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Duragesic product liability - Personal Injury - Claims
Author: Matthew A. Passengers
injury "> Injury lawyers experienced in negligence, misconduct and other types of injuries are actions taken note of the recent action product liability drug Duragesic.
Duragesic ® is the trade name of a pain patch containing fentanyl, a potent opioid analgesic. Duragesic is a transdermal system of medicine, fentanyl is absorbed by the patient's skin and blood circulation, providing relief pain for up to three days (72 hours) from a single patch application.
Duragesic is prescribed in five doses: 12, 25, 50, 75 and 100 mcg fentanyl per hour. 50, 75 and 100 ug / h dose is prescribed only for patients who are already on opioid tolerance and therapy, and require the administration of opiates. In addition, the label indicates that Duragesic 12 mcg / hour as a measure of openness has not been systematically assessed, therefore, that Duragesic should be used in Patients who are tolerant to opiates.
Fentanyl was found to be a good option for the transdermal application due to their physicochemical properties and high analgesic potency. However, fentanyl is not without serious adverse effects. Pharmacologically, fentanyl acts on the central nervous system, causing analgesia, sedation, severe respiratory depression, muscle rigidity, convulsions, and vomiting. The most serious side effects from fentanyl overdose is hypoventilation (respiratory depression), which can be fatal.
Development of Duragesic
Currently, only eleven of transdermally administered drugs on the market, seven of which were developed by ALZA. In 1981, ALZA responded to a call from the White House created committee of scientists and physicians to develop more potent analgesics with other delivery systems for the seriously ill and dying patients with intractable pain. ALZA has begun work on a project to develop a transdermal fentanyl patch in late 1982.
In early 1983, met with representatives ALZA DEA agents to discuss the manipulation of fentanyl. Among other things, the DEA has expressed concern that the dose was reduced to a minimum due to the risk of overdose and abuse.
In 1991, ten years after ALZA proposed developing a transdermal fentanyl patch, Duragesic was offered for sale in the United States. Initially, Duragesic has been approved for the treatment of acute moderate to severe postoperative pain. However, owing to slow the emergence of drug levels in the transdermal delivery and three days to maintain the levels of drug Duragesic, the system is more suitable for the treatment of chronic pain, especially cancer patients. In 1998, the World Health Organization (WHO) recommended that transdermal fentanyl for the treatment of cancer pain patients stable.
From received FDA approval in 1990, Janssen and ALZA aggressively sought the expansion of the use of Duragesic beyond cancer patients. For example, using transdermal fentanyl for the treatment of rheumatic pain and severe back pain.
The FDA has also approved an extension of Duragesic treatment of sick children.
Janssen latest advertising campaign to expand the use of Duragesic was foiled by the FDA. In the 1990s, the company sent a document entitled Ten List Doctors urge doctors to switch patients to its Duragesic patch rather than using more traditional type of pain. Between the reasons listed is the phrase "It's not just for the terminal stage of cancer, no more!" But in 2000, the Ministry of Health and Social Services sent a letter to the company Janssen inform their advocacy efforts on the parts of the extension sentence for Duragesic were false and misleading. The government agency said: " The suggestion that Duragesic can be used for any type of promotion to the management of the Duragesic pain of a much larger which was recommended by the PI, and is therefore misleading. "
Currently, Duragesic is the most widely prescribed drugs transdermally. From 2002 to 2003, the total number of prescriptions of fentanyl patches the United States rose from 4.5 million to 5.4 million twenty per cent increase. And the sales figures for Duragesic has been enormous: the total annual sales in the United States reached a half billion ($ 1,500,000,000.00) dollars per year.
And by 2005, Duragesic generated sales point two thousand billion ($ 2,100,000,000.00) dollars in the world.
Duragesic defects:
Recalls package after of leakage
Design / manufacturing defect, the more applicable to our case is a bad seal on one side of the Duragesic patch, resulting in millions patches living memory. In 2004, ALZA (through Janssen) has launched two major Class I recalls Duragesic for that reason. The first was on February 17, 2004 at which time the control Duragesic No. 0327192 (75 mcg / h) was driven by the market. The reason cited is a potential violation of the seal on one side of the coin, which could lead to leakage fentanyl patch. This withdrawal of about 440,000 pieces.
On April 5, 2004, Janssen expanded the Duragesic recovery of 2.2 million stamps (numbers Control 0327192, 0327193, 0327294, 0327295 and 0330362). Again, the reason is a possible violation of the board, which would result in the loss of fentanyl. Janssen sent a "Dear Healthcare Professional" Newsletter of the extension of the withdrawal.
Escape of a Duragesic fentanyl patch may cause patients to receive either too much or too little of the drug. If leaching of fentanyl piece before application to the skin, patients receive too little in May medicines to treat pain adequately. In this situation, patients are accustomed to a specific experience is from May of withdrawal, including the effects of sweating, insomnia, and abdominal discomfort.
By contrast, fentanyl leaks that occur when the patch is in the skin, expose patients to potentially fatal an overdose of fentanyl. Duragesic is only designed to provide a controlled amount of fentanyl in the patient's skin. Patients with a defective fentanyl patch leak directly to the skin gets a lot of medication. In this case, patients may experience minor complications such as sedation, drowsiness and nausea. Overdosage fentanyl in May and the most serious complications, including fatal hypoventilation (respiratory depression) or stop the heart.
Jansen Duragesic When introduced in 1991, reports of toxicity caused by fentanyl overdose are very rare. In fact, a California study of 112 deaths associated with fentanyl had the conclusion that the general availability of drugs in May is responsible for the high incidence of overdoses.
Furthermore, a recent demand filed against Johnson & Johnson Duragesic, ALZA and Janssen, the plaintiffs argued that "despite the knowledge of the case, the accused (Johnson & Johnson, Janssen, ALZA) took inadequate steps to advise doctors, hospitals, nursing homes and other health professionals of the anomaly and the extent of harm to users of the Duragesic patch. "
Heat-induced Overdose
ALZA and Janssen knowledge of overdose caused by external heat potential dates back to 1986 when ALZA make laboratory tests on a patch of nitroglycerin delivery with the same co-polymer used in Duragesic patches. ALZA then laboratory tests Duragesic in 1988, which showed an increase of five degrees Celsius in temperature Duragesic doubled the rate of release. Dr. Curtis Wright, Medical Review Officer of the FDA was very interested in 1989 and again in 1990, ALZA had not responded to his request for more information effects of external heat. Duragesic after entering the market in April 1991, Janssen and ALZA learned six reports of health care providers that the heat seems to increase fentanyl blood levels in patients outside the hospital and at home.
However, the first time Janssen and ALZA an attempt to warn against the effects heat from the outside came in a January 17, 1994 "Dear Doctor" letter with a draft revision of labeling. The new labeling includes a warning of heat, who was buried on page 10 of the attachment order, but was not mentioned in the warning letter to doctors that the heat applied to the outside can be fatal.
GOVERNMENT REGULATION
In 2004, the FDA has influenced ALZA and Janssen to publish two of the class I recalled Duragesic, "due to the closure one of its edges, which could cause a fatal overdose of fentanyl. Still, this was not the first time the FDA has found problems with companies handling Duragesic. In fact, before the 2004 recall, the FDA has required labeling revisions Duragesic 13 times.
And recently, in July 2005, the FDA issued a Public Health Advisory on use of the Duragesic patch in response to reports of deaths in patients using the patch.
In 1994, the FDA sent an ALZA "letter of caution" certain violations and deviations from good manufacturing practices (GMP) regulations of the Food and Drug Act. This prompted the company to deliver a letter to all health professionals of the warning Duragesic abuse.
In the 1990s, the Ministry of Health and Human Services Human Janssen said that their promotional materials to expand the use of Duragesic is in direct violation of the Federal Food, Drug, and Cosmetic Act and included statements false on the safety and effectiveness. The agency determined that the promotion of part of the "false or misleading because they contain misrepresentations of the information security, expand Duragesic indication, contain unproved, and lack balance. "
After Janssen "voluntary," the Duragesic remember in 2004, the FDA issued a "security alert" warning that the withdrawal was due to a possible leak in the product label, which could lead to skin exposure to fentanyl. The warning adds that "the dermal exposure of flight of a drug Duragesic patch can cause nausea, sedation, drowsiness, or potentially fatal. "Article 6 Govt. Janssen has also written a letter of" health professional [s] "to inform them of the expansion of the mind, in April 2004.
Moreover, the September 2, 2004, the FDA issued another Janssen "warning letter." The letter indicates that the last Duragesic promotional pieces "false or misleading information about potential abuses and dangers of drugs, including non-effective applications of Duragesic." The letter says: " By suggesting that Duragesic has a low abuse potential compared with other opioids, the map file could encourage use of dangerous drugs, can cause severe hypoventilation or death.
The Duragesic product label was updated again in June 2005 to add new data security in several areas of labeling, and Janssen has published another "Dear Healthcare Professional" letter of these changes. Under an article entitled "hypoventilation (respiratory depression)," The letter indicates that "seriously threaten the life or hypoventilation may occur at any time during the use of Duragesic ® in particular during the first 24-72 hours after initiation of therapy and after dose increases. "Janssen also warns against a" potential temperature increases in fentanyl released from the burden system resulting in possible overdose and death. "Therefore, the letter calls on all patients to avoid exposing the Duragesic" direct sources of heat external, such as heating pads or electric blankets, lamps, saunas, spas, and heated water beds, etc, while using the system. "
Finally, the July 15, 2005, the FDA issued a "Notice of public health" on the use of the Duragesic patch in response to reports of deaths in patients using the patch. The FDA has indicated that investigating deaths related to overdoses of fentanyl in patients using Duragesic. According to the FDA, "some patients and health care providers may not be fully aware of the dangers of this very strong narcotic painkiller. Therefore, FDA is issuing This health card to alert patients and their caregivers and health professionals, highlighting the important safety information. "
Medical literature
Overdose of fentanyl
Since Duragesic reached the market in 1991, studies revealed the high number of overdoses involving fentanyl transdermal administration. The most serious side effect is respiratory depression, which can be fatal. A study published in 1991, examined 112 fentanyl-related deaths in the eastern United States, primarily in California. Fentanyl deaths seem to occur quickly, "probably the result of acute respiratory depression." While recognizing the extreme potency of fentanyl, the author suggests that "the incidence of fentanyl-related deaths is probably determined by the availability of drugs, but the relative potency of analogs. "
In a study published in 2000, the Los Angeles County Department of Coroner has analyzed 25 cases of deaths related to fentanyl. The author notes that the judge instruction in Los Angeles County Office of evaluating an event almost every month fentanyl patch death. Another study, this year, has identified 61 cases of overdose transdermal drug in a regional poison information system for a period of five years.
Head induced Overdose
Heat is expected to increase skin permeability, metabolism and elimination of fentanyl. If the release of this system is much faster than the penetration the skin, skin to control the transdermal absorption rate of the patient's systemic circulation, rather than Duragesic special rate control membrane.
Several case reports have described the development of life-threatening overdose caused by a heat pad or elevated body temperature. Frolich et al. reported drug overdose in a patient who was using a heating cover for pain relief after surgery. 17 The medical literature, see Frolich MA, et al. Overdose of opioids in a patient using a fentanyl patch during treatment with a warming blanket, 93 Anesth. Analg. 647-48 (2001) (Not available in paper). The increased absorption of the other in May in connection with the heat associated with transdermal fentanyl toxicity. Newshan G., toxicity related to the heat patch fentanyl, 16 J. Pain Symptom Mgmt. 277-78 (1998) (can not get hard copy).
A 2003 study examined the effect of heat on the absorption of transdermal fentanyl. The authors concluded that increases in skin temperature in May and increased systemic absorption of fentanyl. Consequently, heating blankets and heating pads should not be used in conjunction with, or Duragesic patches.
However, starting in 2003, Duragesic label noted that serum concentrations of fentanyl May "in theory" more than one third of patients with a body temperature of 40 degrees centigrade given the accelerating release and increasing the permeability of the skin. The label warns of possible rise in temperature depends the release of fentanyl from the system. "
About the author:
Matthew A. passengers is a href = "http://www.passenlaw.com"> lawyer Personal Injury Law Group Chicago passengers. Mr. passengers concentrates in all areas of Illinois injury law including truck accidents, auto accidents, wrongful death, brain damage, birth injury, construction accidents and medical malpractice in the Chicago area.
Prior to joining passengers Law Group, Mr passenger was a partner in the litigation department of Jenner & Block LLP.
Mr. passengers received his BA Magna Cum Laude, Phi Bete Kappa in economics from the University of Michigan in 2002. Mr. passengers received her law degree, summa cum laude from DePaul University College of Law in 2006, where she graduated from the School coif. During the school law, which was a passenger as a member of the DePaul Law Review.
During the 2003-04 academic year, Mr. stage passengers of the Honorable Ronald A. Guzman States United District Court for the Northern District of Illinois. He also spent the semester following the cleric U.S. Attorney \ 's Office, Northern District of Illinois.
Mr passenger is a member of the Illinois Bar. This is a member of the Chicago Bar Association, Illinois Trial Lawyers Association, State Bar of Illinois and the Association American Justice. Mr. passengers also works with teachers and elementary students in the Chicago area, public schools, volunteer at the Foundation Constitutional Rights for Chicago \ 's \ "Lawyers in the Classroom" program.
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Day 20 Confrontation
