Did Motrin Blind A Little Girl? A Court Battle Begins
22 CommentsBy Ed Silverman // June 18th, 2008 // 11:22 am
A California couple is suing Johnson & Johnson for allegedly hiding serious adverse events from the FDA when it sought to market the widely used pain reliever, which contains ibuprofen, as an over-the-counter salve for children, a Fox News TV station in Los Angeles reports. The trial began yesterday in Malibu.
A J&J attorney countered there is no way to prove Motrin caused the very rare allergic reaction, known as Stevens-Johnson Syndrome. “You have heard them suggest that Johnson & Johnson placed money over children,” defense lawyer Christy Jones told jurors, according to Fox. “But that, ladies and gentlemen, is not what happened.”
Sabrina Johnson was 6 years old in 2003 when her parents gave her three doses of Motrin to fight a mild fever. Her parents, both engineers with doctorates, wouldn’t have given her more Motrin if the drug had warnings that, in rare circumstances, life-threatening allergies can develop, their lawyer told the court. He also contended reports of blindings and deaths linked to ibuprofen weren’t investigated.
“The FDA is only as good as the information they got, and the drug companies are responsible for giving them that information,” Dan Balaban, the family lawyer, told the jury, adding that J&J was forced to change its label slightly in 2005 when a group of doctors noticed a pattern of disease linked to ibuprofen and successfully prodded the FDA to order it, Fox reports.
A J&J lawyer argued that Stevens-Johnson Syndrome can be caused by dozens of drugs, and there is no proof that J&J’s ibuprofen harmed the girl. “The proof is, ladies and gentlemen, that the FDA was aware of the very- rare reports of people getting Stevens-Johnson Syndrome, and the FDA continued to approve its use as safe and effective for children, and continues to approve it today,” Jones said.
Jones added that, with the number of cases linked to ibuprofen, when compared to the 6 billion doses consumed yearly around the world, “you cannot say if a drug caused this as opposed to the background rate - a certain number of people are going to have it regardless of what drug they took,”
Fox reports.
Justice in MI
As described here, this does not seem a strong case. Beyond the issue of causality, hypersensitivity reactions are certainly listed on every bottle of ibu I’ve ever seen, and SJS is a horrific such reaction. I assume there are similar warnings on the pediatric Motrin salve.
But if you read the story Ed links, the claims are stronger than may be apparent - quoting the aricle, the claim that the company “‘purposefully and callously’ hid medical reports about the dangers of ibuprofen from federal regulators.”
If there is any credible evidence of that - and I certainly have no idea - it becomes a different ballgame.
CMC guy
JIM please point out these accustions were spoken by the lawyer (…an attorney told a Malibu jury Tuesday to open trial of a product-liability lawsuit) and thus may be weaker than apparent.
HorusCat
Stevens-Johnson occurs with many, many meds…on a very rare basis. And it does occurr spontaneously–a friend of mine had it as an infant and barely survived.
OTC pain/fever reducers have all sorts of warnings with them–what would have made her parents take a rash warning seriously?
Justice in MI
CMC Guy - Absolutely. They may have no foundation whatsoever, whoever said them. The only proviso would be to get to the trial stage means that at least some discovery process had taken place. So, at least in the relevant judge’s mind, there is enough reason to proceed.
HC - I think you said what I did above. In any event, the issue (as I’d understand it) is whether there was more specific and relevant data that was, in signicant ways, suppressed. But you are right - even if there was a more specific something like, “In a small number of children, SJS, a [description], has occurred,” it is hard to imagine they would have both noticed and held back from using the product as a result.
HorusCat
JiM,
Maybe all medications, OTC or Rx, should have a big, bold warning: If you take this drug, bad things can happen. Anaphylaxis alone, which can happen with any chemical, would be sufficient to merit the warning.
I’m with you on fraud and suppression of data, but absent that, people just have to accept that s*** happens.
Lana Keeton
I sued Johnson & Johnson myself. They nearly killed me. They defrauded the FDA. They perjure themselves in court. They will do anything to suppress evidence. They were ordered by the court to provide quality control reports for sterizilation to me. They kept producing everything but that.
READ THE FOLLOWING FROM ETHISPHERE MAGAZINE, AN ONLINE PUBLICATION…J&J will harm anyone and They Don’t Care!
The Ethics Crisis at Johnson & Johnson
An in-depth look uncovers astonishing evidence that all is not well at a long-revered icon. How bad is the diagnosis—and could some tough medicine help?
Imagine:
ADMITTING PUBLICLY you have made “improper payments” in violation of the Foreign Corrupt Practices Act.
BEING SUED by the former head of your clinical trials in a whistleblowing lawsuit that alleges he was terminated because he raised safety concerns over
deaths and injuries caused by your products.
BEING FORCED to divulge internal emails over a less-than-forthright Internet-based marketing campaign undertaken to try to blunt negative talk about your products.
BEING ORDERED by a jury to pay $5 million in damages for the death of a one-year-old due to inadequate safety labeling on one of your most popular products.
FACING A CLASS ACTION LAWSUIT in Canada for negligent testing and marketing of your heartburn product which resulted in the death of a 15-year-old girl, among others.
BEING SUED by the Attorney General of Texas for fraudulent dealing and improperly influencing a state employee to purchase more than $100 million of your product.
HAVING A LABORATORY REPORT COME OUT that reportedly uncovers a relatively high amount of undisclosed carcinogenic chemicals in your company’s flagship products: baby and kids’ body washes and shampoo.
Talk about a stunning surprise. For many years, the New Brunswick, NJ-headquartered Johnson & Johnson, or J & J (NYSE: JNJ) has been a poster child for an ethically-managed company— “Exhibit A” in the argument that businesses can do well by doing good.
However, a pattern of developments seem to suggest that halo is no longer deserved.
Granted, the pharmaceutical and drug industry is an area where litigation is rampant. People get sick. Treatments emerge and are effective for many, but some people will die or become further injured. And some of those people will think that it is your product’s fault. They may sue. They may win. But is that an indictment of a business’s ethics?
In most instances, no.
But J & J is emerging as a for-instance where the range and diversity of cases is so severe that perhaps it is not a series of isolated incidents, but rather more a pattern that strongly suggests the business is in the throes of a compliance and ethics crisis.
Each case has been reported in the press as it happened. What no one has done, until now, is assemble all the many pieces into one package—and that is where the story about today’s J & J becomes quite disturbing.
Flashback a quarter-century to the event that sealed J & J’s reputation as one of the good guys. A deranged individual in the Chicago area had tampered with Extra Strength Tylenol capsules by filling them with cyanide and replacing them on store shelves. Seven people died.
Without knowing the scope or source of the problem, the company immediately launched a nationwide recall. Ultimately the company’s manufacturing quality control was exonerated and—because it stuck to a policy of full and honest disclosure throughout the Tylenol scare and it took quick actions to safeguard the public’s health, no matter the cost—J & J emerged from this crisis with a strong reputation and with the Tylenol brand intact.
Much can happen in 25 years.
More recently, has J & J been putting short-term profits ahead of patient safety? Ironically, that is the exact reverse of the famous Johnson & Johnson credo, which starts out, “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.” Shareholders are last in line, assuming that if you take care of everything else the profits will follow (http://www.jnj.com/our_company/our_credo/index.htm).
TEXAS-SIZED LAWSUIT
J & J is not accused of more peccadilloes. One of the hardest slaps came in December 2006, when the State of Texas decided to join a whistleblowing lawsuit filed against the company in 2004. The case revolves around Risperdal, an antipsychotic sold at very high prices (up to $190.49 for a 30-day supply, according to Drugstore.com). Bloomberg News reports that drugs like Risperdal account for more than 90 percent of a $10.5 billion a year market for anti-psychotics, with most of the tab picked up by taxpayers.
A high price alone is not a problem. The sticking point is that according to the Texas suit, J & J improperly influenced the adoption of Risperdal by paying off state officials. Case in point: Dr. Stephen Shon, the former medical director of behavioral health at the Texas Department of State Health Services and original architect of the TMAP initiative prescribing guidelines that encouraged sales of Risperdal. Shon was forced out of his job amidst allegations that he had served as what amounts to a paid mouthpiece for J & J, making nearly 100 paid trips around the country to jawbone officials in other states on behalf of Rispersal.
And then there is TMAP itself. Short for the Texas Medication Algorithm Project, TMAP was a 1995-1997 project offering a series of flowcharts to help doctors determine which psychotropic medication to prescribe for individual patients. The TMAP flowcharts often result in a recommendation to specifically prescribe Risperdal.
Developing TMAP cost the State of Texas $5.6 million. However, a third of the cost ($1.8 million) was offset by a grant from the Robert Wood Johnson Foundation, the nation’s largest health-oriented foundation whose assets are mainly invested in J & J stock. Coincidence?
In 2004, Allen Jones, a former investigator for the state of Pennsylvania filed the original whistleblowing suit, alleging that the company improperly influenced the development of TMAP to promote sales of Risperdal by manipulating data during the algorithm design stage so that Risperdal would appear more effective and safer than it really was.
“We believe Texas has been defrauded, and we’re going to be looking to get our money back” says the state’s Attorney General, Greg Abbott. Over the past three years, Texas alone has purchased nearly $200 million of Risperdal. Analysts estimate that penalties, fines or settlements over this case across a series of states could potentially run into the billions of dollars.
PUBLIC ADMISSION OF BRIBERY
On February 12, 2007, Johnson & Johnson admitted that improper bribery payments had been made in violation of the Foreign Corrupt Practices Act (FCPA).
In its statement, J & J admitted that certain subsidiaries “are believed to have made improper payments in connection with the sale of medical devices in two small-market countries.”
This may be a bigger problem for J & J than it initially appears. As Morgan Stanley analyst Glenn Reicin pointed out in a research note for clients, this public disclosure may well have been a preemptive attempt to avoid federal prosecution. That is particularly important to J & J because “a company that is found guilty of a felony can be barred from Medicare programs,” Reicin wrote.
This is just the latest in a series of overseas missteps for J & J in
recent years.
In early 2006, the company received a subpoena from the SEC requesting documents relating to the participation by several subsidiaries in the United Nations Iraq Oil-For-Food Program. In 2005, Portugal’s regulators fined J & J for participating in an illegal cartel in supply bids to 22 different hospitals on 36 occasions. In 2004 J & J Poland was fined over distribution agreements which illegally restricted market competition and prices under Polish law.
CLASS ACTION IN CANADA OVER KIDS AND HEARTBURN
In January of this year, the Ontario Superior Court of Justice in Canada certified a class action lawsuit against J & J over its Gastroesophageal Reflux Disease (GERD) drug, Propulsid. Many people commonly call GERD symptoms “heartburn.”
This was welcome news to Terence Young, whose 15-year-old daughter Vanessa died of a heart arrhythmia after taking the drug in 2000.
“Vanessa would be pleased because the work that I’ve done is to try and save other families from going through what we went through,” Young, a politician based in Ontario, said to the Canadian Press news agency upon hearing that the suit had been certified.
Propulsid was originally introduced in 1993. While initially only approved for treatment of adult nighttime heartburn, Johnson & Johnson decided that there was a large market for the drug in the pediatric market, despite a lack of studies showing effectiveness—or safety— in children.
Yet J & J marketed aggressively to this demographic, as doctors are generally free to prescribe medicines beyond the specific, FDA-approved uses.
In 1998, Propulsid sales topped $1 billion, according to the New York Times, which noted that perhaps 20 percent of babies in neo-natal intensive care were on the drug. The questionable side, as reported by the New York Times, was that “dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid.”
More questionable still were the aggressive marketing efforts—masquerading as “educational efforts” and thus permissible under FDA guidelines, such as footing the bill for a press run of 10,000 textbooks about childhood digestive problems (the book recommended Propulsid) and sponsoring groups that made presentations about treating reflux with Propulsid to nearly 8,000 pediatric doctors and nurses.
J & J even developed a cherry-flavored liquid version of Propulsid, saying it was designed for geriatric patients. Yet documents show that as much as 90 percent of it actually went to children.
Along the way, doubts and worries began to swirl around Propulsid. In 1998, the FDA even made a presentation to the company expressing its growing concerns over reports of death and injuries resulting from the drug. According to the New York Times, that presentation included a slide that read, “Is it acceptable for your nighttime heartburn medicine to have the potential to kill you?”
By this time the FDA scheduled a meeting to discuss its concerns with a panel of outside experts to be held in a public forum. The New York Times also reported that in preparing for the hearing, a senior J & J executive wrote a note, “Do we want to stand in front of the world and admit that we were never able to prove efficacy!” The words “never able” were underlined for emphasis.
Apparently not. Three weeks before the scheduled hearing, Johnson & Johnson pulled the drug off the market in the United States. The hearing was canceled.
In 2004, Johnson & Johnson reached a $90 million agreement in the U.S. to settle federal class action suits that alleged more than 300 people had died and 16,000 were injured due to the use of Propulsid. The Canadian class action is ongoing.
FABLES AND LABELS
Central to J & J has always been its over-the-counter (OTC) health and beauty product lines—but trouble lurks there too. For example, in February of this year the Campaign for Safe Cosmetics (a coalition of U.S.-based health and environmental NGOs) announced that its lab tests found significant amounts of carcinogenic chemicals in a variety of children’s bath products, including Johnson’s Head-to-Toe Baby Wash and Johnson’s Kid’s Shampoo Watermelon Explosion.
Perhaps more worrisome, however, was last September’s $5 million punitive judgment against J & J’s Ortho-McNeil division for the March 2002 death of a one-year-old infant from Tylenol. J & J initially offered the parents $10,000 to settle the case.
The baby’s parents had sued Johnson & Johnson, claiming that the labeling on Infant’s Tylenol did not adequately disclose that the product is three times stronger than Children’s Tylenol. They argued that it is counterintuitive to think that an infant’s formulation would be that much more potent. The child died from acetaminophen toxicity three days after receiving the medicine for cold symptoms.
This case mirrored a lawsuit from over a decade earlier, where a
14-month old girl underwent a liver transplant due to being overdosed with grape-flavored Infants’ Tylenol. At that time, J & J had vowed changing the labels to prevent recurrence.
A search of the Internet uncovers many other desperate and similar parents’ stories with Tylenol.
STUDENT DIES IN MIDTOWN MANHATTAN
Perhaps no problem faced by J & J was potentially more damaging than a death on April 2, 2004.
On that day, Zakiya Kennedy, an 18-year-old who dreamed of being a model, was waiting for a subway on the 42nd Street platform in midtown Manhattan when she fell down. After getting up, she approached a policeman complaining of a headache and leg pains. Within seconds the Berkeley College freshman collapsed
and died. The tabloids of the nation’s largest city were ready to pounce on the story.
At first the story was that she died due to being pushed by her boyfriend— who was quickly vilified. However, the story took a less interesting turn when an autopsy revealed the cause of death was a blood clot, a pulmonary embolism, which is extremely rare in healthy 18 year-olds.
Later it was learned that the teenager had recently started using the Ortho Evra birth control patch manufactured by Ortho-McNeil Pharmaceutical division of J & J. The teenager’s family began to speak out against the company, and soon a confidentially agreement and financial settlement was reached with them. At that point the story largely disappeared from public view.
Yet this death was important as a tip of the proverbial iceberg—with persistent questions beginning to arise about potential misconduct by Johnson & Johnson around the design, launch and marketing of Ortho Evra patches.
As of December 31, 2006 more than 1,500 claimants were pursuing J & J over Ortho Evra. Claimants include a Texas woman paralyzed by a stroke just 12 days after initial use and the families of a 25-year-old mother of two who died of a heart attack after six weeks on the patch; a 14-year-old girl who died from a blood clot in her lower pelvis after just eight weeks; and a 25-year-old mother of three who died from a brain blood clot after two weeks on the patch.
Grave concerns had in fact taken root still earlier. By late November 2005, the FDA had required J & J to change the product labeling to include bold-face language that stated “You will be exposed to about 60% more estrogen if you use Ortho Evra than if you use a typical birth control pill.”
Ortho Evra remains on the market but sales have dipped due to “labeling changes and negative media coverage concerning product safety” according to J & J.
Bolstering the ever-growing series of legal claims against the company is an increasing amount of evidence that the company knew that its product caused problems.
For example, in the 17 months between April 2002 and September 2003, the FDA logged 9,116 adverse reaction reports, according to Online Legal Marketing Ltd. In contrast, the Ortho birth control pill garnered only 1,237 adverse event reports to the FDA even though six times as many women were using the pill. CBS calculated that the risks of a clot are 14 times higher with the patch versus the pill.
Some think that worse is yet to come for the company.
For example, recent studies have conclusively linked estrogen supplements with increased incidence of breast cancer, due to estrogen providing stimuli to cause the cancer to grow more rapidly. In January 2007, researchers at the University of Illinois extended the link further with studies that found that estrogen also shielded cancerous cells in the breast from the body’s immune system.
If future researchers establish a link between Ortho Evra’s high doses of estrogen and increased rates of breast cancer, J & J would be headed into a financial and PR storm. But that’s the future. J & J is dealing with the here and now.
In the Internet age, news travels fast. Recognizing that, J & J designed a comprehensive online marketing campaign allegedly intended to make negative information on Ortho Evra harder to find.
According to internal documents unsealed by a New Jersey Superior Court this spring (over J & J protestations), the company was in the process of buying (or planning to buy) all the top keyword positions for related searches online, as well as intending to create an “unbranded website” seemingly unaffiliated with J & J. With “search engine optimization” strategies, J & J hoped to have this unbranded website show up as second most popular behind the official Ortho Evra site, thereby covertly getting its message out.
J & J also bought approximately 100 dubious URL names such as: deathpatch.com, badevra.com, the Patchkills.com, ThePatchTruth.org; and patchsucks.com.
CHIEF MEDICAL OFFICER BLOWS THE WHISTLE
On other fronts, things are already getting worse for the New Brunswick company. In November 2006, Dr. Joel S. Lippman, a former VP, filed a wrongful termination lawsuit, claiming that he was dismissed for raising safety concerns about various products, including Ortho Evra as well as at least two products that he had urged not to be released, and which were later recalled after causing injuries or deaths.
J & J denied Lippman’s charges, stating that Lippman was fired “as a result of inappropriate conduct and mismanagement of responsibilities unrelated to the allegations he raises in the lawsuit.”
It’s hard to imagine Dr. Lippman, with a Masters Degree in Public Health from Harvard, as a bad apple. During his 15-year career with Johnson & Johnson, he rose to be head of Clinical Trials at the
Ethicon division.
In 2005, his role was Vice President of Worldwide Medical Affairs and Chief Medical Officer at Johnson & Johnson. And in the fall of that year, he was also feted as “supporter of the year” by the New Jersey-based company at its annual ball.
At this writing, Lippman’s case remains active.
DELIVERING TO THE BOTTOM LINE
Whatever problems there may be, shareholders are also bearing the pain.
Over the past five years, J & J aggregate stock performance has been anemic—flat over the five years ended this March.
J & J stock woes, however, are not transposable to the market at large, or even its industry segment. During the period, the S&P is up over 30%. Meanwhile direct competitors such as Sanofi- Aventis, Novartis and Procter & Gamble rang up 49%, 30% and 40% gains respectively over the same period.
BAND-AID OR A TRANSFUSION?
Back to the original question: are the ethics and compliance efforts at Johnson & Johnson ailing? It appears so. But as the turnarounds at companies like Tyco and Boeing have proven, even sick companies can become well if they take harsh medicine.
Some observers feel that J & J has simply pulled back into a shell in the face of criticism. That is the wrong approach. Ethical leadership cannot be delegated to attorneys, but is the job of the entire executive suite.
The J & J brand remains respected around the world. However, it appears increasingly vulnerable and may be beginning to wane. The good news is that with over $11 billion in annual earnings, the company has the resources to do whatever is necessary.
It is going to take a lot more than a Band-Aid to help it get better, and whether or not Johnson & Johnson will be able to stomach a tough prescription remains to be seen.
© Copyright Ethisphere™ 2006, All rights reserved
For more information, please email info@ethisphere.com
Dr. Sal Giorgianni
Quite an interesting situation with this ibuprofen case.
Let’s see now, this product has been out on the market how many decades? It has been used as an Rx product for how long? It has been used under how many brand names and unbranded labels as an OTC for how long? It has been the subject of or an ancillary medication in how many tens-of-thousands of research studies through the world? It has been taken by how many billions of people?
And, let me get this straight now, after all this time, over all these does, with all these studies J&J single handedly was able to deliberately and maliciously hide data?
GIVE ME A BREAK, FOLKS!
This is almost as sad a tail as the lawsuit that created the infamous “HOT BEVERAGE” warning on hot-coffee cups. Yes, stuff happens, but we live in a society that has refined the place-the-blame-game to a sophisticated art form. Unless some general understanding of medical risk takes hold and some modicum of legal sanity is brought into our legal tort system in medical matters, across the board, I am afraid the US public is going to find itself receiving Third World Care at an exponentially inflated price and trial lawyers going on Medical Tourist junkets to get just whatever they want while relaxing.
Sure, this story should be published here and elsewhere, but I would have loved to see the spin something like “Another Ludicrous, Baseless and Malicious Lawsuit Filed.”
HorusCat
Dr. Sal,
Likewise with the Tylenol. Who cares whether it is “intuitive” that an infant’s med would be more concentrated than a child’s version? (And actually, I would argue it is intuitive, since you want to have to get as little as possible down an infant’s throat, better to concentrate it and reduce the quantity.) READ THE LABEL. I read the label every time I give my kids Tylenol or Motrin. EVERY TIME.
Much of that preceding post is inflammatory garbage written so as to present J&J in as bad a light as possible. The only hot news there is Propulsid–and it was part of the rash of drugs that prolong QTc (remember Celdane and Hismanal?) and when used in combination with other QT-prolonging drugs, can lead to cardiac arrhythmia. And given the fantastically high number of doses of that drug that were given, the number of deaths is very, very low.
As for Risperdal–TMAP may have been partially funded by a foundation sort-of connected to Janssen…but the fact is, at the time TMAP was written, Risperdal was the atypical of choice for schizophrenia. Doctors and companies were being sued for prescribing typical antipsychotics that caused tardive dyskinesia (malpractice awards of $1 million, anyone?), so Risperdal offered the same efficacy and better safety than Haldol et al. And it was, and still is, the cheapest branded atypical on the market. I don’t sell it–I used to compete against it.
Unfortunately, savvy plaintiffs’ lawyers know exactly how to extort money from companies–class action suits are great leverage to get a company to settle–far better to settle than to go bankrupt defending yourself. The public views settlements as admitting fault, which they are not. They are simply an admission of smart cost-benefit analysis.
Justice in MI
HC - Aside from Benedectin, which settlements and or civil litigation over the past fifteen years would you name concerning drugs where there was no demonstrable issue which deserved scrutiny?
(Note: I’m not asking whether cases ought to have been decided a particular way, but where judges were wrong to allow the case to proceed at all.)
Lana Keeton
Dr. Sal Giorgianni and Horus Cat and Justice in MI,
THE LABEL ON THE MOTRIN GIVEN TO SABRINA JOHNSON IS THE PROBLEM. IT HAD NO WARNING OF STEVEVS-JOHNSON SYNDROME AND/OR POSSIBLE DEATH.
Selling adult drugs to children is a way to increase sales for Big Pharma. It is a regular practice when they need additional sales and more BILLIONS OF DOLLARS OF PROFIT. They no longer spend money on R&D for new drugs so they milk the profit out of what is already on the market. They spend literally a billion in advertising to launch a new drug…$250 million before it is ever available for sale and in comparison practically nothing on R&D.
So they have to prey on children to keep their profits up because they no longer develop new drugs.
Check out J&J’s 2006 annual report…over $11 billion in profit…BILLION…in 2006 alone. Their share holders are much more important than the health of children.
Motrin was originally approved for use for athritis as a prescription in the 1970’s. It was then approved for pedriatic prescription some years later. Then it was approved for over-the-counter sale to children again some years later.
The warning label on the Motrin given to Sabrina Johnson by her parents was HIGHLY insufficient to them and to any physician they may have called to help them when she developed symptoms.
The labeling was changed in 2005 to include additonal warnings of Stevens-Johnson Syndrome, 2 years after Sabrina Johnson was BLINDED and severely SCARRED by Motrin.
I was in court yesterday afternoon and saw the evidence presented, including the warning label and it’s insufficiencies.
I saw the evidence of how J&J suppressed information to the FDA despite long time knowledge of these severe complications of SJS…back to the 1980’s. No label warnings added until independent studies from France of over 150 children had been harmed by Motrin in the same way.
Sit back and chuckle you guys. You probably work for some pharmaceutical company. Laughing at the disfiguration of a child. You have bought hook, line and sinker all the advertising of J&J.
Even with clear evidence of their complete lack of ethics, you still root for J&J. They are rated as corporate criminals on some websites. They are.
HorusCat
Lana,
No one is chuckling at what happened to a little girl. Nor do any of us sell Motrin–since it is OTC and comes from many manufacturers, one may purchase ibuprofen from dozens of companies.
The label on a bottle of OTC meds isn’t big enough to contain the entire set of side effects possible. Our point is simply that the incidence of a serious AE like SJ is rare–just like the incidence of a gastric bleed from occasional use is rare. We are pointing out that such a warning probably wouldn’t have deterred her parents from using the medication. Hindsight is always 20/20, so of course they say now it would have stopped them. In all likelihood, being told that SJ is a rare side effect (and it is extremely rare, given the number of doses of ibuprofen given to kids and adults daily around the world) would not have stopped her parents from using ibuprofen to bring down her fever.
Furthermore, there was no fraud or cover-up of SJ on the part of any of the manufacturers of ibuprofen. It is a rare AE–and it is only through the rare case of SJ in unfortunate users such as this little girl that the companies who make it even become aware of the need for a warning.
Our point remains valid: you can’t be warned about every single risk about every single product. Since every product carries risk of multiple common side effects and many rare side effects, and since we should all know that using chemicals carries risk, at some point you have to accept the fact that bad things happen. Much as you want someone to blame and castigate as evil and nasty and money-grubbing, that is not the case, at least in this instance.
None of us has a stake in J&J or Motrin. All of us probably use it. We just don’t have the animosity and hostility toward J&J for selling a product that has been used safely by tens of millions of people of all ages tens of millions–hundreds of millions–of times.
Just A Thought
I’d almost agree with those of you who are stating that everything ingested can be dangerous and that a gazillion people safely take these things everyday. What is bothering me is the question of lessor quality ingredients, from here or other countries, in order to save money. It does go on.
I’ve recently done a lot of reading about pharmaceutical grades of lactose, for instance, which can vary in quality and production method. Air fluidization and wet granulation, the porousness of granuals and how medication is delivered into the system. As one example. Lactose is not simply lactose. Magnesium Stearate is not just magnesium stearate if it derived from a different source.
So when a common drug starts producing more instances of their rare AEs, I always wonder what’s been changed. We all should. I’m not saying that is the case here. I’m just saying that we’d be foolish to assume that a drug we took a year ago is guaranteed to be exactly the same as it is today.
Justice in MI
I am certain I haven’t “bought” anything.
Lana writes: “J&J suppressed information to the FDA despite long time knowledge of these severe complications of SJS…back to the 1980’s. No label warnings added until independent studies from France of over 150 children had been harmed by Motrin in the same way.”
If this is true in the significant and relevant ways - that information was willfully suppressed from FDA, that the numbers are such that they can be linked to the drug (as an eventual label change suggests), then it sounds to me like there is, indeed, reason for this trial to go forward.
To assume from the start that it is Greedy Trial Lawyer Extortion, as some posts suggest, is - to me - the same kind of knee-demonizing as those who are “anti-pharma” whatever pharma does.
Dr. Sal Giorgianni
Justice
I am sorry if I have inadvertently engaged in inappropriate generalizations. Yet, there are some disreputable individuals and organzations on all fronts. My point was not to impune all trial lawyers but to suggest that I would love to see some reporting in the context of product litigation on poor legal practices as well as poor pharma practices. When a sensationalistic story, such as the J&J one, first hits there is a lot of buzz but when that same story pans out to lack merit it gets little coverage. Also, unfortunately, the rhetorical presumption is bad pharma not bad legal action.
Just looking for a little bit of fair balance.
Ed Silverman
Hi Dr. Sal,
Actually, I have run such items about trial lawyers as recently as earlier this month in connection with fen-phen litigation.
http://www.pharmalot.com/2008/06/destroying-documents-fen-phen-lawyers-on-trial/
This was the second such item I’ve run about this episode in the last couple of months.
Cheers
ed
Dr. Sal Giorgianni
Ed
Thanks for the note…my new “retierment job” in academia and my need to try and enjoy the time outside of the Ivy Tower with my family sometimes preclude me from reading all Pharmalot stories. I am glad to see that more than one side gets protrayed in this publication. I wish this were the case with all outlets.
I am a big fan of Pharmalot because you are building it the way you are
freedom
This is happening more than you think, hospitals are not reporting this as they should, they are in bed with the pharmicutical companies and children and adults are suffering because of it. The FDA has failed the people who have payed thier paychecks, this agency should be closed down.
BeeGee
Reports today are that parents admit giving girl 3 doses over two days for a “mild fever”. Not clear as to whether this meant 3 doses/day for two days or a total of 3 doses in two days. They also admit that she turned up with a rash and they gave her more Motrin.
Drug monographs include a mind-numbing amount of detail which most consumers don’t bother to read. I don’t know whether larger black box warnings would do any good as most don’t read those either.
This sounds as though the parents overlooked their daughter’s rash and didn’t connect it with her medication or contact the doctor about it.
BeeGee
Reports today are that parents admit giving girl 3 doses over two days for a “mild fever”. Not clear as to whether this meant 3 doses/day for two days or a total of 3 doses in two days. They also admit that she turned up with a rash after the course of Motrin and they gave her still more Motrin.
Drug monographs include a mind-numbing amount of detail which most consumers don’t bother to read. I don’t know whether larger black box warnings would do any good as most don’t read those either. Rashes are an indication of a problem with almost all drugs. Educated parents (hers are both engineers) should know this without its having to be written in crayon letters two feet tall.
This sounds as though the parents overlooked their daughter’s rash and didn’t connect it with her medication or contact the doctor about it.
BeeGee
Sorry about dupe post. Thought I was editing instead of sending a second post.
George Daymond Lush
I happened upon this site unexpectedly and the responses to the issue (Motrin Lawsuit) are very interesting form the sensible to the hysterical. What interests me is the punitive element. Punitive damages are not unknown in the UK but are, I think, not commonplace. Can somewhone explain to me not why but how punitive damages enter this sort of litigation. Then perhaps tell me who decides them and how do they punish (other than by increasing the defendent’s public liability costs which are then passed back to the plaintiff in higher product costs). This may not be the core purpose of this blog but i would be interested if anyone has the time to pen a few words.
Justice in MI
Hi GDL - As has been also discussed on this blog, punitive damages are probably the aspect of the American tort system that require the most reform.
In most states, they are initially decided by a jury. Often, the jury expects them to be reduced on appeal, which they virtually always are. The idea of very large PDs is to “send a message” to other potential wrong-doers, and thus go beyond compensatory damages alone (which are to compensate the wronged parties).
The major problem with PDs is their inconsistency. This is not the fault of juries. There are very few guidelines about _how_ to come up with whatever amount - what principles should govern. The best read on this, in my view, is Prof. Cass Sunstein at U-Chicago. He has written or edited a number of volumes specifically on punitive damages, including one which is called that, published by Cambridge U Press as I recall.
Most PDs end up being quite small after appeals, etc. In the recent Exxon Valdez cases, for example, they were reduced to the point that each person whose living was destroyed by the oil spill (mainly fisherman) received the equivalent of about fifty dollars, twenty years later. That reflected by CDs and PDs.
They could perhaps buy a fish dinner with that.