Drug Label Failure To Warn

This week’s U.S. Supreme Court argument in Bartlett v. Mutual Pharmaceutical (link goes to my thoughts on the case, which I posted back in December) has taken the issue of “impossibility preemption” for a brief stroll through the rest of the legal world, crossing paths with some major news outlets. Karen Bartlett was given a shot of a pain reliever, sulindac, which caused her to develop Stevens-Johnson Syndrome and toxic epidermal necrolysis so severe her burn surgeon called it “hell on earth.” There would be a handful of legal avenues available to her if she had received the brand-name drug, but, because she received a generic, there’s the looming question as to whether her State tort law lawsuit is “preempted” under the Supreme Court’s 2011 case, PLIVA v. Mensing.

A brief refresher. There are four types of “preemption,” so named when federal law trumps — i.e., “preempts” — state law.

1. Express Preemption is when Congress and the President pass a law that says States’ law on the issue are unenforceable. For example, the preemption clause of ERISA, 29 U.S.C. § 1144, “the provisions of this title … shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan …”

2. Impossibility Preemption is when Congress has not passed any law preempting State law, but “where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963).

3. Conflict Preemption occurs where Congress hasn’t passed a law preempting State law, and where it’s possible to comply with both, but “under the circumstances of [a] particular case, [state] law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

4. Judicial Activism Preemption happens when a judge, or the majority of judges on a federal appellate court, don’t like a particular State law and so make up a reason to get rid of it. No, the courts themselves don’t call it that, they typically call it “impossibility preemption.” This is my term for it.

In the Bartlett case, just like in every other pharmaceutical liability case, there’s no express preemption. In the 80 years since the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress has never once saw fit to preempt State law lawsuits against brand-name or generic drug manufacturers.

In 2011, a slim majority of the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) applied what I call Judicial Activism Preemption under the guise of impossibility preemption, and made up a reason to blow up the majority of lawsuits against generic drug manufacturers. I wrote more about it here. Law professor Leslie Kendrick recently wrote about how problematic impossibility preemption is in the conduct of pharmaceuticals in general.

Mensing involved a “failure to warn” claim — i.e., an allegation that the drug’s warning labels didn’t adequately disclose the drug’s real risks — and the Supreme Court held those claims were preempted. Bartlett on the surface involves a pure strict liability claim — i.e., a claim that the drug is simply unreasonably dangerous given the minor benefits it has compared to the serious risks — and then in the details involves a number of complicated factual and legal issues, including the strange decision by the defendant to waive most of its defenses, complicated issues that, to me, should have caused the Supreme Court to decline the case for consideration.

Be that as it may, the oral argument (transcript here) revealed a lot about the true nature of preemption and the Justice’s thoughts.
Continue Reading Impossibility Preemption, Strict Liability, And The Troll Supreme Court Justice

[Update, June 24, 2013. The Supreme Court ruled against Karen, holding, in essence, that generic drug companies have no responsibilities whatsoever to patients.]

I’ve written before about the United Supreme Court’s dismal PLIVA v. Mensing opinion. Although Justice Scalia recently co-wrote a book on legal interpretation that admitted that a basic principle of federalism is that “a federal statute is presumed to supplement rather than displace state law,” he had no trouble joining Justice Thomas’ opinion finding “implied” pre-emption of all state tort lawsuits that alleged  generic drug manufacturers failed to adequately warn about their product’s risks.

Nevermind that Congress had never passed any statute restricting state torts against generic drug manufacturers; the FDA itself had no problem with the state tort lawsuits, and indeed filed a brief in favor of the injured plaintiff; that the American Medical Association and 42 States supported the plaintiff. The case was, to put it mildly, “result-driven.”

That’s old news (Professor Bernabe’s Torts Blog has been following the fallout), but PLIVA v. Mensing is back in the spotlight: the Supreme Court has granted certiorari in Bartlett v. Mutual Pharm. Co., Inc., a First Circuit Court of Appeals opinion in a generic drug case from earlier this year that was one of the very few bright spots in the darkness created by PLIVA v. Mensing. Pharmaceutical defense lawyers have written endlessly in the abstract about Bartlett (like here and here and here), claiming that it conflicts with PLIVA and that the Supreme Court would reverse. I, of course, don’t agree with PLIVA and so, of course, don’t think Bartlett’s claim should be pre-empted; whether the Court in Bartlett mis-applied PLIVA is another matter.

But before we get there, I frankly think that no discussion of the case is complete without talking about the extraordinary facts of the case. Cases aren’t just names on a page, they’re real people, often with real injuries. 
Continue Reading Will The Supreme Court Cheat The Woman Living In “Hell On Earth”?

[Update, March 2013: I originally wrote this post in December 2012. Three months later, the FDA announced it “is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.” Several news agencies ran with the news, including AP and Bloomberg, as did some pharma industry bloggers. The JAMA Internal Medicine medical journal ran a column urging more research into the link between the drugs and pancreatic cancer, an article with a concerning, but perhaps harmless, revision after it was published. We think the latest attention and research makes the case against these drugs even stronger, and we’re moving forward in our own litigation.]

Diabetes is a global epidemic, affecting over 25 million Americans and ten times that worldwide. That also makes it an economic opportunity: the diabetes control medication market is worth more than $40 billion in the United States alone. There are thirteen types of approved Type 2 Diabetes medications on the market today (comprising over two dozens drugs), with another seven therapies in various stages of research and development. There’s big money to be made, if you’re a pharmaceutical company — hence the recent advertising push for Januvia, Byetta, and Victoza (the one Paula Deen endorses), relatively new entries to the overcrowded diabetes control market.

I’ve discussed before on this blog how one of the biggest public health problems in America is the pharmaceutical industry’s reliance on the “blockbuster” drugs that exceed $1 billion in annual sales. The whole industry, from research, to clinical trials, to physician education, is oriented around creating and promoting drugs that will become household names — to the exclusion of other useful medicines and to the detriment of patient safety. A year ago, I wrote about why Merck still didn’t admit Propecia caused persistent erectile dysfunction more than eight years after competent research showed the problem. The reason is quite simple: Propecia / Proscar was routinely bringing in more than half a billion dollars a year for Merck, and they wanted to keep it going for as long as possible.

Which brings us to Januvia, a drug that stock market analysts call a “real success story” for Merck. The Type 2 Diabetes market is huge, and Januvia (marketed as “Janumet” when mixed with metformin) has captured 75% of the dipeptidyl peptidase 4 (DPP-4) inhibitor market — for $4.6 billion in revenue in 2011 and likely topping $5 billion this year. It’s not hard to see why Januvia and other DPP-4 drugs have been successful and their sales are growing. They’re a one-a-day pill, not a shot, they haven’t been shown to cause weight gain, and they have a lower incidence of the nausea, abdominal pain, and digestive problems that characterize most diabetes treatments.

But there’s a big problem brewing.
Continue Reading Do The Drugs Januvia, Byetta and Victoza Cause Pancreatic Cancer?

Last week, our firm blog posted a short note about how Actos patients with bladder cancer in Kentucky, Louisiana, and Tennessee should move quickly to file because those states have a one-year statute of limitations for personal injury actions. We (and a whole bunch of other lawyers) assume that Takeda Pharmaceuticals will argue that the statute of limitations began to run on June 15, 2011, when the FDA issued an updated warning that one year of Actos use increases the risk of bladder cancer by more than 40%.

As if on cue, the next day Pfizer moved for summary judgment on a whole swatch of consolidated Chantix neuropsychiatric lawsuits (not to be confused with the SSRI birth defect lawsuits), arguing that the statute of limitations for those claims began to run on July 1, 2009, when the FDA mandated the box for the medication warn that the medicine was associated with “serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide …”  On that day, Pfizer also sent out a “Dear Healthcare Provider Letter” notifying prescribing physicians about the change, and there was also some media coverage. 
Continue Reading When Should The Statute Of Limitations Run For Medication Lawsuits?

As I’ve written before, anti-consumer legislators and judges have so thoroughly eviscerated claims against pharmaceutical companies that in most states there’s only a single claim left: the claim that brand-name drug manufacturers failed to warn about the risks of the drug. For example, the IUD Mirena causes pseudotumor cerebri, but the label says nothing about that.

As long as the company warned about the risks of the drugs, they’re essentially immune from liability, even if the drugs weren’t properly tested, even if they were deceptively marketed, and even if the drug didn’t perform as promised. (Sometimes state and federal attorneys general can sue over drugs that were falsely marketed, like how Johnson & Johnson was just walloped for $1.2 billion in Arkansas for improper marketing of Risperdal, but consumers can’t, because those same legislators and judges have delivered mortal wounds to most consumer class actions.)

A slim 5-4 majority of the Supreme Court disappointingly killed the vast majority of generic drug liability last year with PLIVA, Inc. v. Mensing (#1 on my list of most unfair drug and medical device court opinions). Manufacturers of the brand-name drugs that are still under their patents could kill almost all of the rest the litigation if they just bothered to warn consumers about the real side effects of their drugs. But they won’t. As I wrote in November about Propecia, the pharmaceutical industry is simply too dependent on blockbusters and marketing, and so try to squeeze every penny out of each drug, patient safety and lawsuits be damned.

That is, of course, until the FDA awakens from its slumber every now and then and makes the companies fix their labels. Just last week, the FDA released two prescription drug label changes, one for Propecia, another for Beyaz, Safyral, Yasmin and Yaz.

Propecia (new label here, FDA release here) will warn about “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug” with the patient insert noting “reports” of “difficulty in achieving an erection that continued after stopping the medication,” the same sexual side effects in the consolidated lawsuits in New Jersey.

Yasmin / Yaz (new label here, FDA release here) will warn about blood clots or, in the uniquely hand-wringing way drug labels describe deadly risks, it will warn that:

[S]ome epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.

Yasmin’s patient insert is more informative than the warning label itself, noting, “Like pregnancy, birth control pills increase the risk of serious blood clots … Women who use birth control pills with drospirenone (like Yasmin) may have a higher risk of getting a blood clot.”

What Bayer, Merck, and the FDA expect consumers to do with that sort of equivocation is anybody’s guess. (At least it’s better than NuvaRing, which has those same blood clotting risks only they’re twice as likely, not that the prescribing information mentions that.) Given the financial incentive drug companies have to conceal risks, and how slow the wheels turn at the FDA’s bureaucracy, it usually takes a long time for labels to be updated to show their true risks. Hundreds of Actos lawsuits have been filed, but the Actos warning label still only admits “There may be an increased chance of having bladder cancer when you take Actos,” and hundreds of Pradaxa deaths have been reported, but the Pradaxa patient medication guide says only “Pradaxa can cause bleeding which can be serious, and sometimes lead to death,” without a word discussing the lack of a reversal agent or the comparative risk to warfarin.

I raise the actual text of the labels not to address their adequacy per se, but to address another issue near and dear to my heart as a plaintiff’s lawyer: whether or not a FDA labeling change is a “subsequent remedial measure.”Continue Reading Yaz and Propecia Labels Updated; Are They Subsequent Remedial Measures?

The big shift in thinking about antidepressant use in pregnancy began in late 2005, when the FDA warned that Paxil “increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy,” and demanded  GlaxoSmithKline to change Paxil from a “Category C” drug to a “Category D” drug, i.e. a drug known to produce birth defects or injure fetuses.

In February 2006, the landmark “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn (PPHN)” study was published in the New England Journal of Medicine, showing that Prozac use in the third trimester of pregnancy increased the risk of PPHN. That study prompted the first formal SSRI FDA warning in July 2006 across the board for Celexa, Lexapro, Paxil, Prozac and Zoloft. In 2009, the British Medical Journal showed Prozac, Celexa, Paxil and Zoloft were all associated with an increased risk of congenital heart defects, particularly if a pregnant woman used more than one. In January 2012, the British Medical Journal reviewed over 30,000 pregnancies involving SSRI use and found the risk of PPHN was doubled when the baby’s mother used an SSRI. Just a week ago, the Archives of General Psychiatry published a study concluding that pregnant mothers treated with SSRIs had higher rates of premature birth and delayed infant head growth.

The risk is there, and the body of scientific research is growing, but many patients still don’t know the risks of using SSRIs in pregnancy, and today more than 5% of pregnant women take antidepressants. Other than changing the birth defect risk category of Paxil, though, the FDA hasn’t done anything to fix the situation. In December 2011 the FDA issued a drug safety communication that frustratingly said “it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.” Zoloft, Lexapro, Celexa, and Prozac are still listed as a Category C drugs, and none of them warn patients or doctors about the risk. Buried in the fine print of Prozac’s warning label there’s a reference to PPHN and congenital heart defects, but then the risk is dismissed: “There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women.” Zoloft’s warning label doesn’t even mention the possibility of birth defects except through a vague reference to studies of pregnant rats.

All told,  birth defect lawyers have probably done more to educate the public about the dangers of SSRI use in pregnancy by way of television ads than the FDA has. Which brings me to the core of this post: the increasing role of the First Amendment in drug liability lawsuits.Continue Reading Antidepressant Birth Defects and The First Amendment

This post was written for my legal blog — patients injured by Pradaxa should read my Pradaxa bleeding problems  page.

In our medical malpractice and nursing home abuse work, we see one case with disturbing frequency: warfarin overdoses. A recent CDC study confirmed that warfarin, anti-platelet medications, and diabetes control medications together accounted for a whopping two-thirds of all drug-related emergency hospitalizations of senior citizens. Errors in dosing and monitoring warfarin by health care professionals, too, account for a significant (over 1%) of medical malpractice claims. It’s a great drug, but a dangerous one.

Warfarin has a fascinating history. In nature, the molecule on which warfarin is based is produced when the plant compound coumarin — which produces the sweet smell of freshly cut grass or hay — is metabolized by fungi and then reacts with formaldehyde. (The name “warfarin” is a combination of “Wisconsin Alumni Research Foundation” and coumarin.) The chemical was first discovered by veterinarians trying to figure out what killed their cattle (they were eating spoiled sweet grass), and warfarin was literally used as a rat poison before it was used in humans.

Warfarin works in treating or preventing the deadly conditions venous thrombosis, blood clots, and pulmonary embolism by almost creating a different deadly condition: excessive bleeding. It doesn’t take much to push a patient into dangerously high prothrombin ratio (INR) levels, and so healthy patients need to have blood tests weekly or at least monthly, and hospitalized patients need to be monitored every few hours. Warfarin is thus both a wonder drug — which has saved the lives of my own family members diagnosed with pulmonary embolism — and a double-edged sword, because it causes major bleeding episodes in 3-5% of people taking it. Scientists have been trying to find safer replacements for the whole fifty years that it’s been used.

Pradaxa (dabigatran etexilate), manufactured by Boehringer Ingelheim Pharmaceuticals, was supposed to be one of those replacements. In September 2009, the initial results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study sponsored by the company were released, with the study’s authors — the bulk of whom reporting in the study “receiving consulting fees, lecture fees, and grant support from Boehringer Ingelheim” — concluding:

In conclusion, we compared two doses of dabigatran with warfarin in patients who had atrial fibrillation and who were at risk for stroke. As compared with warfarin, the 110-mg dose of dabigatran was associated withsimilar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.

Note the use of the word “similar” in the study’s conclusion. It’s not a scientific term, it’s a term of art. In fact, when the RE-LY study came out, there was already concern among the FDA advisory panel members that the drug didn’t really offer an improvement over warfarin in preventing stroke in patients with atrial fibrillation, but rather offered just a different balance of the risk of bleeding versus the risk of stroke:

“The 110-mg dose, while associated with reduced bleeding, had a 12% higher incidence of ischemic stroke,” said [advisory panel member Dr. Sanjay] Kaul. “In my opinion, it would not offer much of an advantage over warfarin and would likely be an ineffective alternative.”

Asked about the approved doses, FDA spokesperson Sandy Walsh said that FDA reviewers felt the data strongly support the 150-mg dose, noting that it was superior to warfarin on the primary end point and similar in terms of bleeding rates. In reviewing the data, FDA officials noted, like Kaul, there were numerically more ischemic strokes in the dabigatran 110-mg arm when compared with warfarin, and this dose was only statistically noninferior to warfarin in terms of efficacy.

In other words, a 110-mg dose was substantially less effective than warfarin in reducing strokes, while the 150-mg reduced strokes but had the same bleeding rates as warfarin.

On the surface, that makes it sound like Pradaxa is an improvement over warfarin, but it’s not the whole story. 
Continue Reading Pradaxa Bleeding Lawsuits Begin; Still No Reversal Agent Available

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

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

[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like ActosPradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
Continue Reading The Unintentional Message Of The “Worst” Drug And Device Court Opinions