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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
One Unfortunate Fact These Two New Blood-Thinners Have In Common Is That Neither Has An FDA-Approved Antidote At Present Time (Posted by Tom Lamb at Earlier this month the medical journal Chest published online (Epub ahead of print) this article, "Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation". Also earlier this month, JAMA Internal Medicine published online (Epub ahead of print) this article, "Stroke, bleeding, and mortality risks in elderly Medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation." In both of these medical study reports it seemed that Xarelto (rivaroxaban) was more likely to be involved in a serious bleeding event as an adverse reaction than was either Pradaxa (dabigatran) or Eliquis (apixaban). We previously touched upon the significance of these two new medical journal articles about a year ago with this post, "Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events -- Perhaps, But Neither Eliquis Nor Xarelto Have Any Specific Reversal Agent To Stop An Acute Bleed Once It Starts; Only Pradaxa Does". To set up this latest report on the safety controversy surrounding these non-vitamin K antagonist oral anticoagulants (NOACs),... Continue reading
Posted 2 hours ago at Drug Injury Watch
There Is An Apparent Melanoma Skin Cancer Link For Each Of These ED Drugs Given How PDE5 Inhibition Augments Tumor Cell Invasiveness (Posted by Tom Lamb at Viagra (sildenafil) was the first drug prescribed for male erectile dysfunction (ED) associated with an increased risk for malignant melanoma, starting back in 2014. In the past year there have been medical articles published suggesting that the four other brand name ED drugs which are phosphodiesterase 5 (PDE5) inhibitors -- Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil) -- are associated with an increased risk of melanoma skin cancer, too. Essentially, the active ingredients sildenafil, tadalafil, vardenafil, and avanafil which are found in these drugs act by inhibiting the phosphodiesterase 5 (PDE5). In turn, PDE5 inhibition augments tumor cell invasiveness, which promotes the development of malignant melanoma. As regards drug injury lawsuits concerning this melanoma side effect of ED drugs, that litigation began with Viagra cases being filed against Pfizer, the drug company responsible for Viagra. By April 2016 there was a sufficient federal court Viagra lawsuits filed that the Judicial Panel on Multidistrict Litigation (JPML) decided to create the so-called Viagra MDL, known fully as IN RE: VIAGRA (SILDENAFIL CITRATE)... Continue reading
Posted 7 days ago at Drug Injury Watch
While Mechanism And Frequency Currently Unknown, This Situation Can Involve Acute Hepatic Failure Or Fulminant Hepatitis Leading To Liver Transplantation Or Death (Posted by Tom Lamb at Back in May 2016 Health Canada issued a safety warning, "BCR-ABL Tyrosine Kinase Inhibitors [GLEEVEC (imatinib mesylate), TASIGNA (nilotinib), BOSULIF (bosutinib), SPRYCEL (dasatinib), ICLUSIG (ponatinib hydrochloride)] - Risk of Hepatitis B Reactivation", which did not receive much public attention in the US. According to this May 4, 2016 Health Canada document, BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the treatment of specific types of blood cancers, including Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL), and less commonly, other types of cancers. The currently available medicines in this BCR-ABL TKIs class of drugs include: Gleevec (imatinib mesylate) -- Novartis Pharmaceuticals Canada Inc. Tasigna (nilotinib) -- Novartis Pharmaceuticals Canada Inc. Bosulif (bosutinib) -- Pfizer Canada Inc. Sprycel (dasatinib) -- Bristol-Myers Squibb Canada Iclusig (ponatinib hydrochloride) -- ARIAD Pharmaceuticals, Inc. Further, according to Health Canada, this apparent side effect of HBV reactivation in chronic HBV carriers is considered to be a class-effect of BCR-ABL TKIs. __________________________________________________________________ Gleevec / Iclusig Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________________________________ From... Continue reading
Posted Oct 10, 2016 at Drug Injury Watch
Thank you for your email inquiry. 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
October 2016 FDA Drug Safety Communication Warns About These Relatively New Drugs Which Are Increasingly Popular For Treating Chronic Hepatitis C (Posted by Tom Lamb at In April 2016 we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation". Today, about six months later, the FDA indicated their concern for these relatively new chronic hepatitis C treatment drugs -- including Harvoni, Sovaldi, and Viekira Pak -- by issuing a Drug Safety Communication which started with this statement: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in... Continue reading
Posted Oct 4, 2016 at Drug Injury Watch
There has recently been a debate over what to call the class of drugs including Savaysa, Pradaxa, Xarelto, and Eliquis, which still do not have antidotes. Continue reading
Posted Sep 30, 2016 at Drug Safety Developments
I am glad to hear that your are motivated to take action as regards the unfair situations which are the results of how the federal preemption legal doctrine has been and still is applied to many drug injury cases, including yours. You can read a most unfortunate story involving this issue by going to this page: And here is some background about why the federal preemption doctrine has been applied to drug injury cases. The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims (see, in particular, pages 4–14 and 17–20 of this Pliva v. Mensing SCOTUS opinion). Here is a link to that opinion: The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling. Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits: "As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome 'makes little sense'." Please know that your effort and time in connection with this matter are appreciated. Have a good day. Tom Lamb
1 reply
Thank you for your Comment. Unfortunately, this legal obstacle of "impossibility preemption" is being used increasingly by defense lawyers for pharmaceutical companies in drug injury litigation. Besides the Fosamax cases, it is a problem for the Byetta / Januvia / Victoza lawsuits, also. What we need are revised rule and regulations from the FDA and/or new legislation from our US Congress that would roll-back this federal preemption defense. I suggest that individuals contact their representatives in Washington, DC and bring this current legal problem to the attention of our lawmakers. Tom Lamb
1 reply
Use Of Prothrombin Complex Concentrates (PCC) Or Other Procoagulant Reversal Agents Have Not Been Evaluated In Clinical Outcome Studies (Posted by Tom Lamb at In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.: Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information. And here is the "new" section 5.3 Risk of Bleeding part of the Savaysa Prescribing Information document (accessed 9/27/16) -- also known as the package insert or the drug label: Reversal of Anticoagulant Effect There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance [see Clinical Pharmacology (12.3)]. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant... Continue reading
Posted Sep 27, 2016 at Drug Injury Watch
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 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 Sep 20, 2016 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 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 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 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 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 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 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