FDA and Drug Litigation

Proposed FDA Warning Requirements Not Consumer Friendly
The Food and Drug Administration (FDA) has proposed that drug companies should not be able to change warning labels to alert consumers about potential unsafe conditions with their products without first receiving FDA approval. The proposal would be a dev

Study Finds Drug Makers Not Reporting All Trial Results
A recent study published in the New England Journal of Medicine (NEJM) found that manufacturers of antidepressant medication often don't publish drug trials that show negative results - leaving doctors and consumers without all the information they need t

Consumer Group Claims Botox Injections Linked To 16 Deaths
Public Citizen, the national, nonprofit consumer advocacy organization, recently petitioned the Food and Drug Administration (FDA) to immediately increase warnings and to directly warn patients and doctors about the use of botulinum toxins used cosmetical

FDA Gets More Money – But Will It Really Help Consumers?
The Food and Drug Administration (FDA) has been criticized for not adequately protecting the public from injuries sustained from food, drugs and medical devices. The FDA itself recently told Congress that it needs more money to do its job. The Bush Admi

Congressmen Say FDA’s Relationship with Drug Industry ‘Too Cozy’
The Food and Drug Administration (FDA) has come under a great deal of scrutiny for its handling of food safety, medical device review and drug approval. Although the FDA's job is to regulate these industries, some Congressmen have said that its relations

Tysabri Linked To Liver Damage
Tysabri, a drug used to treat patients with multiple sclerosis and Chrone's disease, may cause liver damage within six days of use according to new information from the drug's manufacturer's Biogen Idec, Inc. and Elan Pharmaceuticals, Inc. The companies

Study Shows Procrit and Aranesp Use May Increase Risk of Death
A new study published in the Journal of the American Medical Association (AMA) reports that cancer patients taking Ortho Biotech's (a Johnson & Johnson company) Procrit and Amgen Inc.'s Aranesp, both anemia drugs used to treat weakness and fatigue caused

Supreme Court Allows Rezulin Case to Continue against Pfizer/Warner-Lambert
In a split decision, the U.S. Supreme Court upheld a lower court ruling against drug manufacturing giant, Pfizer, Inc. and allowed a lawsuit alleging that Pfizer's diabetes drug, Rezulin, caused injuries to a group of Michigan residents.

Senator Asks GAO to Investigate FDA Processes
Senator Charles Grassley (R-IA) has asked the Government Accountability Office (GAO) to investigate how the U.S. Food and Drug Administration (FDA) follows through on drug approvals. The investigation comes at a time when an increasing number of approved

FDA Targets Asthma Drug Manufacturers
The U.S. Food and Drug Administration (FDA) has said that it is seeking additional information from drug manufacturers about their asthma products such as GlaxoSmithKine's Serevent and Advair, Novartis AG's and Schering Plough's Foradil and Astrazeneca's

Consumer Product Safety Commission May Get Much Needed Facelift
The Consumer Product Safety Commission (CPSC) may be getting a facelift if either a House or Senate bill becomes law. Consumer advocates say that a facelift is a long time coming as the Commission has been the subject of criticism in the past year - espe

FDA Investigating Association of Merck’s Singulair Use with Suicide
The U.S. Food and Drug Administration (FDA) announced in an Early Communication warning that it is investigating a possible association between Merck & Co, Inc.'s asthma and allergy drug, Singular, to suicide, behavior/mood changes and suicidality (suicid

AAJ Says FDA Allowing Drug Companies to Run Show
The American Association for Justice (AAJ) thinks that the U.S. Food and Drug Administration (FDA) is allowing drug companies to run the show by giving them immunity when they fail to warn the public about a drug's potential dangers.

Regranex: FDA Reports Possible Increased Cancer Risk
The U.S. Food and Drug Administration (FDA) has said that it has received study information that may increase the risk of cancer in patients with diabetes who applied the topical drug, Regranex, directly to their foot or leg. It is currently reviewing th

Ziagen & Videx Linked To Increased Risks of Heart Attacks
The U.S. Food and Drug Administration (FDA) is reviewing newly received information on the increased risks of heart attacks for HIV-1 patients who are taking Ziagen or Videx as part of their drug therapy.

FDA Requests Safety Plans for 25 Drugs
The U.S. Food and Drug Administration (FDA) has announced that it will seek Risk Evaluation and Mitigation Strategies (REMS) from 25 drugs and biologic products by September 21, 2008.

Study Shows 11% of Children Experience Adverse Drug Reactions While Hospitalized
A new study by the Child Health Corporation of America (CHCA) shows that over 11 percent of children experience adverse drug reactions while hospitalized - a much higher number than originally thought. Parents, such as Dennis Quaid, know all too well wha

Ending Clinical Trials Early May Taint Drug Effectiveness
Clinical trials of drugs generally report positive and negative results. Those results are then analyzed to determine whether a drug is safe for the general public's use. However, a newly published study says that when clinical trials that report negati

NuvaRing Linked To Increased Risks of Blood Clotting
NuvaRing, a contraceptive drug manufactured by Schering-Plough Corporation and Organon Biosciences NV, has been linked to increased risks of blood clotting, the death of a New Jersey woman and is the subject of at least 50 lawsuits.

FDA Says Global Economy Means It Can’t Be Pharmaceutical Watchdog
The Director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research recently told a Senate panel that the global economy means that the Administration cannot be a pharmaceutical watchdog for all drugs. Instead, pharmaceu

Major Drug Recalls Associated With Heart Surgeries: An Overview
Recalls of drugs used in heart surgeries seem to be escalating. In the past few months, drugs such as Digitek, Heparin and Trasylol have all been recalled for one reason or another. Unless you're a doctor or pharmacist, keeping track of which drugs have

Congress Accuses Drug Companies Of Misleading Consumers
How many television ads have you seen touting the benefits of a drug? For most people, the answer to the question would be - too many. A large number of drug advertisements seem to promise the world - something that certain members of Congress say is in

Former FDA Commissioner Says FDA Can’t Do Its Job
David Kessler, the U.S. Food and Drug Administration's (FDA) Commissioner from 1990 - 1997 has testified in front of Congress that the FDA simply can't do its job with its current resources. Kessler, along with actor Dennis Quaid, presented testimony abo

Congress Says Drug & Medical Device Makers Should Be Held Responsible
Even after the U.S. Supreme Court ruled that injured patients were preempted from suing medical device makers, many in Congress believe that drug and medical device manufacturers should be held responsible for their actions - and they are considering legislation to make that happen.

Sleep Aid Ambien Linked To Bizarre Behavior – And Public Figures
The popular sleep aid, Ambien, may help some consumers get a good night's sleep, but others have reported engaging in bizarre behavior after taking the drug. In fact, Ambien continues to make headlines as more and more consumers report doing things that they simply can't remember in the morning.

Congress Investigating Indian Drug Giant Ranbaxy
A Congressional panel is investigating whether Indian drug giant, Ranbaxy Laboratories Limited falsified drug data to the U.S. Food & Drug Administration (FDA) and whether the FDA knowingly allowed Ranbaxy to distribute suspect drugs in the United States.

FDA Orders Braun, Baxter and Hospira to Stop Marketing Unapproved Products
The U.S. Food & Drug Administration (FDA) has ordered several U.S. pharmaceutical companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS), used to irrigate the eye during surgery on the eye, and unapproved topical drug products containing papain, used in treating skin ulcers, or risk enforcement action.

Shows Daily COPD Drugs May Increase Risk of Death By 58%
A recently released study of commonly used COPD drugs shows a 58% increase in the risk of cardiovascular death, heart attacks and strokes for people who use the drugs on a daily basis. It is estimated that nearly 12 million people in the U.S. have been diagnosed with COPD and that another 12 million people may have the disease, but not yet know it.

Pharmaceutical Companies May Be Liable For Injuries from Generic Drugs
As the nation waits to hear the U.S. Supreme Court's decision in Wyeth v. Levine and whether pharmaceutical companies can be liable for patient injuries, some of that focus has shifted to a California case that may open up a whole new area of product liability litigation - that pharmaceutical companies may be liable for injuries from generic versions of their drugs manufactured by other companies.

FDA Scientists Accuse Agency of Serious Misconduct
Eight U.S. Food and Drug Administration (FDA) scientists have accused top FDA officials of serious misconduct in their approval of medical devices that the scientists say are unsafe or ineffective.

Internal Documents Show That FDA & Bush Administration at Odds over Preemption
11/3/08: Internal government documents revealed that the U.S. Food and Drug Administration and the Bush Administration have actually been at odds when it comes to preemption of lawsuits against drug manufacturers. The documents, obtained last week by Democratic California Representative Henry Waxman's office, may be instrumental in the Supreme Court's decision of the matter which is being heard today.

FDA Accuses Bayer of Mislabeling and Misbranding Aspirins
The U.S. Food and Drug Administration (FDA) has sent a letter to German-based pharmaceutical giant Bayer, already under fire over the Trasylol scandal, and is accusing the drug maker of misbranding, mislabeling and confusing customers about two of its over the counter products - Bayer Women's Low Dose Aspirin & Calcium and Bayer Aspirin with Heart Advantage.

Ethex Corporation Recalls More Products; Warns Of Overdose
The Ethex Corporation, the Missouri-based subsidiary of the KV Pharmaceutical Company, has issued another recall of its drugs that were released in oversized forms which may cause serious injury or death. This is the company's third recall for the same issue this year.

Will The Obama Administration Overhaul The FDA?
That's what many consumer advocate groups are hoping for after reading the latest report from the Government Accountability Office (GAO) and letters by the U.S. Food & Drug Administration's (FDA's) own scientists who say that the current FDA system is badly broken.

FDA Shuts Down KV Pharmaceuticals
The U.S. Food & Drug Administration (FDA) has virtually shut down St. Louis, Missouri drug manufacturer KV Pharmaceuticals until the company complies with the FDA's Good Manufacturing Practices and new drug approval requirements for five years.

Supreme Court Rules Federal Law Does NOT Preempt State Law Claims
In a highly anticipated decision, the U.S. Supreme Court has ruled that federal law does not preempt state law claims alleging that drugs were not adequately labeled. It is a major victory for those who have been injured by dangerous or defective drugs - and a huge setback for drug companies.

Supreme Court Says No To Drug Preemption: What The Case Means To You
The U.S. Supreme Court has ruled that federal law does not preempt an injured victim from suing a drug manufacturer in state court. The ruling is significant to anyone who has been injured by a dangerous drug that was not adequately labeled. So, what the case may mean to you?

Stryker’s BioTech Division Accused Of Fraud Re Bone Regeneration Products
Michigan-based Stryker Corporation's BioTech division has been accused of fraudulent activity regarding the promotion, sale and reporting requirements for its bone regeneration products. A Massachusetts federal grand jury is investigating the allegations.

Requip Linked To Compulsive Gambling, Sexual & Other Intense Urges
GlaxoSmithKline's drug, Requip, which is prescribed for the treatment of Parkinson's Disease and Restless Leg Syndrome, has been linked to a host of bizarre side effects including compulsive gambling, sexual urges and other intense urges.

More Drug Companies Being Sued For Illegally Pushing “Off-Label” Drug Uses
When the U.S. Food & Drug Administration (FDA) approves a drug, it does so for limited usage. While some drugs may work for other purposes, it is illegal for drug companies to promote their drugs to doctors for non-approved purposes and sidestep the FDA altogether. However, drug companies do just that - and they do it more often than you might think. That practice tends to harm drug consumers more than anyone and many manufacturers are now being sued and fined over pushing off-label drug usage.

Laxatives, Colonoscopies & Kidney Failure: Are You At Risk?
It is estimated that thousands of Americans develop kidney disease from the laxatives they take prior to having colonoscopy and other examinations. Manufacturers often recommend twice the normal dosage of these drugs, known as oral sodium phosphates (OSPs), before an examination - and while that may help their bottom line, so many users have been injured that the FDA has issued a black box warning.

Congress Introduces Bill To Give FDA Power Boost
Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) have introduced the Drug & Device Accountability Act of 2009 in the hopes of giving the U.S. Food & Drug Administration (FDA) additional resources to inspect both US and foreign drug and device manufacturing plants and more authority to impose penalties.

FDA Requires Stronger Warnings For Botox
The U.S. Food & Drug Administration (FDA) will now require manufacturers of licensed botulinum toxin products to strengthen warnings on product labels that warn healthcare professionals about some of the adverse risks associated with the drug.

ACL Calaxo Screw Injuries, Recalls & Lawsuits: The Facts
The Calaxo Screw was approved by the U.S. Food & Drug Administration (FDA) in 2006 to assist in the healing of reconstructive anterior cruciate ligament (ACL) surgery. However, the product has been the subject of numerous injuries, a recall and lawsuits. Here are the facts:

Medtronic Infuse Bone Graft Product: Did Company Pay Doctor To Lie?
Medtronic Inc., the Michigan based medical device giant, has seen its share of troubles in the past few years. From its Sprint Fidelis recall to allegations of corruption, many say that the company's image has become tarnished. In fact, the New York Times recently reported that Medtronic may have paid a doctor to lie about the success of its controversial Infuse Bone Graft product at the Walter Reed Hospital in Iraq.

FDA Recalls Baxter Healthcare's Colleague-Brand Volumetric Infusion Pumps
The U.S. Food & Drug Administration (FDA) has issued a Class 1 recall for Baxter Healthcare's Colleague brand volumetric infusion pumps. A Class 1 recall is the harshest warning available meaning that continued use of the products could lead to serious injury or death.

Rapamune Side Effects - May Increase Risk Of Death In Liver Transplant Patients
A new study released by Wyeth about its anti-organ transplant rejection drug, Rapamune, says that the drug may increase the risk of death when used after a liver transplant. The U.S. Food & Drug Administration (FDA) has issued a warning to doctors about the study's results.

Homeopathic Drugs Not Test Or Approved By FDA
Most homeopathic drugs are not tested by the U.S. Food & Drug Administration (FDA) - although many consumers often don't realize it. However, that realization is changing after the FDA's recent warnings on homeopathic products such as Zicam and Hydroxycut.

Drug At Center Of Supreme Court Preemption Case Now Contains FDA Black Box Warning
Wyeth Pharmaceutical's sedative drug, Phenergan, now contains a black box warning from the U.S. Food & Drug Administration (FDA). Also known as promethazine, the drug was at the center of the U.S. Supreme Court's decision that those injured by dangerous drugs are not preempted from suing drug companies in state court.

KV Pharmaceuticals: Lawsuits Continue After FDA Shuts Drug Maker & Subsidiaries Down
Product liability lawsuits continue to be filed against KV Pharmaceuticals and its subsidiaries Ethex Corporation and Ther-Rx Corporation well after the U.S. Food & Drug Administration (FDA) shut down the companies earlier this year for repeatedly manufacturing oversized drugs which contained more active ingredients than were appropriate, including narcotics such as morphine and oxycodone, cardiac drugs and prenatal and iron supplement products. The companies recalled over 60 products and put thousands of consumers in grave danger of serious injury and death.

International Study Shows Drug Companies Hide Bad Clinical Trial Results
A new study conducted by Canada's Ottawa Hospital Research Institute found that pharmaceutical companies routinely hide bad clinical trial results - putting image, market share and profits over consumer safety.

Study Finds Pregnant Women Taking SSRI Drugs Three Times As Likely To Give Birth Early
A new study reports that pregnant women who take selective serotonin reuptake inhibitor drugs (SSRIs) such as Prozac, Paxil, Zoloft, Celexa and Lexapro are up to three times as likely to have a premature birth than other women.

Lawsuits Allege Polygrip & Fixodent Cause Neurological Damage In Extremities
Polygrip and Fixodent, arguably two of the most popular denture adhesive creams on the market, contain zinc, which can be absorbed by the body and cause neurological damage in users' arms and legs. Dozens of lawsuits have been filed against Polygrip manufacturer GlaxoSmithKline, its subsidiary, Block Drug Company and Fixodent manufacturer Proctor & Gamble. Product liability attorneys say that there may be many more lawsuits against the drug manufacturers as more and more of these often mysterious injuries are linked to denture creams – all of which contain zinc.

FDA Warns Of Increased Risk of Birth Defects With Depakote Use – Again
The U.S. Food & Drug Administration (FDA) notified healthcare professionals and patients that using valproic acid and divalproex sodium products such as Depakote, an anticonvulsant typically prescribed for migraines, seizure disorders and manic episodes associated with bipolar disorder, carries an increased risk of birth defects. This is not the first warning the FDA has issued.

Ibuprofen / Painkillers Increase Risk Of Heart Attack & Stroke
A new study says that common NSAID and COX-2 inhibitor drugs like ibuprofen, naproxen, celecoxib and others could cause heart attacks and strokes.