June 16, 2010

Johnson & Johnson Drug Recall Update: Pharmaceutical Company Not Cooperating According to Oversight Committee

The U.S. House Committee on Oversight and Reform are accusing Johnson & Johnson of being uncooperative, providing false information, and employing delay tactics during its interactions with the House Committee. The congressional investigation launched on May 27, 2010 against Johnson & Johnson, was done so in response to widespread drug recalls by the pharmaceutical company.

Pills%20C%203.bmpAccording to the House Committee, Johnson & Johnson told members of its staff that the recall involves 6 million bottles of children’s medicine, but then informed the FDA that the recall actually involved more than 136 million bottles. The chairman of the House Committee, Edolphus Towns, said, “We need to know where the spin is and where the truth begins.”

Johnson & Johnson has denied the allegations claiming the company provided misinformation, instead providing an alternate interpretation for the wide discrepancy between the two values. Its spokesperson stated that the discrepancy in numbers was in response to two different questions from government officials. Johnson & Johnson says the 6 million bottles refers to the total number of the product in stores at the time of the recall, while the 136 million bottles refers to the estimated amount in the hands of customers.

However, it is unclear whether these estimates include the two new recalled products Johnson & Johnson added to its recall list as of yesterday. Benadryl Allergy Ultratab tablets and Extra Strength Tylenol have now be added to the list of recalled Johnson & Johnson products.

The already recalled products include Children’s Benadryl, Children’s Motrin, Children’s Tylenol, and Infants’ Tylenol. A complete list of all the recalled Tylenol products can be found at the company's website.

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June 4, 2010

GlaxoSmithKline Avandia Case Settles: First of Many Cases Set For Trial

The first Avandia case set for trial against drug manufacturer GlaxoSmithKline (GSK) settled for an undisclosed amount. The pharmaceutical litigation case was brought against GSK after new studies of Avandia revealed that using the drug could increase the risk of heart attacks and strokes.

Avandia%201.jpgNo details of the settlement or the terms were announced except a statement indicating that the details of the settlement were to remain confidential. And while GSK would not indicate how many plaintiffs were involved in the recent settlement, according to reports by Deutsche Bank, as many as 5,000 claims for damages were reportedly consolidated in this Philadelphia case.

If the alleged number of settled claims is correct, then this could mean that GSK has settled almost half of the pending Avandia claims. Analysts have been evaluating the progress of GSK's Avandia lawsuits and had originally estimated there to be around 13,000 claims against GSK that would take around $6 billion in total to settle. While GSK has yet to confirm the actual numbers in any of the Avandia cases, according to a recent Reuters's article by Ben Hirschler, the recent developments indicate that GSK's final payout would be considerably less. New estimates indicated that the final payout might be close to $1.1 billion instead of the $6.6 billion originally anticipated.

It will be interesting to see whether GSK plans to settle the next set of claims, which is scheduled for an October 2010 trial in Philadelphia. To date it has not settled any of its multi-district litigation claims that are pending in federal court.

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May 28, 2010

Recall of Children's Tylenol Subject of Congressional Hearing Entitled "Johnson & Johnson's Recall of Children's Tylenol and Other Pediatric Medicines"

Yesterday the House Committee on Oversight and Government Reform launched a Congressional hearing regarding "Johnson & Johnson's Recall of Children's Tylenol and Other Pediatric Medicines" in order to further investigate McNeil Consumer Healthcare/Johnson & Johnson's recall of numerous children's medicines.

Congress%201.jpgSince its April 10, 2010 voluntary recall, Johnson & Johnson has recalled around 136 million bottles of more than 40 different types of popular medicines. A complete list of all the recalled children's Tylenol products can be found at the company's website. The list of drugs recalled by McNeil include Infants’ Tylenol, Children’s Tylenol, and Children’s Benadryl, and Children’s Motrin.

The massive recall of children's Tylenol products was the result of manufacturing defects and poor quality control at McNeil's manufacturing plants that caused the medications to contain either too much of the active ingredients, inactive ingredients that failed to meet testing standards, or metal specks within the medications.

The House committee's investigation was set into motion by Chairman Towns and Darrell Issa (R-CA) earlier this month due to the large number of medicines included in the Tylenol recall. McNeil Consumer Healthcare could face a number of repercussions from the Food and Drug Administration (FDA), including seizures of its current products, criminal penalties, and/or additional sanctions.

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May 27, 2010

Alli and Xenical (Orlistat) Could Cause Severe Liver Injury: FDA Warns of Dangers of Weight Loss Drug

Yet another weight loss drug has been accused of posing a safety risk due to its potential causing of liver damage or failure. Yesterday the U.S. Food and Drug Administration (FDA) completed its safety review of the the weight loss drug Orlistat, which has been marketed under the names of Alli and Xenical, in connection with reports of severe liver injury. Alli is manufactured by GlaxoSmithKline (GSK), while Xenical is manufactured by Hoffmann-La Roche (Roche).

FDA%20b%201.jpgThese reports of potential liver damage due to a weight loss drug come on the heels of similar reports of liver injury associated with Hydroxycut, which led to a massive recall of the weight loss supplement.

After undergoing an investigation into the safety of Xenical and Alli, the FDA found that Alli and Xenical could in fact cause liver damage in rare cases and therefore has approved the weight loss drugs to stay on the market as long as their labels are changed to include warnings of potential liver damage.

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May 26, 2010

Children's Tylenol Recalled By FDA

The U.S. Food and Drug Administration (FDA) announced what could amount to a nationwide recall of children's Tylenol and dozens of other over-the-counter medicines. The FDA conducted an inspection at a McNeil drug plant in Pennsylvania that has resulted in the recall of more than 40 varieties of liquid pediatric medicines Tylenol, Motrin, Benadryl and Zyrtec. These products may contain metal particles over the limit allowed to meet safety requirements.

Following the discovery that some of the Tylenol products from its plant could contain metal, McNeil initiated a voluntary recall of all products manufactured at that plant. According to McNeil, its April 2010 recall was a precautionary measure and was not based on "adverse medical events". The McNeil recall included not only Tylenol products, but also other popular children's medicines, such as children's Motrin, Zyrtec, and Benadryl products

TylenolLogo%201.gifTylenol is one of the brands made by a unit of Johnson & Johnson. One of the major distributors of these pediatric liquid products is Perrigo, a company based in Michigan that supplies children medicines to big pharmacy companies like Walgreens and CVS. Perrigo has also received a warning from the FDA that it has committed serious manufacturing errors of its own. Tablets of ibuprofen reportedly contained metal shavings.

Also reported by the FDA are questions of safety and reliability of these products. Other deficiencies in the report included bacterial contamination of raw products, inadequate maintenance of equipment and the fact that no follow up was conducted to investigate 46 consumer complaints as to foreign materials and black or dark particles in the products. Some of the complaints are more than a year old.

Click here for the full list of all the recalled Tylenol products.

For additional information on the timeline of the Tylenol recall, see Parija Kavilanz's article at CNNMoney.com.

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April 23, 2010

AstraZeneca Settles Federal Investigation on Illegal Drug Marketing

The U.S. Department of Justice completed a deal with pharmaceutical company AstraZeneca where the drug company agreed to pay $520 million to settle a federal investigation into questionable marketing practices for its anti-psychotic drug, Seroquel.

Pills%20C%201.jpgThe government had accused AstraZeneca of violating anti-kickback laws through its practice of paying doctors to refer Seroquel to patients while it also brought in additional money from government health care programs like Medicare and Medicaid. The pharmaceutical company was also accused of promoting favorable research on Seroquel's effects which misled doctors and patients alike, while at the same time failing to disclose studies that showed Seroquel increased the risk of diabetes.

Currently there are over 25,000 pharmaceutical litigation claims against AstraZeneca alleging that Seroquel caused increased incidences of diabetes and weight gain. AstraZeneca's aggressive marketing and promoting of Seroquel helped increase the prescription of the anti-psychotic drug among children and the elderly, oftentimes for indications or uses not approved by the Food and Drug Administration (FDA).

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March 1, 2010

Wyeth v. Levine Used to Reverse Pre-Emption of Chicago Pharmaceutical Litigation Case Against Glaxo Smith Kline (GSK)

An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.

Rx%20Warning%201.jpgThe original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.

The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent's suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.

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January 13, 2010

Baycol Drug Manufacturing Decision Reversed By Illinois Supreme Court

The Illinois Supreme Court recently clarified the scope of the Illinois Consumer Fraud Act in its decision in the pharmaceutical litigation case of De Bouse v. Bayer AG, et al., No. 107528. The Supreme Court ruled that a consumer could not bring an action claiming fraud under the Act if the consumer had not received deceptive information indirectly or directly from the defendant drug manufacturer.

Rx_symbol%203.pngIn De Bouse, the plaintiff was claiming economic damages against Bayer AG, the manufacturer of the drug Baycol. The plaintiff had purchased and taken Baycol on three occasions prior to the drugs withdrawal from the market for its potential harmful side effects. It is important to note that the plaintiff was not alleging any damages due to the drug's side effects.

The plaintiff's case was brought under the Illinois Consumer Fraud and Deceptive Businesses Practices Act along with several other class action plaintiffs. The claim alleged that the plaintiff was harmed by the Bayer's concealment of Baycol's negative side effects because the drug manufacturer was able to inflate prices for Baycol as a result of its deceptive omissions regarding the drug's potential side effects.

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September 28, 2009

Chicago Area Hydroxycut Lawsuits Pending In Illinois

Since this May, when the U.S. Food and Drug Administration (FDA) reported that Hydroxycut product users could suffer from adverse liver disease, numerous lawsuits have been filed around the country, including several in the Chicago area.

Pills%20gold%201.jpgOn May 1, 2009, the FDA announced that it had been made aware of 23 reports of adverse liver effects that occurred in the course of normal Hydroxycut usage. The reports included injuries that ranged from general liver damage, the need for a liver transplant, and to death. At that time the FDA warned consumers to immediately cease using Hydroxycut products.

Signs and symptoms of liver damage from Hydroxycut usage can include fatigue, malaise/ tiredness, loss of appetite, nausea, jaundice, blurry vision, abdominal itching, abdominal pain, and/or dark colored urine. Hydroxycut has also been known to cause drug-induced hepatitis and liver failure.

In response to the FDA's warning, Iovate, the owner and distributor of Hydroxycut products, agreed to recall its remaining product from store shelves. Hydroxycut was generally sold throughout the United States and Illinois at stores such as Wal-Mart, Walgreens, and CVS Pharmacy, among others.

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August 5, 2009

FDA Warns Consumers on Body-Building Products Sold As Nutritional Supplements

Increased reports of medical problems associated with certain nutritional supplements has prompted The Food and Drug Administration (FDA) to issue a public health advisory on body building supplements. These supplements may contain steroids or steroid-like substances and may be associated with kidney failure and liver failure in men.

Pills%20C%201.bmpWhile the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.

Of those products that the FDA did specifically name, those included MASS Xtreme, TREN-Xtreme, ESTRO Xtreme, HMG Xtreme, AH-89-Xtreme, MMA-3 Xtreme, TT-40-Xtreme, and VNS-9 Xtreme, all of which contained hidden and potentially dangerous steroids. The FDA has taken action in the form of sending a warning letter to these drugs' manufacturer, Americell-Labs, stating that the company should produce products that are in compliance with federal regulations.

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May 29, 2009

Illinois Hydroxycut Users Showing Symptoms Described by FDA

The U.S. Food and Drug Administration (FDA) advised consumers that products sold under the Hydroxycut branded name could cause liver and heart problems. The FDA Hydroxycut advisory stated that "although liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risks.” The results were that its products were recalled.

Pills%20B%202.jpgChicago and Illinois residents have reported symptoms of adverse affects from taking Hydroxycut, which range from stomach and abdominal pain, excessive fatigue, recurring headaches, excessive weakness, vomiting, loss of appetite, to kidney failure and liver damage severe enough to require a liver transplant.

Hydroxycut products are dietary supplements that were marketed for weight loss as fat burners, energy-enhancers, low carbohydrate diet aides, and for water loss. The brand names are marketed by Iovate Health Sciences, Inc., Iovate Health Sciences USA, Inc., Muscle Tech, among other brand names.

The FDA has asked that healthcare professionals and consumers report any serious adverse or side effects from the taking of these products.

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May 7, 2009

Hydroxycut Diet Aid Recalled Nationwide For Causing Heart Problems and Kidney Failure: Chicago Area Health Stores Pull Products From Shelves

The Food and Drug Administration (FDA) has reported that it has received 23 reports of adverse health effects in persons who have used the weight-loss product, Hydroxycut. Reported complications from using Hydroxycut include heart problems and a kind of muscle damage that could lead to kidney failure. One person suffering from severe side effects of Hydroxycut even required a liver transplant.

Pills%20A%201.jpgOn May 1, 2009 the FDA issued a warning to consumers to stop using Hydroxycut. According to the FDA warning the manufacturer, Iovate Health Scientists of Oakville, Ontario, Canada and its American distributor, are recalling Hydroxycut. All in all, lovate is recalling 14 of its product line. This recall will not affect its products Hydroxycut Cleanse and Hoodia, which have different ingredients than the other products.

The Hydroxycut brand has been widely sold at national stores including Vitamin Shoppe and GNC. The product is sold in a form of pills, drinks and powders which is designed to increase energy, burn calories and fat, and control appetite. According to the FDA about nine millions units of the product were sold in 2008. Vitamin Shoppe and GNC reportedly are removing Hydroxycut products from their websites and stores.

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May 4, 2009

Chicago Fleet Phospho-Soda Case Returns Multi-Million Dollar Verdict

I recently came across a case where a Chicago jury returned a verdict of $3.4 million for the plaintiff who had been prescribed Fleet Phospho-Soda Buffered Saline Laxative for a colonoscopy procedure.

Rx%20writing%201.jpgThe case centered on the physician who had prescribed Fleet Phospho-Soda, an over-the-counter oral laxative used to cleanse the system pre-colonoscopy. Recent studies of Fleet Phospho-Soda have shown that the drug can pose a risk of kidney damage in patients with kidney disease.

Prior to being prescribed the oral laxative the plaintiff had blood work done that showed chronic kidney disease. During the trial the plaintiff alleged that the physician should have instead prescribed an alternative drug that posed no risk to the kidneys. The plaintiff ended up suffering from renal failure and required dialysis for two and half years.

Fleet Phospho-Soda has been the subject of multiple pharmaceutical lawsuits connected to its use, including those in Illinois. It is found to cause kidney damage, renal failure and other kinds of kidney ailments.

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April 15, 2009

Illinois Residents Injured by Fleet Phospho-Soda Application

Thousands of Americans across the country, Illinois, and in the Chicago area have suffered life-threatening kidney injuries after taking Fleet Phospho-Soda in preparation of colonoscopies and other surgeries. Fleet Laboratories is the principal manufacturer of Phospho-soda and has been promoting the product without warning of its drug side effects, which can include kidney damage and renal failure.

Rx_symbol%202.pngStudies have revealed that the link between Fleet Phospho-Soda and these side affects could be the result of calcium phosphate tubules that form in a kidney, which can lead to acute renal failure.

As far back as April 2002 a Health Canada advisory first warned the medical community that oral sodium phosphate solutions like Fleet Phospho-Soda can affect heart and kidney function. A later article published by the New England Journal of Medicine in September 2003 warned that this product could result in serious side effects, such as seizures and acute renal failure.

In December 2008 the U.S. Food and Drug Administration (FDA) issued a patient saftey alert which advised that oral sodium phosphates solutions should be available by prescription only. Immediately following that warning Fleet issued a recall of Phospho-Soda, which had been sold as an over-the-counter medication. In their statement regarding the recall, Fleet advised doctors to no longer directed patients to use this product for bowel cleansing.

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March 19, 2009

Do Drug Companies Really Influence Doctor’s Decisions Regarding Dispensing Drugs to Illinois’ Residents?

My brother is a physician and psychiatrist who frequently lectures on the benefits of certain drugs for prescription by family practice physicians, or other practicing physicians. At a recent gathering he reported that he played on the absurdity of drug companies distributing products carrying their name and logo by starting his speech by raving about his stay at the local chain hotel near Chicago's O'Hare airport because they gave him a pen and notepad.

Pills%20Hands%203.jpgWhile my brother dismisses drug company's efforts to win doctors over with pens and notepads, there is a lot of skepticism raised by watch groups about the impropriety of doctors promoting pharmaceuticals especially given the rise of pharmaceutical lawsuits. Recently, drug companies have been prevented from distributing pens, cups, and notepads with its insignia names or drug products. And while my brother and others in the medical field feel these types of freebies are harmless, there are other ways that pharmaceutical companies exert their influence that are much more serious.

The American Medical Students Association (AMSA) is now objecting to the influence of drug companies in medical schools’ educational curriculum. The case of a professor at the Harvard Medical School illustrates this point. In his class the professor promoted the benefits of a cholesterol drug and seemed to belittle a student asking about its side effects. It turns out that this particular lecturer, also a physician, was not only a full time member of the Harvard Medical School faculty, but a paid consultant to ten drug companies, including five makers of cholesterol treatments.

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March 15, 2009

Chicago U.S. Circuit Court of Appeals Upholds Evidence of Suicide-Related Warnings on Antidepressant Package

The 7th U.S. Circuit Court of Appeals in Chicago affirmed a Southern District of Illinois judge's ruling by the district judge in the regarding Wyeth, Inc.'s antidepressant Effexor . Giles v. Wyeth, Inc., No. 07-3149.

drug%20bottle%202.jpgIn Giles, the plaintiff decedent, Jeff Giles, was a coal miner and who became depressed after the coalmine where he worked closed and he lost his job. He was diagnosed with major depressant disorder, for which his physician prescribed the antidepressant Effexor. He committed suicide 2 days after taking three Effexor pills. His wife and son brought an Illinois wrongful death lawsuit against Wyeth.

Effexor carries various warnings, one of which is a suicide precaution. In June 2003, the Food and Drug Administration (FDA) announced it was reviewing reports of a possible relationship between Paxil, an antidepressant not manufactured by Wyeth, and an increase risk of suicide and suicide attempts in children and adolescents. In 2003, Wyeth changed Effexor’s labeling to reflect that its pediatric clinical trial showed an increased risk of suicidal ideation in children using the drug.

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March 9, 2009

Wyeth v. Levine: Supreme Court Overturns Pharmaceutical Litigation Preemption Claim

In its recent ruling the U.S. Supreme Court ruled that premarket approval from the Food & Drug Administration (FDA) does not preempt pharmaceutical companies from being held liable when their drug fails to meet state standards. In Wyeth v. Levine the court held that drug manufacturers can be sued in state courts even when they follow the rules and standards set out by the FDA.

Wyeth v. Levine involves a female, Vermont musician who lost part of her right arm after Wyeth's drug Phenergan was injected into one of her arteries. The drug's FDA-approved warning label warned against administering the drug this way, but did not prohibit it.

Wyeth argued that they were not required to change their labels to comply with Vermont regulations and that meeting the federal standards was enough. Levine argued that she was able to bring a liability claim under Vermont law even though Wyeth complied with federal standards.

The key issue of the case was whether or not Levine's claim was preempted since Wyeth met the federal standards. The Supreme Court ruled that the case was not preempted and that Levine is able to bring a claim under Vermont law.

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January 12, 2009

Illinois Reports That Dangerous Drug Interaction Could Affect Older Adults

A new study by researchers at the University of Chicago Medical Center has stated that at least 2.2 million U.S. adults take medicine in combinations that could trigger dangerous drug interactions. Some of the possible dangerous interactions include muscle breakdown, gastrointestinal bleeding, disruption in heart rhythm, and other serious problems.

Pills%20Hands%201.jpgPerhaps even more alarming is that at least half of these dangerous interactions involve the use of over-the-counter medications, such as aspirin or dietary supplements. According to the study, one in 25 older adults are at risk for serious drug interactions, the study has found. And for men ages 75 and 85, the risk is as high as 1 and 10.

However, the risk might be even higher because the research focused on major interactions among the 20 most common drugs and dietary supplements. “The public has an awareness that two prescription medications used together might be dangerous,” said the study author, Dr. Stacy Tessler Lindau. Lindau is the assistant professor of geriatric medicines, obstetrics and gynecology at the University of Chicago Medical.

The dangerous drug interactions cited in the study were more a byproduct of individuals unknowingly mixing medications rather than the result of pharmaceutical prescription errors by medical providers.

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January 5, 2009

Prescription Medication Helps Only About Half of Those Who Take Them

Imagine you had been taking the drug Tamoxifen in hopes of preventing a recurrence of your breast cancer. Then a new test comes out that suggests that because of your genetic makeup the drug is not doing you any good. This situation is not that uncommon for hundreds of thousands of women in this country, including Illinois, who have been taking Tamoxifen.

Med%20Money%201.jpgHowever, not only those taking Tamoxifen need to worry. Experts say that regardless of the disease, most drugs work for only about half the people who take them. Not only is much of the nation’s approximate $300 billion annual drug spending wasted, but patients are being exposed unnecessarily to risky side effects.

Many policy experts are calling for more studies to compare the effectiveness of different treatments. There is much hope riding on the promise of “personalized medicine” in which genetic screening and other tests give doctors more evidence for tailored prescriptions. Personalized medicine would go beyond the norm by determining which drug or drugs are best suited for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.

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December 22, 2008

Are Pharmaceutical Companies Ghostwriting Their Own Praises?

In a recent and controversial accusation, Elsevier has been questioned about publishing favorable medical reviews of pharmaceutical company Wyeth's hormone replacement therapy drug. The allegations claim that the medical publishing editors at Elsevier were not unbiased, but received payment from Wyeth. In response to these accusations, Elsevier has launched its own investigation into the legitimacy of the claims.

Rx_symbol%201.pngSenator Charles E. Grassley, Iowa (R) was the person who first questioned the article. As a member of the Senate Finance Committee, Grassley is investigating drug companies' influence on doctors and contends that Wyeth, the pharmaceutical giant, commissioned ghostwriters to plug its drugs through several academic journals, including perhaps Elsevier.

The Elsevier article in question by Dr. John Eden was published in a May 2003 issue of the American Journal of Obstetrics & Gynecology. Progestins and Breast Cancer (Am J Obstet Gynecol 2003;188:1123-31), stated that drugs such as Wyeth's Prempro could not be tied to breast cancer as there was "no definitive evidence" that the hormones caused breast cancer. Eden's article was published a little over a year after a landmark federal study linking Wyeth's Prempro hormone product to breast cancer.

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December 1, 2008

Pharmaceutical Liability for Prescription Drugs Possibly Pre-empted by FDA Regulations and Policies

Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

drug%20bottle%201.jpgAnd not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.

The beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone "pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state's rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

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August 20, 2008

U.S. Supreme Court Receives Unsolicited Drug Safety Advice From Top Doctors Questioning the FDA's Ability to Protect Patients

The United States Supreme Court is expected to hear the case of Wyeth v. Levine this November which could have far reaching implications as to pharmaceutical litigation cases against drug companies, including those in Illinois and the Chicago area. Syringe%201.jpg The legal advice comes from top doctors and editors of the New England Journal of Medicine who have submitted a friend-of-the-court brief. The doctors state that the Food and Drug Administration (FDA) “is in no position” to guarantee drug safety. The doctors went on to to say that lawsuits can serve as “a vital deterrent” and protect consumers if drug companies don’t disclose risks.

The underlying case is about Diana Levine, a Vermont guitarist, who lost her right arm below the elbow after being injected with the drug Phenergen, a medicine used mostly for nausea. She sued the drug manufacturer, Wyeth, contending that the drug company had a duty to warn consumers that injections, like the one she experienced, could have devastating consequences. The state courts in Vermont agreed with Ms. Levine in awarding her nearly $7 million.

But Wyeth appealed stating that it was protected from such lawsuits. It argued that the FDA’s judgment could not in effect be overruled by a state court. FDA scientists had weighed the risk and benefits of Phenergan in approving the drug’s safety literature as a guide for doctors. The FDA was aware of the risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used for this patient.

It has been commented before that the FDA has been the “gold standard” in drug evaluation. The New England Journal of Medicine editors warned the justices to be skeptical in taking such a view now.

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January 7, 2008

Paxil-Related Teen Suicide State Lawsuits Not Preempted By Federal Statutes According to Federal Court

Much has been said about the preemption of state actions for Illinois personal injury cases or Illinois wrongful death lawsuits. A recent federal district court decision ruled that a failure-to-warn lawsuit is not preempted by the federal statutes. The suit was brought by the parents of a teenager who committed suicide while taking the antidepressant Paxil.

Pills%201.jpgThe plaintiffs' son was prescribed Paxil by his dermatologist, not for his acne, but to treat a psychiatric disorder in which the individual is overly concerned about real or imagined defects in their physical appearance. Shortly after the second prescription of Paxil was refilled, the plaintiff's son committed suicide.

The parents alleged that the pharmaceutical company was liable for their son's death because it failed to warn the physician about the risk of suicide that the drug posed to children and adolescents. The court rejected the argument raised by pharmaceutical giant, Glaxo-SmithKline (GSK), that preemption applied to this case.

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