Georgia Avandia News: US Senate Reports

Amazing. You just have to read the report released yesterday. From the Senate Report:

Senators "asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients."

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.",


From Sen. Grassley's letter:

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.

Link.

Topamax Maker to Pay $81 Million Fine

The Justice Department announced Thursday that two subsidiaries of the pharmaceutical giant Johnson & Johnson had agreed to pay more than $81 million in a case accusing them of illegally promoting the epilepsy drug Topamax for psychiatric uses. Source.

While the Food and Drug Administration approved Topamax for the treatment of partial onset seizures, Ortho-McNeil Pharmaceutical promoted the drug for unapproved psychiatric uses, the government said

Pain Pump MDL REJECTED

Again.

In re Ambulatory Pain Pump-Chondrolysis Products Liability Litigation, J.P.M.L., MDL No. 2139 (4/14/10).

Injured consumers claim that they developed chondrolysis after a pump used to directly send anesthetic into their shoulder joints following surgery failed.

From the Order:

Although these personal injury actions have some commonality as to whether
shoulder pain pumps and/or the anesthetic drugs used in those pumps cause
glenohumeral chondrolysis, an indeterminate number of different pain pumps made
by different manufacturers are at issue, as are different anesthetic drugs made by
different pharmaceutical companies.

Moreover, not all of the thirteen constituent actions involve pharmaceutical company defendants, and many defendants are sued only in a minority of those actions. The proponents of centralization have not convinced us that the efficiencies that might be gained by centralization would not
be overwhelmed by the multiple individualized issues (including ones of liability and causation) that these actions appear to present. The parties can avail themselves of alternatives to Section 1407 transfer to minimize whatever possibilities there might be of duplicative discovery and/or inconsistent pretrial rulings.

The Court went on to say:

the constituent actions are at widely varying procedural stages. In many, fact
discovery is either over or nearly over. The record shows that expert discovery is underway or has been completed in a number of actions.4 Although movants and other plaintiffs favoring centralization argue that defendants have stymied their efforts to streamline discovery, that argument is undercut by the multiple requests to exclude certain actions on the ground that they are too advanced to warrant inclusion in an MDL. Given all these circumstances, we are still unconvinced
that centralization would serve the convenience of the parties or promote the just and efficient conduct of the litigation, taken as a whole.

Find it here.

PA Medical Malpractice Info

Image by ipeters61 via Flickr

Thanks to the folks at the Torts Prof Blog for this tidbit:


Pennsylvania prepares more detailed med mal filings and verdicts data than most states. 2009 figures were recently released. In 2009, there were 1,533 med mal filings, a 43.9% decline from the "base" years of 2000-2002. In 2003, Pennsylvania enacted two reforms: (1) a certificate of merit requirement and (2) a venue restriction.

Excluding Philly, there were just 4 cases in 2009 with a verdict b/t 1 and 5 M.

South Dakota gets $$$ from AZ

SD's State Attorney General says South Dakota will receive $1.1 million as part of a sweeping settlement with pharmaceutical manufacturer AstraZeneca that resolved allegations of illegal marketing of the company's antipsychotic drug Seroquel.

Source here.

Guidant Plea Deal on Defibs Rejected

Image via Wikipedia

U.S. District Judge Donovan Frank in St. Paul, Minnesota, gave the judicial thumbs down to a plea agreement with prosecutors. He said the company should be placed on probation for failing to disclose defects with its heart devices to regulators. Boston Scientific had agreed to plead guilty to two misdemeanors and pay $296 million to settle a U.S. Justice Department probe.


On February 25, 2010, the United States of America charged Guidant LLC (formerly known as Guidant Corporation and hereinafter referred to as “Guidant”) with two misdemeanor violations of the FDCA pursuant to 21 U.S.C. § 333.

The filing of the Information was pursuant to a plea agreement that was
reached following a lengthy criminal investigation. As described more fully in the plea agreement, Guidant will plead guilty to: (1) making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and (2) failing to notify the FDA of a “correction” to the Contak Renewal
devices, which the company made to reduce a risk to health caused
by the devices.

Source.

“At a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation,” Frank said in his 37-page ruling.


Link here.

GA Avandia: TIDE Trial

From: http://www.theheart.org/article/1069095.do

Looks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.

There are concerns about whether or not the informed consent forms are up to snuff:

"If people were to reexamine the informed-consent forms, particularly in light of the data as of 2010, they may have second thoughts about whether they want to continue the trial at their own institution."

More at the link, above.

Defective Cardiac Science Corporation Powerheart, CardioVive, Nihon Kohden, and GE Responder External Defibrillators: Updated April 27, 2010

From the FDA site:

Device: Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillatorsmanufactured between August 2003 and August 2009. These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are unresponsive and not breathing.

Expanded Scope of Recall

Cardiac Science Corporation issued a press release2 (11/13/09) alerting users of its Powerheart, and CardioVive external defibrillators of defective components and reported failures. This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. Approximately 280,000 Cardiac Science external defibrillators worldwide are potentially affected by this problem.

The updated list of affected models includes:

* Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, and 9390E
* CardioVive 92531, 92532 , and 92533
* Nihon Kohden 9200G, and 9231
* GE Responder 2019198, and 2023440

In addition to failure to deliver needed shocks, other problems with these devices may include:

* Interruption of electrocardiography (ECG) analysis that prevents shock delivery,
* Failure to recognize pad (electrode) placement during use, or
* Interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if an ECG analysis is successfully conducted.

Improper functioning of the device during a rescue attempt may prevent resuscitation of patients and lead to serious adverse health events or death. The Daily/Weekly/Monthly self-tests performed by the affected devices’ software to ensure proper functioning may not detect defects in certain electronic components that can lead to device failure. Cardiac Science issued a software upgrade for the devices’ self tests on 2/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order.

Updated Recommendations

FDA recommends that all users of Cardiac Science external defibrillators affected by this recall take the following precautions:

* High Risk and/or Frequent Use Facilities should obtain an alternate external defibrillator or immediately arrange for repairs or replacement of the Cardiac Science external defibrillator. Examples of such facilities include hospitals, ambulances, clinical settings, high-risk patient population facilities, facilities with only one external defibrillator, and emergency transport settings.
* All other users, including Home Users and Public Access Defibrillation Programs, should take the following steps while arranging for repair or replacement of the Cardiac Science external defibrillator.

More here.

Astra Zeneca Pays $520 Million Fine for Seroquel Off Label Marketing

AstraZeneca has finalized its agreement with US federal and state entities, under which it will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for off-label uses.

The US contends that the company promoted the drug to doctors who do not typically treat schizophrenia or bipolar disorder, for which the drug is FDA approved. Instead, the drug was marketed to physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons for the treatment of unapproved uses including Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder and depression.

As part of the settlement, AstraZeneca has also entered into a corporate integrity agreement with the US Office of Inspector General of the US Department of Health and Human Services (HHS).

From the DOJ Press Statement:

AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.

SCOTUS and Merck Securities opinion

The U.S. Supreme Court has ruled that a securities fraud lawsuit can proceed against Merck over the pharmaceutical company's disclosures to investors about its withdrawn Vioxx pain drug. Find the opinion here.

A full discussion is on Wiki here.

The justices unanimously upheld a ruling by a U.S. appeals court that allowed the lawsuit seeking billions of dollars in damages to go forward. The appeals court held the claims were not time-barred under the statute of limitations.

The securities fraud lawsuit was unrelated to the $4.85 billion settlement in 2007 between Merck and plaintiffs who filed personal injury lawsuits against the company over Vioxx.

A federal judge initially dismissed the lawsuit and ruled the investors had waited too long, more than two years, to file the lawsuit after the first warnings that Vioxx might be unsafe.

But the appeals court in Philadelphia disagreed and ruled the two-year limitations period does not begin to run until the plaintiffs have actual knowledge the defendant intended to mislead investors.

Source here.

FDA warns TEVA

The Food and Drug Administration said it found "significant" manufacturing violations at Teva Pharmaceutical Industries Ltd. (TEVA) facility that makes the sedative drug propofol.

The agency posted a Dec. 11 warning letter to its Web site on Tuesday. The letter involved violations found during a FDA inspection of an Irvine, Calif. facility last July. Propofol, an injectable drug, is used for general anesthesia or sedation in operating rooms and intensive care units.

Source here.

A Challenge to MSP Collection Practices

A reported case is now moving forward with discovery. The case is one where there is a challenge to Medicare's MSP collection practices regarding conditional payments.

The challenge is to the requirement to reimburse Medicare within 60 days prior to resolution of any appeal or waiver request. Also challenged is the practice of PI attorneys having to withhold funds to cover Medicare conditional payments.

The plaintiffs are seeking declaratory and injunctive relief based upon the fact that the Secretary of Health and Human Services exceeded her authority under the Medicare Secondary Payer Act and violated their rights under the Due Process Clause.

This is a key case for consumer lawyers - read it here: Slip Copy, 2010 WL 1452932 (D.Ariz.)


Eventually, the Court will have to determine whether Medicare can require prepayment of conditional payments prior to a determination of whether the amount is correct through the administrative appeal process and whether Medicare can make plaintiff’s counsel financially responsible if they do not hold or immediately provide the settlement proceeds to Medicare.



Further discovery was ordered and the opinion held that judicial review will go beyond the administrative record for the individual plaintiff’s MSP claims. I have attached the recent holding.

Study Skews View of Courts

Kentucky lawyers comment on a Chamber report:

"The report is short on facts and credibility. And even more concerning is the lack of accountability it promotes - the same lack of accountability that pushed our nation into one of the worst economic messes in history."

More here: http://bit.ly/KYCourts

Adderal on 60 Minutes

Adderall is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD)… but apparently it’s also used by college students to stimulate their brains and increase awareness. Some college kids may be using it 'like steroids.'

Based on the studies ofAdderall XR (a long-acting version of Adderall), the most common side effects included:

* Loss of appetite (anorexia)
* Dry mouth
* Difficulty sleeping (insomnia)
* Headaches
* Abdominal pain (or stomach pain)
* Temporary increases in blood pressure
* Weight loss (see Adderall and Weight Loss)
* Emotional changes
* Nausea, upset stomach, or vomiting
* Dizziness
* Diarrhea
* Feeling of weakness (asthenia)
* Increased heart rate (tachycardia)
* Infection, including urinary tract infection (UTI)
* Fever
* Heartburn

FL Court decision - Compulsory Medical Examinations

35 Fla. L. Weekly D909 has a well reasoned case regarding medical examinations requested by a Defendant in an injury case.

Here is the synopsis: Circuit court improperly ordered plaintiff to submit to compulsory medical examination in presence of videographer hired by and acting on behalf of defendant's counsel.

NATALIE PRINCE AND MICHAEL PRINCE, Petitioners, v. RICARDO MALLARI, Respondent. 5th District. Case No. 5D09-2365. Opinion filed April 23, 2010. Petition for Certiorari Review of Order from the Circuit Court for Orange County, Robert M. Evans, Judge. Counsel: Barbara Green, of Barbara Green, P.A., Coral Gables, and Todd E. Copeland, of Todd E. Copeland & Associates, P.A., Orlando, for Petitioners. Andrew J. Leeper and Cynthia D. Lally, of Leeper & Haftel, P.A., Orlando, for Respondent. Sharon C. Degnan, of Kubicki Draper, Fort Lauderdale, Amicus Curiae, for Florida Defense Lawyers' Association.

(PER CURIAM.) Petitioners, Natalie Prince and Michael Prince ["Plaintiffs"], petition this Court for a writ of certiorari to quash an order of the circuit court that requires Natalie Prince to submit to a compulsory medical examination ["CME"] under Florida Rule of Civil Procedure 1.360 in the presence of a videographer hired by and acting on behalf of counsel for Respondent, Ricardo Mallari ["Defendant"]. We grant the writ and quash the order.

Natalie Prince suffered injuries to her neck, back and foot in an accident. She and her husband sued Ricardo Mallari and Bernadett Mallari for her injuries. Defendant served a notice of a CME pursuant to Florida Rule of Civil Procedure 1.360. The notice listed the date, time and location of the examination and the name of the physician who would perform it. The scope of the examination was described only as "neurological." The notice also stated in bold type: "If the plaintiff videotapes the examination, Defendant will also videotape the examination, at its expense."

Plaintiffs objected to the notice, asserting on multiple grounds that a defendant is not allowed to have any videographer or other representative at the examination:

a. [An] IME examination permits a minimal invasion of the right of privacy of a patient to allow a physical or mental examination of Plaintiff by a physician selected by the defense with respect to a physical or mental condition in controversy per Rule 1.360, Fla. R. Civ. P.

b. There exists no authority under Rule 1.360, by Florida Statute or under Florida law to allow a videographer or other representative of Defendant, other than the IME doctor, to attend the IME. In fact, the first District Court of Appeal in Chavez v. J & L Drywall, 858 So. 2d 1266, 1269-70 (Fla. 1st DCA 2003), held that a defense attorney could not attend a IME, emphasizing the privacy rights of the patient examinee.

c. Defendant in this case should not be allowed to do indirectly via a videographer what they cannot do directly under Chavez.

d. Plaintiff is entitled to have an attorney, court reporter, videographer, or other representative attend the IME because of the recognized adversarial nature of a IME and the need to protect the rights of the patient plaintiff. No concomitant need exists for the party hiring the IME doctor who is performing the examination on behalf of Defendant as the expert witness agent of Defendant and its insurance carrier.

e. Under [HIPAA], the Federal government has recognized the sanctity of a patient's rights to privacy with respect to medical and psychological matters and records, and only under limited, necessary, carefully circumscribed circumstances justifying intrusion of that right is a third party allowed to invade an individual's right to privacy on a limited basis.

f. The privacy of the examinee, not the examiner, is the issue, and therefore, the defense has no need or right to record the IME by any means or to have a videographer, court reporter, attorney, or other representative present besides the examining doctor at [an] IME conducted by the very medical expert it hired who will have first hand knowledge of the examination conducted by him/her, author a written report to defense counsel and be able to consult with defense counsel with respect to the examination as a specially hired, professional expert witness. See, Stakley v. Allstate Ins. Co., 547 So. 2d 275 (Fla. 2d DCA 1989).

A hearing was held on Plaintiffs' objections. The defense contended simply that, if Plaintiffs are entitled to videotape the examination, the defense also ought to be entitled to do so. Defense counsel further argued that they should have their own videotape of the examination because Plaintiffs' videotape is Plaintiffs' work product and "we're not going to be able to get it without showing need and the inability to get it any other way." If they do get it, they cannot assure its accuracy without a video of their own.

Plaintiffs' counsel urged that videotaping the rule 1.360 CME by Defendant would violate Plaintiffs' privacy and that the videographer was there for Plaintiffs' benefit and protection. He pointed out that the case law recognized that a plaintiff who submits to a compulsory medical examination is in an inferior position and that one purpose of the videotape is to allow a plaintiff to have the session critiqued by his own expert.

The trial court ordered that the defense be allowed to have a videographer present, remarking: "to me it's logical that if you allow one, you allow the other".

As this Court pointed out in Lunceford v. Florida Central Railroad Co., 728 So. 2d 1239, 1241 (Fla. 5th DCA 1999), quashing an order excluding plaintiff's own videographer, "it is the privacy interest of the petitioner [plaintiff] that is involved, not the privacy interest of the examiner, and if the petitioner [plaintiff] wants to ensure that a compelled examination is accurately preserved, the petitioner should generally be entitled to do so." Id. at 1241 (emphasis added).

The rule is now well established that a plaintiff is allowed to be accompanied at a compulsory medical examination by her counsel and a videographer of her choosing. In U.S. Security Insurance Co. v. Cimino, 754 So. 2d 697 (Fla. 2000), the Supreme Court held that an insured was entitled to have her own attorney or a court reporter attend her examination by the insurance company's doctor. Whether in the context of a personal injury protection claim or in an examination pursuant to the civil procedure or workers' compensation rules, the parties' relationship is "adversarial" and a plaintiff is entitled to protection. Id. at 701.

Florida courts have made it clear that, although the defense has the right, by rule, to a compulsory medical examination of a plaintiff, defense counsel does not have the right to be present at the examination. See Chavez v. J&L Drywall, 858 So. 2d 1266 (Fla. 1st DCA 2003). A plaintiff retains a right to privacy and that right will not allow for the compelled presence of third parties, whether it be counsel or a videographer. Gibson v. Gibson, 456 So. 2d 1320, 1321 (Fla. 4th DCA 1984). Defense counsel cannot do by proxy what they are not permitted to do in person. See McGarrah v. Bayfront Med. Ctr., 889 So. 2d 923, 927 n.3 (Fla. 2d DCA 2004).1

In Chavez, the court issued a writ of certiorari and quashed an order in a workers' compensation case allowing the employer's counsel to attend the CME of the claimant, recognizing the privacy interest of the person being examined. For the same reason, Natalie Prince cannot, against her will, be subjected to a physical examination in the presence of a videographer hired by her opponent's attorney. If the examination is recorded by her own attorney, she has control of it. To allow a stranger into the examining room to record the examination on behalf of one's opponent, to be viewed and used as the opponent sees fit, is completely outside the operation of the rule.

The Chavez court also recognized the adversarial nature of the examination and the need for an unsophisticated plaintiff to have some protection in dealing with a professional expert retained by her opponent in a very unique, difficult circumstance. In a compulsory medical examination, a plaintiff is placed in the awkward position of being physically examined by someone not of his or her choosing, who has no interest in the plaintiff's well-being and not for medical treatment. A physician performing a CME "is essentially an expert witness for the party requesting the examination;" consequently, "the parties' relationship is clearly adversarial." Chavez, 858 So. 2d at 1268. A plaintiff being examined is allowed to have his attorney (or videographer) "present to guarantee, for example, that the doctor does not interrogate the plaintiff on liability questions in order to seek damaging admissions," id., or engage in other unfair or improper conduct. Byrd v. S. Prestressed Concrete, Inc., 928 So. 2d 455, 459 (Fla. 1st DCA 2006), citing Cimino, 754 So. 2d 697. Natalie Prince has the right to such protections, but Defendant has no such right and needs no such protection. The trial court's apparent conclusion that each side should have the same access because each side stands on equal footing is wrong for that reason. A plaintiff has a privacy interest that deserves protection and the defendant already is represented by the examiner.

Defendant's complaint that Plaintiffs are in control of the video record is simply not a reason to order a second videographer. A plaintiff is entitled to record any or all of his or her examination as he or she sees fit, so long as it does not interfere with the examination. If a plaintiff has an incomplete or unclear record, that is a plaintiff's concern, not a defendant's. The defense loses nothing to which it is otherwise entitled, and if a plaintiff elects to use the video at trial, he loses its work product protection. See Maguire v. Pool Doctor of the Palm Beaches, Inc., 23 So. 3d 865 (Fla. 4th DCA 2009); McGarrah, 889 So. 2d 923. See generally Dodson v. Persell, 390 So. 2d 704 (Fla. 1980).

Petition GRANTED; order QUASHED. (GRIFFIN and COHEN, JJ., concur. SAWAYA, J., concurs in result only.)

__________________

1It is also worth remembering that the original argument advanced by defense counsel for not allowing a plaintiff's counsel or videographer to be present was disruption of the examination. Courts have decided, however, that a plaintiff's need for protection outweighed such concerns. Defendant's described "need" in this case carries no such weight.

* * *

In CA, an Offer of Compromise = Claim by Defendant for $460,000 in Botox Lawsuit

The maker of Botox is seeking $460,000 in legal costs from a mother who unsuccessfully sued the company over the death of her 7-year-old daughter after a series of therapeutic Botox injections. Source.

In that case, a jury entered an award for Allergan, a defense verdict.

From the report:

Allergan stated about its request for court costs from Spears: "During the lawsuit, we served plaintiff with a statutory offer to compromise, which they did not accept."

As a result of the jury’s conclusion that the scientific evidence confirmed that Botox played no role in the unfortunate passing of Kristen Spears, pursuant to plaintiff’s rejection of the statutory offer to compromise, Allergan has submitted to the court our request for reimbursement of costs.

FL law: Proposal for Settlement to Multiple Parties Not Enforceable

Image via Wikipedia

The Florida Supreme Court ruled in Attorney’s Title Insurance Fund, Inc., v. Joseph W. Gorka, (SC09-1899)that a a proposal for settlement is invalid if it is conditioned upon actions out of the control of the offeree.

From the opinion:

The issue presented by the conflicting decisions is whether a joint offer of settlement or judgment that is conditioned on the mutual acceptance of all of the joint offerees is valid and enforceable. We approve the decision of the Second District Court of Appeal and hold that this type of joint offer is invalid and unenforceable because it is conditioned such that neither offeree can independently evaluate or settle his or her respective claim by accepting the proposal. The conditional nature of the offer divests each party of independent control of the decision to settle, thereby rendering the offer of judgment invalid and unenforceable.

http://www.floridasupremecourt.org/decisions/2010/sc08-1899.pdf

Tracheostomy tubes recalled after several deaths

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From the FDA:

Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.

The voluntary recall only affects lot numbers from a specific period of time. Only Shiley tracheostomy tubes from lot numbers listed below are affected by this action.

Find the lots here: http://www.fda.gov/Safety/Recalls/ucm209709.htm

MS: State May Sue Bayer, MS Supreme Court Decision

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Find the opinion here.

Bayer was accused of inflating the average wholesale price of medications, causing the state to overpay drug providers to patients on its Medicaid program. The false price reports led the Mississippi Medicaid program to spend millions of taxpayers' dollars unnecessarily according to the State.

According to the decision: "The trial court considered matters outside the pleadings when it took into account the 2001 settlement agreement. Having done so, the trial court was required to convert Bayer's motion for summary judgment."

Daubert Applies during Class Certification says the 7th Circuit

The Seventh Circuit has held that "when an expert's report or testimony is critical to class certification, a district court must conclusively rule on any challenge to the expert's qualifications or submissions prior to ruling on a class certification motion.

The district court must perform a full Daubert analysis before certifying the class is the situation warrants." (Opinion at p. 6). From the decision:

We hold that when an expert’s report or testimony is
critical to class certification, as it is here, see Allen, 264
F.R.D. at 420 (“Mr. Ezra’s wobble decay standard . . . forms
the basis of Plaintiffs’ theory of defect.”), a district
court must conclusively rule on any challenge to the
expert’s qualifications or submissions prior to ruling on
a class certification motion. That is, the district court
must perform a full Daubert analysis before certifying
the class if the situation warrants. If the challenge is to
an individual’s qualifications, a court must make that
determination “by comparing the area in which the
witness has superior knowledge, skill, experience, or
education with the subject matter of the witness’s testimony.”
Carroll v. Otis Elevator Co., 896 F.2d 210, 212 (7th
Cir. 1990)


Find the case here: caselaw.lp.findlaw.com/data2/circs/7th/098051p.pdf

A Must Read: Judge Fallon's L.R. Article: Wellwether Trials in an MDL setting

Find it here:
http://www.jpml.uscourts.gov/Legal_Resources/Bellwether_Trials_Fallon_Grabill_Wynne.pdf

FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil

The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication.

The new warning also states that for patients being started on treatment for hyperthyroidism it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine or surgery. In addition, due to the occurrence of birth defects that have been observed with the use of methimazole during the first trimester of pregnancy (see Data Summary), propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.

Propylthiouracil has been shown to be effective in reducing thyroid hormone levels and decreasing symptoms associated with hyperthyroidism. However, to help patients understand the known benefits and potential risks of this medication, as part of a Risk Evaluation and Mitigation Strategy (REMS), FDA is requiring that a Medication Guide be given to every patient filling a prescription for propylthiouracil.

The recommendations in the Boxed Warning and the requirement of a Medication Guide are based on FDA's review of post-marketing safety reports of propylthiouracil (see Data Summary) as well as meetings with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community.

Source: http://bit.ly/dBQZVY

Hospira- Liposyn/Propofol : Second Drug Recall in 6 Months on FDA Warning

Hospira recalled two drugs for the second because of manufacturing defects that prompted an April 12 warning letter from the U.S. Food and Drug Administration, said Dan Rosenberg, a company spokesman.

The drugs -- Propofol and Liposyn -- were recalled on April 1, 2010. The company told the FDA the products had been contaminated by particulates during the manufacturing process, he said. The drugs are sold to hospitals and doctors.

The company recalled Propofol and Liposyn in late 2009 because of an equipment failure at a manufacturing facility in Clayton, North Carolina. The FDA inspected the Clayton plant in January and February.

More here.

Georgia: Report - FDA May Halt Avandia Safety Study

According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.

FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."

Sharfstein said no decision had been made on the trial -- the FDA has asked a government scientific panel to review the ethics of head-to-head trials, the Journal said.

Link here: http://online.wsj.com/article/SB10001424052748704508904575191944217066832.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

Instructions Not to Answer

Found this recent case on the subject:

ZCT SYSTEMS GROUP, INC. v. FLIGHTSAFETY INTERNATIONAL

ZCT SYSTEMS GROUP, INC., Plaintiff,
v.
FLIGHTSAFETY INTERNATIONAL, Defendant.

Case No. 08-CV-447-JHP-PJC

United States District Court, N.D. Oklahoma

On Jan. 26, 2010, ZCT served a Rule 30(b)(6) Notice on FSI that it would take the depositions of certain FSI corporate representatives on specific topics. FSI designated Pitts for deposition on Feb. 12, 2010 at 9:30 a.m. on two topics: (1) the creation, contents, interpretation, and authentication of FSI’s spreadsheets produced in discovery and (2) FSI’s business dealings and contractual relationship with Aeroism and Tricom including a description of the types of codes FSI has provided to Aeorism and Tricom. [Dkt. No. 101, Exh. 1]. FSI designated Van Maren for deposition on Feb. 16, 2010 on two topics: (1) FSI’s business dealings and contractual relationship with Aeroism and Tricom including the services provided by Aeroism and Tricom and the intended use by FSI of the deliverables provided by Aeroism and Tricom. [Dkt. No. 101, Exh. 1].

By agreement of the parties, Pitts and Van Maren were to be deposed as 30(b)(6) witnesses first. following their depositions as corporate representatives, both men were to be deposed as individual fact witnesses.[ 1 ]See Dkt. No 139, Exh. 3 & 4.

A. Instruction Not to Answer Based on Scope of 30(b)(6) Notice.

At their 30(b)(6) depositions, Pitts and Van Maren were frequently instructed by counsel not to answer questions on the ground that those questions were outside the scope of the 30(b)(6) notice. FSI contended that these questions should instead be reserved for the Rule 26 depositions. ZCT contends that the questions were not outside the scope of the 30(b)(6) notice, and that in any case it was improper to instruct the witnesses not to answer. the Court agrees with this latter point.

The Federal Rules of Civil Procedure are clear:

A person may instruct a deponent not to answer a question only when necessary to preserve a privilege, to enforce a limitation ordered by the court, or to present a motion under Rule 30(d)(3).

Fed. R. Civ. P. 30(c)(2).

The instruction not to answer on 30(b)(6) scope grounds was improper because FSI was not seeking to preserve a privilege, enforce a limitation ordered by the court or in order to present a motion under Rule 30(d)(3).[ 2 ]

The two leading cases on the scope of a Rule 30(b)(6) deposition are King v. Pratt & Whitney, 161 F.R.D. 475, 476 (S.D.Fla. 1995) (allowing questioning beyond the areas listed in a Rule 30(b)(6) notice) and Paparelli v. Prudential Insurance co., 108 F.R.D. 727, 730 (D.Mass. 1985) (limiting a Rule 30(b)(6) deposition to matters stated with “reasonable particularity” in the deposition notice). however, even Paparelli held that it is improper to instruct a witness not to answer on the grounds that questions were outside the scope of the 30(b)(6) notice. Id. at 730-31.

FSI’s counsel should have simply allowed the questioning of Pitts and Van Maren to proceed while noting where necessary that the witness’ answer was not binding on the corporation. This is not a special rule of this Court as has been suggested. for example, in Detoy v. City and County of San Francisco, 196 F.R.D. 362 (N.D.Cal. 2000), the Court noted:

If the examining party asks questions outside the scope of the matters described in the notice, the general deposition rules govern (i.e. Fed.R.Civ.P. 26(b)(1)), so that relevant questions may be asked and no special protection is conferred on a deponent by virtue of the fact that the deposition was noticed under 30(b)(6).

Id. at 366-67 (emphasis added). See also Batts v. County of Santa Clara, 2010 WL 545847 (N.D.Cal. Feb. 11, 2010) (holding that instructing a witness not to answer a question on grounds that it was outside the scope of the 30(b)(6) notice was “clearly improper.”)

Counsel’s instructions not to answer was clearly improper, in violation of the Federal Rules and unreasonably obstructed the depositions.

Study: Yasmine may cause increase in blood clots (Georgia/Florida)

An independent study was conducted by researchers at the Leiden University Medical Center in the Netherlands. The results were published in the British Medical Journal during the summer of 2009.

The Leiden University study concluded that birth control pills containing the ingredient drospirenone – like Yasmin – are two times more likely to cause blood clots than other birth control pills, which generally contain levonorgestrel. The alleged increased risk of blood clots from Yasmin side effects was not offset by effectiveness. Researchers discovered that all of the oral contraceptives involved in the study were equally effective in preventing pregnancy.

From the abstract:
Participants Premenopausal women <50 years old who were not pregnant, not within four weeks postpartum, and not using a hormone excreting intrauterine device or depot contraceptive. Analysis included 1524 patients and 1760 controls.

Main outcome measures First objectively diagnosed episodes of deep venous thrombosis of the leg or pulmonary embolism. Odds ratios calculated by cross-tabulation with a 95% confidence interval according to Woolf’s method; adjusted odds ratios estimated by unconditional logistic regression, standard errors derived from the model.

Results Currently available oral contraceptives increased the risk of venous thrombosis fivefold compared with non-use (odds ratio 5.0, 95% CI 4.2 to 5.8). The risk clearly differed by type of progestogen and dose of oestrogen. The use of oral contraceptives containing levonorgestrel was associated with an almost fourfold increased risk of venous thrombosis (odds ratio 3.6, 2.9 to 4.6) relative to non-users, whereas the risk of venous thrombosis compared with non-use was increased 5.6-fold for gestodene (5.6, 3.7 to 8.4), 7.3-fold for desogestrel (7.3, 5.3 to 10.0), 6.8-fold for cyproterone acetate (6.8, 4.7 to 10.0), and 6.3-fold for drospirenone (6.3, 2.9 to 13.7). The risk of venous thrombosis was positively associated with oestrogen dose. We confirmed a high risk of venous thrombosis during the first months of oral contraceptive use irrespective of the type of oral contraceptives.

Conclusions Currently available oral contraceptives still have a major impact on thrombosis occurrence and many women do not use the safest brands with regard to risk of venous thrombosis.

http://www.bmj.com/cgi/content/abstract/339/aug13_2/b2921

Denture Cream (Fixodent, Poli-Grip) and Claimed Link to Neuropathy

From Neurology Today:

An unusual source of excess zinc, leading to hypocupremia and neurologic disease
S. P. Nations, MD, P. J. Boyer, MD, PhD, L. A. Love, MD, M. F. Burritt, PhD, J. A. Butz, BA, G. I. Wolfe, MD, L. S. Hynan, PhD, J. Reisch, PhD and J. R. Trivedi, MD.

From the abstract:

Background: Chronic, excess zinc intake can result in copper deficiency and profound neurologic disease. However, when hyperzincemia is identified, the source often remains elusive. We identified four patients, one previously reported, with various neurologic abnormalities in the setting of hypocupremia and hyperzincemia. Each of these patients wore dentures and used very large amounts of denture cream chronically.

Objective: To determine zinc concentration in the denture creams used by the patients as a possible source of excess zinc ingestion.

Methods: Detailed clinical and laboratory data for each patient were compiled. Tubes of denture adhesives were analyzed for zinc content using dynamic reaction cell-inductively coupled plasma-mass spectrometry. Patients received copper supplementation. Copper and zinc levels were obtained post-treatment at varying intervals.

Results: Zinc concentrations ranging from about 17,000 to 34,000 µg/g were identified in Fixodent and Poli-Grip denture creams. Serum zinc levels improved in three patients following cessation of denture cream use. Copper supplementation resulted in mild neurologic improvement in two patients who stopped using denture cream. No alternative source of excess zinc ingestion or explanation for hypocupremia was identified.

Conclusion: Denture cream contains zinc, and chronic excessive use may result in hypocupremia and serious neurologic disease.

Source.

Do Some Anticonvulsant Drugs ncrease Suicide Risk?

Image by braineater via Flickr

Two years ago, the U.S. Food and Drug Administration published information showing that people taking anticonvulsant medications, drugs used to treat epilepsy, have twice the risk of suicidal behavior and suicidal thoughts.

From JAMA:

Context In 2008, the US Food and Drug Administration mandated warning labeling for anticonvulsant medications regarding the increased risk of suicidal thoughts and behaviors. The decision was based on a meta-analysis not sufficiently large to investigate individual drugs.

Objective To evaluate the risk of suicidal acts and combined suicidal acts or violent death associated with individual anticonvulsants.

Design A cohort study of the risk of suicidal acts and combined suicidal acts or violent death in patients beginning use of anticonvulsant medications compared with patients initiating a reference anticonvulsant drug.

Setting and Patients Patients 15 years and older from the HealthCore Integrated Research Database (HIRD) who began taking an anticonvulsant between July 2001 and December 2006.

Main Outcome Measures Cox proportional hazards models and propensity score–matched analyses were used to evaluate risk of attempted or completed suicide and combined suicidal acts or violent death, controlling for psychiatric comorbidities and other risk factors, among individual anticonvulsants compared with topiramate and secondarily carbamazepine.

Results The study identified 26 completed suicides, 801 attempted suicides, and 41 violent deaths in 297 620 new episodes of treatment with an anticonvulsant (overall median follow-up, 60 days). The incidence of the composite outcomes of completed suicides, attempted suicides, and violent deaths for anticonvulsants used in at least 100 treatment episodes ranged from 6.2 per 1000 person-years for primidone to 34.3 per 1000 person-years for oxcarbazepine. The risk of suicidal acts was increased for gabapentin (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.11-1.80), lamotrigine (HR, 1.84; 95% CI, 1.43-2.37), oxcarbazepine (HR, 2.07; 95% CI, 1.52-2.80), tiagabine (HR, 2.41; 95% CI, 1.65-3.52), and valproate (HR, 1.65; 95% CI, 1.25-2.19), compared with topiramate. The analyses including violent death produced similar results. Gabapentin users had increased risk in subgroups of younger and older patients, patients with mood disorders, and patients with epilepsy or seizure when compared with carbamazepine.

Conclusion This exploratory analysis suggests that the use of gabapentin, lamotrigine, oxcarbazepine, and tiagabine, compared with the use of topiramate, may be associated with an increased risk of suicidal acts or violent deaths.

Source: http://jama.ama-assn.org/cgi/content/abstract/303/14/1401

Toyota MDL California

The JPML Order may be found here:

http://www.jpml.uscourts.gov/Recent_Orders/Recent_Orders/MDL-2151-TransferOrder.pdf

From the Order:

The parties have suggested a number of very acceptable transferee districts and judges. However, for the following reasons, we have settled upon the Central District of California as the most appropriate choice. Toyota maintains its United States corporate headquarters within this district, and relevant documents and witnesses are likely located there. Far more actions are pending there than in any other district. Among the cases pending there are potential tag-along cases that
assert personal injury or wrongful death claims.4 After consulting with Chief Judge Audrey B. Collins, we have selected Judge James V. Selna as the transferee judge. He is a well regarded and skilled jurist. Moreover, Judge Selna’s 28 years of private law practice at the very highest levels and in some of the most complex cases leaves him well prepared for a case of this magnitude.

Some counsel did express concern about the docket conditions in this district. The ability and willingness of even the most experienced judges to devote the necessary time to a complex MDL is always a factor in our assignments. In this particular instance, our consultations with Judge Selna and Chief Judge Collins convince us that Judge Selna is positioned to devote all the time necessary to manage and decide the important issues these cases raise.

Oftalmi Product Recall

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US Oftalmi Corp. has announced the voluntary recall of 15 mL plastic bottles of over-the-counter Camolyn Eye Drops and Fisiolin Nasal Drops. The FDA announced the recall after it was discovered that the products be unsterile, subsequently posing safety hazards to consumers.

According to the FDA, the recall was issued “due to conditions at the manufacturing facility that cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening”. Although the recalled products have yet to cause any injuries, illnesses or harmful effects, US Oftalmi issued the recall as a safety precaution. The chances of consumers suffering any unpleasant reactions from the recalled eye and nasal drops were reportedly deemed to be slim and unlikely, however, the firm did not want to take any chances with regard to the safety of the product. US Oftalmi has stopped production, importation and distribution of the recalled eye and nasal drops for the time being.

Here are the products:

•CAMOLYN HOMEOPATHIC

Lot #: 049036, 087934

Expiration dates: 05/2011, 08/2009

UPC codes: 591196, 00446

•CAMOLYN PLUS, NAPHAZOLINE + CHAMOMILE 15 ml.

Lot #: 037691, 097420

Expiration Dates: 03/2010, 10/2010

UPC codes: 66482, 00018

•CAMOLYN REFRESH 15 ml.

Lot #: 116636, 107610

Expiration Dates: 11/2009, 11/2010

UPC codes: 66482, 00020

•CAMOLYN-A, NAPHAZOLINE + PHENIRAMINE 15 ml

Lot #: 057063, 058962, 106606, 099487

Expiration Dates: 05/2009 ,04/2010, 10/2008, 09/2011

UPC codes: 66482, 00019

•FISIOLIN NASAL DROPS SODIUM CHLORIDE PEDIATRIC USES 15 ml.

Lot #: 028659

Expiration Dates: 03/2011

UPC codes: 591196, 00375

FDA Investigates Companies Using "Fat Melting Shots"

The FDA (Food and Drug Administration) is cracking down on companies making claims that you can lose weight through something called “fat melting shots.” These are injections known as mesotherapy, injection lipolysis and going under numerous other names.

The FDA notified several companies that their claims are considered deceptive. The companies were claiming that the injections simply melt away fat and there were no chances of side-effects resulting. However, there were many side-effects reported to the FDA. Permanent blemishes and lumps under the skin, where the contents of the injection did not dissolve, are some of the ailments that led to complaints.

More here.

FDA: Byetta May Have Cancer Risk

Data on intravenous dosing and a once-weekly version of Byetta “seem to give a similar signal” as cancers seen in rodent studies of Novo Nordisk A/S’s competing Victoza, said Curtis Rosebraugh, head of the Food and Drug Administration’s Office of Drug Evaluation II, in a Jan. 25 memo posted on the agency’s Web site.

Source here.

FDA to review Trial Data on Stalevo (Parkinson's drug)

The FDA will review clinical trial data from a four-year study conducted by Orion to see if patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer.

The FDA said the review of Stalevo is ongoing, and no conclusions or recommendations about the use of this drug have been made. Prior trials of shorter duration evaluating Stalevo did not find an increased risk of prostate cancer.

A prior trial showed 3.7% of men who took Stalevo contracted prostate cancer, compared to 0.9% of those taking Sinemet.

Source.