Pradaxa Fraud

Pradaxa Fraud

Warfarin has been an effective blood-thinning product for nearly 60 years. Like any blood thinner, it can work too well and cause uncontrolled bleeding; but there is an anecdote to stop the bleeding from Warfarin. Such is not the case with Pradaxa.

Touted by Boehringer Ingelheim Pharmaceuticals  as a new generation of Warfarin, Pradaxa is a disaster. Unlike Warfarin, there is no anecdote to stop the bleeding of someone taking Pradaxa; a patient can consequently bleed to death. Pradaxa’s creator rushed it to market without properly studying it for safety. The research behind Pradaxa shows little to no substantive proof that it works as well or any better than Warfarin, or any definitive proof that it is even safe, whether its benefits can be said to outweigh its serious risks. Pradaxa is a fraud perpetrated on the public.

Boehringer Ingelheim Pharmaceuticals sells Pradaxa (dabigatran etexilate mesylate) to reduce the likelihood of stroke in atrial fibrillation patients, or those with  irregular heart rhythm.

An anticoagulant, Pradaxa works by blocking an enzyme in the blood necessary for clotting. Blood clots can lead to strokes.

Lawsuits filed against Boehringer Ingehleim Pharmaceuticals charge that the company misrepresented Pradaxa as safe and effective, though they were aware, and several studies later proved, that no antidote exists to undo the drug’s penchant for causing uncontrolled bleeding.

Lawsuits also charge that Pradaxa’s maker negligently failed to use due care in developing Pradaxa, failed to provide Pradaxa users with adequate warnings,  failed to give actual rates of irreversible bleeds associated with Pradaxa, failed to conduct adequate trials, released misleading information regarding Pradaxa.

Suits also claim that Pradaxa’s makers concealed knowledge that Pradaxa can cause life-threatening, irreversible bleeds, hence failing to warn plaintiffs, their decedents, the general public and the medical community of Pradaxa’s real dangers.

Some facts and observations regarding Pradaxa:

a. There is no research for the safety of Pradaxa and no good-faith attempt to instruct users in how to stop the uncontrolled bleeding which can occur from its use.

b. The study on which Pradaxa was approved is based on lies.

c. the maker of Pradaxa was told not to use direct-to-consumer marketing, but did so anyway.

d. the makers of Pradaxa have been sanctioned by the court four times for discovery violations.

e. Pradaxa makers have claimed their product is 35 percent better than Warfarin, but there may be a fraction of one percent difference in effectiveness.

f. In May 2013 the FDA told Pradaxa’s makers that they could no longer use the bogus 35% for their claims of greater effectiveness.

SSRIs and Pregnancy

SSRIs and Pregnancy

What every mother should know

Women of child-bearing years often wonder if the drugs they consider taking could have a negative impact on their baby’s development should they become pregnant. Such women would do well to understand the FDA’s designation of Pregnancy Categories X, D, C, B and A, and to understand that these categories are not as clearly delineated as one might think. In fact, the pregnancy category can even change depending on the problem which the drug is prescribed to treat.

To further show the difficulties in assessing the safety of the categories, a Pregnancy Category B drug might seem, intuitively, to be safer than a Pregnancy Category C drug for a woman wishing to become pregnant. However, this is not necessarily the case, as the former has not been studied as extensively in regard to fetal development as the latter.

All women of child-bearing years should be apprised that popular Selective Serotonin Reuptake Inhibitors (SSRI’s) such as Celexa, Effexor, Lexapro, Paxil, Prozac and Zoloft are all either Pregnancy Category C or D drugs, while popular anti-seizure medications Depakote and Topamax are in Pregnancy Category D or X, depending on what problem they are prescribed to treat. Depakote and Topamax are in Category D when used for the treatment of epilepsy or manic episodes associated with bipolar disorder; however, Depakote and Topamax move to Pregnancy Category X when prescribed for the prevention of migraine headaches.

Pregnancy Category X is the most dangerous drug designation for a developing fetus. Category X  means that studies in pregnant animals or humans have demonstrated that the drug can cause fetal abnormalities. Pregnancy Category X drug indicates that the drug’s risks of use for a woman trying to become pregnant clearly outweighs any possible benefits of the drug.

Pregnancy Category D means that positive evidence of fetal risk exists for humans based on adverse reaction data from investigations, studies or marketing experiences. Nevertheless, according to the category D rating which the FDA has determined to be “appropriate,” potential benefits of the drug may be worth the risks for pregnant women, depending, of course, on the individual situation.

Pregnancy Category C means that animal studies have shown adverse effects on the unborn, but that there are no adequate, well-controlled studies in humans. Does that mean the drug is safe for the potential fetus of a woman trying to become pregnant, or safer than a Pregnancy Category D drug? The dearth of research is hardly assuring. Again, the FDA says of drugs in this category that the possible benefits may make the drug worth the risk for pregnant women.

Pregnancy Category B indicates that minimal reproduction studies have not demonstrated a risk to the fetus, and that there are no adequate, well-controlled studies in pregnant women. Does that mean a drug in this category is safer than a drug in Category C? We will not bet our future on it.

Pregnancy Category A means that adequate, well-controlled studies have failed to demonstrate a fetal risk in the first trimester of pregnancy, and that there is no evidence of risk in later trimesters.

The lesson seems clear. Read the fine print before taking any drug, and carefully weigh the benefits with the potential risks.

PI Law Group is handling cases all across the country involving the SSRI’s Celexa, Effexor, Lexapro, Paxil, Prozac and Zoloft, as well as anti-seizure medications Depakote and Topamax. 

If you or someone you love has been injured by one of these drugs schedule your free initial consultation online or call us at 508-499-3366.

Judges: Infuse lawsuits not preempted

Judges: Infuse lawsuits not preempted

August 26, 2013 # 10:18 am # Pharmaceutical Watch # No Comment

Plaintiffs won an important preemption battle in U.S. District Court in Ariz. in August when Judge G. Murray Snow ruled that Medtronic changed the calculus of preemption by breaking federal law in promoting off-label use of Infuse. Consequently, the judge ruled, the company was no longer able to claim immunity by federal preemption.

The court wrote: “In short, the FDA strictly regulates manufacturers based on the intended use of the device, and manufacturers can deviate from those specifications only with permission.”

Lawyers for Medtronic, Inc., had claimed that federal law preempts state law in this case; they argued that because Infuse had been approved by the FDA (in 2003), it was then shielded from liability if it injured anyone. Though shot down in Arizona, that argument appeared to work a week earlier in a court in Minnesota, where Medtronic maintains headquarters.

Minnesota Ruling Differs

In Minneapolis, Judge Laurie Miller ruled in August that federal law will not allow Minn.  courts to hear the cases of dozens of people  injured by Medtronic Inc.’s Infuse spinal device. Judge Miller granted the motion to dismiss based partly on recent U.S. Supreme Court rulings that found medical device makers could not be sued by patients if the  FDA had already approved their products.

This decision was controversial, to say the least. Nevertheless, Judge Miller did leave  the legal door open for plaintiffs to re-plead the cases under different causes of action;  so there is still some hope left for these Infuse-injured people whose cases were filed in Minnesota.

Cook County Ruling also for Plaintiffs

Plaintiffs also won an import decision in July 2013 when a lower court judge in Illinois ruled that a Medtronic Infuse lawsuit can go forward despite defense arguments that the lawsuit is preempted by federal law. The lawsuit alleges that Medtronic promoted unapproved uses of  Infuse Bone Graft and it also alleges faulty labeling.

Eperts say it is illegal for Medtronic to promote Infuse off-label (though it is not illegal for doctors to use a product off label), and Judge Eileen M. Brewer agreed. In Cook County Circuit Court, Judge Brewer denied a defense motion to dismiss a Medtronic Infuse bone graft lawsuit based on the fact that state law claims parallel federal law in this case. Furthermore, the judge ruled that makers of medical devices are not entitled to liability protection if the manufacturer’s failure to follow federal law results in patient injury.

Based on the assumption that the plaintiff’s claims are federally preempted by the Food, Drug and Cosmetic Act, Medtronic filed a motion to dismiss the lawsuit. Judge Brewer, however, ruled that the claims are not preempted, because the off-label use and the promotion of that off-label use violated FDA regulations for the device.

In this  case, the Infuse bone graft injury occurred after a procedure that fused vertebrae in the cervical spine. The lawsuit was filed after plaintiff, Karl Sanda underwent cervical spinal surgery in Jan. 2011. The suit alleges the Infuse bone graft was used off-label based on promotion by Medtronic sales representatives who paid key opinion leaders to promote the off label usage.

Jury awards $2 million in damages in Bard TVM case

Jury awards $250,000 in injury damages and 1.75 million in punitive damages in Bard TVM case

A federal jury in a bellwether injury lawsuit re-trial this week arrived at a $250,000 injury judgment against  transvaginal mesh device maker, C.R. Bard. This Bard case, the first to come before West Virginia’s Federal multi-district litigation (MDL) court, was declared a mistrial last month after testimony revealed the mesh product had been removed from the market, a disclosure which ran afoul of the court’s pre-trial instructions. This time the jury made it to a verdict, which declared C.F. Bard’s Avaulta pelvic mesh device to be defective, and determined that Bard failed to warn about the mesh’s defects.

The jury in the retrial, which began on July 29 and lasted six weeks, awarded the plaintiff $250,000 in compensatory damages, then later added an additional $1.75 million in punishment damages. Though the punitive portions of these damage awards are seldom collected by plaintiffs, the amount in this case clearly indicates that the jury felt the company knew about problems with the Avaulta product, yet failed to properly disclose them to the plaintiff. The jury deliberated for 12 hours over two days. Judge Joseph Goodwin of the U.S. District Court for Western Virginia presided.

Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Transvaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls. These mesh devices were approved through an FDA fast-track process known as 510(k), which requires no formal review for safety or efficacy; consequently, the 510(k) route has drawn criticism for being used to gain clearance for transvaginal mesh and other controversial devices.

This is the first federal lawsuit to come to trial that alleged the device harmed a patient. Myriad companies – including Boston Scientific, Endo Health Solutions, Cook Medical, and Johnson & Johnson’s  Ethicon subsidiary – face more thant 4,000 federal lawsuits related to transvaginal mesh devices.

“The jury award reflected the surgeries the woman suffered post implant and the problems she had pre-implant,” said attorney David Matthews, whose firm of Matthews & Associates, along with Freese & Goss – of Dallas, Texas; Jackson, Miss.; and Mobile, Ala. – will try five mesh cases in the next year.  The firms’ five trial cases, however, all concern mesh slings used for stress urinary incontinence (SUI), as opposed to the mesh which was used, in this West Virginia case, to treat pelvic organ prolapse (POP).

The difference in the types of mesh could be important for trial outcomes. The distinction was made somewhat clear in June 2011 when the FDA announced that it would like to see more testing of the transvaginal mesh used for POP; but the agency essentially seemed to agree with manufacturers that the slings being used for SUI did not require further testing, that slings were the “gold standard” for SUI treatment. Whether the slings’ risks outweigh their benefits and whether the women who have been slinged were properly warned of the dangers in the event of the sling’s failure will be determined in the courts.

The FDA has stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA also recently reported that the most common complications associated with transvaginal mesh may include:

• Exposure, extrusion, or protrusion (mesh erosion through the vagina)
• Pain
• Infection
• Bleeding
• Pain during sexual intercourse (dyspareunia)
• Organ perforation
• Urinary problems

If you have been injured by a mesh implant schedule your free initial consultation online or call us at 508-499-3366.

Transvaginal Mesh trials in W.Va. MDL

Transvaginal Mesh trials in W.Va. MDL

A jury trial in a lawsuit involving transvaginal surgical mesh pelvic repair products is underway in U.S. District Court in Charleston, W. Va., site of the multi-district litigation (MDL) federal court.

The case is brought by Donna Cisson of Georgia, who is suing C.R. Bard. Inc., for a pelvic mesh implant she received that was made by the company. Ms. Cisson’s  case is the first of thousands of surgical mesh lawsuits filed nationwide to go to trial in the federal W. Va. MDL.

The lawsuits accuse the implants’ manufacturers of inadequate testing, failure to disclose potential risks, fraudulently promotion of the mesh as a safe medical device, and defective product design.

A first trial of Cisson’s lawsuit ended in a mistrial earlier in July.

The Cisson lawsuit is one of four bellwether cases that U.S. District Judge Joseph Goodwin will hear to determine the next step in litigation for the remaining lawsuits.

Another bellwether case against Johnson & Johnson’s Ethicon division in the federal multi-district litigation court (MDL) in West Virginia beginning Jan. 14, 2014.

NuvaRing Lawsuit Ruling

NuvaRing Lawsuit Ruling

A state judge in New Jersey refused this Spring to strike down claims for punitive damages in nine NuvaRing contraceptive cases scheduled to be tried in the next three years. Lawyers for Merck and Organon USA Inc., makers of NuvaRing, had moved for summary judgement to dismiss punitive damages in these cases. Judge Brian R. Martinotti refused to grant that judgement, because the injuries plaintiffs allege from the popular contraceptive implant drug device occurred in several different states, each of which has an interest in deciding punitive damages for itself.

Depakote increases birth defects risk

Depakote increases birth defects risk

Children born to women who took the epilepsy drug valproic acid (Depakote or Depakene) during their pregnancy’s first trimester are more than 2.5 times more likely to have serious births defects. These injuries can affect the brain, heart and limbs, according to a study published in the New England Journal of Medicine.

Serious Depakote birth defects include:
◆   Cleft palate
◆   Hypoplastic right heart (underdeveloped right side)
◆   Undescended testes
◆   Hand malformations
◆   Dysplastic (abnormally developed) ribs
◆    Hypospadia (male baby’s  urethra opening occurs in wrong place)
◆   *Spina Bifida (spinal column fails to enclose spinal cord)
◆    Fetal death

*Among the most severe side effects, spina bifida is a birth defect in which the spinal cord and backbone fail to develop or close properly. The risk of spina bifida in the offspring of mothers taking valproic acid during pregnancy is 1 – 2 percent, while a recent study found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida compared to babies whose mothers did not take the drug.

Lolkje T.W. de Jong-van den Berg and colleagues at the Netherlands’ University of Groningen found babies subjected to their mothers’ use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida than babies whose mothers never took the drug.
Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (heart), about five times as likely to have a cleft palate (upper lip and roof of the mouth) or hypospadias (abnormal penis), more than twice as likely to be born with an extra hand digit (polydactyly), nearly seven times more likely to have craniosynostosis (premature skull fusion restricting skull, brain growth).

While valproic acid was associated with a higher relative risk of the six birth defects, researches noted the absolute risk of having a baby with any of the defects remains small. For example, the risk of a baby’s having spina bifida was 0.6 percent – or six in 1,000 – among women who took the drug, compared to five in 1,000 of babies born to mothers who didn’t.

But given mounting evidence of the risks of valproic acid to fetuses, researchers urged women of childbearing age to try other drugs to control their seizures.

“These findings provide further evidence to avoid valproic acid, if possible, in pregnant women and (for doctors) to discuss with girls and women of childbearing potential the risk of the drug for the unborn child,” van den Berg said.

Dr. Kimford Meador – a professor of neurology at Emory University in Atlanta – echoed that warning: “This drug should not be used as a first-line drug for epilepsy in women of childbearing age. (There) are multiple types of malformations that can be associated with valproic acid.”

The review was published in the June 10, 2010 issue of the New England Journal of Medicine (NEJM).

Researchers first looked at eight studies that included nearly 1,600 births and identified some 14 birth defects that seemed to be much more common among the children of women who took valproic acid early in pregnancy.

Armed with that information, researchers analyzed data from a large European study that included nearly 4 million births and 98,000 birth defects. They found women who took valproic acid in early pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs. The findings were similar when birth defect rates among those taking valproic acid were compared to the rates for women who took other epilepsy drugs, leading researchers to conclude it was the valproic acid, not some other epilepsy drug, that was to blame.

Among those who took valproic acid during early pregnancy, the chances of having a baby with any of the defects was less than 1 percent — cleft palate (0.3 percent), hypospadias (0.7 percent), polydactyly (0.2 percent), craniosynostosis (0.1 percent).

Previous research has also linked valproic acid to spina bifida, other birth defects, cognitive problems in children, Meador noted. In April 2009, Meador was lead author of a study that appeared in NEJM linking exposure to valproic acid in the womb to lower IQ scores in children.

The American Academy of Neurology recommends pregnant women avoid valproic acid, according to background information in the publication. Yet because roughly half of pregnancies are unplanned, according to the study, researchers said all women of childbearing age should be warned about the dangers.

Despite such concerns, Meador said valproic acid is often still prescribed. In 2006, valproic acid was the second most commonly prescribed epilepsy drug. Meador added that Valproic acid is also prescribed to prevent migraines and to treat bipolar disorder.

Meador also said that despite the risks, valproic acid can be a very effective drug and may be the best choice for some patients whose seizures are not well-controlled by other medications.

Reuters was the source for much of this story.