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.