Recently in Drug Recall Category

Infants' Tylenol Oral Suspension Recalled

February 19, 2012, by JONES WARD PLC

Approximately 574,000 1oz. bottles of grape flavored Infants' Tylenol Oral Suspension are being recalled. According to the FDA, problems with the product's SimpleMeasure dosing system prompted the recall. SimpleMeasure includes a dosing syringe, which a caregiver or parent inserts into a protective cover, or "flow restrictor," at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by any type of defective or recalled product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Pradaxa Attorney: Bleeding Complications Are Dangerous

February 14, 2012, by JONES WARD PLC

WARNING: If you cut yourself, you have a real risk that you may bleed to death. Go to the hospital immediately for a blood transfusion.

If the language above was in the Pradaxa label, would you buy it? I didn't think so. And neither does the maker of Pradaxa. If they included the language above, their sales would plummet. So what does the company do, they minimize the very serious risk of death and/or blood transfusions in the Pradaxa label.

Is that right? Is it fair? I don't think so. And lawyers across the country don't think so. In fact, Pradaxa attorneys across the country are hearing from the families of Pradaxa users who have suffered serious injuries and death because of this drug. Unlike it competitors, Pradaxa has no antidote for uncontrollable bleeding. There are no medicines that can cause the blood to coagulate and stop the bleeding naturally.

If you or a family member has been injured or killed because of uncontrollable bleeding caused by Pradaxa, contact Pradaxa attorney Larry Jones by clicking here.

Yaz Yasmin Settlement: Lawyer says Gallbladder Patients are being ignored

February 14, 2012, by JONES WARD PLC

What's a gallbladder worth? This is the question that I've heard over and over and over again as it relates to the Yas, Yasmin and Ocella settlement discussions currently taking place across the country. Bayer (the maker of Yaz, Yasmin and Ocella) says a gallbladder is worth zero, nothing, nada, zip. Bayer says that the woman who lost their gallbladders were fat, out of shape, old, and generally unhealthy. Bayer says that they are not responsible for gallbladder losses because there are no epidemiological studies showing an increased risk of gallbladder disease in Yaz, Yasmin and Ocella users.

What do I say? Bring it on. A gallbladder removal is a very serious injury. I represent teenagers, as well as middle-aged women, in the Yaz, Yasmin and Ocella litigation. They aren't all fat or old or out of shape. Indeed, there are thousands of young woman (pretty, thin, and in shape) who have lost their gallbladders. These women had no prior health history that would suggest gallbladder disease. These women never knew that they were at risk. The women never knew that a Canadian Medical Association published a study that found that there was a "statistically significant" increase in gallbladder disease for Yaz, Yasmin and Ocella users when compared to other oral contraceptives.

So what's it worth? I'm an experienced trial lawyer. I can try these cases. I can't imagine that a jury would not award six figure verdicts. So when Bayer comes knocking at my door, they better be ready to negotiate reasonable settlements. If not, I'll go to court and try my cases on behalf of my gallbladder clients. We don't plan on letting them get away with endangering our daughters, moms, aunts, and nieces who have used Yas, Yasmin and Ocella.

Reglan (Metoclopramide) Attorneys

February 4, 2012, by JONES WARD PLC

Jones Ward PLC is actively litigating nearly 100 cases across the country (mainly in Boston, Philadelphia and St. Louis) related to the use if Reglan (metoclopramide) and its link to the tragic muscle movement disorder known as tardive dyskinesia. Much of the litigation is centered on the generic manufacturers of metoclopramide, who claim that they had no duty to contact the FDA and request a label change despite very clear evidence that the metoclopramide was linked to tardive dyskinesia. For more information from the FDA, check out this link: http://youtu.be/dum81RdFrhM

There is much more to this story. If you would like to know more, don't hesitate to send me an email at larry@jonesward.com


Glass Fragments Prompt Leukemia Drug Recall

January 29, 2012, by JONES WARD PLC

Teva Pharmaceutical Industries Ltd. and its U.S. subsidiary Cephalon has recalled a lot of its Treanda leukemia drug, because glass fragments were found in one of the vials. According to the FDA, Cephalon distributed the Treanda lot TB30111 to wholesalers and distributors between March 22 and October 5, 2011. The company notified those recipients about the recall on November 18, 2011. The FDA instructed hospitals and health care professionals in possession of vials in lot TB30111 to stop using them immediately. Thankfully, Cephalon said that it had not received any report of an adverse event related to particulate matter in the vials.

The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by Treanda or any other type of product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Novartis Recalls Select Excedrin, NoDoz, Bufferin and Gas-X Products

January 10, 2012, by JONES WARD PLC

Novartis Consumer Health, Inc. recently announced the voluntary recall of select bottles of Excedrin, NoDoz, Bufferin and Gas-X. According to reports, these products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. The recalled Excedrin and NoDoz products have expiry dates of December 20, 2014 or earlier. The recalled Bufferin and Gas-X Prevention products have expiry dates of December 20, 2013 or earlier.

The potential presence of foreign tablets or chipped tablets places consumers at serious risk. The mixing of different products in the same bottle could result in consumers taking the incorrect product, receiving a higher or lower dose than intended, or receiving an unintended ingredient. Such results could cause overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. This recall is at the consumer level so persons who purchased these products should discontinue use immediately.

The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by Excedrin, NoDoz, Bufferin, Gas-X or any other type of recalled product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Tekturna Recall? Lawyer Says Lawsuits Likely Will Result from Suspension of Tekturna Sales

January 6, 2012, by JONES WARD PLC

Novartis is looking at big trouble over the side effects caused by Tekturna (Aliskiren), a blood pressure drug sold by Novartis, after Tekturna's clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).

During the clinical trials, Novartis was testing Tekturna to see if it could be useful in the treatment of hypertension by diabetics. The results were disastrous. Rather than helping those who ingested Tekturna, Novartis that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.

As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched this week in Canada, where the medication is sold under the brand name Resilez.

Here's where Novartis went wrong. Long before testing the safety and efficacy of Tekturna on diabetic patients, Novartis engaged in extraordinary reckless behavior --all in the name of increasing its profits. Among other things, Novartis was instructing its sales representatives to engage in "off-label marketing" of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had "protective effects" on these patients even though it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.

Novartis announced the cancellation of the clinical trials via a December 20, 2011 press release. The trial, which was known as ALTITUDE, involved 8,609 patients from 36 countries. The ALTITUDE trial was a randomized, double-blind, placebo-controlled study of the drug's use in patients with diabetes and kidney problems. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE study found an increase in Tekturna side effects after 18-24 months. These dangerous side effects included not only strokes and renal complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause dangerous circulatory problems, such as a low pulse and heart rate. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE trial involved the use of Tekturna along with agiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE trials were cancelled after an independent Data Monitoring Committee (DMC), which was overseeing the clinical trial, became alarmed by the high rate of Tekturna health risks among the ALTITUDE trial subjects and recommended that Novartis immediately stop the study because of the dangerous side effects and the risk to the study's participants. See http://www.rttnews.com/1784537/novartis-reveals-termination-of-altitude-trial-with-rasilez-tekturna.aspx

Tekturna (Aliskiren) is an anti-hypertensive (blood pressure lowering) medication. Novartis claims it works by decreasing substances in the body that narrow blood vessels and raise blood pressure. Tekturna was launched by Novartis in April 2007. See http://www.drugs.com/tekturna-hct.html

Tekturna is indicated by the FDA for the treatment of hypertension, to lower blood pressure. See http://www.drugs.com/tekturna-hct.html

TekturnaHCT contains a combination of hydrochlorothiazide and Aliskiren. Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. TekturnaHCT is indicated for the treatment of hypertension, to lower blood pressure in: (a) patients not adequately controlled with monotherapy; or (b) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. See http://www.drugs.com/tekturna-hct.html

Valturna is a combination of aliskiren, a renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB). Valturna is indicated for the treatment of hypertension, to lower blood pressure: (a) in patients not adequately controlled with monotherapy; (b) May be substituted for titrated components; (c) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Novartis launched Valturna in January 2010. See http://www.drugs.com/pro/valturna.html

TekAmlo contains a combination of Aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker. Novartis launched TekAmlo in 2011. Amlodipine relaxes (widens) blood vessels and improves blood flow. TekAmlo is indicated for the treatment of hypertension, to lower blood pressure: (a) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals; (b) in patients not adequately controlled with monotherapy; (c) as a substitute for its titrated components. See http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=28627

Amturnide is a combination of Aliskiren, amlodipine besylate (a dihydropyridine calcium channel blocker) and hydrochlorothiazide (HCTZ) (a thiazide diuretic). Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine besylate relaxes (widens) blood vessels and improves blood flow. HCTZ is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Amturnide is indicated for the treatment of hypertension, to lower blood pressure, and is not indicated for initial therapy. See http://dailymed.nlm.nih.gov/dailymed/mobile/drugInfo.cfm?id=56247

Novartis' Off-label Promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide

According to messages from sales representatives on CafePharma, Novartis engaged in an off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated. See http://www.cafepharma.com/boards/showthread.php?t=480316 See also http://www.cafepharma.com/boards/showthread.php?t=482965 See also http://www.cafepharma.com/boards/showthread.php?t=486183

In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince prescribers that these drugs had positive health effects for the diabetic patient population. The sales aid was known as the "flash card campaign." http://www.cafepharma.com/boards/showthread.php?t=486183 See also http://www.cafepharma.com/boards/showthread.php?t=486127

According to some, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.

On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

What is Next?

Novartis has not yet released data from the study, but has informed all of the clinical trial's investigators to remove Tekturna products from their patients' treatment regimen. The company is also in consultations with governments worldwide about Tekturna health risks.

JONES WARD PLC partner Larry Jones says, "Given the level of misconduct associated with the marketing and off-label promotion of this drug, combined with the disastrous side effects, it is likely that Novartis will soon be taken to task for putting the desire for profits over the safety of consumers. We intend to be intimately involved with holding Novartis responsible for the lives it has damaged."

For another great article on the topic, look at Dr. Shezad Malik's blog http://fortworth.injuryboard.com/fda-and-prescription-drugs/novartis-tekturna-problems-study-cancellation.aspx?googleid=297374

For more information about Tekturna lawsuits, feel free to contact The Recall Lawyers or dangerous drug attorney Larry Jones by clicking here: larry@jonesward.com.

FDA to Hold Transvaginal Mesh Hearings This Week

September 6, 2011, by JONES WARD PLC

The Food and Drug Administration plans to hold a subcommittee meeting to discuss "the safety and effectiveness of transvaginal surgical mesh for repair of pelvic organ prolapse" this week on September 8 and 9. This meeting comes at a time when consumer groups are calling for the widespread recall of surgical mesh due to severe complications.

Tranvaginal surgical mesh is used to treat Pelvic Organ Prolapse, a condition that occurs when the support in the vagina is lost which results in the dropping of the bladder, urethra and other pelvic organs. Vaginal mesh has also been used to treat Stress Urinary Incontinence, a condition that occurs due to weakening of the pelvic area muscles and causes short bouts of incontinence.

The FDA first warned of serious complications from transvaginal surgical mesh in October of 2008. It warned of erosion through vaginal epithelium--the wearing away of the thin lining covering the vaginal wall. Surgical mesh has also been linked to infection, pain, urinary problems, bowel, bladder or blood vessel perforations.

Continue reading "FDA to Hold Transvaginal Mesh Hearings This Week" »

Actos: Bladder Cancer

August 9, 2011, by JONES WARD PLC

Takeda Pharmaceuticals Co. Ltd., which manufactures of the best selling diabetes drugs in the world, is facing several hundreds of lawsuits due to recent reports that patients who take the bill for a year or longer may develop bladder cancer.

actos-pioglitazone-hydrochloride.jpg

Actos was pulled from the market in Germany and France in June "after pressure from regulators" in the two countries, which raises the question of why the US has not halted sales of this highly profitable drug. FDA and the European Medicines Agency have "issued warnings about the cancer risk based on new research, but they have allowed sales to continue."

Jones Ward PLC's lawyers are experienced pharmaceutical injury lawyers. We are currently evaluating Actos bladder cancer cases. If you would like to have your case evaluated free of charge, feel free to contact us.

MDL Primer: Multi-District Litigation 101

August 5, 2011, by JONES WARD PLC

This is an article that is scheduled to be published in the upcoming issue of the Kentucky Justice Association's Advocate Magazine.

By: Lawrence L. Jones II

Almost all attorneys have at least a vague understanding of what a "mass tort" is but few know about the Multi-District Litigation (or "MDL") device that was created by Congress in 1968 to efficiently manage mass tort litigation in federal courts. Many Plaintiffs' lawyers try to avoid the MDL process like the plague. These lawyers believe that an MDL ultimately delays the resolution of their clients' cases because of the lengthy "life cycle" of an MDL. Some also resent paying a "case tax" (sometimes as high as 10%) to the members of the MDL's steering committee, a panel of lawyers appointed by the transferee court to litigate the issues common to all of the cases.

Regardless of what your thoughts are about the MDL process, it pays to know what an MDL is before your case suddenly becomes part of one against your will. The following is a primer based upon the author's experiences handling numerous MDL cases, both as class counsel and as appointed members on the Plaintiff's Steering Committee and various subcommittees.

What is the Judicial Panel on Multi-District Litigation?

Congress created the United States Judicial Panel on Multi-District Litigation with its passage of 28 U.S.C. §1407. The MDL Panel consists of seven United States District and Circuit Court Judges (each serving a seven-year term), including its Chairman. Unbeknownst to many Kentucky attorneys, United States District Court Judge John G. Heyburn II currently serves in the prestigious role of Chairman of the MDL Panel. The Chief Justice of the United States Supreme Court selects both the Chair and the MDL panelists.

The MDL Panel was created by Congress to determine whether civil cases filed in various federal jurisdictions share common questions of fact that may make them appropriate for centralization in one federal district court for coordinated pre-trial proceedings. This centralization process is intended to avoid duplicative discovery, to prevent inconsistent pretrial rulings in factually similar cases and to conserve the resources of the parties who may be managing hundreds or even thousands of similar cases across the United States.

Since its creation, the MDL Panel has considered centralization motions involving more than 300,000 cases, involving millions of claims. While many think of the MDL process as something that applies to pharmaceutical cases, the MDL Panel's docket is much more diverse. In addition to pharmaceutical cases, the MDL Panel has considered cases involving wage and hour litigation, airplane crashes, train wrecks, hotel fires, asbestos, securities and financial fraud, antitrust, and patent cases. However, it is true that the bulk of the MDL Panel's docket does include pharmaceutical cases.


How does a case get selected for MDL treatment?

A case does not just automatically get selected for MDL treatment; one of the parties must ask for such treatment. To begin the process of creating an MDL, a party must file a motion pursuant to 28 U.S.C. §1407 requesting centralization of all similar cases for purposes of conducting pre-trial proceedings. The motion is filed with the MDL Panel and a copy of such motion must be filed with district court in which action is pending. Koerner & Associates, Inc. v. Aspen Labs, Inc., 492 F.Supp 294 (S.D. Tex. 1980).

The party seeking centralization must make a showing that the pending cases are factually similar and that centralization will benefit the parties and conserve judicial resources. The moving party bears a strong burden of showing that common questions of fact are so complex and that the accompanying discovery is so time consuming as to overcome the inconvenience to the party whose action is being transferred. In re Interstate Medicaid Patients at Good Samaritan Nursing Center, 415 F.Supp 389 (JPML 1976).

Is there anything I need to know about practicing before the MDL Panel?

If one intends to practice before the MDL Panel, you are advised to carefully review the Rules of Procedure of the Judicial Panel on Multi-District Litigation. The Rules are a guide to the MDL Panel's mandates for such things as service of process, number of copies, style of pleadings, and relevant deadlines.

For illustrative purposes, the following scenario assumes that it is the plaintiff who has filed a 1407 motion for centralization, although defendants also file such motions because of the economic advantages of litigating and/or settling hundreds or thousands of cases in a centralized manner.

After a plaintiff files a 1407 motion seeking centralization, the MDL clerk will notify all of the parties of the motion's filing date, caption, MDL docket number, briefing schedule and the pertinent MDL Panel policies. JPML Rule 7.2(b). The defendants must respond within 20 days (or seek an extension of time pursuant to JPML Rule 6.2) or the Defendant is deemed to have acquiesced to the request for MDL centralization. JPML Rule 7.2(c).

The initial motion for centralization must include averments in numbered paragraphs, each of which shall be limited, as far as practicable, to a statement of a single factual averment. The response to those averments in motions shall be made in numbered paragraphs, each of which shall correspond to the number of the paragraph of the motion to which the responsive paragraph is directed. Much like an answer to a complaint, each responsive paragraph must admit or deny wholly or in part the averment of the motion, and shall contain the respondent's version of the subject matter when the averment or the motion is not wholly admitted. JPML Rule 7.2.

Within eleven days after the motion for MDL transfer is filed, each party or designated attorney must enter an appearance by notifying the MDL Panel's Clerk, in writing, of the name and address of the attorney designated to receive service of all pleadings, notices, orders and other papers relating to practice before the MDL Panel. JPML Rule 5.2(c). Only one attorney shall be designated for each party.

The response to the 1407 motion, which is due within 20 days, must also include a brief in support thereof in which the background of the litigation and factual and legal contentions of the respondent shall be concisely stated in separate portions of the brief with citation to applicable authorities. JPML Rule 7.2(a)(i). All briefs are limited to twenty pages, exclusive of exhibits, unless the MDL Panel orders otherwise. JPML 7.2(f).

In addition to the response brief, each responding party is required to simultaneously file a one page statement indicating the responding party's position regarding whether oral argument before the MDL Panel is necessary or not, including the reasons why. JPML Rule 16.1(b).

If there is an objection to the 1407 motion for centralization, the MDL Panel will not transfer the case without a hearing on the motion except in cases where the MDL Panel determines that: (i) the dispositive issues have been authoritatively decided; or (ii) the facts and legal arguments are adequately presented in the briefs and record, and oral argument would not be helpful to the MDL Panel's decision-making process. JPML Rule 16.1(c).

All parties and counsel are also required to promptly notify the MDL Panel's Clerk of any potential "tag-along actions" in which that party is also named or in which that counsel appears. JPML Rule 7.2(i). A "tag-along action" refers to a case that is pending in a federal district court and involving common questions of fact with actions previously transferred under Section 1407. JPML Rule 1.1.

Once the MDL Panel schedules the oral argument which normally takes place at the MDL Panel's next bi-monthly hearing, you will appear at the hearing to present reasons why the cases should be centralized and to argue to the MDL Panel which jurisdiction would be appropriate for centralization.

Once at the MDL Panel's hearing, it is very important that counsel limit oral argument to the "appropriate criteria" as spelled out in In re East of the Rockies Concrete Pipe Antitrust Cases, 302 F. Supp. 244, 255-56 (J.P.M.L. 1969). In sum, there are twenty questions that the East of the Rockies case focuses on.

Among other things, the MDL Panel wants to know a) How many common questions of fact are there and what is the nature of the common questions?; b) How many cases have been filed, where they are currently venued, whether additional cases will be filed and the anticipated venues of those filings; c) Whether transfer and centralization will operate to save the parties and the courts from duplicative work and inconsistent rulings; d) What detriment, financial or otherwise, will be imposed upon any of the parties by ordering transfer?; e) Are pretrial proceedings already far along in any one or more of the cases?; f) What is the availability of a judge in the proposed transferee court or courts?; g) Will the advantages of transfer and centralization overcome the normal desirability of having the same judge who conducts the trial also conduct pretrial proceedings?; and h) Will transfer and centralization impede or promote the prospect of settlements?

The hearing itself is a very interesting experience. Hundreds of plaintiff and defense lawyers come from across the country to attend the MDL hearing. Yet, most of the lawyers are merely observers since the MDL Panel limits the oral argument time. If the plaintiffs and the defendants agree that the cases should be centralized, then the arguments many times focus on which court would be the appropriate transferee court. Factors argued by the parties, and considered by the Court, are: a) Whether the proposed venue has a major airport nearby which would accommodate counsel traveling from across the country; 2) The location of the corporate defendants; 3) The proximity of evidence and witnesses to the proposed venue; and 4) The desire of the proposed transferee judge to handle a complex and time-consuming MDL proceeding.

What Happens After the MDL Hearing?

The MDL Panel is generally pretty quick with its decisions. The MDL Panel usually issues a ruling on 1407 motions within two weeks after the hearing. The order will mandate whether or not the cases are to be centralized and, if so, to which federal district court judge the cases are transferred. So, generally, the process takes approximately 90 days from the filing of the motion until the MDL Panel's ruling is issued -which has been a marked improvement under Judge Heyburn's leadership.

Once the MDL Panel chooses the transferee court, the transferee judge assumes control over all current and future cases involving the common questions and common defendants. In re Equity Funding Corp. of America Securities Litigation, 375 F.Supp 1378 (JPML 1973) (It is province of Judicial Panel to decide in the first instance whether litigation should be transferred for coordinated or consolidated pretrial proceeding while it is the province of transferee judge to determine whether and to what extent the trial proceedings should be coordinated or consolidated.) Indeed, the transferee court assumes complete jurisdiction for pre-trial purposes and has authority to settle all pre-trial motions including dispositive motions such as those for summary judgment or approval of a settlement. In re Agent Orange Product Liability Litigation, 597 F.Supp 740 (E.D.N.Y. 1984), affirmed, 818 F.2d 145, cert. denied, 108 S.Ct. 695, 484 U.S. 1004, 98 L.Ed.2d 648, on remand, 689 F.Supp. 1250. The transferee court is also authorized to handle matters relating to class action certification in order to prevent inconsistent rulings and to promote judicial efficiency.

After the MDL Panel issues its ruling and transfers the cases for coordinated proceedings, the transferee judge promptly schedules a conference with all lawyers involved in the litigation. At this initial status conference, the transferee court will begin to address case management issues (such as electronic preservation of evidence, the use of master complaints, service of process issues, etc.) that will be included in the Case Management Order (or "CMO"). Additionally, the Court usually appoints temporary lead or liaison counsel to be the spokespersons for the Plaintiffs and the Defendants, until such time as permanent lead or liaison counsel can be appointed.

Since there may be hundreds or even thousands of plaintiff lawyers involved in a particular MDL, the transferee court cannot possibly accommodate having that many lawyers appear at hearings and expect to be heard. Therefore, the transferee court
will issue an order relating to applications for a position on the Plaintiff's Steering Committee ("PSC"). Alternatively, the Court may ask the temporary lead counsel to propose a "slate" for potential appointment on the PSC. Sometimes the applications, which are largely recitations of one's experience with complex cases, can be quite colorful. In the recent round of applications for the Toyota MDL, one lawyer touted that he had donated an organ to a family member as an example of his selfless nature.

After the PSC is appointed by the court, the lawyers on the PSC will control the litigation for all of the non-PSC members. All case strategy and much of the day-to-day work is completed by the PSC and the various "sub-committees" created by the PSC. Yet, once the discovery is complete regarding the issues common to all of the cases, the PSC's work is done and the individual cases are remanded to their home district for trial.

What happens after the discovery is finished?

After several years of being constantly bombarded with electronic filings from the MDL case, one day you may realize that the parties have finally completed discovery. By this time, Daubert motions related to general causation experts have been resolved, expert depositions have been completed, and the corporate officers have been deposed. What happens next?

Well, the individual plaintiff lawyer finally regains control of his/her own individual case. As a benefit of the "tax" that you will be required to pay to the PSC upon settlement of your case, you will receive access to the millions of documents that have been unearthed during discovery. In fact, you will have access to all of the discovery completed in the case, including the expert depositions. From there, you are on your own to try your case (or engage experienced co-counsel chosen from the PSC) and hold the individual corporate wrongdoer accountable for its conduct.

Right or wrong, like it or not, this is how a case proceeds through the MDL process! If you don't like it, find a non-diverse defendant to sue and fight like mad to keep the action in state court.

Lawrence L. Jones II is a founding partner of Jones Ward PLC in Louisville, Kentucky. His firm focuses much of its practice on mass tort litigation in state and federal courts across the country. The firm is currently involved in several MDL proceedings. For more information about the author, visit www.the-recall-lawyers.com.

Medtronic Paid Surgeons Who Miminized Risk of Bone Growth Product

August 1, 2011, by Jasper Ward

Medtronic, the national device manufacturer that is a defendant in numerous lawsuits over pain pump and other recalled or dangerous devices, is the subject of a new controversy. According to the Spine Journal, the nationally recognized leading journal for medical research and articles dealing with the spine and back, Medtronic promoted the Infuse bone growth product for use in spinal fusion surgeries. According to the New York Times, the Spine articles highlighted how surgeons with financial backing from Medtronic vastly downplayed the serious risks of injury to patients and overstated the product's benefits.

In fact, the Medtronic-paid doctors claimed there were no risks. In a highly unusual, inter-medicine editorial, the writers at Spine Journal called out their colleagues: "It harms patients to have biased and corrupted research published" and went on to say that it harmed patients to have "unaccountable special interests permeate medical research."

The side effects from the Infuse include infection, bone loss, male sterility, and unwanted bone growth. The FDA recently rejected a stronger Medtronic product similar to the Infuse because of a link to increased risk of cancer.

In our cases, we've seen drug companies highlight journal articles and studies that supposedly show the risk of their drugs or devices are minimal. However, drug companies often pay for these studies, and we have seen certain manufacturers exclude data as "outliers" - when that data shows clearly the increased risk of their product.

Continue reading "Medtronic Paid Surgeons Who Miminized Risk of Bone Growth Product" »

Yaz, Yasmin Studies Show Double Gallbladder, Clot Risk

April 22, 2011, by Jasper Ward

Recent studies have confirmed that thousands of lawsuits regarding Yaz, Yasmine and Ocella over gallbladder disease, blood clots and heart related trouble have merit.

According to the Canadian Medical Association Journal, a survey of health databases show that the risk to women on Yaz and Yasmin is double that of other birth control drugs of having to have their gallbladder removed. Researchers analyzed a database of more than 2.7 million women who used birth control pills. The analysis showed that newer birth control brands had increased risk of gallbladder disease when compared to previous generations, but that the increased risk of Yaz and Yasmin for gallbladder removal and disease was twice as much as any other.

In addition, a recent study published in the British Medical Journal showed that the risk of blood clotting disorders was twice as much for users of Yaz and Yasmine than other drugs. To make that determination, researchers from the Boston Collaborative Drug Surveillance Program at the BU School of Medicine analyzed about 900 women on birth control since the year 2002. For women taking Yaz or Yasmin, the rate of blood clots was 30.8 per 100,000 person-years. For women talking levonorgestrel-based pills, the rate was only 12.5 per 100,000 person-years.

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Medtronic Pain Pumps Recalled By FDA

February 22, 2011, by Jasper Ward

Medtronic's infusion pumps are implanted into the abdomen to gradually deliver drugs or fluids to patients. During the refill process, the inadvertent injection of all or some of the prescribed drug directly into the patient instead of the pump has resulted in drug overdose and death. On January 14, 2011, Medtronic sent a letter to physicians reminding them of the proper refill procedures. Medtronic has also taken steps to update the warning labels and instructions.

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Despite these actions, on February 16, 2011, the U.S. Food and Drug Administration (FDA) issued a Class I recall on Medtronic's infusion pumps. Class I recalls are the most serious issued by the FDA. In order to classify as a Class I recall, there must be a reasonable probability that the use of the product will cause serious harm or death.

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GE CT Scan Overexposure To Brain Radiation Alleged In New Lawsuit

February 7, 2011, by Jasper Ward

Plaintiffs in California have brought what appears to be the first of many likely lawsuits against GE and hospitals for injuries resulting from overexposure - as much as eight (8) times the recommended dosages - to radiation during CT brain perfusion scans. The overexposure can reportedly cause hair loss, cataract problems and potentially increase the risk of cancer.

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According to the hospital sued in the California case, the settings on the machine and the way it is manufactured mean there's a very good chance similar injuries or overexposure incidents have occurred in radiology departments across the U.S.

The FDA is recommending steps to fix the problems, including making sure the default settings matched the recommended settings from the manufacturer, making sure the dose information was easily viewable by the machine's operator, changing settings to make sure the dosage information was correct before proceeding and protecting the settings so that only the manufacturer could change them.

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CBS News Report About ReQuip Causing Compulsive Gambling and Sex Behaviors

February 2, 2011, by JONES WARD PLC

At first blush, people laugh when they hear about stories like the one below. Surely a drug could never cause someone to be a compulsive gambler or sex addict. Surely not.

Well, stop laughing because it is true --and the manufacturers of drugs like Mirapex and ReQuip know it. In fact, the makers of Mirapex have even lost at trial on the issue. This is a serious problem that is causing people to lose hundreds of thousands (and sometimes millions) of dollars gambling. The drugs also cause compulsive sex and compulsive shopping behavior. We represent over a hundred such individuals and we've seen the toll that this has taken on their lives.

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The warnings of these side effects are hidden deep in the product warning sections, where most consumers never look. The companies try to escape liability under a legal doctrine known as the learned intermediary doctrine, which says that your doctor is charged with giving you the warnings if the manufacturer adequately warned the doctor. The problem, however, is that doctors prescribe thousands of drugs every year and don't have time to read the physicians desk reference from cover to cover every year. Therefore, consumers never get warned about serious side effects and the manufacturers escape liability many times.

I'll step off of my soapbox now and share the article with you. Here it is: ReQuip Lawsuit Article