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Pharmaceutical Drug & Medical Device Litigation
Many injuries occur each year in the U.S. due to prescription and over-the-counter drugs. Patients are harmed generally due to dangerous side effects, with some of these injuries resulting in death. Thornton & Naumes is a national leader in representing people injured by hazardous or unsafe drugs and medical devices. We have successfully litigated and settled lawsuits on behalf of people who have suffered serious health problems caused by unsafe pharmaceutical drugs and defective medical devices. Our extensive experience in medical device litigation includes representing over 500 people in the Silicone Breast Implant litigation in both individual lawsuits and national class action settlements and successfully representing hundreds of plaintiffs with Dalkon Shields and orthopedic screw claims. In the area of pharmaceutical drug litigation, our experience includes representing over 1000 individuals in the diet drug litigation involving Fen-Phen (Pondimin and Phentermine) and Redux (Dexfenfluramine), both within the national settlement and in individual lawsuits. In 1999, we were appointed Coordinating Counsel on behalf of all plaintiffs with lawsuits concerning these drugs pending in the Massachusetts State Courts.
We are currently investigating and/or litigating pharmaceutical drug and medical device cases were there has been a withdrawal or recall of the drug/device from the market or where we believe there have been far more serious health effects than reported by the manufacturer. Those drugs and devices including the following:
Skip ahead to:
- Genzyme Drug Contamination
- Avandia (diabetes treatment)
- Trasylol®
- Tysabri
- Singulair
- Medtronic Defibrillator Lead Recall
- Vytorin & Zetia
- Permax and Dostinex And The Development of Heart Valve Problems
- Recall of Certain Composix Kugel Mesh Patches Used In Hernia Repair
- Fen-Phen and Redux
- Serzone (Nefazodone Hydrochloride)
- Guidant Corp. Defibrillators
- Ephedra
- Zyprexa & Risperdal
- Hip/Knee Implants
- Breast Implants
- Additional Pharmaceutical Drugs and Medical Devices Under Investigation
- Important Links
- Vioxx
Genzyme
November, 2009. After a five-week review of Genzyme's Allston, Massachusetts plant, the FDA reported that pieces of steel, rubber and fiber were found in five Genzyme drugs manufactured there. Those drugs include:
- Cerezyme, a treatment for Gaucher disease;
- Fabrazyme, for Fabry disease;
- Myozyme, which treats Pompe disease;
- Aldurazyme, for mucopolysaccharidosis, a metabolic disorder; and
- Thyrogen, for thyroid cancer.
The report came about five months after an unrelated virus was discovered in some tanks at the same Allston facility. Genzyme’s temporary shutdown of that facility led to worldwide shortages of Cerezyme and Fabrazyme.
Patients treated with medication that has been contaminated could experience adverse reactions including local pain, swelling and inflammation at the injection site. If the particles get into the blood stream, more serious injuries may occur, including blood clots, pulmonary embolisms, anaphylactic shock and damage to blood vessels. The FDA has decided not to recall the Genzyme drugs because they are in short supply and needed by those who suffer from these serious and rare diseases.
Return to TopAvandia
According to the analysis published in the New England Journal of Medicine on May 21, 2007, Avandia, the widely used drug for treating type 2 diabetes, increases the risk of heart death by 64 percent and the risk of heart attack by 43 percent. The drug, manufacturered by GlaxoSmithKline, is taken by 1 million Americans and generated sales of $3 billion last year.
If you or a loved one took Avandia for treatment of your diabetes and suffered a heart related injury, please contact us.
Vioxx
On September 30th Merck & Co., Inc., voluntarily withdrew VIOXX from the market
On September 30th, 2004, Merck & Co., Inc., the makers of the arthritis and acute pain medication VIOXX, voluntarily withdrew the drug from the worldwide market. The decision was made after a three year study found an increased risk for confirmed cardiovascular events such as heart attack and stroke after 18 months of treatment. If you or a loved one have taken VIOXX and have suffered a cardiovascular event such as heart attack or stroke, please contact us immediately to discuss your options.
For more information about what YOU should do, please call Thornton & Naumes, LLP toll free at (800) 431-4600 or visit our Vioxx practice area.
Serzone (Nefazodone Hydrochloride)
Serzone is an anti-depressant drug approved by the FDA in 1994. The manufacturer, Bristol-Myers Squibb, announced in May of 2004 that it would pull the drug from the market, with distribution ending on June 14, 2004. The company blamed lagging sales as the reason for the decision, but Serzone has been blamed for dozens of cases of liver toxicity, resulting in liver failure, death or transplantation. On December 7, 2001, the FDA informed Brystol-Myers that it must include a black box warning afer it learned that Serzone was responsible for life-threatening liver failures. Black box warnings are intended for use only with the most serious side effects in medications. On January 8, 2003, European markets pulled Serzone; Canadian regulators followed and on December 24, 2003, it pulled the product off the market. Bristol-Myers did not halt global sales, including those in the United States, until May of 2004, nearly three years after the FDA required a black box warning for the drug.
Guidant Corp. Defibrillators
On June 17, 2005 Guidant Corp. recalled nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of defects that could cause the devices to short-circuit. It is believed that approximately 38,000 defibrillators have been implanted in patients in the United States. The defective Guidant models are: Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. Less than a week later Guidant issued a second safety advisory concerning its implantable defibrillators. Guidant informed doctors to stop using five of the models because they could malfunction due to a defective switch. The second safety advisory is for Guidant's Contak Renewal 3 and 4 models, Renewal RF model and the Renewal 3 and 4 AVT devices.Recalled Models:
- Prizm 2 DR, Model 1861
- Contak Renewal, Model H135
- Contak Renewal 2, Model H155
- Prizm AVT Vitality AVT Renewal 3
- AVT Renewal 4 AVT
- Contak Renewal 3 and 4
- Renewal 3 and 4 AVT
- Renewal RF
Ephedra
Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.
On December 30, 2003, the Department of Health and Human Services Secretary, Tommy Thompson and Mark McClellan, the Commissioner of the FDA, announced their steps to ban ephedra. The Department of Health and Human Services stated that Ephedra can be linked to numerous health dangers, including heart attacks, strokes, seizures and death. The FDA then urged Consumers to immediately stop consuming Ephedra-containing products and manufacturers of such products were urged to recall products still on the shelves. On April 12, 2004 the FDA ban became effective and buying or selling a dietary supplement containing ephedra is now against the law and all products containing Ephedra were removed from the shelves
One of the most popular supplements containing Ephedra is Metabolife®356 which is manufactured by Metabolife International, Inc. These supplements have been linked to numerous adverse effects, the most serious of which include heart attack, stroke and death. If you or a loved one have taken Metabolife® products and suffered serious adverse effects, please contact us. Thornton & Naumes is currently litigating such cases with the law firm of Kline & Specter in Philadelphia .
Ephedra-containing products made up less than one percent of all dietary supplement sales but account for 64 percent of adverse events associated with dietary supplements.
Zyprexa & Risperdal
Thornton & Naumes is currently investigating legal claims involving these drugs and off-level use resulting in diabetes and diabetes-related injuries, particularly in children.
Hip/Knee Implants
We are currently investigating the failure of certain hip and knee implants that were manufactured beginning in the early 1990's by the following manufacturers:
- Depuy
- Howmedica Osteonics Corp.
- Howmedica, Inc.
- Osteonics Corp.
- Zimmer
- Biomet
Each case is unique and requires a thorough review of the individual's medical records to determine proper product identification and to determine potential damages as a result of the placement of a hip or knee implant.
Breast Implants
On April 2, 2004, Judge Denise Page Hood entered an Order setting the Effective Date for June 1, 2004. This means that eligible, approved claims can begin to be paid by the Settlement Facility beginning soon thereafter. We are very excited that this long awaited date has now been set. Our office is actively reviewing our cases involving Breast Implants. Should you have a change in your condition or if you had your implants removed, please contact our office at 800_431-4600 so that we may update our files with your new information. For additional updates, please view The Dow Corning Settlement at www.dcsettlement.com or The Tort Claimant's Committee at www.tortcomm.org.
Additional Pharmaceutical Drugs and Medical Devices Under Investigation
- Access Cardiosystems Emergency Defibrillator Failures
- Alpha Interferon (PEG_INTRON) and Ribavirin-persons on the combination drug therapy used to treat hepatitis C
- Accutane-causing birth defects
- Actos/Avandia-causing liver damage
- Arava-causing liver damage
- Baxter Dialyzer-causing death in kidney dialysis patients (recall)
- Baycol-causing rhabdomyolosis (recall)
- Bextra-causing skin hypersensitivity disorders including Stevens John Syndrome
- Celebrex-causing an increased risk of heart attack and stroke
- Cordis Cypher Stent-causing thrombosis (clotting), and hypersensitivity reactions including anaphylaxis
- Crestor-causing muscle toxicity (myopathy and rhabdomyolosis)
- Dialysis Tubing-recall of tubing used in Meridian Dialysis machines
- Enbrel-causing serious infections including sepsis
- Gynecare Intergel-adhesion prevention (withdrawal) causing post-operative pain, repeat surgeries and tissue adherence
- Kava-dietary supplement causing severe liver injury
- Lamisil-treatment of nail, skin and other fungal infections and the development of congestive heart failure (CHF)
- Lariam-and its relation to suicide
- Levoxyl-causing thyroid disorders such as hyperthyroidism
- Lipitor-causing muscle toxicity (myopathy and rhabdomyolosis)
- Lotronex-causing serious and unpredictable gastrointestinal adverse events, including death
- Meridia-causing cardiovascular events and death
- Neurotonin-an anti-epileptic drug and its relation to suicidal behavior
- Olympus Bronchoscopes (voluntary recall)-defective bronchoscopes causing trapping and spreading of bacteria potentially leading to pneumonia and other infectious diseases
- Paxil-an anti-depressant causing suicides in adolescents
- Pergolide-developed for the treatment of Parkinson's Disease, causing cardiac valvulopathy and serious heart valve disease
- Remicade-causing tuberculosis, invasive fungal infections and heart failure
- Rezulin-causing liver failure
- St. Jude Heart Valve-defective heart valves causing leakage and thromboembolic events
- Vioxx-causing an increased risk of heart attacks
- Zocor-causing muscle toxicity (myopathy and rhabdomyolosis)
- Zoloft-antidepressant causing increased suicidal symptoms/suicide
- Zyprexa-antidepressant causing serious side effects including diabetes and pancreatitis
If you know that you have a medical problem related to taking any pharmaceutical drug or medical device, please call Attorneys David C. Strouss or Marilyn T. McGoldrick 800-431-4600. We will provide you with a free and confidential consultation at no further obligation.
Important Links
- American College of Cardiology
- American Heart Association
- FDA
- FDA Medical Products Reporting Program
- Federal Government Litigation Information
- Mayo Clinic
- National Library of Medicine Search
- AHP National Diet Drug Settlement
Permax and Dostinex And The Development of Heart Valve Problems
An article in the January 4, 2007 issue of the New England Journal of Medicine revealed that Eli Lilly drug Permax (Pergolide) significantly increases the risk of developing valvular heart problems in users with Parkinson's disease. Two recent studies of the drug, which is also used to treat restless leg syndrome, found that users were at least seven times more likely to develop valvular heart damage than those taking other Parkinson's treatments; patients taking the highest Permax doses were at a 37 times greater risk of developing heart damage. The heart damage experienced by study participants ranges from moderate valve damage and leaky valves to heart failure and sudden death.
Permax was introduced in 1989. If you or a loved one has been injured by this drug, please contact us for further information.
Dostinex™
In the same New England Journal study, users of Pfizer drug Dostinex (Cabergoline) were found to be 4.9 times more likely to suffer heart problems than patients taking similar drugs. At the highest doses, the probability of experiencing valvular damage rose to 50.3 times greater for Dostinex users. In the United States, Dostinex is marketed only for a hormonal disorder, hyperprolactinemia, but is marketed for Parkinson's outside the country. Currently, the Dostinex package insert and label lists heart valve damage only as a "precaution."
Recall of Certain Composix Kugel Mesh Patches Used In Hernia Repair
Specific lot numbers of the Composix Kugel Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, were recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. The recall occurred after it was discovered that the "memory recoil ring," which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Affected lots were recalled between December 2005 and March 2006. In March of 2006, the FDA sent a recall letter to physicians and patients advising patients implanted with one of the recalled lot numbers to seek immediate medical attention if they experience persistent or unexplained abdominal pain, fever, tenderness at the implant site, or other related symptoms. Patients should also contact their physician, if they have not done so, for further evaluation.
This recall is product code- and lot-specific and applies to the large sized patches. The specific Product Codes and Descriptions recalled at this time are:
(Recalled December 2005 and January 2006)
| PC# 0010206 | Bard Composix Kugel | Extra Large Oval | 8.7" x 10.7" |
| PC#0010207 | Bard Composix Kugel | Extra Large Oval | 10.8" x 13.7" |
| PC#0010208 | Bard Composix Kugel | Extra Large Oval | 7.7" x 9.7" |
(Recalled March, 2006)
| PC#0010209 | Bard Composix Kugel | Oval | 6.3" x 12.3" |
| PC#0010202 | Bard Composix Kugel Large | Oval | 5.4" x 7" |
| PC#0010204 | Bard Composix Kugel | Large Circle | 4.5" |
If you or a loved one has been harmed by this product, please contact our office to discuss your rights: mmcgoldrick@tenlaw.com, dstrouss@tenlaw.com or call our toll free number 1-800-431-4600 to speak directly with an attorney.
Fen-Phen and Redux
On September 15, 1997, at the request of the US Food and Drug Administration, Redux and Fen-Phen were withdrawn from the market. This followed reports that heart-valve abnormalities were found in 30% of Fen-Phen users who were given diagnostic echocardiograms at the Mayo Clinic. Additional studies also indicated that Fen-Phen caused the deadly lung disease, Primary Pulmonary Hypertension (PPH), in some patients taking the drugs.
The FDA, along with the Centers for Disease Control and the National Institute of Health, recommend that anyone who has ever taken either Redux or Fen-Phen alone or with other diet-drug medication, should see their doctor immediately for a physical examination to determine if any heart or lung damage has occurred-even if no symptoms are apparent.
The occurrence of heart valve related health problems associated with the use of Fen-Phen and Redux resulted in a National Class Action Settlement with American Home Products Corp (AHP), now known as Wyeth, the manufacturer of these diet drugs. The Settlement received final Judicial Approval on January 3, 2002, triggering a number of deadlines. If you ingested Fen-Phen, Pondimin or Redux you are automatically a member of the Settlement unless you filed the required paper work to "opt-out" or withdraw. In order to be eligible for certain benefits you must first register and you must have an echocardiogram (a non-invasive ultrasound of the heart). Individuals who have registered and who meet the requirements for "Matrix" level benefits for heart valve damage and related health problems may be eligible to receive between $7,389 and $1,485,000 in benefits. Thornton and Naumes is currently working with experienced cardiologists located at the New England Medical Center in Boston who review echocardiogram tapes to determine eligibility for Matrix benefits.
It is also important to note that the Settlement does not cover or provide benefits to persons diagnosed with PPH. These individuals can proceed with individual lawsuits against Wyeth if they meet the criteria for PPH, as defined in the Settlement program.
Since 1997 Thornton & Naumes has represented a large number of individuals suffering from PPH or serious valve damage who chose to pursue individual claims against Wyeth. After extensive preparation of the cases scheduled for trial, Thornton & Naumes and its co-counsel were able to obtain significant settlements on behalf of all of these clients.
Medtronic Defibrillator Lead Recall
On October 15, 2007, Medtronic, the manufacturer of implantable cardiac defibrillators, recalled the Sprint Fidelis lead used in its products because of a potential to fracture. Patients with these leads (approximately 235,000 according to the manufacturer) are urged to see their doctors to determine if they are in the recalled group and if the leads have developed a fracture. If the lead has fractured, it could cause the device to fail, preventing the administration of life-saving therapy or it could cause the device to shock unnecessarily. The manufacturer estimates that up to 5000 patients could have leads that experience some kind of failure.
If you are a defibrillator patient, you should contact your doctor immediately. Patients are being asked to come in for computerized testing that could detect abnormalities in resistance and other electrical functions that could signal an impending fracture in the lead. The identifying numbers for the leads in the Medtronic recall are 6930, 6931, 6948 and 6949.
If you have been injured by or have had a Sprint Fidelis lead implanted in you as part of an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillators---(CRT-D) you may have legal recourse against Medtronic. Please contact our firm either by email mmcgoldrick@tenlaw.com or phone: 1-800-431-4600.
Trasylol®
Thornton & Naumes, is investigating cases involving Trasylol (aprotinin), a drug marketed by Bayer Corporation that is primarily used post surgery to assist in coagulation. Trasylol is most commonly used in heart bypass and valve replacement or repair surgeries. On September 21, 2006, the FDA held a public advisory committee meeting to discuss the safety profile for Trasylol. The public advisory committee reviewed two published observational studies, the Bayer Worldwide Safety Review, and the FDA's post- marketing database. Shortly thereafter, Bayer announced to the FDA that it had carried out a third safety study that the FDA did not know about. Bayer suggested that this new observational study indicated that the use of Trasylol may increase the risk of death, serious kidney failure, congestive heart failure and strokes.
On November 5, 2007, the FDA requested Bayer to agree to a marketing suspension of Trasylol pending a detailed review of the preliminary results from a Canadian study which suggested an increased risk of death. On November 19, 2007, the FDA suggested that Trasylol may have killed more than 200 people. On November 26, 2007, Trasylol sales were suspended in the United States suggesting that Trasylol was associated with sudden death.
Trasylol is a very expensive medication which costs at least $1,300 per dose. Amocar (aminocaproic acid) and Cyklokapron (ranexamic acid) are drugs that are used for the same purposes, and have been deemed safe and effective. Amocar costs $7 a dose and Cyklokapron costs $44 per dose.
Most recently, "60 Minutes" on CBS aired a special on Trasylol injuries. Click here for a link to the story: http://www.cbsnews.com/stories/2008/02/14/60min...
The use of the medication is often not disclosed to the patient. Investigation will require a review of the surgical record to ascertain the use of Trasylol in the particular case. However, if you had heart surgery and suffered kidney failure, congestive heart failure or a stroke, please contact attorney Marilyn T. McGoldrick at mmcgoldrick@tenlaw.com for more details.
Tysabri
On February 27, 2008, FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians have been instructed to inform patients that Tysabri may cause liver injury.
The FDA Investigates A Possible Link Between Singulair and Suicide
Singulair is used for the treatment of asthma in adults and pediatric patients 12 months of age and older. It ia also approved to help relieve of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older. On Thursday, March 27, 2008, the FDA requested Singulair’s manufacturer, Merck & Co., evaluate the drug’s data and is reviewing reports it has received of patients who claim to have experienced behavior and mood changes after taking the drug. The FDA estimates it could take up to nine months to complete the evaluations and issue possible recommendations to the public.
The FDA urged patients not to stop taking Singulair before talking to their doctor if they have questions about this new information. Health care professionals and caregivers are urged to monitor patients taking Singulair for suicidality and changes in behavior and mood until there is more information available.
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