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Ohio Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Litigation and drug injury cases
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Spread Awareness of Drug Risks & Outcomes

In 2020, the U.S. Food and Drug Administration posted laboratory results showing N- Nitrosodimethylamine (NDMA) levels in some metformin products approved in the U.S.

FDA has determined that the levels of NDMA in metformin products tested in low levels, although experts are uncertain if long-term exposure to such toxins can lead to cancer.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.The health effects of overexposure to NDMA include jaundice, nausea, fever, vomiting, abdominal cramps and dizziness. High levels of exposure can cause reduced function of the kidneys and lungs, and has been linked to cancer.

Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

FDA plans to post the methods used in laboratory testing of metformin in the near future. FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.

FDA will continue to monitor NDMA in metformin, along with other drugs products, and will provide updates on developments, including product recalls.

Zantac NDMA contamination has also been a source of concern and has led to drug cancer lawsuits.

Joe Lyon is a highly-rated pharmaceutical injury attorney investigating NDMA contamination cancer risks and Metformin injury and complications for injured plaintiffs.

The Lyon Firm works with industry experts to build the strongest case and engage large drug companies following drug defect injury.


Metformin Cancer Risk


Following reports of contamination of N-nitrosodimethylamine (NDMA) in metformin in other countries, the FDA is addressing the levels of NDMA in the nation’s metformin supply. This FDA action follows a recent statement regarding similar NDMA contamination in ranitidine and a recall of generic angiotensin II receptor blockers.

A Metformin recall has not been initiated at this point. As of now, the FDA suggests patients continue taking metformin to keep their diabetes symptoms under control. Metformin is the first-line drug used for high blood sugar levels in type 2 diabetes patients.

Levels of NDMA have been found in metformin supplies in other countries, according to the FDA. The acceptable daily intake limit for NDMA is the U.S. is set at 96 nanograms. Toxic substances like NDMA may increase the risk of cancer if people are exposed to unacceptable levels or have long-term exposure.


Metformin Recall


Most drugs containing Metformin are still on the market, and have not been recalled. However, in Canada and other nations, the  health authorities have taken the step of recalling contaminated Metformin products.

In 2018 the American Diabetes Association (ADA) reported over 34 million Americans, or around 10 percent of the population, had diabetes. The CDC has stated that up to 100 million Americans are living with pre-diabetes. Another 1.5 million diabetes patients are diagnosed each year.

Patients are typically moved onto various diabetes drugs and medications, including inculin, Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT-2 inhibitors. Metformin is used in medication under the brand names Glumetza, Riomet, Fortamet, Glucophage, and Janumet.

According to the Mayo Clinic, metformin is usually one of the first medications prescribed for type 2 diabetes, and is the most extensively used oral therapeutic agent for type 2 diabetes mellitus (T2DM).

The American Diabetes Association and other medical experts recommend it as the first line treatment for T2DM. However, the drug is not without risks. Patients have reported serious health issues and Metformin injury, including kidney disease, and liver damage.

A report published by Diabetes Care analyzed data from several studies and found individuals taking a metformin drug performing significantly worse on cognitive performance tests. Patients with type 2 diabetes performed poorly on cognitive impairment tests, with patient taking metformin performing even worse.

The researchers also found metformin was associated with a vitamin B12 deficiency, potentially linked to the impaired cognitive performance. Metformin has been called a wonder drug in treating type 2 diabetes, and has saved lives, though is not without health risks. The FDA is now investigating whether Metformin is contaminated with cancer-causing contaminants.


Metformin Injury & Complications


Metformin continues to be heavily prescribed, in conjunction with other diabetes medications. Currently, over 150 million people worldwide are using metformin in some form. The most common side effects include gastrointestinal distress, nausea, diarrhea and upper abdominal discomfort. A larger concern is the potential for lactic acidosis, which can be serious.

Metformin may cause lactic acidosis when lactic acid production is high and lactic acid disposal is reduced, such as in cases of circulatory failure, sepsis, and anoxia or hypoxia.

Recent medical studies involving diabetic patients using SGLT-2 inhibitors show patients at an increased risk of lower limb amputation, Fournier’s Gangrene, bone fractures, kidney and liver failure and heart attacks.

The New England Journal of Medicine published a recent report that concludes SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) are associated with approximately twice the risk of diabetic ketoacidosis as DPP4 inhibitors, another option for diabetes patients.

Since two clinical studies demonstrated a link between one SGLT-2 drug, Invokana, and an elevated risk of lower limb amputations, the U.S. Food and Drug Administration (FDA) has advised prescribing doctors to discontinue the medication for patients who experience unusual pain, sores or lower extremity infection.

This class of diabetes drugs is relatively new, but already hundreds of injury claims have been filed against pharmaceutical companies by individual patients. Patients are reporting kidney damage, Fournier’s Gangrene, amputations, ketoacidosis and heart attack events.

Attorneys claim the drug manufacturers involved have failed to properly warn consumers and doctors of the SGLT-2 drug injury risks and failed to properly test the medication before selling it to the public.


What is Diabetes?


Diabetes is a disease described when blood sugar (glucose) levels are too high in an individual. Glucose is generally replenished with foods and beverages a person consumes. Most people consume sugars and their body responds by releasing insulin, a hormone that breaks sugars down into glucose. The glucose becomes a person’s basic energy source.

But patients with diabetes have trouble with this process. With type 1 diabetes, the body will not produce enough insulin, and in type 2 diabetes, the body may not use insulin properly. In both types, there is too much glucose in the blood, and leads to complications and the need for medications. Without diabetes drugs, patients risk heart attacks, strokes, kidney disease and other health risks.

Diabetes medications are designed to assist the body balance glucose levels, though some drugs, including Invokana, Onglyza and others may lead to more severe drug injury. There are a variety of diabetes medications that may keep blood sugar levels under control. Incretin mimetics, for example, are a drug that “mimics” incretin hormones, prompting the pancreas to release more insulin.

Another popular diabetes drug is Invokamet, which is a SGLT2 inhibitor combined with metformin. But Invokana and Invokamet may increase the risk of ketoacidosis, acute kidney injury, urinary tract infections, bone fractures, and leg and foot amputations.

Recent research of one SGLT-2 inhibitor called Invokana concluded that the risk of amputation doubled during drug use in some patients. Individuals taking any SGLT-2 inhibitor should remain vigilant for signs of increased tenderness, sores, ulcers, and infections in the lower extremities.

Immediately notify a medical professional if such symptoms appear. The FDA has warned of several severe side effects including Fournier’s Gangrene infection.

Other serious complications of SGLT-2 medications may include the following:

•    Amputation
•    Renal Failure
•    Ketoacidosis
•    Kidney Failure
•    Heart Attacks
•    Fournier’s Gangrene
•    High amounts of potassium in the blood
•    Serious urinary tract infections
•    Low blood sugar when combined with other diabetes medicine
•    Yeast infections
•    Bone fractures
•    Increased cholesterol

photo of attorney Joe Lyon
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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