PRODUCT LIABILITY CLAIM

[sylviak]

If you have suffered injuries or serious side-effects caused by the you are taking or have taken, you may have a product liability claim.In a products liability lawsuit, the plaintiff seeks compensation for injuries caused by a consumer product provided that a) the drug causes unreasonably dangerous side effects, and b)the manufacturer, doctor, or pharmacy (among others) failed to provide adequate warnings or instructions regarding the use of the drug.
You will have to prove three things in order to win your lawsuit:
a) you were injured or suffer losses b)the statin you took causes unreasonably dangerous side effects or the manufacturer, pharmacy, doctor, or others didn’t provide adequate warnings or instructions regarding the use of the statin, and c)the statin was the cause of your injury.
You may also have a medical malpractice claim or other legal claims depending on the details of your particular case.
Many drugs carry serious risks but as long as you were properly advised of those risks and you and your doctor decided the risks are worth taking in view of your condition, the case will not prosper.
You can also join a class action suit! There is a site that deals with this
*http://www.myclassactionlawsuit.com/rhabdomyolysis_lawsuit.html

Law firm handling the Lipitor case (class action) *http://www.krumlaw.com/lipitor.html

[sylviak]

Hagens Berman Sobol Shapiro filed a whistleblower lawsuit against the world's largest drug manufacturer, Pfizer, claiming the company illegally boosted sales of its most successful drug, Lipitor, through a scheme designed to convince physicians to prescribe the drug for unapproved, off-label use through it's marketing and promotional materials including 'education programs.'

The plaintiff, who once served as the company's director of outcome management strategies, was fired after he claims he called into question the company's marketing tactics.

The lawsuit alleges Pfizer produced and distributed material for off-label uses, without FDA approval, in an effort to expand its market and profits. These materials are alleged to have provided false and misleading information about the authoritative NCEP cholesterol guidelines. Among the list of alleged violations includes hosting continuing medical education events for physicians, including dinner and valet service, which essentially served as a sales pitch for unapproved, off-label uses of the drug. The suit alleges these educational programs deliberately misrepresented the drug's label to encourage Lipitor therapy for people in the moderate-risk category who didn't need the drug.
*http://www.hbsslaw.com/pfe.htm

[sylviak]

There is a petition prepared by John Lehmann, PHD

*http://www.petitiononline.com/Statins/petition.html

It could have been prepared by the Research & Technology Center in Toxicology ( see *http://www.rtctox.com/lehmann.htm

[Cat Mom2]

You will have to prove three things in order to win your lawsuit:
a) you were injured or suffer losses b)the statin you took causes unreasonably dangerous side effects or the manufacturer, pharmacy, doctor, or others didn’t provide adequate warnings or instructions regarding the use of the statin, and c)the statin was the cause of your injury

A- How do we prove that when the doctors won't even acknolage you have a problem, or that it was caused by a drug they fully believe in?
B-Damaged by statins? Doctors are brainwashed into thinking the statins are not the cause of all your sudden new problems and most refuse to even listen while your quality of life slip away right in front of them... BUT, they are ready and willing to order many, many tests.
C- See "B"....

More whistleblower's is what we need and they will eventually be the downfall of the whole scam!

I looked at the onlinepetition and it looks to me like they are being asked to police themselves and that is what they are already doing and we know how that is working. The words "Sponsor and perform" killed any desire for me to sign this one unless those words are taken out of it.

[sylviak]

It has to be proven that that the drug company had not adequately warned the doctor or that the doctor had not warned the patient of the drug's risk, that it did not conceal information and that the drugs caused the effect. In the light of scientific evidences (including new evidences) that the drugs cause muscle and nerve problems, there is a chance for the case to prosper. A strong argument is the fact that for the drug companies knew that it was essential to take COQ10 while on statins, but this information was not relayed to the doctors and patients. Of course, the drug companies can argue that only less than 5% (rare cases) develop the side effects, but in the light of more recent findings that there are actually many who experience the side effects ( independent researchers estimate 50%) , this could be a strong argument.
Did the drug companies manipulate data? Record will be subpoenaed. An interesting case was the judgment of August 19, 2005 wherein a jury in Texas voted 10-2 to hold Merck liable for the death of Robert Ernst, a 59-year old man who allegedly died of a rofecoxib-induced heart attack. The plaintiffs' lead attorney was Mark Lanier. Merck argued that the death was due to cardiac arrhythmia, which had not been shown to be associated with rofecoxib use. The jury awarded Carol Ernst, widow of Robert Ernst, $253.4 million in damages.
An example of an expert opinion *http://www.justiceseekers.com/files/NLPP00000/003.PDF

Proving Causation:In order to prove causation, you will need the assistance of an expert witness, usually a doctor, who will testify that the drug caused your injury. (could be an independent doctor)
Your attorney will collect information and evidence from the defendant through a process called discovery.A party may present expert medical testimony if the expert’s opinion is scientifically valid and it will assist the jury. Daubert, 509 U.S. at 589-93.

he experts can also rely on a "differential diagnosis"In performing a differential diagnosis, a physician begins by “ruling inâ€Â

[sylviak]

Medical professionals are not insurers. They do not guarantee a cure for the ill health or medical problems of the patient. Nevertheless, they are held to certain standards of care. If a health professional causes injury or loss through error and that error is not one an average member of the profession would make, the professional will be liable to the patient for the loss.The current legal standard of care imposed upon doctors, hospitals nurses and other medical professionals is one where the medical practitioner must not fall below the ordinary skill of an ordinary practitioner exercising and professing to have the particular skill in issue. In all litigation the burden of proof of causation lies on the Plaintiff. The Plaintiff must prove that the Plaintiff’s damage or loss was caused by the Defendant’s negligence. In other words, it is not sufficient to prove negligence; it is necessary to connect that negligence with the damage.
Some things you need:
•Taking the patients history: investigating the hospital file
•Locating and using expert witnesses
•Locating experienced counsel
•Case management
•Compiling details of loss

There is an association of lawyers in Europe dealing with medical negligence: *http://www.peopil.com/medical_negligence.php

[sylviak]

*http://www.avma.org.uk/pages/about_us.html

For UK residents,there'sa group promoting patient safety and justice.The group is transparent.

[sylviak]

A newly published paper from Cornell University School of Law raises the question whether Lipitor's advertisements, which omit that Lipitor's clinical trial found slight increased risk for women, is consistent with the Food, Drug, and Cosmetics Act and related Food and Drug Administration (FDA) regulations.
"This article presents: (1) meta analyses of studies of cardioprotection of women and men by statins, including Lipitor (atorvastatin), and (2) a legal analysis of advertising promoting Lipitor as preventing heart attacks. The meta analyses of primary prevention clinical trials show statistically significant benefits for men but not for women, and a statistically significant difference between men and women. The analyses do not support (1) statin use to reduce heart attacks in women based on extrapolation from men, or (2) approving or advertising statins as reducing heart attacks without qualification in a population that includes many women. The legal analysis raises the question whether Lipitor's advertisements, which omit that Lipitor's clinical trial found slight increased risk for women, is consistent with the Food, Drug, and Cosmetics Act and related Food and Drug Administration (FDA) regulations. The analysis suggests that FDA regulation should not preempt state law actions challenging advertising that is not supported by FDA-approved labeling. Our findings suggesting inadequate regulation of the world's best-selling drug also counsel against courts accepting the FDA's claimed preemption of state law causes of action relating to warnings and safety. Courts evaluating preemption claims should consider actual agency performance as well as theoretical institutional competence. Billions of health care dollars may be being wasted on statin use by women but the current regulatory regime does not create incentives to prevent such behavior. "
Accessed on the 4th of August, 2009 from ,"Eisenberg, Theodore and Wells, Martin T.,Statins and Adverse Cardiovascular Events in Moderate Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims(May 21, 2008). Cornell Legal Studies Research Paper No. 09-003. "

[sylviak]

" With respect to advertising, Pfizer markets as preventing heart attacks.The advertising does not disclose that the drug was associated with increased risk to women, not decrease risk, and the physician who only reads the main ASCOT's article's abstract does not learn of the possibly increased risk to women.Physicians who use the professional's portion of Pfzier's website are not told of the CASHMERE'S RESULT or of the women-ASCOT specific results ( clinical results which show no improvement for women when using statin).The failure to effectively report the results to health professionals raises legal questions.Under state tort law,the "learned intermediary doctrine" sometimes insulates (drug)manufacturers from liability based on the presumed knowledge of an expert intermediarry-in this case a doctor- If doctors lack full information regarding the drug's safety,the assumption underlying the learned intermediary doctrine-expert's knowledge-is not warranted and the doctrine is of questionable applicability."
Source: Eisenberg,T. and Wells,M (2009)Statins, Cholesterol ,Women and Primary Prevention: evidence -based medicine or wishful thinking? Future Cardiol (2009)5:1

[Biologist]

Nice work, sylviak.

Biologist

[sylviak]

See the following link for a recent judgement on Pfizer

*http://www.pj6.com/Cases/CNYPfizer.htm

[sylviak]

The US Supreme Court ruled in March, 2009 that pharmaceutical companies can be sued over serious side effects of drugs even when warning labels have been approved by the Federal Drug Administration.The court rejected arguments by Wyeth, the drug's manufacturer, that the Federal Drug Administration had approved warning labels for the drug and that that took precedence over the state law under which the suit was brought.

"In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling," Justice John Paul Stevens writing for the majority said. Congress has repeatedly declined to preempt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight," the opinion said.
Lawyers said the judgement opens the way for individuals to bring lawsuits against manufacturers for negligence even when the FDA has approved a drug and the warning labels it bears."

Summary of the Case: *http://www.oyez.org/cases/2000-2'009/2008/2008_06_1249/
..
Full Text:*http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
.*
Comments & Implications for statin victims*
*http://theuniversalseduction.com/articles/supreme-court-strikes-down-fda-pre-emption

[sylviak]

The US Supreme Court ruled in March, 2009 that pharmaceutical companies can be sued over serious side effects of drugs even when warning labels have been approved by the Federal Drug Administration.The court rejected arguments by Wyeth, the drug's manufacturer, that the Federal Drug Administration had approved warning labels for the drug and that that took precedence over the state law under which the suit was brought.

"In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling," Justice John Paul Stevens writing for the majority said. Congress has repeatedly declined to preempt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight," the opinion said.
Lawyers said the judgement opens the way for individuals to bring lawsuits against manufacturers for negligence even when the FDA has approved a drug and the warning labels it bears."

Summary of the Case: *http://www.oyez.org/cases/2000-2'009/2008/2008_06_1249/
..
Full Text:*http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Comments & Implications for statin victims*
*http://theuniversalseduction.com/articles/supreme-court-strikes-down-fda-pre-emption

[sylviak]

*http://www.yourlawyer.com/topics/overview/vytorin

[sylviak]

This site provides information useful for attorneys and victims. There is a message board where you can exchange information.

The latest query concerns a patient who developed urinary bladder cancer
which is suspected to be due to statin medication.
*http://classactionworld.com/forum/viewtopic.php?p=2752
*http://classactionworld.com/aboutus.php

[Allen1]

Hi there sylviak,

I just read the information in your link and apart from being great news it was laid out in an easy to comprehend way, half the time brain fog or fatigue means things have to be read a few times to get the picture but whoever wrote that must have had people like us lot in mind as its readers.
*http://theuniversalseduction.com/articles/supreme-court-strikes-down-fda-pre-emption
Thanks for sharing this, its time for big changes to take place and I hope that more good news like this keeps on coming :-)

Well I am off to bed now so all the best, Allen :-)

[sylviak]

A. Clinical Negligence

There are a number of elements to establishing that medical treatment was negligent. The patient has to prove (on "the balance of probabilities") that the clinical practitioner has been negligent. This means showing that the standard of care fell below what could "reasonably have been expected'. Medical opinion often differs over treatment for a particular ailment and it is a valid defence if it can be shown that the treatment was in accordance with the views of "a responsible body of medical opinion".

Even if you can show that the standard of care was negligent, you still have to prove that the negligence actually caused the injury. This is often the trickiest part of the case. The medical practitioner may claim that the injury arose from the illness itself and not from the treatment; or that the injury would have come about in any event. Detailed medical evidence will be called with specialists arguing for each side.

2. Product Liability

Unfortunately, people are frequently harmed by dangerous or defective products and if you are one of the unlucky ones you may be able to make a personal injury compensation claim.

Some groups that could help you:

The General Medical Council (GMC) hears complaints about serious professional misconduct by a GP or hospital doctor. The address of the GMC is: 178 Great Portland Street, London W1N 6JE. Tel: 020 7580 7642.

The Health Service Ombudsman investigates, reports and makes recommendations to the government about the activities of health authorities. The Ombudsman will not investigate any complaints until the NHS complaints procedures have been exhausted except where that is unreasonable.

To contact the Ombudsman, you should write to:
England The Health Service Commissioner for England, 11th Floor, Millbank Tower, Millbank, London SW1P 4QP. Tel: 020 7217 4051
Northern Ireland Parliamentary Ombudsman and Commissioner for Complaints, 33 Wellington Place, Belfast BT1 6HN. Tel: 028 9023 3821
Scotland The Health Service Commissioner for Scotland, 28 Thistle Street, Edinburgh EH2 1EN. Tel: 0131 2257 465
Wales The Health Service Commissioner for Wales, 5th Floor, Capital Tower, Greyfriars Road, Cardiff CF10 3AG. Tel: 029 2023 0785

The Patient's Association is a campaigning body which is a useful source of advice and assistance for individuals who are not happy with their treatment by the NHS. Their address is: 18 Victoria Park Square, Bethnal Green, London E2 9PF. Helpline: 0845 608 4455

Action for Victims of Medical Accidents (AVMA) advises those who have been injured as a result of clinical treatment. Their address is: 44 High Street, Croydon, Surrey CR0 1XB. Tel: 020 8291 2793.

National Institute for Health and Clinical Negligence is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.

Citizens Advice Bureau
Consumer Direct *http://www.consumerdirect.gov.uk/
Product Safety Recalls (*http://www.tradingstandards.gov.uk/advice/advice-recall-list.cfm)

[sylviak]

Link
*http://books.google.com/books?id=z3e8AAAAIAAJ&pg=PA18&lpg=PA18&dq=pharmaceutical+product+liability+in+the+UK&source=bl&ots=ZmUhnDbyXA&sig=lofCp7hGfl5TQwy6kifF_AgOQUU&hl=en&ei=4zZ6StXiCs2E-QaO-MlG&sa=X&oi=book_result&ct=result&resnum=5#v=onepage&q=&f=false

[sylviak]

See *http://damag.es/drugs.html

Multi-Party Claims
Although each product liability claim is different, there are some situations in which many people are injured in the same or similar ways by the same defect. In these circumstances, there may be a multi-party action with many people all suing the manufacturer for injury caused by their defective products. If this happens, it is common for a solicitor’s firm to take on multiple clients who all have the same or similar claims.

Proving Product Liability
In product liability claims the court will consider all the circumstances of the case, including the way in which the product was advertised and marketed to consumers, the warnings and cautions supplied with it and the intended purpose of the product, as well as the time when the product was supplied to the recipient. However, some cases are provable on a strict liability basis. In these cases, there is no need to prove negligence: the mere fact that the manufacturer supplied the product is enough to prove liability. This is the case with e.g. pharmaceutical drugs.

[vicki]

The latest query concerns a patient who developed urinary bladder cancer

I developed Chronic lymphocytic leukemia, type 2 diabeties and other major problems. Cancer has never ran in my family. I advise everyone to get more tests and start collecing all your lab work, office calls for future use.