FDA Alerts Blog

Risperdal Settlement of $5.9 Million in Montana

April 18th, 2014

In 2008, Montana’s attorney general filed a lawsuit against Johnson & Johnson, claiming that it heavily promoted its antipsychotic drug Risperdal despite the fact that the tablets have been linked to the development of diabetes. Risperdal, the trade name of the drug risperidone, is used to treat schizophrenia as well as certain symptoms of bipolar disorder and autism.

Risperdal

Just this month, a Johnson & Johnson subsidiary agreed to pay $5.9 million to resolve the suit. Janssen Pharmaceutical Inc. agreed to the settlement without admitting to any wrongdoing, as part of a deal that prevents it from misleading consumers about its drugs in the future.

Risperdal has been involved with a number of lawsuits. In 2012, Johnson & Johnson settled a lawsuit claiming that Risperdal caused hundreds of male patients to grow breast tissue and another claiming that it had promoted Risperdal for non-approved uses including dementia, anger management and anxiety. In November 2013, Johnson and Johnson settled out of court for $2.2 billion in response to allegations that they encouraged the overmedication of children as well as the elderly and disabled by showering doctors with kickbacks.

The settlement funds Montana is now set to receive will be divided among courts, hospitals and the state’s newly formed awareness groups. Roughly $1.5 million of the settlement funds will go towards a new program in the state to prevent prescription drug abuse, while another $1.5 million will go towards funding mental health services and programs in Montana, according to the statement.

This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to health care providers. If you have been wrongfully prescribed Risperdal or taken Risperdal and experienced some symptoms of diabetes, you should contact a health care provider as soon as possible then consider whether or not you should make a claim against its manufacturer.

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Transvaginal Mesh Manufacturer Sets Aside $520 Million For Future Settlements

April 15th, 2014

Johnson & Johnson, Boston Scientific Corp, C.R. Bard Inc. and Endo Health Solutions Inc. all face large vaginal mesh injury lawsuits and a multidistrict litigation in West Virginia and various state courts around the Country. Of those four medical supply companies, Bard is the furthest along in litigation. Throughout these trials, we want to provide continual updates including both the corporations’ and the plaintiffs’ product liability arguments and the final outcomes. If you happen to know anyone harmed by a vaginal mesh product, made by one of these manufacturers or not, there is still time to file a complaint.

Endo Health Solutions Inc. (Parent Corporation to American Medical Systems) anticipates it will cost at least $520 million to settle or otherwise exit the product liability litigation it faces, which primarily consists of thousands of vaginal mesh injury cases relating to the following products:

Elevate: Anterior/Apical &Apical/Posterior Pro

Apogee

Perigee

Monarc Subfascial Hammock

Sparc Sling

Mini-Arc Precise Single Incision Sling

Mini-Arc Single Incision Sling

In-Fast Ultra Transvaginal Sling

BioArc

In 2013, Endo recorded an incremental pretax charge of about $316 million, increasing its product liability reserve to about $520 million as of the end of last year according to a securities filing. A loss in excess of that figure remains a “reasonable possibility,” Endo said.

The pharmaceutical company’s American Medical Systems Inc. (AMS) unit faces more than 20,000 lawsuits claiming its vaginal mesh products are defective and have caused chronic pain, incontinence and other injuries or relapses of previous conditions.

“The increase in our reserve reflects management’s ongoing assessment of our product liability portfolio, including the vaginal mesh cases, the status of the company’s ongoing settlement discussions related to vaginal mesh litigation and the inherent uncertainty as to the ultimate costs of resolving this litigation,” Endo said. “AMS and the company intend to contest vigorously all currently pending cases and any future cases… and to explore other options as appropriate in the best interests of the company.”

It said it believed the settlements, judgments and legal defense costs related to the mesh litigation may be covered in full or in part by its product liability insurance policies. It had not recovered any insurance money as of the end of 2013, however.

AMS transvaginal mesh jury trials are currently set for June 2, 2014 and July 7, 2014. AMS previously agreed to settle a small number of cases last year and the company is expected to attempt a global settlement of the cases pending in federal court in West Virginia before Judge Joseph R. Goodwin in 2014 or 2015.

If You Have Questions

If you or someone you love has questions, please contact the law firm of Childers, Schlueter and Smith, LLC based in Atlanta, Georgia.  Childers, Schlueter & Smith, LLC  attorneys will speak with you free of charge.  All inquiries are strictly confidential and will be handled with discretion.  Our trained transvaginal mesh implant lawyers are accustomed to handling personal matters like this.

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Alli Recall Voluntary but Significant

April 15th, 2014

Alli maker GlaxoSmithKline Consumer Healthcare is voluntarily recalling all Alli weight loss products from U.S. and Puerto Rican retailers because some product packages were allegedly tampered with and may contain a product that is not the authentic, FDA-approved weight loss product Alli.

According to a March 2014 report in USA TODAY, GlaxoSmithKline Consumer Healthcare has received inquiries from 12 consumers in seven states about packages of Alli purchased in retail stores that contained tablets and capsules that were not the weight-loss product. The affected states included Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. The tablets and capsules were various shapes and colors, and some bottles were missing labels and had tamper-evident seals that were not genuine.

Alli has had similar problems before. Back in 2010, the FDA warned that a counterfeit version of Alli potentially harmful to consumers was being sold online, although no reports of serious illness related to the recent tampering and recall have been received. GlaxoSmithKline is unsure about how or where the bottles had been tampered with and is conducting an investigation, and also working with the FDA on the recall.

Alli is an over-the-counter fat-blocking pill meant to be taken in conjunction with exercise and a healthy diet. The active ingredient in Alli is orlistat, which was linked to an increased risk of rectal bleeding as well as kidney, liver, and thyroid problems by a 2009 Consumer Reports article. Following the article, the FDA changed the label on products containing orlistat, including Alli, to include new information about cases of severe liver injury. Alli’s new label contained a warning about “rare reports of severe liver injury.”

Consumers should confirm that the Alli they have matches this description: Turquoise blue capsule with a dark blue bank imprinted with the text “60 Orlistat.” Alli is packaged in a labeled bottle that has an inner foil seal imprinted with the words, “Sealed for Your Protection.” Pictures of the product are available on www.myalli.com.

The diet supplement injury lawyers at Childers, Schlueter & Smith, LLC continue to investigate and review new potential diet supplement cases all over the United States. If you have questions about a potential diet supplement injury, give us a call. All initial case reviews are free of charge and are kept completely confidential.

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Stryker Hip Lawsuit Bellwether Jury Trials To Start Summer 2015

March 15th, 2014

More than 570 federally-filed Stryker hip lawsuits have been filed in a multi-district litigation (MDL) now underway in the U.S. District Court, District of Minnesota. According to documents filed March 14, 2014, the Court anticipates selecting 3-5 bellwether cases for trial sometime during the Summer of 2015.

The Minnesota District Court will continue to reach out to New Jersey and Florida state court judges to explore the potential of a coordinated settlement of all the state and federal cases involving Rejuvenate and ABG II. At the present time, nearly 800 Stryker hip lawsuits have been filed in Bergen County Superior Court in New Jersey, and 13 such cases were consolidated in Florida on October 3, 2013.

All of the lawsuits involve similar claims regarding the tendency of the Rejuvenate and ABG II hip stems to fret and corrode, causing the recipients to experience osteolysis, tissue necrosis, and other complications that require replacement of the device. Revision surgery is generally more difficult and takes longer to perform than the initial hip replacement, according to the Orthopaedic Research Institute.

Stryker recalled its Rejuvenate and ABG II hip stems in July 2012 after the company determined that the metal hip stems could fret and corrode at the modular-neck junction. The company has recommended that all Rejuvenate and ABG II recipients undergo blood and imaging tests to ensure that their hip stems are functioning properly, even if they have not experienced any symptoms of a failing hip implant, which include thigh pain that radiates to the knee, particularly while walking or going from a sitting to a standing position.

Although a typical hip replacement is expected to last between 15 and 20 years, the defects with the Stryker Rejuvenate and ABG II hip implants were detected in less than two years. Other metal on metal hip implant manufacturers have had similar issues, including DePuy maker Johnson & Johnson, who recently made offers to settle lawsuits involving nearly 8,000 patients for more than $4 billion.

The Stryker Hip Implant Lawyers of Childers, Schlueter & Smith continue to review and file Stryker hip implant cases. If you have questions about your rights, contact us today for a free evaluation of you potential Stryker hip implant lawsuit.

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Topamax Has Helped Some, Hurt Others

March 14th, 2014

Topamax is an anti-epilepsy drug marketed by the Johnson & Johnson unit Janssen Pharmaceuticals. It received FDA approval in 1996, and is prescribed to prevent epileptic seizures and migraine headaches. While Topamax has helped many patients, it also has caused dangerous side effects and birth defects.

While Topamax was FDA-approved to treat epilepsy conditions and migraine headaches, it has been prescribed for many other uses, including:

  • Alcohol dependency
  • Bipolar disorder
  • Drug addiction
  • Post-traumatic stress disorder

Topamax Side Effects

Initially approved by the FDA as a Category C drug with warnings that studies on animals have shown adverse effects on fetuses, Topamax was made a Category D medication in 2011 after an alert was issued by the FDA. Some common side effects of Topamax includes:

  • Fatigue
  • Dizziness
  • Trouble concentrating
  • Coordination and speech problems
  • Blurred or distorted vision
  • Sensory distortion
  • Diarrhea
  • Weight loss

The FDA has issued several warnings regarding the use of Topamax, outlining the following risks:

Topamax has also been shown to increase the incidents of cranial defects such as cleft lips and palates in newborn babies, prompting several costly lawsuits.

Topamax Lawsuits

Topamax lawsuits allege that Janssen Pharmaceuticals failed to adequately warn consumers about the dangers caused by the drug, accusing the company of negligence, misrepresentation, fraud, and breach of warranty.

Topamax has been the target of three lawsuits in Pennsylvania alleging that the company failed to update the drug’s label to warn users of increased risk of birth defects. The lawsuits returned verdicts of $3 million, $4 million, and $10 million to the plaintiffs in the past several months, and a fourth Topamax case began in late February 2014. Janssen also agreed to pay more than $81 million to end a U.S. Department of Justice inquiry into off-label marketing of the drug in 2010.

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Popularity of Yaz Comes With a Dangerous Price

March 13th, 2014

Yaz is a birth control pill that has been prescribed to as many as 100 million women since its release in 2006. Bayer, the maker of Yaz, initially marketed the drug as a safe birth control alternative with limited premenstrual syndrome (PMS) bloating and acne, as compared to traditional oral contraceptives. Once the most popular birth control pill in the U.S., Yaz has come under fire in the last few years for causing dangerous and even fatal side effects.

What is Yaz Used For?

Yaz is used as a contraceptive to prevent pregnancy by causing changes in the cervical and uterine lining, making it harder for sperm to reach the uterus and harder for the fertilized egg to attach to the uterus.

It is also used to treat moderate acne in women over the age of 14 who have started their period and want to use birth control pills to prevent pregnancy, and for the symptoms of premenstrual dysphoric disorder (PMDD).

Early testing revealed that Yaz produced a variety of side effects common to birth control bills in general, including:

  • High blood pressure
  • Liver disruption
  • Allergic reactions
  • Upper respiratory infections
  • Headaches
  • Yeast infections
  • Irregular non-menstrual bleeding
  • Stomach cramps
  • Hair loss
  • Weight gain

Yaz and Blood Clots

In recent years, researchers have found that drospirenone, the fourth-generation progestin contained in Yaz, raises the levels of potassium in the blood, which increases the risk of blood clots and clot-related events such as:

  • Strokes
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)
  • Blood Clotting Events

Many medical groups, including the Institute for Safe Medication Practices, the FDA, and publications such as the New England Journal of Medicine, and the British Medical Journal, have issued blood clot warnings associated with taking Yaz. According to the FDA, 22,000 women who have taken Yaz have reported adverse side effects, including over 3,500 reports of pulmonary embolism and nearly 3,000 cases of deep vein thrombosis.

Yaz Lawsuits

Yaz recently announced that it has reached settlement in over 17,000 cases brought by women who say that they have suffered blood clots and other injuries as a result of taking the drug. Bayer still faces thousands of lawsuits across the country, and reportedly has spent nearly $1 billion to settle Yaz claims. The Yaz Lawyers at Childers, Schlueter & Smith continue to review and file Yaz Lawsuits on behalf of victims nationwide. If you have questions about your injuries or your rights, give us a call to learn how we can help.

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Dietary Supplement OxyElite Pro Believed To Cause Liver Damage

March 12th, 2014

Approximately 180 million Americans use diet supplements every day, but it is extremely difficult for the FDA to oversee their use. Manufacturers do not need FDA approval before selling dietary supplements, although they are required to prove that any new ingredients are safe for consumption. The burden is on the FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or take it off the market.

Aegeline Though to be the Culprit

OxyElite Pro contains aegeline, an extract from the Bael tree native to India and Southeast Asia. According to the FDA, aegeline is relatively untested and its side affects are largely unknown, but doctors say they are relatively certain that aegeline was the harmful ingredient in OxyElite Pro that caused serious side effects, including hepatitis and liver damage.

According to WebMD, one person has died, numerous people have been hospitalized, and others have received or are awaiting liver transplants due to the dangerous side effects of OxyElite Pro. After nearly 60 cases of liver damage were linked to the supplement, the FDA required the supplement’s maker, USPLabs, to remove the product from the market in November 2013.

OxyElite Pro Lawsuits

OxyElite Pro was recalled, but not in time to stop a growing number of product liability lawsuits brought by victims alleging that the supplement caused them to suffer hepatitis or liver damage severe enough to require liver transplants.

Concerns about OxyElite Pro began in September 2013 when health officials in Hawaii noticed a growing number of hepatitis and liver injury claims from those who had taken the supplement, which is designed to help lose weight and increase muscle mass. Although most of the OxyElite Pro liver injury cases have occurred in Hawaii, since the recall the adverse side effects of the supplement have begun to spread across the continental U.S., and numerous federal lawsuits have been filed.

The lawsuits raise allegations that USPLabs placed unsafe ingredients in OxyElite and then failed to adequately warn consumers about the risk of liver damage. The U.S. Judicial Panel on Multidistrict Litigation (JPML) will consider a motion later this month on whether to consolidate and centralize all the OxyElite Pro lawsuits filed nationwide in federal court.

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Surgical Mesh Implant Cases Are Moving Forward In 2014

March 6th, 2014

Endo Health Solutions Inc. anticipates it will cost at least $520 million to settle or otherwise exit the vaginal mesh product liability litigation it now faces. In 2013, Endo recorded an incremental pretax charge of about $316 million, increasing its liability reserve to about $520 million as of the end of last year, according to a securities filing. A loss in excess of that figure remains a “reasonable possibility,” Endo said.

The pharmaceutical company’s American Medical Systems Inc. (AMS) unit faces about 22,000 lawsuits claiming its vaginal mesh products are defective and have caused chronic pain, incontinence and other injuries. The suits are consolidated in multidistrict litigation in West Virginia, as well as other state courts.

“The increase in our reserve reflects management’s ongoing assessment of our product liability portfolio, including the vaginal mesh cases, the status of the company’s ongoing settlement discussions related to vaginal mesh litigation and the inherent uncertainty as to the ultimate costs of resolving this litigation,” Endo said. “AMS and the company intend to contest vigorously all currently pending cases and any future cases… and to explore other options as appropriate in the best interests of the company.”

Endo said it believed the settlements, judgments and legal defense costs related to the mesh litigation may be covered, in full or in part, by its product liability insurance policies. Endo has not recovered any insurance money as of the end of 2013, however according to reports.

AMS vaginal mesh trials were scheduled to begin last December but were delayed due to ongoing obligations. AMS previously agreed to settle a small number of cases, and the company is expected to attempt a global settlement of the cases pending in federal court in West Virginia before Judge Joseph R. Goodwin at some point in the future. The first AMS bellwether trial is now scheduled to begin on April 7, 2014 and the second trial is set for May 5, 2014.

Johnson & Johnson, Boston Scientific Corp and C.R. Bard Inc. also face thousands of vaginal mesh injury lawsuits.  Bard is the furthest along in litigation. Bard was hit with a $3.6 million verdict in a California state court trial in July 2012.

In addition, at least two Bard mesh bellwether trials in the West Virginia MDL have resulted in victories for the plaintiff. In August 2013, a jury awarded plaintiff Donna Cisson $2 million in damages, and plaintiff Wanda Queen settled her mesh case on the eve of trial for an undisclosed sum.

The transvaginal mesh implant lawyers of Childers, Schlueter & Smith continue to review and investigate new potential claims for victims across the U.S. If you have questions, please contact us for a free evaluation of your potential case.

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Pradaxa Maker On Legal Hot Seat in United States

March 1st, 2014

Since it hit the market in 2010, the blood-thinning drug Pradaxa has definitely been making waves. According to the New York Times, although Pradaxa has generated more than $2 billion in sales in the U.S. and has been prescribed to 850,000 patients, it has been found to cause fatal bleeding and been linked to more than 1,000 deaths reported through the end of 2012. As a result, the drug’s maker, German company Boehringer Ingelheim, is currently facing more than 2,000 lawsuits in the U.S. Boehringer Ingelheim is standing by the drug, insisting that it is safe according to clinical trials.

Pradaxa is a drug that keeps the platelets in blood from clotting. It is used to prevent blood clots and reduce the risk of stroke in people with a specific type of heart rhythm disorder. But because Pradaxa keeps blood from clotting, it also makes it easier for someone to bleed, even after a minor injury. There is currently no antidote for Pradaxa to reverse its blood thinning effects, so consequently patients who take the drug run the risk of bleeding to death since there is no medical remedy currently available to prevent it.

One of Pradaxa’s main selling points to consumers is that the drug does not require regular blood tests to ensure that it is working properly. But that precise point has been the subject of intense debate among heart and stroke specialists for several reasons:

  • Not all people metabolize the drug in the same way
  • Few dose options are available
  • There are no tests available in the U.S. to monitor those who might be at a higher risk for bleeding

Pradaxa is approved in the U.S. in a 150-milligram dose and a 75-milligram dose for those with low kidney function, but the FDA did not approve a 110-milligram dose because it was believed that the lower dose would not be beneficial to the majority of patients. In Europe, where Pradaxa was approved in 2008, an additional dose and a test are available. Despite the numerous patient bleeding deaths and the absence of an antidote, Pradaxa remains on the market, although the FDA has announced plans to perform a large new safety assessment of the drug.

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J&J Wins “Defense Pick” TVT Mesh Case

February 28th, 2014

On February 18, 2014, Johnson & Johnson won the first MDL bellwether trial against their company Ethicon Inc. in the litigation over alleged transvaginal mesh injuries. The five-day trial over the TVT product used to treat stress urinary incontinence concluded when U.S. District Judge Joseph R. Goodwin granted a motion for judgment as a matter of law in favor of Johnson & Johnson and its unit, according to Court filings that Tuesday.

The case involved a plaintiff by the name of Carolyn Lewis ( 59 years old) that had to endure a revision/repair surgery of her TVT mesh product implanted 3 years prior due to complications. This result, although disappointing, was complicated by numerous factors that played out in the trial that is not likely to be the case in the thousands of tvm cases to follow. It is important to note however that this tvm bellwether was a defense selected case which are typically problematic cases for plaintiffs based on the initial fact and circumstances of each.

Ethicon said in a statement Tuesday that Judge Goodwin found that plaintiff Carolyn Lewis had not shown enough evidence to back her claim about defects in Ethicon’s TVT pelvic mesh product, commonly used to treat stress urinary incontinence in women. The defendants argued in their motion that Lewis could not prove that the product caused chronic pain. Defendants argued that Lewis, who received the mesh in 2009 and began her suit in July 2012, overshot the two-year limitations period since the time when she should have discovered her injury.

The negligent design claims were all that Lewis had left after the Court dismissed her failure-to-warn claims in January as well as her breach of warranty and manufacturing defect claims on legal grounds.

Before the trial began on February 10, 2014 U.S. Magistrate Judge Cheryl Eifert found that Johnson & Johnson had failed to preserve documents related to the litigation. But on the Friday before the trial, she granted a motion to exclude the spoliation allegations from the trial because they were not germane to the remaining legal theories in Mrs. Lewis’ case. Johnson & Johnson argued in that motion that it no longer mattered what information a sales representative had told Lewis’ physician, because her claim that Johnson & Johnson had failed to warn her physician of the product’s risks was no longer at issue.

One Ethicon spokesman claims that “TVT continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence.” Considering Lewis’s case is just one of thousands, we aren’t so sure about that.

As we progress into 2014, many more TVM cases will be tried. To date, this is the only trial that the defense has won as the other 4 tvm trials thus far have resulted in verdicts for the plaintiffs in each of those cases.

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