medication adverse events Archives

SCOTUS Decision on Medication Safety: No Product Liability

Published on January 18, 2016

20979 views

Over two years ago, amidst the DOMA and Voting Rights cases, the Supreme Court of the United States (SCOTUS) quietly ruled in favor of pharmaceutical companies indicating that generic drug makers have no legal obligation to update labeling and warn patients of nasty side-effects should those reactions occur post FDA approval. The case, Mutual Pharmaceutical Co. v Bartlett is a decision that will affect medication safety, healthcare responsibility and states rights for years to come, but few in the media bothered to cover the ruling.

Background of the Case: Mutual Pharmaceutical Co. v Bartlett

In 2004 Karen Bartlett was prescribed a topical NSAID pain-reliever called Sulindac for her shoulder pain. Sulindac is generic version of Merck’s Clinoril that is manufactured by Mutual Pharmaceutical. Shortly thereafter she developed toxic epidermal necrolysis (TEN) – a severe, life threatening and debilitating adverse reaction to the drug. Sulindac caused her skin to peel away from her body, a gruesome, flesh-eating reaction that spread over most of her body.

According to documents discovered later, the drug makers, Merck originally and Mutual for the generic version, knew about the potential for TEN but failed to label it. (Merck has since changed their labeling). Ms. Bartlett sued Mutual under New Hampshire’s design-defect law and was awarded $21 million. Mutual appealed under the auspices that they were not responsible for labeling because that rested with the federal government and the FDA. Since the FDA had not, in its original approval of the drug included the warning, the generic company could not change the labeling without violating federal law. Moreover, even though not labeling the drug violated New Hampshire state law, under which the case was originally brought, state law was in conflict with federal law.

Ms. Bartlett’s case before SCOTUS rested on the fact that Mutual knew about the ‘defect’ and failed to warn consumers. In state court she won. But in the appeal, Mutual contended that even though they knew about the dangers of the drug, as a maker of generic drugs, which are essentially copies of the name-brand drugs, they were not only not responsible for the labeling, Merck and FDA were, Mutual could not change the labeling under federal law. The state’s remedy, and upon which much of the SCOTUS case rested, was to not permit the sale of the ‘defective’ product – the drug – in New Hampshire. In other words, to abide by state law, Mutual should not have sold and not be allowed to sell the product in New Hampshire. SCOTUS again disagreed, effectively forcing the sale of ‘defective’ products’ in states.

There was no question that the drug was responsible for Ms. Bartlett’s injuries, but the since the case rested on the eminence of federal versus state law and the work-around proposed by the state, there was ample precedence for SCOTUS to overturn the lower court’s ruling and they did so, 5-4, mostly along party lines.

SCOTUS documents:

We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels.

In an opinion written by Justice Alito:

Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981) .

The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.

Why This Matters

SCOTUS ruled that manufacturers of generic drugs have no safety or labeling obligations beyond what was expressly given by the brand name company and the FDA approval. If the FDA approved a particular label and adverse events appear later, even when associated with the generic drug, the manufacturer of the generic drug is not liable. The makers of the brand name drug are still liable, but only for their brand name drugs. When an individual is given the generic version rather than the brand name version, even if those two compounds are exactly the same, the individual cannot sue the generic manufacturer per this new ruling, nor can he/she sue the brand name manufacturer, because the adverse event occurred with the generic and the brand name company is not responsible for the generic.

Since the majority of all prescriptions are for generic medications, this ruling effectively absolves drug manufacturers of responsibility for adverse events, once FDA approved. What’s more, where states could have stepped in and prevented the sale of defective products within their boundaries, this ruling preempts that protection as well. If the federal agencies say it is safe, the states can do nothing. For a conservative court, this is a pretty big usurping of states rights.

Can we sue the FDA for failing to protect consumers?

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

A Suicide Note

by Chandler Marrs, PhD

Published on January 7, 2016

3232 views

Someone I know tried to kill herself this morning. Thankfully, she hasn’t succeeded, yet, but we are not out of the woods. Her suffering, like so many of the women I work with is immense. She lost her daughter to a medication adverse event, a medication that was common and promoted as entirely safe, even necessary. It isn’t.

The pain of losing a child is unimaginable, but when it is compounded by the institutionalized medical malfeasance that plagues women’s healthcare, and more and more, general medicine, the loss is unbearable. How does one continue on knowing that the medication that killed your child is prescribed to millions of others, causing ‘rare’ adverse events, some of them deadly, many of them serious and chronic, in tens of thousands of young girls and women annually? How does one continue on knowing that other families will suffer just as immensely as you and yours are suffering now? How does one continue on knowing that your child’s death was entirely preventable?

As a mom, I do not know the answers to these questions. As a mom, to begin to contemplate the death of one of my children by any means puts a pit in my stomach so deep I want to vomit; but to contemplate a death by medication reaction, especially one that is so frequently forced upon women with such callous disregard for its effects, that must be a special kind of hell.

Few, except those who experience these events understand this hell. There are no support groups for these families. There is little cultural or national understanding of these deaths. There is very little recognition that these deaths occur, they are ‘rare’ after all, let alone that they are connected to a certain pharmaceutical. Indeed, if your family member is unfortunate enough to die from certain classes of medications or vaccines, those that are particularly entrenched in medical ideology, it is more likely that the product manufacturers, the physicians, and everyone involved, will attack the credibility of such an assertion and the person making it, than take any responsibility whatsoever – a more sinister version of the all-in-your-head gaslighting that modern medicine is so fond of evoking.

Who among us would survive such tragedy?

My friend has. Despite the hell of losing her daughter, she swore to not let her daughter’s death be in vain. Over the years, I have no doubt that her efforts have saved many lives. She is a force to be reckoned with, corralling researchers, advocates, families and survivors, all focused on bringing attention and much needed research to the dangers of this class of medications. What she has accomplished is nothing short of remarkable and we are just beginning. Five years from now there will be a sea change, a paradigm shift; one that she brought to bear. Only, I know she doesn’t see it this way. She doesn’t see how integral she is to these efforts. She doesn’t see how deeply her spirit affects those of us fortunate enough to be around her. She doesn’t recognize her strength. She is weary. And for that reason I am worried.

If you read this my friend, please let us help you.

Postscript: It gives us great sadness to report that our friend is no longer with us. We were too late. Our hearts go out to her family and everyone that was touched by the kindness of her spirit.

You will be missed my friend.

Image by 1857643 from Pixabay.

Insurance Liability and Medical Adverse Events

by Patti Ireland

Published on September 23, 2015

2458 views

In reading a blog the other day, I was reminded how little many people understand about their health insurance (or any insurance), particularly how personal insurance works when injuries or damages are caused by a person or company with legal responsibility for those injuries or damages. Insurance is a subject that for most of us, causes great pain and consternation; we don’t get it, our eyes roll back in our heads and our brains go into explode mode if we have to read an insurance contract. More often than not, we just rely on the agent or claims person to explain to us. (I understand that- because that is how I felt before I actually went to work in the insurance industry.)

Who Pays What and When

Most of us think that if we get sick or injured, we go to the doctor or hospital, pay our co-pay or deductible, and are good to go. For your average illness, or accidental injury, that is the case. However, in certain circumstances, this does not hold true. For example, if you are injured as a result of your job, you may be covered under Workman’s Compensation, and your health insurance is not responsible for your medical care and bills. Or, if you are in an auto accident and if you did not cause the accident, then the auto insurance of the person who caused it is responsible for your medical expenses. Your health insurance is only responsible for any cost above the amount of the limits that driver’s insurance policy, and/or any amount that is paid under your own uninsured/underinsured motorist coverage on your own auto policy, if you have one.

Medical Adverse Events or Injury Claims

In the case of injury/damage from a medical device or a negligent physician, your personal health insurance is not responsible for the cost of your medical care that results from that damage. And that is the issue I’d like to discuss today- the medical/negligence issues. If you suffer from injuries that are the result of a faulty device, a reaction to a medication, a negligent doctor, etc., your insurance company will generally initially cover your bills, but if you go to court, and it is determined that another person or manufacturer are actually at fault in causing your injuries, and therefore legally responsible for what happened to you, then your health insurance policy is not responsible for any of your care that is a result.

So, how does it work? In most cases, the actual cause of the injury/damage is not known at the time you begin to seek medical treatment, and your insurance is covering those expenses. But once it has been determined in court that there is a party that is legally responsible for the injuries, then your health insurance company is not held responsible. Even though they did pay at first, the party that has been found responsible, whether a company or an individual, is now responsible for all of the medical costs associated with the cause of the injury/damage. As a result, the insurance company must be reimbursed for the payments they made on your behalf.

This is covered under the law by what is called “Double Indemnity”. This means that one cannot be recompensed twice for the same loss. So, for example, in a car accident, if you are not at fault, you can’t get payment of the cost to replace your car from both your insurance company and the insurance company of the other party. You can’t have the same medical bill paid by both your insurance and the other party’s insurance. You can’t purchase 2 insurance policies to cover the same item, or risk (such as health insurance). And in the case of product liability or negligence, you cannot be paid twice for the cost of your medical care. When settlement is paid, it includes the cost of the medical care. If you were the one who originally paid the full amount for the medical care, you keep the money.

If your insurance company paid for the medical care. You must pay them back.

Now in settling these cases, there may be multiple types of payment ordered to the injured party, which can include medical expenses, lost wages, cost of any home health or general care required as a result of the injury, and there can also be additional payments for pain and suffering, loss of companionship suffered by one’s spouse, loss of care to one’s children, etc. On top of that, depending on the individual case, there may be punitive damages that the party responsible must pay. (This is most frequent in a case against a corporation found to have been willfully negligent).

Usually, you will receive a check from the company/individual for the full amount of the settlement, and you are then responsible for reimbursing the insurance company from the settlement amount you received. In a few cases, the court may direct the responsible party to make payment directly to the insurance company for the portion of the award that covers those expenses, with the rest to the injured party, but most often, the injured party receives the entire sum and must reimburse the insurance companies themselves. Here is where it sometimes gets confusing for the injured party.

Class Actions are Different

Now, a caveat is in order here. The above describes what will generally happen in the case of an individual personal lawsuit. Levels of responsibility and damages awarded will vary in individual cases, but will generally address the actual expenses of the individual plaintiff, and settlements are awarded on that basis. There is, however, another type of case that many victims of medical malfeasance may become involved in, and that is the “Class Action Lawsuit”. Unfortunately, in a class action lawsuit, the amount of the award that goes to any individual plaintiff may not cover all of the individual’s medical expenses. In a class action suit, each individual agrees to accept a specific percentage of the aggregate award, after attorney’s fees are deducted from the award, regardless of their individual expenses.

An individual plaintiff’s award may not be enough to cover either real expenses or pain and suffering, yet due to the finding of liability on the part of the third party, the plaintiff may still be held responsible for reimbursement of the insurance company.

This is actually a subject for a more in-depth article in the future, but in the mean time, you should know that participating in class action suit may not yield a financial award sufficient to cover your medical expenses.

How Insurance Rates Are Determined

I would just like to add a note regarding the determination of the cost of individual health insurance policies and how rates are determined. (This actually applies to all catastrophic insurance policies as well, including auto and homeowner liability). Rates are set based on projections of how much an insurance company can be expected to pay for casualty losses of ALL their customers in a given time frame, and for losses that are not the result of negligence or intent by a third party. This is because of the liability laws that can hold a third party financially responsible for damage to another that is the result of negligence or malice. If the insurance companies were required to pay for losses to their customers that were caused by a third party, either intentionally or due to negligence, then rates would have to be factored to include those costs as well, and costs would skyrocket to the customer.

What This Means For You and Yours

The cause of illness or injury may not always be clear when it first occurs. And of course, the initial action taken should be to consult your physician, or in the case of emergency get to a hospital. Your personal health insurance will generally be the first source of payment. Should it turn out to be the potential liability of a third party, whether a person or a company, when consulting an attorney regarding a lawsuit, it is important to discuss with them the specific details regarding what sort of judgment is expected. Some basic questions to consider may include the following: Can you expect that all of your actual expenses (medical losses, loss of wages, any home health or household assistance, loss of future income if one is long-term or permanently disabled, etc.) will be covered? Can you ask for punitive damages? How will attorney fees and other legal fees be charged (Can the defendant be expected to pay, or will they deducted from your award)? This can help prevent surprises, and unexpected costs once the case is settled.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

Image by LEANDRO AGUILAR from Pixabay.

Lucine Research Featured in International Innovation

by Chandler Marrs, PhD

Published on June 15, 2015

2084 views

Lucine Health Sciences, the parent company of Hormones Matter^TM and Heal with Friends^TM, was featured in a recent piece on women’s health, in International Innovation. Entitled Data, Decisions and Discovery, the article is a first in a series of articles that will highlight our unique approach to research. From the article:

Medical science was, and still is to some degree, predicated upon physicians and researchers having a controlling view of patient health. Among scientists, there is a tendency to favour pristine and highly controlled experiments that address just one variable at a time. Yet while this may result in neat, publishable studies, it fails to take into account the complexities of life and human physiology. “When you isolate one variable at a time, you may obtain some interesting insights into the operation of that variable – but this does not address the complexity of the systems in human health and disease,” Marrs elucidates. “Science will only move forwards if we successfully capture the messiness of multiple variables and understand how they interact with each other within the context of health and disease.”
For modern research to be effective, it must take into account the patient’s knowledge about his or her health and move beyond the paradigm that equates health with simple linear equations. By putting the patient at the centre of the research equation and considering multiple variables, Lucine Health Sciences is well-placed to explore the efficacy of medications, as well as their potential side effects.

To read the full article: Data, Decisions and Discovery.

About Lucine Health Sciences

Lucine Health Sciences is a social-benefit company committed to improving healthcare by providing critical and credible health information to consumers, physicians and industry. We leverage the broad social media reach generated by Hormones Matter^TM to conduct large-scale and much needed research in the field of women’s health. Studies address the side effects associated with common medications, vaccines and surgical procedures used in women’s healthcare. Contract research services are available.

Crowdsourced Women’s Health Research

by Chandler Marrs, PhD

Published on March 12, 2013

20839 views

A dirty little secret in the world of women’s health – there are relatively few data guiding medical decision-making. Indeed, across all medical specialties the auspices of evidence-based are crumbling quickly in the face of open access and open science. Recent reports suggest less than 50% of all medical treatments have any data to support their efficacy. Of that evidence, much could be suspect given the rampant payments from pharmaceutical and device companies to physicians and other decision-makers, plus the well-documented publishing bias and even fraud plaguing the scientific publishing industry.

In women’s health, matters are even worse. Not only are evidenced-based, clinical practice guidelines nearly non-existent in Ob/Gyn (only 30% of practice guidelines based on data) and women still not included in early stage clinical trials in sufficient numbers, but regulatory agencies do not mandate gender analytics for new medications. The result, post market adverse events – think death and disabling injury – are more common in women than men.

Why do women die and suffer from adverse events at a much higher rate than men? Because most medications reach the market without having ever done the appropriate testing or analytics to distinguish why women might respond to said medications differently than men. Even in the lab, male rodents are used about 90% of the time.

What about medications developed specifically for women? These too are poorly understood, mostly because the outcome variables are not focused on the totality of women’s health. For example, it is important that oral contraceptives prevent pregnancy, but it is equally important that they don’t cause blood clots, stroke, heart attack or cancer. And if blood clots, stroke, heart attack or cancer are deemed acceptable risks for birth control (and I don’t think they are), then shouldn’t we know which pills are the most dangerous and which women are most at risk?

One cannot manage, what one does not measure and we don’t measure critical components of women’s health. We also don’t track adverse events or side-effects very well. Question: have you ever reported a side-effect to a doctor? Do you know if he/she reported it to the FDA, the CDC or any other adverse events registry? Probably not, and that is the problem.

If you knew you had a 20 times higher risk of stroke or heart attack for one medication versus another, would you choose differently? I bet you would, but as medical consumers, we don’t have that information. In many cases, those data don’t exist.

That’s where crowdsourced research comes in. At Lucine, the parent company of Hormones Matter, we think the lack of data in women’s healthcare is unacceptable. We know that the larger companies who sell these products have no motivation to gather or make public these type of data – too many billions of dollars are at stake – and so, it is up to us, the women who need safe health products, to be the change agents.

The simple act of completing surveys on critical topics in women’s health can and will save lives. Your data will tell a story. Add that to the data from hundreds, and hopefully thousands of other women, from all over the world and from all walks of life and we will be able to determine which medications, devices or therapies work, which ones don’t. We can give women the information needed to make informed medical decisions.

We are currently running four women’s health surveys, but plan on running many more. So check back regularly. If you qualify for any or all, take a few minutes and add your data. If you don’t qualify for these, share these surveys with your friends and family through social media. The more data we can gather, the more clear our medication choices will become.

Health Surveys for Real Women

Oral Contraceptives Survey

Oral contraceptives (birth control pills) are used by 98% of the female population at some point in their lives. They are prescribed for a myriad of reasons unrelated to pregnancy prevention. Sometimes they work; sometimes they don’t. Wouldn’t it be nice if we knew which brands of birth control pills worked for which conditions? Better yet, wouldn’t it great if we could avoid the pills that didn’t work, made a particular condition worse or had a higher than average side-effect profile? Take this survey if you have ever used oral contraceptives. Help determine which birth control pills are safest and have the fewest side-effects. You may save another woman’s life and health.

The Hysterectomy Survey

By the age of 60 one in three women will have had a hysterectomy. Hysterectomy is one of the most common surgical procedures for a range of women’s health conditions. For some conditions, hysterectomy works wonders. While, for other conditions it is only nominally successful. The purpose of the hysterectomy survey is to learn more about why hysterectomy works for some women’s health conditions and not others. We’d also like to learn more about the long term health affects of hysterectomy – does a woman who has had a hysterectomy have a higher or lower risk of other health conditions? Take this survey and help improve women’s health.

The Gardasil Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for, and nature of, adverse events associated with each of the HPV vaccines, Gardasil and Cervarix. Take this survey and help improve women’s health options.

The Lupron Side Effects Survey

Leuprolide, more commonly known as Lupron, is the GnRH agonist prescribed for endometriosis, uterine fibroids or cysts, undiagnosed pelvic pain, precocious puberty, during infertility treatments, and to treat some cancers. It induces a menopause like state stopping menstruation and ovulation. It’s widespread use for pain-related female reproductive disorders such as endometriosis or fibroids is not well supported with very few studies indicating its efficacy in either reducing pain or diagnosing endometriosis or other pelvic pain conditions. Conversely, reports of safety issues are mounting, especially within the patient communities. The Lupron Side Effects Survey was designed to determine the range, rate and severity of side-effects and adverse events associated with Lupron use in women.

All surveys are anonymous and participation is voluntary. More information about individual surveys can be found: Oral Contraceptives Survey, The Hysterectomy Survey, The Gardasil Cervarix HPV Vaccine Survey.

Visit our Take a Health Survey page for new surveys and updates or better yet, sign up to receive our weekly newsletter for all the latest research and hot topics pertaining to women’s health.

Over-Prescribing Antibiotics

by Elena Perez

Published on September 21, 2012

2218 views

As the school year begins and cold and flu season approach, it is important to remember that antibiotics do not work for cold and flu or other viral infections. New research shows that our over-reliance on antibiotics is linked to a marked increase in the number of serious, long-term side effects experienced by patients and deadly infections that are resistant to most, and sometimes all, antibiotics.

Antibiotics are used to treat bacterial infections, but the excessive use and misuse of antibiotics, particularly fluoroquinolones (Cipro, Levaquin, Avelox), is linked to serious side effects, such as retinal detachment and acute kidney failure, according to a recent report published in the Journal of the American Medical Association. The fluoroqinolones are also associated with tendon rupture, prompting the FDA to issue black box warnings and spawning thousands of lawsuits.

Researchers speculate that because doctors are eager to provide a solution and patients expect prescription medications for most illnesses, antibiotics are often prescribed when they are not needed or are misprescribed- a newer, more potent antibiotic is selected when an older, safer antibiotic would suffice.

Over the last two years, the number of reported adverse events for a certain class of antibiotics-the fluoroquinolones has increased drastically. The adverse events for Levaquin, a potent antibiotic, meant for the most serious and often life-threatening bacterial infections, has increased significantly along with its increase in use. A steadier increase in reported adverse events can be seen for ciprofloxacin (Cipro), another fluoroquinolone, on AdverseEvents.com, suggesting an increase in the use of Cipro since 2008.

In addition to having a negative impact on the patient’s health, the overuse of antibiotics is thought to be responsible for bacterial strains that have become resistant to many antibiotics. Methicillin-Resistant Staphylococcus Aureus, or MRSA, is one strain of staph bacteria that has become resistant to the antibiotics commonly used to treat it.

MRSA infections are becoming more frequent in hospitals, nursing homes, prisons and even in school locker rooms where large groups of people reside or congregate and individuals with weakened immune systems are present. Just one look at MRSA makes the risks of antibiotic over-use apparent. Here’s another picture.

Next time you have the cold or flu, remember antibiotics don’t work on viral infections. If you do have a bacterial infection, work with your physician to find the most effective antibiotic or treatment. There may be alternative options. The point is, before you request antibiotics for the cold or flu or other conditions, ask if there are alternatives, ask if the medication is linked to any adverse effects and if there are other safer antibiotics than the one being prescribed.

Read more about the adverse effects tied to fluoroquinolones at the New York Times.

medication adverse events

Background of the Case: Mutual Pharmaceutical Co. v Bartlett

SCOTUS documents:

Why This Matters

We Need Your Help

Related posts:

You might be interested in

Related posts:

You might be interested in

Who Pays What and When

Medical Adverse Events or Injury Claims

Class Actions are Different

How Insurance Rates Are Determined

What This Means For You and Yours

We Need Your Help

Related posts:

You might be interested in

About Lucine Health Sciences

Related posts:

You might be interested in

Health Surveys for Real Women

Related posts:

You might be interested in

Related posts:

You might be interested in