Drug Recall Lawyer Blog

We’ve been fielding questions lately about the cardiac stents that have been all over the news here in Baltimore. One of the inevitable questions is whether the stent is defective. There’s no indication that the stents implanted at St. Joseph Medical Center are defective—in fact, there is no evidence that the stents are of any particular brand or manufacturer. A few years back there was discussion about defective Johnson & Johnson Cypher Stents, which one Cleveland Clinic study showed to be four to five times more likely to cause blood clotting. The issue here is not one of defective stents, but rather medical malpractice.

Though it is outside the scope of this blog, it does touch close to home, happening here in Maryland. And, we’ve been fielding questions about these stents, so this is as good a forum as any. So, a little discussion.

Continue reading " St. Joseph’s Stents: Device Defect or Medical Malpractice? " »

The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

• Issues related to predicate devices;
• Issues related to new technologies and scientific evidence;
• Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
• Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

• Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
• Live webcast

Related documents:

• The FDA’s Press Release
• Notice of the Public Meeting
• Background information of 510(k) process
• Announcement of Institute of Medicine’s study of 510(k) process

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

In the wake of last Friday’s $5.5 million verdict for a pain pump patient and his wife, the media has picked up the pain pump story. Interestingly, The New York Times has an article in the Sports section, “Studies Link Rare Ailment to Pain Pumps.”

The article is in the Sports section for good reason—many of the patients whose shoulders have been ruined by pain pumps were high school and college athletes. I’ve spoken with swimmers, volleyball players, and softball players. One bowhunter I spoke to told me how humiliating it was to be hunting with his buddies, using a crossbow while they used compound bows, simply because he no longer had the arm strength to pull back the bowstring.

Continue reading " The Media’s Take On Pain Pumps " »

Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

• Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
• Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

On Friday, an Oregon state court jury determined that I-Flow Corporation (through Kimberly Clark, its parent company as of late last year) owes Matthew and Krista Beale $5.5 million for defects associated with their On-Q pain pump. The pain pump is a device used after surgery to continuously administer anesthetic (usually bupivacaine or ropivacaine-type drugs) for a few days. I-Flow heavily marketed the drug for use in the shoulder joint after arthroscopic shoulder surgeries (SLAP tear repairs, rotator cuff tears, etc…), despite numerous rejections by the FDA for that indication, because of a lack of safety information. The anesthetic used in these pumps is toxic to cartilage cells, and exposure of even one day can completely destroy the shoulder cartilage, which cannot regrow or heal itself.

Like so many other patients who received the pain pump, Mr. Beale will have to endure at least one shoulder reconstruction surgeries, potentially permanent loss of mobility, and likely constant pain in his shoulder. Mr. Beale is a 38-year old father of four. The verdict was $4.225 million to Mr. Beale, and $1.275 million to Mrs. Beale.

This is simply the first of many plaintiffs’ verdicts. There are numerous pain pump manufacturers, including Stryker, Breg and McKinley Medical. There are very few things that can cause this type of injury, making the pump an easy suspect to rule in. Furthermore, the regulatory behavior of the device manufacturers clearly indicates that they did not have the right to market the pumps for this off-label use. However, they ignored the risks and promoted the pump directly to orthopedic surgeons, who relied on the manufacturers for their expertise.

See other Drug Recall Lawyer Blog posts on pain pumps, or refer to our pain pump website for more information.

Judge Sandra Mazer Moss ruled in the Philadelphia hormone therapy cases that plaintiffs’ expert witness testimony was admissible, contrary to defendants’ assertions that the testimony was novel, and that the conclusions used by the experts relied on differential diagnosis. The Judge held that “I am not convinced by a preponderance of the evidence that differential diagnosis . . . is novel science.” FYI, differential diagnosis, a process of elimination, is a fundamental means of diagnosis taught by all medical schools. Therefore, the evidence will be admissible, and defendants may attack it in front of a jury.

The ruling applies to the majority of Philadelphia’s Court of Common Pleas hormone therapy cases. One new hormone therapy trial started yesterday, and another will commence next Monday.

Back in June (Statistics, Part I), we reported on the U.S. Department of Justice’s Civil Justice Survey of State Courts, covering 2005 state court trials. Though official statistics have not been released by the DOJ for 2006 to 2009, a recent Bloomberg article, Jurors Turned Against Companies in 2009 Product-Defect Cases, analyzes last year’s product liability verdicts through the lens of the recession and general consumer distrust of Big Business.

The reporter, Margaret Cronin Fisk, notes the following for 2009 product liability lawsuits (which were not limited to just state courts):

• The top 5 product defect verdicts were 52% larger in 2009 (at $620 million), as compared to 2008
• The largest 2009 product defect verdict was for $300 million (Altria’s Philip Morris was the defendant in tobacco litigation)
• 5 of the 50 largest verdicts in 2009 were for defective products (compared to only 1 in 2008)
• In 200, 10 of the 50 largest verdicts were for defective products.

In 2005 state courts, there were 346 product liability trials, 28 of which were for drugs or medical devices. Excluding asbestos cases, plaintiffs won 19.6% of product liability trials in 2005. Also interesting, is that in 2005, 10.2% of all tort cases in Philadelphia were product cases (this is a trend that likely continues, in large part because of the hormone therapy cases). The only other county with a higher percentage was San Francisco, at 12.7%.

I’d love to get my hands on the raw data used by the DOJ—it would be interesting to compare the largest product liability verdicts from pre-recession 2005 with those reported by Bloomberg for 2009. That data must be on the internet somewhere…

Bisphenol-A (BPA) is a chemical used in production of polycarbonate plastics and epoxy resins, and until recently it featured largely in baby bottles. In 2008, the public consciousness was flooded with reports that BPA leeches from bottles into liquid (more or less, depending on the temperature of the liquid). Other reports have indicated the potentially dangerous effects of BPA. In April of 2008 the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (part of the National Institutes of Health) drafted a brief concluding that exposure may affect human development (including early puberty, prostate gland changes, behavioral changes) or reproduction.

The concern for babies is that they have potentially the highest BPA intake—on a pound-for-pound basis, they consume more than adults and additionally suck on plastic items that increases the risk of exposure. In rodent tests, there is evidence that young animals cannot metabolize the chemical as efficiently, and therefore have higher concentrations in their blood.

While the FDA was initially lukewarm about BPA concerns, it has raised the temperature of its response by announcing last week that “on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.” Read the full FDA update here.

Other studies, however, have refuted any harmful causes of BPA, including one from the Environmental Protection Agency.

On the litigation front, MDL 1967: In Re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation was transferred to the U.S. District Court for the Western District of Missouri (Judge Ortrie D. Smith) on August 13, 2008. The allegations against bottle manufacturers and baby formula manufacturers (retailers were dismissed) at time of transfer were that BPA is toxic, and may cause cancer. In November of last year, the judge dismissed all of the formula defendants and ordered the parties to submit dates for completion of discovery, filing of motions for class certification, and other motions.

Whether this is overly paranoid or not, most people (especially parents) are taking the safe road, and avoiding baby products containing BPA.

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

The 406 YAZ, Yasmin and Ocella cases filed or transferred to the Southern District of Illinois before Judge David R. Herndon are proceeding apace.

The Judge has been primarily concerned with case management and establishing procedures that will guide the litigation through to completion, including potentially bellwether trials (early trials that can reveal case strengths and weaknesses as viewed by juries, and which often promote settlement). Also on the Judge’s list has been finding a way to deal with several of the foreign entities. In litigation where foreign entities are involved (in this case, the Germany-based Bayer has several corporate offshoots), service is oftentimes required to be done following procedures set in the Hague Convention, which can include translating documents to the foreign language at issue. (Judge Polster dealt with this in the Gadolinium litigation, and decided that after the translation and service of one complaint following Hague guidelines, formal adherence to those rules were no longer necessary). The Docket of the YAZ cases is here—there are 393 filings to date, with most of them being the opening of “member cases.” Member cases are cases received from other federal courts, transferred to the Southern District of Illinois through MDL protocols. You can also see the following documents:

• Minutes of the December 17, 2009 status conference
• Protective Order, as codified in Order 7 by the Court

For more information on the YAZ, Yasmin and Ocella litigation, see prior Drug Recall Lawyer Blog postings, and see our YAZ injury website.

A number of news outlets have reported Ralph Tyler’s switch as Maryland insurance commissioner head of the Maryland Insurance Administration to his new position as top dog in the FDA’s legal department (Law.com, Maryland Lawyer Blog, Maryland Daily Record and FDA Law Blog).

While in his post as the insurance commish for Maryland (since September 2007) he fought over the compensation package for CareFirst BlueCross BlueShield’s former CEO, William Jew. Tyler cut the compensation down from $18 million to about $9 million (that decision was overturned by the Baltimore County Circuit Court in November—the agency has filed a notice of appeal). He also managed to return about $100 million ($13.8 million to the doctor-policyholders, and $84.1 million to the state of Maryland to make up for subsidies that slowed years of malpractice insurance rates) from Medical Mutual Liability Insurance Society of Maryland. To much fanfare in Maryland, he helped to crush a proposed 72% rate increase by Baltimore Gas & Electric.

But, he left all of that behind last week, and is expected to formally start at the FDA on January 19, replacing interim General Counsel Mike Landa. No word yet on what Tyler’s plans for the FDA are—at this point, he states that he is planning to assess the agency’s needs, and go from there. He’s a smart guy, and he has a good track record—I’m sure the FDA and consumers of drugs and medical devices will be well-served.

Here are some of the stories we’re following this week:

• Janumet: Shearlings Got Plowed reports that the FDA is revising the label for Janumet to warn about pancreatitis. A link to the FDA’s prescribing information is here
• Seroquel: Tom Lamb reports on the difficulties that plaintiffs are facing in these cases, of late. It seems that the odds are against us and the situation is grim—a good time for a reversal
• Prempro: NPR reports on the marketing masquerading as research by drug-makers trying to profit from menopause
• Levaquin: The Mass Tort Defense blog reports on the status of the bellwether trials: consolidation rejected
• Conflicts of Interest: The New York Times reports that Pfizer gives $3 million to Stanford University for creation of continuing medical education courses, where Pfizer has no say on what the money is spent for. Does this prevent conflicts of interest or is it “self-satirizing?”

Happy Monday!

The Associated Press reports yesterday's decision by the 8th U.S. Circuit Court of Appeals (St. Louis) that overruled a 2008 federal district court opinion precluding remand of hormone therapy suits to Minnesota state court. The appellate court also held that the dismissal of lawsuits then pending in Little Rock was erroneous. The holding was premised on jurisdictional grounds--the cases, pending in state court, could not properly be dismissed by the federal judge. This ruling gives hope to over 100 women and their families who have thus far been precluded from their day in court.

The full opinion is available on the court's website.

Tom Lamb and the Drug Injury Watch have a good article on the selective information given by Amylin Pharmaceuticals about their diabetes drug Byetta (co-marketed with Eli Lilly) to the media and their investors in October, 2009. Apparently, they released the good information that the FDA approved it as a stand-alone medication for adults with type 2 diabetes. The only caveat was that the labeling would have to warn about the risk of pancreatitis in patients with severe kidney disease.

At the end of December, however, when the FDA letter to Amylin was obtained, a more complete picture emerged. It seems that the FDA also required human and animal studies to further investigate the risk of pancreatitis “to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and acute renal failure.” These additional studies are necessary because “an analysis of spontaneous postmarketing adverse events reported . . . will not be sufficient to assess the signal of a serious risk of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis, and the signal of a serious risk of thyroid neoplasms.”

See also the Bloomberg article on the selective information given by Amylin, which goes into more detail about the effects on Amylin’s stock prices.

For more information on Byetta, see previous posts of the Drug Recall Lawyer Blog, and our website. Of course, please contact us for more information or a free case evaluation.

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The FDA is making temporary recommendations about Perfusion CT scans. We first wrote about the concern of excessive radiation exposure in our December 16, 2009 post.

The recommendations include:

• Facilities assess whether patients who underwent CT perfusion scans received excess radiation
• Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
• Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered
• Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient
• If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study

Additionally, manufacturers of the scanners should reevaluate their training manuals and procedures, and improve surveillance systems to more quickly identify problems with particular machines or in particular hospitals.

Of course, it’s very important that patients take their own safety into their own hands, and ask specific questions when receiving any type of scan involving radiation. See the American College of Radiology’s website for more information.

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

Continue reading " Pennsylvania Appellate Court Overturns JNOV In Hormone Therapy Case " »

It’s going to be a great year. If one of your new year’s resolutions is to follow industry news more closely, here’s some required reading:

• Hormone Therapy: Bloomberg reports on the latest Plaintiff’s Prempro victory (actually, the drug at issue here was Provera, later combined with Premarin by Wyeth to make Prempro)—a Pennsylvania appeals court ruled that the trial court wrongly granted judgment for defendants, notwithstanding a jury verdict for Plaintiff. We’ll report more on this later in the week.
• Conflicts of Interest: The New York Times notes that two Harvard Hospitals (Massachusetts General and Brigham and Women’s) have issued new guidelines on outside pay for senior officials. They can now only accept a maximum of $5,000 per day of actual work—and no stock. Importantly, speaker’s fees from drug companies are prohibited for all employees. The momentum is good—let’s hope these attitudes spread.
• Res Ipsa Loquitur in a Medical Device case: We don’t usually agree with the Drug and Device Law blog, but we come as close as humanly possible in this situation—a federal judge in Connecticut dismissed a product defect case for orthopedic bone screws because (get this) plaintiff did not hire an expert. Maybe plaintiff could not find an expert (in which case, the case probably should not have been filed), or maybe the plaintiff could not afford an expert in a tentative case (in which case, you get what you ask for). This world is too complicated to do without experts.
• FDA Fails to Learn: MSNBC reports that the suggestions of congressional investigators following the Vioxx debacle have gone largely unheeded by the FDA. That report suggested that the FDA could better detect problem drugs by giving more decision-making power to scientists who monitor drug side effects following approval.
• More Drugs For “Neglected” Diseases: The FDA Law Blog comments about the rise in drug approvals for historically neglected diseases, including malaria, kinetoplastids, diarrheal diseases, roundworm, bacterial pneumonia and meningitis, and typhoid and paratyphoid fevera. Many of these disproportionately affect third-world countries, so we’re glad to see this advancing research.

Okay—now back to work!