Chicago-Land Personal Injury Lawyer

Pradaxa vs. Warfarin: The Rest of the Story

Steven Davis — Thu, 16 May 2013 14:53:01 GMT

Pradaxa, Boehringer Ingelheim’s (“BI”) competition to warfarin (brand name: Coumadin) in the anti-coagulation market, was approved for use to reduce the risk of stroke in those patient who have non-valvular atrial fibrillation, a heart rhythm disorder. The FDA approved Pradaxa (dabigatran) based on BI’s RE-LY study, an open-label clinical trial that studied more than 18,000 patients. According to BI, the benefits of Pradaxa are a 35% reduced risk of stroke, as compared to warfarin, and greater convenience, in that Pradaxa does not require the blood tests or dietary restrictions that accompany warfarin therapy, all in the context of safety comparable to warfarin. Further study of the RE-LY data, however, calls these claimed benefits into question. Here’s the rest of the story.

To begin, BI’s claimed context of safety appears to be inaccurate. RE-LY data shows that patients on Pradaxa are more likely to suffer severe bleeds; often, these have occurred as GI bleeds. Further, unlike warfarin, Pradaxa has no reversal agent, meaning that doctors cannot administer a drug to reverse Pradaxa’s effects. In the event a Pradaxa patient experiences a bleed, a traumatic injury, or the need for emergency surgery, doctors must often delay treatment (especially surgery) until Pradaxa has been eliminated from the patient’s body. Compromised kidney function increases the risk further. Pradaxa, unlike warfarin, is eliminated through the kidneys. Compromised kidney function slows the body’s availability to eliminate Pradaxa, meaning that needed treatment may be delayed even further. In some cases, delayed treatment has led to death. In other cases, treatment could not be delayed and patients bled to death because doctors could not reverse Pradaxa’s effects. Given the increased risk of bleeds and the increased difficulty in reversing Pradaxa’s effects, one might question whether Pradaxa really is as safe as warfarin. Even if Pradaxa is not as safe, a patient might still chose to use it if Pradaxa provides a benefit that outweighs the increased risk.

BI touts Pradaxa as being 35% more effective than warfarin. A full reading of the RE-LY data reveals that the 35% reduction in stroke risk applies only to patients who were poorly controlled. If a patient is poorly controlled on anti-coagulation therapy, the blood may be too thin, leading to an increased risk of severe bleeding, or too thick, leading to an increased risk of stroke. Among RE-LY patients who were well-controlled on warfarin, Pradaxa was no more effective at preventing stroke. If Pradaxa is no more effective at preventing stroke in a well-controlled warfarin patient, why should the patient switch to Pradaxa?

Pradaxa is more convenient than warfarin, according to BI’s promotional material. This is, BI says, because patients on Pradaxa need not undergo regular blood tests to determine whether they are well–controlled, while warfarin patients must be regularly tested so doses can be adjusted to keep the blood properly thinned. Warfarin also requires certain dietary restrictions. Certain foods, including green vegetables, contain vitamin K, which counteracts the effects of warfarin. Pradaxa carries no dietary restriction. Are these tests and dietary restrictions such an inconvenience that patients should switch to Pradaxa? Not according to the RE-LY data. According to a recent evaluation of RE-LY data ("Assessing the Impact of Dabigatran and Warfarin on Health-Related Quality of Life: Results from an RE-LY Sub-study" published in the International Journal of Cardiology on May 10, 2013):

"anticoagulated patients without outcome events (e.g. strokes or major bleedings) had stable [health related quality of life]. Scores between dabigatran and warfarin were comparable, which was unexpected given the known complexities of warfarin treatment.”

According to BI’s own data, excluding those patients who are successfully treated (meaning the treatment didn’t fail, resulting in stroke, or cause a bleed) with these two anti-coagulants, there is no difference in quality of life as related to health and medical treatment. That is to say, according to the patients successfully treated, using Pradaxa is no more inconvenient than using warfarin. It should also be noted that this data was gathered at a time when BI did not recommend any testing for patients on Pradaxa. BI now recommends that Pradaxa patients undergo kidney function testing.

We’ve asked before, and we ask again: why should a patient who is well-controlled on warfarin switch to Pradaxa? In such a patient, according to the available data, Pradaxa is no more effective, no more convenient, more likely to cause a bleed, and harder to reverse in an emergency. While Pradaxa may be appropriate for patients poorly-controlled with warfarin, the data seems to suggest that, among those well-controlled with warfarin, Pradaxa provides no clinical benefit.

Here’s another question: why did BI not release all of this information when it released Pradaxa in 2010? RE-LY, the source of all of this data, was completed long before Pradaxa hit the market. BI had the data, and certainly could have – almost certainly should have – publicized this data. What could BI have to lose by keeping this data to themselves for years?

Originally posted at The Legal Examiner by Steven Davis

6.5 Million Jury Verdict in First Actos Trial

Eric Terry — Fri, 26 Apr 2013 19:07:31 GMT

A California state court jury has reached a verdict for the plaintiff in the first Actos trial in the country. The verdict comes after almost two months of trial, and jury deliberations that lasted more than a week. The jury ruled Takeda failed to warn plaintiff, Jack Cooper, of the risks of bladder cancer. Cooper and his wife were awarded 6.5 million dollars in damages.

Cooper was granted an expedited trial date under California state procedural rules. Cooper’s attorney, Michael Miller, argued that Takeda downplayed risks of bladder cancer to protect profits. There are more than 3,000 cases filed nationwide that contain similar allegations.

Originally posted at The Legal Examiner by Eric Terry

$7 Million "Popcorn Lung" Lawsuit Upheld

Jacob Plattenberger — Tue, 23 Apr 2013 16:36:07 GMT

A federal court in Colorado has dismissed the defendant’s post-trial motions for judgment as a matter of law for a new trial. The court upheld a $7.5 million jury award to plaintiff, Wayne Watson, who sued the manufacturer and retailers of microwave buttered popcorn that caused him to develop “popcorn lung” after eating two bags daily for 10 years. Wayne Watson v. Dillion Cos., Inc. was the first case involving a consumer of microwave popcorn diagnosed with Popcorn Lung.

Diacetyl is the one of the most dangerous substances ever exposed to workers and consumers. Exposure to it can leave workers and consumers with a severe, disabling and potentially lethal lung disorder – constrictive bronchiolitis obliterans – in which the smallest airways of the lung become scarred and constricted, blocking off movement of air.

Dr. Cecile Rose, a lung specialist at the National Jewish Medical Research Center in Denver (and Wayne Watson’s doctor) told the CBS Early Show in 2007 that initially she was unsure what could have caused his ailment, but, knew it came from something he had inhaled. When Watson’s medical history turned up nothing but eating two bags of popcorn for two years, Dr. Cecile Rose took action to see that others knew of the dangers. Dr. Rose wrote a letter to federal agencies warning that an unidentified person may have developed the first case of the disease outside factory workers.

Even with warnings from Dr. Rose, the National Institute for Occupational Safety and Health and other groups, many people are working with this substance and consumers are risking their health using products containing diacetyl in their homes on a daily basis.

According to the Colorado federal court, punitive damages were appropriate in this case because “a reasonable jury could conclude that the Defendants knew about the risk posed to consumers from diacetyl in their microwave popcorn products, and that this conduct could be construed as willful and wanton.”

Originally posted at The Legal Examiner by Jacob Plattenberger

Do Popular Diabetes Drugs Contribute to Pancreatic Cancer Development?

Jacob Plattenberger — Fri, 19 Apr 2013 18:11:36 GMT

Today an independent body released the results of its research indicating that an entire class of type-2 diabetes drugs known as incretin mimetics may carry up to 25 times the risk of developing pancreatic cancer for patients taking these drugs. These drugs are known commercially as Januvia, Byetta, Victoza, Onglyza, and Tradjenta.

The Institute for Safe Medication Practices "ISMP" analyzed data from the FDA's Adverse Event Reports between July 1, 2011 and June 30, 2012 from 1,723 patients taking these drugs. The ISMP concluded that the increased risk of developing pancreatic cancer for patients taking these drugs could be as much as 25% higher than those who were taking other medications to control their type-2 diabetes. . . .

Tom Moore, a senior scientist for drug safety and policy at the ISMP said, “I think the whole class is in question.” Moore further stated that additional analysis is required, but “if the results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”

This class of drugs is collectively referred to as incretin mimetics. Some work by mimicking a hormone called GLP-1 to stimulate natural insulin production. Other drugs in this class are known as DDP-4 inhibitors and they work by inhibiting glucagon release thereby stimulating insulin secretion. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continuing to investigate the connection between this class of drugs and pancreatic cancer.

Although this data has some inherent limitations because it is based on adverse event reporting, it is a significant signal that more study and investigation should be undertaken, especially considering the reports from different, independent, investigators published in February.

We call on the manufacturers to focus on patient safety and truly and transparently study the safety of their drugs.

Originally posted at The Legal Examiner by Jacob Plattenberger

Transvaginal Mesh Product Manufacturers Receive Powerful Message

Jacob Plattenberger — Thu, 28 Feb 2013 16:07:47 GMT

Unaccountability in business is unacceptable. In the case of Gross v. Johnson & Johnson, the jury awarded $7.76 million in punitive damages today, adding to the $3.35 million they awarded in compensatory damages this past Monday, sending a powerful message to Johnson & Johnson.

The punitive damages verdict is not only meant to punish Johnson & Johnson for their reckless disregard for human safety, but also as a crystal clear message to other manufactures to stop similar unjust business practices. In this instance, Johnson & Johnson improperly decided to forego testing their transvaginal mesh product before placing it on the market for sale, choosing instead to compare it to Gynecare Prolift, a similar product already on sale. Further, Johnson & Johnson placed their product for sale prior to FDA approval.

The jury set a commanding precedent for future decisions. Unethical business practices with zero accountability and only profit margins as the goal are no longer tolerable. The safety and well-being of consumers must be first priority.

Originally posted at The Legal Examiner by Jacob Plattenberger

Jury Awards Plaintiff Millions in Compensatory Damages for Failed Transvaginal Mesh

Jacob Plattenberger — Mon, 25 Feb 2013 12:39:57 GMT

In a resounding victory for Plaintiff, Ms. Linda Gross, in the Superior Court of Atlantic County, N.J., the jury reached a partial verdict in her favor for $3.35 million in compensatory damages against Johnson & Johnson for their defective transvaginal mesh implant.

Transvaginal mesh implants are implanted to help strengthen pelvic muscles following prolapse. The mesh will harden in the tissues, causing scaring and inflammation; the mesh fused with muscles and tissues, which makes removing it very difficult. Women who have mesh implants may suffer from perforation of organs, erosion of vaginal tissue, vaginal bleeding, vaginal scaring, and sever pain. Gross, a former nurse, had the device implanted in mid-2006 for pelvic organ prolapse, but instead of strengthening and relieving pain, the device actually caused more agony. Gross was so uncomfortable and in such excruciating pain, she was unable to sit down.

Johnson & Johnson released the product prior to FDA approval; instead of conducting lengthy tests, the company compared the Gynecare Prolift to another one of its mesh products already on the market, Gynecare Gynemesh. Internal emails show the pharmaceutical company was aware of the failure rate during testing, disregarded the potential risks, and placed the implant on the market for sale. Johnson & Johnson is not the only company manufacturing mesh products, other major mesh manufacturers include: American Medical Systems, Boston Scientific and C.R. Bard, Inc.

Originally posted at The Legal Examiner by Jacob Plattenberger

Urgent Recall of Dialysis Drug Omontys

Jessica Hoerman — Sun, 24 Feb 2013 10:08:04 GMT

The U.S. Food and Drug Administration announced a recall of all lots of Omontys (pegniesatide) after serious hypersensitivity reactions occurred.

Omontys injection is produced by Affymax and Takeda and is used in the treatment of anemia due to chronic kidney disease in adult patients on dialysis. It was approved the FDA in March 2012.

Fatal reactions have occurred in approximately 0.02% of patients and the reaction has occurred within 20 minutes of administration of the injection. More than 25,000 patients have received Omontys since its release.

Diaylysis organizations have been instructed to discontinue use of Omontys immediately. If you are a dialysis patient, it is worth it to confirm your center has discarded this medication.

Furthermore, if you are a patient that had a serious reaction and required medical intervention after receiving dialysis, report this information to the FDA. In addition, you may have legal rights and should consider talking to a lawyer.

Originally posted at The Legal Examiner by Jessica Hoerman

Did Takeda Have Reason to Worry About Actos and Cancer Link?

Eric Terry — Fri, 15 Feb 2013 19:18:51 GMT

Behind closed doors, Takeda knew this was coming.

In 2003, Takeda Pharmaceutical Co. was already starting to worry that its diabetes drug Actos might be linked to cancer - so much so that the company secretly surveyed a dozen doctors to see if a warning label mentioning a fatal ailment would decrease the likelihood that a doctor would prescribe the drug.

According to allegations made in California court filings, the survey found that “a bladder cancer warning would destroy the sales of Takeda’s most important drug.”

This isn’t the first time allegations that Takeda withheld knowledge had been made. Past allegations brought to light the possibility that Takeda underreported the incidents of bladder cancer in Actos users.

These allegations will play a central role when the first Actos case goes to trial in California on February 19.

More than 3,000 lawsuits are already pending, each alleging that Actos was the cause of bladder cancer. Recent studies have confirmed that long term usage of Actos can result in an increased risk of bladder cancer.

The FDA has also warned about the risk of bladder cancer associated with Actos.

As trials in California begin, and as cases continue to push forward in federal court in Louisiana and state court in Illinois, the truth concerning Takeda’s actions and decisions will hopefully be exposed.

Originally posted at The Legal Examiner by Eric Terry

France Acts Swiftly on Contraceptives Linked To Blood Clots

Eric Terry — Wed, 30 Jan 2013 16:16:23 GMT

France’s National Security Agency for Medicines and Health Products (“ANSM”) announced today that swift action has been taken to halt the sale of the hormonal acne drug, Diane-35. Linked to the deaths of four women recently, the drug manufactured by Bayer was also being prescribed as a birth control pill in Europe. Women in France will need to find a new birth control/acne medication within the next three months.

French investigators have also requested that the European Medicines Agency (an agency similar to the FDA that harmonizes all medicine agencies in the European Union, including France) change prescription guidelines for so-called third and fourth generation oral contraceptives after these drugs were found to carry a higher risk of blood clots as compared to earlier versions.

In addition to today’s action, France’s ANSM initiated an investigation into Méliane, another of the newer generation contraceptives manufactured by Bayer. Meliane has also been linked to life threatening blood clots.

France has indicated that the investigations will not end with Diane-35 and Meliane. Bayer’s Yasmin line (Yaz, Yasmin and Ocella) are also newer generation contraceptives that have been linked to blood clots and are likely to be added to the French investigation. In the United States, there have been just short of 23,000 adverse health reports where Yaz was found to be the primary suspect.

We will continue to watch where the EMA takes this investigation. In the United States, Bayer finds themselves deeply entrenched in litigation with regards to Yaz, Yasmin and Ocella. Just last November, Bayer announced $750 million settlement to 3,490 claimants and those settlement will continue to grow as more women come forward to report their injuries.

So with serious injuries continuing to mount, evidence of overstated success already demonstrated, and overseas investigations ongoing, one can only hope that manufacturers like Bayer work to fix the damages they have already caused.

Originally posted at The Legal Examiner by Eric Terry

Zoloft Litigation Continues to Move Forward

Steven Davis — Wed, 30 Jan 2013 16:13:36 GMT

Since the first Case Management Order, setting the initial policies and protocols for the litigation, was entered in October, Zoloft litigation under the honorable Cynthia M. Rufe in the Eastern District of Pennsylvania has continued to move forward.

On November 15, 2012, the Court issued a Joint Discovery and Scheduling Plan. Thus, discovery has already begun, with Pfizer beginning the process of producing documents and identifying witnesses for trial. Furthermore, the scheduling for Daubert motions (arguments for admissibility of expert testimony) have been set, as has the date for the first trial, which is to begin no later than September 12, 2014.

On January 17^th, the Court issued Pretrial Order No. 17, which established that an initial discovery group of 25 cases was appropriate. Selection of these 25 cases will be divided among Plaintiffs’ Counsel and Defense Counsel and will serve as the initial group for discovery and trial preparation.

While this does not mean that all 25 of these cases will be tried, or even that the initial 25 selected cases will be the final ones evaluated for trial, it does mean that a framework is in place that will significantly advance this litigation.

Although progress is being made and discovery is under way, there is still a lot of work ahead. We will continue to fight for those who have suffered injuries caused by Zoloft.

Originally posted at The Legal Examiner by Steven Davis