg and knee areas.  Some patients required amputations involving more than one area, or more than one surgery.