[By Staff Writer Jay Belle Isle]

In a letter dated July 13, the FDA issued serious warning to C. R. Bard Inc. due to multiple violations. The company has been given fifteen business days to respond to the letter or else it may face “seizure, injunction and civil money penalties.” The warning is based on inspections of Bard’s Queensbury, NY and Tempe, AZ manufacturing facilities and is focused on Bard’s Recovery Cone Removal System, Models RC-15 and FBRC.

The FDA has several concerns with these devices, including that they are:

…adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

… misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

market[ed] … without marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States.

Further, the inspection revealed issues with Quality Control of Bard’s IVC filters:

Specifically, IVC filter cleaning, to include removal of chemical processing contaminants, has not been validated for IVC Filters to include Simon Nitinol Filters, Eclipse Filters and Denali Filters. For example, production of Denali Filters requires the use of several processing agents, including, but not limited to the following: nitric acid, methanol, sulfamic acid solution, thermo quench salt, glycolic acid, citric acid, and/or hydrofluric acid. The cleaning processes for IVC filters are not validated or otherwise verified to demonstrate that the above substances are reduced to acceptable levels during routine processing under worst case conditions. Therefore, your manufacturing process was not validated with a high degree of assurance and approved according to established procedures, nor were the process results fully verified by subsequent inspection and test, as 21 CFR 820.75(a) requires.  

As if that wasn’t enough, Bard’s system for reporting and investigating product complaints was found to by woefully inadequate.

The company also incorrectly filed or failed to file adverse event reports. One of these reportable instances involved a death potentially due to a Bard device malfunction. Misreporting of 10 cases as Medical Device Reports (MDR) instead of serious injury events was also noted.

The FDA found Bard’s previous answers to the results of the inspections to be insufficient. The company has until August 3 to report satisfactory resolution of the issues or plans to do so.

U.S. District Judge Cynthia Rufe or the Eastern District of Pennsylvania made the only call she could on Tuesday: the postponement of Daubert hearing in Zoloft birth defects case until September. The multidistrict litigation (MDL) against Pfizer, claiming its popular antidepressant, Zoloft causes birth defects, came to a halt as the plaintiffs’ expert was disqualified due to errors in the article upon which he was basing his argument in the plaintiffs’ favor.

The postponement came during the Daubert hearing – one that allows parties to challenge each other’s expert testimony pre-trial to save time later – when defendant Pfizer revealed a report from its own medical expert, Dr. Stephen E. Kimmel. After reviewing Dr. Nicholas Jewell’s article in the New England Journal of Medicine, Dr. Kimmel noted some data errors. Dr. Jewell’s article provided plaintiffs’ needed support in their argument that Zoloft causes congenital heart defects when used by pregnant women.

Dr. Kimmel’s report states that he contacted Dr. Jewell and told him of the errors, at which point Dr. Jewell confirmed the mistakes. Dr. Jewell then contacted the Journal to request corrections. Based on this finding, Dr. Kimmel gave the opinion that Dr. Jewell’s article could no longer be used.

Judge Rufe had no other course of action but to agree with Dr. Kimmel and decided that the rest of the Daubert hearing would have to wait until the fall so the plaintiffs could conduct further discovery and depositions. Jared: Do we want to link to the CDC piece here as a suggestion?

According to Judge Rufe, plaintiffs’ legal team has “a lot of people to talk to, we have to give them some time. I do see an advocate’s responsibility to try to determine how this change occurred.”

This isn’t the first blow plaintiffs have received in terms of experts. Anick Bérard, the first expert, was removed following a weeklong Daubert hearing in 2014. Contrary to common practice, the judge allowed a second expert. It’s unclear if the plaintiffs will get a third. That isn’t the extent of the expert epic, though.

Judge Rufe ruled in favor of Pfizer in a motion to produce a report by plaintiffs’ expert Dr. Jewell from similar litigation involving Prozac. She ordered plaintiffs to turn over both the report and the testimony from Dr. Jewell.

According to Pfizer, “Dr. Jewell and plaintiffs’ counsel, who are also counsel in the Prozac litigation, insist that the entirety of Dr. Jewell’s expert report and deposition are confidential and thus subject to a protective order. That blanket assertion is highly suspect and implausible. Dr. Jewell is a general causation expert who presents a statistical analysis of data. He typically does not review or discuss plaintiff-specific information or medical records and has not done so in this matter. His opinions in the Prozac litigation, as they are in this litigation, are presumably based primarily upon publicly available, peer-reviewed literature.”

As stated, the plaintiffs were ordered to release the report. Despite Pfizer’s assertions, there were parts that Eli Lilly had identified as confidential redacted. There were also parts that contained personal health information normally protected by HIPAA.

Pfizer’s motion further stated, “In making a blanket assertion of confidentiality over the entire deposition and report, plaintiffs’ and Dr. Jewell’s motives are transparent: They do not want the defendants or the court to ascertain and explore whether there are any inconsistencies in his methodologies in the different SSRI litigations.”

To date, Pfizer has won two of the Zoloft birth defects cases out of the approximately 550 total cases.

 

Source:

Pa. Federal Judge Postpones ‘Daubert’ Hearing in Zoloft MDL

 

A subpoena is a court order telling someone to appear at a legal proceeding or to produce certain documents. Generally, if someone is subpoenaed, that person must comply. In other words, the person must appear at the place and time designated in the subpoena, and if the subpoena requires the production of certain documents, the person is legally bound to produce them.

Courts’ subpoena power comes from Federal Rule of Civil Procedure 45 which states that ‘‘[e]very subpoena shall . . . command each person to whom it is directed to attend and give testimony or to produce and permit inspection . . . of designated . . . documents.’’

Generally, if one fails to appear as ordered by the subpoena, or fails to produce the requested documents, he or she will likely be found in contempt of court and sanctioned with jail time and fines. Of course, there are a few well known exceptions to this rule that one must testify or produce documents if subpoenaed.

First, one may have the right to refuse to answer questions or produce documents if doing so might incriminate oneself in a crime. Second, one may also refuse to testify if answering the question or producing the document violates a legally-recognized privilege, such as a marital privilege, an attorney-client privilege, or a doctor-patient privilege.

However, there is another, less commonly known exception to the “subpoena rule.” If one is a federal employee, he or she may avoid testifying or producing requested documents due to something called “Touhy regulations,” named after the landmark case, United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).

Under federal Touhy regulations, federal employees generally cannot be compelled to testify or produce documents even when they have extremely relevant information. Such employees testify and disclose information only if the federal agency ultimately agrees it is in the agency’s best interest. Awfully convenient for the federal agency—and awfully inconvenient for the party trying to establish facts by having federal employees testify or disclose certain documents.

Since the FDA is a federal agency, Touhy regulations are a good thing to be aware of if you bring a lawsuit involving pharmaceutical companies and defective medicines. Since federal employees of the FDA may be key witnesses to your claims, Touhy regulations can certainly present a challenge. Every agency has its own Touhy regulations, and therefore it is important to check the FDA’s specific regulations to determine what steps need to be taken to overcome the regulations and acquire the testimony or documents that you need.

Typically, an agency’s Touhy regulations’ first step requires you to submit a formal written request identifying which federal employees you want as witnesses and the areas of testimony. Despite the obstacles that Touhy regulations may present, our firm remains determined to help you navigate the steps involved in your potential case and successfully serve a subpoena on a federal agency if need be.  Please call us for a free consultation.

 

Between 2008 and 2009, a number of adverse events were reported to the FDA regarding second-generation (atypical) antipsychotic drugs Seroquel (quetiapine fumarate), Risperdal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Abilify (aripiprazole) among children aged 6-17.

Click here to read the full FDA Adverse Event Report on Atypical Antipsychotics among children (2008-2009).

The report states that adverse events most commonly included “Type I/II diabetes, weight gain, and high cholesterol/triglycerides”, and stresses that not all adverse events experienced are reported to the FDA, so the rate of certain adverse events cannot be determined from Adverse Event Reports.

Here is a summary of adverse events detailed in the FDA report:

abilify-lawyer-abilify-lawsuit-abilify-diabetes-lawsuit

Concerning Abilify, the cases of diabetes are as follows.  First, a 12-year-old girl who used Abilify for bipolar disorder developed type-II diabetes and gained 150 pounds in one year alone, reporting blood glucose of 195-305.  A 17-year-old male who was also using Abilify for bipolar disorder “developed diabetes” and experienced weight gain of 14-40 pounds.  Lastly, a 14-year old male using Abilify presented with “Polydipsia, polyuria, diabetes mellitus, fatigue, hyperglycaemia, ketoacidosis, pollakiuria, urine abnormality, vision blurred, ketonuria, type 1 diabetes mellitus, [and] weight decreased”.

Due to the fact that the manufacturers of second generation antipsychotics such as Abilify and others have failed to adequately warn users of the risk for diabetes associated with their products, a number of Abilify diabetes lawsuits and antipsychotic diabetes lawsuits have been filed.

If you or a loved one used Abilify or another antipsychotic and developed diabetes as a result, you too may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Abilify diabetes lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Recently, there has been a dramatic increase in deaths associated with coronary stents.  These tiny metal-mesh tubes, “stents,” are placed inside arteries to keep them open, ensuring adequate blood flow.

According to MedlinePlus, an online medical encyclopedia curated by the US National Library of Medicine and the National Institutes of Health, “Most of the time, stents are used to treat conditions that result when arteries become narrow or blocked”, such as Coronary heart disease (CHD) (angioplasty and stent placement – heart); Peripheral artery disease (angioplasty and stent replacement – peripheral arteries); Renal artery stenosis; Abdominal aortic aneurysm (aortic aneurysm repair – endovascular); and Carotid artery disease (carotid artery surgery).

While these uses account for many of the cases in which coronary stents are used, Bloomberg News states that more than half of the time coronary stents used in the US (which number about 700,000 annually) are cases of “elective-surgery patients in stable condition”.  That Bloomberg News article continues, stating, “[Overuse], death, injury and fraud have accompanied the devices’ use as a go-to treatment, according to thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.”

Sadly, it seems that stents represent a cheaper, less effective, and more dangerous means of maintaining proper blood flow.  According to an interview Nortin Hadler of The University of North Carolina, Chapel Hill, gave Bloomberg, “‘Stenting belongs to one of the bleakest chapters in the history of Western medicine,’ [and cardiologists] ‘are marching on’ because ‘the interventional cardiology industry has a cash flow comparable to the GDP of many countries’ and doesn’t want to lose it”.

Another article, this published to the WebMD website, also purports that coronary stents are overused among patients with stable heart conditions: “an analysis of eight large clinical trials found that the addition of opening narrowed arteries with stents provided no added benefit over aggressive therapy with medication alone as a first treatment for patients with stable disease.”

WebMD continues, stating that American Heart Association records show “400,000 non-emergency coronary stenting procedures are performed each year in the U.S.”  And based on an interview with medical researcher David L. Brown, MD, of Stony Brook University Medical Center in New York, “If two-thirds of these operations were avoided, the savings in health care dollars would be huge.

“By one estimate, reducing elective stent procedures by just one-third would save the U.S. health system $6 billion to $8 billion annually.”

An article published in a 2012 edition of JAMA Internal Medicine that studied 7,229 patients compared the health outcomes of patients who used stents with stable heart conditions to the health outcomes for patients who used other methods to ensure arteries stay open, found that “Initial stent implantation for stable CAD shows no evidence of benefit compared with initial medical therapy for prevention of death, nonfatal MI, unplanned revascularization, or angina.

Percutaneous coronary intervention (PCI) reduces death and nonfatal myocardial infarction (MI) in the setting of acute coronary syndromes.12  However, the role of PCI in treatment of stable coronary artery disease (CAD) remains controversial.34

Despite recent studies clearly demonstrating that initial PCI offers no benefit in terms of reducing death or other cardiovascular events over optimal medical therapy in the setting of nonacute CAD,57 these findings have not been incorporated into clinical practice.89.”  For clarity, the phrase “percutaneous coronary intervention (PCI)” here refers to the use of a coronary stent.

Though this paper, published by Kathleen Stergiopoulos, MD, PhD; David L. Brown, MD (titled “Initial Coronary Stent Implantation With Medical Therapy vs Medical Therapy Alone for Stable Coronary Artery Disease”) represents a landmark study in the field, many other research studies have been published demonstrating that stents are unnecessary or dangerous when used in stable heart condition.

Due to the fact that a large number of Americans have been given stents unnecessarily, coronary stent lawsuits are currently being filed in great number across the country.  If you or a loved one was given a stent and you have a stable heart condition, you may be at risk for a number of coronary stent complications and may be entitled to significant financial compensation for any injury you have incurred.

For a free, no-obligation case consultation, contact our team of coronary stent lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855) 452-5529

justinian@dangerousdrugs.us

Call today and see how we can help!

What is the “revolving door” I’m always talking about?  It’s this.  The former head of the FDA now is in private industry and he’s proposing drastic cuts to the clinical trial process.  Yet no one complains.

The council’s report establishes an ambitious, yet reachable, national goal: doubling the current annual output of new medicines for patients. We believe existing evidence suggests this goal can be met by altering the FDA’s onerous clinical-trial requirements.

Source: FDA Reform Can Lift U.S. Economy – Bloomberg

Imagine if he went to work for a trial lawyer lobbying group and proposed allowing generics to update the warning label so consumers could sue them….

coverNoted medical doctor and ethicist Carl Elliott is the author of White Coat, Black Hat, a book about the “dark side of medicine.”  The New York Times reviewed the book and highly recommended the entertaining and extremely readable essays regarding the way our for-profit health-care system really works.

He was interviewed at Pharmalot  regarding the book, and I happened to read the interview.  While the whole interview was interesting, the part that jumped out at me was when Dr. Elliott referred to trial lawyers as a “gleam of sunshine” in the otherwise cloudy skies of medical ethics.

Most doctors think of trial lawyers as a disease for which tort “reform” is the only cure.  So when I saw that Dr. Elliott describes us in positive terms, I had to know more.  So I e-mailed him the following four bolded questions, and he was kind enough to answer them:

1: In most cases, protective orders prevent trial lawyers from disclosing information they discover about the safety and efficacy of a drug.  How do you feel about that?

Well, I think that has to change.  We owe a debt of thanks to the attorneys and expert witnesses who have made documents from these lawsuits publicly available.  If not for those documents, we would have no clue about the extent to which pharmaceutical companies have spun and manipulated the scientific data about their drugs.

2: Some people argue that the disclosure of internal company documents is bad for the public because the documents can be taken out of context.  Do you agree?

No, but if that’s the concern, then the solution is to put the documents into context.  Pharmaceutical companies are free to do this.  Science can only work if scientific data is available to everyone.  If the data is hidden away and only made available selectively, it’s not science; it’s spin.

3: What affect, if any, do you believe the threat of litigation has on the way that pharmaceutical companies conduct business?

Litigation has taken the place of regulation.  I wish we had a regulatory system that made litigation unnecessary, but we don’t.

4: Anything you’d like to say to the trial bar?

Saying this will make me very unpopular with doctors, but I wish litigators would broaden the scope of their lawsuits.  Part of the problem now is that pharmaceutical companies have such deep pockets that litigation is just the cost of doing business.  But pharmaceutical companies are not alone in manipulating the scientific literature.  They also hire ghostwriters, academic thought leaders, medical education companies and even ethicists, each of whom may well be complicit in the deception.  These other parties are rarely punished for their complicity.  If they were named in litigation alongside the pharma companies, they would think twice about getting involved.

I also wish that trial lawyers would start looking more closely at industry-sponsored clinical trials and not just product liability.  It is shocking just how little ethical oversight of these trials there is, and the burden of taking part falls disproportionately on the poor.  Litigation may well be the best way to push for some serious social change.

Amen, Dr. Elliott.

Now let me go ahead and say something that will make me very unpopular with some trial lawyers.  If you’re a lawyer who just parks his cases in an MDL, never reads the “hot docs,” and would never ever consider challenging a protective order because that might upset the apple cart, then you’re a part of the problem, too.

In every docket, there are plenty of liability documents that don’t contain trade secrets and thus should not be subject to a protective order.  As a recent example, let’s use the famous “Caubel letter” from Ortho-Evra.  In that letter, a J&J VP resigned because he believed J&J wasn’t seriously evaluating the safety problems with Ortho-Evra.  That document has been covered by a protective order for years, and it shouldn’t have been.

Just this week I had to review the death certificate of a girl who died from a Pulmonary Embolism while wearing the patch.  I bet she wouldn’t have been wearing it had she known about Caubel’s resignation.  Too bad no one fought the battle to get that document released to the public.

At any rate, I want to thank Dr. Elliott for taking the time to answer my questions, and I’d like to invite everyone to read the NY Times review of his book here, or to order it at Amazon.com here.

 

My name is Justinian Lane, and I’ve been writing about dangerous and defective drugs since 2003.  In fact, one of the reasons I went to law school is because two of my family members both needed liver transplants after receiving a contaminated batch of prescription drugs.  I graduated from Michigan State University College of Law in May of 2010 and am currently awaiting the results of the July 2010 bar exam.

One of the reasons I started this blog was so that I could share information with the public that drug companies won’t.  For that reason, I often post documents filed in prescription drug lawsuits.  There is no better way for patients, doctors, and the rest of the public to find out the hidden dangers of prescription medication than to read the documents produced in drug lawsuits.

I also talk a lot about the law of defective drugs at this blog.  None of this information is offered as or should be considered as legal advice.  Legal advice only comes when you hire a licensed attorney and he or she examines your case in detail.  I may even discuss a case that sounds *just like* your case, but that doesn’t mean it is.  If you think you need legal advice, contact me and I’ll put you in touch with a top-notch drug attorney who can help you.

Please also feel free to contact me if you have questions, contacts, suggestions, or criticisms for me.  Or, if you don’t like using forms, you can email me at justinian AT justinian DOT us.

 And don’t worry – I’ll never sell your contact information, and no one will ever contact you without your permission.