Richmond Virginia Personal Injury Lawyer - FDA & Prescription Drugs

The Billion Dollar Antipsychotics Settlement?

Zev Antell — Tue, 20 Jan 2009 15:49:27 GMT

According to an article published in last week’s New York Times, goliath drug maker, Eli Lilly appears poised to agree to a $1.4 billion settlement related to marketing and use of its antipsychotic drug, Zyprexa. The article reports that the suit alleges the company sought to push the drug for sedation of unruly seniors in nursing homes and children with behavioral problems. Like other antipsychotic drugs, Zyprexa was not specifically developed for the purpose of sedating the aged, nor was it developed to treat disruptive children. Antipyschotics like Zyprexa and Risperdal are vastly powerful and demand a healthy respect for potential side-effects. Certainly, when dealing with vulnerable classes like juveniles and infirm seniors, this is especially true. Zyprexa has been a fantastic seller for Eli Lilly, but the article and possible settlement raise questions about some of the marketing and uses that made the drug such a huge commercial success.

Originally posted at InjuryBoard by Zev Antell

Prescriptions of Antipsychotics to Children Attract Scrutiny

Zev Antell — Tue, 02 Dec 2008 08:00:00 GMT

Last week I wrote a short blog touching on the increasing frequency with which antipsychotic drugs like Risperdal and Zyprexa were being prescribed to children. I primarily focused on the use of antipyschotics in the treatment of juvenile attention disorders. Only in passing did I mention the current increase in children diagnosed as having bipolar disorder. According to a Boston Globe article, though not originally intended for use in children, Risperdal has apparently gained favor among physicians treating children thought to be afflicted with bipolar disorder. Moreover, the article reports that a strong Risperdal proponent not only may have ties to the drug’s manufacturer, but also is “the country's most prominent advocate of diagnosing bipolar disorder in children.”

This all may amount to nothing, and that bipolar disorder in children both occurs frequently and demands aggressive treatment with antipyschotics. That said, it seems that given Risperdal’s potential side effects in children, a healthy measure of caution would be prudent.

Originally posted at InjuryBoard by Zev Antell

Anti-Psychotic Drugs Prescribed To Children With ADD

Zev Antell — Mon, 24 Nov 2008 19:30:20 GMT

Attention Deficit Disorder ("ADD") affects countless school age children. ADD is often treated with drugs like Ritalin or Adderall. Both are widely acknowledged as effective weapons against attention disorders in both children and adults. Recently however, some physicians have begun prescribing powerful anti-psychotic medications to treat attention disorders in children. Drugs like Risperdal and Zyprexa were not developed for use in treating children, but some doctors have begun prescribing them nonetheless.

A recent New York Times article discussed certain observed side effects of Risperdal’s use in children. According to the article, children using Risperdal have suffered stroke, movement disorders, and weight gain. The evidence pointed to seems somewhat anecdotal, but does deserve attention, especially in light of the fact that Risperdal is not approved for use in treatment of juvenile attention disorders. None of this is to mention the potential effect anti-psychotic drugs may have on the brain function and neurochemistry of a still developing brain.

Originally posted at InjuryBoard by Zev Antell

Documents Reveal Bush Administration Top Priority: Exempt Big Business from Civil Justice System

Michael Phelan — Thu, 16 Oct 2008 11:16:02 GMT

According to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ), the Bush Administration's attempt to shield big business and Wall Street from the free market date back long before the current bail out. Documents released by AAJ detail how helping corporations escape accountability for dangerous products by denying consumers their Seventh Amendment right to trial by jury and by abrogating the Republican party's long-standing state's rights principles has long been the administration’s top priority. People at the highest levels of the Bush administration repeatedly ordered federal agencies to usurp state law and undermine consumer protections.

The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to negligent corporations.

AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. I wrote about the Administration's use of "preambles" to regulations and policy statements in final agency rules to effect back-door tort reform in an earlier blog about preemption. Beginning in 2005, statements claiming that federal agency rules preempt state law began surfacing in the preambles of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.

“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” according to AAJ President Les Weisbrod. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.

Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.

Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”

In piecing together the emails from the FOIAs, AAJ uncovered the sleazy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.

AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.

Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.

Federal agencies like the FDA, the Consumer Protection Agency, the Centers for Disease Control, and the National Highway Transportation and Safety Administraion exist to protect tax paying citizens from dangerous food, drugs, vaccines, medical devices, consumer products and other products. The Bush Administration turned this regulatory scheme upside down by placing lobbyists for the industries the agencies were supposed to regulate in charge of those very agencies and then instructing its minions to write into the agencies' preambles and final rules language preempting citizens' Seventh Amendment rights to trial by jury in state courts.

It ain't right!

Link to AAJ's full report of this scandal, titled,“Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability”.

View the Wall Street Journal's article "Bush Legacy Could Be Found In Tort Reform" online.

Originally posted at InjuryBoard by Michael Phelan

The New England Journal of Medicine Offers the Supreme Court Some Advice on Drug Company Liability

Zev Antell — Mon, 18 Aug 2008 18:28:41 GMT

No drug company wants to face the massive liability created when a Fen-phen or Vioxx is exposed as being dangerous. Thus, much has been made in the press of the new in vogue defense employed by big drug companies. They argue that because prescription drugs are federally regulated, companies that make dangerous drugs are not responsible for their side effects. At its basic level, the defense amounts to "Not my problem..." Rather than simply make their products safer or provide adequate warnings, drug companies have instead determined they are liability proof, provided the given drug and warnings are FDA approved. The matter has made it all the way to the Supreme Court. It appears now that the American public has a powerful new ally in the fight to hold drug companies accountable. No less than the country’s preeminent medical journal, The New England Journal of Medicine (the “NEJM”) has come out decidedly against the argument. In a "Friend of the Court" brief filed with the Supreme Court, the NEJM correctly notes that civil lawsuits deter irresponsible and dishonest behavior by drug companies.

The FDA is of course the federal body that oversees drug safety in this country. Prescription drugs do not hit the market until they win the FDA's seal of approval. Unfortunately, the FDA lacks the resources to fully investigate every new drug that will hit the market. Moreover, drug companies do all they can to lobby and convince the FDA of approval. This is because they spend million after million on research and development and make no return unless the product makes it to market. The process often means the FDA may not get the whole picture and may not know all there is to know about a drug before it appears in pharmacies and hospitals. To think the FDA alone can fully protect the public is dangerously naïve.

As the FDA can only do so much, the NJEM correctly notes that civil lawsuits against drug companies are a crucial way of preventing the public from being put at greater risk. Without the threat of legal action, drug companies would have far less incentive to make safe drugs. Rather, their only goal would be to get a drug past the FDA as cheaply as possible. Everyday, we trust doctors with our lives. If the country’s leading medical journal says making big drug companies immune from liability is a bad idea, than I am inclined to agree with them. Hopefully, the Supreme Court will reach the same conclusion.

Originally posted at InjuryBoard by Zev Antell

Digitek® (digoxin tablets) Recalled Due to Deadly Manufacturing Defect

Michael Phelan — Thu, 15 May 2008 16:18:05 GMT

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution

The following is an FDA notice of the nationwide recall of Digitek (digoxin tablets):

FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

This incident highlights the fact that premarket approval of a drug by the FDA does not guaranty safety. A drug may pass the federal safety review in the premarket stage, and, as in this instance, be negligently manufactured. The fact that the FDA approved digoxin is of little solace to those who ingested potentially fatal, toxic doses of the drug as a result of a manufacturing error.

Originally posted at InjuryBoard by Michael Phelan

Here's Why Preemption is a Joke

Michael Phelan — Thu, 01 May 2008 11:33:28 GMT

Aredia, Baycol, Bextra, Celebrex, Fen Phen, Rezulin, Vioxx, and Zyprexa. These are all drugs that were "approved" by the FDA. Does FDA approval mean that the FDA tested these drugs itself? No! The FDA does not have the resources to test the food, medical devices, and drugs it is empowered to regulate. The FDA relies upon the manufacturer seeking approval of its drug or device to test its own product. The manufacturer's clinical trials, animal studies, and other test data is submitted to FDA advisory panels for review. The FDA does not have adequate staff to look behind the data the manufacturer chooses to share with the FDA. How many times in the past 15 years has the FDA learned after approving a drug that the manufacturer withheld or hid during the drug approval process critical safety or efficacy information. Oops, we forgot to submit that offshore clinical trial that showed a strong association between our drug and strokes! To compound the problem, the FDA advisory panels are fraught with conflicts of interest. It is not uncommon for the manufacturer seeking approval of a drug to have paid consulting fees to members of the FDA advisory panel charged with regulating the drug.

The most recent example of the fallacy of treating FDA approval as some sort of gold standard is the heparin debacle. American companies like Scientific Protein Laboratories, which supplied the contaminated heparin to Baxter International, which manufactured and distributed the finished heparin, have decided to outsource supply and production for some of their products to China. In the case of heparin, the pig intestine product is coming from the bowels of rural China. The FDA has now identified Changzhou, SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin that has killed over 80 people. According to a Congressional investigator, the contaminated crap used by Chagzhou cost $9.00 a pound compared with $900.00 a pound for heparin. Once again, Americans are being killed unnecessarily because a company put profits over safety.

And get this! The FDA admits it neglected to inspect the Changzhou plant, and China is now refusing to permit the FDA to inspect the plant in the future. Does this sound like the FDA has the wherewithal to guarantee the safety of a product that gets injected into the bloodstream?

Incredibly, the argument put forth in products liability cases involving unsafe drugs by the Administration and the Supreme Court in favor of denying an injured American his or her Seventh Amendment right to a trial by jury boils down to the fact that the drug was "FDA approved." Yet, the bipartisan consensus in Congress is that the FDA needs a rapid increase in its budget to be able to ensure the safety of the nation's drugs, medical devices, and food. The Bush Administration's response was to propose a budget for the FDA that does not even cover its expected cost increases. It's time to take cronyism out of this equation. Product safety must be the goal, not appeasing the interests of the drug manufacturers. Until the FDA has the resources to ensure product safety, the concept of federal preemption of drug cases is a joke.

Originally posted at InjuryBoard by Michael Phelan

Heparin Linked to More Deaths

Michael Phelan — Sun, 02 Mar 2008 13:00:17 GMT

The Food and Drug Administration reported last week that the number of deaths associated with heparin, a brand of blood thinner, has risen. The brand of heparin associated with the problems is made by Baxter International. Baxter produces most of the heparin used in the United States. Heparin is made from pig intestines, which, of course, could be supplied by U.S. farmers. Baxter buys its supplies from a Chinese plant. Federal drug regulators said last Thursday that they found "potential deficiencies" at a Chinese plant, Changzhou SPL, that supplied much of the active ingredient for heparin.

The FDA also said it was investigating two Chinese wholesalers that supplied crude heparin to Changzaou SPL, as well as those that sold raw ingredients to the wholesalers. The New York Times reported last week that at least one of the Chinese wholesalers received supplies from small, unregulated family workshops that scraped the mucous membrane from pig intestines and cooked it, producing crude heparin. Changzaou SPL began shipping the heparin ingredient to Baxter in 2004, but the FDA did not get around to inspecting the Chinese plant until last week! Getting access to this plant could not have been difficult because the majority owner of the plant is Scientific Protein Laboratories, a Wisconsin company. The FDA now admits that it violated its own policy by failing to inspect this plant. The FDA inspection last week found multiple safety violations, including the fact that the plant made some heparin with "material from an unacceptable workshop vendor.' The image conjured by that description is of a poor, unsanitary Chinese farm.

This alarming news coincides with the federal preemption decision last week by the U.S. Supreme Court in which the Court held that lawsuits against manufacturers of certain medical devices which received from the FDA pre-market approval, were pre-empted by federal law. The decision, authored by Justice Scalia, assumes the FDA pre-market approval is a rigorous process. One hopes that this flawed rationale is not extended to pharmaceutical drugs such as heparin. As the heparin situation illustrates, the FDA is impotent to keep up with even minimal safety inspections. The FDA does not itself test new drugs submitted by manufaturers for FDA approval. Rather, the FDA relies upon pre-market clinical studies submitted to the FDA by the drug manufacturer. The flaw in this system is that history is replete with examples of drug manufacturers submitting only the clinical trial test results that support a conclusion of safety and efficacy, and hiding from the FDA test that show the proposed drug is unsafe and/or not efficacious. Once the drug is approved, the post-marketing safety process is essentially to use as canaries in a coal mine the U.S. consumer. Manufacturers continue to move much of the manufacturing process overseas to countries like China, and the FDA is slow to inspect the overseas plants. There seems to be an epidemic of poisonings of U.S. citizens by food and drug products coming from China. This is exactly the wrong time for the Supreme Court to try to preempt the very lawsuits that may be the last line of defense against these dangerous products.

Originally posted at InjuryBoard by Michael Phelan

Avandia Story Follows Predictable Pattern

Michael Phelan — Mon, 04 Jun 2007 13:49:01 GMT

From Fen Phen, to Rezulin, to Vioxx, to Avandia, the story follows a predictable pattern. The Food and Drug Administration, which currently sees itself as an arm of the pharmaceutical industry rather than a consumer protection agency, approves a drug with little more than reliance upon data provided by the drug manufacturer and advice from FDA advisory panels which are increasingly comprised of paid consultants to the very drug manufacturer seeking approval of its drug. Following drug approval, mega-marketing campaigns convince consumers and prescribing physicians to switch from tried and true drugs to the new "blockbuster" drug. Often, the new drug is more expensive, less effective, and more dangerous. The next predictable event is the publication in the medical literature of proof that the manufacturer of the blockbuster drug knew either from pre-marketing clinical studies or post-marketing surveillance that the drug posed serious, unnecessary health risks. Does the manufacturer immediately upon discovery of this information warn the public, warn the prescribing physicians, and

disclose all to the FDA? The answer is a predictable, "NO.' Instead, the predictable course of action is that the manufacturer attacks the messenger. The Avandia debacle is unfolding in the same all too predictable pattern. On Saturday, the New York Times reported that John B. Buse, M.D., the incoming President of the American Diabetes Association, and early whistle blower concerning Avandia's health risks, was the target of an effort by Avandia's manufacturer, GlaxoSmithKline, to silence his criticism of the drug. I reported last week that Dr. Buse raised a red flag about the danger of Avandia as early as 2000. Congressional investigators are looking into the allegation that Glaxo tried to intimidate Dr. Buse and others who warned about the cardiovascular risks of Avandia. Dr. Buse is scheduled to testify before a Congressional committee on Wednesday. One of his colleagues confirmed that Glaxo tried to pressure Dr. Buse by contacting his employer, the University of North Carolina Medical School. Glaxo's foundation donates millions of dollars to UNC, and Glaxo tried to use its financial leverage to silence Dr. Buse. The time has come to end the incestuous relationship among the FDA, the drug manufacturers, the medical research institutions, and the doctors who serve on the drug advisory panels. Dr. Buse deserves credit for having the courage to report the truth.

Originally posted at InjuryBoard by Michael Phelan

FDA Warned About Avandia's Risks Seven Years Ago

Michael Phelan — Thu, 24 May 2007 12:19:51 GMT

Dr. John B. Buse is the chief of endocrinology at the University of North Carolina and is about to become the president of the American Diabetes Association. In 2000, Dr. Buse sent a letter to the FDA warning of the heart risks of the drug Avandia. The letter cited

"a worrisome trend in cardiovascular deaths and severe adverse events"

among patients using Avandia.

A search of the FDA's database revealed that the agency reprimanded Avandia's manufacturer, GlaxoSmithKline, in 2001 for trying to minimize Avandia's risks. Six years later, Glaxo is responding the same way to the article and editorial published this Monday in the New England Journal of Medicine. Dr. Buse acknowledged to the New York Times yesterday that his opinion of Avandia had not changed since he wrote the 2000 letter. Since then, Avandia has been used by an estimated six million people in the United States. Glaxo marketed the drug as a safer alternative to a similar diabetes drug, Rezulin, which was withdrawn from the market in 2000 because it caused serious liver damage in some patients.

Jerome L. Avorn, M.D., a doctor and Harvard professor, said that with both Rezulin and Avandia,

there were signals of a very dangerous side effect that were ignored." "Then massive marketing created a tremendous uptake of the drug."

Last year, worldwide sales of Avandia topped $3 billion, making it one of Glaxo's best selling drugs. Is it any wonder Glaxo has been hiding the ball from diabetes patients and their doctors for seven years?

Originally posted at InjuryBoard by Michael Phelan