Are all Doctors Trustworthy?

Are all Doctors Trustworthy?

Common sense is not that common, as the saying goes. The legal system is at least partly to blame. It has evolved into a cult of experts, not that the everyday world doesn’t work in much the same fashion. Many of us tend to trust the “experts” with anything that concerns us before we trust our own intuition and even personal experience. We turn to nutritionists for diet advice, magazines for style, personal trainers for physical well-being, psychologists for mental health, movie critics for advice on whether to spend ten bucks or more on the latest blockbuster film. How many of us even step outside our front doors anymore and actually  gauge the weather ourselves by feeling it to consider how to dress instead of consulting our favorite meteorologist’s predictions on the TV or iPad?

Sure, it’s great to have all this “expert” advice and help in planning our days and lives. But is there no point of diminishing returns as regards “the experts”? Do we not at some point give something up when we take all this advice from “experts”? Can we make any decisions on our own anymore? Can we use our own intuition or creative ability or imagination without consulting one expert or another?

The legal field, too, is run by experts. The court system is run by nothing if not a steady genuflection to experts. Few pharmaceutical cases can be made, for example, without the help of costly experts. It is not enough for you or someone you love to have suffered a stroke or heart attack while taking drug X. Your attorney in a drug case needs to enlist experts who can examine studies and statistics that can show that the health records of hundreds, thousands, or even millions of people were examined to arrive at the conclusion that drug X caused more problems than it solved, that its cost-benefit ratio wasn’t worth four bucks a pill, or that its risk of deadly side effects was greater than that which the drug maker revealed upon promotion of the drug.

Of all the experts on whom we most depend, doctors are probably the most important. Doctors are the No. 1 expert most of us turn to for health concerns. But are all doctors “expert”? We’ve all heard the phrase, “Trust your doctor.” Can we always trust our own doctor to make the best possible decision(s) concerning our health? Are all doctors trustworthy?

“Trust Me, I’m a Doctor” was a TV program aired on BBC. It examined the state of health care in Britain with factual reporting and satire. Dr. Phil Hammond presented the series from 1997-99.  A book by Hammond complemented the series. Doctors are not infallible, was the message, and one would be wise to learn as much about one’s healthcare as possible.

Thanks to Hammond and others, it has now become a running gag to say, “Trust me. I’m a doctor.” Josef Mengele (pictured in his Nazi uniform) was a doctor. Was he trustworthy by virtue of his title?

Dollars for Docs

Today, in the information era, you can check out Dollars for Docs atPropublica.org to see if your own doctor may have some conflicts of interest as regards his or her drug prescription choices. Money obviously poisons politics; so who’s to say it doesn’t also have some impact on a doctor’s choice of prescriptions or medical treatments?

AMA advertised Cigarettes

The official publication of the AMA, the Journal of the American Medical Association (JAMA) accepted cigarette ads long after the science became clear that cigarettes cause cancer. The AMA saw the science, too, but either chose to ignore it, or used cognitive dissonance to imagine it wasn’t good science. Many doctors promoted cigarettes for years when common sense might have told anyone that sucking smoke and chemicals deep into the lungs was not a good idea.

It’s worth pointing out that doctors aren’t always right. Doctors also helped promote margarine as an improvement over butter, and we all know how that turned out.

Edward Bernays, a nephew of Sigmund Freud, also helped promote cigarettes. He was very good at his job. Barnays once explained, “[Y]ou can get practically any idea accepted if doctors are in favour. The public is willing to accept it because a doctor is an authority to most people, regardless of how much he knows or doesn’t know” (Bryson 2004).

Maybe we need to think twice the next time somebody says, “Trust me. I’m a doctor.” Given that many “experts,” including doctors, are paid for their opinions and sometimes have vested interests in the opinions they put forth, we probably need to refresh a little trust in ourselves in our seemingly endless genuflection to experts, whether in the health or legal field or any other.

Trust yourself, oh ye of little faith.

If you have been injured by the advice of your doctor, schedule an appointment for a free consultation online or contact us at 508-499-3366 today.

Tylenol Lawsuits rise as acetaminophen kills

Tylenol Lawsuits rise as acetaminophen kills

Tylenol with acetaminophen can damage your liver and kill you. Though it has been sold over the counter for pain relief for more than 50 years, so many Tylenol users have suffered major liver damage or even died after taking it that Tylenol’s manufacturer will now warn of these dangers emphatically. McNeil Consumer Healthcare will now inform users of these dangers with a big red warning label on the cap.

Even in recommended doses, acetaminophen – the primary active ingredient in Tylenol – can cause major liver damage, even liver failure and death. Acetaminophen is currently the leading cause of sudden liver failure in the U.S. Its metabolites are toxic enough to kill liver cells. Acetaminophen is so toxic, in fact, that emergency room personnel see roughly 80,000 people annually as a result of acetaminophen poisoning. Five hundred or more end up dead from acetaminophen-caused liver failure.

Meanwhile, Tylenol Lawsuits rise as more than 85 personal injury lawsuits are currently filed in federal court – in U.S. District Court in the Eastern District of Pennsylvania – against McNeil Consumer Healthcare.

AP’s Matthew Perrone wrote:  “The warning will make it explicitly clear that the over-the-counter drug contains acetaminophen, a pain-relieving ingredient that’s the nation’s leading cause of sudden liver failure. The new cap is designed to grab the attention of people who don’t read warnings that already appear in the fine print on the product’s label, according to company executives.”

“CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL,” is the new legend slated to  appear on all bottles of Extra Strength Tylenol.  This “extreme” product contains more than 50 percent more acetaminophen per dose than the regular strength Tylenol. Soon, according to McNeil, regular strength Tylenol will also show the new label.

The AP adds that some 78 million people take an acetaminophen product such as Tylenol daily. Problems with Tylenol can also occur when someone is taking an additional product which also contains acetaminophen, which is contained in more than 600 over-the-counter products. Excedrin, NyQuil and Sudafed are just a few of the many popular products containing acetaminophen.

The maximum daily dose of acetaminophen is set at 4,000 milligrams daily, but some who stay within that dose still become ill or die from it. This suggests that the toxicity may be greater than imagined, or perhaps that any level of acetaminophen is toxic to some people.

PI Law Group is accepting Tylenol cases with acetaminophen injury.  Schedule your free initial consultation online or call us today at 508-499-3366.

Fosamax Femur Fractures Update

Fosamax Femur Fractures Update

The number of Fosamax cases filed in the country against Merck, the maker of Fosamax, has continued to grow. The main injures in these cases are femur fracture and osteonecrosis of the jaw. Multidistrict Litigation courts (MDLs) have been set up in N.J. and in N.Y. to handle these injuries separately.

Some 4,100 cases of people claiming femur fracture as a result of Fosamax have been filed in the N.J. MDL and in state courts. More than 1,000 of them have been filed in the Fosamax Femur Fracture MDL.

Judge Joel Pisano of the U.S. District Court for the District of New Jersey has set May 2014 for the bellwether trial of one femur fracture case.

More than 2,500 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The next trial there is scheduled to begin in March 2014. Roughly 500 cases alleging Femur Fractures have been filed in California state court.

Merck won at least one of the Fosamax trials on federal preemption grounds, but plaintiffs have also won jury trials against Merck over Fosamax;  so this litigation will likely continue into several more trials before any sort of settlement can be reached, if one is ever reached, to bring justice to the thousands of people injured by Fosamax.

Beware of Generic Drugs

Beware of Generic Drugs

Think twice the next time you accept a generic version of a brand-name drug. Americans are not protected by tort liability law if they become injured after taking a generic version of any drug. Though 84  percent of prescriptions written in the country are filled by a generic, the U.S. Supreme Court, in two hotly contested 5-4 votes, ruled to give international drug makers a free pass from liability whenever their generic drugs harm people. (See Pliva, Inc. v. Mensing  and Mutual Pharmaceutical Co. v. Bartlett).

The makers of brand-name drugs, by contrast, can still be held accountable when the drugs they make harm people, that is, if those peoples’ attorneys can prove the drug maker failed to adequately warn of the potential harm, or else exaggerated the benefits, or perhaps simply committed negligence or fraud in getting the drug placed on the market in the first place.

Considering the millions of Americans this miscarriage of justice concerns daily, there has been almost a media blackout regarding the issue. Recent developments, however, show this may be changing. NBC’s Today Show on November 8 aired the story of Viola Purcell, a woman suffering from a permanent nerve disorder called tardive dyskinesia, which was caused by a generic version of Reglan that she took for five years. Ms. Purcell is not alone. Thousands of others were also hurt by generic versions of Reglan, and thousands more have been hurt by generic versions of other drugs. Many of these cases sit in legal limbo in state courts across the country, while lawyers attempt to navigate around the Supreme Court blockade against people hurt by generic drugs.

While plaintiffs lawyers from Matthews & Associates in Houston and a few other law firms continue trying to get around the blockade by bringing various state court actions to hold generic drug makers accountable, the FDA also seems to finally be ready to take action to give generic drug makers the incentive to report adverse events and to change their drug labels as needed.

It’s too little too late for Ms. Purcell and the thousands of other injured people the highest court hung out to dry; but it may someday help restore the discerning drug taker’s confidence in generic drugs and the FDA’s ability to work for the tax payers they’re entrusted to protect.

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.

Zoloft Lawsuits in Philly MDL

Zoloft Lawsuits in Philly MDL

Roughly 330 Zoloft birth defect lawsuits have been filed against Pfizer in the MDL (federal multidistrict litigation) established in U.S.District Court, Eastern District of Pennsylvania. The first Zoloft trials are scheduled to begin in 2014. These cases involve birth defects resulting from the use of Zoloft.

Twenty five lawsuits will be chosen among the total pending, 12 from a list chosen by plaintiffs’ lawyers and 13 by defense attorneys. After discovery and pre-trial proceedings are completed, the first bellwether trial regarding birth defects linked to Zoloft will begin in mid September 2014. Bellwether trials are considered cases which test the waters to give indications about how the litigation will proceed in the long run.

Virtually all of the Zoloft lawsuits claim that the drug taken during pregnancy can increase the risk of delivering a baby with severe birth defects, and Pfizer knew about the link between Zoloft and birth defects.

The birth defects include heart defects, clubbed foot, oral clefts, cleft lip and palate, delayed development, Autism, Persistent Pulmonary Hypertensin of the Newborn (PPHN), Gastrochisis, atrial and ventrical septal heart defects, pulmonary atresia and stenosis, Hypoplatic Left Heart Syndrome (HLHS), Transposition of Great Arteries, Coarctation of the Aorta (coA), Tetralogy of Fallog (TOF), cranial defects, neural tube defects, Spina Bifida.

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

Supreme Court rules against drug victims

Supreme Court rules against drug victims

The Supreme Court ruled in a 5-4 vote today that people hurt by generic drugs cannot collect compensation from the companies that made those drugs. The case was Mutual Pharmaceutical Co., Inc. v. Bartlett.

The same five justices who voted against compensating Gladys Mensing (Pliva v. Mensing) and thousands of others hurt by generic drugs also voted against Karen Bartlett and the many thousands of others who will continue to be affected by generic drugs that have harmed them: Antonin Scalia, John Roberts, Clarence Thomas, Anthony Kennedy, Samuel Alito.

See the full Supreme Court ruling

Z-pack FDA Warnings

Z-pack FDA Warnings

Z-pack – azithromycin – could lead to deadly heart rhythms

The popular antibiotic Azithromycin could trigger a potentially deadly irregular heart rhythm for some patients, the FDA warned in March 2013.

Sold as Zithromax, Zmax,  a “Z-Pack” is prescribed to treat bacterial infections such as bronchitis, pneumonia, ear infections and more.

The FDA has warned that the pills can cause abnormal changes in the heart’s electrical activity that could lead to a fatal heart rhythm. Patients at greatest risk are those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or those who use  certain drugs to treat abnormal heart rhythms.

In a March 12, 2013 update, the FDA stated: “Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.”

A May 2012 study triggered the new guidance, along with, another study by Pfizer, the antibiotic’s maker, which assessed risks to electrical activity of the heart in those taking azithromycin.

A New England Journal of Medicine study last May – which was paid for by the National Heart, Lung and Blood Institute – found there would be 47 extra heart-related deaths per one million course of treatment with five days of Zithromax, as compared to 10 days of amoxicillin and other antibiotics. The FDA said risks of cardiovascular death associated with levofloxacin (Levaquin) treatment were similar to those associated with azithromycin treatment.

• Zithromax antibiotics tied to rare heart risks

Dr. Harlan Krumholze, a Yale University health outcomes specialist who was not involved  in the study, downplayed its findings. He told the AP last May: “People need to recognize that the overall risk is low.” He also posited that more research was needed, but said that patients with heart disease, “[s]hould probably be steered away” from Zithromax.

The FDA also issued a post-study statement in May 2012 that the agency was aware of the findings, and it would review the results and communicate any new information.

The AP also reported that Zithromax sales totaled $464 million in 2011, according to health care information company IMS Health.

Anatomy of a Lawsuit

Anatomy of a Lawsuit

Many of our clients understandably ask about the process of filing their drug case. We hear many questions repeatedly: How does my drug case work? How long does it take to file my drug case? How long before I see some money or some results?

The basic procedure works this way. Once companies receive copies of our petition informing them that we have filed a lawsuit, they have approximately 20 days to answer.  Their response is typically in a form that basically says, “We didn’t do it.  Prove it, if you can.”

The next step in the process is called discovery.  This is the time given us by the court to investigate and develop the case.  Discovery can  last from six to twelve months or longer, depending on the scope of the litigation.

One of the first steps in discovery requires  a plaintiff to answer many written questions (interrogatories) and provide several documents relevant to the lawsuit, through a formal request for production. Once we receive the interrogatories and request(s) for production of documents, we contact the plaintiff to help answer the questions and locate the relevant documents.  We  then type everything and submit the final document  to  defense.

As part of the discovery process, the plaintiff and many other key witnesses and experts will also be interviewed in person and under oath by lawyers for the defendants.  This interview under oath is called a deposition.  During the deposition, a plaintiff will be asked many of the same questions previously answered in writing, and also some new questions.

Once discovery is complete, if the Court has not yet assigned a trial date, we request one.  Prior to trial, the court may require we participate in a dispute resolution process called mediation.  If a case is not settled during mediation, we move forward to trial preparation. Though we typically handle  many of cases at one time, we work every case with the assumption that it will go to trial. The litigation process  in a drug case typically takes between two and five years, depending on many factors; but it can take longer, as with the Accutane litigation which still continues after more than seven years.

Anyone with questions is urged to contact us at 508-499-3366.

Judge overturns $6.5 Million Verdict

Judge overturns $6.5 Million Verdict

It’s a wonder we even bother to hold trials anymore. In the latest miscarriage of justice, a California judge overturned the verdict of a six-week jury trial by accepting defense arguments that an expert whom the jury had seen interrogated in court was not qualified to determine that Actos had caused plaintiff Jack  Cooper’s bladder cancer.

On May 1, Judge Kenneth Freeman overturned $6.5 million dollar jury verdict (entered on April 26) for plaintiff Jack Cooper in Cooper vs. Takeda  (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles). Freeman granted two key Takeda’s motions which lead to his reversal.

Freeman granted Takeda’s motion to exclude the opinions of Dr. Norm Smith, the plaintiff’s causation expert who had hypothesized that Actos was a substantial causal factor in Mr. Cooper’s bladder cancer.  Granting that motion meant that no opinion supported the cancer causation finding; so the judge then granted Takeda’s motion for non suit, which threw out the verdict.

Judge Freeman dismissed Dr. Smith’s work thusly:

“[I]t is evident to the Court that the matter in which Dr. Smith conducted his differential diagnosis is based on speculation, is not reliable, not done with intellectual rigor expected of an expert, and is therefore inadmissible under prevailing California law.”

Absent Dr. Smith’s opinion that Actos specifically caused Mr. Cooper’s bladder cancer, there was no other evidence, according to Judge Freeman, to support the jury’s verdict against Takeda; therefore Freeman granted a non suit.

Mr. Cooper’s lawyers will appeal Freeman’s decision to an appellate court. One can only wonder how Judge Freeman could dismiss the jury verdict on an apparent technicality.  The jury had six weeks to look at all the evidence, to hear the qualifications and the testimony of Dr. Norm Smith, and to hear him cross examined for hours by Takeda defense lawyers. The jury also heard all the testimony of all the experts hired by Takeda. The jury then decided, and then Judge Freeman decided the jury couldn’t be entrusted to do the job they were chosen to do. What’s the point of having a jury trial at all if the jury’s decision can be so easily dismissed by a judge?

What is this whole decision if not complete contempt for the entire jury system? If you want to ask what’s wrong in this country, you might start by asking why it’s ok for a judge to categorically dismiss the work of an impaneled jury who have heard six weeks of testimony from both sides.

Actos Verdict: $6.5 Million

Actos Verdict: $6.5 Million

First Actos Trial

A Los Angeles jury on April 26, 2013 found Takeda liable for injuries that included bladder cancer suffered by a former Pacific Bell telephone cable splicer, Jack Cooper. The jury returned a verdict of $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).

Jury deliberations lasted eight days following testimony before Judge Kenneth Freeman in Los Angeles Superior Court. The jury found defendants’ failed to provide adequate warnings about Actos’  dangers, and that Takeda’s Actos was a substantial factor in Mr. Cooper’s injuries.  The jury also awarded $1.5 million for loss of consortium.  Cooper was diagnosed with bladder cancer in November 2011 after taking Actos for diabetes for more than two years.

Evidence in the nearly two-month trial revealed in-house emails in which Takeda executives urged colleagues to persuade the U.S. FDA not to demand increased bladder cancer warnings on Actos’ label.

In one email, Takeda executive Kiyoshi Kitzaawa wrote: “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”

Actos’ sales peaked in 2011 at 4.5 billion, which was then about 27% of Takeda’s revenue, according to data gathered by Bloomberg news. Takeda today faces more than 3,000 suits alleging Actos causes bladder cancer or other ailments. Other cases wait in state court in Illinois. More than 1,200 suits have been consolidated before a federal judge in Louisiana. According to court filings, the first federal case is set for trial in January.

See the full Bloomberg article: Takeda Denies Actos Bladder-Cancer Link at First Trial

In August 2011, a report by eHealthMe based on FDA reports and the user community stated that 50 (0.22%) of 22,512 people reporting Actos side effects,  had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients. It found that one-fifth of patients reporting bladder cancer were taking Actos.

Dose-Related Dangers

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer compared with never taking Actos.

A French Medicines Agency study found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

Supreme Court’s Generic Drug Injustice

Supreme Court’s Generic Drug Injustice

ABC News with Diane Sawyer on Tuesday finally gave badly overdue mainstream media airtime to the tremendous injustice the Supreme Court has done to victims of generic drugs. More than 80 percent of prescription drugs consumed in the country are generic, so the overwhelming majority of drug-induced injuries result from generic drugs. Nevertheless, the Supreme Court ruled 5-4 in 2011 (Pliva v. Mensing) that victims of generic drugs were not entitled to compensation from the company that made the drug which hurt them. The court essentially ruled that multiple-billion-dollar Generic companies were helpless but to reap enormous profits while simultaneously carrying no responsibility for their products.

No corporation in the world can be allowed to reap profits from the blood of the very people who trust and use their product without being simultaneously responsible for the content of the product they make. Adding insult to injury, many generic companies aren’t even American-based, and their profits leave our country. A government which fails to protect its own people from multi-national corporations is practicing taxation without representation. If the so-called Tea Party stood for what its namesake implies, and hadn’t been co-opted by the Koch brothers and other corporate giants, it might take note. This shouldn’t be a partisan issue, though the five Republican-appointed members of the highest court all voted to protect multiple-national drug makers at the expense of the people who fund the FDA and pay for the drugs which often cause more problems than they solve.

The system isn’t perfect and nobody can reasonably expect that it should be; but Tort law was in place to protect people from corporations for 100 years until the court turned common sense and natural law on its head with Mensing.

We pray the extreme five will reconsider Mensing as it debates Bartlett. We pray the court comes to its senses and realizes its Mensing decision was a catastrophic miscarriage of justice.