Duragesic & Fentanyl News - Angel Reyes Blog

Another Fentanyl Fatality

Angel Reyes — Thu, 09 Apr 2009 16:46:59 -0600

At some point Johnson & Johnson, ALZA Corp., Janssen Pharmaceutica, Sandoz, Mylan, and Watson will come to their senses and stop prescribing these death patches.

See article below.

2 years after student's death, SMU bans fraternity from holding parties
By SAMANTHA URBAN / The Dallas Morning News
Tuesday, April 7, 2009

Two years after an SMU student died from an overdose at the Sigma Alpha Epsilon house, the university has acknowledged that drug use at the fraternity was not limited to that isolated incident and issued SAE a $5,000 fine.

]]>The university has barred the fraternity from holding any parties until November. The university chose not to suspend the fraternity because the majority of its current members were not affiliated with SAE at the time of Jake Stiles' death.

"SMU has concluded that the use of illegal drugs by members of the fraternity was not isolated to the student who died," the university said in a statement released Monday. "Statements made by several SAE members indicate there was drug use by additional fraternity members in the SAE house or as part of fraternity activities."

The fraternity now must adhere to certain stipulations or face possible removal from the university.

Stiles, a 20-year-old sophomore from Naperville, Ill., was found dead in his bedroom at the SAE house on Dec. 2, 2006. The cause of death was a prescription painkiller called fentanyl, even though preliminary tests had showed traces of cocaine and alcohol.

Since his death, Stiles' family had raised questions and pushed for further investigation.

"We accept the fact that Jacob made the wrong and unfortunate choice to take these drugs," Stiles’ father, Tom Stiles, told the SMU Daily Campus in July 2007. "However, we don't understand why SMU has not aggressively investigated the case and has not been forthcoming with the media and our family. All we ask is that the university discloses the truth and that those involved in our son's death be held accountable."

In its February edition, Texas Monthly published an article that questioned the university's handling of the investigation and said the school described Stiles’ death as an "isolated incident." S. Leon Bennett, the school's general counsel and vice president for legal affairs and government relations, told Tom Stiles in a letter: "(Jake) Stiles' death was not a result of any other person's involvement, directly or indirectly."

Tom Stiles could not be immediately reached for comment Tuesday morning.

The university said in a statement Monday that it faced obstacles during its investigation.

"Following the death, some members of the fraternity did not fully cooperate or were not forthcoming with SMU officials, and such actions have hampered efforts to investigate this tragedy," the school said.

The fraternity is being placed under a deferred suspension that would prohibit any social events with or without alcohol, according to the university. The deferred suspension will last for the remainder of the spring semester and until Nov. 1, the equivalent of one semester, SMU said in a news release.

SAE must participate in a community service project that focuses on substance abuse prevention and education. The $5,000 fine will be given to the university's drug and alcohol education and prevention fund.

SAE adviser Don Donnally declined to comment Tuesday.

Within six months of Stiles’ death, two more SMU students had died abusing either drugs or alcohol. On May 2, 2007, a freshman named Jordan Crist was found unconscious in a dorm room. Two hours later he was dead, his blood-alcohol level was five times the legal limit. Two weeks later, senior Meaghan Bosch was found dead, her body discovered in a portable toilet in a construction site in Waco. She had overdosed on cocaine, methamphetamine and oxycodone.

After these deaths, the university formed the SMU Task Force on Substance Abuse Prevention in June 2007. The task force made a dozen recommendations to curb substance abuse on campus. Among the recommendations were registering of certain social events, extended health center hours, parental notification after a student’s first offense for a substance-abuse.

In February, SMU’s Kappa Alpha Order was suspended until the 2011-2012 academic year for violating terms of its deferred suspension when it hosted an off-campus event with alcohol. And Kappa Sigma was put on probation for various offenses committed during the fall semester.

Pills & Patches - The American Painkiller Scourge

Angel Reyes — Wed, 11 Feb 2009 15:55:17 -0600

According to the FDA, in 2007 alone, U.S. pharmacies dealt out 21 million prescriptions for 24 different opioid painkiller meds, which are used by 3.7 million Americans. So 3.7 million Americans are in such excruciating pain, they have to be on opioid medication, one of the most powerful and addictive classes of drugs there is. Now the FDA is finally expressing concern over highly potent and potentially lethal drugs such as fentanyl. My firm, HORP&B, recently won a $16.5 million verdict against the makers of the fentanyl pain patch, Duragesic. Fentanyl is named in the FDA's list of unsafe narcotic products.

]]>One of the FDA's biggest concerns is that doctors dole out these painkillers like candy. For example, fentanyl should be used only in patients with severe or chronic pain - such as cancer pain. But doctors have been known to prescribe fentanyl for ailments as minor as sprained ankles and headaches. As a result, people are dying and manufacturers are being sued.

Additionally, "non-medical" use (meaning recreational use) of these opioid meds for 18 to 25-year-old Americans rose from 4.1% in 2002 to 4.6% in 2007. This means that opioid painkillers are so readily available, they're now considered street drugs.

And what is the FDA doing about this problem? They're considering an REMS (Risk Evaluation and Mitgation Strategy). They're not establishing one...they're considering one. The FDA defines its REMS as follows: "A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS ."

To sum it all up, the FDA is possibly planning to make a plan. What else is new? Read the Wall Street Journal article below:

Pain Drugs to Get New Restrictions
FEBRUARY 9, 2009, 10:34 P.M. ET
By JENNIFER CORBETT DOOREN

The Food and Drug Administration said Monday it will subject the makers of certain extended-release pain drugs to a new risk-management program designed to cut down on misuse and abuse of the products. New government figures show a rise in non-medical use of prescription pain drugs among adults.

Opioid drugs formulated in extended-release versions of OxyContin, morphine and fentanyl patches are meant for round-the-clock pain management for patients with cancer and other chronic conditions.

Misuse and Abuse
FDA officials have said they've seen reports of inappropriate prescribing by doctors amid the increase in misuse and abuse, both intentional and unintentional, of the products since the drugs were first approved in the mid-1990s.

Active ingredients in the drugs are designed to treat pain for an extended time, such as 12 hours. Drug abusers can tamper with such products and get all the effects of a drug at once, creating a heroin-like high.

"We continue to see reports of an ankle sprain and [patients] are given a fentanyl patch," said John Jenkins, the director of the FDA's office of new drugs. He said a major part of the new program will be efforts to educate doctors about appropriate prescribing of the products. "This obviously is going to be the largest risk-management program we've undertaken," he said.

Although Mr. Jenkins and other agency officials wouldn't speculate about what the final risk-mitigation program would look like, it could have elements of a program designed to limit the use of the acne drug isotretinion (commonly known by the brand name Accutane) by women of child-bearing age because the product causes birth defects. That program requires doctors, pharmacists and patients to register and meet certain requirements in order to get a new prescription each month.

The agency sent letters to 16 manufacturers of 24 products including Purdue Pharma LP, the maker of OxyContin, which is available in an extended-release form; a unit of Johnson & Johnson that makes a fentanyl patch; and King Pharmaceuticals Inc., the maker of an extended-release form of morphine. The letters told the drug makers of agency plans to require a risk-evaluation and -mitigation strategy, or REMS, "to ensure that the benefits of the drugs continue to outweigh the risks."

Getting Input
The FDA said it would meet with the drug manufacturers next month to talk about developing a REMS and would then meet with other federal agencies, patient and consumer-advocacy groups and health-care professionals to get additional input in the coming months.

There will be no immediate changes for prescribers or users of extended-release pain pills. An estimated 21 million prescriptions for extended-release opioids were prescribed for 3.7 million patients in 2007, Mr. Jenkins said. Other pain pills that are immediate-release and more commonly prescribed for pain won't be affected.

The agency noted that previous efforts to cut down on abuse and misuse of extended-release products, such as putting additional warnings on products labels, haven't really worked.

"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," the agency said in a statement posted on its Web site. "The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access."

The FDA can mandate the elements of a risk-management plan as part of legislation that took effect last year. Mr. Jenkins said that authority should make the new effort to cut down on abuse and misuse more effective than previous plans.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

Johnson & Johnson and Duragesic - When Will the Dangers End?

Angel Reyes — Fri, 02 Jan 2009 11:42:09 -0600

As reported by me many times over the past few years, my firm has been working on hundreds of Duragesic pain patch wrongful death cases. The cases involve leaking and defective patches manufactured by Johnson & Johnson's subsidiaries, ALZA and Janssen Pharmaceutica. Twice our firm successfully helped victims' families achieve a measure of justice, via a jury trial, for the loss of one of their loved ones due to the malfunction of a Duragesic patch. In both of those cases, one in Federal Court, the other in state court, the juries awarded multiple millions of dollars to the surviving family members and held Johnson & Johnson, ALZA, and Jannsen liable for the damages.

]]>Perhaps when the Obama administration finally takes the reins at the FDA, we will see public safety and protection rise to the priority it once held and so richly deserves. Neither of my firm's jury verdicts, one for $16.5 million and one for $5.5 million were flukes, they were claims made before juries who decided that defectively manufactured Duragesic fentanyl pain patches were a matter for public protection and in the end held Johnson & Johnson, ALZA, and Jannsen to be negligent. For my money, those companies are simply being unscrupulous.

The new FDA Chairperson needs to seriously consider pulling fentanyl pain patches completely off of the market. The product has been subject to too many known manufacturing defects and too many recalls. Indeed, the most recent recall just occurred. Read the full story here. Then get a letter fired off to your Congressman telling them you believe that defective fentanyl patches should not be available via a simple prescription for the drug currently being sold by Johnson & Johnson's subsidiaries and several generic manufacturers. Don't wait, far too many people have died from fentanyl overdoses through no fault of their own. This is a matter of public protection. Spread the word.

$16.5 Million in Duragesic Fentanyl Verdict

Angel Reyes — Fri, 21 Nov 2008 16:41:41 -0600

The Duragesic death saga continues. On November 17, 2008, my law firm, Heygood, Orr, Reyes, Pearson & Bartolomei, achieved a $16,560,000 verdict for the family of a Cicero, Illinois woman who died while wearing a Duragesic fentanyl transdermal pain patch. After a 3 week trial, a Chicago jury found two Johnson & Johnson subsidiaries liable for the death of 38-year-old Janice DiCosolo, a mother of three.

]]>Duragesic is a patch containing a gel form of the opioid drug fentanyl, which is 100 times stronger than morphine. On February 15, 2004, Mrs. DiCosolo died as a result of using a defective Duragesic patch that her doctor had prescribed to alleviate the intense pain she experienced from a neurological condition called "reflex sympathetic dystrophy." The patch was part of a lot of patches that ALZA recalled in 2004 due to seal breaches that allowed leakage that could cause an increased, life-threatening absorption of the drug. That same year, an FDA investigator found deficiencies in ALZA's manufacturing practices and quality control assurance policies and procedures.

My firm’s Partners, Jim Orr and Michael Heygood, were the lead attorneys representing the DiCosolo family in the case against the defendants, Janssen Pharmaceutica Inc. and ALZA Corporation. Orr and Heygood were assisted in the case by HORP&B Partner Charles Miller.

According to Jim, “They knew this patch was dangerous and defective but they continued to sell it and make money, and that's the only reason Janice DiCosolo is dead." Michael added, "They even knew there was a safer design, one that would prevent the fentanyl from leaking, but they chose not to use it."

This is the second Duragesic case where HORP&B has prevailed on behalf of a client who lost a loved one due to a defective fentanyl patch. Last year, a federal court jury in Florida awarded $5.5 million to the father of 28-year-old Adam Hendelson, who died while using a Duragesic patch that was prescribed for hip pain.

If you or someone you know has suffered injury or died as a result of wearing a Duragesic patch, or other fentanyl pain patch, please email me at Angel@ReyesLaw.com.

HORP&B Fentanyl Pain Patch Case

Angel Reyes — Fri, 14 Nov 2008 17:18:30 -0600

If you’ve been following this blog for long, chances are you know my firm has been the leading firm in the nation when it comes to pursuing the manufacturers of faulty fentanyl pain patches that have caused the deaths of innocent victims. In June of last year, we obtained a $5.5 million verdict against two subsidiaries of pharmaceutical giant Johnson & Johnson when we successfully represented the family of a Florida man who died from a fentanyl overdose.

]]>We now find ourselves in a similar battle against Johnson & Johnson subsidiaries as we represent the family of Janice DiCosolo, a 38-year-old mother of three, who died while wearing one of Janssen Pharmaceutica’s patches from a batch that was recalled the exact day after DiCosolo died from an overdose. My partners, Jim Orr and Michael Heygood, have done an outstanding job pursuing this case with the passion and purpose deserved by our client and we look forward to a positive verdict.

Bloomberg writer, Andrew Harris has the following to say about the case:

Bloomberg.com
By Andrew Harris
November 14, 2008

The Johnson & Johnson units that make and sell the Duragesic pain-killing patch should be forced to pay at least $25 million to the family of a woman who died after using a defective one, two attorneys told a Chicago jury.

Janice DiCosolo, 38, of suburban Cicero, died of a drug overdose in February 2004 that lawyers for her husband, John, and their three children say came from a lethal amount of the narcotic fentanyl, the main ingredient in the patch. "Fentanyl killed Janice DiCosolo. It's the elephant in the room," plaintiffs' lawyer Jim Orr today told the jury of seven men and seven women, including two alternates, as he summarized more than two weeks of trial testimony in Illinois state court. "It's obvious to everyone."

The Duragesic-brand patch is made by Alza Corp., a Mountain View, California, company owned by New Brunswick, New Jersey based Johnson & Johnson, the world's biggest maker of medical devices.

The patches were distributed by another J&J unit, Janssen Pharmaceutica. The patches generated $1.16 billion in sales last year for Johnson & Johnson, making them the company's seventh best-selling product, according to data compiled by Bloomberg.

The DiCosolo trial started on Oct. 29, one day after a Sanford, Florida, jury awarded more than $13 million to the family of Susan Hodgemire, a 34-year-old mother of five who died after using a Duragesic patch in 2002.

'No Real Evidence'

"This is a story that can be told from beginning to end without a leaking patch," Rita Maimbourg, an attorney for the companies, told the Chicago jurors during her closing argument. Orr and his colleagues produced "no real evidence" of a defect in the patches used by Janice DiCosolo before she died, Maimbourg said.

Citing the results of an autopsy, the defense lawyer said DiCosolo died from the interaction of at least five drugs, including fentanyl, found in her system by a Cook County coroner, Lawrence Cogan.

"Fentanyl is a painkiller 100 times more powerful than morphine," Orr's partner, Michael Heygood, said. The patches, prescribed for people combating chronic pain, are to be worn for 72 hours and then discarded. Janice DiCosolo was found wearing one when she died.

"Each patch contains enough fentanyl to kill 10 300-pound men," said Orr.

Janssen recalled one lot of Duragesic patches in February 2004, a day after DiCosolo died, because of improper sealing, defense lawyer David Sudzus wrote in a court filing. "The patch worn by DiCosolo was from that lot," he said.

That patch wasn't defective, said Maimbourg, a partner in the Cleveland office of Tucker, Ellis & West.

Johnson & Johnson paid more than $2.5 million in July to settle claims its Duragesic patch killed a Florida man, three people with knowledge of the accord told Bloomberg News.

The case is DiCosolo v. Janssen Pharmaceutica, 04L5351, Cook County, Illinois, Circuit Court, Law Division (Chicago).

VIDEO: Angel Reyes & Jim Orr on 2007 Duragesic Fentanyl Patch Verdict

Angel Reyes — Mon, 28 Apr 2008 22:56:31 -0600

Attorney's Angel Reyes and Jim Orr join Jan Schlichtmann of the Legal Broadcast Network while at the recent CLE event in Scottsdale, AZ put on by the Wyoming Trial Lawyers Association. Learn a bit more about the legal team that won the largest Duragesic Patch verdict in 2007 and how their firm approaches mass tort litigation. WATCH VIDEO...

Attorney Jim Orr Featured on the Legal Broadcast Network

Angel Reyes — Thu, 27 Mar 2008 09:41:29 -0600

James (Jim) Orr, a partner in my firm, Heygood, Orr, Reyes, Pearson & Bartolomei, is a frequent guest and contributor to the Legal Broadcast Network, a website that uses blogging, video and audio podcasting to provide commentary for attorneys. As of this date, Jim is featured in an article and podcast on the homepage of this site for his expertise on fentanyl, a dangerous opioid pain medication that is 100 times stronger than morphine, and is used during surgery for anesthesia. The article cites Jim as “one of the nation’s leading experts in Duragesic or fentanyl patch liability cases.”]]>first Federal case against the manufacturers and marketers of the Duragesic® fentanyl pain patch that was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division. A $5.5 million jury verdict was achieved for the family of a 28-year-old Florida man (Adam Hendelson) who died while wearing a Duragesic® fentanyl pain patch.

I’m proud to have Jim as a partner in my firm. Please read the article and listen to the podcast (linked below):

Jim Orr on Actavis generic Fentanyl patch recall
Legal Broadcast Network
March 22, 2008
Frequent guest and contributor, Attorney Jim Orr of the Dallas, TX based Heygood, Orr, Reyes, Pearson and Bartolomei firm, joins Speaking of Justice host Scott Drake to discuss the recent recall of a generic based copy of the Duragesic patch. The product defect recall by Actavis Inc, the U.S based arm of the international drug manufacturing company Actavis Group hf, is important to note in that it is a total recall of ALL patches manufactured during significant time frame.

You may link to the FDA press release on the recall with all the lot and information numbers by clicking here.

As listeners to LBN know, we have been following the Duragesic/Fentanyl patch litigation and recalls closely, including some video and audio podcasts with Jim Orr in the past. Important news in this particular podcasts covers the scope of the recall of the generic fentanyl patch, updates on the depositions that have recently been taken with the inventor/designer of the patch and further discussion of the manufacturing defect known as a fold over defect that dramatically increases the chances of leaks in the patch. If you are an attorney investigating or looking to get involved in Fentanyl patch litigation you should listen in to this podcast with Jim Orr, one of the nations leading experts in Duragesic or Fentanyl patch liability cases.

Click here to listen to the entire podcast with Attorney Jim Orr on the recall of the Actavis generic Fentanyl patch.

Fentanyl Painkiller Patches Recalled

Angel Reyes — Tue, 12 Feb 2008 16:55:28 -0600

In several of my articles, I’ve talked about the dangers of the Duragesic Pain Patch containing the prescription painkiller, fentanyl. The Duragesic Patch, which is approximately 80 times more powerful than morphine, certainly does kill pain, but unfortunately, it also kills people. In my last article I asked, “With all the severe side effects, and even deaths caused by this patch, what is it going to take before the manufacturer finally recalls this dangerous drug from the market?” It seems they finally got a clue. A recall was issued on Tuesday, February 12 for all 25-microgram-per-hour Duragesic and Sandoz fentanyl pain patches with expiration dates on or before December 2009. Read the AP article in its entirety below:]]>Painkiller Patches Recalled
By NATASHA T. METZLER
Associated Press Writer

WASHINGTON (AP) -- Patches containing the prescription painkiller fentanyl were recalled Tuesday, because of a flaw that could cause patients or caregivers to overdose on the potent drug inside.

Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz Inc., the recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.

Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, it could cause a patient or caregiver to come into direct contact with this powerful "opioid" drug. This could result in difficulty breathing and a potentially fatal overdose.

If this reservoir is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.

In December, the FDA put out its second warning in two years about the dangers of misusing the powerful drug.

The drug is intended for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people not used to this family of painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.

PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak.

For details on Duragesic patches sold by PriCara, call 800-547-6446. For details on generic fentanyl patches sold by Sandoz, call 800-901-7236.

The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc.Ranbaxy Laboratories Ltd.

All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Second Safety Warning on Fentanyl Skin Patch

Angel Reyes — Thu, 27 Dec 2007 17:18:35 -0600

The FDA has now issued its second safety warning regarding the Fentanyl Skin Patch, a patch that delivers pain medication through the skin that is at least 80 times more potent than morphine. With all the severe side effects, and even deaths caused by this patch, what is it going to take before the manufacturer finally recalls this dangerous drug from the market?]]>U.S. Food and Drug Administration in its entirety below.

Second Safety Warning on Fentanyl Skin Patch
Date Posted: December 21, 2007

FDA issued its second safety warning on Dec. 21, 2007, about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, FDA issued a similar warning to the public and to health care providers emphasizing that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.

The agency is also asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients. The patch is marketed as Duragesic by Johnson and Johnson, and generic versions are sold by other manufacturers.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The patch was approved by FDA in 1990 for use in people with persistent, moderate-to-severe pain who have become opioid-tolerant—meaning that they have been using another strong opioid narcotic pain medicine around-the-clock for a week or longer. The skin patch is most commonly prescribed for people with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after health care professionals inappropriately prescribed the patch or after people used the patch incorrectly.

Advice for Consumers:
• Fentanyl patches are only for people who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional, or mild pain, or pain after surgery.
• Be aware of the signs of fentanyl overdose: trouble breathing, or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, get medical attention right away.
• If you are prescribed the fentanyl patch, tell your doctor, pharmacist, and other health care professionals about all the medicines you take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood.
• Read the instructions on how to use the fentanyl patch in the patient information that comes with the patch (www.fda.gov/cder/drug/infopage/fentanyl/DuragesicPPI.pdf).
• Do not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds, or take hot baths or sunbathe while wearing a patch. If your temperature is higher than 102 degrees while wearing a patch, call the doctor right away.

For More Information:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl

Nothing Safe About Fentanyl Drug Patches

Angel Reyes — Tue, 04 Sep 2007 09:16:20 -0600

My law firm partners and I are convinced that you just can't safely deliver fentanyl transdermally. On the heels of our $5.5 million dollar verdict in the Adam Hendelson case, this article appeared in the LA Times (below). Duragesic needs to be taken off the market before it kills one more person.]]>Dangers of drug patches overlooked
The FDA has cautioned about delivering painkiller fentanyl through the skin, but healthcare providers don't seem to be getting the message. Other drugs pose problems too.
By Ricardo Alonso-Zaldivar, Los Angeles Times Staff Writer
August 27, 2007

WASHINGTON -- Army Master Sgt. Harold Kinamon entered a military hospital in Ohio for routine respiratory surgery to help him sleep better. The operation, in October 2005, progressed smoothly. He went home with nothing more than a raw throat and a painkiller contained in an adhesive patch on his skin.

That night, Kinamon, 41, died in his sleep -- killed by an overdose of the drug delivered through the patch.

What made his death even more tragic was that the dangers of using skin patches to administer the particular painkiller he received, an opium-like drug called fentanyl, were clearly understood at the time. Only three months earlier, the Food and Drug Administration -- responding to a number of similar deaths -- had issued a strong warning: Though beneficial under appropriate conditions, fentanyl patches should be used with great caution, and not for postoperative pain relief.

Kinamon's death reflects more than an individual misfortune. Healthcare providers nationwide are still not getting the message as fentanyl patches continue to be implicated in scores of deaths.

Failure to solve the problem is all the more serious because the use of patches is spreading to other drugs, including other painkillers, contraceptives and medications for children with attention deficit disorder. Moreover, a new generation of high-tech patches is expected to make many more drugs available in patch form.

The benefits of patches have been accompanied by problems, replicating a pattern common to many medical advances: Breakthroughs often come with risks and downsides that may not be fully recognized until later.

Drug safety experts are urging the FDA to reexamine the issue of medicinal patches. One primary problem seems to be how to get the right dose of a drug through a patch for different patients under differing conditions.

Patches are "a neat way of delivering drugs," but they are not an unalloyed blessing, said Dr. Curt D. Furberg of the Wake Forest University medical school.

The appeal of the patches is clear: They solve a host of problems with more traditional methods of administering medications. Unlike injections, they don't hurt. Unlike pills, they don't have to be swallowed. They resolve the common problem of patients not taking drugs in the right amount at the prescribed intervals. And their medicine enters the bloodstream directly, rather than via the stomach.

Those advantages are real, medical experts say, but they are not the whole story.

Sales of Ortho Evra, the first birth-control patch, plunged last year after the FDA cautioned that it exposed women to higher levels of a hormone linked to dangerous blood clots than do oral contraceptives.

With pills, the drug level spikes after consumption, dropping as the time for the next dose approaches. Patches maintain a steadier level, but, over time, this can lead to higher total exposure to the drug. That can cause problems, and the trade-offs are not well understood, experts say.

"What is the corresponding patch level that would be equivalent to oral drugs?" Furberg asked. "People use different formulas and there is disagreement."

The Daytrana patch for attention deficit disorder recently ran into problems. Opening the patch and getting it to stick was difficult. (The maker says the adhesion problem has been fixed.) And the medication can irritate the skin, causing welts. The FDA is investigating.

The effect of any patch can vary considerably from patient to patient. "Some people may not get enough of the drug, which defeats the purpose of taking it. And some may get too much... which is going to hurt some people," Furberg said.

For instance, heat affects the rate at which the skin absorbs a drug. Sunbathing, a hot shower or exercise can trigger an overdose.

Also, some people have thicker skin, which is more resistant to absorbing a drug. Speed of absorption can vary by a factor of about three, which can complicate finding the right dosage.

Another problem is psychological: Patients and medical professionals have a tendency to see patches as benign devices akin to a bandage. It's easy to forget the powerful, potentially dangerous drug within.

"Patches are not innocuous," said Kenneth Sloan, a medicinal chemist at the University of Florida whose research has shown wide variations in how quickly individuals absorb drugs through the skin. "One patch does not fit all."

That's why the FDA said in July 2005 that in the case of fentanyl, patches should be prescribed at the lowest practicable dose, should not be used to treat short-term pain or pain after an operation, and should only be used by patients already established on opioid drugs.

Patients and caregivers must be fully informed about safety, the FDA said.

According to Kinamon's sister Deana, that did not happen in his case. His patch provided the second-highest available dose of fentanyl. And she said she did not recall receiving special instructions about the patch when she picked her older brother up at the hospital. "They didn't even tell me it was a narcotic," she said. "They just said, 'Change it in three days.' "

He went in on his day off for surgery to correct his sleep apnea, said his sister. "There's honor in dying for your country on the battlefield, but there is really no kind of honor associated with that."

Harold Kinamon's case is an example of "totally inappropriate prescribing," according to Larry D. Sasich, pharmacist and professor at the Lake Erie College of Osteopathic Medicine in Pennsylvania.

Kinamon's hospital, Wright-Patterson Medical Center, declined to comment on his case, citing privacy laws. His doctor also declined an interview. The hospital says it has established safeguards for fentanyl patches since the Defense Department Patient Safety Program issued recommendations last year. (A hospital spokesman said federal law prevented him from discussing what the precautions entailed.)

In Los Angeles County and Florida, similar deaths continue to occur, statistics show. The L.A. County coroner's office investigated 32 accidental deaths related to fentanyl in 2006, the same number as in 2005, the year the FDA issued its warning. Florida authorities reported 126 accidental deaths related to fentanyl in 2006, a rate one expert in the state described as "steady."

Ortho-McNeil, which manufactures Duragesic, the brand-name form of the fentanyl patch, says stronger safety measures are needed. "Philosophically, we would support any new efforts that would strengthen safety and ensure this product is used appropriately," said spokesman Greg Panico.

Whereas the opioid patch was intended for cancer patients and others with unrelenting pain, Ortho Evra, the birth-control patch, was designed for active younger women.

Kristen Britt, 28, a veterinary nurse from Stockton, said she thought the patch would fit her lifestyle. "I was looking to find something easy and safe," she said. "To put one on and not have to change it for a week, I liked that a lot."

Seven months after she started using the patch in 2005, she felt a pain in her right leg. At first, she said, she thought it was muscle strain, but the pain grew worse.

"One day, I couldn't walk anymore," she said. "I was literally screaming in pain." Doctors found a blood clot. For months she had to take blood-thinning medications, which have risks of their own.

Soon after Britt's experience, the FDA issued a new warning for Ortho Evra, saying the patch exposed women to about 60% more estrogen than did a typical birth-control pill. Estrogen is known to increase the risk of blood clots, which can cause strokes and other complications.

The maker of Ortho Evra says the patch has not been conclusively linked to a higher blood-clot risk.

Now Britt is at higher risk of blood clots, especially if she becomes pregnant. She is suing the company. Her attorney, Lori E. Andrus of San Francisco, says about 1,900 plaintiffs have filed federal suits and hundreds more cases are in state courts.

The president of the Institute for Safe Medication Practices, Michael R. Cohen, said: "Patches are convenient, and patients do like them, but there are reasons to examine the whole patch issue."

So far, the FDA is sticking with the status quo. "FDA reviews patch products, like any other products, on a case-by-case basis for safety and effectiveness," said Susan M. Cruzan, a spokeswoman.

But critics say that in the case of fentanyl, the FDA has been ineffective. Fentanyl patch sales grew 10% the year after the warning, with more than 4.7 million prescriptions written, according to Verispan, a market analysis firm.

Said Furberg: "The purpose of the [warning] was to cut back on prescriptions, so it's a failure."

ricardo.alonso-zaldivar@latimes.com

©2007 Angel Reyes
www.ReyesLaw.com

Congratulations to the Fentanyl (Duragesic) Trial Team

Angel Reyes — Wed, 20 Jun 2007 14:20:56 -0600

I want to congratulate the trial team I had the privilege of playing with the past few weeks in Federal Court-Southern District of Florida, West Palm Beach. Kudos go out to Ike Gulas, Jason Stuckey, Ed Angwin (Ike, Jason and Ed are from the Gulas & Stuckey Law Firm), Jim Orr, and Charles Miller for all of their efforts in the Lee Hendelson v. Johnson & Johnson et al trial.]]>Duragesic (fentanyl) pain patch, our trial team persuaded the jury to award Lee Hendelson $5.5 million dollars for the wrongful death of his only son, Adam Hendelson.

Below is a small list of the many news articles regarding this important case. Click on any of the links below to read more:

6/19/07 - Bloomberg.com – J&J Units Ordered to Pay $5.5 Million in Patch Case
6/19/07 - MedaNews.com – Heygood, Orr, Reyes & Bartolomei and Gulas & Stuckey: $5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - Forbes.com – Jury Awards $5.5M in Drug Patch Case
6/19/07 - NYTimes.com – Companies Lose Drug Patch Suit
6/19/07 - BusinessWeek.com – Jury awards $5.5M in drug patch case
6/19/07 - CNNMoney.com – J&J To Pay $5.5 Million In Wrongful Death Verdict
6/19/07 - Palm Beach Post – $5.5M awarded in pain-killing patch death
6/20/07 - San Jose Mercury News – J&J units ordered to pay patch user's father
6/19/07 - Sun Sentinel – Father of man who died while wearing painkiller patch awarded $5.5 million
6/19/07 - RTT Global Financial News – Johnson & Johnson Subsidiaries Loses Duragesic Patch Trial; Family Awarded $5.5 Million Damages
6/19/07 - Houston Chronicle – Jury Awards $5.5M in Drug Patch Case
6/20/07 - PR-Inside (Austria) – U.S. jury awards $5.5M in Johnson & Johnson drug patch case - U.S. jury awards $5.5M in Johnson & Johnson drug patch case
6/20/07 - CBC News (Canada) – Family of man who died wearing drug patch awarded $5.5M US
6/19/07 - Palm Beach Post – Jury deciding if pain patch leaked, killing man, 28
6/07 – Johnson & Johnson Ignored Duragesic Pain Patch Defects, Lawyer Says

Heygood, Orr, Reyes & Bartolomei and Gulas & Stuckey: $5.5 Million Award in First Federal Fentanyl Patch Trial

Angel Reyes — Wed, 20 Jun 2007 10:19:18 -0600

Jury finds Johnson & Johnson subsidiaries liable in death of 28-year-old
From www.medadnews.com
WEST PALM BEACH, Fla.,
June 19, 2007
PRNewswire

The family of a Florida man has won a $5.5 million wrongful death verdict against two subsidiaries of pharmaceutical giant Johnson & Johnson in the nation's first federal trial involving a patch form of the narcotic painkiller fentanyl.]]>U.S. District Court for the Southern District of Florida.

Janssen Pharmaceutica Products, LP, and ALZA Corp. were sued by the family of 28-year-old Adam Hendelson following his death on Dec. 17, 2003. Both companies are subsidiaries of New Brunswick, N.J.-based Johnson & Johnson.

Mr. Hendelson suffered chronic hip pain as a result of an automobile accident, and wore a Duragesic (R) patch on his right arm. Duragesic is the brand name of a transdermal patch that contains a gel form of the drug fentanyl, an opium-like substance that is up to 100 times stronger than morphine.

"In essence, the jury found that Adam Hendelson did not have to die," said Jim Orr of Dallas' Heygood, Orr, Reyes & Bartolomei, attorney for the Hendelson family. "The facts and the evidence clearly showed that Janssen and ALZA knew that problems with the Duragesic patches could hurt or kill someone, and in Adam's case, that's exactly what happened."

Also representing the Hendelson family were Mr. Orr's partners Angel Reyes and Charles Miller, along with attorneys Ike Gulas, Jason Stuckey, and Ed Angwin from the Birmingham, Ala., firm of Gulas & Stuckey, P.C.

Janssen and ALZA both manufacture and sell Duragesic patches, which accounted for $1.5 billion in total sales in 2005. In June 2005, more than a year after Mr. Hendelson's death, the defendants issued new health warnings regarding the use of Duragesic.

Heygood, Orr, Reyes & Bartolomei is an AV-rated firm that focuses its practice on the representation of plaintiffs in business disputes, civil litigation matters, and more. With 12 attorneys and a staff of 50, the firm's trial teams handle a full array of civil litigation and business cases across Texas and the United States.

More information is available at http://www.reyeslaw.com.

For more information on the verdict, please contact Mark Annick at 800-559-4534 (office), 214-213-1754 (mobile) or mark@legalpr.com

CONTACT: Mark Annick for Heygood, Orr, Reyes & Bartolomei, 1-800-559-4534,cell, 214-213-1754, mark@legalpr.com

Web site: http://www.reyeslaw.com/

Ticker Symbol: (NYSE:JNJ)

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Jury deciding if pain patch leaked, killing man, 28

Angel Reyes — Tue, 19 Jun 2007 14:52:43 -0600

By JANE MUSGRAVE
Palm Beach Post Staff Writer
Tuesday, June 19, 2007

WEST PALM BEACH — Having survived a horrific car accident, Adam Hendelson was killed by medicine that was supposed to help him deal with lingering pain, a federal jury was told Monday.

Instead of releasing a small amount of a powerful drug into his system to deaden his pain, a patch produced by pharmaceutical giant Johnson & Johnson leaked, delivering a fatal dose to the 28-year-old Deerfield Beach resident, attorney Jim Orr said during his closing arguments in U.S. District Court.

]]>

"Clearly this patch did not perform as designed because it killed Adam Hendelson," Orr said. "It definitely malfunctioned."

Lee Hendelson of West Palm Beach should be awarded millions for the loss of his son, Orr said.

"Millions of dollars would be appropriate," said the attorney from Dallas. "Whether it's $5 million or $3 million or $10 million, that's in your hands."

Attorneys representing Alza Corp., a subsidiary of the Cincinnati-based company, countered that Hendelson's 2003 death was a tragic accident. But, they said throughout the two-week trial, it can't be blamed on the patch, which they claimed millions have used without ill effect.

Miami attorney William Upshaw told the jury of six women and two men that Hendelson overdosed on the combination of drugs he was taking, not because the Duragesic patch leaked.

In addition to the patch, which contained fentanyl, a painkiller 100 times more potent than morphine, Hendelson was taking antidepressants. It proved to be a deadly combination, Upshaw said, referring to an autopsy report by Broward County's medical examiner.

"He was a man in pain," Upshaw said of Hendelson who shattered his hip in a 1996 traffic accident and was struggling to deal with the effects. "What happened to Mr. Hendelson was not a defective patch, it was a mistake in his medication."

Concern about the safety of the patch spurred the U.S. Food and Drug Administration in 2005 to issue a public health advisory, requiring manufacturers to include detailed product safety information with the medication and to alert doctors of the dangers of using the fentanyl patch in combination with other drugs.

A jury in Houston last summer became what was believed the first in the nation to find the patch defective when it ordered Johnson & Johnson to pay $772,500 to the daughter of a Texas woman who died after her pain-killing patch leaked. About 100 similar cases have been filed nationwide.

Like Hendelson, the Texas woman was using the patch to deal with the pain of injuries she suffered in a car accident. Like Hendelson, the woman had highly elevated levels of fentanyl in her blood system, which Johnson & Johnson attorneys blamed on "postpartum redistribution."

They offered the same explantion for why Hendelson's levels were nearly five times above what is considered safe.

The jury is to resume deliberations this morning.

J&J Units Should Pay `Millions' Over Pain Patches, Lawyer Says

Angel Reyes — Mon, 18 Jun 2007 17:26:21 -0600

Below is the latest press from the Federal Court trial. Ike Gulas, Jason Stuckey, Ed Angwin Jim Orr, Charles Miller, and I just finished up in the Southern District of Florida, West Palm Beach.

I'll keep you posted on what the jury decides. Tune in tomorrow.

Angel Reyes
]]>2007-06-18 17:20 (New York)
By Lindsay Fortado and Jef Feeley

June 18 (Bloomberg) -- Two Johnson & Johnson units should pay "millions of dollars'' to the family of a Florida man who died after a patch designed to deliver measured doses of pain-killing drugs leaked, a lawyer told a Florida jury.

Executives at Johnson & Johnson's Janssen Pharmaceutica Products and Alza Corp. subsidiaries knew some of the patches were defective and continued to sell them anyway, Jim Orr, a lawyer for the family of Adam Hendelson, told jurors today during closing arguments in West Palm Beach federal court. Hendelson, 28, was using the patch to treat pain from a 1996 car accident.

"We believe millions of dollars is appropriate'' to compensate the Hendelsons over the loss of their son, Orr said. "Whether that's $5 million or $3 million or $10 million is in your hands.''

The Duragesic case is the first to reach trial in federal court. It's also the first to come before a jury since a 2006 Houston state court jury said that Janssen and Alza must pay $772,500 to the family of a Texas woman who died after her patch leaked. The companies appealed the verdict. Johnson & Johnson, the world's largest medical device maker, had $1.29 billion in worldwide sales of the patches in 2006.

A lawyer for the Johnson & Johnson subsidiaries told jurors in his closing argument that Hendelson's family didn't produce any evidence of leaks in the patch that their son, a computer technician, was wearing when he died.

"If there was no defect in the actual patch that was there, it was not the cause of Mr. Hendelson's death,'' said Anthony Upshaw, a Miami-based lawyer representing the companies.

Shares of New Brunswick, New Jersey-based Johnson & Johnson fell 44 cents to $62.33 in New York Stock Exchange composite trading. The shares have fallen 5 percent so far this year.

The case is Lee Hendelson v. Janssen Pharmaceutica Products LLP and Alza Corporation, CA No. 05-8116, U.S. District Court for the Southern District of Florida (West Palm Beach).

--With reporting by Justin Blum in Washington. Editor: Rovella

J&J Ignored Duragesic Patch Defects, Lawyer Says

Angel Reyes — Tue, 12 Jun 2007 14:24:55 -0600

Bloomberg.com
By Jef Feeley
jfeeley@bloomberg.net

NEW BRUNSWICK – Johnson & Johnson officials knew some of the company's Duragesic patches for treating pain had defects and failed to warn consumers, a lawyer argued in the first federal product-liability case to go to trial over the devices.]]>Janssen Pharmaceutica Products and Alza Corp. units "turned a blind eye" to reports that some patches leaked, Jim Orr, a lawyer for the family of Adam Hendelson, said Tuesday. The family contends that the 28-year-old Florida man died of an overdose of the pain medication released by his patch.

The companies "knew that leaking patches were coming off their assembly line," Orr told jurors in federal court in West Palm Beach, Fla., in opening arguments in the trial of a lawsuit filed by Hendelson's family over his death. The Johnson & Johnson units "provided no warning at all," he said.