Drug Litigation News

Personal Injury Lawsuits Filed Against Pfizer Over Undisclosed Risks of Blockbuster Cholesterol Drug Lipitor

NEW YORK, June 8 /PRNewswire/ -- A pair of personal injury lawsuits has been filed against Pfizer Inc. charging the giant drug company with concealing serious health risks associated with its blockbuster anti-cholesterol medication Lipitor. The suits accuse Pfizer of deceptive marketing practices and allege that the company promoted Lipitor as a safe drug with minimal health risks while knowingly failing to warn physicians and patients of Lipitor's more dangerous side effects, including nerve damage, memory loss and other cognitive impairment. Aggressive marketing of Lipitor -- supported by physician "education" groups funded by Pfizer -- has helped secure its status as the best-selling drug in the world, with sales exceeding $12 billion in 2005. The two new lawsuits were filed in New York State Supreme Court on behalf of Charles M. Wilson, a 60-year-old former insurance executive from Atlanta and Michael Mazzariello, a 47-year old attorney from New York. Mr. Wilson has suffered a series of irreversible health problems, which he asserts were caused by taking Lipitor during a 17 month period in 2002 and 2003. Among the damages he alleges were provoked by Lipitor are peripheral nervous system damage (peripheral neuropathy), inflammatory demyelinating polyneuropathy, and memory loss. Nearly three years after discontinuing the medication, he continues to suffer from loss of balance, burning in the hands and feet, and bouts of fatigue. He was forced to leave his job as a result of his injuries. Mr. Mazzariello, who practiced criminal trial law throughout New York State, suffered debilitating injuries to various muscles forcing him to walk with a cane and endure repeated hospitalizations. He also suffered extensive memory loss, which he attributes to his statin usage. The two men announced their lawsuit at a news conference in New York City, during which they were joined by individuals from other parts of the country describing their own personal health problems associated with Lipitor. Included in the group was Susan Nelson of Bainbridge Island, Washington. Mrs. Nelson claims that her teenage son Jacob, a gifted gymnast, began experiencing severe bouts of depression and violent nightmares after he began a course of Lipitor to reduce his cholesterol in 2001. He committed suicide in 2003.

"It is very clear to me that the culprit of the depressions ... and suicide of my son is due to the side effects of the cholesterol-lowering drugs Mevacor and Lipitor," Mrs. Nelson wrote in a letter. "Had I known that the nightmares, lack of concentration, and depression... could have been warning signs for side effects of these medications, the doctors, my husband, son and I could have taken another course and gotten (him) off these supposed wonder drugs! There is no doubt my son Jake would be alive today had I been warned... " "Pfizer has aggressively promoted Lipitor to consumers as a safe drug with manageable and limited side effects despite apparently knowing and fraudulently concealing the serious health risks associated with statins," said attorney Mark Jay Krum, who represents Mr. Wilson and Mr. Mazzariello. "The complaints allege that the company has negligently misled both physicians and patients and is apparently more concerned with driving sales of Lipitor than with the safety of its users." The complaints note that despite receiving two letters since 2001 from the Food & Drug Administration expressing concerns that Lipitor's marketing material did not reflect the heath risks the drug poses, Pfizer promoted the drug as virtually symptom free, stating on its Web site: "In fact, in some clinical studies, Lipitor has been proven to be as safe as taking a sugar pill." Statins work by blocking certain cholesterol-producing enzymes, but a number of physicians have warned that the process to curtail cholesterol inhibits other metabolic functions that can lead to a host of medical issues. One doctor who has written extensively on the risks of statin usage declared recently, "The inevitability of significant, serious and even lethal side effects has been knowingly accepted by the manufacturer."That Pfizer was well aware of the cognitive risks associated with its statin drug is evident in a letter by a Pfizer physician dated October 2003. "A search of our postmarketing safety surveillance datatbase for Lipitor revealed that we have received spontaneous reports of amnesia and thinking abnormal since the market introduction of Lipitor," the doctor wrote. Pfizer conducted its own controlled studies of cognitive function and found a .3% incidence of amnesia from Lipitor and a .2% rate of what the company called "abnormal thinking." Together, those two outcomes would translate into more than 100,000 cases of mental impairment given the current population of Lipitor users.

This past March, Pfizer was sued by a group of union and employee insurance plans who charged the company with fraudulently marketing Lipitor for off-label uses not approved by FDA protocols for cholesterol treatment. The employee and third-party health plans allege that Pfizer's off-label promotion of Lipitor has resulted in billions of dollars in unnecessary prescriptions for the drug. The health plans challenged Pfizer's creation and funding of "educational" organizations offering physicians continuing medical education courses and publication of articles extolling the off-label usage. There is also a class action pending against Pfizer for its marketing of Lipitor to women.The latest personal injury suits contend that Lipitor is defectively designed and inadequately tested, and lacks the proper patient warnings as to its dangers. At the news conference, Mr. Wilson and Mr. Mazzariello were joined by several other patients who described experiencing similar serious health problems from Lipitor use, including a former airline pilot from Washington, D.C. who believes his loss of motor function and severe chronic pain were caused by statin usage; and a former Army helicopter engineer from Corpus Christi, Texas, who believes that his memory loss and disorientation are the result of taking Lipitor. Also participating to discuss the effects of statin drugs was Dr. Paul Rosch, president of the American Institute of Stress and a clinical professor of Medicine and Psychiatry at New York Medical College. "Statin drugs make enormous amounts of money for the pharmaceutical industry, the power and influence of which should not be underestimated," said Dr. Peter Langsjoen, a noted cardiologist from Texas who attended the news conference. "By lowering cholesterol they give doctors and their patients a false sense of security by treating 'cholesterol neurosis,' but statin adverse effects are insidious and are often delayed for several years." The group will meet with members of the Senate Finance Committee in Washington, D.C. on Friday to discuss their concerns over potential harmful effects of Lipitor and to call for stricter federal health warnings on statin usage.

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	Did You Know?
	Drug companies spend more on marketing than R&D The top 10 drug companies spent nearly three times more on marketing, public relations and administration than they did on research and development.