Defective Medical Products Law Blog

ADHD Medication and Cardiac Death

2009-06-18T08:44:00.000-07:00

ADHD Medications that may be associated with sudden death in healthy children, according to the FDA: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Research data published in the American Journal of Psychiatry suggests there may be an association between the use of stimulant medications prescribed to children with ADHD and sudden death in healthy children.

Our lawyers are available for a free consultation to any parent whose child has died or become seriously ill while using any of the ADHD medications above, the most common of which is Ritalin: 1) Call our lawyers at 1-888-377-8900 (toll free) or submit our free consultation form for review by our lawyers.

In the study, funded by the FDA and the National Institute of Mental Health (NIMH), the investigators compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. According to the study report, out of 564 healthy children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of 564 healthy children who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death.

Zicam Lawsuits

2009-06-16T21:27:00.001-07:00

On June 16, 2009 FDA altered consumers to the risk of anosmia (loss of smell) with the use of certain Zicam products marketed by Matrixx Initiatives. These Zicam products are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms.

The Zicam products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

For information about a Zicam lawsuit, please contact Pritzker Olsen Attorneys:

1-888-377-8900 (toll free)
Submit our free consultation form

Denture Cream Lawsuit

2009-06-05T12:30:00.000-07:00

Denture users throughout the nation are suing denture cream manufacturers Proctor & Gamble Co. and GlaxoSmithKline PLC, alleging that Fixodent and PoliGrip denture creams cause zinc poisoning (hyperzincemia) and dangerously low copper levels (hypocupemia), which leads to loss of balance, paralysis, tingling, numbness, pain and other neurological problems.

Cases from California, Colorado, Florida, New York, Ohio, Oklahoma, Pennsylvania and Tennessee have been filed and may be consulidated in multidistrict litigation (MDL) (In re Denture Cream Products Liability Litigation, M.D.L. No. 2051). If this happens all denture cream zinc poisoning cases filed in federal court will be part of the MDL.

Our law firm supports MDL for denture cream lawsuits because the pre-trial procedures will be streamlined, which should result in quicker recoveries for clients. When an elderly client's quality of life is diminished because a manufacturer failed to warn him or her of the risk of zinc poisoning and the resulting neuropathy, justice requires swift action that fully compensates that injured person.

Please contact us for denture cream lawsuit information. Our lawyers have a national reputation and have appeared on CBS News and Fox News discussing product safety litigation.

Our lawyers can help you:

1-888-377-8900 (toll free) or
Complete our free consultation form.

For more information, please see the following:

Super PoliGrip Lawsuit

2009-06-03T12:14:00.000-07:00

People who use dentures should be aware that lawsuits have been filed alleging that use of PoliGrip and other denture creams caused zinc poisoning, which can cause paralysis, loss of balance, tingling in the arms and legs, unexplained pain and other neurological problems.

A simple test will determine if you have zinc poisoning.

If you do, please contact our law firm about a PoliGrip lawsuit. Our law firm is investigating the connection between PoliGrip and zinc poisoning. We are representing several people injured by medical products, and have gained a national reputation in the area of complex product liability litigation. Our lawyers have appeared on CBS News, Fox News and numerous local television stations.

Contact our law firm for a free consultation about a possible Super PoliGrip lawsuit: 1-888-377-8900 (toll free) or complete our free consultation form.

Fixodent Lawsuit

2009-06-03T11:54:00.000-07:00

Pritzker Olsen law firm is accepting cases involving people who have tested positive for zinc poisoning after using Fixodent denture cream.

Fixodent lawsuits are alleging that the Fixodent denture cream used by claimants had levels of zinc high enough to cause zinc poisoning (hyperzincemia), which can result in copper deficiency (hypocupremia) and profound neurological disease.

If you, your spouse or your parent has tested positive for zinc poisoning, please contact our law firm: 1-888-377-8900 (toll free) or submit our free consultation form.

Anyone who uses dentures and is experiencing extreme fatigue, difficulty walking, tingling in the arms or legs, unexplained pain or other neurological symptoms, should seek medical attention and ask to be tested for zinc poisoning. If the test is positive, contact us about a Fixodent lawsuit.

Pritzker Olsen attorneys are representing many clients like you who are suffering from serious injury due to a defective medicine. We would be happy to talk with you about our experience and how we can help you get the compensation you deserve.

Levaquin Lawsuit - Ruptured Tendon

2009-05-26T08:50:00.000-07:00

Pritzker Olsen Attorneys is representing people who suffered a ruptured tendon after taking Levaquin. To contact our attorneys about our Levaquin lawsuit cases, please call 1-888-377-8900 (toll free) or submit our Levaquin lawsuit consultation form.

We handle Levaquin cases nationwide. For each case, we are investigating both product liability and medical malpractice issues.

The Levaquin lawsuits involving product liability claims may be consolidated in multi-district litigation (MDL), which would streamline pre-trial preparations, which includes requests for documents, interrogatories (requests for answers to specific questions), and depositions (interviews of witnesses and others taken in the presence of a court reporter).

Levaquin, a fluoroquinolones antibiotic, has been associated with an increased risk of tendon rupture. According to research, this risk is increased in patients over 60, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Companies associated with the manufacture of Levaquin include the following:

PriCara, a division of Ortho-McNeil-Janssen Pharmaseuticals, Inc.
Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaseuticals, Inc.
Ortho-McNeil-Janssen Pharmaseuticals, Inc.

Although Levaquin has other side effects, our law firm is only taking Levaquin tendon rupture cases.

Medtronic Pacemacker Information

2009-05-20T19:29:00.000-07:00

Certain Medtronic Kappa® and Sigma® pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g., battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

Medtronic has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism.

Wire separation on a Medtronic Kappa or Sigma pacemaker may cause serious injury or death:

Some patients, whose devices experience a wire separation resulting in a loss of pacing output, will experience a return of bradycardia symptoms (e.g. fainting or lightheadedness). In rare cases involving pacemaker dependent patients, loss of pacing output may result in death or serious injury. Medtronic has received two reports of patient death where it is possible but unclear whether this issue may have been a factor.

If you would like information about a Medtronic lawsuit, please contact Attorney Elliot Olsen, managing attorney for our Medtronic lawsuits.

You may look up specific model and serial numbers to see if your pacemaker is affected.

Iovate Health Sciences Lawsuit

2009-05-06T12:23:00.000-07:00

Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York have issued a recall on the following Hydroxycut products because they may cause liver disease:

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

The Hydroxycut recall was issued on May 1, 2009. At least as early as 2005, there were recorded cases of liver injury--specifially acute hepatitis--associated with use of certain Hydroxycut products.¹

For those who have suffered liver injury, including hepatitis and liver failure, an Iovate Health Sciences lawsuit would seek compensation for your medical expenses, lost wages, disability, and pain and suffering. To contact a lawyer at Pritzker Olsen for a free consultation, please call 1-888-377-8900 (toll free) or submit our free consultation form.

Iovate Health Sciences Hydroxycut Case Studies

Case Study 1:

A 40-year-old female with a prior medical history notable only for hypothyroidism and diet-controlled hyperlipidemia presented to the Emergency Department with 3 d of new-onset crampy, mid-epigastric abdominal pain and non-bloody diarrhea. She noted subjective fevers and chills, and two isolated episodes of nausea and vomiting, anorexia and profound fatigue. One week prior to presentation, she began using Hydroxycut, 6 pills daily in preparation for a bodybuilding competition. . . She denied taking any other supplements or alternative medications. . . Her laboratory profile on admission revealed an acute hepatitis, inflammation of liver cells.²

The patient tested negative for hepatitis A, B and C, ruling out viral hepatitis.

Case Study 2:

A 33-year-old female with a prior medical history of a pituitary adenoma presented to the Emergency Department with 1 mo of new-onset jaundice. She reported a flu-like illness of 2 wk duration with nausea and crampy abdominal pain and began to experience jaundice, acholic stools, dark-colored urine, pruritus, and profound fatigue. These symptoms appeared to be improving during the week prior to admission except for worsening jaundice and fatigue. She noted that during the month prior to admission, she had taken Hydroxcut supplements for 2 wk to help achieve weight loss, but discontinued this medication upon onset of symptoms. She additionally reported eating lobster during the month prior to admission, but could not recall other individuals who became ill. Her only medication was Ortho-Novum contraceptive, which she had been taking for 2.5 years. Her social history was unremarkable without regular alcohol ingestion, and the absence of risk factors for chronic viral hepatitis. She was afebrile with stable vital signs, and normal body mass index. Her exam was notable only for jaundice and scleral icterus. She had no liver enlargement and no stigmata of chronic liver disease. Her laboratory profile at admission was notable for acute hepatitis.²

The patient also tested negative for hepatitis A, B and C.

References: 1. Stevens T, Qadri A, Zein N, Two patients with acute liver injury associated with the use of the herbal weight loss supplement Hydroxycut, Annals of Internal Medicine, March 2005, 142(6):477-78. 2. Jones FJ an dAndrews AH, Acute liver injury associated with the herbal supplement Hydroxcycutin a soldier deployed to Iraq, October 2007, 102(10): 2357-8.

Hydroxycut Liver Failure and Damage

2009-05-05T09:18:00.000-07:00

The FDA has received reports of liver injury associated with the use of certain Hydroxycut products manufactured by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York. Liver injuries have included jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA.

Compensation for Hydroxycut liver failure and other liver damage may include the following:

Medical expenses
Cost of care
Lost wages
Pain and suffering
Disability

When applicable, there may be recovery for past and future expenses, losses and pain and suffering. In addition to physical pain, “pain and suffering” can include emotional distress, suffering and embarrassment. Our attorneys will fight to get you the compensation you deserve. We also feel strongly that large recoveries from manufacturers send a message that companies need to put consumer safety first. To contact a lawyer at Pritzker Olsen about a Hydroxycut lawsuit, please call 1-888-377-8900 (toll free) or submit our free consultation form.

Symptoms of Hydroxycut Liver Failure and Liver Damage

Symptoms of liver damage including the following:

Jaundice, a yellow discoloration of the skin and eye whites due to abnormally high levels of bilirubin in the bloodstream
Excessive fatigue
Weakness
Stomach or abdominal pain
Itching
Loss of appetite
Dark urine
Pale stool
Bone loss
Easy bleeding and bruising
Small, spider-like blood vessels visible in the skin
Enlarged spleen
Fluid in the abdominal cavity
Chills
Pain from the biliary tract or pancrea
Enlarged gallbladder
Impaired consciousness
Changes in logical thinking, personality, and behavior
Mood changes
Impaired judgement
Drowsiness
Confusion
Sluggish speech and movement
Disorientation
Loss of consciousness
Coma

Liver Disease Related Health Problems

Common health problems associated with liver disease:

Jaundice, a yellow discoloration of the skin and eye whites due to abnormally high levels of bilirubin (bile pigment) in the bloodstream
Cholestasis, reduced or stopped bile flow
Liver enlargement (hepatomegaly)
Portal hypertension, abnormally high blood pressure in the portal vein, which supplies the liver with blood from the intestine
Ascites, fluid build-up in the abdominal cavity, caused by fluid leaks from the surface of the liver and intestine
Liver encephalopathy, the deterioration of brain function due to toxic substances

Hydroxycut Liver Damage Prompts Recall

In response to reports of liver failure and other liver damage associated with certain Hydroxycut products, Iovate has issued a recall of the following products:

Hydroxycut Hardcore 8 fl. oz. Grape Explosion
Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
Hydroxycut 280ct-3 Pak Kit *Discontinued*
Hydroxycut 280ct-6 Pak Kit *Discontinued*
Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
Hydroxycut 2x60ct Club Pack US Kit
Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit
Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit
Hydroxycut Sachet Twin Pack US Kit
Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
Hydroxycut Hardcore Shredded Stack Kit120ct
Hydroxycut 60 Rapid Release Caplets
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut Recall

2009-05-01T12:36:00.000-07:00

The FDA has received 23 reports of serious health problems associated with certain Hydroxycut products. Most of the 23 reports involved liver injuries, including liver damage and liver failure, some requiring a liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

In response, Iovate Health Sciences has agreed to a Hydroxycut recall of the following products:

Hydroxycut Hardcore 8 fl. oz. Grape Explosion
Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
Hydroxycut 280ct-3 Pak Kit *Discontinued*
Hydroxycut 280ct-6 Pak Kit *Discontinued*
Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
Hydroxycut 2x60ct Club Pack US Kit
Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit
Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit
Hydroxycut Sachet Twin Pack US Kit
Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
Hydroxycut Hardcore Shredded Stack Kit120ct
Hydroxycut 60 Rapid Release Caplets
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut Recall: Liver Damage
and Liver Failure Compensation

If you have suffered liver damage or liver failure after using Hydroxycut, contact our law firm regarding a Hydroxycut lawsuit seeking the following:

Medical expenses (past and present)
Lost wages (past and future)
Pain and suffering (past and future)

Pain and suffering can include compensation for physical pain associated with liver damage and liver failure, suffering, emotional distress, and disability.

Partner Elliot Olsen is managing attorney for these cases. To contact Elliot, please call 1-888-377-8900 (toll free) or submit our free consultation form.

Posted May 2009

Lead Removal Medical Malpractice

2009-04-16T12:04:00.000-07:00

Pritzker Olsen law firm is actively investigating possible claims of medical malpractice in the surgical removal of leads for implantable cardiac devices such as pacemakers and defibrillators (lead extraction malpractice). In addition to injury cases, we are representing the family of a man who died after having a Medtronic Sprint Fidelis lead removed. With the Medtronic Sprint Fidelis cases, we are pursuing product liability and medical malpractice claims. Read about a Medtronic lawsuit.

Removal of an old lead is a very difficult and challenging procedure because the lead may have become overgrown with fibrous tissue and therefore stuck inside a major blood vessel. Extracting the lead can be dangerous but leaving it in place can make it more difficult to remove later because of the growth of fibrous tissue.

If you or a loved one have been the victim of complications during a cardiac lead extraction, please contact attorneys Elliot Olsen and Fred Pritzker for a free consultation.

Posted May 2009.

Medtronic Catheter Recall

2009-04-06T05:18:00.000-07:00

Medtronic and the FDA have announced a recall of the following ventricular catheter models:

Innervision Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27782
Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27802
Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27708

According to Medtronic, it has been determined from nine reports of disconnected catheters requiring revision surgery, that the listed ventricular catheters may become detached from the snap base assembly after implantation and that this condition may increase the need for emergency revision surgery.

Consequences for a patient with failure of a Medtronic ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions.

If you or a loved one has had to have emergency surgery due to a defective Medtronic catheter, you may have grounds for a Medtronic lawsuit.

Our law firm is representing a number of patients in Medtronic lawsuits. Our managing attorney for these Medtronic lawsuit cases is Elliot Olsen. If you would like to discuss your Medtronic catheter case with Elliot or another attorney at our law firm, please call 1-888-377-8900 (toll free) or submit our free consultation form.

You should also ask us about federal preemption and Riegel v. Medtronic, which may affect your ability to obtain compensation from Medtronic.

Medtronic Sprint Fidelis Death Cases: Families Deserve Compensation

2009-03-16T08:13:00.000-07:00

In a letter to doctors dated March 13, 2009, Medtronic Inc. told doctors that 13 deaths may be associated with the Medtronic Sprint Fidelis lead and that 4 of these deaths were associated with lead extraction:

The Panel [Medtronic’s Independent Physician Quality Panel] has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed.¹

Even as Medtronic is acknowledging that their Sprint Fidelis lead has led to patient deaths, the company refuses to compensate the families for their loss. In the name of decency and justice, the legal wrangling to avoid responsibility to these families should end, and Medtronic should fairly, fully and adequately compensate these families. Read about the tragic case of the Turnidge family. A mother is left to raise two young sons alone. Our lawyers are representing the Turnidge family and several other Sprint Fidelis shock victims and their families in Medtronic lawsuit cases.

In the same letter to doctors, Medtronic acknowledge that FDA has received reports of 107 deaths that “include allegations that the Fidelis lead may have caused or contributed to a patient death”:

Approximately 268,000 Fidelis leads have been implanted worldwide. The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.¹

Medtronic states on its website that its mission, “penned more than 40 years ago,” is “to alleviate pain, restore health, and extend lives.”² If this really is the mission of the company, Medtronic’s goal in these 107 death cases should not be to avoid liability at all costs. Medtronic should take a caring look at the cases and compensate deserving families. This is the right thing to do.

References:
1. Medtronic Letter to Doctors: http://www.medtronic.com/product-advisories/physician/sprint-fidelis/PHYSLETTER-2009-03-13.htm.
2. Medtronic Mission Statement: http://www.medtronic.com/about-medtronic/index.htm.

Posted March 2009.

Medical Device Safety Act Introduced

2009-03-07T14:04:00.000-08:00

On March 4, 2009, in the case of Wyeth v. Levine, the U.S. Supreme Court preserved the right of people injured by dangerous and defective prescription drugs to sue the drug maker for compensation for injuries. It was an important victory for patients.

Thursday, following on the heels of the Wyeth decision, the Medical Device Safety Act was introduced in the Senate by Senators Edward Kennedy and Patrick Leahy and in the House by Representatives Waxman and Pallone. This bill will restore the rights of patients injured by faulty medical devices – a right patients lost last year as a result of the Supreme Court’s decision in Riegel v. Medtronic.

While the Wyeth decision is an outstanding victory, there is still hard work to be done, including making clear, once and for all, that Congress does not intend for FDA regulation to preempt claims against device manufacturers. As part of this fight, AAJ is participating in the Campaign to Stop Corporate Immunity, and we encourage you to visit www.StopCorporateImmunity.org to learn more about the campaign.

For more information:

Posted March 7, 2009.

Medtronic Sprint Fidelis Case Highlights Need for Legislation to Nullify Riegel v. Medtronic

2009-02-20T10:46:00.000-08:00

Last month, Mark Turnidge, a 33-year-old husband and father, died after doctors removed a fractured Medtronic Sprint Fidelis lead from his body. Medtronic had recalled Sprint Fidelis leads due to the fracturing problem in 2007 after over 200,000 patients had Sprint Fidelis leads implanted in their bodies.

Wendy Turnidge, Mark Turnidge’s wife, told The New York Times that Medtronic offered her $800. She turned it down. According to the Times story, her attorney, Fred Pritzker, said he is considering suing the hospital and Medtronic. Pritzker and his law firm PritzkerOlsen have filed a number of claims for other Sprint Fidelis patients in Minnesota state court. Pritzker told the Times that recent U.S. Supreme Court ruling in Riegel v. Medtronic made it likely that a state judge would reject such cases.

In Riegel v. Medtronic, the Court held that the pre-emption clause in The Medical Device Amendments of 1976 “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.”

Fairness, decency and justice would require Medtronic to compensate Mr. Turnidge’s family for his death. But U.S. District Courts are citing Riegel v. Medtronic and the MDA’s pre-emption clause to bar families like Mr. Turnidge’s from suing Medtronic.

Our law firm believes in justice and opposes this sweeping use of the MDA and Riegel v. Medtronic to deny people their day in court. Thankfully, some federal legislators are looking at this problem and taking steps to give patients back the right to sue when they are injured by a defective medical device. According to The New York Times:

But now, some members of Congress want to give potential plaintiffs like Ms. Turnidge a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.

The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

Most people assume any product approved by the FDA is safe. Wendy Turnidge and many others know this is not true. We ask that you support any efforts to nullify Riegel v. Medtronic. Wendy Turnidge is going to be raising her sons alone. She deserves justice.

Posted February 2009.

Cephalon Lawsuit Involving Actiq and Off-Label Uses

2009-02-05T08:11:00.000-08:00

Wrongful death cases allegedly involve Cephalon Inc., one of the nations largest pharmaceutical companies, and one of its products, Actiq.

In September of 2008, Cephalon Inc. plead guilty to a criminal misdemeanor and agreed to pay a $425 million settlement in a federal case filed in Philadelphia. The case centered around Cephalon’s alleged marketing of Actiq for “off-label” uses, which increased the sales of the drug dramatically. Actiq is approved by the FDA for use for pain management on cancer patients, who experience excruciating pain. The Actiq label reads as follows:

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

ACTIQ is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, ACTIQ is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.¹

The active ingredient of Actiq is fentanyl. According to attorney Fred Pritzker, “Fentanyl is a strong and dangerous drug that requires the utmost caution by both doctors and patients. We see many cases in which people die as a result of not being properly screened, trained, and instructed regarding use and danger of this drug and the various systems used to deliver it to the human body.”

Actiq is considered a fentanyl “lollipop.”

Federal prosecutors alleged that Cephalon was marketing the use of Actiq for migraine headaches and other “off-label” purposes. Fentanyl is a drug that is 100 times more potent than morphine. People allegedly died using Actiq for these “off-label” purposes.

Wrongful death lawsuits against Dr. Stephen Schneider allegedly involve Actiq and fentanyl overdose:

In December 2008, the family of Robin Geist-Wick - a 45-year-old patient who died of fentanyl intoxication on May 15, 2007 - added Cephalon as a defendant in its wrongful-death lawsuit against Schneider and another doctor from his clinic, Lawrence Simons, who also had treated Geist-Wick.²

According to the complaint, Dr. Schneider had prescribed Actiq for Ms. Geist-Wick’s migraine headaches.

To contact our law firm about an Actiq wrongful death and a Cephalon lawsuit, please call 1-888-377-8900 (toll-free) or submit our free case consultation form.

Important related FDA information: In January, the FDA finalized new guidelines that allow pharmaceutical companies to market off-label uses for drugs. We are concerned that these new guidelines will endanger the lives of countless patients. If you would like federal legislation to prevent this type of marketing, please contact your federal legislators. It is vitally important for all of us to care about the safety of our health care system. Given the FDA's track record, we cannot rely on the FDA to protect the public.

References:
1. http://www.actiq.com/ 2. Roxana Hegeman, Drugmaker Cephalon linked to indicted Kan. Doctor, Forbes, February 3, 2009.

Attorney Elliot Olsen Speaks at Conference

2009-01-19T12:16:00.000-08:00

Attorney Elliot Olsen recently spoke at the Seventh Annual LifeScience Alley Conference in Minneapolis on Preemption and the Future of Medical Device Litigation. He appeared with Randall Pattee of Lindquist and Vennum and Jean Lance, VP of corporate legal and general counsel for Boston Scientific. Topics included:

What does the future hold for mass-tort, defective design and failure-to-warn claims against device manurfacturers?
What claims survived the Supreme Court’s decision in Riegel v. Medtronic?
What new defenses do device manufacturers have?

Elliot Olsen has extensive experience with medical device litigation. To contact Elliot, please call 1-888-377-8900 or submit our contact form.

Stryker Implant Recall

2008-12-24T13:38:00.000-08:00

FDA has determined that the Stryker cranial implant recall is a Class I recall, which means the product could pose an imminent hazard to health. After determining that the sterilization validation of the product was not performed according to appropriate standards, Stryker CMF recalled 322 Custom Cranial Implant Kits.

Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.

Custom cranial implant is designed individually for each patient to correct trauma and/or defects in the lower jaw (mandibular), upper jaw and face (maxillofacial) or the cranium and the face (craniofacial bone).

Our law firm handles wrongful death and injury claims involving post-operative infections, including Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli (E. coli). In these cases, there may be both product liability and medical malpractice claims.

To contact a lawyer about an infection after implant surgery, please call 1-888-377-8900 (toll-free) or submit our case review form.

Keywords: Stryker cranial implant recall, jaw implant infection, face implant infection, implant surgery, wrongful death, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli.

Posted December 2008

Fleet Phospho-Soda Recall

2008-12-15T14:09:00.000-08:00

We are representing a number of people who developed kidney failure after using Fleet Phospho-Soda for bowel cleansing before a colonoscopy. Fleet Phospho-Soda is an over-the-counter oral sodium phosphate product.

Due to the great number of people who have experienced kidney failure (renal failure) after using this product, the FDA has decided to amend its position on Fleet Phospho-Soda and other over-the-counter sodium phosphate products. As a result, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.

For more information about the Fleet Phospho-Soda recall, please see the following:

To contact an attorney at our law firm form information about our Fleet Phospho-Soda lawsuits, please call 1-888-377-8900 (toll-free) or submit our free Fleet consultation form.

Herbal Science International Recall: Dietary Herbal Supplements

2008-04-11T11:16:00.000-07:00

The FDA has announced an Herbal Science International recall of dietary herbal supplements. Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) has recalled twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers, according to the FDA.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands:

Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the United States.

All of the twelve products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.

The FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

Read the full Herbal Science international recall announcement on the FDA website.

Posted April 2008.

Selenium in Total Body Formula

2008-04-11T10:21:00.000-07:00

On March 27, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of serious, adverse reactions from persons in nine states, Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Posted April 2008.

Baxter Heparin Recall Investigation Update

2008-03-05T20:18:00.000-08:00

We are not taking heparin cases.

Fentanyl Patch Recall

2008-03-03T11:26:00.000-08:00

Actavis Inc. has announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This Fentanyl patch recall is an expansion of an initial Fentanyl recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008 (Fentanyl recall - Fentanyl death - Fentanyl overdose). That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the Fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

Fentanyl patches are dangerous, and anyone coming in contact with the Fentanyl gel within the patch is at risk for serious adverse events, including respiratory depression and possible overdose, which may cause death.

If you are using a Fentanyl patch and have not experienced any adverse events, you need to contact your medical provider immediately.

If you believe you have been injured by Fentanyl, contact one of our lawyers regarding this Fentanyl patch recall and other Fentanyl recalls. You may be entitled to compensation for your injuries. If a family member died after using a Fentanyl patch, contact us for information on wrongful death litigation. To contact us, please call toll-free at 1-888-377-8900 or submit our free case consultation form.

Again, this Fentanyl patch recall is extremely serious and all caution should be used regarding the Fentanyl patches. We urge you to contact your medical provider immediately if you are using a Fentanyl patch. We also urge you to send this information to anyone you know who may be using a Fentanyl patch.

Posted March 2008.

B. Braun Heparin Syringe Recall

2008-01-28T21:05:00.000-08:00

B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes. (Read about the AM2Pat Inc. Heparin Recall.) This recall has prompted B. Braun Medical to recall its affected products, which includes the following Heparin syringes and normal saline flush syringes:

Normal Saline 3mL in 12 mL Syringe, Catalog #513584
Normal Saline 5mL in 12 mL Syringe, Catalog #513586
Normal Saline 10mL in 12 mL Syringe, Catalog #513587
10 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513610
100 units/mL Heparin, 3mL in 12 mL Syringe, Catalog #513611
100 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513612

Customers that have the recalled product in their possession should discontinue use immediately. Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

We are investigating cases involving Heparin products. To contact a lawyer at PritzkerOlsen, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Heparin Recall

2007-12-26T20:35:00.000-08:00

We have been contacted regarding the Heparin recall initiated by AM2 PAT, Inc. The recall includes one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The CDC tested some of the Heparin syringes in the recalled lot and found contamination with Serratia marcescens. FDA believes that the contamination has resulted in patient infections, according to the FDA announcement of the Heparin recall.

Our law firm has been investigating a variety of injuries associated with Heparin products. For more information on this Heparin recall, please see the following:

To contact a lawyer at Pritzker | Olsen regarding the Heparin recall, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Image of Serratia marcescens courtesy of Lee Baines Photography, all rights reserved.