An Idaho woman has filed a lawsuit against Genzyme, charging that a long-standing shortage of its Fabrazyme treatment for Fabry disease led to the death of her husband two years ago. And he would still be alive, she claims, if the biotech had not experienced severe and persistent quality control problems that led to a subsequent rationing program.
In her wrongful death lawsuit, Janet Schubert maintains that her deceased husband, William, was diagnosed with Fabry disease, a rare, but life-threatening genetic condition, in 2005 and was in acceptable health until mid-2009, when Genzyme began rationing its drug. And she attributed his March 2010 death to the insufficient dosing the biotech imposed on patients.
Specifically, Schubert points to viral contamination that emerged at a Genzyme facility as well as an episode in which glass, rubber and steel particles were found. The ongoing manufacturing problems eventually prompted Genzyme to sign a consent decree with the FDA and dampened its stock price to the point where Sanofi later decided the biotech was a good deal (see here, here and here).
Genzyme was "aware that the lower dose of Fabrazyme posed a deadly risk to patients and consumers," the lawsuit charges. The biotech "grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals and the public of the lethal risk presented due to inherent and customary manufacturing defects and imperfections in the product" (here is the lawsuit).
This is not the first time that Genzyme has been sued over Fabrazyme shortages. A lawsuit that was filed last year by several Fabry patients mentioned that at least three people may have died as a result of the rationing (look here). But this appears to be the first time that a wrongful death lawsuit has been filed over the manufacturing problems.
A common thread, however, is the contention that Genzyme never tested to determine whether the reduced dosage was safe or effective for treating Fabry disease, and failed to warn about the risks associated with dosages that were lower than what was originally approved by the FDA. We asked Genzyme for comment and will update you accordingly. Also named as defendants are Sanofi and Mt. Sinai School of Medicine, which was awarded an NIH grant and invented Fabrazyme.
[UPDATE: A Genzyme spokeswoman send us this: "We have shared the patient community’s desire to return to normal supply of Fabrazyme, and we announced last week that patients in the U.S. have resumed to their normal dosing. While we understand the challenges the supply shortages have made for both patients and physicians, we cannot comment on specific patient experiences or on litigation.]
Meanwhile, Sanofi ceo Chris Viehbacher two days ago said that Fabrazyme production should double by the end of this year. His comments came a few weeks after the FDA and the European Medicines Agency approved a new plant in Framingham, Massachusetts, a move that Sanofi has been counting on to validate its $20 billion Genzyme purchase (see this).
Last month, by the way, more than two dozen people who suffered Fabrazyme shortages filed a lawsuit against the US Department of Health and Human Services, the FDA and the National Institutes of Health, arguing their rights were violated because the federal government failed to take adequate enforcement actions against Genzyme or allow for alternative means to protect supplies (read here).
26 Comments
Schubert should have told her doctor to obtain a supply of Replagal from Shire Laboratories under an FDA sanctioned emergency IND that has provided over 100 other Fabry patients with life saving medication to date.
A bit of legwork and her husband might still be alive today. Judge for yourself.
http://abcnews.go.com/Health/fabry-disease-patients-hopeful-fda-approval-shire-drug/story?id=14836161
This comment is ridiculous and offensive. Genzyme exported full doses to Europeans while underdosing Americans or banning access altogether. Why did you not just suggest that U.S. Fabrazyme patients move to Europe during the shortage where full Fabrazyme dosing was available? Blaming the American victims of the shortage is like blaming the passengers of the Titanic for not bringing lifeboats.
Right, let's sue the bastards who invented and produced the drug which has saved many lives, and extended this man's life for some time. I can understand why she's upset but she's just going for the perceived deep pocket. It's not going to bring her husband back. In fact, suits like this contribute to scientist/pharma reluctance to take a risk. Selfish suits like this do nothing to solve the very real problem of shortages and quality control issues. Selfish suits like this drive medication costs way up for everyone. I am not in pharma, just using common sense. Try it some time.
Anne, you are enso right. Everyone is trying to score a fast buck off of pharma any way they can. If I ever go back to working for a company I'm going to demand an office big enough for two, with my criminal defense attorneys there to review adverse event reports with me.
Look no farther than these boards and pick your favorite. I certainly have mine: patient lawsuits, product liability lawsuits, personal injury lawsuits, overtime lawsuits, whistleblower lawsuits, gender discrimination lawsuits, maternity lawsuits, drug shortage lawsuits, bugs in the vial lawsuits, metal shavings in the vial lawsuits, vaccine klilling kids lawsuits, bugs in the baby formula lawsuits, antidepressant patients jumping off bridges lawsuits, smoking cessation suicide lawsuits, I-want-my-Viagra lawsuits; a veritable cornucopia of unsatisfied customers.
Step right up folks, take a number, its pummel the pharma company 2012 version. Better hurry before the pot o' gold runs dry!
BTW, Mr Black, if you think my earlier comment was offensive, i'll use your Titanic analogy on you, borrowing a bit from Anne's comment:
Please describe for your readers exactly how it would have benefitted the passengers going down with the ship if they had grabbed the expensive gold leaf flatware and stuffed it into their waistcoats, clutching the priceless pieces as they gurgle gurgled their last breath on the way down to the bottom of the Atlantic.
Pray tell
As patients paying more than a quarter of a million dollars to pharm a year to stay alive, it is not unreasonable to believe that our drug supply will be secure. Bad things happen. Then we might expect that all patients be treated equally, we be fully informed we would not have to find out about our drugs in the New York Times, and finally the decisions about who lives and who dies is not made arbitrarily by country.
If we were not ill there would be no industry. I am very sorry but I do not see who is stuffing gold flatware--me--I scrimp every day to have the drugs I need.
Gretcen, why are you paying anything close to $250,000/year for your medication? Isn't there supposed to be a Patient Assistance Program to defray these costs? Also, Fabrazyme treatment is a covered benefit under most major insurance plans, as well as the Medicare and Medicaid programs. Notwithstanding the merits of anyone's position above, you should not have to be paying this kind of money under any circumstances.
No person ever trades their spouse's or child's health or lives for a chance to be in a lawsuit-- the accusation that they would is utterly offensive. American taxpayers funded the invention through an NIH grant but were denied access to the very drug they paid for. Thousands of American (but not European) Fabry patients were subsequently hurt and some died while Genzyme CEO Termeer walked away with $175 million during the shortage. Pro-drug shortage arguments are ridiculous.
Termeer's severance was less than 1/20th the potential profits from annual US sales of Cerezyme alone, notwithstanding Genzyme's other drugs. With all due respect, your "people versus profits" argument is a non-starter, Mr Black.
@Allen Black
Who's arguing in favor of drug shortages?
@George
OII and his argument that the innocent victims of drug shortages deserved to die (or were acceptable deaths) and thus these victims should not be compensated for their or their children's deaths and injuries. OII is arguing that the costs of the carnage caused by drug shortages should be borne by the innocent victims and not the manufacturers that caused the shortage in the first place. It is also argued that Termeer was underpaid for his actions denying patients access to the very drug they paid for with the NIH grant. These are pro-drug shortage arguments.
To echo George's point, why would drug company wish to cause a shortage, artificial, real or otherwise for a drug that it makes $250,000/patient/year? Furthermore, why should any "victim" earn money based on a shortage that was neither planned nor anticipated?
That's about as specious an argument as the Farmers of West Texas suing the local water company for failing to anticipate the drought by promoting water conservation, thereby ultimately preventing rationing of the water supply. Or farmers suing the State of California for failing to hire better scientists who could have predicted the Colorado River would dry up, causing economic ruin to S California farmers.
Termeer was underpaid if you compare his parachute to Hank McKinnell ($186 million, including $540,000 for unused vacation days).
When in doubt, go to the trial data.
"Genzyme was aware that the lower dose of Fabrazyme posed a deadly risk to patients and consumers,” the lawsuit charges". I can categotically refute as follows:
1) the clinical trial efficacy dose ranging studies showed that doses ranging from 0.3 to 3.0 mg/kg/day worked equally as well.
2)The 70% reduced dose means that Schubert was taking the low, yet efficacious dose of 0.3 mg. Thus he could not have died at this dose without some intercurrent illness.
3) there were no deaths in the Fabrazyme trials at any dose, further support that the low dose did not kill Mr Schubert.
If you get any half-smart defense MD expert to cite the above points than I can assure you that Mrs Schubert won't have a legal leg to stand on. Problem is that the jury will probably throw her a bone based on emotion.
@Allen Black :"OII and his argument that the innocent victims of drug shortages deserved to die"
C'mon now, Oii didn't say that.
@ George
C'mon, Oii hates widows and orphans of drug shortages. He actually said that the victim's widow may be "throw(n) a bone based on emotion," comparing her suffering to dog begging for a treat. Disgusting.
@Oii,
"The CHMP [of the European Medicines Agency] noted that since the introduction of a lower dose of Fabrazyme in June 2009, there has been a steady increase in the number of reported adverse events, matching the increase in the number of patients on the lower dose. At first, most of the events were pain-related, soon followed by reports of events affecting the heart, the central nervous system and the kidneys. This pattern suggests a progression of Fabry disease. Recently, a decrease in number of reported adverse events has been observed, which reflects the fact that more patients have either been switched to Replagal or have started receiving a full dose of Fabrazyme again."
Clearly, the European Medicines Agency disagrees with you. Perhaps you would like to volunteer your expertise to Genzyme for the case?
Allen, I actually have previously donated my expertise to Genzyme, but in a different therapeutic category. Look up Thyrogen (recombinant TSH). We worked with Genzyme in my former company to develop that drug and get it approved for diagnostic testing in the followup of thyroid cancer patients post operatively. To put it modestly the product has been a Godsend.
You point out recent trends in the data for Fabrazyme. That's one of the things we do in clinical research. Sort out the secular trends from those that are statistically meaningful. Since your starting point is 2009 it is too early to tell which is which. Correlation is not causation, and all that you and EMEA have presented is correlation and speculation, different from a statistically meaningful trend.
I've worked with a number of companies in partnership over the years, and while I can't speeak for the company as a whole, the Genzyme people I've worked with are the best in the business.
George, I think that Allen Black is a nom de plume for a novelist, since Allen writes such terrific fiction.
Allen, my apologies for the canine analogy. Look up the meaning of the word euphemism. Perhaps I should have said that "Mrs Schubert can expect to receive a modest jury award based on the emotional difficulties exacerbated by her husband's unfortunate death due to Fabry's Disease".
Feel better, Allen?
It is repulsive to me that Original Industry Insider (OII) writes that Schubert’s widow is greedy. It is revolting to me Anne’s position that it is a selfish lawsuit. I am sure that OII and Anne are intelligent. But that intelligence sure does not shine when they personally attack with words of greed and selfishness and direct those words to folks who have been harmed by the pharmaceutical industry.
I ask if OII and Anne – and George too – would support suing the automotive industry – if their car had a defect such as an accelerator sticking which led to a crash causing death. Or to sue a homebuilder – if their home was built with wallboard that caused respiratory and health problems with their children. Or if their parents or grandparents were exposed to asbestos during decades of work, to encourage them to sue asbestos manufacturers and – yes, let’s sue those manufacturers who used asbestos in their products. Let us not forget the granddaddy of them all – the tobacco industry.
Oh, I am mistaken. Yes, suing is greedy, selfish, and leads to reluctance to take risk. What garbage! I continue to be amazed how the pharmaceutical industry wraps themselves with a cloak of benevolence. In my line of work if decisions were made that adversely affected the customer monetarily or their very existence because of delays or shortages, or by defective product, or just walked away from a contract lawsuits would fly.
There are numerous drug shortages more so than any other time. Hospira has a number close to thirty (30) drugs on the shortage list. Why is that? Logic and common sense would dictate one of two reasons: either incompetent manufacturers or the decisions made based on profitability - consumers be damned. In the Fabrazyme , Cerezyme, and Thyrogen drug shortages, Genzyme Sanofi seems likely to be guilty of both.
The FDA continues to consider new drug applications from Hospira. What? Companies in other industries with such a record and disregard would be fined, be named defendants in lawsuits, etc., and likely be pushed out-of-business or taken over by a competent entity.
Yes, OII and Anne - continue thinking as you do. Let us know when a family member is adversely affected by a drug shortage. We would like to tune in and hear your position then.
Now we have the main players assembled on stage. To fill everyone in, Allen Black is actually patent attorney C. Allen Black, PhD, who, working together with co-petitioner Joseph Carik filed a March-in Petition in 2010 to NIH seeking to strip Genzyme as sole licensee to make and sell Fabrazyme. That petiton was denied by NIH on several grounds that you can read below. The denial has been appealed subsequently based on updated information on the Genzyme manufacturing siutation.
It would be educational of either Dr Black and/or Mr Carik could update us with the latest information on the status of the march-in petition.
http://www.patentlawyersite.com/FabrazymePage5.html
Hi Folks,
You can read a conversation with Joseph Carik here...
http://www.pharmalot.com/2011/04/why-joe-carik-is-fighting-over-a-genzyme-drug/
And many of the documents pertaining to the march-in petition and related litigation can be found by doing a quick search on Pharmalot for Fabrazyme.
Regards ed
@ Oii,
The reason I listed my full name in my response is that I absolutely defend and support drug shortage victims. I do not have any fear or trepidation in making these statements. Indeed, I am very humbled by patients entrusting their cases to me and will do everything in my power to help them, including speaking out. I am not affiliated with Mrs. Schubert, but I support her fully.
The NIH petition is not the only pro-bono work I have done for drug shortage patients. I have also filed a pro-bono petition with the FDA (http://www.pharmalot.com/2011/01/patients-petition-fda-over-genzyme-drug-shortage/), and I initiated a lawsuit against the HHS, FDA, and NIH pro-bono (http://www.pharmalot.com/2012/02/rights-denied-patients-sue-feds-over-shortages/). I currently represent patients affected by the Fabrazyme shortage, the Aquasol A shortage, and the Doxil shortage.
BTW, the NIH agreed to re-hear the petition and it is still pending.
Oii's mention of being involved in Thyrogen manufacturing is interesting. Thyrogen is an ongoing shortage too, and no alternative cancer treatment is available. Ironically, Oii may actually receive his desired opportunity to testify on behalf of Genzyme, if a Thyrogen patient takes the shortage to court.
Thanks, Ed. It seems that march-in petition notwithstanding, the main concern of the patients is to get the drug to US Fabry patients first, and then only export the remainder after the US needs are met.
Towards this end I would just a very straightforward question. Does the FDA, the Secretary of HHS or any other United States public health official have the legal authority to require a US pharmaceutical company to distribute its product in a prescribed fashion? We know that for diseases the CDC can direct distribution of certain vaccines to at-risk individuals and population centers. Could that authority be extended to the Fabry situation?
I understand the angle of suing under the US Constitution, but this problem seems to require a more immediate response than can be obtained by putting constitutional lawyers in a courtroom.
Allen, despite my earlier association with Genzyme, I find some of their recommendations on Thyrogen usage to be indefensible. For example, post-thyroidectomy cancer patients require Iodine 131 radioablation of thyroid remnants 4-6 weeks after surgery to catch any residual tumor tissue. The procedure requires Thyrogen or else the patient must undergo the debilitating process of going off replacement LT4 to raise the TSH levels high enough to do the radioiodine ablation.
The longer remnant ablation is delayed the greater the chance of tumor recurrence. Thus I can't abide Genzyme's recommendation to doctors that they schedule these procedures around when Genzyme thinks the Thyrogen shortage will be fixed.
do ya'll not work? get a freakin life and get off the computer.
Ok, try this. The real problem is too many regulations. Regulators are too insistent on demanding a manufacturer produce drug products in a repeatable manner so as to enable the product claims of safety and effectiveness when used according to the label instructions.