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Tom Lamb
Wilmington, NC, USA
Tom Lamb is a lawyer who represents patients and their family in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Bottom Line Is That The Fate Of These Lawsuits Against Merck Is In The Hands Of The U.S. Court of Appeals For The Third Circuit (Posted by Tom Lamb at DrugInjuryWatch.com) Back in June 2015 U.S. District Judge Freda Wolfson of the District of New Jersey dismissed the last remaining cases in the Fosamax - femur fracture federal court MDL. However, those cases -- as well as some earlier dismissed Fosamax lawsuits concerning femur fractures -- could be reinstated if plaintiffs win an appeal currently pending before the U.S. Court of Appeals for the Third Circuit. And since that time the federal court Fosamax MDL has been in a "holding pattern" while the parties wait for the appellate court to issue rulings on at least two appeals regarding the Fosamax label, or package insert, information about the femur fracture side effect. And for the New Jersey state court Fosamax litigation, it appears that the presiding judge is content on waiting for the federal appellate court rulings to be issued. One of the main legal issues in those pending appeals is whether Merck could have strengthened the Fosamax drug label warnings about this apparent femur fracture side effect. For additional information... Continue reading
Posted 5 days ago at Drug Injury Watch
Thank you for your Comment. I suggest you contact a medical malpractice attorney in the state where the doctor(s) prescribed you the Cymbalta. I wish you the best in all aspects going forward. Tom Lamb
1 reply
Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. I will point out that at the current time Pradaxa has an FDA-approved reversal agent, Praxbind. At the current time there is no FDA-approved reversal agent for Xarelto, Eliquis, or Savaysa. Warfarin has long had an "antidote". I wish you the best in all aspects going forward. Have a good weekend. Tom Lamb
1 reply
Have you taken Nexium, Prilosec, or Prevacid and suffered kidney damage? Read more to see whether you may have a posible drug injury case. Continue reading
Posted Sep 16, 2016 at Drug Safety Developments
Eliquis Has Caused Irreversible Bleeding Events, Such As Trauma Incidents And Hemorrhagic Strokes, Which Can Be Life-Threatening And Sometimes Fatal (Posted by Tom Lamb at DrugInjuryWatch.com) Eliquis (apixaban) was approved by the FDA in December 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis. It is important to know that as of September 2016 Eliquis does not currently have an FDA-approved antidote, or reversal agent, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. These serious medical conditions have been associated with the use of Eliquis: • Serious Bleeding Events • Irreversible Fatal Bleeding Events • Trauma-induced Atypical Bleeding Incidents • Gastrointestinal (GI) Bleeds • Rectal Bleeding • Hemorrhages • Brain Hemorrhage • Intracranial Hemorrhage • Hemorrhagic Stroke • Cardiac Bleeds ____________________________________________ Free Case Evaluation (select one) Eliquis --- Savaysa --- Xarelto Strictly Confidential, No Obligation. ____________________________________________ While an Eliquis antidote will someday be available to help patients suffering an acute bleed, unfortunately, it is too late for some people who suffered serious bleeding events or bled to death, already. Our law firm is handling Eliquis cases which involve people who had excessive bleeding, bled to death, or experienced other serious side effects... Continue reading
Posted Sep 15, 2016 at Drug Injury Watch
Ed: Thank you for your Comment and question. As regards such lawsuits, no products liability lawsuits against the drug company that I am aware of at the present time, although there may be one or more out there. Such a situation may also give rise to a medical malpractice lawsuit against the doctor(s). Tom Lamb
1 reply
Increasing Number Of Women Who Have Allegedly Been Harmed By The Essure Inserts Have Filed Lawsuits Against Bayer (Posted by Tom Lamb at DrugInjuryWatch.com) Bayer's Essure® product is a permanent birth control system that a woman can get with a non-surgical procedure to help her stop worrying about an unplanned pregnancy. But while that may sound all good, the Essure birth control insert product has been surrounded with controversy having to do with its safety and some past clinical trials. Not surprisingly, these issues have resulted in lawsuits filed by women who allege being harmed by the Essure inserts. Starting with the Essure safety issues, we get the following from a May 31, 2016 "Dear Healthcare Professional Letter" issued by Health Canada with the title "ESSURE (permanent birth control system) - Risk of Serious Complications": Complications have been reported in some patients with the use of ESSURE (permanent birth control system) including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and various non-specific symptoms suggestive of sensitivity or immune-type reactions. Some complications may be considered serious. In some cases, the extent of the symptoms led to the removal of ESSURE. The removal of ESSURE... Continue reading
Posted Sep 7, 2016 at Drug Injury Watch
Julie: Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. I wish you the best in all aspects going forward. Have a good week. Tom Lamb
1 reply
Why didn't they tell us sooner? A review of the medical literature from the past 22 years warning about the relationship between heartburn drugs & AIN. Continue reading
Posted Aug 29, 2016 at Drug Safety Developments
This Class Of (Heavily Advertised) Drugs Includes Farxiga, Invokana, And Jardiance, Which Also Are Linked To Kidney Failure And Heart Attacks Or Myocardial Infarction (Posted by Tom Lamb at DrugInjuryWatch.com) In an earlier article, "Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations", we pointed out that Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride) had a July 2016 label change for fatal cases of ketoacidosis, but several other diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors did not have a similar label change. It turns out that this was only a matter of time, or timing. In August 2016 we saw FDA letters about approving and mandating a label change for ketoacidosis cases go out for the remaining diabetes medicines in this SGLT2 inhibitors class of drugs: Invokana (canagliflozin); Invokamet (canagliflozin and metformin); Farxiga (dapagliflozin); and, Xigduo XR (dapagliflozin and metformin extended-release). For use as an example, here is the relevant part of an August 17, 2016 FDA Supplemental Approval letter to AstraZeneca Pharmaceuticals LP for Farxiga: Please refer to your supplemental New Drug Application (sNDA) dated and received July 28 2016, submitted under section 505(b)... Continue reading
Posted Aug 29, 2016 at Drug Injury Watch
Portola, Which Developed AndexXa, Estimates 100,000 Patients Per Year Suffer From Severe Uncontrollable Bleeding Events That Could Require Such An Antidote (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-August 2016 the US FDA rejected Portola Pharmaceutical's application to market AndexXa (andexanet alfa) as an antidote to three direct Factor Xa inhibitors: Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb; Xarelto (rivaroxaban) from Bayer/Johnson & Johnson; and, Savaysa (edoxaban) from Daiichi Sankyo. The reason this FDA rejection of the AndexXa application is remarkable: There is no reversal agent for Factor Xa inhibitors approved in the United States. And these Factor Xa inhibitors, which serve as blood-thinner drugs, are being used by an increasing number of patients for stroke prevention and for treatment of deep vein thrombosis and pulmonary embolism. From this August 18, 2016 article, "Is It "Game Over" After Portola's FDA Rejection?", posted on The Motley Fool website, we get this contextual information: Portola Pharmaceuticals developed AndexXa to reverse the anticoagulant effects of a new and fast-growing class of drugs known as factor Xa inhibitors.... Factor Xa inhibitors' advantages have turned Xarelto and Eliquis into multibillion-dollar-per-year blockbusters already. But the absence of an antidote that can reverse their anticoagulant effects has kept factor... Continue reading
Posted Aug 22, 2016 at Drug Injury Watch
This is the second article in the Nexium, Prilosec, Prevacid series, in which some of the possible side effects of taking these drugs are discussed. Continue reading
Posted Aug 22, 2016 at Drug Safety Developments
Australia's Drug Regulator Issues Warnings And Mandates Label Changes, Following Similar Action In Europe; Will FDA Follow Thess Leads? (Posted by Tom Lamb at DrugInjuryWatch.com) In early August 2016 we learned about some new apparent side effects of Prolia as well as Xgeva, QT interval prolongation and severe symptomatic hypocalcemia. Denosumab is the active ingredient for Prolia and Xgeva, both of which are made by biotech pharmaceutical company Amgen Inc. Prolia is a treatment for osteoporosis and osteopenia. Xgeva is a drug used for the prevention of skeletal-related events in adults with bone metastases from solid tumors. This emerging drug safety issue was recently addressed by Australia’s Therapeutic Goods Administration (TGA), and was initially identified by that drug regulator during an assessment of adverse event reports relating to Prolia and Xgeva. From this August 12, 2016 article, "Australia’s TGA issues warning on denosumab and QT prolongation", published on the ThePharmaLetter (subscription required) website, we get this detailed information: Product information update Hypocalcemia is a known effect of denosumab and was already captured in the Product Information (link is external) (PI). However, there was previously no reference to QT prolongation, which is a potentially life-threatening disorder, or to severe symptomatic hypocalcemia.... Continue reading
Posted Aug 15, 2016 at Drug Injury Watch
A discussion of common Proton Pump Inhibitor drugs such as Nexium / Prilosec / Prevacid, reasons for their prescription, and their link to kidney injuries. Continue reading
Posted Aug 11, 2016 at Drug Safety Developments
To the best of my knowledge, as of today (8/9/16) only Pradaxa has an FDA-approved reversal agent, or antidote; it is called Praxbind. Tom Lamb
1 reply
Current Product Liability Litigation Cases Involving Popular Drugs With Serious Side Effects That Are Starting To Gain More Attention (Posted by Tom Lamb at DrugInjuryWatch.com) This article will feature three types of drug injury cases that are starting to gain some momentum in terms of the number of lawsuits filed against the responsible pharmaceutical companies in courts across the country. (1) Diabetes Medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Class of Drugs Invokana (canagliflozin) — Janssen Pharmaceuticals Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company These drug injury lawsuits primarily involve the following side effects: Diabetic Ketoacidosis (DKA) Ketoacidosis Ketosis Acute Kidney Injury Kidney Failure / Renal Failure Kidney Damage Pyelonephritis (kidney infection) Urosepsis (blood infection) Urinary Tract Infection (UTI) (2) Erectile Dysfunction (ED) Pills, Benign Prostatic Hyperplasia (BPH) Medicines, and Pulmonary Arterial Hypertension (PAH) Medications in the Phosphodiesterase 5 (PDE-5) Inhibitors Class of Drugs Adcirca (tadalafil) -- Eli Lilly and Company Cialis (tadalafil) -- Eli Lilly and Company... Continue reading
Posted Aug 5, 2016 at Drug Injury Watch
New studies are comparing Eliquis, Savaysa, Xarelto, Pradaxa, and Coumadin for effectiveness in blood clot treatment and risk for major bleeding events. Continue reading
Posted Jul 29, 2016 at Drug Safety Developments
To Date, More Attention Paid To The Association Between These Sodium-Glucose Cotransporter-2 Inhibitors And Diabetic Ketoacidosis Or Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Over the past year the FDA has mandated several drug label changes for Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, to increase the warnings about some serious side effects linked to these relatively new diabetes medicines. And the FDA is currently investigating additional adverse reactions that may be associated with these sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs. To date, most attention has been directed to the association between the SGLT2 inhibitors and diabetic ketoacidosis. For example, see this December 2015 article, "FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors". More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect, as covered in this June 2016 article, "Invokana, Invokamet, Farxiga, Xigduo: Warnings About Acute Kidney Injury Risk Are Increased On Revised Drug Labels For These Diabetes Medicines". What has received less attention, it seems, is the fact that these still relatively new diabetes drugs -- Invokana, Farxiga, and Jardiance, as well as their several... Continue reading
Posted Jul 27, 2016 at Drug Injury Watch
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Though the main legal focus has concerned the risk of melanoma as a side effect of Viagra, research shows that Cialis and Levitra can also cause melanoma. Continue reading
Posted Jul 19, 2016 at Drug Safety Developments
According To Drug Regulators, New Possible Side Effects Include: Fatal Cases Of Ketoacidosis; Leg, Foot, And Toe Amputations; And, Lactic Acidosis (Posted by Tom Lamb at DrugInjuryWatch.com) On June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. These relatively new diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors. Notably missing from this June 2016 drug safety warning were Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride), which are also part of the SGLT2 Inhibitors class of drugs. About a month later, however, only those three diabetes drugs from Boehringer Ingelheim Pharmaceuticals, Inc. received a Supplemental Approval letter from the FDA concerning a label change about ketoacidosis, an apparent serious side effect. Using the July 8, 2016 FDA letter for Jardiance as a representative document showing this most recent revision to the safety information for these drugs: Please refer to your Supplemental New Drug Application (sNDA) dated and received February 12, 2016.... This Prior Approval supplemental new drug application proposes to amend the Jardiance Prescribing Information and Patient Information with new text informing that fatal... Continue reading
Posted Jul 13, 2016 at Drug Injury Watch
The EMA will now investigate all SGLT2 inhibitor diabetes drugs for a possible link to increased lower-extremity amputations. Continue reading
Posted Jul 11, 2016 at Drug Safety Developments
Melanoma Skin Cancer: FDA Is Evaluating The Need For Regulatory Action; More Lawsuits Filed; Another Research Study (Posted by Tom Lamb at DrugInjuryWatch.com) In late June 2016 the Food and Drug Administration (FDA) said it will study a potential link between melanoma skin cancer and erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra. This announcement appeared in the agency's latest watch list of drugs with possible safety issues, "January - March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)". In relevant part, the document listed these drugs which have been associated with melanoma as a serious side effect. PDE-5 inhibitors: Adcirca (tadalafil; Eli Lilly and Company): tablets Cialis (tadalafil; Eli Lilly and Company): tablets Levitra (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets Revatio (sildenafil citrate; Pfizer): tablets, oral suspension, and injection Staxyn (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets Stendra (avanafil; Vivus and Auxilium Pharmaceuticals): tablets Viagra (sildenafil citrate; Pfizer): tablets From this July 1, 2016 Medscape article, "New FDA Watch List: Possible ED Drug–Melanoma Link and More", we get some background information about that June 2016 FDA investigation announcement: The agency will be on the heels of other researchers when... Continue reading
Posted Jul 6, 2016 at Drug Injury Watch
Some Xarelto And Eliquis Lawsuits Accuse Drug Makers Of Failing To Warn That In Event Of Uncontrollable Bleeding There Is No Antidote, Just Like With Savaysa (Posted by Tom Lamb at DrugInjuryWatch.com) The headline of a recent medical news report about Savaysa (edoxaban), from Daiichi Sankyo, made it seem that there are no serious problems with the use of this still relatively new non-vitamin K antagonist oral anticoagulant. Published June 20, 2016 by Healio - HemOnc Today, "Edoxaban safe, effective for extended prevention of recurrent VTE" starts out with this apparent ringing endorsement: Extended treatment with the oral anticoagulant [Savaysa (edoxaban)] prevented recurrent venous thromboembolism and led to fewer major bleeding events than warfarin among patients with venous thromboembolism, according to a post-hoc analysis of a randomized trial. For what it is worth, I want to point out that Daiichi Sankyo funded this study. But more interesting, I think, is how this Healio - HemOnc Today news reports ends, focusing on the continuing lack of any FDA-approve antidote for Savaysa, as well as Eliquis and Xarelto. The growing availability of agents for the reversal of bleeding caused by direct oral anticoagulants suggests that they can be used regularly and safely,... Continue reading
Posted Jun 30, 2016 at Drug Injury Watch
I appreciate you sharing this most unfortunate story with us. We wish you the best in all aspects going forward. Tom Lamb
1 reply
Meanwhile Jardiance, Glyxambi, And Synjardy, Also In The SGLT2 Inhibitors Class Of Diabetes Drugs, May Help Slow Progression Of Kidney Disease In Patients At High Cardiovascular Risk (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2016 this drug safety labeling change for Invokana (canagliflozin) was approved By FDA Center for Drug Evaluation and Research (CDER): WARNINGS AND PRECAUTIONS Acute Kidney Injury and Impairment in Renal Function INVOKANA causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving INVOKANA; some reports involved patients younger than 65 years of age. Then on June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. Based on recent reports, the side effects warnings in the drug labels have been revised to include more exact information about acute kidney injury. More precisely, from the Data Summary part of this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)", we get this detailed information: A search of the FDA Adverse... Continue reading
Posted Jun 22, 2016 at Drug Injury Watch