Published By: Maxwell S. Kennerly, Esquire

Consumer Protection

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Over at Abnormal Use, insurance defense lawyer Stuart Mauney says something careless:

[W]hile I was eating those yummy, yummy peanuts, I noticed this disclaimer written on the container: “CONTAINS PEANUTS.” Really? I thought I was eating lima beans! Given that I had now seen the word “peanuts” written sideways, upside-down, and in six different languages, I decided to read further: “Manufactured on shared equipment in a facility that processes peanuts.” There it is again! Peanuts. (By the way, with whom do they “share” their equipment?)

You know what this means? Sometime, somewhere, somebody ate some peanuts that he did not know were peanuts, became ill, and almost died. Then he hired a lawyer. … Of course, consumers must be adequately informed of a product’s features and tendencies. But, come on, now! I really did know I was not eating lima beans. I don’t even like lima beans.

Yes, that old saw: blame the plaintiff’s lawyers for the evils of harmless labeling. Philip K. Howard has made a whole career out of claiming unnecessary warning labels are a cancer on American society, and has used silly anecdotes about peanuts and fishing lures to advocate laws that would provide complete legal immunity to companies that, you know, actually give Americans cancer. E.g., here he is moaning about people given cancer by asbestos. George Will is also fond of this idiocy, blaming warning labels for all the problems in our society.

You know what a “CONTAINS PEANUTS” label really means?
Continue Reading Why A Container Of Peanuts Says “CONTAINS PEANUTS”

It’s déjà vu all over again. Remember how, three years ago, Pfizer paid $2.3 billion to the Department of Justice to settle off-label claims relating to Bextra and other drugs, and Eli Lilly paid $1.4 billion for Zyprexa marketing?

If so, then last week was no surprise: GlaxoSmithKline agreed to pay a whopping $3 billion to settle criminal and civil charges brought against it by the Department of Justice. Quoting from the DOJ press release, GlaxoSmithKline was accused of:

  • distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18,
  • GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.
  • GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents.
  • GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.
  • GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends.   The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.
  • GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile … GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks.
  • GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs [Paxil, Wellbutrin, Avandia, Advair, Lamictal, and Zofran] as well as the drugs Imitrex, Lotronex, Flovent and Valtrex.

Let’s call GlaxoSmithKline what it is: a criminal enterprise. GSK didn’t miss the finer points of a couple red-tape regulations: the DOJ alleged they tampered with scientific studies, concealed safety data, then lied to doctors and patients and, if that didn’t work, outright bribed the doctors. Why?
Continue Reading The Big Pharma Business Model: Deception And Bribery

Have you ever seen a commercial on TV, or heard a commercial on the radio, or read an advertisement in a magazine, or saw a commercial on a website, for a prescription drug?

Of course you have, if you’re in the United States (or New Zealand — the rest of the modern world bans the practice). You see them all the time. Why? Because, as io9 profiled extensively, “For every dollar spent on ads for drugs, over four dollars in retail sales are garnered. A May 2011 study showed that new drugs that feature direct-to-consumer advertising are prescribed nine times more than their new counterparts that lack consumer advertising.” Billions of dollars are spent on ads to patients to convince them (1) to “ask your doctor about” whatever medication is most profitable and lobby for it based on the advertising and (2) to choose the medication over other available options.

There’s nothing novel or even disputable about that, but try pointing out the purpose and effect of prescription drug advertising to the Supreme Courts of the three dozen or so states — including most of the large population states like California, New York, Florida, Illinois, Pennsylvania, Ohio, Michigan, and so on — that have followed some version of the “learned intermediary doctrine.” (Only one court, West Virginia, has expressly rejected the doctrine, in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913–14 (W. Va. 2007)). Texas formally joined the ranks of learned intermediary courts about two weeks ago. LexisNexis summarizes here, there’s some defense oriented coverage here and here and here, and I haven’t seen any plaintiff’s comment (but feel free to email me).

Under the most basic version of the learned intermediary doctrine, prescription drug users are considered by law to be lab rats who have no say in what their doctor prescribes and have no ability to turn the medication down. More formally, the doctrine provides:

 (1) that manufacturers of prescription drugs and medical devices discharge their duty to of care to patients by providing adequate warnings to prescribing physicians, and (2) that any failure to warn cannot be considered a proximate cause of a subsequent injury if the physician was fully aware of the dangers that would have been included in an alternative warning.

Greaves v. Eli Lilly, 2011 U.S. Dist. LEXIS 129443 (E.D.N.Y. Nov. 8, 2011). In Greaves, a man developed diabetes as a result of 9 years of Zyprexa use. Six years into his Zyprexa use, the doctor learned Zyprexa could cause diabetes, and continued prescribing it. When the doctor was later asked if knowing Zyprexa could cause diabetes would have changed anything about his interactions with the patient or his prescription, the doctor said no, he would have prescribed it just the same, regardless of the warning and regardless of how his patient felt about that, even though Abilify — which the patient was eventually moved to once he was diagnosed with diabetes — would have worked just as well. That’s when the learned intermediary rule came into play: because the doctor said he wouldn’t have done anything different if the doctor had known about the risk of diabetes, the plaintiff’s testimony was irrelevant, and so the plaintiff’s claim was dismissed.

There are thousands of cases like Greaves. Consider Wendell v. Johnson & Johnson,  2011 U.S. Dist. LEXIS 144437 (N.D. Cal. Dec. 15, 2011), where a young man developed hepatosplenic T-cell lymphoma (and died from it) as a result of irritable bowl syndrome medications. When the young man was diagnosed with lymphome, his treating doctor didn’t even suspect the medications — but not long after the man’s death, the doctor stopped giving that therapy to patients. Under the learned intermediary doctrine, it didn’t matter: the doctor didn’t emphatically state that he would have changed everything in response to an adequate warning, and so “Plaintiffs lack evidence that any further warning regarding the use of 6-MP, such as a warning about its use in combination with Humira, would have changed the manner in which Dr. Rich treated Maxx.”

It’s a bad rule, a sleight of hand that allows the prescription drug company to avoid liability for misleading prescription drug users by pointing the finger at their doctors. All a doctor has to say — and we’ll get to why they would say this in a moment — is, “a better warning wouldn’t have changed my prescribing decision” and, poof!, the plaintiff’s case vanishes. The whole case is decided without even considering whether the defendant drug company had warned the patient — the one who, at all times, had the final say on whether or not they actually took the medicine — about the real risks. 
Continue Reading The Learned Intermediary Doctrine And Dollars For Docs

It’s like a question you would ask on a law school exam, except that it’s too easy. Consider these facts: A patient is considering whether or not to have a medical device surgically implanted. The patient is given a “user guide” before their surgery which says the implant is warranted to be free of defects for one year. Before the surgery, the patient also talks with a sales representative for the medical device manufacturing company, who says that a critical part of the implant is “guaranteed to last at least ten years.” Six months after the surgery, the patient’s symptoms come back, and so they have a surgery to remove the device. The device is sent back to the manufacturer, which confirms the implant failed because the critical part was defective.

The patient sues the manufacturer. What result?

As every law student who took Contracts and every lawyer who passed the bar can tell you, the above is a classic example of a “breach of warranty.” The manufacturer issued a written warranty and their sales representative (who was the “Territorial Manager,” and thus management-level, too) “guaranteed” even more. The result should be summary judgment entered by the court in the plaintiff’s favor, because there’s no genuine dispute that the manufacturer failed to live up to its own written warranty (the existence of the oral guarantee, unless admitted by the representative, goes to the jury).

Alas, that’s not how it usually turns out, because we’re talking about medical devices, where we don’t apply any of the same legal rules that apply to you, me, or the vast majority of smaller businesses in America. Like with prescription drugs, the judicial activists on the Supreme Court have bent over backwards to shield medical device manufacturers from any responsibility for their actions, frequently twisting the words of Congress — sometimes outright inventing Congressional statutes that don’t exist, like in PLIVA, Inc. v. Mensing — to protect medical device and implant manufacturers.

What seems like a plain-as-day breach of warranty case thus turns into an almost insurmountable challenge when a medical device is involved. In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),

In 1996, Charles Riegel underwent angioplasty to dilate his coronary artery. During the procedure, Riegel’s doctor ultimately inserted the Evergreen Balloon Catheter into Riegel’s artery and inflated the device several times, up to a pressure of ten atmospheres. On the final inflation, the Evergreen Balloon Catheter burst, and Riegel began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. Riegel survived, but suffered severe and permanent personal injuries and disabilities.

If there’s anyone who deserves compensation, it’s someone who, while unconscious in surgery, is horribly injured by a defective medical product that exploded while being used properly. But that’s not how the Supreme Court saw it. 
Continue Reading A Rare Medical Implant Breach of Warranty Preemption Win

The transvaginal mesh implant erosion litigation continues to move forward, with an interesting ruling last week. In short, Judge Carol Higbee, who is presiding over the consolidated In re Pelvic Mesh/Gynecare Litigation in New Jersey state court, denied Ethicon and Johnson & Johnson’s motion to keep a number of “product and regulatory related” documents confidential. We already knew, thanks to the FDA’s warning last year, that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare,” and that the FDA’s Obstetrics & Gynecology Devices Advisory Committee was trying to figure out what the real risks and benefits were, but now the public and medical researchers might get a glimpse at the best source of data on the most common meshes out there: the Gynecare Prolift, TVT Sling, and Gynemesh Prolene.

To understand why that’s a big deal requires a bit of background. As the Supreme Court of New Jersey has explained, “the universal understanding in the legal community is that unfiled documents in discovery are not subject to public access.” Estate of Frankl v. Goodyear Tire, 853 A. 2d 880 (2004); compare Keddie v. Rutgers, The State Univ., 148 N.J. 36, 51, 689 A.2d 702 (1997) (distinguishing between filed and unfiled discovery, holding that “[o]nce the records and documents were filed with courts . . . without being sealed, Rutgers no longer retained any expectation of confidentiality in them”). Then again, “a person’s desire for confidentiality is not honored in litigation. Trade secrets, privileges, and statutes or rules requiring confidentiality must be respected, see Fed.R.Civ.P. 45(c)(3)(A)(iii), but litigants’ preference for secrecy does not create a legal bar to disclosure.” Gotham Holdings, LP v. Health Grades, Inc., 580 F. 3d 664 (7th Cir. 2009).

Summing up, documents that are “filed” in discovery — meaning they were attached to some court filing or another — are public record, while documents that were produced to the other side but had no reason to make it in front of the court are assumed to remain private, with the exception being for trade secrets and records that are by law meant to be confidential, which can remain private even if they would’ve otherwise become public due to the document being “filed.” It’s confusing, and, despite the New Jersey Supreme Court describing it a “universal understanding in the legal community,” it’s also not how a lot of judges see it: I have had more than one judge tell me that they presume all materials produced in discovery to be public, even if the documents haven’t yet been “filed” the court.

That’s the law, but here is how it works in practice.
Continue Reading Court Rules Johnson & Johnson’s Data On Gynecare Mesh Injuries Not Confidential

Two weeks ago, NBC’s Rock Center aired an investigative report questioning the safety of the Common Fire Control of over 20 million Remington firearms, including the best-selling Sportsman 12 shotgun, the 870 shotgun, and the 742 semi-automatic rifle. About two years ago, CNBC did a similar report on the Remington Model 700 bolt-action rifle. Odds are, if you’ve ever been out with anyone shooting a rifle or a pump shotgun, you’ve been around one of these. If you’re in law enforcement, then you’ve been around them on a weekly basis.

And there’s a big problem with them. A thousands of complaints and over one hundred thirty-five lawsuits problem. These firearms go off without the trigger being pressed, even when the safety is on.

As a plaintiff’s lawyer, seeing a news story about problems with Remington gun misfires is like seeing a story on the dangers of old tires: it’s not news to us, it’s something we talk about frequently, and litigate often as well. The trial lawyers association has a whole litigation group dedicated to firearms and ammunition dangers.

I’m not as familiar with the shotgun issues, but Remington Model 700 misfire lawsuits are so common that lawyers can practically cut-and-paste the relevant pleadings and briefs. (If you’re a lawyer representing a Remington malfunction victim, be sure you read this brief on similar incidents from the Montes case.)

The problem is simple, but takes a minute to explain. The Model 700 (and its variants, the ADL, BDL, CDL, and Safari, as well as the newer Model 710 and Model 770) is based on Merle H. Walker’s “firing mechanism” patent 2,514,981, patented in 1950. In the design, the trigger the operator sees isn’t really the trigger — the real trigger is a piece called the “connector” that’s inside the gun and held against the trigger by a spring.

As Jack Belk explains,

The Remington-Walker’s ‘trigger’ is not the piece you put your finger on. The part that acts as the trigger under the sear is actually the connector which is ‘flexibly connected’ to the trigger body. The trigger return spring pushes the connector which then pushes the trigger body into position under the sear. The connector offers a complication that is not needed in the trigger. The addition of the connector only adds to the complexity of what is a very simple and amazingly reliable mechanism when its parts are limited to only what’s necessary to do the job.

Is a mechanism that’s called upon to return one lever with one spring more reliable than a spring pushing on an intermediary part and then the lever? Of course it is. The fewer parts, the simpler the mechanism, especially when dealing with simple levers. With the re-positioning of the trigger-connector required after each shot, in the presence of recoil and powder residue and debris, the answer becomes even more certain. More parts means more complications without benefits.

Those “complications” cause a couple problems in the actual use of the Remington Model 700, which Remington itself broke down into Fire on Bolt Closure, Fire on Bolt Opening, Fire on Safe Release, and Jar Off. “Jar Off” is a standard industry term for a firearm discharging when struck or dropped. The rest mean what you think they mean: someone was opening or closing the bolt, or simply releasing the safety when, boom, the gun went off. 
Continue Reading Defective Remington Triggers Under Fire Again, Still Not Recalled

Some of the largest drug companies in the United States are based in, of have their U.S. headquarters in, New Jersey — e.g., Johnson & Johnson is in New Brunswick, Merck is in Whitehouse Station, Roche is in Nutley, Barr (now owned by Teva) is in Montvale, Sanofi is in Bridgewater — and so New Jersey state courts are home to a huge volume of pharmaceutical injury litigation.

There’s so many Accutane (Roche) and Fosamax (Merck) cases they’re deemed a mass tort, and there’s a good chance that Propecia (Merck) might end up as one, too. Same goes with a large number of the vaginal mesh erosion cases, because Ethicon / Gynecare are made by Johnson & Johnson, and C.R. Bard is in Murray Hill. (But not the two new huge drug cases: Boehringer Ingelheim, maker of Pradaxa, is in Connecticut, while Takeda, maker of Actos, is in Illinois.)

All of which to say is: when the New Jersey Supreme Court releases a new drug or medical device opinion, it’s a big deal. A thousands-of-cases big deal.

There’s thus been a lot of anticipation surrounding the Court’s opinion in Kamie S. Kendall v. Hoffman-LaRoche, Inc., et al., which was decided Monday. The opinion is here. Some reporting has already come out at Pharmalot, and there’s commentary from the mass torts defense firms Ballard Spahr and Dechert (I’ll get that in a moment).

Kendall is an Accutane case, in which the plaintiff developed inflammatory bowel disease (apparently both ulcerative colitis and Crohn’s Disease; her symptoms were so severe she had her colon removed) as the result of Accutane. A jury awarded her $10.5 million back in 2008, then the case then went into a complicated appellate posture. Roche argued (1) that the case should have been barred by the statute of limitations and (2) that its defense was unfairly prejudiced by the trial court’s restriction on the way the parties could present the number of adverse case reports as evidence that Roche acted too slowly in responding to reports that Accutane caused IBD. The New Jersey Appellate Division held the case was filed within the statute of limitations, but nonetheless ordered a new trial on the adverse case reports issue.

The New Jersey Supreme Court then granted an appeal on only the statute of limitations issue. It was a bit of a “head’s you lose, tails I win” situation for the plaintiffs: if they lost in front of the New Jersey Supreme Court, they lost for good, whereas if they won they still had to go through a retrial to fix the adverse events issue. I don’t fault the New Jersey Supreme Court for that — it’s appropriate for Supreme Courts to cherry-pick issues from cases — but I mention it to further dispel tort reform myths that these types of cases are easy money for injured patients and trial lawyers. Kendall’s lawsuit was filed in December 2005, and now, seven years later, neither she nor her lawyers have been paid a dime, and they still have to go through another trial where they could lose.

So let’s move to the big issue in the Kendall case. New Jersey, like every state, has a statute of limitations for negligence and product liability lawsuits, and also has an exception called the “discovery rule” for cases where the plaintiff didn’t learn until later that their injury could have been the result of negligence. The rule is:

Those considerations [of fairness] comprise the so-called “discovery rule,” the goal of which is to avoid [the] harsh results that otherwise would flow from mechanical application of a statute of limitations. Accordingly, the doctrine postpones the accrual of a cause of action so long as a party reasonably is unaware either that he has been injured, or that the injury is due to the fault or neglect of an identifiable individual or entity. Once a person knows or has reason to know of this information, his or her claim has accrued since, at that point, he or she is actually or constructively aware of that state of facts which may equate in law with a cause of action.

Caravaggio v. D’Agostini, 166 N.J. 237, 245 (2001). 
Continue Reading New Jersey Supreme Court Re-affirms Discovery Rule For Statute of Limitations in Pharmaceutical Negligence Lawsuits

As I’ve written before, as a legal matter, drug companies have it easy. Consider what drug company lawyers called their ten “best” court opinions of the past year, many of which involved courts re-writing laws to dismiss lawsuits brought by injured patients. In the notorious PLIVA v. Mensing case, a 5-4 Supreme Court tried its hardest to wash away any claims injured consumers could have against generic drug manufacturers by ruling that, as a matter of law, any lawsuit would conflict with the FDA’s regulations — even though the Supreme Court couldn’t point to any actual conflicting regulations, and even though the FDA itself said there wasn’t a problem. That’s a big reason why commercials for Actos lawsuits and Pradaxa claims are so big now: they’re still patented, brand-name drugs.

Any hopes that consumers of generic drugs would be protected by the FDA’s own oversight of generic drug manufacturing came to a crashing halt earlier this week when the Department of Justice and the Food and Drug Administration jointly announced their Consent Decree with Ranbaxy Laboratories:

Through investigation by the department and the FDA, the government uncovered numerous problems with Ranbaxy’s drug manufacturing and testing in India and at facilities owned by its U.S. subsidiary, Ranbaxy Inc. These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.

The government also determined that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed. All of these actions constituted violations of the federal Food, Drug and Cosmetic Act, making many of Ranbaxy’s drugs adulterated, potentially unsafe and illegal to sell in the United States.

As one member of the DOJ’s civil division said in the press release, “Submitting false data to the FDA in drug applications will not be tolerated.” These weren’t minor mistakes. It was a gross disregard for public safety covered up by deliberate falsifications to authorities.

And then we find out the penalty:
Continue Reading “No Tolerance” for Drug Manufacturers Fabricating FDA Data Doesn’t Mean Much

We have a fair number of hip replacement lawsuits at the firm, so we follow all of the news related to them, including last week’s article in the New York Times about “The High Cost of Failing Artificial Hips“, which included a key point that hasn’t received much attention in the press:

In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills.

I can guarantee you Mr. Dougherty’s insurer, hospital, and orthopedic surgeon don’t plan on taking payment in flowers and boxes of chocolate notes. As the article continues:

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.

While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer’s money.

“All these payers want to be paid back,” said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Perhaps it’s best to explain the situation by explaining what the New York Times means when it says Garretson’s firm “manages” product liability cases. We’ve retained Garretson’s firm in the past: they don’t represent clients in litigation, but rather assist plaintiff’s lawyers with “lien resolution,” a multi-billion-dollar industry that deserves a lot more attention from legislators in this day and age.
Continue Reading Subrogation, Where Much Of The Hip Implant Settlement Money Will Go

A few days ago I reviewed the list of “worst” pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the “best” prescription drug and medical device decisions.

The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries’ factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn’t find a federal statute or regulation in support of granting generic drug manufacturers legal immunity and so contrived an argument the Court admitted “makes little sense,” or Garza v. Merck & Co., in which the Texas Supreme Court held that it was unreasonable for a jury to agree with two cardiologists that Vioxx caused a heart attack?

As with their “worst” list, the “best” list is most interesting for what it reveals about the current state of drug and medical device company liability: heads defendant wins, tails plaintiff loses. In Mensing (#1), a plaintiff’s claim was dismissed because the Court didn’t want to speculate about what the FDA would do if a drug company proposed strengthening a warning label, while in Dobbs (#8) a plaintiff’s claim was dismissed because the Court speculated that the FDA wouldn’t accept a drug company’s proposal for a strengthened warning label. In Williams (#4), a plaintiff’s claim was dismissed because her doctors disposed of the pieces of the device in question, while in Wolicki-Gables (#6), a plaintiff’s claim was dismissed because, even though the plaintiff asked in writing for her doctors to preserve the device, a representative of the device manufacturer slipped into the surgery without the patient’s consent, took the device, lied to the patient about testing it and destroyed it, leaving the plaintiff nothing to examine or to test.

Let’s roll the tape.
Continue Reading The Most Unfair Prescription Drug And Medical Device Opinions Of 2011