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Recent studies suggest a common type of heartburn medication called proton pump inhibitors (PPIs) are linked to increased risks of chronic kidney disease. This class of drugs includes popular brands such as Prilosec, Nexium and Prevacid.

In February of 2016, the Journal of the American Medical Association (JAMA) published results of a study showing that people who take Prilosec and other Proton Pump Inhibitor (PPI) medications may have a 20 to 50 percent increased risk of chronic kidney disease. The study indicates that the longer the medication is taken, the greater the risk.

Researchers found the risk of end-stage kidney failure is 96 percent higher for those taking PPIs, particularly those using the drugs for many months or years. Some experts are calling the increase of kidney issues in the American public an “epidemic.”

An estimated 15 million Americans were prescribed PPIs in 2013 at a cost of more than $10 billlion. However, the number of those at risk of health problems is likely to be much higher because most of these drugs, including Prilosec, Nexium, and Prevacid, are now available over-the-counter.

Lawsuits filed against PPI manufacturers such as AstraZeneca claim the companies have failed to provide adequate warnings about the risks their product presents. The Prilosec lawsuit claims allege companies knowingly hid dangers of their medications from the public. The uncovered kidney damage risks could affect thousands of Americans.

AstraZeneca has faced legal issues in the past. In fact, the company settled a $20 million class action lawsuit related to deceptive marketing of Nexium. The lawsuit claimed the drug company “defrauded” consumers with dishonest advertising. Prilosec Lawsuit Settlements are now being considered.


Prilosec Lawsuit & PPI Warnings


The recent study’s results indicate that the longer PPIs like Prilosec are taken, the greater the risk to the patient. Heavy use in a short amount of time can also be dangerous. Patients who take the medication more than once per day face a greater risk.

This information is based on a number of broad studies. Researchers in one study examined the records of more than 248,000 people treated in a Pennsylvania hospital system.

In another study, assessing the safety of these medications, researchers analyzed information from the Department of Veterans Affairs national databases.

After identifying over 170,000 new users of PPIs, they compared them to over 20,000 new users of histamine H2 receptor blockers, an alternative class of drugs also used to suppress stomach acid. Over five years of follow-up, results showed that 15 percent of people using PPIs were diagnosed with chronic kidney disease. After controlling for other factors, this translated to a 28 percent increased risk of developing kidney disease for PPI users.


PPI Side Effects & Complications


Even before recent damaging information came to light, PPIs were associated with short-term kidney problems like acute kidney injury and an inflammatory kidney disease called acute interstitial nephritis.

In one study at Johns Hopkins University, over 10,000 adults with normal kidney function were monitored from 1996 to 2011. They found that PPI users were between 20 and 50 percent more likely to develop chronic kidney disease than non-PPI users.

This discovery was mirrored in a second study, in which over 240,000 patients were followed from 1997 to 2014. One out of four of the kidney patients had been previously treated using a PPI.

In both studies, people who used a different class of medications to suppress stomach acid, such as H2-blockers, did not share the same risk of developing kidney disease. Also, among the total group of patients, PPI use was linked to a 76 percent increased risk of dying prematurely.


PPI Overuse & Prilosec Injury


All the new research indicates long-term use of this class of medication used to treat heartburn, acid reflux, and ulcers may lead to an increased risk of kidney disease and kidney failure.

The results of the most recent study highlight that patients should use PPIs “only when it is medically necessary,” and should limit duration of exposure to the minimum necessary to treat their medical condition.

The lead author of the JAMA study states, “Patients should only use PPIs for FDA-approved indications, and not to treat simple heartburn.” The study concluded that, “It is very reasonable to assume that PPIs themselves can cause chronic kidney disease.”

Gastroenterologists are already cautious in prescribing PPIs, as they’ve been linked to other health problems, including bone fractures and an increased risk of infections like C. difficile. Doctors and experts are concerned that many people continue to use the drugs long after symptoms subside, largely because they are so readily available over-the-counter.

Typically, doctors recommend patients with acute symptoms take the drugs for two weeks, while those with more substantial symptoms may need them for six to eight weeks followed by a reassessment. Some Prilosec Lawsuit files suggest doctors are recklessly prescribing PPIs.

Dr. Arora, whose team completed a seven-year study of PPIs, says that PPIs are often “prescribed outside of their approved uses.” Studies have shown that as many as 70 percent of those people don’t need the drugs, and 25 percent who use them on a long-term basis could stop without developing symptoms.


What is Prilosec?


Prilosec, produced by AstraZeneca, was the first FDA approved Proton Pump Inhibitor (PPI), marketed to treat gastroesphageal reflux disease (GERD) and peptic ulcer disease (PUD).

It is estimated that the company’s sale proceeds from Prilosec topped $6 billion by the year 2000. Up to 14 percent of adults in the U.S. have been prescribed Prilosec or other PPI medications, and many more may have taken over-the-counter medicines as well.

In 2001, when Prilosec’s patent expired, AstraZeneca introduced a similar PPI drug called Nexium. Shortly after, in 2003, Prilosec became available over-the-counter. Most of the popular PPI medications, including Prilosec, Nexium and Prevacid, are now available over-the-counter.


PPIs Heavily Overprescribed


Researchers suggest that PPIs are heavily overprescribed. In one recent study, as many as 80 percent of patients prescribed PPIs had no “valid documented indications” of having true gastroesophageal reflux disease (GERD).

According to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, almost 20 percent of adult Americans have been diagnosed with GERD or Peptic Ulcer Disease.

There are a number of treatment options for GERD, yet by all measures, prescriptions for proton pump inhibitors have overshadowed all other acid inhibiting agents. PPI drugs like Zantac, Nexium, Prilosec and Prevacid now account for over 90 percent of the market share.


PPI Medication Risks


The PPI group of medications now includes nine drugs, including the following:

  • Prevacid
  • Prilosec
  • Nexium
  • Protonix
  • Aciphex
  • Zegerid
  • Dexilent
  • Kapidex

FDA Prilosec Warnings


Concerns about the safety of Prilosec emerged as early as 2002. Recent results of studies are even more troubling as they have shown the risk in the consumer population may worsen over time.

  • Bone Fractures: A 2006 study published in the Journal of American Medical Association (JAMA) showed that long-term Prilosec use increased the risk of hip fractures, particularly in the elderly. In 2010, the FDA echoed a prior warning, and issued a new warning to consumers, stating that Prilosec may cause an increased risk in bone fractures.
  • Dependency: In 2009, a Danish study showed that Prilosec use may lead to a dependency on the medication due to a “rebound” effect of stomach acid if a patient stops taking the medication. The study had concerns with a number of patients experiencing a “withdrawal” from the drug.
  • Blood Issues: In 2011, the FDA issued another warning, this time regarding the long-term risk of Prilosec causing hypomagnesemia. Such low magnesium levels in the blood may cause neurological, muscular, and cardiac effects.

PPI Chronic Kidney Disease


According to the American Society of Nephrology, chronic kidney disease is increasing in the United States. More than 20 million Americans, or more than 13 percent, are now affected by the disease, which also can lead to cardiovascular problems and greater than normal risk of death.

Chronic Kidney Disease, also known as chronic renal failure, occurs when long-term damage is done to the kidneys, reducing the ability to filter toxins and metabolic products from the bloodstream. The kidneys become damaged and they are unable to filter blood as they should. Diabetes and high blood pressure are two common risk factors for kidney disease.

Chronic kidney disease can lead to total kidney failure and the need for dialysis or a kidney transplant. Chronic kidney failure is progressive and will get worse over time. Symptoms of kidney failure should be reported to a medical professional. Chronic Kidney Disease may present with symptoms such as:

  • Swelling
  • Fluid in lungs
  • Arrhythmia
  • Hypertension
  • Electrolyte abnormalities
  • Nausea and Vomiting
  • Loss of Appetite
  • Inability to urinate
  • Fatigue

Prilosec Risks & Side Effects


Several safety concerns have been identified over the years. In 2015, one study indicated that PPI drugs may increase the heart attack risk by up to 21 percent, even if the patients had no history of heart disease. Side Effects of PPI drugs can include:

  • Pain in joints or muscles
  • Headaches
  • Intestinal disruption
  • Nausea
  • Rashes
  • Anxiety

More serious adverse events may include:

  • Heart attack
  • Liver failure
  • Hypomagnesemia (low magnesium levels)
  • Osteoporosis and bone fractures
  • Liver toxicity
  • Cardiac issues

Prilosec Lawsuit Settlements


Although modern medicine seems like the best option to treat uncomfortable symptoms, patients should take steps to ease heartburn-related symptoms through lifestyle changes. This can be as simple as diet change. Losing weight, avoiding high-fat foods and avoiding eating late at night can be very helpful.

It is also worth noting that medications such as Zantac and Pepcid, which combat heartburn by blocking histamine production, do not appear to cause similar issues. PPI medications affect the body and treat symptoms differently than other antacid or anti-ulcer drugs. Experts urge patients and clinicians to discuss the “potential alternative regimens” before riskier drugs like Prilosec are prescribed.

There are safer ways to control unpleasant symptoms of heartburn, acid reflux, and ulcers. The most logical place to start is to utilize less-severe methods to control the issue. Doctors say lifestyle changes like diet changes and weight loss should be the first considerations.

There are also effective, less expensive, safer drugs available, such as antacids and H2 blockers which are not correlated to high rates of kidney damage. If the alternatives are not effective, and a person does have a prescription for a PPI, it should be used sparingly and only taken for a short period of time.

Consumers should be wary of this new information, and contact a heartburn drug injury lawyer following kidney issues.  Given the widespread use of these drugs, even a small increased risk of medical issues could have a considerable impact on public health.

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A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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