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Perspective of a Legal Specialist in Whistleblower Law and Pharmaceutical Injury
Wednesday, September 19, 2012
Tuesday, August 28, 2012
Faulty Retrievable Inferior Vena Cava Filters Cause Serious Physical Injuries
Cases involving faulty retrievable Inferior Vena Cava (IVC) filters are currently being litigated due to their propensity to fracture or migrate within the human body and/or perforating the IVC. The failure of these devices often result in serious bodily injuries including: perforations of vessels and organs, hemorrhaging, cardiac/pericardial tamponade, cardiac arrhythmia, severe and persistent pain and death. The FDA is currently conducting a review to evaluate the risk vs. benefit profile of IVC filters. To date, the FDA has recommended that IVC filters be removed as soon as the risk of pulmonary embolism has subsided. The IVC filters are manufactured by C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. IVC filters manufactured by Cook Medical are also at issue.
The medical and scientific evidence demonstrates that Bard's retrievable IVC filters, in particular, are prone to an unreasonably high risk of failure and patient injury. Multiple studies have reported that Bard's IVC filters have a fracture and migration rate ranging from 21% to 31.7%. This far exceeds the reported fracture rates of comparable devices.
Thursday, August 2, 2012
Our ongoing investigation: Antidepressants and birth defects
In the investigation of antidepressants and birth defects, we continue to represent families where the mother took one of the drugs (especially in their third trimester) and the child was born with birth defects.
The brand names of the most well-known of these drugs include Celexa, Cymbalta, Effexor, Lexapro, Luvox, Paxil, Prozac and Zoloft. For a comprehensive list of the SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin-norepinephrine reuptake inhibitor) drugs, see our firm’s webpage on antidpressants and birth defects.
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The most serious defect for the children is called “persistent pulmonary hypertension of the newborn” (PPHN). The baby might experience this at birth and beyond or develop later, ranging from serious to life-threatening, with organ failure and even death.
Symptoms include breathing and heart issues, as well as low oxygen that may present as “bluish” skin.
Children under 18 whose mothers took these drugs have experienced these severe and in some cases life-threatening birth defects that have required surgeries and other treatment. If you as the mother or someone in your family or friends took antidepressants and had children with PPHN, you should contact me immediately for a free no obligation consultation to learn your options. There may be compensation available to you, but there is a time limit.
Most people know if the drug they’ve taken is an antidepressant, but may not know it’s classified as one of the SSRI or SNRI drugs. Doctors do not always tell their patients what type of drug they are prescribing. All patients should always be advised what kind of drugs they are taking.
Again, you can see the comprehensive list of the SSRI and SNRI antidepressant drugs that are under investigation on our firm’s webpage, “Antidepressants and Birth Defects.”
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There are still families out there who aren't aware their child’s health problems might be linked to these drugs. Contact me for a no obligation, no cost consultation to learn your options and protect your child's health now and in the future
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The most serious defect for the children is called “persistent pulmonary hypertension of the newborn” (PPHN). The baby might experience this at birth and beyond or develop later, ranging from serious to life-threatening, with organ failure and even death.
Symptoms include breathing and heart issues, as well as low oxygen that may present as “bluish” skin.
Children under 18 whose mothers took these drugs have experienced these severe and in some cases life-threatening birth defects that have required surgeries and other treatment. If you as the mother or someone in your family or friends took antidepressants and had children with PPHN, you should contact me immediately for a free no obligation consultation to learn your options. There may be compensation available to you, but there is a time limit.
Most people know if the drug they’ve taken is an antidepressant, but may not know it’s classified as one of the SSRI or SNRI drugs. Doctors do not always tell their patients what type of drug they are prescribing. All patients should always be advised what kind of drugs they are taking.
Again, you can see the comprehensive list of the SSRI and SNRI antidepressant drugs that are under investigation on our firm’s webpage, “Antidepressants and Birth Defects.”
Monday, July 30, 2012
Pliva, Inc. v. Mensing: Consumers lose right to pursue justice for injury caused by generics
Here's a communication I received as a member of the Leaders Forum for the American Association for Justice.
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Dear Colleagues,
As a Leaders Forum member, you are among the first to receive the latest update on the work of the Center for Constitutional Litigation.
In this last year since the Supreme Court of the United States ruled in Pliva, Inc. v. Mensing, the Center for Constitutional Litigation has worked on a number of cases that challenge the reach of that decision. As you know, in Mensing, the court ruled 5-4 that in most cases generic drug makers cannot be sued for failure to warn. The Court held that it was impossible for the generic manufacturers to comply with federal law—which requires generic labels to match brand-name labels—and state law—which may require a stronger warning.
In particular, among other issues, CCL is arguing that “impossibility preemption” does not apply to design defect cases. At this point, among the courts, there is a difference in opinion.
Thank you for your dedication and support of AAJ as a member of Leaders Forum.
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Mensing Does Not Preempt…
In the case of Bartlett v. Mutual Pharm. Co., Inc., the U.S. Court of Appeals for the First Circuit ruled that the Supreme Court’s decision in Mensing did not preempt state law design defect claims against the generic drug manufacturer.
In this case, CCL worked with the New Hampshire Association for Justice and filed an amicus brief in support of the plaintiff who used a drug called sulindac, which blinded her and caused much of her skin to burn off. The doctor had prescribed the brand name version of this non-steroidal anti-inflammatory drug, but the pharmacy dispensed the generic form, sulindac.
At trial, the district court told the jury that in order to find for the plaintiff, it must find that “sulindac’s design was in a defective condition unreasonably dangerous to consumers.” The jury decided in favor of the plaintiff and awarded her $21 million.
In his opinion for the court, Judge Michael Boudin wrote that, “…it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. Given the widespread use of generic drugs and the developing split in the lower courts…this issue needs a decisive answer from the only court that can supply it.”
Mensing Does Preempt…
One of the courts that concluded differently is the U.S. District Court, Eastern District of Kentucky. In a joint motion to dismiss filed by multiple defendants in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Judge Danny C. Reeves ruled that the Mensing decision applies to design defect and failure-to-warn claims.
One of the most compelling arguments for preserving these cases is that the clients took a generic form (propoxyphene) of Darvon/Darvocet which has been pulled off the market. The removal of the drug from the market bolsters the design defect argument that the drug’s risks outweighed its limited benefits.
CCL Senior Litigation Counsel, Lou Bograd, will handle the appeal of this ruling to the Sixth Circuit. Briefing in the Court of Appeals is scheduled to begin in August.
____________________________________________________
Dear Colleagues,
As a Leaders Forum member, you are among the first to receive the latest update on the work of the Center for Constitutional Litigation.
In particular, among other issues, CCL is arguing that “impossibility preemption” does not apply to design defect cases. At this point, among the courts, there is a difference in opinion.
Thank you for your dedication and support of AAJ as a member of Leaders Forum.
_____________________________________________________
Mensing Does Not Preempt…
In the case of Bartlett v. Mutual Pharm. Co., Inc., the U.S. Court of Appeals for the First Circuit ruled that the Supreme Court’s decision in Mensing did not preempt state law design defect claims against the generic drug manufacturer.
In this case, CCL worked with the New Hampshire Association for Justice and filed an amicus brief in support of the plaintiff who used a drug called sulindac, which blinded her and caused much of her skin to burn off. The doctor had prescribed the brand name version of this non-steroidal anti-inflammatory drug, but the pharmacy dispensed the generic form, sulindac.
At trial, the district court told the jury that in order to find for the plaintiff, it must find that “sulindac’s design was in a defective condition unreasonably dangerous to consumers.” The jury decided in favor of the plaintiff and awarded her $21 million.
In his opinion for the court, Judge Michael Boudin wrote that, “…it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. Given the widespread use of generic drugs and the developing split in the lower courts…this issue needs a decisive answer from the only court that can supply it.”
Mensing Does Preempt…
One of the courts that concluded differently is the U.S. District Court, Eastern District of Kentucky. In a joint motion to dismiss filed by multiple defendants in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Judge Danny C. Reeves ruled that the Mensing decision applies to design defect and failure-to-warn claims.
One of the most compelling arguments for preserving these cases is that the clients took a generic form (propoxyphene) of Darvon/Darvocet which has been pulled off the market. The removal of the drug from the market bolsters the design defect argument that the drug’s risks outweighed its limited benefits.
CCL Senior Litigation Counsel, Lou Bograd, will handle the appeal of this ruling to the Sixth Circuit. Briefing in the Court of Appeals is scheduled to begin in August.
Sunday, July 29, 2012
FDA "Bad Ad" Initiative: Encouraging Health Care Professionals and the Public to Report MIsleading Drug Ads
Martin Berman-Gorvine writes about the FDA continuing to publicize the program for health care professionals and the public.
In the past two months, FDA’s Office of Prescription Drug Promotion has been advertising its “Bad Ad” program in several medical journals, encouraging healthcare professionals to report potentially misleading drug promotion.
The ads have been running in the Journal of the American Medical Association, American Family Physician, the American Journal of Health-System Pharmacy and others. For more information, see information later in this post.
The FDA website also contains information on evaluating "direct to consumer" (DTC) advertising. Most people don't know that only one other country in the world, New Zealand, allows this type of advertising.
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Representing Whistleblowers, Beyond "Bad Ads"
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What may be critical to note here is some healthcare professionals, pharma industry employees, and others can have information far more than just a "bad ad"- there may be the possibility of criminal action on the part of the pharma company, for not just illegal marketing but fraud, failure to warn, and violations of the False Claims Act.
My specialty is to represent whistleblowers who bring this information forward.
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Here's a little known fact, you can find this in the information on the "Bad Ad" program direct from the FDA's website:
The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as they do advertising to consumers, according to the Congressional Budget Office.
The webpage continues, describing the program.
For more information on how to proceed as a whistleblower:
Call me at 215-790-7300 or write chomolash@sheller.com. Timing is important- our firm not only has the resources and track record representing whistleblowers, we bring a strategic perspective to how and when to file, optimizing the potential for both "first to file" and subsequent claims.
Tuesday, April 10, 2012
Claudine Homolash Featured on "Legally Speaking" WMPV 1440 on April 4
I was featured on Radio Show, "Legally Speaking," on WMPV 1440 on Wednesday, April 4, 2012. www.wnpv1440.com Click on the image below to listen to the program.
Topics included pharmaceutical whistleblower cases, cash payments made to doctors by pharma co.'s and general discussion about pharmaceutical injury cases.
Topics included pharmaceutical whistleblower cases, cash payments made to doctors by pharma co.'s and general discussion about pharmaceutical injury cases.
Monday, March 19, 2012
Women's Roundtable for The Legal Intelligencer
On March 13, I participated in a Women's Roundtable discussion for a supplement for The Legal Intelligencer which will be published in April 2012. The discussion included a variety of topics including rainmaking, mentoring, raising children while practicing law, and also included solutions to many problems women face in the legal profession.
I believe that having a mentor can assist many women in advancing in the legal field. After being one of 12 female attorneys selected in Philadelphia for this discussion, I found myself asking why, at this stage of my career, do I see so few women advancing, especially in the plaintiffs' field. Over 50% of my graduating class were women - very intelligent and gifted women - where are these women now, why did they leave the profession, and what can we do to keep them in it - all good questions for us to ponder.
The roundtable discussion focused more on solutions. Let's try to continue this discussion.
View an excerpt from the Roundtable:
I believe that having a mentor can assist many women in advancing in the legal field. After being one of 12 female attorneys selected in Philadelphia for this discussion, I found myself asking why, at this stage of my career, do I see so few women advancing, especially in the plaintiffs' field. Over 50% of my graduating class were women - very intelligent and gifted women - where are these women now, why did they leave the profession, and what can we do to keep them in it - all good questions for us to ponder.
The roundtable discussion focused more on solutions. Let's try to continue this discussion.
View an excerpt from the Roundtable:
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