Drug Recall Attorneys Blog

Mirena IUD lawyers at Pintas & Mullins report that a federal judge in New York recently encouraged plaintiff's lawyers to include women in the leadership committee given the nature of the cases. More than 50 lawsuits are currently consolidated in the New York court, with over 100 more pending in state courts.

This assertion took place during the first status conference over the Mirena multi-district litigation (MDL) in White Plains, NY, when four male lawyers asked to be appointed to the executive committee for the proceedings. The U.S. District Judge, Cathy Seibel, urged the attorneys to include at least a few women in their leadership ranks, stating that a female presence, particularly for this specific case, was important.

Further emphasizing this point was the disagreement among other plaintiff's lawyers who were not entirely happy with the all-male leadership. In a May 2013 letter to Judge Seibel, for example, a lawyer from Michigan argued that the female plaintiffs would certainly benefit from at least some qualified female attorneys who could not only better relate to their struggle but promote empathy to a jury as well.

The letter went on to note that Bayer, the defendant in the Mirena cases, is likely to use gender strategically when choosing its lawyers. Currently, Bayer's lead lawyer is a woman. One of the proposed leads for the plaintiffs asserted that, along with the four-member lead committee, plaintiffs want to select a separate, larger committee to steer the litigation efforts.

A bigger committee such as this would help fund litigation costs as well as give the case the power it needs to organize and prepare for the major testimonies and trial proceedings. Experts are expecting thousands of Mirena lawsuits to be filed in the MDL by the time it goes to trial.

All of these lawsuits are being filed on behalf of female patients who were implanted with the Mirena IUD without knowledge of its possible risks and complications. As a result of this negligent and fraudulent lack of disclosure, many women suffered significant and life-altering injuries from the IUD, such as the IUD piercing the uterine wall and migrating into other organs, necessitating surgical removal. Because the IUD was marketed to women who had not yet had children, hundreds of patients are now permanently infertile as a result of this spontaneous migration and will never be able to bear children.

Bayer contends that, since Mirena's introduction in 2001, the company adequately warned about the risk of perforation and migration. It further claims that it warned both doctors and patients to monitor the device's placement by consistently checking for the thread attached to the device, and that, had the company warned about the possibility of spontaneous migration, doctors would have continued to recommend the IUD anyway.

After the initial conference, an attorney stated that the lawyers for plaintiffs would meet in ensuing days to select a steering committee, which will include more gender diversity. In related news, the first lawsuit alleging injuries from the transvaginal mesh product Gynecare Prolift recently concluded, awarding the plaintiff more than $11 million. It was the first transvaginal mesh lawsuit of more than 4,000 currently pending over Johnson & Johnson's defective product.

Continue reading "Judge Calls for More Female Lawyers for Mirena IUD Litigation" »

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" »

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 " »

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.

Continue reading "Consumers Urge FDA to Review Metal on Metal Hip Implants " »

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 " »

Dangerous device lawyers at Pintas & Mullins report that the FDA recently proposed new requirements for automated external defibrillators (AEDs) manufacturers, which will include increased premarket approval requirements. This action is the result of the numerous AED malfunctions and recalls in recent years, which the FDA says proves that the current rules are unsuccessful.

AEDs are portable devices that are often seen in offices, schools, and shopping malls, and are always carried by emergency response crews. They are used to shock hearts back into rhythm that have experienced a sudden cardiac arrest, and are made by companies like Royal Philips Electronics NV, which is based in Amsterdam.

Between 2005 and 2012, reports of AEDs malfunctioning numbered about 45,000 and 88 different products were recalled. The chief scientist of the FDA's Center for Devices and Radiological Health stated that the agency does not have confidence in the AEDs currently on market.

Sudden cardiac arrest stops the human heart completely, and typically causes death within just a few minutes, before emergency response teams can arrive at the scene. In the U.S. alone there are about 300,000 sudden cardiac deaths each year.

Once the new FDA regulations are made final, manufacturers will be required to complete pre-market applications and submit clinical data with the findings of the risks of illness or injury. If a premarket approval is not filed for an AED within 90 days after the final order, the device will be deemed defective, and may not be placed into distribution. However, because AEDs are so widespread and critical to saving lives, the FDA proposed that the devices may be accepted as long as the manufacturer notifies the agency within 90 days saying it intends to file a premarket approval. The FDA will wait 15 months after the final order to exercise enforcement.

The FDA believes that most AED distributers already have enough clinical data to support a premarket approval, and it is not expecting any AED shortages throughout the country. The new requirements will become official at the end of 2014, and manufacturers will be required to pay more than $245,000 per application for the FDA to review before it can be placed back on the market.

In 2012, many AEDs were recalled because they contained a defect that would cause the device to not deliver defibrillation. Because of the seriousness of this, the FDA initiated a Class I recall to numerous devices, meaning the defects pose significant risk of severe injury or death.

External defibrillators are not the only heart devices experiencing mass malfunctions. St. Jude recently recalled two of its Riata Defibrillator Leads, which are implanted internally. Unfortunately, due to delays and miscommunications, nearly 80,000 patients are still living with the recalled devices inside them.

If a defibrillator malfunctions, several serious outcomes may occur, all of which will require immediate medical attention. The lead wires connect directly to the heart, and if they malfunction, detach, or break, the device is then unable to sense irregular heartbeats, and will be completely unable to provide the electric shocks required to keep the patient alive. Like AEDs, the lead wires in internal defibrillators were never required to undergo any human testing before they were released onto markets.

Continue reading "FDA Increases Regulations on Defibrillators as Recalls and Malfunctions Mount " »

Contaminated drug lawyers at Pintas & Mullins announce yet another recall initiated by a compounding pharmacy, this time Pallimed Solutions of Woburn, Massachusetts. The company is recalling all sterile compound products distributed since January 1, 2013.

The recalled products from this pharmacy were distributed to patients and healthcare facilities in 21 states, including California, Florida, Illinois, New York, Texas, and Wisconsin. The FDA is urging anyone who received Pallimed products to immediately discontinue use and return the product to Pallimed. All consumers receiving recalled products - which include eye treatments, erectile dysfunction, and hormone replacement therapies - can expect to be notified by the company via telephone, fax, or mail. A comprehensive list of all recalled products can also be found here.

Regulators reportedly found foreign matter in certain vials of drugs used for injections at the pharmacy, causing the state board to order Pallimed to stop producing its sterile products. The board also required Pallimed to quarantine the products in its possession, and initiate this recall to avoid any patient infections from the contamination. The pharmacy will continue to produce and distribute its non-sterile products.

State and federal governments have significantly increased the oversight into compounding pharmacies after the outbreak of fungal meningitis in 2012, which continues to infect patients still today. The facility responsible for the outbreak, the New England Compounding Center, is also located in Massachusetts, only about 30 miles from Boston, where the Department of Public Health operates from. The fungal meningitis outbreak has so far killed about 50 people and injured more than 700 others.

The New England Compounding Center is now facing dozens of lawsuits from the mold contamination and recently filed for bankruptcy protection. Dozens if not hundreds of other affected patients are expected to file lawsuits in the months to come, as patients continue to be infected.

This most recent recall comes only about a week after another compounding pharmacy, Clinical Specialties, recalled its Avastin medications after one man died and dozens of others were sickened. This recall was announced after five initial reports were released of patients contracting eye infections from the drug, which was contaminated with bacteria. Avastin is an intravenous cancer drug, although Clinical Specialties allocated it into smaller doses to treat patients suffering from wet macular degeneration, an eye condition.

A third compounding pharmacy recall was recently announced from New Jersey's Med Prep Consulting, which suspended its operations when mold particles were visible in some of its IV medications. The pharmacy agreed to cease manufacturing and shipping while the syringes, bags, and vials of premixed solutions were recalled. Mold was found in at least five bags of vital injections drugs at a Connecticut hospital, which sparked the recall.

Due to the recent fatal contaminations, state and federal authorities have significantly increased the scrutiny over compounding pharmacies, which undoubtedly led to the two most recent recalls at Clinical Specialties and Pallimed. This increase in oversight, however, is long overdue, as experts state that the deadly outbreak of fungal meningitis was merely a calamity waiting to happen.

This is because compounding pharmacies are not as strongly regulated as major drug manufacturers, such as Pfizer or Johnson & Johnson. Compounding pharmacies mix specific drugs for individual patients, which is something larger drug companies do not do. Unfortunately, these new, specialized drugs are not subject to FDA-approval, and are mixed in facilities that are not consistently inspected.

Continue reading "Another Compounding Pharmacy, Pallimed, Announces Recall " »

Dangerous drug lawyers at Pintas & Mullins recently reported of the story of a woman, Karen Bartlett, who took a generic form of a pain medication and developed Steven John's Syndrome, which permanently damaged her lungs, esophagus, and rendered her legally blind. Bartlett was initially awarded $21 million by a state jury trial, but her case was appealed all the way to the Supreme Court, where it now stands.

CNN reporters observing the proceedings have stated that it will be difficult to anticipate how the justices will rule in this case, as the bench appeared cautious while Bartlett's condition was debated before them. The defendant, Mutual Pharmaceuticals, is arguing that it received FDA approval and that, because it is required to use the same ingredients, labels, and warnings as the brand-name drugs, it cannot comply with safety and marketing regulations.

Justice John Roberts highlighted the state jury's decision, which found that the risks of Sulindac, the pain medication, outweighed the benefits, and that it should not have been marketed in the first place. Justice Roberts affirmed that this was indeed inconsistent with the initial FDA approval.

Justice Elena Kagan stated that Mutual Pharmaceuticals could be held responsible for the generic's defects, stating that this case extends to both generic and brand-name drugs, and that the two go hand-in-hand when discussing the drugs' design defects.

Karen Bartlett's story illuminates the catastrophic and devastating effects pharmaceuticals can have on an unsuspecting patient. Bartlett suffered from shoulder pain, and was prescribed a generic form of Sulindac, from which she developed a rare hypersensitivity reaction known as Steven John's Syndrome (SJS). This side effect caused her skin to burn off, leaving open wounds all over her body, even more severe than third-degree burns.

She was placed in a medically-induced coma for 100 days, and had to stay in a hospital burn unit for two months after that. Today, nearly a decade later, she is permanently blind, has undergone 12 surgeries, and suffers from irreversible damage to her lungs and esophagus. She needed help standing in the Supreme Court plaza after the arguments, led down the steps by her lawyer.

In recent years, the Supreme Court has been faced with numerous cases concerning the generic liability from defective drugs. Drug companies such as Mutual repeatedly argue that they should be exempt from product liability lawsuits if the drugs in question have met federal safety approval regulations.

In 2012, the Supreme Court upheld this argument when it ruled, five to four, that generic manufacturers do not share the same levels of responsibility as brand-names. Specifically, it found that generics did not have to update warning labels when significant new risks and adverse events are reported. In this case, the Court ruled that Congress, not the courts, should change the law on generics if it sees fit.

Bartlett based her case on the claim that the drug itself, whether generic or not, was unsafe. A federal appeals court supported this claim, stating that Mutual should have simply taken the medication off the market after receiving initial reports of its excessive dangers.

Continue reading "Safety of Generic Drugs Argued in Supreme Court " »

Dangerous drug lawyers at Pintas & Mullins remind the public of the very real risks of taking over the counter drugs, such as Tylenol, that contain acetaminophen. This ingredient can cause life-threatening liver failures, and about half of overdoses are accidental.

Many medications label acetaminophen as "APAP," which misleads many consumers who may not recognize the abbreviation and cause them to accidentally overdose. Nearly a decade ago, one of these consumers, Anthony Benedi, started taking Tylenol Extra Strength to treat symptoms from the flu.

After taking the medication for several days, always adhering to recommended doses, Benedi fell into a coma and was hospitalized. His liver had failed, and doctors told his family he would require a full liver transplant, which he received in February 1993.

Benedi filed a lawsuit against Tylenol manufacturer McNeil Consumer Products, which is a subsidiary of Johnson & Johnson. During the lawsuit, the company argued that Benedi regularly drank wine with dinner, and that alcohol consumption can make the liver more sensitive to Tylenol, rendering it more prone to damage. Benedi argued that, while this is true, Johnson & Johnson failed to warn the public about this fact. Benedi wound up winning $8.8 million because Tylenol Extra Strength did not include adequate warnings on its labels. An appeals court upheld this verdict two years later.

Surprisingly, as it turns out, Tylenol is the number one cause of liver failure in the United States - even more than alcohol. More than 40,000 Americans overdosed on Tylenol in 2011, which ultimately resulted in over 16,000 liver failures. At least 600 medications have acetaminophen as an active ingredient, both in prescription and over the counter drugs.

Recent studies found that at least half of Tylenol overdoses are due to the large number of medications that contain acetaminophen. Doctors recommend a maximum dosage of 3000 mg of the ingredient over a 24 hour period, although liver failure can occur at lower dosages.

In 2011, in order to reduce the number of accidental overdoses, the FDA required prescription drug manufacturers to reduce the amount of acetaminophen in drugs to no more than 325 mg per tablet. Alarmingly, this requirement did not apply to over the counter medications, even though pills of Extra Strength Tylenol contain 500 mg of acetaminophen.

Additionally, the FDA required all drugs containing acetaminophen to include a black box waning informing consumers of the risk of liver damage and failure at more than 4000 mg per 24 hours. It also required dosing recommendations to lower from four - six hours to six hours.

Consuming alcohol activates enzymes that turn acetaminophen into a chemical that can cause liver damage, similar to the damage done to the liver through binge drinking. The more the alcohol and/or acetaminophen consumption, the more likely the chemicals are to cause liver failure and, ultimately, death. Unfortunately, several college students have died from this dangerous combination in recent years, when they took Tylenol to either treat or prevent a hangover.

Acetaminophen is the key ingredient in other incredibly common medications, such as Nyquil and TheraFlu, and Americans are constantly and unknowingly putting themselves in grave danger by combining these drugs with alcohol. The average American has no idea what acetaminophen even is, much less that it has deadly side effects, and that it is an active ingredient in hundreds of common medications.

Continue reading "Tylenol may Lead to Fatal Liver Failure " »

Stryker device lawyers at Pintas & Mullins report that the company recently received an FDA warning letter for failing to notify the agency of an extensive product recall and for other quality concerns.

In November 2012, the FDA inspected Stryker's instruments division in Portage, Michigan. In the warning letter, the agency cites numerous observations made from that inspection concerning quality system failures. Earlier in 2012, Stryker initiated a Class I recall of its Neptune Rover Waste Management Systems, meaning the devices could cause serious injury or death in patients.

The Neptune products are intended to amass and dispose of surgical waste in operating rooms and facilities. One device, the Neptune 2 Ultra, eliminates the smoke generated by electro or laser devices used in surgical sites. All Neptune systems were recalled after two reports of serious tissue damage injuries were received. In one fatal event, a doctor was attempting to connect a Neptune 2 to a chest drainage tube after a surgery. The patient died, although there was no warning on the devices stating that connecting the system to a passive chest drainage tube was dangerous.

Stryker initially failed to notify the FDA about this Neptune recall. The company is also under fire by the FDA for marketing its Neptune Silver and Neptune 2 devices as safe and effective, although they do not currently have a 510 (k) clearance, which is required. A 510 (k) clearance requires device manufacturers to register with the FDA within 90 days before starting to market a device. This is also known as a premarket notification, or PMN. Advanced notification allows the FDA to fully evaluate whether the device being marketed is safe and effective. Stryker has reportedly submitted corrective action plans to the FDA about how they will resolve the quality system observations and recall issues.

This is not the first time Stryker has attempted to side-step federal regulations. In 2012 Stryker was ordered to pay the U.S. Department of Justice $33 million for marketing a knee device that was not cleared by the FDA. In 2007, the company paid the government $16 million over allegations of fraudulent health care billing. That same year, the FDA inspected Stryker plants in Cork, which led to all devices manufactured at that plant to be permanently taken off the market. The company spent $50 million bringing its facilities up to federal standards.

One month before the Neptune recalls, Stryker initiated a recall of two of its artificial hip implant systems: the Rejuvenate Modular and the ABGII Modular-Neck Hip Stems. Three months prior, the company sent an Urgent Field Safety Notice to surgeons and hospitals notifying them of the potential health risks associated with these devices. The hip implants show an increased risk of corrosion.

The products are manufactured with a titanium alloy blend that includes titanium, iron, zirconium, and molybdenum. When the devices corrode, small particles of metal can flake off and release into the body and cause severe metallosis, or metal toxicity. This type of toxicity can cause serious injuries around the implant site, including bone loss, tissue death, and potential damage to the kidney, liver, and other internal organs.

Continue reading "Stryker Receives Warning Letter from FDA over Neptune Recall and Quality Concerns " »

Transvaginal mesh lawyers at Pintas & Mullins announce that the first lawsuit involving Johnson & Johnson's Gynecare Prolift product recently reached a compensatory damages verdict of $3.35 million. The jury will now consider a punitive damages award, which may reach as high as $16.75 million.

An Atlantic City, New Jersey, jury found that Johnson & Johnson's Ethicon unit, the manufacturer of Gynecare, failed to warn the plaintiff about the risks associated with the vaginal mesh implant and deceptively misled her. The plaintiff is Linda Gross, a 47-year-old nurse from South Dakota, who, along with her husband, sued the company after suffering 18 operations and constant pain from the device.

After five days of deliberations, the jury awarded the couple $1.1 million for pain and suffering, $680,000 for past and future lost wages, another $180,000 for loss of consortium, and more than $1.3 million for past and future medical treatment. A Superior Court judge ruled that jurors can now determine punitive damages, which are amounts intended to punish the defendants for reckless disregard.

In 2010 alone, doctors implanted over 70,000 transvaginal mesh products in American women. Unfortunately, there have been thousands of reports of organ damage and serious complications associated with these products, which are sold by more than 30 manufacturers. More than 2,000 women have filed lawsuits against Johnson & Johnson alone.

In this New Jersey trial, company documents and e-mails revealed that Ethicon was completely aware that the transvaginal mesh would cause extensive pain and harm in women. Lawyers argued that Ethicon was aware the device could become exposed through the vaginal skin and that it could harden in women's bodies, making it difficult for surgeons to remove.

This mesh hardening is exactly what happened to Gross, which subsequently led to 18 painful operations, chronic pain, and other health problems. Gross testified that her life changed dramatically since the Prolift implantation - she can no longer sit comfortably and is prescribed to 20 different medications for her pelvic problems. She has had more than 400 doctor and physical therapist visits for treatments, therapy, and traumatic exams.

When she was initially implanted, in 2006, she was told there were very few risks, and that it could be removed easily if need be. Like thousands of other misled women, had she known of the reality of this product, she never would have chosen the Prolift. The Gynecare Prolift is made from polypropylene mesh, and was taken off markets in August 2012 along with four other Johnson & Johnson mesh products.

In October 2012, California's attorney general reached out to Johnson & Johnson about a probe regarding the company's marketing of the mesh products. The investigation is currently underway in 42 states. Earlier that year, the FDA told Johnson & Johnson, along with over 30 other manufacturers, that they had to conduct a study regarding the rates of organ damage and other complications linked to the mesh implants.

Other liable manufacturers include Boston Scientific, American Medical Systems, and C.R. Bard. The lawsuits involving C.R. Bard's product are expected to begin on June 24, 2013. This means victims of this company's defective product still have time to file claims.

Continue reading "Jury Awards over $3 Million to First Gynecare Prolift Victim " »

Fungal meningitis lawyers at Pintas & Mullins continue to report on developments in the outbreak of fungal meningitis from the New England Compounding Center that has so far killed nearly 50 people. More than six months after the first outbreaks, reports of infections continue to rise.

According to NBC News, at least two to three people are reporting fungal meningitis infections every week. The infections are caused by steroid injections contaminated with mold from the New England Compounding Center, which closed shortly after the first reports were released.

Fungal meningitis develops after fungus - in this case, mold - spreads from the injection site throughout the bloodstream. This particular outbreak is incredibly dangerous and deadly because those who require steroid injections often already have weakened immune systems. Like any other infection, fungal meningitis is significantly more fatal in those with compromised immune systems, such as the very young and very old, and AIDS or cancer patients.

So far, the outbreak has killed about 50 people and infected more than 700. Several patients have also suffered strokes as a result of the contaminated drugs. Signs and symptoms of fungal meningitis include fever, stiff neck, nausea, sensitivity to light, and altered mental state.

What is so troubling about these most recent outbreaks is that most of the patients previously tested negative for fungal infections, only to be sickened a few months later. Some of the infection patients had MRIs or lumbar punctures in October, when the contamination was first discovered, which showed they were clear of infection.

The CDC released a health alert recently, urging doctors and clinicians to remain on high alert for new infections, especially in Michigan, where more than 250 cases have been reported. Nearly 14,000 people were exposed to the infected steroid, and an estimated 11,000 people in 20 states were actually injected. The steroids are used most often to remedy back and neck pain, although there have been meningitis reports associated with injections into knee, shoulder and ankle joints.

Fortunately, this form of fungal meningitis is not contagious, and many of the most recent patients are reporting lesser illnesses caused by the injections. Some of these patients are suffering from infections at the site of injection, leading to epidural abscesses or arachnoiditis, which is the inflammation of nerves close to the spine. While these infections are serious, they are not as potentially fatal as fungal meningitis. Symptoms of these conditions include neurological problems, numbness, and stinging and burning pain in the legs or lower back. In severe cases, arachnoiditis can lead to paralysis of the lower limbs, so contact a doctor immediately if you have any suspicions.

The FDA and CDC went into the New England Compounding Center to investigate almost immediately after the first reports of meningitis were uncovered. Unfortunately, the agencies discovered that other products were infected with bacteria and fungus, and the CDC has received reports of illnesses in those taking these other products. There have not been any reports of fungal meningitis or spinal infections from these products, however. Most of these patients reported having meningeal inflammation, which is a less severe form of meningitis.

Continue reading "Six Months after Discovery, Patients Still Being Infected with Meningitis " »

Dangerous drug lawyers at Pintas & Mullins highlight the troubling story of a woman who was prescribed a generic pain reliever, sulindac, and suffered from a severe side effect that burned the majority of her skin off and rendered her permanently blind. In a lawsuit against the manufacturer, she was awarded $21 million.

Karen Bartlett of Plaistow, New Hampshire was prescribed the mild pain pill after experiencing shoulder pain in 2004. Within a few weeks after taking the drug, Bartlett's skin started degrading, falling off her body in chunks, until almost two-thirds of it was completely gone. She was placed in a medically-induced for several months, until she was able to be admitted to a burn unit, where she stayed for two more months. She suffered permanent lung and esophagus damage and is now legally blind. Her burn surgeon described her pain as hell on earth, and testified for her in court.

Bartlett filed a lawsuit against sulindac's manufacturer, Mutual Pharmaceutical Company, arguing that the design of the drug was dangerous and defective. She received $21 million by a jury trial, a verdict that an appeals court later upheld. Bartlett doesn't want anyone else to go through what she did, and believes sulindac should be taken off the market completely.

Her reaction is characterized as a severe form of Steven John's Syndrome (SJS), which is fatal in about 15% of cases. SJS is a rare skin disease, which forms lesions and blisters on the skin, usually around the mouth, throat, eyes, genital tract, and intestines. When it progresses, SJS causes skin to deteriorate and detach completely, such as in a third-degree burn, but the disease is far more serious than a burn.

SJS is a known and labeled potential side effect of pain medications, even of over-the counter medications like Motrin. Nearly a decade ago, a seven-year-old girl took Children's Motrin and subsequently developed SJS, causing her to lose 90% of her skin and her eyesight. She will only have 20% capacity of her lungs for the rest of her life.

The little girl's family filed a lawsuit against Motrin, alleging the company did not provide enough warnings about the life-threatening side effects. The jury placed 100% liability on Motrin, and awarded the family $63 million.

Dilantin, a popular anti-seizure medication, is also linked to SJS, and has been subject of much litigation over the past few years. Dilantin is currently one of the most widely-prescribed anti- seizure medications in the United States, and Stanford estimates that one in 10,000 Dilantin patients suffer serious SJS reactions. The drug is manufactured by Pfizer, and in 2011, the family of a child who took Dilantin received nearly $4 million in a settlement after their child died. Eight other companies make generics of Dilantin, including Mylan and Baxter.

Because the drug that Bartlett took was the generic for Clinoril, leaders in the industry closely watched her trial to see how the judge and jury would rule. Two years ago, in Pliva v. Mensing, the Supreme Court made a decision that significantly limited the ability of consumers to sue generic drug companies, because they do not have control over the drug's labeling or design. The Supreme Court ruled that generic drug manufacturers could not be held liable for failing to warn patients of the risks of taking their drugs.

However, Bartlett claimed in her lawsuit that the drug itself was defective, not the warning label, which enabled her case to make it to trial. Mutual still disagrees with this argument, claiming that the company was not responsible for the drug's design. By law, generic manufacturers must adhere to the same ingredients and designs as the brand-name version of the drug.

Continue reading "Woman Sues Generic Drug Company, Recieves $21 Million " »

Drug recall lawyers at Pintas & Mullins announce that hundreds of women recently filed lawsuits stemming from the 2011 recalls of Qualitest, Pfizer, Glenmark, and Sandoz birth control pills.

Shanta Russell, like millions of American women, took her birth control pills correctly and religiously for more than a decade without any problems. Suddenly, in June 2011, she suspected she may be pregnant, which was confirmed with several positive tests. She was stunned, confused, and unprepared to carry and raise a child. She wondered how, after a decade of regular use, her contraceptives suddenly failed.

The pills Russell took were manufactured by Qualitest, which is a subsidiary of Endo Health Solutions based in Alabama. A few months after she confirmed her pregnancy, Russell received a letter from Qualitest in the mail informing her that her birth control pills may have been placed in the wrong order during manufacturing, rendering them ineffective. Russell's shock and confusion quickly turned to anger as she realized that her pregnancy was the result of defective manufacturing processes.

Similar birth control recalls were issued by Pfizer, Glenmark Generics, and Sandoz in the ensuing months, and affected millions of packages. The recalls were due to defective blister packs, which were distributed to warehouses and pharmacies across the country. Officials said the defaults were inevitable, and the consequence of ineffective federal monitoring over pharmaceutical manufacturing factories.

Russell is now 33 years-old and a single mother to a one year-old girl. She, along with hundreds of other women who became pregnant while taking the birth control pills, filed a lawsuit against Qualitest, its parent company, Endo, and the corporation responsible for the faulty blister packs. The plaintiffs are seeking compensation for medical bills, emotional distress, and the immense costs of raising and educating a child. Of the more than 200 women involved in the birth control lawsuit, many had to drop out of all levels of schooling, some had to give their babies up for adoption, and others were forced to have abortions.

Before her daughter was born, Russell worked two jobs and traveled around the world. She was planning on going back to school in the health care field. Today, she no longer has time for both jobs, won't be able to return to school soon, and had to rearrange her finances so she can pay for clothes, day care, diapers and doctor appointments. She no longer travels, but loves her daughter unconditionally.

Blister packs, when working correctly, provide the hormone pills for the first 21 days of a woman's reproductive cycle. These pills contain two hormones: progestin and estrogen, which block eggs from being released, therefore blocking any possibility of fertilization. For the last seven days of a woman's cycle, the hormone pills are replaced by placebos, usually sugar pills, which mark the week the woman has her period.

Due to the packaging errors, the placebo pills were mistakenly placed during the first seven days of the woman's cycle, when she should have been taking the hormone pills. This rendered the medication largely ineffective, as evidenced by the hundreds of unexpected pregnancies.

Continue reading "Women Sue Birth Control Companies for Unexpected Pregnancies " »