Drug Recall Attorneys Blog

Drug recall lawyers at Pintas & Mullins highlight a recent study which found that, between 2004 and 2012, dietary supplements made up more than half of all FDA Class I drug recalls. "Class I" refers to recalls of drugs that have a reasonable probability of causing serious health consequences or death.

The study was published in JAMA Internal Medicine, and begins by noting that the FDA recently identified an emerging trend in which dietary supplements are being manufactured with hidden and potentially harmful hidden ingredients. Dietary supplements are defined as products taken orally that contain dietary ingredients meant to supplement the diet. This can refer to anything from vitamins and herbs to weight-loss pills.

Unlike pharmaceuticals, federal law does not require dietary supplements to undergo grueling review before they are sold and advertised. The government does, however, require these manufacturers to use good practices to ensure quality, and test some drugs post-market . Despite this, thousands of dietary supplements are released onto U.S. markets each year contaminated with undeclared pharmaceutical compounds, exposing consumers to harmful and dangerous side effects.

In the eight years studied, 465 drugs caused a Class I recall, and 51% of those were dietary supplements. The three types of supplements with the highest amount of recalls were: sexual enhancement, body building, and weight loss. Sexual enhancement supplements had by far the most, making up 40% of all Class I recalls.

Some of the most recent recalls were for sexual enhancement drugs Vicerex and Black Ant, which are both manufactured by American Lifestyle. Vicerex was discovered to have the drug tadalafil (generic for Cialis) in its ingredients, and Black Ant was found to contain sildenafil (generic for Viagra). Both of these undeclared drugs can cause dangerously low blood pressure among other adverse health effects.

There are about 65,000 dietary supplements currently on American markets, many of which were manufactured abroad. There is an enormous network of supplement manufacturers around the world, the majority of which always seems to be one step ahead of regulatory detection. Once a drug is found to have adulterated substances, standard procedure requires the FDA to contact the manufacturer to trace the contamination and initiate the recall. A recent investigation, however, revealed that the FDA does not possess accurate contact information for about 20% of manufacturers.

In response, the FDA recently initiated a widespread media campaign and created enforcement groups in numerous nations to help improve and spread awareness of this issue. Despite these measures, however, drugs subject to Class I recalls continue to be sold and consumed.

Continue reading "Dietary Supplements Account for Over Half FDA Class I Recalls " »

Drug recall lawyers at Pintas & Mullins report of yet another compounding pharmacy recall, this one initiated by The Compounding Shop of St. Petersburg, Florida. The recall was triggered by problems uncovered during FDA health inspections.

The Compounding Shop is currently in the midst of alerting its customers of the recall while the FDA is recommending healthcare professions quarantine the drugs and not administer any to patients. Since the contaminations at the New England Compounding Center (NECC) in late 2012, there have been about eight recalls spurred by the immense increase in FDA oversight into these compounding facilities.

The outbreak of fungal meningitis from NECC contaminated products was the result of unsterile practices at the company. Several lots of the sterile injections were tainted with fungal bacteria and then injected into patients throughout the country, resulting in the death of 55 people and sickening of more than 740 others.

This devastating contamination forced healthcare officials to re-consider how compounding pharmacies are managed and regulated. Previously, for many years, oversight of these facilities was left largely up to individual state's health departments. Compounding pharmacies were originally intended to mix unique pharmaceuticals for patients with specific needs. The drugs would be ordered by physicians or pharmacists for those patients, and the compounding pharmacies would mix them.

Due to the recent increase in our dependence on pharmaceuticals, these compounding pharmacies have become exceedingly popular, and have even started compounding drugs in mass quantities. Unsurprisingly, the facilities started to overwhelm state health departments, leaving many of the pharmacies to largely regulate themselves, which in turn resulted in the accumulation of unsafe, unsterile conditions.

In light of these developments, the FDA recently started a comprehensive check on these compounding facilities. So far in 2013, along with the nine recalls recalls, the FDA has issued an impressive 43 inspectional observation warnings to U.S. compounding facilities. These observations (compiled in a "483 Form") require the company to promptly respond to the FDA addressing each item, indicating agreements and either providing a timeline for corrections or clarification requests.

Despite the federal agency's attempted increase in oversight, several compounding facilities refuse to cooperate, and with more than 7,000 pharmacies in the U.S., the FDA is having trouble controlling them. The FDA commissioner, Dr. Margaret Hamburg, recently asked Congress for more explicit power in regulating these pharmacies, particularly those that are manufacturing drugs on a large scale. She stated that many of these larger facilities are refusing to let the FDA examine their operations, creating complex legal barriers.

Undoubtedly, these pharmacies are trying to avoid the implications the NECC is now subject to because of its unsterile practices. In the wake of the fungal meningitis outbreak, the NECC filed for bankruptcy and is facing hundreds of lawsuits along with criminal prosecution.

Continue reading "More Sterile Compounded Products Recalled " »

Transvaginal mesh lawyers at Pintas & Mullins recently reported on a Gynecare Prolift plaintiff who won $3.35 million in compensatory damages in her lawsuit against Johnson & Johnson. Jurors recently determined the punitive damage award to be $7.76 million.

The trial took place in Atlantic City, NJ, and was the first of more than 4,000 lawsuits over Johnson & Johnson's pelvic mesh product, which is manufactured by the company's Ethicon unit. The $11.1 million will go to plaintiff Linda Gross of South Dakota, a nurse who was forced to undergo nearly 20 operations due to the defects of the Gynecare Prolift, which was supposed to strengthen her pelvic muscles.

Instead of strengthening them, however, Gross has been living in constant pain for the past seven years, since she was implanted with the device in 2006. At the time of the initial procedure, she was told there were very few risks associated with the device, and that, if need be, it could be easily removed. 18 operations later, Gross maintains that, had she known about the actual risks of the Prolift, she never would have chosen to have the defective product implanted.

Unfortunately, this is also the case for thousands of other women who were misled and deceived by Johnson & Johnson. The Gynecare Prolift was taken off markets in 2012, along with similar products from more than 30 other companies. The FDA banned them after a study linking the transvaginal mesh products to significantly high rates of organ damage and other serious complications.

Four years prior to its banning, however, the FDA revealed that it received over 1,000 reports of serious transvaginal mesh complications. In 2011, the agency again warned there had been a five-fold increase in these complications reports since 2008. Other liable manufacturers include American Medical Systems, Boston Scientific, and C.R. Bard. The C.R. Bard Avaulta mesh implant lawsuits are expected to begin in September 2013 in multi-district litigation. The first trial, which concluded in July 2012, ended with the jury awarding the Avaulta plaintiff and her spouse $5.5 million.

In late February 2013, the Atlantic City jury found that Johnson & Johnson was not only liable for the complications suffered by Gross, but that it failed to warn her surgeon of the risks and fraudulently misled them as well. The damages were meant to deter and discourage the healthcare giant from ever again engaging in this type of deception.

At trial, a forensic economics expert was called to testify about Johnson & Johnson's finances. He stated that the company has assets in excess of $121 billion, with a net worth of nearly $65 billion. It's advertising and marketing expenses alone totaled nearly $21 billion last year, which averages out to $57 million every single day.

Gross's initial compensatory damages award was $3.35 million. The economics expert asserted that Johnson & Johnson spends this amount every 45 minutes, just on marketing and advertising. The company's manager of financial reporting also testified that, in his analysis of Prolift sales between 2005 and 2012, the company earned $128 million, with a profit of $5.6 million, although this was speculated to be significantly underreported.

Continue reading "Johnson & Johnson to pay more than $11 Million in First Vaginal Mesh Case " »

Contaminated food lawyers at Pintas & Mullins announce that Nestle USA recently issued a recall of select varities of its California Pizza Kitchen (CPK) and DiGiorno brand frozen pizzas. Several other popular food brands, like Carson's Deli and Bakery, also recently initiated recalls.

There are four CPK and DiGiorno frozen pizzas affected by the recall: CPK Crispy Thin Crush White, and Limited Edition Grilled Chicken with Cabernet Sauce, and DiGiorno's Crispy Flatbread Pizza Tuscan Style Chicken and the Pizzeria! Bianca/White Pizza. These products were distributed nationwide, and the specific affected production codes may be found here.

These frozen pizzas were recalled due to the possibility of them containing fragments of clear plastic. A number of consumers recently reported that they found plastic in the CPK Crispy Thin Crust White pizza. Upon receiving these reports, Nestle investigated and found that the contamination directly relates to a specific lot of spinach Nestle received from one of its suppliers.

All recalled pizzas were produced during February and March of 2013. Nestle has already instructed its store delivery team to remove the affected pizzas at locations nationwide. The production codes may be found in the blue or pink rectangular box on a side panel of the pizza box. The specific code is on the second line of the printed code and is the first ten digits. Consumers who bought a recalled pizza should contact Nestle Consumer Services at 800.456.4394 or nestlepizza@casupport.com for further instructions. The company will provide replacement coupons to those customers and make arrangements to retrieve the products.

Carson's Deli and Bakery also initiated a recall a few days ago, on April 30, 2013, which affects its Assorted Cookie Pack and Fudge Brownie Cookie. The recalled lots were distributed to five retail stores in New York State's Niagara and Erie Counties.

The Carson's recall was initiated after a consumer complained that the cookie products contained walnuts, which the package did not reveal. The FDA inspected the products and found that there were several other allergens in the ingredients that were not declared on the labels, such as soy and wheat flour. These types of allergies can be life-threatening to people who ingest the allergens without knowing.

The recalled cookies have a "sell by date" of between 4/26/13 and 5/03/13. Consumers with the affected Carson's cookie products can return them to the place they were purchased for a full refund. Questions and concerns may be directed at 716.433.2248.

Prime Foods USA also just issued an Alert about the possible Listeria contamination in its Latis brand Herring Filet "Antalja" in Oil and Herring Fillet in Oil with Spices. Listeria can cause serious complications in those prone to infections and may cause stillbirth in pregnant women. In healthy individuals Listeria poisoning often causes extreme flu-like symptoms. Consumers should return the Herring to the place of purchase or call 718.439.0376 for more information.

Lastly, Krinos Foods voluntarily recalled jars of its Tahini Sesame Paste due to possible Salmonella poisoning. Like Listeria contaminations, Salmonella can be fatal in people with compromised immune systems, or in young children and the elderly. Healthy individuals who ingest Salmonella may experience fever, bloody stool, nausea, and abdominal pain. More severe cases can result in arterial infections, arthritis, and endocarditis.

Continue reading "California Pizza Kitchen, DiGiorno Announce Recalls" »

Dangerous drug lawyers at Pintas & Mullins warn patients taking the acid reflux and heartburn drug Reglan that it has been linked to serious, permanent, and fatal side effects. Similarly, patients taking multiple sclerosis medication Tecfidera may be at risk of developing a fatal brain disease.

Reglan, which is the brand name for generic metoclopramide, is often used to treat Gastroesophageal Reflux Disease (GERD), along with other acid reflux and heartburn conditions. Unfortunately, some Reglan patients are experiencing serious side effects, including Tardive Dyskinesia, which is a disorder involving involuntary movements, particularly in the lower face.

Tardive Dyskinesia can be reversed by stopping Reglan immediately, however, in some cases, the involuntary movements may become permanent or even significantly worse. Symptoms of this condition include repetitive chewing, facial grimacing, finger movement, and jaw swinging. There is no known treatment for the condition.

Another significant and potentially fatal side effect is Neuroleptic Malignant Syndrome, which is a rare disease that can itself cause a wide range of side effects. If not treated properly, this syndrome can be fatal, especially if the medication is taken in higher-than-recommended doses. Symptoms are often immediate and have a severe impact on the body, and include muscle rigidity or cramping, fever, instability, cognitive changes, and convulsions, among many others.

Neuroleptic Malignant Syndrome occurs most often in males, although women have developed the condition post postpartum. However, about 10% of the patients who experience this side effect do die. As a result of this, in February 2009, the FDA announced that Reglan would now come with a black box warning, which alerts patients that the drug may cause serious side effects if used longer than three months. The black box warning states that the elderly, particularly elderly women, were at the highest risk of experiencing Tardive Dyskinesia.

Another drug, Tecfidera, manufactured by Biogen/Idec and used to treat multiple sclerosis, is now associated with a serious and fatal brain disorder called progressive multifocal leukoencephalopathy (PML). The FDA approved Tecfidera just a few months ago in March 2013. Shortly thereafter, medical officials in Germany and the Netherlands (where the drug is called Fumaderm), reported at least four case of patients taking the medication for several years developing PML.

Although the release of Tecfidera was much anticipated in the MS community, scientists are largely unsure of the drug's exact mechanisms of action. PML is a fatal brain disease that inflames the brain's white matter in several separate locations. The disease destroys portions of the patient's brain cells, impairing electrical communications and signals. Symptoms of PML include impaired speech, paralysis, vision loss, and cognitive deterioration, and detection can be accomplished through an MRI. No known treatment for PML exists, and patients usually pass away within four months of diagnosis.

Another multiple sclerosis and Crohn's disease medication, Tysabri, is also associated with PML, with more than 100 reported cases in the U.S. In 2011 the FDA released a Safety Announcement for Tysabri patients, stating that the agency is continuing its evaluation of the risk of PML. The agency also revised the drug's label to include a table summarizing the rates of PML and information on a newly identified PML risk factor: patients who took an immune system suppressing drug prior to taking Tysabri.

Continue reading "Reglan, Tecfidera Carry Serious, Life-Altering Side Effects" »

Dangerous drug lawyers at Pintas & Mullins report that dozens of colleges throughout the country are tightening the rules on A.D.H.D. diagnoses and treatments in effort to curb illegal use of the drugs. Some are re-considering whether or not their student health offices should handle A.D.H.D. treatments at all.

The use and abuse of amphetamine-based medications on college campuses is nothing new - various studies have estimated that approximately 35% of American college students illegally take these drugs, which include Adderall, Vyvance, and Ritalin. Most of these students are unaware that their habit is a federal crime, and have serious side effects like anxiety, depression, and psychosis.

The University of Alabama, Marist College, and California State University, among others, now require students to sign contracts stating they will not misuse or doll out the pills to other classmates. Other schools are forbidding college clinicians to diagnose A.D.H.D. at all, which also prohibits them from prescribing those medications. Students at Marquette University are required to sign releases allowing clinicians to call their parents for medical histories and confirmation of the validity of their symptoms.

One California State University, Fresno student endured two months of testing and paperwork before she was approved for a prescription. She notes that the process deterred some of her classmates from using the university's health office to get an A.D.H.D. medication. Fresno State tightened its regulations after an alarming number of students were requesting an A.D.H.D. diagnosis, which prompted numerous media reports of stimulant abuse and questionable diagnostic processes.

These measures, however, have both legal and ethical implications. The new college policies, for example, are only applying to A.D.H.D. medications, not painkillers or other drugs with high rates of abuse. The chief executive of Children and Adults With Attention-Deficit/Hyperactivity Disorder stated that, if a school is concerned that its students are abusing stimulants, the last thing it should do is outsource diagnoses to unknown community clinics. Stimulant abuse is indeed a serious problem, one that cannot be handed off to someone else off campus.

Many students will simply continue to bring their prescriptions on campus from practitioners back home, where they can be used as motivators to get work done or to make quick cash. The Fresno State student says she was even offered up to $150 dollars per pill during finals week her junior year.

In 2011, Duke University amended its academic dishonesty policy to include any unauthorized use of prescriptions to enhance academic performance, which essentially means that any student caught taking a stimulant they aren't prescribed to would be subject to disciplinary action for cheating.

One year earlier, a student at Vanderbilt University committed suicide one year after being prescribed to Adderall. Throughout that year, the student, who his parents called strong and in-charge, became increasingly paranoid, ultimately stepping in front of a train.

Adderall helped him stay up at night to study and perform well the next day. He would mix it with alcohol while partying, and, because of confidentiality laws, his parents never knew about his bogus Adderall prescription.

Continue reading "U.S. Colleges Attempt to Regulate A.D.H.D Prescriptions " »

Crestor lawyers at Pintas & Mullins affirm that the drug's manufacturer, AstraZeneca, is reporting profit drops of more than 35% due to loss of exclusivity and litigation surrounding its top-seller, Crestor. The popular statin drug is associated with an increased risk of liver and kidney injury, along with other life-threatening health effects.

Crestor, along with its stain counterparts (Zocor, Lipitor, Mevacor, and Vytorin), are cholesterol-lowering medications for patients with high LDL cholesterol at risk for heart attack, stroke, or heart disease. These are among the best-selling drugs in the United States, however, they are also extremely dangerous, particularly when taken in large doses or for a long period of time.

There has been much research in recent years confirming the link between statin use and the development of type 2 diabetes, which is one of the more severe side effects Crestor patients may experience. Prescribing statins to people with elevated blood sugar levels may push them into the diabetic range, even if the risk is relatively low. Experts are still trying to determine the exact cause of the diabetes link, although the increase risk has been reported to be as high as 12%.

There is also a risk of the drug negatively affecting liver and kidney function and causing rhabdomylosis, a rare disease that depletes muscle mass and strength. In fact, the FDA initially withheld Crestor approval because of concerns surrounding a similar medication that caused serious kidney and muscle side effects. It was ultimately approved in 2002, however, two years later, the non-profit organization Public Citizen requested that the FDA remove Crestor from American markets because of its severe side effects.

In response to the Public Citizen request, the FDA issued a Public Health Advisory in June 2004, warning patients of the increased risk of serious muscle toxicity, especially in the highest doses (40 mg). One year later, the federal agency issued another alert stating that many Crestor patients were experiencing serious muscle damage (rhabdomyolysis), and changed the medication's labels to highlight these important risks. In February 2012 the drug's labels again changed to reflect the increased risk of elevated blood sugar levels and consequent development type 2 diabetes.

The muscle breakdown caused by rhabdomyolysis releases muscle tissue into the blood stream and, in time, overburdens the kidneys. This can subsequently cause the kidneys to shut down, which may lead to death if left untreated for any amount of time.

The manufacturer of Vyotrin, a statin similar to Crestor, is also in the midst of serious litigation after numerous studies proved that it was linked to an increased risk of heart attacks and other adverse cardiovascular events. Compounding this is that several experts assert that they believe these statin drugs are not only dangerous, but largely ineffective as well.

Continue reading "Crestor Manufacturer Struggles in Face of Litigation, Patent Loss" »

Actos attorneys at Pintas & Mullins report that a California jury recently awarded $6.5 million to a man who sued Takeda Pharmaceutics after he developed bladder cancer. This is one of more than 3,000 similar Actos cases currently pending in the United States.

The plaintiff in this case, Jack Cooper, obtained an early trial date because of his advanced cancer. He is 79-years-old and suffering from terminal metastatic bladder cancer, which he claims he developed from Takeda's popular anti-diabetic medication. The two-month-long is considered a bellwether trial, meaning that other courts and judges will look to this case as a precedent, to indicate future trends in litigation.

The FDA approved Actos as a treatment for type 2 diabetes in 1999, and, by 2007, it was Takeda's best selling drug. In 2011, the FDA issued a safety warning associating Actos with an increased risk of bladder cancer. One study found that patients taking Actos for more than one year were found to have a 40% elevated risk of developing bladder cancer, and those females taking the drug were five times more likely to suffer from the cancer.

Several European regulators suspected the sale and prescribing of Actos after a study of over 150,000 diabetes patients confirmed these risks. Instead of banning the drug, the FDA decided to add new warnings and information to the drug's label to alert patients of the risks.

Actos' chief rival, Avandia is also currently facing litigation over allegations that it causes adverse cardiac episodes, such as heart attacks. Avandia's manufacturer, GlaxoSmithKline, stopped promoting the drug worldwide in 2011, and it is now only prescribed to those diabetic patients who have exhausted all other treatment methods. Glaxo announced that year that it was setting aside nearly $6.5 billion to cover expenses associated with the Avandia litigation and investigations.

Like Avandia plaintiffs, those injured by Actos are alleging that Osaka, Japan-based Takeda failed to adequately warn patients and healthcare professionals about the risks of Actos to protect its profits. Damagingly, several of Takeda's internal studies showed links to bladder cancer as early as 2004, even though the company did not alert U.S. officials until 2011 (also the year Actos sales peaked, at $4.5 billion, or 27% of Takeda's total revenue).

This was undoubtedly because diabetes medications are a big deal in the United States, where 8.3% of the population has diabetes. Other damaging Takeda internal documents produced during the California trial included those in which executives urged each other to persuade the FDA to not include bladder cancer warnings on Actos labels. It was, ultimately, the company's responsibility to fully disclose the drug's risks upon introduction into U.S. markets - a responsibility it did not take seriously, at the peril of thousands of already ill patients.

Other witnesses testified that Actos executives indeed put drug sales ahead of consumer safety, proving their claims through multiple 2005 e-mails. The documents detail attempts to persuade FDA and European regulators in various levels of Takeda management. Officials stated that the worst case scenario for them would be for global regulators to mandate the addition of a bladder cancer warning on the drugs' labeling, and they therefore had to act "carefully and successfully."

Continue reading "First Actos Plaintiff Awarded $6.5 Million" »

Product recall lawyers at Pintas & Mullins report on the most recent products taken off the market due to the increased risk of entrapment and choking. Carter's alone has recalled more than 200,000 of its one-piece, footed cotton clothing for infants.

The Carter's recall involves eight styles of the infant onesies, which have a zipper from the foot to the neck and were sold in sizes newborn, three, six, and nine months. The following imprints are printed on the fabric inside the neck collar: Baby's B'gosh, Child of Mine, or Just One You. These products were sold at OshKosh B'gosh, Target, and Walmart between December 2012 and January 2013 nationwide. The zippers on these products can become detached, posing a choking hazard to young children.

Parents are urged to take the recalled clothing immediately away from infants and return them to Carter's for a full refund. The company may be contacted at 888.282.4674, or online at carters.com (click on the Product Recalls tab). A comprehensive list of all the affected products may be found here.

A second recall was recently announced by Children's Apparel Network, affecting more than 9,000 of its Girl's Three-Piece Clothing Sets. The vests that come with these sets come with a belt that could become caught in small or protruding spaces (such as vehicle doors) and poses a risk of entanglement. The recall involves girl's "Young Hearts" brand sets, which were sold with a pink vest, black pullover shirt and knit pants in sizes 12 months to 6X.

"Young Hearts" is printed on the inside shirt label of the affected products, along with a black bow on the left front and pink elastic belt with silver clasps. The Consumer Product Safety Commission (CPSC) urges consumers to immediately remove the pink belt from the vest to eliminate the hazard or return the product to the store where it was purchased for a full refund. The Young Hearts sets were sold primarily at Conway, Citi Trends, Duckwall-Alco, and on Amazon.com from September 2012 to December 2012.

A third recall was recently initiated by the Land of Nod retail store, affecting more than 2.500 plush dolls. The small hands on these dolls can easily detach, posing choking hazard to young children. The CPSC has already received at least one report of the doll hand detaching and three of the hands loosening. The plush dolls were sold at the Land of Nod retail store and on its website, between October 2012 and March 2013, for about $30.

The dolls come in five styles and colors, made completely of fabric, and are about 12 inches tall. They are dressed in a one-piece printed floral fabric with a white lace trimmed bonnet over the head. They include the Clara doll in yellow, Eleanor doll in light blue, Hannah doll in cream, Lila doll in dark blue, and Rose doll in red.

Continue reading "Recent Children's Products Choking Hazards Recalls " »

Januvia and Janumet lawyers at Pintas & Mullins report of some troubling new studies recently published linking the diabetes medications with an increased risk of pancreatitis and pancreatic cancer. As two of the nation's largest drug companies, Merck and Pfizer, team up to develop a new type 2 diabetes medication, other treatments are further sickening patients already ridden with diabetes.

There are nearly 26 million people in the United States currently battling diabetes, making it one of the leading causes of death in the country, and responsible for about $170 million in health care costs. Nearly every major pharmaceutical company has a hand in diabetes treatment, although some treatments are coming with their own life-threatening side effects.

This is clearly a very competitive field of research, and Merck and Pfizer's new drug, an oral sodium glucose cotransporter (SGLT2) inhibitor is about to begin phase III studies, ushering in a new class of antidiabetic drugs. Johnson & Johnson also just introduced a new SGLT2 inhibitor, and Lilly/Boehringer and Bristol-Meyers have something on the horizon as well. This news is particularly welcomed because the older classes of antidiabetic drugs are causing serious and life-altering side effects in many patients.

There has recently been uproar among patients and healthcare professionals over the very real risks associated with diabetic drugs in the incretin mimetic class. These drugs, which include the wildly popular Janumet, Januvia, Byetta, and Victoza, among others, are now associated with a significant risk of pancreatitis and pancreatic cancer. Between October 2006 and February 2009, the FDA received 88 reports of patients taking these drugs developing pancreatitis (although it should be noted that this number is a significant under-representation, as all cases reported to the FDA are voluntary.)

Other diabetes drugs, such as the former blockbuster Avandia, later proved to have an increased risk of heart attack in patients, and is now restricted only to those who have tried and failed to respond to other treatments. Avandia is also now banned in Europe.

As a result of these problems, the FDA is requiring Johnson & Johnson to conduct five long-term studies, in addition to those already required of new drugs, for its SGLT2 inhibitor, Invokana. The agency is requiring Johnson & Johnson to look in into the long-term effects on patient's cardiac, liver, and pancreatic health, along with any potential carcinogenic properties. This will cost the company hundreds of millions of dollars, however, Reuters is projecting Invokana to have potential sales of $416 billion by 2016.

Meanwhile, Merck's only significant commitment to the billion-dollar diabetic industry is with Januvia. With its new partnership with Pfizer, and their joint-development of a SGLT2 (called ertugliflozin), the companies are hoping to reestablish the trust diabetes patients lost in Merck with Januvia and Janumet.

In early 2012 the FDA sent Merck a warning letter for failing to conduct post-market studies for Januvia and Janumet, which was required of them if the FDA was going to approve any new supplemental drugs. For some reason, Merck failed, or was unable, to meet the deadlines for these submissions, raising suspicion in the medical community.

Despite this, in 2011, Januvia and Janumet totaled nearly $5 billion in sales even as the drugs put thousands of patients at risk of pancreatic problems. In the warning letter, the FDA told Merck that it had not provided adequate explanation for the extensive delay, and that it faces up to $250,000 in fines for each violation. Forbes reported that the agency was genuinely angry, and that it was considering fines of up to $10 million.

Continue reading "Developments in Diabetes Treatment Reflect the Best and Worst of Big Pharma " »

Drug recall lawyers at Pintas & Mullins report of two additional compounding pharmacies that recently issued major recalls. The first was Florida-based Balanced Solutions Compounding Pharmacy and involves all lots of its sterile drug products. The second was an Indianapolis compounding pharmacy, Nora Apothecary Alternative Therapies.

Nora Apothecary is recalling nearly 100 of its compounded drugs after federal investigators discovered problems in the facility's safety policies. The recalled drugs were made on or before April 19, 2013. During inspections, the FDA found quality control problems that could have potentially affected the sterility of its products. Lack of sterility can cause infections, ranging from mild to fatal.

One of the more extreme examples occurred late in 2012, when an outbreak of fungal meningitis affected hundreds of patients throughout the country. The outbreak, caused by the unsterile environment of the New England Compounding Center, ultimately killed 51 people and sickened 700 more. Since this, the FDA and state authorities have investigated 55 similar compounding pharmacies, and are keeping a watchful eye on dozens more.

The FDA Commissioner, Margaret A. Hamburg, recently assured the House Energy and Commerce subcommittee that the agency is being much more aggressive now than it ever has before with these types of facilities. Compounding pharmacies, unlike major drug manufacturers, mix pharmaceuticals for individual patients based on their unique prescriptions.

Because there is no way the FDA could be responsible for the oversight of these new, specialized medicines, of which there are millions on a daily basis, it was delegated to each state's board of health. However, due to industry lobbying groups and state's failure to adequately oversee the facilities, the FDA was left with ambiguous authority over compounding pharmacies, which turned out to have catastrophic consequences.

Unfortunately, the practice on compounding medication has evolved in recent decades and outgrown the law in many areas. Many pharmacies are now mass-producing drugs, more resembling larger manufacturers (such as Pfizer) that are regulated by the FDA. The federal agency is now seeking the right to inspect these pharmacies and obtain samples of drugs and records.

So far there have been nine recalls of compounded and repackaged drugs, one of the most recent being from Balanced Solutions. The FDA encouraged health care centers who have received products from this facility to immediately quarantine the products and follow recall instructions. Additionally, patients who were administered any of the recalled drugs from any of these nine pharmacies should contact their physicians.

In an investigation, the FDA sampled chromium chloride injections from the pharmacy and identified bacteria, which can cause disease and infection in patients. Balanced Solutions is a faction of Axium Healthcare Pharmacy, Inc.

Continue reading "Two More Compounding Pharmacies Issue Recall" »

Metal-on-metal hip implant lawyers at Pintas & Mullins report that more than 11,000 consumers recently asked the FDA to re-classify all high risk implants, such as those made by Stryker and DePuy. The reclassification would require the manufacturers to prove that these medical devices were safe and effective before they can be put on the market.

The letter, sent by the Consumer's Union, urged the federal agency to subject these implants to a premarket approval process (PMA), which is a scientific and regulatory review. It is the most rigorous type of device marketing application required by the agency, and is based on adequate legitimate scientific evidence that the device is effective and safe.

About two months ago, in February 2013, the FDA proposed this very action, although it has not yet made a final decision. The Consumer Union letter was written in attempt to persuade the agency to adopt the proposal in whole. All U.S. residents may comment on FDA proposals. Comments are due for this action by May 28, 2013, and a link to which may be found here.

Hundreds of thousands of patients have been seriously injured by these metal- on-metal implants; among the most common include early device failure, metallosis, and other internal injuries. Metallosis occurs in many patients because the implants are made from a metallic blend that generates high levels of metal ions. These small metal particles can release into the body when corroded, often causing metallosis and premature device failure. Symptoms of this condition include swelling or pain around the implant site, loosening of the device, changes in walking ability, and sounds coming from the implant. The condition can cause severe bone and tissue damage, and may render patients permanently disabled. If the metallosis goes untreated for a long period of time it may lead to severe cognitive and cardiac damage and even death.

Traditionally, hip and knee implants were made from plastic, and lasted about 15 years before wearing out. The monetary and physical costs of replacement surgeries are extensive, and metal-on-metal implants were designed to be longer lasting. Due to authoritarian mishaps, hip implant manufacturers were only required to demonstrate that the products were similar in design to hip implants already on the market before being approved by the FDA. Since these metal-on-metal devices were indeed similar to other plastic implants, the agency did not require and safety testing before it released the devices onto U.S. markets.

The result of this is dangerous, even catastrophic in certain patients. Thousands of patients have filed lawsuits against the various manufacturers responsible for these injuries, which include Stryker, DePuy, Biomet, and Zimmer. The specific products subject to lawsuits include the DePuy ASR and Pinnacle, Biomet M2A Magnum, Zimmer Durom, and Stryker Rejuvenate.

Recently, in March 2013, a jury ordered Johnson & Johnson (the parent company of DePuy) to pay $8.3 million to a patient implanted with the ASR XL hip implant. The man, Loren "Bill" Kransky, accused the company of knowingly marketing a defective implant, which was later recalled. After being implanted in 2007, Kransky experienced premature failure and was forced to undergo a painful revision surgery. He testified that, as a result of the defective device, he had to live in constant pain, was unable to walk, and suffered from metal poisoning.

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Green Valley Drugs, of Henderson, Nevada, is voluntarily recalling all lots of its sterile products. Drug recall lawyers at Pintas & Mullins announce that this is the fifth recall since the outbreak of fungal meningitis from the New England Compounding Center (NECC) killed 51 people and sickened 700 more.

Since the fatal NECC outbreak in late 2012, the FDA has investigated more than 30 similar compounding pharmacies and kept a watchful eye on dozens more. Those recent inspections led to national recalls, warning letters, and shut-down notices for Med Prep Consulting, Pallimed Solutions, Clinical Specialties, Medi-Fare Drug and Home Health Center, and now, Green Valley Drugs.

There are more than 7,000 compounding pharmacies in the U.S., which are licensed and overseen not by the FDA, but by individual state's boards of health. Such facilities mix and manufacture prescriptions on a patient-by-patient basis, to fill unique and specific prescriptions that large drug companies, such as Pfizer or Johnson & Johnson, cannot. There is such a large demand for these drugs, however, that hundreds of facilities started (illegally) mass-manufacturing these products, without notifying or adhering to the FDA and its sterility standards.

The results of this practice have proven dangerous, even devastating to some patients. The recall initiated by Clinical Specialties, for example, was spurred by the death of one man and sickening of dozens of others from eye injections that were contaminated with bacteria. The drug, Avastin, is a cancer drug, although the company was mixing it in apparently unsterile doses to treat patients with a rare eye condition. Another recall, by Med Prep Consulting, was initiated after visible particles of mold were found in at least five of its IV medications. The pharmacy agreed to suspend shipping and manufacturing operations while the syringes, bags, and vials of premixed solutions were recalled.

This most recent recall by Green Valley Drugs was based on observations made by investigators into the facility's clean room personnel and certain aseptic techniques. The recall affects all lots of its sterile products, and notification letters went out yesterday, on April 11, 2013. The products were distributed nationwide, and a full list of the affected products can be found here.

Fortunately, this recall is in effort of sterility assurance, and no ill or injured patients have yet been reported. Green Valley stated that, until further notice, health care providers should stop using all lots of its sterile products and immediately return them to the company's headquarters in Nevada.

The increase in oversight that led to these numerous recalls and shut-down notices is long past overdue. Many experts noted that the deadly fungal meningitis outbreak was merely a calamity waiting to happen. This is because compounding pharmacies lack regulation due to the specificities of its products. There is no conceivable way that the FDA could be responsible for the magnitude of new, specialized medicines that are requested by health care facilities on a daily basis. So, this responsibility of oversight was given to state boards of health.

Unfortunately, too many state boards entrusted the pharmaceutical companies to largely govern themselves, which led, as it always does, to abuse of the system. Dr. Margaret Hamburg, FDA commissioner, recently asked Congress for explicit power to regulate those compounding pharmacies that are producing drugs on larger scales. She stated that an alarmingly high number of these facilities are not cooperating with the federal agency, refusing to let it inspect facilities and creating complex legal barriers to prevent them from doing so.

Continue reading "Yet Another Compounding Pharmacy Issues Recall " »

SJS and TENS lawyers at Pintas & Mullins report of the latest class of drugs that may induce Stevens - Johnson syndrome (SJS): sulfa-based antibiotics. Recently, a 34-year-old man sought treatment for an upper respiratory tract infection and he was prescribed ciprofloxacin, which ultimately caused his SJS.

The patient went to his family physician for his minor throat condition and was prescribed ciprofloxacin, an antibiotic classified as a sulfonamide. Sulfa-based drugs have an array of serious side effects, including liver or kidney damage, allergic reactions, neurological symptoms, and gastrointestinal effects. The young man in this case, however, was unaware of the risk he was taking with this medication, and started on the week-long regimen immediately.

Five days into his regimen the man started running up a high fever, chills, sore throat, and general weakness and discomfort. His symptoms worsened until he was hospitalized, where doctors discovered several mucocutaneous lesions, which are painful ulcers on the skin. In the next few days, the man's skin erupted in these lesions, largely around his mouth, that were so painful he was completely unable to eat or drink.

Hospital physicians were mystified and unable to uncover the source of his illness until one medical student uncovered a detailed history of his medical records. It was then discovered that he had a previous outbreak of erythema multiforme, which is a skin disorder from an allergic reaction. Physicians realized he was allergic to sulfa-based medications, and that the ciprofloxacin antibiotic was responsible for the outbreaks.

In the ensuing days, in part due to the delay in treatment, the patient's lesions worsened until he was diagnosed with SJS, which is the most severe form of erythema multiforme. The lesions around his mouth quickly spread to the rest of his face, causing much of his skin to slough off, and rendering hi partially blind, most likely for the rest of his life.

Unfortunately, an SJS side effect, though rare, is associated with a wide range of drugs, perhaps most troublingly with Children's Motrin. About ten years ago, a seven-year-old girl in Massachusetts took the popular pain killer and developed the most severe form of SJS, known as toxic epidermal necrolysis (TENS). The little girl lost more than 90% of her skin and was permanently blinded. The TENS spread to her lungs and brain, her internal organs so swollen that doctors had to place her in a medically-induced coma.

Her family sued Motrin manufacturer Johnson & Johnson in 2007 and received $63 million in compensatory damages. They alleged the company failed to disclose information about the risk of life-threatening reactions to the over-the-counter children's medication.

Other drugs associated with SJS and TENS include anti-gout medications, NSAID pain killers, penicillins, and anticonvulsants for seizure disorders. Stanford Hospital estimates that about one in 10,000 patients using Dilantin, an anti-seizure drug, will suffer an SJS reaction. In 2008, the FDA alerted that Dilantin had an increased risk of SJS and TEN developments in those with Asian ancestry.

One woman who suffered the devastating reaction is taking her claim all the way to the Supreme Court. Karen Bartlett was prescribed a generic NSAID pain medication after experiencing should pain in 2004. She developed SJS, causing two-thirds of her skin to slough off her body. She was placed in a medically-induced coma for several months until she was able to be admitted to a burn unit, where she remained for two more months. Doctors called her experience a hell on earth; she still suffers from permanent lung and esophagus damage and is legally blind.

Continue reading "Stevens-Johnson Syndrome from Sulfa-Based Antibiotics " »

Mirena lawsuit attorneys at Pintas & Mullins report a new development in the litigation involving injured Mirena IUD users. A federal judicial panel recently ordered all Mirena IUD cases to be consolidated into a multi-district litigation (MDL) in the Southern District of New York. This consolidation will allow those injured by the Mirena IUD to more efficiently receive compensation for their suffering.

To be eligible for an MDL, the group of lawsuits against a particular brand or drug must involve at least one common complaint. The transferee court, in this case, the Southern District of New York, will control the pace and scope of the trial. It will allow most expert witnesses to testify only once, and benefit the plaintiffs by ensuring they are all treated with consistency and fairness. Additionally, the publicity surrounding an MDL may cause new plaintiffs to come forward who would have otherwise not known that they were eligible to receive compensation for their injuries and medical bills.

The judicial panel ordered this consolidation because it was clear that most Mirena plaintiffs were claiming similar injuries from the dangerous device. More than 45,000 women throughout the United States who were implanted with the IUD have reported significant adverse side effects to the FDA. The most common and recurrent issues include perforation and forced surgical removal. Many women have had to undergo complete hysterectomies at a very young age, some even before they had a chance to bear children at all.

In one of the first lawsuits filed against Mirena manufacturer Bayer, a woman in Arizona alleged that the IUD spontaneously migrated into her pelvic region three years after its insertion. The device went through her uterus, to which she experienced extensive damage and severe and permanent injuries. The woman, like thousands of others, was never warned that spontaneous perforation and migration was a possibility. Had she known about this risk, she would not have chosen to have Mirena implanted.

About two million women in the U.S. use Mirena, trusting the device to work as promised, safely in the most precious of their organs. The grim reality is, however, that Bayer fraudulently concealed the risks of the device to these women. Most are wholly unaware that the IUD could migrate, puncture the reproductive organs, and lead to permanent infertility. Some women have suffered ectopic pregnancies from such migration, which is a pregnancy that occurs outside the womb. Ectopic pregnancies must always be terminated through a painful procedure and are potentially life-threatening.

Mirena migration can only be corrected through an invasive surgery called a laparoscopy. Women forced to undergo such a procedure are also placed at a higher risk of adhesions to the reproductive organs, which can in turn cause infertility. Plaintiffs are alleging that Bayer's failure to make these side effects known to consumers was purposeful, done to increase profits of this already multi-billion dollar company. This concealment is a violation of basic consumer rights, as is the company's blatant exaggeration of the IUD's benefits.

The known and documented health risks associated with Mirena only continue to mount. They range from minor, such as headaches and nausea, to devastating. One study published in the American Journal of Obstetrics and Gynecology found that the IUD was associated with significantly higher rates of herpes, gonorrhea, complaints of expulsion, and unintended pregnancies.

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