Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

Manufacturer of Fentanyl Patches Recalibrates Machines

Watson makes a generic version of the Duragesic fentanyl patch using the reservoir design.  Like Alza, the company that makes Duragesic, Watson has had recalls due to defective patches.

Watson Recalibrates Equipment After Fentanyl Patch Recall

Watson Pharmaceuticals has adjusted calibration for a machine that manufactures its fentanyl transdermal patches after a small number of them that leaked prompted a voluntary recall of one lot of the product.

Source: Watson Recalibrates Equipment After Fentanyl Patch Recall

Correction Regarding Mylan Facilities In West Virginia

A reader brought to my attention that all of Mylan's fentanyl patches are made in Vermont, not West Virginia.  Therefore, no matter if the allegations that West Virginia employees bypassed safety mechanisms are true, that could in no way have any bearing on the safety of the Mylan fentanyl patch.

Hopefully, no similar conduct occurred on the fentanyl line in Vermont.

Mylan Changes Management After Damaging Report About Quality Control

What's next in the saga of Mylan, the fentanyl patch manufacturer whose employees allegedly bypassed quality controls? 

NEW YORK, July 29 (Reuters) - Mylan (MYL.O), the world's No. 3 generic drugmaker, said on Wednesday that it had reshuffled its management after a report on its quality controls sparked volatility in its share price.

Heather Bresch, formerly chief operating officer, is being promoted to the position of president, and Rajiv Malik will take on the role of chief operating officer, the company said. Most recently, Malik headed global technical operations, overseeing quality and regulatory affairs, among other areas.

Source: Reuters

Not sure what to make of the fact that the individual who was chagred with "overseeing quality and regulatory affairs" got a promotion out of this... but then again, the allegations are that employees hid defects from the quality control department.

FDA Contradicts Mylan's Position Regarding Investigation

Yesterday, I blogged about the allegations that Mylan employees knowingly bypassed safety procedures to boost production.  Today, there's another story worth blogging about:

According to a press release issued by Mylan, the plant has been cleared of any problems by the Food & Drug Administration following a visit to the facility by agency officials on Monday. But in its statement the FDA’s assistant commissioner for compliance policy, Steven Solomon, said the investigation is not over.

“This investigation involves allegations of compliance violations that the FDA takes very seriously,” Solomon wrote. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue.”

Source: FDA, Mylan, at odds over status of probe at W.Va plant

I'm sure Mylan would like the investigation to be over, but I for one am relieved that the FDA is continuing to look into these allegations.  Many of the products made at this West Virginia plant, like Mylan's fentanyl patch, can be deadly if not manufactured according to specifications.

Considering how many lawsuits have already been filed against Mylan alleging their fentanyl patch is defective, I can't help but wonder if the safety procedures were skipped on the fentanyl line...

Did Mylan Employees Knowingly Release Defective Fentanyl Patches?

When I read the following article this morning, the first question I had was whether these Mylan employees overrode quality control guidelines for the Mylan fentanyl patch:

MORGANTOWN, W.Va. -- Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

Source: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MT8ZvQJB

The article doesn't specifically mention the Mylan fentanyl patch, but it doesn't exclude it, either.  I'm glad that Mylan management took the initiative to launch an investigation, but I'm disturbed that overriding the quality control mechanisms was apparently as simple as "right-clicking" the red screen.

Many people refer to Windows crashes as "The Blue Screen of Death." If Mylan employees knowingly released defective fentanyl patches, perhaps we should start talking about "The Red Screen of Death," as a defective patch can certainly kill someone.  In fact, many lawsuits have been filed over deaths attributed to Mylan fentanyl patches already.

New Fentanyl Patch Approved, But It Isn’t a Substitute for Duragesic

This one is a mouth patch, and it isn’t supposed to be used as a substitute for the Duragesic patch or the other generic fentanyl patches.

The U.S. Food and Drug Administration on Thursday formally approved Onsolis, Raleigh-based BDSI's mouth patch that delivers the painkilling drug fentanyl to cancer patients suffering severe “breakthrough pain” that doesn't respond to other medications.

Onsolis is manufactured by Aveva Drug Delivery Systems of Florida and marketed under license from BDSI (Nasdaq: BDSI) by Meda Pharmaceuticals. With FDA approval of Onsolis, BDSI is due about $27 million in milestone payments, which Sirgo said would be directed to the company's drug pipeline.

The company also is developing the product BEMA Buprenorphine, a form of painkilling drug buprenorphine that is often given intravenously to treat chronic pain. Like Onsolis, the product uses the company's BEMA technology, which delivers drugs through mucous membranes in the mouth via a small patch.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Source: FDA approval pumps $27M into BDSI pipeline - Triangle Business Journal:

Technorati Tags: Duragesic,fentanyl

Duragesic Fentanyl Patch Sales Down

Johnson & Johnson, the makers of the Duragesic fentanyl patch reported that sales for the patch are down 12.3% worldwide from this quarter last year.

One has to wonder if all of the Duragesic recalls and bad press over the various lawsuits has eaten into sales.  Note that U.S. sales are down much more than global.

Here’s a link to the PDF reporting J&J’s earnings.

Technorati Tags: Duragesic,Duragesic lawsuit,fentanyl lawsuit,fentanyl

Canadians Seek Duragesic Class Action Lawsuit

I wish them the best of luck.  I also wish that they’ll send me any documents they obtain from the Canadian subsidiaries they plan on suing.

EDMONTON — The last time Ellen Robb spoke with her brother, he was doing chores and laundry at home, optimistic that with his chronic back pain under control, he would soon be back at work as an electrician.

Four days later, after many unanswered phone calls, Robb found Doug Hoy dead on his apartment floor, barefoot as if he were on his way to get his laundry basket across the hall.

Months later, a toxicology report revealed Hoy’s blood had three times the safe amount of fentanyl, Robb said.

Fentanyl is an opiate 80 to 100 times as strong as morphine, and approved for use as a pain medication in Canada and the United States.

Hoy had been prescribed the fentanyl patch to treat his severe chronic back pain after another powerful opiate, OxyContin, failed to bring relief.

Now, Robb and her family have taken steps to launch a class-action lawsuit against five pharmaceutical companies, alleging the companies that design, test and distribute fentanyl patches were negligent in warning people about the risks of breathing problems or death, as well as severe weakness, drowsiness and confusion.

Source: Family of dead Alta. man seeks class-action lawsuit against drug-makers

Technorati Tags: Fentanyl,Duragesic,Duragesic lawsuit,fentanyl lawsuit,Duragesic class action

Duragsesic (Fentanyl) Patch Recall Information

SAFETY ALERT: OVER 60 MILLION DURAGESIC (FENTANYL) PATCHES RECALLED

On February 12th of 2008, Pricara announced a recall of 38 million Duragesic and generic Fentanyl patches because they "may have a cut along one side of the drug reservoir within the patch."  (Duragesic is the brand name of a patch that contains the drug Fentanyl.)  Because of this cut, the Fenantyl inside the patch can leak out and cause an overdose to anyone who handles the patch.  The recalled patches are the 25mcg patches and will have an expiration date on or before December of 2009.  There are two types of patches being recalled: The brand-name Duragesic patches, and the generic Fentanyl batches.  The Duragesic patches will likely have a "Duragesic" label on them, while the generic patches will likely just say "Fentanyl."  The Duragesic patches are sold by Pricara, which is owned by Ortho-McNeil-Jannssen Pharmaceuticals, Inc.  The generic Fentanyl patches are sold by Sandoz, Inc.  All of the patches are made by ALZA corporation, which is why they have the same defect.

If you think you have a defective 25mcg Duragesic patch, call 1-800-547-6646.  If you think you have a defective 25mcg generic Fentanyl patch, call 1-800-901-7236.

On February 2nd and March 3rd of 2008, Actavis announced two recalls of all of their generic Fentanyl patches, which is estimated to be over 21 million patches.  Like the Johnson & Johnson Duragesic Fenatyl patch, the Actavis generic Fentanyl patch suffers from a manufacturing defect that can kill individuals who handle the patch. 

Actavis recalled all of their 25mcg, 50mcg, 75mcg, and 100mcg doses with expiration dates between May and December of 2009.  If you think you have a defective Actavis Fentanyl patch, call 1-877-422-7452.

If you accidentally touch one of these patches, wash your hands with water only.  DO NOT USE SOAP as this increases the likelihood you will be injured by the patch.

How do I know if I've been injured by a Duragesic or Fentanyl patch?

The most serious injury that can occur with a defective Duragesic or Fentanyl patch is death.  If an autopsy was performed, "Fentanyl overdose" or "Fentanyl toxicity" may be listed as one of the causes of death.

Other symptoms of Fentanyl Toxicity include: agitation, circulatory failure, coma, confusion, convulsions, hallucination, hypotension, myoclonic jerks, nightmares, pinpoint pupils, renal failure, respiratory depression, rhabdomyolysis, and vivid dreams.  If you think you’ve experienced an overdose of Fentanyl, get medical help immediately. 

Do I need a Duragesic or Fentanyl Lawyer?  Should I file a lawsuit?

If you or a family member were injured by a defective Duragesic or Fentanyl patch, you may want to consult with an attorney to see what your legal rights are.  I personally know several attorneys involved in Duragesic & Fentanyl litigation, and can put you in touch with one of them to see if you have a case.  The lawyers I know aren't paying me to refer them cases.  And I'm not getting a "cut" of any recovery you may receive.  All I ask from you is that you consider writing a letter to your elected representatives to tell them you oppose FDA preemption, which will prevent many injured citizens from filing lawsuits against manufacturers of defective drugs.

I'm not an attorney - I'm a law student.  So contacting me does not and can not create an attorney-client relationship.  And I will not give you any legal advice, either.  What I will do is listen to your story and put you in touch with an attorney I believe may be able to help you.  I can't promise that the attorney will win your case, if you have one.  All I can promise is that the attorney I put you in contact with will treat you and your family with dignity and respect, and that he or she will vigorously fight for your rights.

Over 60 million defective patches?  What happened?

Several problems contributed to all of these defective patches.  For one thing, it's only recently that the manufacturers implemented an electronic inspection program to verify the patches weren't defective.  Before then, they were relying on purely visual inspection.  This is a problem because the machine that makes the patches was spitting them out at a rate of 240 per minute.  That's four patches every second. No one can look at four patches every second.

Another problem is that the way the patches are made makes it impossible for there not to be leaking patches.  One of the manufacturers even stated that leaking patches are an inherent part of the manufacturing process.  The internal goal was for only 1/10th of 1% of patches each year to leak.    1/10th of 1% is still 8,000 defective patches per year, meaning that if everything went according to plan 8,000 people per year could be injured or die from defective patches.  Does that sound acceptable to you? Unfortunately, the defective lots had a rate closer to 20% of all patches being defective.

The recalled patches were defectively manufactured.  But there's also plenty of evidence that the design of the patch is defective, too.  If the manufacturers switched over to what's called a "Matrix" design, or to a "drug in adhesive" design, there would be little to no risk of leaky patches.  In fact, ALZA corporation even acknowledged to the FDA that a "Matrix" design would eliminate the risk of gel leakage.  In fact, Fentanyl patches sold in Europe do use the Matrix design.  You're probably wondering why we don't use the Matrix design here.  If you've been injured by a Duragesic or Fentanyl patch, perhaps the manufacturer will have to tell a jury why it doesn't use a safer design.

Federal Appellate Court Allows Duragesic (Fentanyl patch) Lawsuit to Proceed

The 11th Circuit Court of Appeals is allowing the family of Chad Edgar Beal to proceed in their lawsuit against the manufacturers and distributors of the Duragesic patch.  Beal died after just one day of using the 75mcg patch.  He died in March of 2004, which is the same timeframe in which lot number 0327192 of the 75mcg patches was recalled.  I’m not sure whether Beal received one of the defective patches.  Certainly there is a good chance of it.  If he did receive one of those defective patches, his case will be easier to prove since that lot is known to be defective. 

If he received a patch from another lot, his family still may be able to win their lawsuit, it will just be more of an uphill battle.  The manufacturer expects a minimum of 8,000 defective patches per year, and that number should be over and above however many patches were in the defective lot.

 

Family waited too long to file Duragesic lawsuit, so they automatically lost

This case illustrates how important it is to act quickly if you’re considering filing a lawsuit over Duragesic, or any defective drug.  On June 21st of 2008, a federal court decided the case of Schmelzle v. Alza Corp.  (Alza manufactures Duragesic (Fentanyl) patches.)  Kelly Sue Schmelzle died on December 12th of 2003 after using a Duragesic patch.  Her family waited until December 11th of 2006 to file the lawsuit – a day shy of three years.

Unfortunately, Kelly passed away in Wyoming, a state that has only a two-year statute of limitations.  Because her family didn’t bring the lawsuit on or before December 12th of 2005, her family automatically loses.  That means that Kelly’s family won’t have the chance to prove a defective Duragesic patch killed her.  And it means that even if the patch was unquestionably defective, Alza won’t have to pay her family a dime.  Not even her funeral expenses.  Does this seem fair to you?  Well, companies like Alza think it is.  They spend millions of dollars every year lobbying for drastic changes to the legal system that make it harder for people like Kelly’s family to hold companies accountable for wrongdoing.  You may have heard of these lobbying efforts: they’re often referred to as “tort reform.” 

If Wyoming had a four-year (or even a three-year) statute of limitations, Kelly’s family might have had the chance to pursue some small measure of justice.  Instead, her family will receive nothing.  Perhaps you can find a moment to write your state legislators and tell them you think your state should have a four-year statute of limitations for wrongful death and other personal injury lawsuits.

Mylan Pharmaceuticals sued in West Virginia over their “drug in adhesive” Fentanyl patch

James Pope was prescribed 50mcg Fentanyl patches on July 23rd of 2007, and died just six days later of a Fentanyl overdose.  This lawsuit is a little different than other Fentanyl lawsuits, as it doesn’t involve the recalled Duragesic or recalled Fentantyl patches.  As far as I know, Mylan has not issued a recall notice for any of its Fentanyl patches.  Mylan also advertises that their patch is made with a “drug in the adhesive” design, as opposed to the gel-filled reservoir design of Duragesic.   Remember, the manufacturer of Duragesic expected to have at least 8,000 defective patches manufactured per year.  Since this patch is designed differently than the Duragesic Fentanyl patch, it will be interesting to see how this case turns out.  It may be that this design is no more safe than the gel-filled design.

 

Duragesic / Fentanyl patients should stay away from grapefruit, heat

In February, the FDA approved changes to the warning label for the Duragesic (Fentanyl) pain patch, including adding warning patients using the patch not to drink grapefruit juice or expose the patch to a direct heat source.

Dose increases should be approached with caution, and patients should avoid grapefruit or grapefruit juice... (Emphasis added.)

. . . .

Patients and caregivers should also be advised to avoid exposure of the patch application site to direct external heat sources because of the potential for temperature-dependent increases in fentanyl release that may result in overdose and death. (Emphasis added.)

Heat sources include heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds; sunbathing and hot baths should likewise be avoided. Patients in whom fever or increased core body temperature from strenuous exertion develops should be monitored for opioid adverse events, and fentanyl dosage should be adjusted accordingly.

Source: FDA Safety Changes: Ultram ER, Reyataz, Duragesic