San Diego Pharmaceutical and Medical Device Attorneys

At this time, CaseyGerry attorneys are not accepting new clients seeking legal representation for pharmaceutical cases.

For more than two decades, CaseyGerry’s Pharmaceutical and Medical device attorneys have represented individuals nationwide against the manufacturers of dangerous drugs and medical devices. The firm has represented individuals in high profile pharmaceutical cases involving the manufacturers of Rezulin, Propulsid, Metabolife 356, Phenylpropanolamine (“PPA”), Hydroxycut, Fen-Phen, and Baycol, among others. Over the years, CaseyGerry attorneys have also worked on a full range of medical device litigation, including the Sulzer hip, the Taxus stent, and Guidant pacemakers/defibrillators.

With more than 75 years of combined experience among them, our partners have received numerous accolades and awards, and have routinely been named among San Diego’s “Top Lawyers” by the San Diego Daily Transcript, in addition to being recognized by their peers for their legal acumen.

Partner Gayle M. Blatt – assisted by fellow partner Wendy M. Behan  – has played a role in cases involving L-Tryptophan, Baycol, Propulsid, Rezulin, Metabolife and she has served on court-appointed steering committees in the Sulzer, Baycol, and Metabolife statewide and/or national coordinated litigation.  Blatt was appointed by U.S. District Judge Barry Ted Moskowitz to serve on the Plaintiffs’ Steering Committee as Liaison Counsel for the large number of Hydroxycut personal injury cases in Multi-District Litigation (MDL 2087), settled in the Southern District of California.

Manufacturers of pharmaceuticals and medical devices should be held accountable.

For more than two decades, CaseyGerry’s Pharmaceutical and Medical Device Litigation attorneys, led by partner Gayle M. Blatt, has represented individuals nationwide against the manufacturers of dangerous drugs and medical devices. We have the experience and know-how to understand how the fine details of manufacturer liability interact with our clients’ individual health and medical care – as well as the resources to see your case through.

All too often a medication or medical device that an individual believes is helping resolve a painful or life-threatening condition in fact causes more harm than good – or even death.

For the multinational pharmaceutical companies that bring in more than $100 billion a year, the sooner they can get a drug to the market, the bigger their profits – and the risk of fast-tracking their way into problems. CaseyGerry attorneys believe individuals have the right to expect these companies to be held responsible for making their drugs safe and, if they’re not, for any harm their products cause.

The history of litigation

When a patient runs into complications from a drug like ACTOS that is meant to treat Type II diabetes or an implant to repair a hip or knee, the painful and sometimes fatal results may be the only hint that something has gone wrong. And often, those affected are our most vulnerable senior citizens, who have more ailments and a reduced capacity to metabolize the many medications they may be taking.

Since 1993, when the Food and Drug Administration created a “fast track” for reviewing new drugs, sometimes the clinical trials created to ferret out problems before drugs were approved to have been inadequate. Over the last ten years, more than a dozen drugs – from the prescription diet drug Fen-Phen to the cholesterol-lowering drug Baycol – and devices like silicone breast implants have been taken off the market.

These cases, and many that are pending involving such products as Actos and Yaz, as well as metal-on-metal hip implants, show that FDA approval does not assure safety. Nor does it mean that the pharmaceutical company or device maker is not liable if the drug, medication, or device was used as it was intended.

How CaseyGerry can help

If you or a loved one have been injured through the use of a pharmaceutical or medical device, contact a pharmaceutical attorney at CaseyGerry. We will carefully evaluate the case and give you sound recommendations on your rights and available actions. Contact us today to arrange a free consultation.

At CaseyGerry, we believe that equal protection under the law demands representation of our society’s most vulnerable citizens against the irresponsible rush to market decisions of powerful international drug companies.

Yet suing a multinational drug company is a very expensive and complex undertaking. You will need a firm with the skill and the resources to go the distance for you, through research, discovery, trial, and possibly an appeal.

The team approach

When CaseyGerry takes on a pharmaceutical or medical device case for an individual or their family, we put together a team led by an experienced partner that includes attorneys, investigators, paralegals, and expert witnesses to investigate the case and develop a plan. We commit to doing everything that it takes to reasonably and properly prosecute the case, with the aim of securing the most favorable resolution possible for our client. We often represent individuals, rather than class actions, opting to focus on the welfare of each individual client.

When you contact CaseyGerry, one of our partners will discuss your case with you to help you determine the best way to proceed.

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CaseyGerry pharmaceutical litigation attorneys address frequently asked questions about dangerous drugs and pharmaceutical litigation

Who is at risk from dangerous drugs?

People 65 and older constitute only 14% of the US population, yet they take more than 33% of all prescription medications. The average senior takes four to six prescribed medications, in addition to over-the-counter drugs. CaseyGerry’s pharmaceutical litigation attorneys know that this level of usage increases the risk of dangerous drug interactions.

How has the FDA’s fast-track approval of drugs increased the risks to consumers?

The greatest threat from prescription drugs remains the FDA’s fast-track approval policy. Originally conceived by advocates for critically ill patients, fast-track has become the tool of earnings-driven multinational drug corporations, who lobby for the premature release of promising medications, without adequate clinical trials, and without sufficient knowledge of how the drug will work in real-life patients. Our attorneys have seen the consequence: the most vulnerable members of our society – children, the seriously ill, and the elderly – have become the final test subjects, unwitting guinea pigs for huge pharmaceutical conglomerates whose rush for profits puts drugs on the market without sufficient knowledge of their dangers.

**CASEYGERRY IS NOT CURRENTLY ACCEPTING CLIENTS FOR THE BELOW DRUGS AND DEVICES**

Device	Manufacturer
Metal-on-metal hip implants	DePuy ASR, DePuy Pinnacle, Zimmer, Durom
Transvaginal mesh	American Medical Systems, Boston Scientific, C.R. Bard Inc., Ethicon, Johnson and Johnson
Shoulder pain pumps	Stryker, I-Flow, Sorenson, Breg
Zimmer NexGen Knee Implant System	Zimmer

Drug	Indication
ACTOS, ACTOplus met, ACTOplus met XR Duetact	Type II Diabetes
Darvon®/Darvocet®	Pain
Fosamax®	Osteopenia/Osteoporosis
Pradaxa®	Anticoagulation/Atrial Fibrilation
Procepia®	Male Pattern Hair Loss
SSRI Antidepressants (Celexa, Effexor, Lexapro, Paxil, Pristiq, Prozac, Zoloft)	Depression
Topamax® (During pregnancy)	Migraine Headaches, Seizures, Lennox-Gastaut Syndrome
YAZ®/YASMIN®	Birth Control, Acne

INVOKANA

CaseyGerry is not currently accepting clients for this case.

Invokana is a popular drug by Johnson & Johnson, which is part of a class of prescription medicines (SGLT2 inhibitors) that are FDA-approved, along with diet and exercise, to lower blood sugar in adults with type 2 diabetes. The drugs effectively reduce blood sugar by causing the kidneys to remove sugar from the body through the urine.

In March 2013, the U.S. Food and Drug Administration (FDA) approved Invokana use in treating type 2 diabetes. However, the FDA panel, voting 10-5 in favor of approval, had concerns over the drug’s safety and ordered long-term studies, due to concerns in part over an elevated risk of stroke and heart attacks.

Despite questions about its safety, Invokana was the first in this new class of diabetes drugs to receive FDA approval. These medicines are available as single-ingredient products and also in combination with other diabetes medications.

The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.

Warning

The US Food and Drug Administration (FDA) has warned that Invokana, as well as other SGLT2 Inhibitors – including Farxiga, Invokamet, Glyxambi, Xigduo XR and Jardiance – may lead to ketoacidosis, a serious health condition where the body produces high levels of blood acids called ketones, causing a severe accumulation of keto acids and decreasing PH of the blood. In more serious cases, ketoacidosis may require hospitalization – and can be fatal.

The FDA issued a safety announcement on May 15, 2105, advising patients using Invokana and other SGLT2 inhibitors to pay close attention for any signs of ketoacidosis and seek immediate medical attention if they experience possible Invokana side effects such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness.

Additionally, the FDA said health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

“We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs,” the FDA said in its announcement.

Invokana Lawsuits

Claims involving Invokana and other SGLT2 inhibitors are in the early stages. The Invokana claims allege that both the manufacturers and marketers of SGLT2 inhibitors, among them Johnson & Johnson, Janssen Pharmaceuticals Inc., AstraZeneca & Boehringer Ingelheim, did not properly warn patients and physicians of the many risks – including ketoacidosis – associated with Invokana and other drugs in this class.

Spending an estimated $30 billion each year, more than half of American adults take dietary and herbal supplements. Alarmingly, many consumers believe that what’s on the label is in the bottle – which in many instances is not the case. GNC, Target, Walmart, Walgreens selling bogus herbal supplements, NY charges.

NY Attorney General Asks Major Retailers to Halt Supplement Sales

Accusing them of selling fraudulent and dangerous products, the New York Attorney General asked GNC, Target, Walmart, and Walgreens to halt sales of certain top-selling herbal supplements, following research which found a majority of store-brand herbal products did not contain ingredients listed on their labels.

Attorney General Eric T. Schneiderman recently announced that his office sent cease and desist letters to the four major retailers for allegedly selling store-brand herbal supplements in New York that either could not be verified to contain the labeled substance, or which were found to contain ingredients not listed on the labels. As a result, Schneiderman called for the retailers to immediately stop the sale of popular products including Echinacea, Ginseng, St. John’s Wort, and others. The letters come following an ongoing investigation by the Attorney General’s Office which included DNA testing on the products.

Attorney General’s Report

In fact, the DNA testing on hundreds of bottles of herbal supplements – sold to treat everything from memory loss to insomnia – revealed that not only did four out of five products contain none of the herbs on the label, but were instead packed with fillers such as wheat, rice, beans or houseplants, resulting in potentially dangerous product contamination.

ABC News Report

While the FDA has targeted individual supplements found to contain dangerous ingredients. This marks the first time a law enforcement agency had threatened big retailers with legal action for selling misleading herbal products. Read more.

Major retailers targeted

It is frightening to think that some of the country’s biggest retailers may be selling adulterated and mislabeled products – these include Walmart Spring Valley Brand, Walgreens Finest Nutrition Brand, GNC Herbal Plus Brand and Target Up and Up Brand. Mislabeling and false advertising is illegal – and can have dangerous and far-reaching consequences. 

CaseyGerry has a successful track record of standing up to big pharma companies.

Benicar (Olmesartan Medoxomil)

CaseyGerry is not currently accepting clients for this case.

Overview: High Blood Pressure Treatment

Every year, millions of patients take Benicar (Olmesartan Medoxomil), a popular drug used to treat high blood pressure. The medication works by blocking substances that tighten blood vessels, allowing blood to flow more smoothly and the heart to pump more efficiently. Over the last several years, the drug has been linked to a number of severe gastrointestinal side effects. Symptoms are similar to celiac disease – a condition that damages the lining of the small intestine – and may include chronic diarrhea, vomiting, intestinal inflammation and weight loss. As a result, the FDA has approved label changes of these drugs as well as issued a warning. Warnings about the possible repercussions of Benicar were added to the medication’s label in late 2013. Drug Safety 

Benicar Warning: Extreme Gastrointestinal Distress

Benicar is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure or hypertension – alone or with other antihypertensive agents – and is one of eight marketed ARB drugs. The U.S. Food and Drug Administration (FDA) warned that the blood pressure drugs marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics can cause severe intestinal problems, also known as sprue-like enteropathy.

Read the FDA Report on Drug Safety

The concerns stem from research conducted by The Mayo Clinic, which examined 22 patients who reported suffering from diarrheal illness for an average of 19 months, and determined that when the patients discontinued using the drug, they gained an average of 27 pounds. Researchers concluded that Olmesartan might be associated with a severe form of sprue-like enteropathy, with symptoms that include severe, chronic diarrhea, nausea, and vomiting with substantial weight loss. Chronic diarrhea from use of the medication may also cause villous atrophy, a disorder that causes abnormalities in the intestinal lining.

Over the years, victims have suffered from sprue-like enteropathy after taking Benicar, but were often misdiagnosed with celiac disease.

The enteropathy may develop months – even years – after starting the drug, and sometimes requires hospitalization. If patients taking the medication develop symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. The FDA will continue to evaluate the safety of these medications and will communicate again if additional information becomes available.

 Benicar Lawsuits

Consumers across the country have filed product liability lawsuits against New Jersey-based drug maker Daiichi Sankyo, Inc. after developing severe gastrointestinal issues while taking Benicar. The lawsuits – both individual and class actions – are being reviewed across the country.  According to reports, plaintiffs allege the drug manufacturer may have been aware of the association between Benicar and severe stomach issues, yet did not divulge important consumer information – and also failed to conduct adequate studies on Benicar’s long-term effectiveness and risks.

For decades, CaseyGerry has represented individuals in high profile pharmaceutical and medical device cases across the nation.

Testosterone Medication

CaseyGerry is not currently accepting clients for this case.

Recent research reveals that prescription testosterone medication – in the form of tablets, patches, gels, and injections – can cause serious illnesses, among them deep vein thrombosis, pulmonary embolism, heart attack, and stroke.

A new study – published recently in the online journal PLOS One, and conducted by researchers at the University of California, Los Angeles, the National Institutes of Health and Consolidated Research – found that testosterone tripled the risk of heart attacks in one group of more than 48,000 middle-age men with previous histories of heart disease and doubled the risk of cardiovascular disease in more than 7,000 men over age 65. Overselling Testosterone

Additionally, a 2013 report, published in The Journal of the American Medical Association determined that patients using testosterone faced a nearly 30 percent increased risk of stroke or heart attack – or even dying from the medication – than those not on the hormone. The findings call for more cautious prescribing of testosterone by physicians.

In response, officials at the Food and Drug Administration recently announced that they will reexamine the safety of testosterone products and investigate rates of stroke, heart attack, and death in men using the drugs.

Background

Testosterone is the male sex hormone that helps maintain bone density, muscle strength and mass, and red blood cell production. Natural levels of the hormone in the body peak in early adulthood, then decline with age. Widely touted as a way to help men bolster diminished energy and boost sex drive, testosterone therapy has been used in recent years as a cure-all for a full range of maladies – from fatigue to depression. The medication is approved by the FDA to treat specific medical conditions, such as hypogonadism, known as low testosterone or “Low T,” a syndrome characterized loss of sexual drive and decrease in physical strength, among other symptoms.

Due to an intensive marketing campaign by American drug companies, the amount of testosterone prescribed to men in this country has surged. According to a study last year in JAMA Internal Medicine, between 2001 and 2011, use of testosterone by men 40 and over nearly quadrupled.

In the United States, sales of testosterone products reached $1.6 billion in 2011. The appeal of the hormone therapy is indisputable. It can build muscle, increase bone density, improve libido, and influence emotional and physical well-being. Benefits of Increasing Testosterone.

Millions of U.S. males use testosterone therapy to reverse the hormone’s natural decline – at a risk. According to the New York Times, teststosterone has been perilously overprescribed – with some alarming consequences. Overselling Testosterone

The drugs help control blood sugar levels by mimicking the incretin hormones that the body produces naturally to stimulate the release of insulin in response to a meal. FDA Report

However, researchers have found that these drugs may have harmful effects on the pancreas. In fact, a UCLA study provides evidence of increased pre-cancerous changes in diabetic patients using incretin-mimetics. Bloomberg Report

The concern is that the drugs work by increasing levels of glucagon-like peptide-1, a hormone which may accelerate precancerous conditions already present in middle-aged people. New York Times Story

Lawsuits related to these medications have been filed in seven federal judicial districts, including the Southern District of California, the District of Arizona, and the District of Colorado, and various state courts. All of the lawsuits involve allegations that the manufacturers of the medications failed to provide patients and doctors with adequate warnings about the risks of pancreatic cancer, thyroid cancer and pancreatitis.

In response to the increasing number of lawsuits related to the drugs, the Judicial Panel on Multidistrict Litigation recently ordered that dozens of Januvia, Byetta and Victoza lawsuits be consolidated in the Southern District of California.

While the panel noted that it is unusual to consolidate lawsuits involving competing drug companies, it determined that the manner in which the drugs manage blood insulin levels and pancreatic cancer allegations were similar enough to merit consolidation.

Januvia, Byetta and Victoza

Since these drugs were approved, multiple warnings have been issued by the FDA www.fda.gov warning about potential complications. Concerns about pancreatic cancer surfaced in 2009, when the FDA ordered the manufacturer of Januvia to include a warning about its connection to pancreatitis.

Two years later, a study by Gastroenterology www.gastro.org/journals-publications/gastroenterology raised the possibility that Januvia or Byetta may also cause serious side effects, such as pancreatitis and pancreatic cancer. The study even found that Byetta (exenatide) may increase risk of thyroid cancer. When compared to other treatments, the researchers found a six fold increase of reported cases of pancreatitis (inflammation of the pancreas) linked to patients taking Januvia or Byetta; a 2.9-fold increase in reported cases of pancreatic cancer among those taking Byetta and a 2.7-fold increase of reported pancreatic cancers among Januvia users. USA Today Report

Additionally, examination of pancreases from 20 diabetics showed a 40 percent increase in pancreatic cells as well as cell damage in the people treated with incretin therapy. Of the 20 pancreases, eight were from people taking incretin therapy, while 12 were on other treatments, according to a study in Diabetes, the journal of the American Diabetes Association. Seven of the eight patients taking incretin therapies for a year or more were using Merck’s Januvia while the other was using Byetta. Bloomberg News Report

In the Spring of 2013, the U.S. Food and Drug Administration www.fda.gov posted safety information for patients and healthcare providers on: “Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas.”

Byetta

CaseyGerry is not currently accepting clients for this case.

Byetta – along with its longer-acting version Bydureon —  is a prescription injectable medicine used for treatment of type 2 diabetes, a condition in which a person is not producing enough insulin and as a result has high blood sugar.  Manufactured by Bristol-Myers, it is injected twice a day before meals to control the amount of sugar in the blood stream. www.byetta.com

Currently, the FDA is evaluating unpublished new findings from academic researchers that suggest a possible link between Byetta and risk of pancreatitis, pre-cancerous cellular changes and potential pancreatic toxicity. FDA Drug Safety

In addition to pancreatitis, Byetta has been associated with thyroid cancer.

Victoza

CaseyGerry is not currently accepting clients for this case.

An injectable medication used daily for type 2 diabetes, Victoza is known generically as liraglutide. www.victoza.com

In addition to studies linking it to pancreatitis and pancreatic cancer, Victoza has been associated in animal studies to an increased risk of a rare thyroid cancer, according to the FDA.

In 2012, the public advocacy group Public Citizen www.citizen.org filed a petition with the FDA requesting the agency remove Victoza from the market. Public Citizen cited the risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure as outweighing any possible benefits to the drug. In a news release, Public Citizen noted that two FDA pharmacologists and an FDA clinical safety reviewer advised against approving Victoza.

Januvia

CaseyGerry is not currently accepting clients for this case.

An oral antihyperglycemic, Januvia www.januvia.com is a top selling drug manufactured by Merck and is either used alone or in combination with other oral antihyperglycemic agents, such as metformin. Medilexicon Information

It is a once a day prescription pill used for treatment of type 2 diabetes and may be prescribed with other diabetes medications. Like other incretins, Januvia has been linked to thyroid cancer and has been found to cause pancreatitis, which is linked with an increased risk of pancreatic cancer. USA Today Report on Pancreatic Cancer

Symptoms of Pancreatitis

Signs and symptoms of pancreatitis may vary, depending on which type you experience.

Acute pancreatitis signs and symptoms include:

• Upper abdominal pain
• Abdominal pain that radiates to your back
• Abdominal pain that feels worse after eating
• Nausea
• Vomiting
• Tenderness when touching the abdomen
• Chronic pancreatitis signs and symptoms include:
• Upper abdominal pain
• Indigestion
• Losing weight without trying
• Oily, smelly stools (steatorrhea)

Make an appointment with your doctor if you have persistent abdominal pain. Seek immediate medical help if your abdominal pain is so severe that you can’t sit still or find a position that makes you more comfortable. Mayo Clinic Health

Tylenol

CaseyGerry is not currently accepting clients for this case.

The Warning:

According to recent reports show that acetaminophen overdose is the number one cause of acute liver failure in this country.

Acetaminophen is the generic name for the drug used in over-the-counter medications such as Tylenol.

In fact, the most serious complication of a Tylenol overdose is severe liver damage, which can necessitate a liver transplant. The Food and Drug Administration (FDA) estimates that more than 50,000 emergency room visits, 25,000 hospitalizations and 450 deaths are a result of acetaminophen overdose each year.

Users of the popular painkiller who are most at risk include those with depression, chronic pain, alcohol/narcotic use, and those who take several acetaminophen-containing products at the same time, they added. Acetaminophen is Leading Cause of Acute Liver Failure

Many consumers are unaware of just how easy it is to accidentally take an unintentional overdose of acetaminophen. Therefore, it is very important for anyone taking Tylenol and similar drugs to carefully read the bottle and not to exceed the recommended dosage.

The FDA has asked manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule, and also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

In addition, the FDA is requiring a warning on labels of all prescription products that contain acetaminophen highlighting the potential for allergic reactions

Background

Acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) – one of the most popular is Tylenol  – as well as prescription medicines, and used to alleviate pain and fever. Tylenol can cause serious liver damage if more than directed is used — however symptoms may take time to appear.

According to Sandra Kweder, M.D, deputy director of FDA’s Office of New Drugs, overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S, many of which result in liver transplant or death.”

“The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period,” said Kweder. Other risk factors can include consuming alcohol while taking the drug.

Symptoms of Tylenol overdose include nausea, unusual bleeding/bruising, flu-like symptoms, vomiting, sweating and jaundice of the eyes or skin. Signs & Symptoms of Liver Damage from Acetaminophen

If you experience such symptoms, call your local emergency number (such as 911) or the National Poison Control Center at 1-800-222-1222.

For more information, please visit: www.fda.gov/acetaminophen

DePuy implant

CaseyGerry is not currently accepting clients for this case. 

DePuy ASRTM XL Acetabular or Pinnacle hip replacement has been linked to serious pain, diminished ability to walk, and other symptoms.

What are the symptoms?

Symptoms may include hip/groin pain, local swelling, numbness or changes in your ability to walk. It is important that to contact your physician to help determine why you are experiencing any of these.

What is the DePuy Hip Replacement?

The Pinnacle Hip Replacement System, the ASR XL Acetabular System total hip replacement and the ASR Hip Resurfacing System were designed to eliminate device failure because of overuse. One of the features of these systems – metal-on-metal construction – was supposed to help mitigate failure rates. Instead, research shows that the construction can generate serious problems.

Designed to last longer than other implants, studies show they wear out sooner – especially in women and patients with larger implants.

What are the other specific dangers of these devices?

Metal-on metal devices which can potentially trigger metallosis – an adverse reaction to metals in the body which can result in pain, limited mobility, failure of the hip joint, tumor-like growths, dissolution of the bone and chromosomal aberrations in some patients. Patients with metal-on-metal implants have been found to have high levels of metal ions in their bloodstream, evidence of the microscopic wear particles escaping into the body. There have been a few case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart and thyroid gland.

The medical device attorneys at CaseyGerry, a San Diego based personal injury law firm, have led the way on hip implant litigation with cases filed against Depuy metal-on-metal implants and similar systems. In addition, partners Gayle M. Blatt has represented clients in a number of high-profile nationwide pharmaceutical and medical device cases, including the Sulzer hip, the Taxus stent, and Guidant pacemakers/defibrillators.

DePuy Hip Replacement Background

As the population ages, increasing numbers of people are getting hip implants, which can cause complications. Metal-on-metal hip implants – where both the ball and socket components are made of metal – are under increasing scrutiny.

Serious problems associated with the all-metal implants – including high early failure rates and the shedding of tiny metal particles into the body – have led to calls for stricter laws. FDA Toughens Stance on All-Metal Hip Implants

In fact, The U.S. Food and Drug Administration has proposed tighter regulations – that would require makers of metal-on-metal hip-replacement implants to either prove their products are safe or stop selling them. Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews

Earlier this year, DePuy, the orthopedic unit of Johnson & Johnson, announced it was phasing out production of all-metal replacement hips. The company is facing a deluge of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. J.&J. Unit Phasing Out All-Metal Hip Devices

Medical Device Manufacturer Recalls Potentially Defective Hip Implant Devices

Stryker Corporation – a New Jersey-based manufacturer of medical devices – recently announcing the recall of the Rejuvenate Modular and the ABG II modular-neck hip implants due to the risk of wear-and-tear and corrosion at the modular-neck junction, which can cause swelling, pain and device failure. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon, and those uncertain if they have one of these products implanted should consult their surgeon or medical records.

The two products were voluntarily recalled after complaints from patients who say their implants caused serious infection. Both are metal-on metal devices which can potentially trigger metallosis – an adverse reaction to metals in the body which can result in pain, limited mobility, failure of the hip joint, tumor-like growths, dissolution of the bone, DNA changes and chromosomal aberrations in some patients. Typically, the syndrome occurs when metallic debris builds up in the soft tissue surrounding the artificial hip. The recalled devices are capable of deteriorating and releasing metal debris over time. Corrosion or fretting of the device releases microscopic metallic ions into the body, causing an autoimmune response.

Ultimately, hospitalization and corrective surgeries may be necessary if elevated metal levels (cobalt and/or chromium) are found in a patient’s blood.

According to reports, the Stryker devices are linked to a higher than expected early failure rate, resulting in some patients requiring revision surgery to replace their hip replacement implants.

CaseyGerry has extensive experience with medical device litigation. As the population ages, an increasing number of people are getting hip implants, which can cause some complications. Metal-on-metal hip plants are now under scrutiny, and may not last as long as ceramic or plastic counterparts, requiring repeat surgery.

What are metal on metal implants?

Metal-on-Metal devices are hip implants where both the ball and socket components are made of metal. These metal implants have been used in total hip replacement surgeries and hip resurfacing procedures.

What are the other specific dangers of these devices?

Metal-on metal devices which can potentially trigger metallosis  — an adverse reaction to metals in the body which can result in pain, limited mobility, failure of the hip joint, tumor-like growths, dissolution of the bone and chromosomal aberrations in some patients. Patients with these metal-on-metal implants have also been found to have high levels of metal ions in their blood stream, evidence of the microscopic wear particles escaping into the body. There have been a few case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart and thyroid gland.

In addition, the syndrome can result in the loosening and ultimate failure of the device.

What are Symptoms?

Symptoms may include hip/groin pain, local swelling, numbness or changes in your ability to walk. It is important that to contact your surgeon to help determine why you are experiencing any of these.

Who are some of the manufactures of these devices and how do I know if I have one?

Manufacturers of recalled device included DePuy and Stryker. Patients are usually told about the type of implant they are receiving prior to the surgery. If you are uncertain about which type you have, contact the orthopedic surgeon who performed your procedure.

How can CaseyGerry Help?

The pharmaceutical and medical device attorneys at CaseyGerry continue to lead the way in hip implant litigation, having filed cases against the manufacturers of the recently recalled, DePuy metal-on-metal ASR hip implants, and other similar systems.

One of the most respected and oldest plaintiffs’ personal injury law firms in Southern California, CaseyGerry has represented individuals in high profile pharmaceutical and medical cases across the nation.

Actos

CaseyGerry is not currently accepting clients for this case.

A recent FDA warning relates the extended use of the drug to bladder cancer, and an initial analysis of the data shows that patients who take Actos for longer than twelve months are at significantly increased risk. In June 2011, Actos had its sales suspended by medical regulators in France and Germany, following a study that found people taking Actos were more likely to develop bladder cancer.

The FDA warns patients who are taking Actos and who are experiencing the following symptoms to contact their physician immediately.

Symptoms of bladder cancer include:

• Blood in urine.
• Lower back and abdominal pain.
• Urgent need to urinate.
• Pain during urination.

Pradaxa

CaseyGerry is not currently accepting clients for this case. 

Pradaxa is the leading alternative treatment to warfarin for non-valvular atrial fibrillation, the most common type of heart rhythm abnormality. A safety announcement released in December 2011 by the U.S. Food and Drug Association (FDA) indicates that patients who use Pradaxa may be at risk for serious and sometimes fatal bleeding. As reported in Reuters the manufacturer of Pradaxa, Boehringer Ingelheim, related 260 fatal bleeding deaths to the drug as of November 2011.
A study recently performed by researchers at the Cleveland Clinic looked at more than thirty thousand patients and found that patients who are taking Pradaxa have an up to 33% increase risk of heart attack or acute coronary syndrome than those taking warfarin.

The FDA warns that discontinuing the use of Pradaxa can put patients at greater risk for a stroke. However, you are encouraged to seek professional care immediately if you notice the following symptoms: uncontrolled or unusual bleeding, suspicious bruising, blood in urine or stool, or coughing or vomiting blood.

 Nizoral

CaseyGerry is not currently accepting clients for this case. 

Nizoral (ketoconazole) oral tablets are used to treat fungal infections, and can cause liver injury, potentially resulting in liver transplant or death.

The Food and Drug Administration (FDA) reports that during 2012 alone, approximately 5.2 million Nizoral (ketoconazole) prescriptions were dispensed, of which 609,000 (12%) were for the tablet formulation. 
Safety Announcement

The Warning:

The FDA has revised its boxed warning for Nizoral tablets – stating that Nizoral oral tablets should not be a first-line treatment for any fungal  infection and adding a strong recommendation against its use in patients with liver disease, with new recommendations for assessing and monitoring patients for liver toxicity.

According to the FDA, Nizoral can cause severe liver injuries and adrenal gland problems, as well as lead to dangerous drug interactions with other medications, causing serious and potentially life-threatening outcomes such as heart rhythm problems. As a result, the FDA  recently approved the label changes and added a new Medication Guide to address safety concerns.  Nizoral Risks

The label now states, “NIZORAL® Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.” The FDA also requires that the label include a new contraindication that patients with liver disease should not use Nizoral.

Additionally, The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) recommended against continued sale of ketoconazole-containing products in Europe. The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.

Background

Nizoral (Ketoconazole) is used to treat fungal infections – such as yeast infections of the mouth, skin, urinary tract, and blood – that begin on the skin or in the lungs and can spread to different parts of the body through the bloodstream. Also used to treat fungal infections of the skin or nails that cannot be treated with other medications, it is in a class of antifungals called imidazole and works by slowing the growth of fungi that cause infection.

Serious liver damage has occurred in patients receiving high doses of the drug for short periods of time as well as those receiving low doses for long periods. Symptoms of drug-induced liver damage may include nausea, vomiting, loss of appetite, weakness,  jaundice, and pain or discomfort in the right upper abdomen, where the liver is located.

In addition, these tablets may cause adrenal insufficiency by decreasing the body’s production of hormones called corticosteroids – which affect the body’s balance of water and salts and minerals (electrolytes).

Transvaginal Mesh Warnings and Litigation

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The Food and Drug Administration (FDA) has received more than 3,000 reports of complications associated with transvaginal mesh – surgical devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

A net-like implant device, transvaginal mesh is typically made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. The term “transvaginal” means through the vagina – and refers to the surgery used to implant the mesh.

The Warning:

Transvaginal mesh products are inserted into the abdomen or pelvis to alleviate pressure on tissue that has been damaged or weakened, often through hysterectomy, childbirth, or menopause. Increasing numbers of women have reported serious complications from the use of these mesh products, which include bladder slings, patches, and tape.

In 2008, the FDA issued a safety alert addressing complications related to transvaginal mesh devices.

Three years later, the agency warned that there had been a dramatic increase in reports of problems associated with the use of vaginal mesh.

At this time, the FDA warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage and noted that thousands of women have reported serious complications. According to the FDA it is “not clear that transvaginal POP repair with mesh is any more effective than traditional repair and may expose patients to greater risk.”

Background

The surgical procedure involving mesh has become more prevalent in recent years. In 2010, more than 75,000 women underwent vaginal surgery with mesh to repair POP.

POP affects many women as they age, with the FDA estimating that up to 50 percent of all women may experience it during their lifetimes. POP occurs when the tissue holding the uterus, bladder, bowel and rectum is weakened, allowing the organs to prolapse – or slip out of place. Pelvic Support Problems

SUI results in leakage of urine, especially if the patient coughs, laughs or exercises.

Typically, surgical mesh is implanted to reinforce the weakened vaginal wall – either to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence. By reinforcing the vaginal wall and urethra, transvaginal mesh is designed to mitigate the negative impact of SUI and POP.

Unfortunately, over time, erosion or contraction of the mesh  can result in serious injuries and complications.

In fact, thousands of women have suffered the effects of improperly placed mesh, and thousands of cases have been consolidated into multidistrict litigation (MDL) in the U.S. District Court of West Virginia.  These lawsuits allege that various models share similar design flaws and risks. The cases were centralized into MDL because they all contain similar sets of facts and injuries.

A variety of mesh devices have been marketed and sold by companies including: Gynecare, American Medical Systems (“AMS”), Boston Scientific, C.R. Bard, Inc., Ethicon and Johnson and Johnson.

However, the complications associated with the use of surgical mesh have not been linked to a single brand.

Transvaginal Mesh Side Effects

The most common complication reported to the FDA for surgical mesh devices involves mesh erosion – which can damage the tissue of the vaginal wall – causing pain, infection, bleeding, organ perforation and urinary problems. Another  potential consequence is mesh shrinkage, which may cause a painful shortening and tightening of the vagina

Equally painful is transvaginal mesh organ perforation, which can occur when the sharp edges of mesh cut into organs.

Ironically, many women have reported a reoccurrence of vaginal prolapse or stress urinary incontinence when using these devices.

Yaz and Yasmin

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Yaz and Yasmin are two of the most popular birth control pills in the United States today, mostly because of a long series of commercials that played up the alleged benefits of the drugs and downplaying the severe and potentially life-threatening side effects. Millions of women elected to use Yaz and Yasmin to combat acne, reduce the symptoms of PMS, and help prevent pregnancy without knowing that these drugs also significantly increased the risks of:

• Heart Attack
• Stroke
• Blood Clots
• Gall Stones due to high blood potassium
• Liver Damage
• Allergic Reactions (hives, rashes, itching, swelling, wheezing, difficulty breathing or swallowing)

In fact, a woman in Illinois filed a lawsuit on August 18, 2009, claiming that Yaz caused her to develop a blood clot in her lung that erupted into a life-threatening pulmonary embolism, as well as an infection in the area.

Unfortunately, this is not an isolated incident. Between 2004 and 2008, Yasmin and Yaz have been liked to more than 50 deaths in a broad cross section of women, including one especially tragic case of a fatality of a 17 year old girl.

The alleged danger of Yaz and Yasmin stems from its new combination of several hormones that can have a myriad of different effects on the physiology of the women that take them. Because the combination is so new, there are few long range studies that can truly measure what damage it can cause, and millions of women could pay the price of this lack of vision.

In 2008, The Food and Drug Administration insisted that Bayer AG, the manufacturer of Yaz and Yasmin, run a series of commercials saying they overstated and misled women on the benefits of Yaz and Yasmin, and to clarify the exact conditions the drugs were designed to treat.

Furthermore, on August 5, 2009, the FDA sent a letter to pharmaceutical manufacturer Bayer AG to notify them that their plant in Germany failed to use proper testing methods when determining results for the consistency of their products.

Millions of women have taken Yaz and Yasmin since its inception, and there have been hundreds of lawsuits against Bayer due to the drug’s side effects and misleading marketing.

Zimmer NexGen CR-Flex

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The Zimmer NexGen CR-Flex is a knee replacement system that is designed to offer a greater range of motion than the standard model. In addition to superior flexibility, Zimmer designed a version of the CR-Flex that does not require cement adhesive; rather it is intended to fuse naturally to the adjoining bones. However, one of Zimmer’s top consulting physicians, Dr. Richard Berger began noticing problems with the device shortly after he began using it in 2005.

Prompted by indications from Zimmer that his technique was at fault, Dr. Berger conducted an independent study which showed that the device had an early failure rate of 9%, as well as an overall device loosening rate of nearly 50%.

Prior to his negative reporting, Dr. Berger worked closely with Zimmer for more than a decade. He was trusted by Zimmer to develop surgical tools and instruct the proper surgical techniques for use with their products. It is estimated that Dr. Berger trained hundreds of surgeons for Zimmer nationwide.

Drugs containing bisphosphonates

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FDA safety investigations into the class of drugs containing bisphosphonates began in 2007, in response to an article published in The New England Journal of Medicine, which claimed that the drug caused increased rates of atrial fibrillation. Since that time, bisphosphonates have been investigated for their relationship to numerous alarming medical conditions, including but not limited to: atypical femur fractures and osteonecrosis of the jaw.

Adverse affects of GranuFlo

Hundreds of thousands of Americans receive dialysis for kidney failure – and Fresenius Medical Care treats a significant number of those patients. The U.S. Food and Drug Administration is investigating whether the country’s largest operator of dialysis centers failed to inform patients about the adverse affects of GranuFlo, a substance used in the blood-cleansing procedure.

The Warning:

The FDA announced a Class I recall of dialysis products GranuFlo and NaturaLyte in June 2012 – linking Fresenius Medical Care with health care concerns around the country, in particular heart attack and death.

According to The New York Times, the FDA is investigating whether Fresenius violated federal regulations by failing to inform physicians and patients of a potentially lethal risk connected to Granuflo. An internal memo obtained by the Times appears to indicate that  the company knew about the  dangerous side effects of GranuFlo and failed to warn of the risks associated with the product.

Background

GranuFlo has been used to treat over 275,000 patients in more than 2,700 kidney dialysis clinics throughout North America, Europe, Asia, Africa and Latin America.

A medical treatment prescribed for people with kidney failure, dialysis does the kidneys’ job of clearing toxic waste in the blood. Part of the dialysis process involves taking bicarbonate to neutralize acid in the blood. During hemodialysis, a patient’s blood is circulated through a machine, cleansed of impurities and reintroduced to the body in purified form. GranuFlo is used to evenly distribute electrolytes during dialysis – however an active ingredient in GranuFlo converts to bicarbonate. Elevated bicarbonate levels – from the combination of prescribed bicarbonate and that produced by GranuFlo – could result in metabolic alkalosis, a condition which can generate deadly effects including cardiopulmonary arrest, heart attack, and stroke.

Dangerously high levels of bicarbonates in the dialysis treatment may have impacted thousands of dialysis patients nationwide.

Currently, there are more than 200 actions pending in the GranuFlo Multi-District Litigation (MDL). All involve allegations that plaintiffs suffered injury or death caused by the use of GranuFlo during hemodialysis – potentially resulting in low blood pressure, heart attack, cardiac arrhythmia or stroke.

Legal Consultation

According to news reports, the failure of Fresenius Medical Care to warn about the significant health risks associated with elevated bicarbonate levels could have led to numerous preventable health issues.

Omontys 

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Omontys, also known as Peginesatide, is an approved injectable drug sold to treat anemia in patients undergoing kidney dialysis.

The Warning 

Drugmaker Affymax and supplier Takeda Pharmaceutical, which jointly market the drug, recently announced the recall, following reports that the drug had caused severe allergic reactions, including some that proved fatal. The notice is posted by the FDA.

According to the FDA, it has received 19 reports of anaphylaxis — a severe all body allergic reaction. Three of the patients have died, while others required immediate medical intervention or hospitalization.

The Story 

Omontys is used for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg Multi-dose vials. The move affects thousands of kidney-disease patients who have been treated with the new drug, promoted as a less expensive alternative to Epogen,

Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval less than a year ago.  Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.

The companies and the FDA said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration.

The product can be identified by its product labeling featuring the name Omontys, distributed Nationwide, including Puerto Rico and Guam, to dialysis centers via specialty distributors.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

 

Fungal Meningitis Outbreak Linked to Tainted Medications

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Incidents of a rare strain of fungal meningitis and other related infections continue to mount, with at least 363 cases and 28 deaths in 19 states linked to contaminated steroid injections supplied by the New England Compounding Center (NECC), in Framingham, Massachusetts.

Casting doubt on the overall safety of U.S. drugs, the facility has since recalled all of its products and been stripped of its pharmacy license. A broad range of products is subject to the recall.

The unprecedented outbreak of Fungal Meningitis was originally linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain.

The warnings have since spread to patients who received other injectable medications from NECC. In fact, the FDA now suspects fungal contamination is possible in all of the supposedly sterile products made by the NECC on or after May 21, 2012, including injectables used in eye treatment or heart surgery, and has advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after that date. According to the CDC, as many as 14,000 people may have received the tainted injections.

The following link lists medical facilities throughout the country that received products shipped on or after that date from the Framingham facility – with the specific affected products included.

In the meantime, patients who received injections of NECC drugs should be alert for symptoms of fungal infection:

• Fever
• Swelling
• Increasing pain, redness, or warmth at injection site
• Changes in vision (if injection was in the eye)
• Pain, redness, or discharge from the eye (if injection was in the eye)
• Chest pain (if drug was used during heart surgery)
• Drainage from the surgical site (infection within the chest, if drug was used during heart surgery)

Patients should also be alert of symptoms of Fungal Meningitis, which may be very mild at first, and include slight weakness, nausea and vomiting or mild headache. The CDC is also warning patients who received suspect medications to also be alert for more severe symptoms of fungal meningitis, including:

• New or worsening headache
• Fever
• Sensitivity to light
• Stiff neck
• New weakness or numbness in any part of your body
• Slurred speech
• Increased pain, redness, or swelling at your injection site

Most patients with infections developed symptoms one to four weeks after infection, but the incubation period could be longer. During a recent conference call with the media, Florida Surgeon General and Secretary of Health John Armstrong said that while health officials have said that the incubation period could be up to six weeks, they now believe it could take even longer for the illness to show up. //www.ocala.com/article/20121029/ARTICLES/121029682

For the latest information on the Fungal Meningitis outbreak, visit the CDC Multistate Fungal Meningitis Outbreak Investigation site //www.cdc.gov/HAI/outbreaks/meningitis.html. For FDA Updates, visit www.fda.gov/Drugs/DrugSafety/FungalMeningitis/default.htm

Should you have any symptoms of meningitis – a serious, life threatening condition – please see a physician immediately.

Darvon and Darvocet

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Reports link injury or death to the use of propoxyphene, the active ingredient in the popular prescription painkillers, Darvon and Darvocet. Propoxyphene has been on the market for more than a half-century, and has been considered by many as an antiquated means of pain reduction for some time. In fact, the consumer group Public Citizen began filing petitions with the FDA to ban the drug as early as 1978.

In a study conducted by the U.S. Food and Drug administration (FDA), which ultimately led the manufacturer to voluntarily pull Darvocet from the market, researchers found that even prescribed doses of propoxyphene can lead to cardiotoxicity in patients. Cardiotoxicity creates an irregular heartbeat, known as arrhythmia, which leads to congestive heart failure, heart attack and death. Dr. John Jenkins of the FDA says, “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

 

Hydroxycut: Weight Loss Supplement Carries Risk of Serious Liver Damage

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On May 1, 2009, the Food and Drug Administration announced that it had received 23 reports of people who had used Hydroxycut products and had suffered serious health problems. It warned all users of Hydroxycut products to stop using them immediately, and in its letter to healthcare professionals, it stated that “we believe (Hydroxycut) presents a serious public health risk.”

Hydroxycut is the name of a group of 14 non-prescription products sold as dietary supplements manufactured by Iovate Health Sciences Inc., of Oakville, Ontario, Canada, and its US distributor, Iovate Health Sciences USA Inc. of Blasdell, N.Y Hydroxycut is marketed as a weight loss aid, an energy-enhancer and fat burner, as a diet supplement for low carbohydrate diets, and for promoting fluid loss. Here is a list of the Hydroxycut products that Iovate has withdrawn:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

In the face of the FDA’s warning, Iovate has agreed to immediately withdraw all Hydroxycut products from the market.

Users of Hydroxycut have reported jaundice and elevated liver enzymes, which are indicators of possible liver injury. Some users experienced liver damage so severe that they required a liver transplant. The FDA has received one report of the death of a Hydroxycut user due to liver failure.

In all of these cases, the users were using Hydroxycut according to the manufacturer’s instructions, at the dosages recommended on the product label.

Symptoms of liver injury include jaundice, in which the skin and/or the whites of the eyes turn yellow, as well as discolored, dark brown urine. Other symptoms of liver injury include excessive fatigue, weakness, nausea, vomiting, itching, loss of appetite, light-colored stools, and stomach or abdominal pain.

Symptoms may occur while a person is using Hydroxycut. They can also occur over a period of several months after the person has stopped taking it.

Other health problems reported to the FDA by people who had taken Hydroxycut were cardiovascular disorders, seizures, and rhabdomyolysis, a very serious breakdown of muscle tissue that can result in kidney failure.

In its letter to health care professionals, the FDA stated that “we believe (Hydroxycut) presents a serious public health risk.”  The full text of the FDA’s letter is published on its web site.

Hydroxycut is manufactured by Iovate Health Sciences Inc., of Oakville, Ontario, Canada, and its US distributor, Iovate Health Sciences USA Inc. of Blasdell, N.Y In the face of the FDA’s warning, Iovate has agreed to immediately withdraw all Hydroxycut products from the market.

 

Propecia 

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The drug finasteride was originally approved by the U.S. Food and Drug Administration (FDA) in 1994, and sold under the brand name Procar as a treatment for enlarged prostates. In 1997, the FDA approved finasteride for the treatment of male pattern hair loss and the drug has been sold for that purpose under the brand name Propecia ever since.

Propecia works by blocking the chemical androgen, which is essential to male sexual health. Recent studies published in The Journal of Sexual Medicine indicate that the use of Propecia can trigger irreversible damage to the male reproductive system.

Patients report:

• Erectile Dysfunction
• Loss of Libido
• Inability to form an erection
• Reduction of semen volume
• Complete loss of orgasm

If you have taken Propecia and have experienced a loss of sexual function you are not alone. Although some men experience some degree of return to sexual normalcy after they stop using Propecia, many unfortunately do not.

Intra-articular pain pumps

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Intra-articular pain pumps are believed to be the cause of postarthroscopic glenohumeral chondrolysis (“PAGCL,” or commonly known as chondrolysis) in shoulder surgery patients. Chondrolysis is a condition that occurs when the normal cartilage cells of a joint are suddenly destroyed leading to a rapid progression of severe arthritis. The shoulder pain pumps are used to deliver various anesthetics directly into the joint via an implanted catheter during the days immediately following arthroscopic surgical procedures.

Between 2006 and 2008, 35 cases of chondrolysis (primarily in the shoulder) were reported to the FDA where the patient was administered continuous intra-articular infusions of local anesthetics. (32 of those patients were administered bupivacaine in the pump.) A study published in The American Journal of Sports Medicine suggests that the continuous presence of anesthetics within the joint causes the cartilage to deteriorate resulting in bone-on-bone contact.

Unfortunately, chondrolysis is a devastating and permanent injury, which can lead to future surgeries and lifelong pain and disability. Treatment of chondrolysis can include multiple costly surgeries, and in some cases requires a prosthetic joint replacement.

These shoulder pain pumps have been marketed and sold by a variety of manufacturers, including: Stryker Corporation, I-Flow Corporation, BREG, Inc., and DJO, LLC.

The most common devices used are:

• Stryker®
• Stryker® PainPump 1®
• Stryker® PainPump 2®
• PainPump® Blockaid®
• I-Flow®
• On-Q® Painbuster®
• Donjoy®
• Donjoy® Pain Control Device
• Accufuser® Plus Pain Pump

Symptoms of chondrolysis include:

• Continued Joint Pain or Stiffness
• Popping or Grinding During Articulation
• Limited Range of Motion
• Decreased Strength

Topamax (topiramate)
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The dangerous drug Topamax (topiramate), has been shown to greatly increase the risk of oral clefts (cleft lip and cleft palate) in the children born to women who have ingested Topamax during their 1st trimester of their pregnancy.

In a safety communication, published March 2011, the U. S. Food and Drug Administration (FDA) warns of this newly discovered risk, and reports that they have reclassified Topamax from Pregnancy Class C to Pregnancy Class D. The FDA explains the reclassification by saying, “Pregnancy Category D means there is positive evidence of human fetal risk based on human data.”

Topamax is approved to prevent seizures and migraine headaches, as well as to treat Lennox-Gastaut syndrome in children and adults. However, Topamax was also used for a variety of off-label uses, including the treatment of psychiatric disorders, obesity, bulimia nervosa, drug and alcohol dependency, and obsessive-compulsive disorder. The subsidiary of Johnson & Johnson that is responsible for discovering/developing Topamax pled guilty in U.S. District Court to illegally marketing the drug for uses that were not approved by the FDA.

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