July 19th, 2009 at 07:07am
Under Personal Injury Law
Personal Injury Law Firms experienced in negligence, malpractice and other types of personal injury actions have taken note of recent product liability actions involving the drug, Duragesic.
Duragesic® is the trade name for a pain-medication patch containing fentanyl, a potent opioid analgesic. Duragesic is a transdermal system-the medicine, fentanyl, is absorbed through the patient’s skin and into the bloodstream, providing pain relief for up to three days (72 hours) from a single patch application.
Duragesic is prescribed in five dosage strengths: 12, 25, 50, 75 and 100 mcg of fentanyl per hour. The 50, 75, and 100 ug/h doses are only prescribed for patients who are already on and tolerant to opioid therapy, and require continuous opioid administration. Moreover, the Duragesic label warns that 12 mcg/hour as an initiating dose has not been systematically evaluated; therefore, Duragesic should be used only in patients who are opioid-tolerant.
Fentanyl was found to be a good choice for transdermal application because of its physicochemical properties and high analgesic potency. However, Fentanyl is not without its serious adverse effects. Pharmacologically, fentanyl acts on the central nervous system causing analgesia, sedation, severe respiratory depression, muscle rigidity, seizures, coma, and hypotension. Adverse reactions include mood changes, euphoria, dysphoria, drowsiness, constricted pupils, nausea, and vomiting. The most serious side effect of fentanyl overdose is hypoventilation (respiratory depression), which can be fatal.
Development of Duragesic
Currently, only eleven transdermally administered drugs are on the market; seven of which were developed by ALZA. In 1981, ALZA responded to a plea from a White House-created committee of scientists and physicians to develop more potent analgesics with alternative delivery systems for critically ill and dying patients who were suffering from intractable pain. ALZA began work on a project to develop a fentanyl transdermal patch in late 1982.
In early 1983, ALZA representatives met with agents from the DEA to discuss the handling of fentanyl. Among other issues, the DEA expressed concern that the dosage be kept to an absolute minimum, because of the potential for overdose and abuse.
In 1991, ten years after ALZA proposed the development of a transdermal fentanyl patch, Duragesic was made available for sale in the United States. Originally, Duragesic was approved to treat acute, postoperative and moderate-to-severe pain. However, due to the slow onset of drug levels from the transdermal delivery and three day maintenance of drug levels with Duragesic, the system was more suited for treatment of chronic pain conditions, in particular, cancer patients. By 1998, the World Health Organization (WHO) recommended transdermal fentanyl for treatment of cancer pain in stable patients.
Since receiving FDA approval in 1990, ALZA and Janssen aggressively sought the expansion of Duragesic use beyond cancer patients. For example, transdermal fentanyl has been used to treat rheumatologic pain and severe back pain.
The FDA has also approved an expansion of Duragesic to treat pediatric patients.
Janssen’s most recent advertising campaign to expand the use of Duragesic was thwarted by the FDA. In the late 1990s, the company sent a document called Top Ten List to doctors urging physicians to switch their patients to Duragesic patches rather than use more traditional type pain relievers. Among the reasons listed is the phrase “It’s not just for end stage cancer any more!” However, in 2000, the Department of Health and Human Services wrote a letter to Janssen informing the company that its promotional pieces concerning the “Broadening of indication” for Duragesic were misleading and contained misrepresentations. The government agency responded, “The suggestion that Duragesic can be used for any type of pain management promotes Duragesic for a much broader use that is recommended by the PI, and thus, is misleading.”
Currently, Duragesic is the most widely prescribed transdermal medication. From 2002 to 2003, the total number of fentanyl patch prescriptions within the United States rose from 4.5 million to 5.4 million-a twenty percent increase. And the resulting sales figures for Duragesic have been enormous: total annual sales in the United States have reached one and a half billion ($1,500,000,000.00) dollars annually.
And in 2005, Duragesic sales generated two point one billion ($2,100,000,000.00) dollars worldwide.
Duragesic Defects:
Package Leak-Subsequent Recalls
The design/manufacturing defect most applicable to our case is an improper sealing of one edge of the Duragesic patch, resulting in millions of patches being recalled. During 2004, ALZA (through Janssen) initiated two large Class I recalls of Duragesic for this exact reason. The first was February 17, 2004 at which time Duragesic Control No. 0327192 (75 mcg/hr) was pulled from the market. The cited reason was a potential seal breach on one edge of the patch, which could result in fentanyl leaking from the patch. This recall included about 440,000 patches.
On April 5, 2004, Janssen expanded its recall of Duragesic to include 2.2 million patches (Control Numbers 0327192, 0327193, 0327294, 0327295, and 0330362). Again, the reason cited was the potential for a breach of the seal, which would result in fentanyl leakage. Janssen sent a “Dear Healthcare Professional” letter to inform of the expanded recall.
A leak of fentanyl from a Duragesic patch could cause patients to receive either too much or too little of the drug. If the fentanyl seeps out of the patch before its application to the skin, patients may receive too little medication to adequately treat their pain. In this situation, patients used to a specific does may experience withdrawal effects including sweating, sleeplessness, and abdominal discomfort.
Conversely, fentanyl leaks that occur while the patch is on the skin expose patients to a potentially life-threatening overdose of fentanyl. Duragesic is designed to deliver only a controlled amount of fentanyl into the patient’s skin. Patients wearing a defective patch that leaks fentanyl directly onto the skin will receive too much of the medication. If this occurs, patients could experience minor complications such as sedation, drowsiness, and nausea. Fentanyl overdose may result in more serious complications, including fatal hypoventilation (respiratory depression) or cardiac arrest.
When Jansen placed Duragesic on the market in 1991, reports of toxicity due to fentanyl overdosing were fairly common. In fact, one study in California of 112 deaths associated with fentanyl concluded that the general availability of the drug may be responsible for the high incidence of overdoses.
Furthermore, in a recent Duragesic lawsuit filed against Johnson & Johnson, Janssen, and ALZA, the plaintiffs alleged that “despite knowing of this defect, the defendants (Johnson & Johnson, Janssen, ALZA) took inadequate steps to advise physicians, hospitals, nursing homes and other health care professionals of the defect and the significant damages to users of the Duragesic patches.”
Heat-Induced Overdose
ALZA and Janssen’s knowledge of the overdosing potential caused by external heat dates back to 1986, when ALZA did lab testing on a nitroglycerin-delivering patch using the same co-polymer membrane used in Duragesic patches. ALZA subsequently did lab testing on Duragesic in 1988-that showed that a five degree Centigrade increase in temperature doubled Duragesic’s release rate. Dr. Curtis Wright, the FDA Medical Review Officer, was quite concerned in 1989 and again in 1990 that ALZA had not responded to his request for more information on the effects of external heat. After Duragesic hit the market in April of 1991, ALZA and Janssen learned of six reports from healthcare providers that external heat appeared to increase blood fentanyl levels in patients in the hospital setting and at home.
However, the first time Janssen or ALZA made an effort to warn of the effects of external heat came in a January 17, 1994 “Dear Doctor” letter with an attached proposed labeling revision. The labeling contained a new heat warning, which was buried at page 10 of the attachment, but no mention was made in the letter itself to alert physicians that external heat applied to the patch was potentially life-threatening.
GOVERNMENT REGULATION
In 2004, the FDA influenced Janssen and ALZA to issue two Class I Recalls of Duragesic, “due to improper sealing of one of their edges,” which could result in a life-threatening overdose of fentanyl. Yet, this was not the first time the FDA encountered problems with the companies’ handling of Duragesic. In fact, prior to the recalls in 2004, the FDA has required Duragesic labeling revisions 13 times.
And, as recently as July 2005, the FDA issued a Public Health Advisory concerning the use of Duragesic Patches in response to reports of deaths in patients using the patch.
Beginning in 1994, the FDA sent ALZA a “warning letter” identifying certain violations and deviations from Good Manufacturing Practices (GMP) regulations under the Food and Drug Act. This prompted the company to issue a letter to all health care professionals warning of Duragesic misuse.
In the late 1990s, the Department of Health and Human Services warned Janssen that its promotional materials to expand the use of Duragesic were in direct violation of the Federal Food, Drug, and Cosmetic Act and contained misrepresentations as to the safety and efficacy of the product. The agency determined that the promotional pieces were “false or misleading because they contain misrepresentations of safety information, broaden Duragesic’s indication, contain unsubstantiated claims, and lack fair balance.”
Following Janssen’s “voluntary” recall of Duragesic in 2004, the FDA issued a “Safety Alert” warning that the recall was “due to a potential leak in the product seal,” which could result in skin exposure to fentanyl. The warning adds that “skin exposure to any leaked medication from a DURAGESIC patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications.” Govt Regulation 6. Janssen also wrote a letter to “Healthcare Professional[s]” informing them of the expanded recall in April 2004.
Furthermore, on September 2, 2004 the FDA issued Janssen another “warning letter.” This letter states that the latest Duragesic promotional pieces make “false or misleading claims about the abuse potential and other risks of the drug, including unsubstantiated effectiveness claims for Duragesic.” The letter states, “By suggesting that Duragesic has a lower potential for abuse compared to other opioid products, the file card could encourage the unsafe use of the drug, potentially resulting in serious or life-threatening hypoventilation.”
The Duragesic product label was again updated in June 2005 to add new safety information in several areas of labeling, and Janssen issued another “Dear Healthcare Professional” letter about these changes. Under a section entitled “Hypoventilation (Respiratory Depression),” the letter warns that “Serious or life-threatening hypoventilation may occur at any time during the use of DURAGESIC® especially during the initial 24-72 hours following initiation of therapy and following increases in dose.” Janssen also warns of a “potential for temperature-dependant increases in fentanyl released from the system resulting in possible overdose and death.” Therefore, the letter instructs all patients to avoid exposing Duragesic to “direct external heat sources, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, and heated water beds, etc., while wearing the system.”
Finally, on July 15, 2005 the FDA issued a “Public Health Advisory” concerning the use of Duragesic Patches in response to reports of deaths in patients using the patch. The FDA stated it is conducting an investigation into the deaths related to fentanyl overdose 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 public health advisory to alert patients and their caregivers and health care professionals by highlighting the following important safety information.”
MEDICAL LITERATURE
Fentanyl Overdose
Since Duragesic hit the marketplace in 1991, studies have shown continued high numbers of overdoses involving transdermal delivery of fentanyl. The most serious side effect is respiratory depression, which can be fatal. One study, published in 1991, examined 112 fentanyl-related deaths in the Eastern United States, mostly in California. Fentanyl deaths appeared to occur rapidly, “probably the result of acute respiratory depression.” While acknowledging the extreme potency of fentanyl, the author suggests that “the incidence of fentanyl-related deaths is probably determined by the general availability of the drug, rather than the relative potency of the analogs.”
In a study published in 2000, the Los Angeles County Department of the Coroner analyzed 25 cases involving fentanyl-related deaths. The author notes that the Los Angeles County Coroner’s Office evaluates nearly one case each month involving fentanyl patch-related death. Another study that same year identified 61 cases of transdermal drug overdoses in a Regional Poison Information System over a five-year period.
Head-Induced Overdose
Heat is expected to increase skin permeability, metabolism and elimination of fentanyl. If drug release from the system is much faster than permeation through the skin, the skin controls the transdermal absorption rate into the patient’s systemic circulation, rather than Duragesic’s special rate control membrane.
Several case reports have described the development of life-threatening overdose caused by a heating pad or rise in body temperature. Frolich et al. reported a narcotic overdose in a patient that was using a warming blanket to relieve pain following surgery. Medical Literature 17, see M.A. Frolich et al., Opioid Overdose in a Patient Using a Fentanyl Patch During Treatment with a Warming Blanket, 93 ANESTH. ANALG. 647-48 (2001) (unable to obtain hard copy). The increase in absorption may account for other heat-related toxicity associated with transdermal fentanyl. G. Newshan, Heat-Related Toxicity with the Fentanyl Transdermal Patch, 16 J. PAIN SYMPTOM MGMT. 277-78 (1998) (unable to obtain hard copy).
One study, in 2003, examined the effect of heat on transdermal fentanyl absorption. The authors concluded that increases in skin temperature may result in increased systemic absorption of fentanyl. Therefore, warming blankets and heating pads should not be either used in conjunction with, or placed over Duragesic patches.
However, as of 2003, the Duragesic label warned that serum fentanyl concentrations may “theoretically” increase by one third in patients with a body temperature of 40 degrees Celsius because of accelerated drug release and increased skin permeability. The current label warns of a “potential for temperature-dependent increases in fentanyl release from the system.”
Matthew A. Passen is an
experienced Chicago Personal Injury Lawyer with Passen Law Group. Mr. Passen concentrates in all areas of
Illinois personal injury law, including truck accidents, auto accidents, wrongful death, brain injury, birth injury, construction accidents, and
medical malpractice in the Chicago area.
Prior to joining Passen Law Group, Mr. Passen was an associate in the litigation department of Jenner & Block LLP.
Mr. Passen received his B.A. magna cum laude, Phi Bete Kappa, in Economics from the University of Michigan in 2002. Mr. Passen obtained his law degree, summa cum laude, from DePaul University College of Law in 2006, where he graduated Order of the Coif. During law school, Mr. Passen was as a member of the DePaul Law Review.
During the 2003-04 academic year, Mr. Passen clerked for the Honorable Ronald A. Guzman, United States District Court for the Northern District of Illinois. He also spent the following semester clerking at the United States Attorney’s Office, Northern District of Illinois.
Mr. Passen is a member of the Illinois Bar. He is a member of the Chicago Bar Association, Illinois Trial Lawyers Association, Illinois State Bar Association, and the American Association for Justice. Mr. Passen also works with elementary teachers and students in Chicago-area public schools, as a volunteer in the Constitutional Rights Foundation of Chicago’s “Lawyers in the Classroom” program.
July 18th, 2009 at 07:07am
Under Legal Malpractice
Medical Malpractice is a legal term associated to lawsuits alleging damage to a patient because of various circumstances like misdiagnosis, mistreatment, or various types of negligence made by medical professionals, including doctors. Readers should note that not all errors in medical diagnosis and treatment are necessarily malpractice, because there are certain risks and margins for error that arise inherently in the practice of medicine.
According to JAMA – Journal of the American Medical AssociationMedical malpractice has become the third leading cause of death in the United States, after deaths from heart disease and cancer. The chief allegation is misdiagnosis, either delayed diagnosis or mismanagement of diagnostic tests. It has been observed in a study that the top five diseases that receive monetary awards for medical malpractice, in terms of value, are breast cancer, lung cancer, colorectal cancer (including colon cancer and rectal cancer), heart attack, and appendicitis.
Some of the most common medical malpractice conditions which occur as a result of negligence of doctors or other medical professionals are Cerebral Palsy, Erbs Palsy, Birth Defect Litigation, Birth Injury, Cancer Misdiagnosis and Nursing Home Abuse.
In order to successfully win a medical malpractice award, there are several obstacles to overcome. The first is that the case must be started before the statute of limitations has run out, and this length of time varies by state (and country) and also varies depending on the type of lawsuit or specific allegations
There are several obstacles to overcome in order to win a medical malpractice award. The first and foremost is that the case must be started before the statute of limitations (time limit that restricts when you can start a lawsuit) has run out. The statute of limitations varies by state (and country) and also differs depending on the type of lawsuit or specific allegations.
Since some of the medical errors are considered “normal” and many surgeries, procedures, and drugs have known risks and side effects, it is necessary to prove medical malpractice, rather than a medical error or other adverse event that may not be considered negligence or malpractice.
Always consult with your attorney or other legal professional for any legal advice related to medical malpractice. The information provided in this article is for general informational purposes, and does not constitute legal advice. There are few web sites (like SelectCounsel.com) which evaluate your medical malpractice case for FREE!
George Miller is an experienced legal writer and presently looks after content management for
SelectCounsel.com
July 11th, 2009 at 06:21am
Under Appeals and Writs
On March 23, 1989, the supertanker Exxon Valdez pulled out of Valdez, Alaska, loaded with more than 56,000,000 gallons of crude oil. Captain Joseph Hazelwood, the Master of the vessel, had spent the day drinking with crew members. He had consumed at least eight vodka doubles and his blood alcohol level stood at .241 – more than six times the permissible level under Coast Guard regulations. Third mate Gregory Cousins was on duty beyond the limits specified by federal fatigue laws. Hazelwood, Cousins and the rest of the crew faced a night voyage through ice in Prince William Sound. Hazelwood’s intoxication was evident from the alcohol on his breath, his slurred speech (captured on audiotape) and, most of all, his actions as the ship navigated the sound.
While passing through fishing grounds, Hazelwood took the Exxon Valdez outside established shipping lanes to avoid ice. He put the vessel on automatic pilot, accelerating at Bligh Reef. Hazelwood then left the bridge in violation of Federal Pilotage Regulations. As he went below, Hazelwood gave vague instructions to the inexperienced and fatigued Cousins. Within minutes, the supertanker struck Bligh Reef, spilling 11,000,000 gallons of oil, thereby causing the largest oil spill and greatest environmental disaster at that time experienced in American history.
Following the grounding, lawsuits were filed in Alaska State and Federal Court on behalf of approximately 45,000 individuals, businesses, native corporations and local governments, seeking both compensatory and punitive damages. Most of the state court actions were ultimately removed to federal court. The Federal District Court carefully managed this litigation. It entered hundreds of orders, and the discovery master entered hundreds more. The trial plan provided for four separate phases of trial. The first three phases were to be tried to a single jury of 12 (rather than the customary six), with a unanimous verdict required. Trial proceeded as follows:
1. Phase 1 and began on May 9, 1994, 5 years after the spill, and ended on June 6, 1994. A week later, on June 13, 1994, the jury returned a verdict that both Exxon and Hazelwood had been reckless.
2. Phase IIA went to trial in June 20, 1994, to determine the lost harvest, loss price and permit valuation claims in the Prince William Sound, Kodiak, Cook Inlet, and Chignik salmon and herring fisheries. After deliberating a month (from July 11, 1994 to August 11, 1994), the jury awarded hundreds of millions in compensatory damages on these claims.
3. Phase III was tried between August 22, 1994 and August 29, 1994. In this phase, the jury was asked to decide whether Exxon and/or Hazelwood should be assessed punitive damages, and if so, in what amount. The jury returned its verdict on September 16, 1994, awarding punitive damages against Exxon in the amount of $5 billion and against and Hazelwood in the amount of $5,000.
The compensatory damage claims of all other plaintiffs, not earlier decided in Phase II of the trial, were to have been decided in Phase IV. Phase IV settled before trial, in mid-1996.
Exxon and Hazelwood filed countless post-trial motions. These motions resulted in the District Court issuing approximately 250 pages of rulings. Due to this delay, final judgment was not entered until September 24, 1996. An Amended Judgment was ultimately issued on January 30, 1997.
Appeals and cross appeals next ensued. The Ninth Circuit Court of Appeals issued its first decision on November 7, 2001. In essence, the court remanded the case to the trial judge, requesting that Judge Holland evaluate the appropriate amount of punitive damages in light of United States Supreme Court decisions, BMW and Cooper. (It should be noted that neither of these Supreme Court decisions existed at the time of the trial of the Exxon Valdez litigation.)
Ultimately, Judge Holland reluctantly reduced the jury’s punitive damage award from $5 billion to $4.5 billion. Judge Holland went on to note that interest on the judgment itself would be somewhere in the range of approximately $2.5 billion. Exxon appealed again.
On Friday, December 22, 2006, the Ninth Circuit Court of Appeals again issued decision, reducing the punitive damage award against Exxon from $4.5 billion to $2.5 billion. Exxon immediately sought en banc rehearing before the Ninth Circuit Court of Appeals. On May 23, 2007, rehearing was denied. This left Exxon with the option of a writ to the United States Supreme Court, which it did.
Incredibly, on October 29, 2007, the United States Supreme Court granted Exxon’s Writ, and has agreed to decide the propriety of the revised judgment. The case will likely be argued in during spring, 2008. One Justice, Samuel Alito, recused himself due to ownership of between $100,000 and $250,000 in Exxon stock.
Clearly, this is one of the oldest pieces of environmental disasters litigation in the country. Who would have ever imagined that following one of the largest oil spills in the world, caused by a clearly drunken Captain, over 18 years would pass without one penny in punitive damages being paid to those so greatly damaged by the spill.
From a practical standpoint, many damaged by the spill believe that Exxon has already prevailed because they’ve literally worn people out. Following the environmental disasters, numerous people were forced into bankruptcy. Since the spill, numerous others have died, leaving their heirs to seek recompense. Even some of the most prominent lawyers involved in the litigation (Melvin M. Belli, Sr., Jerry Cohen, Leonard Ring, Richard Gerry, among others), have since passed away. Though bittersweet, perhaps this tragic litigation is finally nearing completion.
From a legal perspective, there is much to be said about the Ninth Circuit Court of Appeals December 22, 2006, opinion. Was the award of $4.5 billion “grossly excessive”? After a defendant displays egregious, reprehensible, conduct sufficient to justify an award of punitive damages, should conduct taken by defendant thereafter serve to reduce a jury’s punitive damage award? Perhaps these questions would be best answered through the analysis of cases other than the Exxon Valdez litigation. But, whether one agrees with Judge Schroeder’s analysis, or not, surely everyone agrees with her comment, “It is time for this protracted litigation to end.”
Unfortunately, with the United States Supreme Court’s grant of Exxon’s Writ, the saga is guaranteed to continue, and potentially with significant consequence to the victims of this avoidable tragedy.
automobile accidents,airplane crashes, traumatic brain injury, head injury, personal injury, catastrophic personal injuries,medical malpractice , professional negligence.