Dangerous Drugs / Medical Devices

Matthews & Associates represent people injured by dangerous drugs, vaccines and medical devices including Vioxx, Medtronic Heart Defibrillators, Gardasil, Rezulin, Avandia, Ortho Evra, Tylenol, Haldol, Gadolinium, Seroquel, Cymbalta, Fentanyl/Fentora, Oxycontin, Trasylol, Fosomax and many other dangerous drugs and medical devices.

Medtronic Inc./Guidant defibrillator recalls

Medtronic Inc. announced in mid October 2007 that is was stopping distribution of wires that connect some of its defibrillators to patients' hearts after learning they may have contributed to five deaths. More than 268,000 of the leads have been implanted. A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

 

Medtronic said it discovered a "small chance of fractures in particular locations" on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return unused leads to Medtronic. A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. Medtronic did not call its response a "recall," but the FDA did.

 

On June 17, 2005, Guidant Corporation issued a defibrillator recall for cardiac defibrillators due to potentially fatal malfunctions of the devices. There are approximately 38,000 patients in the United States with Guidant brand defibrillators, which reports indicate have failed 45 times and are responsible for at least two deaths so far.  

 

  The Guidant recall was issued for the following models of cardiac defibrillators and pacemakers:

Prizm 2 DR model 1861

1. Contak Renewal model H135
2. Contak Renewal 2 model H155
3. Ventak Prizm AVT
4. Vitality AVT
5. Renewal 3 AVT
6. Renewal 4 AVT ICD's
7. PULSAR® MAX Models 1170, 1171, 1270
8. PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
9. DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
10. MERIDIAN® Models 0476, 0976, 1176, 1276
11. PULSAR MAX II Models 1180, 1181, 1280
12. DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
13. CONTAK TR® Model 1241
14. VIRTUS PLUS® II* Models 1380, 1480
15. INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
16. * VIRTUS PLUS II and INTELIS II models available only outside the U.S.
17. The Guidant Defibrillator Recall
    Critical wiring errors in Guidant defibrillators may cause a short circuit which can overload their delicate wiring. Prizm AVT, Vitality AVT and Renewal AVT can be serviced at a doctor’s office to reduce this risk, but Prizm 2 DR and Contak Renewal must be replaced in order to eliminate potential hazards. Those at the greatest risk should immediately consult their doctors and continue to have checkups every three months to ensure that the devices are still working properly.
18. The Food and Drug Administration released a statement stating that they did not require Guidant to recall its products, but that they nevertheless supported the decision to address such serious allegations. The fact that this issue was finally addressed is of small comfort to the 50,000 people who continue to live in constant fear that their life-saving medical equipment may fail them.

 

Pharmaceutical Liability - An Overview

"Pharmaceutical liability" is a term used to describe the legal consequences a manufacturer of drugs may face if its products injure people. The manufacturer may be found liable for making and selling a defective product (a claim of strict liability), or it may be found liable for not taking reasonable care to keep its products from causing injury (a claim of negligence). The law treats these two approaches to liability as distinct theories, and depending on the particular facts of the case, a person might recover damages on one theory but not the other. In some states, however, a statute creates a single claim for product injuries, which may combine aspects of the two. Accordingly, if you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer with experience in this area.

Legal Claims Against Drug Manufacturers

Claims against drug manufacturers usually take two forms: strict liability and negligence. In a strict liability case, the focus is on the product and the question is whether it has a defect that makes it unreasonably unsafe. In a negligence case, the question is whether the manufacturer has acted with reasonable care. In both cases, manufacturers may assert that medications have reasonable risks or that another party (such as a doctor) is responsible for the patient's injuries. Accordingly, if you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer with experience in this area.

Pharmaceutical Liability Resource Links

National Library of Medicine
This resource is part of the National Institutes of Health. Users can get information about drugs using either the generic or brand same. The site also contains warning and recall information.

US Food and Drug Administration/FDA Consumer
A searchable archive of the Food and Drug Administration's publication, FDA Consumer, with information relating to healthcare, medications, and other health-related issues.

MedWatch
The FDA has an on-line system called MedWatch for reporting serious reactions to and problems with medications, dietary supplements, and herbal remedies. The form can be printed out and completed (the site suggests you might ask your doctor or pharmacist for help in filling it out) or it can be completed and submitted online. Instructions are located at http://www.fda.gov/medwatch/report/consumer/instruct.htm.