Recently in Product Liability Category

Actos Plaintiff Receives $9 Billion Jury Award

April 9, 2014

952313_gavel.jpgThe jury is out, and the manufacturers of Actos, the once-popular type 2 diabetes medication, are now ordered to pay $9 billion (yes, with a 'b') to a man who developed bladder cancer from the medication. The award is the seventh-largest in U.S. history, and there thousands more Actos cases still to be heard. Actos attorneys at Pintas & Mullins take a closer look at Actos' first U.S. trial and what it could mean for other Actos plaintiffs.

The defendants in this case, Eli Lilly and Takeda Pharmaceuticals, are accused of many things in this Actos litigation, ranging from designing a defective drug to intentionally covering up its true side effects. The jury decided on such a large amount in part because of the seriousness of the drugs' side effects, and in part due to the poor conduct of Lilly and Takeda during the trial.

The plaintiff in this case, Terrence Allen, like too many others, developed bladder cancer from taking Actos, which was prescribed to help him manage his type 2 diabetes. The drug was introduced in 1999 and quickly became one of the hottest medications on the market; sales peaked in 2011, at $4.5 billion.

Allen and other Actos plaintiffs argue that the drugmakers knew the medication could cause cancer and chose not to adequately warn doctors and patients in efforts to boost drug sales. Pharmaceutical executives are accused on intentionally downplaying the risk of bladder cancer and misled the FDA about its true safety.

The link between Actos and bladder cancer was scientifically proven in 2004, but the manufacturers refused to acknowledge the association until 2011, when it finally placed warning labels on the drug at the request of federal regulators.

Allen was prescribed the drug in 2006 - meaning after the medical and pharmaceutical community knew of the link between Actos and bladder cancer, but before Lilly and Takeda decided to properly warn patients on the drug. He developed bladder cancer five years after he started taking the drug.

Evidence and Documents Destroyed

One of the most egregious aspects of this case, apart from the seriousness of the injury itself, was how Takeda and Lilly handled its events. Going back to 2004, when the bladder cancer risk was associated, Takeda executives sent internal emails stating that Actos was vital to the company's financial survival and to drag out placing a cancer risk on warning labels as long as possible.

These emails were produced in court because both Takeda and Lilly were under court orders to preserve all documents regarding Actos as evidence. Despite this order, Takeda failed to preserve much of its internal Actos documents - whether this was done intentionally or not is a point of debate, but after lawsuits started being filed the company destroyed the files of over 45 former and current employees, including top executives and sales representatives, so you be the judge.

Regardless, the evidence about how much Takeda knew and when was largely lost, so the judge penalized Takeda by telling jurors that the files may have strengthened and supported Allen's arguments about the company's wrongful information withholding.

Many believe that this document destruction bolstered the jury's award decision, to punish a drug company acting with such malice and disregard for not only patient safety but legal proceedings as well. This was the first bellwether trial in the Actos multi-district litigation (MDL), which consolidates thousands of Actos cases before a single judge in Louisiana.

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Medical Device Recall Rates Double

March 21, 2014

5205198800_afbc523eb7.jpgOver the past decade, recalls of defective and dangerous medical devices have nearly doubled in the United States. There has also been a substantial increase in defects that could cause very serious injury or death, rather than minor faults. Medical device recall lawyers at Pintas & Mullins examine how and why the recall rates are increasing.

In 2003, just over 600 medical devices were nationally recalled; by 2012, that number jumped to 1,190. A few years ago, the Government Accountability Office wrote a report noting that device recalls often were not announced until it was far too late to prevent injuries in patients. One example of this type of negligence occurred in 2007, when Medtronic recalled its Sprint Fidelis defibrillator wires, which are implanted in patients with irregular heartbeats.

These defibrillator wires were recalled because they could fracture while inside patients, causing death or very serious injury. Some patients did die, because by the time Medtronic decided to recall the wires they had already been implanted in thousands of people, many of whom had no idea there was a recall at all.

A Class I recall is the most serious type of recall, reserved for devices that have reasonable potential to cause devastating injury and death. One of the most recent Class I recalls was initiated in August 2013 by Medline Industries. The company recalled its ACME Monaco Guidewires, similar to the Medtronic defibrillator wires, because the coating could flake off the wires.

Recalls with Real Consequences

An executive at AdvaMed, a medical industry trade group, stated that the spike in recalls can be attributed to device manufacturers being more conscientious and pro-active approach to FDA compliance. Other experts wonder if the recalls are reflective of a more serious problem - the lack of rigorous federal oversight during the premarket approval process.

Some officials note that, had the FDA required more testing on these medical devices before they were approved for sale, some recalls could be avoided completely. However, it is a significant step forward that the federal government is making attempt to analyze this information at all.

When a recall occurs, patients can request repair kits or go to the hospital to receive a replacement device, free of charge. If the recalled medical device is implanted inside the patient, however, the remedial options are often detrimental to the patients.

Take for example, the recent massive recalls of metal-on-metal hip implants due to high rates of premature failure, dislocation and metal poisoning. Patients who require hip implants are already vulnerable to injury, and forcing them to undergo painful and often risky revision surgeries to remove and replace the recalled hip is incredibly negligent and certainly not in the best interest of the patient.

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New Cholesterol Drugs Linked to Brain Disorders

March 10, 2014

lipitor-bottle_l.jpgThe FDA recently announced that it was aware that patients taking new, experimental drugs to treat high cholesterol were suffering adverse cognitive events. The new drugs, developed by Sanofi and Regeneron, are known as PCSK9 inhibitors. Cholesterol drug lawyers at Pintas & Mullins explain the potential side effects among these and other cholesterol-lowering drugs.

Both Pfizer and Amgen are also currently developing PCSK9 inhibitor medications, which investors are watching very closely and with high expectations. An estimated one in six adults, or about 17% of the population, has high cholesterol according to the CDC. This condition is a major factor in the development of heart disease and diabetes, and many patients need medications to maintain normal cholesterol levels in addition to diet and lifestyle changes.

The most popular class of cholesterol-lowering drugs is known as statins, and includes drugs like Crestor, Lipitor, and Zocor (UPDATE: generic Lipitor was recently recalled, read more here). These medications block the liver's ability to produce LDL, or "bad" cholesterol and are prescribed to about 20 million Americans.

Similarly, PCSK9 drugs block the protein that maintains the presence of LDL cholesterol in the blood. In the most recent clinical trials, the FDA observed adverse neurocognitive side effects, such as memory loss and confusion, in patients. As a result, the agency has requested that Sanofi and Regeneron consider including neurocognitive tests in at least one group of patients.

Statins are also linked to adverse neurological side effects, including Lou Gehrig's disease, though for statin patients memory loss may be the least of their worries. Statins, particularly in high doses, are associated with extensive liver damage, muscle damage (rhabdomyolysis) and type 2 diabetes.

The FDA recently required all statin drugs to include the risk of increased blood sugar and type 2 diabetes, specifically among women. The side effects associated with cholesterol drugs have become increasingly serious, with patients losing their jobs due to memory loss and confusion, and being diagnosed with diabetes despite lifestyle changes.

It is important for patients to realize that once you decide to begin a medication to help lower your cholesterol, you will likely have to stay on it indefinitely. The only exception is in patients taking significant measures to change their diet and lifestyle. Factors that contribute to high cholesterol and can be changed through will alone include:

• Smoking
• A diet high in fat, salt and of course, LDL cholesterol
• Lack of exercising (about 30 minutes per day)
• Heavy alcohol use
• Stress and anger management
• Being overweight or obese

The FDA has been criticized in the past for failing to warn patients and physicians early enough about the risks of drugs. It seems that they are increasing the effort to be as transparent as possible and make the public aware of possible side effects. The warnings regarding PCSK9 drugs are part of the FDA's oversight of new drug development.

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High Court Rules Pharma Companies are Liable for Drug Design and Marketing

January 27, 2014

12151375045_6985691b46.jpgPennsylvania's Supreme Court recently ruled that pharmaceutical companies may be held liable for negligently designing and marketing drugs. The case specifically centers on the now-discontinued drug Redux, which was created by Pfizer. Our team of dangerous drug lawyers explains what this Pennsylvania ruling means for future plaintiffs injured by pharmaceuticals.

Redux (dexfenfluramine) was a diet drug approved by the FDA in 1996 and pulled from the market just over a year later, in 1997. The drug was recalled along with fenfluramine in the infamous "fen-phen" heart valve disease debacle. There has been extensive litigation over fen-phen and Redux injuries, which is currently ongoing in Pennsylvania.

Pfizer attempted to argue that it was immune from most claims of negligence and particularly from negligent marketing. The plaintiff in this case, Patsy Lance, had a daughter who took Redux and ultimately died from pulmonary hypertension. Lance is now arguing that Redux was an excessively dangerous drug that should have never been sold in the first place.

Pharmaceutical plaintiffs in Pennsylvania typically sue drug companies under failure-to-warn claims, however, Lance is arguing much broader claims of negligence, including defective design and fraudulent marketing. She also claims Pfizer knew of the drugs' severe health risks and that they far outweighed the supposed benefits.

The 4-2 Pennsylvania Supreme Court ruling for Lance is significant because it could open up a plethora of opportunities for injured patients. It is important to note, however, that this ruling likely only extends to drugs that have been withdrawn from the market by the FDA.

It is also worth noting that the majority opinion for this ruling was penned by Justice Saylor, who is a Republican and who does not usually err on the side of plaintiffs. He wrote that pharmaceutical companies violate standards of care if it chooses to market a drug it knows to be harmful. He further asserted that Pfizer did not present a reasonable argument as to why it should be immune from responsibility in the death of Lance's daughter.

FDA Approval Process Widely Criticized

Much of Pfizer's argument relies on the notion that if the FDA approves a drug as safe and effective, patients must defer to that authority. The FDA's approval process, however, has come under immense fire in recent years, and is subject to extensive scientific criticism.

The highly-esteemed Journal of the American Medical Association recently released a series of reports and studies centering on FDA dysfunction, the results of which are very alarming. The report receiving the most public attention examined nearly 200 new drugs approved between 2005 and 2012, and found that one-third of them were approved based on one, short-term clinical trial (more on that study here). Researchers wrote that the flexibility of approval standards leads to differing, inconsistent levels of certainty over the actual risks and benefits of new drugs.

The FDA responded by citing its "extensive" post-market surveillance programs. These reporting systems, however, are notoriously lax, and fail to accurately reflect the actual harm done to patients by drugs and medical devices.

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One-Third of Drugs Approved Using Single Study

January 22, 2014

pills-7_l.jpgA study recently published in the esteemed Journal of the American Medical Association (JAMA) found that one-third of all drugs were approved by the FDA based on one clinical trial. This is incredibly important, as Americans are seriously injured and killed every day from unknown effects of pharmaceuticals and medical devices, while medical companies reap the profits. Dangerous drug attorneys at Pintas & Mullins take a closer look at the JAMA study.

Researchers identified 188 new drugs approved by the FDA between 2005 and 2012, ranging from cancer treatments to drugs for cardiovascular diseases. About 37% of these drugs were approved based on a single clinical trial, despite clear federal rules that require at least two pivotal trials before approval.

So what is the difference between drugs that are studied in-depth and those that only require preliminary evidence of efficacy and safety? In the case of medical devices, many cardiovascular products, such as defibrillators, are approved without ever being tested in humans. This is possible through a specific FDA program that allows devices that are similar to other, older devices to be quickly approved.

Surveillance Programs not Enough

In a statement, the FDA asserted that it tailors approval requirements for each individual drug and disease area, and that it has a strict surveillance program in place to monitor new drugs and devices after market release. This practice is backwards and dangerous, placing American lives at risk.

Nowhere is this more evident than in the recent recalls of two cardiac defibrillators, the Riata from St. Jude Medical and the Medtronic Sprint Fidelis. These devices are implanted in patients with irregular heartbeats and shock the heart with electrical wires if an irregularity occurs. They were approved through the accelerated FDA process because they were similar in design to previously-approved devices. These defibrillators have caused dozens of deaths due to bad wiring and other defective parts.

Having a "strong" surveillance program does nothing to protect innocent patients who are being used as little more than guinea pigs for Big Pharma's latest development. In fact, most follow-up studies requested by the FDA are never even conducted. Of all the follow-up studies requested in 2008, only 31% had been carried out by 2013.

In effort to remedy this, JAMA researchers urged the FDA to place statements on drugs' labels that clearly define what type - and how much - evidence went into the approval of the drug. A novel and admirable concept, but not one I see happening anytime soon.

The goal of rushing drugs onto the market, for some ailments, makes sense. Patients fighting cancer do not have time to wait for three clinical trials to be completed before they can start taking a promising new drug. That makes sense. But for ailments like type 2 diabetes or osteoporosis, for which there are already dozens of drugs on market, accelerated approval does not make sense and is causing great harm.

Further compounding the problem, only about 34% of all new drug approvals are based on studies that last longer than six months. This is unacceptable for many reasons, most importantly because patients blindly trust the FDA to approve drugs that are extremely effective and do not carry any serious side effects. It is impossible for medical researchers to determine the true risks of a prescription drug after only six months of use. For most drugs, the actual long-term risks are not known until years, even decades after initial approval.

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Accutane Manufacturer Loses another Legal Battle

January 17, 2014

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for 1409595_gavel_5.jpgHoffman-La Roche, the manufacturer of acne drug Accutane, recently tried to remove the judge presiding over its consolidated injury cases. The New Jersey Supreme Court rejected the drug maker's request, making for what we can assume will be a very awkward court proceeding. Our Accutane attorneys take a closer look at this massive acne drug litigation.

There are over 7,700 lawsuits currently consolidated in the Accutane multidistrict litigation (MDL), which is presided over by Judge Carol Higbee. Hoffman-La Roche (Roche) attempted to expel Judge Higbee because of comments she made during a conference about the Accutane MDL. Higbee apparently criticized Roche for refusing to settle the injury cases and how it treated plaintiffs.

Accutane Recalls, Million-Dollar Verdicts

The Accutane plaintiffs all suffered serious injuries and health complications after taking the acne drug, including inflammatory bowel disease (Crohn's Disease and colitis), suicidal thoughts, bone growth issues, and birth defects. Thus far, Roche has paid about $53 million to Accutane plaintiffs nationwide, all of whom suffered from inflammatory bowel disorder from taking the acne medication.

In 2008, the first Accutane trial was won by a plaintiff who was awarded $10.5 million by a jury. One year after this case Accutane was permanently recalled from the market, though it still sells the drug under the name Roaccutane in other countries.

In 2010, a year after the official recall, Roche was forced to pay over $25 million to a single patient who developed severe inflammatory bowel disease from Accutane. The man had to undergo five surgeries and have his colon completely removed as a result. This case was presided over by none other than Judge Higbee, who ordered the court to pay another $18 million in 2012 to two Accutane patients who developed ulcerative colitis.

What won the case for these plaintiffs were internal Roche documents dating from 1994 which outlined a series of Accutane patient reports experiencing IBD. Accutane was approved in 1982, and by 1997 the FDA began receiving its own reports of IBD in Accutane patients, along with cases of severe depression, suicidal thoughts and actions, and psychosis. By 2005, there were nearly 200 suicides associated to Accutane use.

An End in Sight

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Lipitor Maker Slammed with Whistleblower Lawsuit

January 14, 2014

lipitor-bottle_l.jpgPfizer, the world's largest research-based pharmaceutical company, was recently slapped with a federal lawsuit over its marketing of popular cholesterol drug, Lipitor (atorvastatin). The whistleblower in this suit, Health Support Awareness Inc., argues that Pfizer deceptively misbranded Lipitor to keep it in high demand and at inflated prices. Lipitor attorneys at Pintas & Mullins are anxious to see what is revealed during the course of this case.

A whistleblower, or qui tam lawsuit, can be filed by anyone who has information that a company is in anyway defrauding the federal government. If the case results in a settlement or verdict, that whistleblower is then entitled to a percentage of the money, typically between 15 and 30%.

In the Pfizer Lipitor case, Health Support accused the healthcare giant of, among other things, defrauding Medicare and Medicaid out of billions of dollars. Indeed, the rate of Lipitor's prescriptions is jarring: between 2007 and 2010, over 43% of Medicare patients were prescribed to a statin, which is a class of cholesterol-lowering drugs and for which Lipitor is a front-runner. Just in 2010, this cost the federal agency $6.7 billion.

Half of men aged 65 to 74 are prescribed a statin drug to control cholesterol levels, and the drugs are generally helping curb the rates of fatal heart disease. However, in its haste to develop and market statins to a nation plagued by heart disease, Big Pharma failed to adequately test the drugs for long-term health effects.

Knowing Fraud

Pfizer is specifically accused of fraudulently keeping Lipitor prices high and engaging in illegal promotions to keep demand up. The company's aggressive, misleading marketing campaign worked, and Pfizer enjoyed major profits from the drug at the expense of the American healthcare system.

Lipitor was developed by Warner-Lambert, which in 1997 hired Pfizer to market the drug. In its first year, the statin reaped over $1 billion in sales. Pfizer accomplished this by pouring millions into TV ads and hiring high-profile spokespeople, such as Dr. Robert Jarvik. Another major and incredibly deceptive tactic Pfizer employed to boost sales was to lower the doctor-recommended cholesterol levels for prescribing. As a result, exactly as they had hoped, this led to even more demand for the statin drug.

Pfizer also engaged in several extremely underhanded activities during the time Lipitor's patent was supposed to end, including paying a generic company to delay its release of the generic Lipitor and then pitting another generic maker against it so the two would release the drug at the same time. In turn, the other generic company agreed to give Pfizer 70% of its generic Lipitor profits.

All the while, Pfizer steadily increased the price of Lipitor and continued to bombard the public with TV ads. The FDA sent numerous warning letters to the company regarding these ads, requesting that many be discontinued due to blatant overstatement of Lipitor's benefits.

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Feds Investigate Maker of Cholesterol Drug, Juxtapid, over False Marketing

January 13, 2014

5776691316_d050fefb1b.jpgThe CEO of Aegerion Pharmaceuticals, which manufactures popular cholesterol drug Jextapid, recently went on CNBC's Fast Money to talk about the drug. During his interview, the CEO stated that Juxtapid could prevent heart attacks and lengthen life, though neither claim has been studied or approved. Dangerous drug lawyers at Pintas & Mullins see this type of fraudulent marketing all too often by Big Pharma, and remind Juxtapid patients that the drug should only be used for treatment of HoFH.

Familial homozygous hypercholesterolemia, or HoFH, is a rare genetic disorder causing dangerously high cholesterol. The disease renders patients unable to remove LDL, or "bad" cholesterol from the blood, significantly increasing the risk of cardiac arrest and heart disease. Symptoms of this disorder include cholesterol deposits in the eyelids, fatty skin deposits on the ankles, hands, elbows, or knees, and chest pain.

False Claims, Subpoenas, and Federal Investigations

When Aegerion's CEO, Marc Beer, appeared on Fast Money, he illegally touted Juxtapid (lomitapide) for the prevention of heart attacks and extending life in general practice. The FDA notes that clinical trials used for market approval show no such data, as the pill was only effective in lowering LDL cholesterol in HoFH patients. After his illegal promotion, the FDA sent Beer a warning letter, reminding him that Juxtapid is not approved or labelled as a treatment to prevent heart attacks and lengthening life expectancy.

Juxtapid costs HoFH patients over $250,000 per year, and Aegerion is clearly hoping to get the drug prescribed in higher numbers in 2014. Confirming this, the company increased its sales predictions for 2013 from $15-25 million to $30-35 million, though the actual sales numbers are much, much higher. The company is projecting sales of $210 million for 2014.

A few months after the warning letter, the U.S. Department of Justice sent Aegerion a subpoena requesting documents related to the marketing and sales of Juxtapid. The federal investigation will undoubtedly lead to a hefty fine for Aegerion for its misbranding.

Fast Money interviewed Beer on June 5 and October 31, 2013. Among his misleading claims, he is quoted as saying that the drug can significantly lower the risk of death in younger patients, and that HoFH patients will suffer fatal cardiac events if not prescribed to Juxtapid therapy. Federal agencies could not let these statements slide, as they were both misleading and failed to address the true risks of such therapy.

Aegerion was swiftly asked to stop misbranding and recommending Juxtapid for unapproved uses. The company was also required to submit a plan of action to the FDA by November 22, 2013, correcting any misimpressions the public may have gleaned from the interview (a copy of the FDA warning letter can be read here).

Potential Lawsuits

If a drug is prescribed to you for uses not intended on its labels and you suffer a serious adverse event, you have every right to file a lawsuit, particularly if the drug's manufacturer knowingly marketed it for unapproved uses. Similarly, if a prescription or over-the-counter drug causes a serious side effect that was not listed on its labels, patients may file a lawsuit for the manufacturer's failure to warn.

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OTC Laxatives may Lead to Death, Kidney and Heart Injuries

January 10, 2014

11825448006_e5b61d4729.jpgThe FDA recently issued a warning regarding the use of over-the-counter laxatives manufactured by C.B. Fleet Company. According to the agency, these laxatives are causing severe kidney and heart damage, and potentially death, if more than one dose is taken within one day. Drug injury lawyers at Pintas & Mullins remind consumers taking OTC laxatives to avoid this dangerous product.

Many consumers taking C.B. Fleet's laxatives products have been hospitalized for dehydration and dangerously low electrolyte levels, with at least one suffering fatal kidney and heart injuries. As stated, these products are most likely to cause severe injury if more than one dose, or a larger-than-recommended dose, is taken within 24 hours.

Negligent Warnings

Although the drugs warn consumers not to take more than one dose within 24 hours, C.B. Fleet failed to include certain age and health restrictions. The laxative labels failed to alert consumers that those over age 55 and patients with certain health conditions need to speak to a physician before taking the over-the-counter sodium phosphate drug. Consumers in those specific groups are at much higher risk of serious side effects.

Patients with the following conditions or taking the following medications need to consult a doctor before taking any type of sodium phosphate laxative:

• Colon inflammation
• Kidney dysfunction
• Patients taking aspirin
• Ibuprofen
• Other non-steroidal anti-inflammatory drugs
• Diuretics
• Angiotensin-converting enzyme inhibitors
• Angiotensin receptor blockers (such as for high blood pressure)

It is important to note that some laxatives are sold under generic and store-brand labels (opposed to labels denoting C.B. Fleet). These products are sold both as oral tablets and as enemas. It is impossible for the FDA to know the true amount of serious incidents and deaths related to these products, however, because adverse events are not required to be reported to the government.

Mining the data it does have available, however, the FDA knows of at least 54 patients who were critically injured by sodium phosphate laxatives over the past few decades, including more than a dozen deaths. The actual number, as stated, is unknown.

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This Week in Recalls: Car Seats, Land Rover, Prego Italian Sauce

January 3, 2014

11677930183_f6eb2411b0.jpgAnother week, another slew of recalls from the U.S. FDA, CPSC (Consumer Product Safety Commission), and NHTSA (National Highway Traffic Safety Administration). Among the most significant recalls include nearly 4,000 Range Rover SUVs, 300 cases of Prego Traditional Italian Sauce, and over 33,000 Combi car seats. Product recall lawyers at Pintas & Mullins

The Combi USA recall was issued because the car seat harnesses do not meet federal standards for strength. Anyone who bought a Combi car seat - labeled Coccoro, Zeus 360 and Zeus Turn - prior to January 2013 is likely affected. Federal standards for harness strength (No. 213) are extremely important for children's safety; among their requirements, harnesses are subjected to a crash test of 30 MPH and measure the head injury and excursion, force on chest, and knee excursion.

According to federal officials, the Combi harnesses broke during dynamic tests, thus failing to meet minimum strength requirements. Fortunately, Combi car seats manufactured after January 2013 are not affected by the defects. Consumers will receive complimentary harness replacement kits beginning in February 2014. The company can be reached at 800.543.7734.

The Range Rover recall affects model years 2013 and 2014, and is the result of defective front seat airbags. The airbags on both passenger and driver sides can easily be disconnected, rendering them ineffective during a crash. The problems that could result in such a failure, I believe, are self-evident.

The recall will officially begin on January 17, 2014, and consumers will be able to bring their Rovers into dealerships, where the connectors will be modified. Fortunately, there have not yet been any reports of accidents or injuries linked to the airbag defects.

Campbell also recently initiated a recall, which extends to about 300 cases of Prego Traditional Italian Sauce. The sauce is packaged in 24-ounce jars, and is at significant risk of early spoilage due to inadequate quality control testing. The affected cases were distributed to the following states: Arizona, Arkansas, Kansas, Missouri, Nebraska, New Mexico, and Oklahoma.

The recalled jars were manufactured on December 15, 2013 and can be identified using the "Best By" date, which is June 16, 2015. More identification information may be found here, on the FDA's website. As with the other recalls, consumers should not use the product and return it to the store it was purchased for a full refund. Any questions should be directed at Campbell, at 866.270.9303.

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Gardisil Vaccines Recalled for Broken Glass

December 23, 2013

6219578509_8557c82c48.jpgThe Centers for Disease Control and Prevention (CDC) recently issued a media statement informing hospitals and patients that at least one lot of the Gardasil HPV vaccine has been recalled due to glass contamination. Gardasil's manufacturer, Merck, voluntarily recalled over 743,000 shipments, which went out between August 20 and October 9, 2013. Gardasil attorneys at Pintas & Mullins are currently reviewing cases of serious injury caused by broken glass in vaccine vials.

The recalled Gardasil vials can be identified by lot number J007354. Since the vaccines were shipped out starting in August, it is likely that some patients have already received injections potentially contaminated with broken glass shards. Merck contends the contamination occurred during the manufacturing process.

Fortunately, to date, only mild reactions have been reported by Gardasil patients, such as redness and swelling around the injection site. Clinicians who see any type of negative reaction from the vaccine should report the event to the Vaccine Adverse Event Reporting System (VAERS), found here. The CDC has been pushing clinicians to increase HPV vaccination among boys and girls aged 11 and 12, which has been met with some controversy.

About 79 million Americans have HPV, with some 14 million new infections every year. Gardasil (along with another similar vaccine, Cervarix) is administered in a three-shot series to protect against four types of HPV, which can cause several types of cancer in both men and women. The most serious side effects from the vaccine include fainting, generalized weakness, and unusual neurological symptoms. There have been a few dozen deaths linked to Gardasil on VAERS, however, none can be conclusively linked to the vaccine itself.

Gardasil contains synthetic protein particles and aluminum, which is supposed to protect patients against HPV, however, the exact mechanism is unknown. The vaccine was fast-tracked into American markets in 2006 despite being tested in less than 1,200 girls under the age of 16, so it is currently unknown if the vaccine can protect against HPV long-term.

One hundred years before Gardasil's introduction, the U.S. Supreme Court ruled in Jacobson v. Massachusetts that it was within the power of each state to enact a required vaccination law. This decision was based on the benefits of the smallpox vaccine, which Massachusetts wished to require all residents to receive. SCOTUS agreed, with the exception of children with a physician-signed certificate noting they were unfit for vaccination.

There is intense debate among state legislatures on whether or not to require school-aged students to receive an HPV vaccine, as the virus is believed to cause virtually all cases of cervical cancer, and there is no cure for the infection. In the U.S., about 3,700 women die each year from cervical cancer, and it is the second leading killer of women throughout the world.

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Paxil Re-Branded as Menopause Drug

December 19, 2013

Thumbnail image for 2169000524_ca20ccf787.jpgOral tablets of paroxetine has been on American markets since 1993 to treat an array of mental disorders, such as anxiety and OCD, and is now being re-branded to treat hot flashes in menopausal women. The problem with this re-branding is that paroxetine is just the generic name for the hotly contested antidepressant Paxil, which has been subject to mass litigation. Our Paxil attorneys remind women considering a prescription to the new drug Brisdelle that it is the exact same drug as Paxil.

The company marketing Brisdelle, Noven Therapeutics, is advertising the new drug as a non-hormonal option to treat hot flashes. Traditional menopause treatments, such as Prempro, are combination drugs containing hormones estrogen and progestin. It was recently revealed, however, that this type of hormonal treatment is associated with significantly increased risks of invasive breast cancer and heart disease.

Reasonably, many women are now looking for a non-hormonal alternative to treat their symptoms - a market Noven recognized and is now targeting with a feminine-sounding version of Paxil. Some women may be surprised to learn that using antidepressants to treat symptoms of menopause is not new; gynecologists have been prescribing these types of drugs to treat hot flashes for many years, though this is being done "off-label," meaning it is not approved by the FDA.

That is all about to change with the introduction of Brisdelle, a selective serotonin reuptake inhibitor (SSRI) theorized to help regulate body temperature among other chemical imbalances. The new drug is formulated in lower doses than typically prescribed for depression, so cognitive function may not be so severely affected. It is disconcerting, however, that there have been no large studies conducted on paroxetine's effect on hot flashes, and the clinical trials associated with Brisdelle are questionable to say the best.

In March 2013, the FDA's advisory committee voted, in a ten-to-four decision, against recommending Brisdelle for market because the risks clearly outweighed the benefits (more on that later). Members of the panel said that they did not see any discernable difference in hot flash frequency and severity among women taking paroxetine over those taking a placebo. Panelists also highlighted the drug's illustrious litigation history, and, most importantly, its black box warning.

The FDA is not bound by its advisory committee's recommendation, however, so Brisdelle was approved anyway. It is worth noting that Noven conveniently excluded women with a history of depression or suicidal thinking from its clinical trial.

Suicidal Thoughts and Behavior

Black box warnings are the most dangerous labels the FDA can place on drugs, alerting patients that the drug they are prescribed to can potentially cause very serious, sometimes fatal side effects. For paroxetine, the black box warning was added in 2004 to include that risk of suicidal thinking and behavior in patients. That label was again amended in 2007 to include the risk of such thoughts, particularly in young adults aged 18 to 24.

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Bayer's Other Ugly Stepsister: Essure

December 10, 2013

Bayer Healthcare Pharmaceutical's immensely popular intrauterine device (IUD), Mirena, is now subject to mass litigation throughout the country and abroad. Lesser attention is being paid to its other IUD, Essure, despite its equally damaging health effects. IUD injury attorneys at Pintas & Mullins highlight this dangerous contraceptive device so women are better informed of their options.

322811730_edef4837a5.jpg IUDs are implanted by trained healthcare professionals, typically an OB/GYN, to prevent pregnancies long-term. Unlike the Mirena, Essure does not release hormones to prevent egg fertilization for up to five years; rather, the Essure is a more permanent solution, with coil devices implanted in the fallopian tubes. Physicians insert the flexible coils internally (through the uterus) using a catheter, leaving the tip of the device outside for visual placement confirmation.

After the initial procedure, it takes about three months for the body to grow tissue and form the natural barrier to prevent pregnancy. An Essure Confirmation Test is then conducted to confirm full tube blockage. Conversely, the Mirena device is implanted into the uterus and releases a hormone, progestin, to prevent pregnancy.

Although the two IUDs work differently, the serious health risks associated with them are very similar, and both are relatively new to the market. Many experts believe, in hindsight, that Bayer's IUDs were rushed onto the market through inadequate and exaggerated clinical trials. Among their complications, both the Mirena and Essure can spontaneously migrate outside the uterus and fallopian tubes, which can cause painful perforation, adhesions, scarring, and permanent infertility.

Some of the most serious health effects associated with IUDs are ectopic pregnancies and required hysterectomies. An ectopic pregnancy occurs when the fertilized egg is unable to pass through the fallopian tube into the uterus, which can cause devastating and life-threatening effects. Forced hysterectomies usually result from extensive perforation, embedment, or severe allergic reactions.

Essure is held in place by inner stainless steel coils and an outer nickel titanium alloy coil. Surprisingly, physicians are not required to test patients for nickel allergies before implantation. One woman suffered from debilitating pain after Essure implantation, ultimately being admitted to a hospital where the surgeon had to perform an emergency hysterectomy to remove her fallopian tubes and uterus. She was only 25 years old at the time.

There are thousands of other women in the U.S. with similar Essure stories. According to the FDA, the most frequent adverse event reported by Essure patients are device migration (where the Essure falls out of travels to the end of the tube), incompatability, malposition, and breakage. Women severely injured by this device are urging patients to report their adverse events to the FDA's MedWatch program, so the device can be more closely monitored and possibly even recalled.

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FDA Warns of Philips Healthcare Defibrillators High Failure Risk

December 5, 2013

2339489611_70e2305a47.jpgCertain defibrillators manufactured by Philips Healthcare were recalled in 2012 due to internal electrical component failure. Now, over one year after the recalls, the FDA is warning patients still implanted with the devices that there is a high possibility they will fail in medical emergencies. If the heart skips a beat or is otherwise beating irregularly, cardiac defibrillators must send electrical shocks to restart normal rhythm. Defective defibrillator lawyers at Pintas & Mullins warn that any type of electrical failure in these devices may result in cardiac arrest and death.

The defective Philips defibrillators included: the HeartStartFRx, HeartStart HS1 Home, and HeartStart HS1 OnSite, which were distributed between 2005 and 2012. The recall affected more than 700,000 devices, many of which are still implanted in patients, who are either unaware of the recall or are waiting for a replacement.

All patients currently implanted with a recalled Philips defibrillator are urged to contact Philips Healthcare immediately. The company will inspect the defibrillator and recommend a replacement. In a March 2011 warning letter, the FDA noted that Philips' failure to correct defibrillator defects resulted in at least one fatality.

During plant inspections, the FDA also found numerous quality assurance violations at Philips facilities, where it was discovered the company failed to establish procedures for reviewing patient complaints and failed to report adverse events to the FDA. In additional oversight efforts, the FDA announced in March 2013 that it will require AED manufacturers to submit premarket approval applications. These applications will focus specifically on the requirements necessary to ensure AEDs are safe and effective, further improving reliability.

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FDA Issues Warning on Seizure Drug Onfi

December 4, 2013

3003880273_bfd6a655d2.jpgThe FDA recently warned consumers and physicians about the dangerous and potentially life-threatening reactions the popular seizure drug, Onfi, may cause. Onfi's labels will soon be changed to reflect the possibility of devastating skin reactions, which is most prevalent during the first two months of treatment. Stevens-Johnson Syndrome lawyers at Pintas & Mullins highlight this recent development and urge patients prescribed to Onfi to speak with your doctor as soon as possible.

Onfi (clobazam) is manufactured by Lundbeck Inc., and prescribed to patients in combination with other medicines to treat seizures associated with Lennox-Gastaut Syndrome. The skin reactions Onfi may cause, known as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) can occur at any point, but are most likely to manifest within eight weeks of starting Onfi.

SJS and TEN begin as rash, blisters, hives or peeling on the skin or around the mouth. Eventually, the top layer of skin dies and sheds away, presenting a medical emergency that almost always requires extensive hospitalization. Other preliminary signs that you may be having a serious skin reaction include fever, burning eyes, sore throat, and coughing.

According to the FDA at least one Onfi patient has died from the reaction and one has been permanently blinded; all other cases required immediate hospitalization. Some anti-seizure medications are known to cause SJS and TEN, such as Dilantin and Tegretol. Onfi's new labels note that SJS and TEN have been reported in both children and adults. The FDA also sent letters to over 22,000 healthcare professionals to make the label changes known.

Recent SJS and TEN Lawsuits

Some of the most common household medicines, such as Tylenol and Children's Motrin, have also caused these devastating skin reactions. Acetaminophen, the active ingredient in dozens of over-the-counter medications, is not as safe as most assume it is. The FDA recently required all manufacturers of acetaminophen-containing products to include a warning, similar to Onfi's, of the risk of SJS and TEN, no matter how small.

This action was prompted largely by a lawsuit filed on behalf of a three-year-old girl who was sick with a fever in 2000. Following their pediatrician's advice, her parents gave her alternating doses of Children's Tylenol and Children's Motrin to relieve her pain. In the ensuing days, the little girl started getting a rash and was red around her eyes and mouth, which eventually covered her body.

She was admitted to a hospital burn unit where she underwent numerous surgeries to repair the skin that was literally falling off her body. Now, over a dozen years later, she is blind in one eye, suffers recurring eye and lung infections, and experiences seizures due to oxygen-deprivation during her time at the burn unit. Her parents sued Johnson & Johnson on her behalf, claiming the company failed to adequately warn them of the SJS and TEN risk, ultimately winning over $10 million.

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