tag:blogger.com,1999:blog-9002218232182793493.post7491039971877885913..comments2024-03-28T18:27:20.251-07:00Comments on PharmaLittle: HELP ME OUT, SMART PEOPLE!Unknownnoreply@blogger.comBlogger42125tag:blogger.com,1999:blog-9002218232182793493.post-53237498985267409862009-04-16T07:21:00.000-07:002009-04-16T07:21:00.000-07:00A Dallas-Fort Worth news crew convinced the VA to ...A Dallas-Fort Worth news crew convinced the VA to send 300 local veterans to private hospitals for surgeries, shortening wait times from a year to three or four months:<br /><br />http://www.wfaa.com/sharedcontent/dws/wfaa/latestnews/stories/wfaa090415_mo_waittimes.dbda7f8c.htmlAnonymoushttp://www.wfaa.com/sharedcontent/dws/wfaa/latestnews/stories/wfaa090106_mo_veterans.ad6a15f5.htmlnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-5264204533665693742009-04-13T14:12:00.000-07:002009-04-13T14:12:00.000-07:00Veterans are waiting over a year for surgeries in ...Veterans are waiting over a year for surgeries in Dallas, Texas. Podiatry and orthopedics specialty surgeries have the longest wait times...<BR/><BR/>http://www.wfaa.com/sharedcontent/dws/wfaa/latestnews/stories/wfaa090106_mo_veterans.ad6a15f5.html<BR/><BR/>I wonder how long veterans who volunteered for the stent study had to wait:<BR/><BR/>http://content.onlinejacc.org/cgi/content/full/j.jacc.2008.11.029v1Anonymoushttp://www.clinicaltrial.gov/ct2/show/NCT00247208?term=sos+va&rank=1noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-40399929156445430322009-04-13T13:58:00.000-07:002009-04-13T13:58:00.000-07:00The always reliable Wall Street Journal published ...The always reliable Wall Street Journal published the March 10 article on the Boston Scientific Securities law suit as well, here:<BR/><BR/>http://online.wsj.com/article/PR-CO-20090310-906567.html?mod=wsjcrmainNancyhttp://online.wsj.com/article/PR-CO-20090310-906567.html?mod=wsjcrmainnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-6390743467149338652009-04-13T13:37:00.000-07:002009-04-13T13:37:00.000-07:00The above link for the article "Medical Device Sto...The above link for the article "Medical Device Stocks Rattled by Push for US Health Reform" is no longer valid. You can find the same article here:<BR/><BR/>http://online.wsj.com/article/BT-CO-20090312-713889.html?mod=wsjcrmainNancyhttp://online.wsj.com/article/BT-CO-20090312-713889.html?mod=wsjcrmainnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-22916953324101987072009-03-12T17:18:00.000-07:002009-03-12T17:18:00.000-07:00James, this story is growing legs. The headlines r...James, this story is growing legs. The headlines read "Medical Device Stocks Rattled by Push for US Health Reform." Click on my name to read the article.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-60120869923030903282009-03-12T13:58:00.000-07:002009-03-12T13:58:00.000-07:00James, Thank you for this - details are good. I am...James, Thank you for this - details are good. I am going to mull this over now. Very interesting.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-40528266462074408502009-03-12T13:36:00.000-07:002009-03-12T13:36:00.000-07:00NancyI am not familiar with Securities Fraud Litig...Nancy<BR/><BR/>I am not familiar with Securities Fraud Litigation but from reading the Memorandum and Order issued by Judge Woodlock it would appear to me that the "Fraud on the Market Theory" is only used in Securities Litigation and is simply a means used to gain Class Certification. So to answer your first question; this theory would not be relevant for medical devices. <BR/>As to your second question; the theory did work because the Judge granted Class Certification. <BR/>As to the eventual success at trial, that depends on the Judge or if applicable the Jury. <BR/>Below is a brief summary of what I learned from Reading Judge Woodlock’s Memorandum and Order: <BR/>The Judge’s Order outlines the various criteria required for a case to be Class Certified under the Fraud on the Market Theory. <BR/>The Judge's order also informs us that there are separate opinions within the Circuit Courts as to what level of proof is required for Class Certification to proceed with a Fraud on the Market Theory; for example in the 2nd Circuit the Plaintiff must demonstrate that a material fact was withheld from the investors and there is sufficient evidence to demonstrate that revealing this withheld evidence had a direct correlation on a Stock’s price decline. <BR/>In this case at least, The Judge ruled that there is sufficient evidence to proceed as a Class and that the Plaintiff successfully demonstrated that there may be a triable issue of fact.<BR/><BR/>A brief analysis of what the Court might look at: <BR/> <BR/>I reviewed the price of the Stock during the relevant period and the share price for Boston Scientific in November 2003 was $34.00; the Stock rose to a high of $45.00 in June and declined from that point forward. However the Stock did not go straight down, it appears that immediately following the news the Stock dropped to $34.00, but by September had recovered to $39.78, essentially 11% off its peak price.<BR/>A review of Boston Scientifics Stock price as compared to an Exchange Traded Fund shows that while the ETF declined at the same point as did Boston Scientific, the ETF did show peaks and valleys, while Boston Scientifics Stock continued to decline. <BR/><BR/>An ETF is an Exchange Traded Fund that is made of stocks in a particular sector, in this case pharmaceuticals.<BR/><BR/>As to selling by insiders I looked at recent SEC filings and the Officers for Boston Scientific are selling. What I found interesting, at least in the filings I looked at, was the Officers were selling their shares at a little over $1.00 and the Stock is trading at approximately $7.00; Genworth Financial seemed to be the primary purchaser of the stock. I don’t have an explanation for why the Officer’s would do this, but it does seem to indicate to me that the Stock must only be worth a $1.00. <BR/>I know I rambled a bit and may have given more information then you really needed.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-89732713893713364582009-03-12T08:56:00.000-07:002009-03-12T08:56:00.000-07:00James, the plaintiffs in Public Employees’ Retirem...James, the plaintiffs in Public Employees’ Retirement System of Mississippi (PERS) v. Boston Scientific invoked the fraud-on-the-market theory. Are you familiar with this strategy and has it ever been used in a case involving medical devices? Do you think the theory will hold up in this case? <BR/><BR/>PERS alleges that the company made misleading statements about its drug eluting stent, which was eventually recalled. PERS charges that the company's actions inflated the value of the stock artificially, which benefited the company executives and harmed the investors.<BR/><BR/>I understand that the cofounders of the company are selling shares:<BR/>http://www.boston.com/business/articles/2009/03/10/gorillas_everywhere/<BR/><BR/>What does this mean?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-85034159364002257762009-03-12T04:58:00.000-07:002009-03-12T04:58:00.000-07:00JusticeA CDS is a Credit Default Swap; these are t...Justice<BR/><BR/>A CDS is a Credit Default Swap; these are the financial instrument that is sucking money from the Government to help keep AIG afloat. Basically it's insurance that a particular financial instrument is not going to default. The fact is a buyer of a CDS did not even have to have a position in the instrument for which they were buying the insurance. It's like me buying Fire Insurance on your house. They are not really knew, if you know your financial history a similar scam was responsible for causing the Panic of 1907; back then speculators’ could buy insurance on the direction the market was going to take on a particular day; these bets were sold in establishments known as "Bucket Shops." States enacted laws which legislated Bucket Shops out of existence, however under the Commodity Futures Modernization Act of 2000; the Federal Government essentially invalidated the State Bucket Shop laws. <BR/>As far as your teaching method for preemption, I think that's a great method; I used to be an Arbitration Advocate on behalf of management and we had a fairly extensive database of Arbitration Decisions. When I prepared for a case my initial research always involved researching the cases we lost on the issue being advocated. I found it very useful in anticipating the opposition's strategy and was able to establish points on how the case at bar was not the same as the prior decisions or through an analysis of the previous decisions cite where the ruling Arbitrator was not presented with a particular argument when reaching a decision.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-12119485801610297362009-03-11T23:46:00.000-07:002009-03-11T23:46:00.000-07:00Jim--What is the "CDS"? Meanwhile, back at the ra...Jim--What is the "CDS"? <BR/><BR/>Meanwhile, back at the ranch, I am about to indoctrinate an innocent group of undergraduates into the rarefied world of preemption. And, yes, not only will it be fair and balanced, but I will push for the side that isnt mine.<BR/><BR/>That's not because I'm an otherwise good person or teacher (although I may be...). It's because it will help everyone be a better advocate, since most of the students will migrate toward the anti-preemption side anyway. <BR/><BR/>Also, this is incredibly complex stuff. Beyond being pro or anti, one has to talk about the full spectrum of preemption perspectives--the Sharkey model, the fraud exception model, the negligence model, etc etc.<BR/><BR/>If they come out understanding half of that, they'll be a few steps beyond most of the discussion on this issue.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-17311451640893195202009-03-11T20:36:00.000-07:002009-03-11T20:36:00.000-07:00Just one more thing; the company that sells covere...Just one more thing; the company that sells covered devices can offer a stock purchase warranty with every implant; it would do wonders for market capitalization. <BR/>I can see the marketing people and the geniuses that invented the CDS working on this as we speak, figuratively of course.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-691477161704744492009-03-11T20:23:00.000-07:002009-03-11T20:23:00.000-07:00It just goes back to that old standby; the Golden ...It just goes back to that old standby; the Golden Rule; them that got the gold make the rules.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-26948008919274487072009-03-11T20:19:00.000-07:002009-03-11T20:19:00.000-07:00I was being facetious of course, but I have no dou...I was being facetious of course, but I have no doubt that the bean counters for the funds that held shares in Medtronics for the period of time that Medtronics knew their new lead was reliable then their old lead are going back and looking at share price fluctuations and insider trading.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-58361853126025721362009-03-11T19:22:00.000-07:002009-03-11T19:22:00.000-07:00Nice to see this thread come to life again....I li...Nice to see this thread come to life again....<BR/><BR/>I like the plan Jim suggests. Of course, I assume the share of any settlement received depends on how many shares you own in the first place...<BR/><BR/>Also interesting that, within preemptionworld, people can file suit if they are shafted financially but not if they are simply shafted.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-46565179431083278062009-03-11T18:30:00.000-07:002009-03-11T18:30:00.000-07:00Here's some light bedtime reading--the Boston Scie...Here's some light bedtime reading--the Boston Scientific securities litigation memorandum and order certifying the class action lawsuit:<BR/><BR/>http://www.zimmreed.com/pdf/BSX-Class-Cert.pdfAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-30909862210641501112009-03-11T18:14:00.000-07:002009-03-11T18:14:00.000-07:00Interesting, so if you want to get around the MDA,...Interesting, so if you want to get around the MDA, the solution is, if you need a pacemaker or stent or any other device covered under the MDA, buy shares in the company that manufactures the covered device and if it fails your estate can proceed with a shareholder lawsuit.Unknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-51247273319439353352009-03-11T17:54:00.000-07:002009-03-11T17:54:00.000-07:00Boston Scientific securities lawsuit alleges known...Boston Scientific securities lawsuit alleges known manufacturing defects with company's drug-eluting stent: <BR/><BR/>http://www.msnbc.msn.com/id/29623116/Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-47250293185408835252009-01-23T18:19:00.000-08:002009-01-23T18:19:00.000-08:00Anon. - Makes sense to me! Likewise, Former's exc...Anon. - Makes sense to me! Likewise, Former's excellent commentary. Still, I want my students to put themselves in the role of those who would try to prove such assertions and wonder how anyone would. And also woder if anyone has. But I think you make a telling point. (And, as I recall, at least some of the Justices picked up on the fact that these were assertions without evidence.)<BR/><BR/>What I find also interesting is that the doom they foretell - lost innovation, higher drug prices, miraculous cures withheld, etc. - are precisely the arguments that were used agaist the FDA itself when today's preemptors were yesterday's deregulators. <BR/><BR/>If nothing else, they can be nailed for lack of creativity.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-35136058010129686972009-01-23T16:19:00.000-08:002009-01-23T16:19:00.000-08:00Then we can work toward dismantling their evidence...Then we can work toward dismantling their evidence.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-58863337351041166752009-01-23T16:12:00.000-08:002009-01-23T16:12:00.000-08:00No, Justice, that is not what we are left with. Th...No, Justice, that is not what we are left with. The industry must prove their point. <BR/><BR/>It is on the drug companies to prove they are being damaged in other areas by litigation. It has to be on them because they are the only ones who really know. They must support their claims. It is right and just that they must prove it. How many times have they held their consumers to prove they were damaged? No way it should be assumed that they are telling the truth without documentation.<BR/><BR/>It should not be up to us to help them decide how to prove it, because to do so will show them how to work the system. If the Supreme Court is willing to take them at their word then the anti-preemption cause is already lost and shame on the Justices for costing us our rights without enough evidence.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-91356953058763939772009-01-22T08:36:00.000-08:002009-01-22T08:36:00.000-08:00This is an interesting topic.To the claim litigati...This is an interesting topic.<BR/><BR/>To the claim litigation stifles new drug development, no it "should not" (italics do not work). That is an empty argument. It is like saying something along the lines of "We are going to bring a product to market, but if during the use of the product, a consumer is injured while using the product and it has been found that we were negligent in anyway, and are sued and the consumer wins,then we will be forced to reduce our activities on the market place." This is wrong on several fronts. A statement like the example I am giving makes me believe that the industry feels that there are too many "bogus" complaints filed and consumers are looking for "get rich quick schemes" so they, the consumer, are looking to be harmed. This conjures up the idea that there is also a complete lack of faith in our judicial system and would raise the alarm that the judicial system is incapable of discerning whether or not any claim of rights has merit at all - scary stuff!<BR/><BR/>To the claim that litigation raises drug costs - good, let's stay with that idea. Of course it does and it should be avoided and the only way to avoid it is for complete transparency!<BR/><BR/>To the claim litigation leads to danger over warning. Can someone expound on this? what is the danger of being over warned? You will sell less of one drug, but you will be less likely to be exposed to litigation costs because the risks would have been full disclosed.<BR/><BR/>Now, what if we had universal health care? What if the consumer were not directly paying for the drug or the device. How would this change the system. If it were be funded by tax payers dollars (just think of the health care system we could have today if we had not been footing the bill for Iraq - which was a completely bogus sham and ripping off of American taxpayers, but I digress)<BR/><BR/>great topic!Former Marketinghttps://www.blogger.com/profile/00141174600868695378noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-64541625827157132312009-01-22T08:22:00.000-08:002009-01-22T08:22:00.000-08:00Anon. writes: "The assertions would have to be sup...Anon. writes: "The assertions would have to be supported to be disputed. Can the industry support their own claims?"<BR/><BR/>Exactly. To this point, I have not seen any credible studies which do support these claims, although they are made continuously (read the Levine briefs that support Wyeth - besides "chaos of conflicting standards," it is these claims that are reiterated constantly. (The "chaos" theory has even less empirical foundation, in my view).<BR/><BR/>Still, exactly because these are empirical claims, it would seem there might/must be some way to test them one way or other. <BR/><BR/>On the other hand, perhaps there are issues that are so complex, or involve so many variables, that it really is _not_ possible to prove one point or other. At that point, you end us with "faith-based policy." Is that where we are?Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-66265963118391540462009-01-22T04:25:00.000-08:002009-01-22T04:25:00.000-08:00Justice, You are looking for what is right and go...Justice, <BR/> <BR/>You are looking for what is right and good but if rightness does not benefit these companies they will find a way to make their cases for self preservation. What does each stage of drug development cost from planning to distribution and how is it more costly for a company who has recently gone through litigation. Is the additional cost in planning or in clinical trials or in actual production. It does not make sense that development costs go up because of litigation. That assertion would have to be supported to be disputed.<BR/><BR/>1. Litigation stifles new drug development.<BR/>Problem is in determining if projects did not go forth because of litigation or if the product was doomed for some mysterious internal reason. If the pipeline is there and moves are made according to plan, stifling is not occurring. By that logic, however, it would be easy enough to name a future product with no intent to pursue it, for the purpose of being able to claim any number of things from losses to litigation.<BR/><BR/>2. Litigation raises drug costs.<BR/>Litigation or no, there is no good way to dispute pricing causation information from planning through distribution.<BR/><BR/>3. Litigation leads to danger "over-warning."<BR/>There must be some truth in this if you think that one bad product caused a manufacturer to have to be more cautious with the next product. This is a good argument in favor of litigation if public safety is the main concern.<BR/><BR/>The assertions would have to be supported to be disputed. Can the industry support their own claims?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-85619802319433289672009-01-21T23:42:00.000-08:002009-01-21T23:42:00.000-08:00JusticeGreat point from Business Week on stretchin...Justice<BR/><BR/>Great point from Business Week on stretching the rules; just ask anyone who has received $1.00 as a settlement for a Mass Tort Claim against the credit card industry.<BR/>As to the studies that purport to show that increased product liability lawsuits actually decrease consumer protection; the logic seems counter intuitive. However, I am sure that prior to the rulings in Mapp, Gideon and Miranda studies showed that the population at large was much safer. Hence, less rights more individual protection, except that is from the State and their Corporate overseers. <BR/><BR/>JimKUnknownhttps://www.blogger.com/profile/10063644654105039683noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-48362456307280883002009-01-21T20:30:00.000-08:002009-01-21T20:30:00.000-08:00The following from a March, 2006, article in Busin...The following from a March, 2006, article in Business Week on "tort reform" that is relevant:<BR/><BR/>"Problem is, much of the discussion has been distorted by hyperbole from both sides. Despite the alarmism from Corporate America, most of the big verdicts that become urban legends are reduced on appeal. Nor is there authoritative evidence that plaintiffs' lawyers are weighing down the economy. This is, in part, because there are no reliable aggregate data about the system. America's network of federal, state, and local tribunals is sprawling and undigitized. Nobody knows how many cases are filed each year or how they turn out -- especially since the vast majority are settled out of court. So any macroeconomic conclusions are speculative. When Bush claims that the annual "litigation tax" in America is $246 billion, it's a guess.<BR/><BR/>To the extent that reliable data do exist, they show no signs of broad systemic breakdown. The latest statistics from the Bureau of Economic Analysis indicate that legal services accounted for less than 1.5% of gross domestic product in 2003 -- a slightly lower share than in 1990. That means the legal industry has lagged the overall economy. Such slow growth suggests that lawyers are not reaping a bonanza from winning -- and defending -- big corporate cases. Moreover, the strong productivity gains in recent years undercut the argument that rapacious plaintiff lawyers are strangling growth.<BR/><BR/>Does this mean there's no case against the tort system? Not at all. Just that the strongest evidence of plaintiffs' lawyer misconduct doesn't rest on broad economic data. Rather, the real crisis lies in the proliferation of specific types of bogus cases -- ones in which nobody has been injured, no malfeasance has occurred, or regulators have already taken care of the problem. Despite their claims of being selfless safety advocates, plaintiffs' attorneys in 2005 are analogous to chief executives in 1999: Most of the players are making an honest living. But an unacceptably high percentage of them are stretching the rules."Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.com